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Sample records for single pill once-daily

  1. Open-Label Single-Sequence Crossover Study Evaluating Pharmacokinetics, Efficacy, and Safety of Once-Daily Dosing of Nitisinone in Patients with Hereditary Tyrosinemia Type 1.

    Science.gov (United States)

    Guffon, Nathalie; Bröijersén, Anders; Palmgren, Ingrid; Rudebeck, Mattias; Olsson, Birgitta

    2018-01-01

    Although nitisinone is successfully used to treat hereditary tyrosinemia type 1 (HT-1) with the recommended twice-daily dosing, data describing a long half-life motivate less frequent dosing. Therefore, in agreement with the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency, this study was performed to investigate the switch to once-daily dosing. This open-label, non-randomized, single-sequence crossover study evaluated the pharmacokinetics, efficacy, and safety of once-daily compared to twice-daily dosing of nitisinone in patients with HT-1 (NCT02323529). Well-controlled patients of dry blood spots by tandem mass spectrometry. The primary endpoint was C min of nitisinone after ≥4 weeks of treatment on each dosing regimen. Secondary objectives were evaluation of efficacy and safety during each dosing regimen. In total, 19 patients were enrolled and 17 included in the per-protocol analysis set. The mean (SD) nitisinone C min decreased by 23%, from 26.4 (10.2) to 21.2 (9.9) μmol/L in dry blood spot samples (not equivalent to plasma concentrations), when patients switched from twice- to once-daily dosing. There was no apparent age- or bodyweight-related trend in the degree of C min decrease. No patient had quantifiable succinylacetone levels during the once-daily treatment period, indicating efficacious treatment. All adverse events were mild or moderate and judged unrelated to nitisinone. The switch to once-daily treatment with nitisinone appeared efficacious and safe in the treatment of patients with HT-1.

  2. Legal, ethical, and economic implications of breaking down once-daily fixed-dose antiretroviral combinations into their single components for cost reduction.

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    Ramiro, Miguel A; Llibre, Josep M

    2014-11-01

    The availability of generic lamivudine in the context of the current economic crisis has raised a new issue in some European countries: breaking up the once-daily fixed-dose antiretroviral combinations (FDAC) of efavirenz/tenofovir/emtricitabine, tenofovir/emtricitabine, or abacavir/lamivudine, in order to administer their components separately, thereby allowing the use of generic lamivudine instead of branded emtricitabine or lamivudine. The legal, ethical, and economic implications of this potential strategy are reviewed, particularly in those patients receiving a once-daily single-tablet regimen. An unfamiliar change in antiretroviral treatment from a successful patient-friendly FDAC into a more complex regimen including separately the components to allow the substitution of one (or some) of them for generic surrogates (in the absence of a generic bioequivalent FDAC) could be discriminatory because it does not guarantee access to equal excellence in healthcare to all citizens. Furthermore, it could violate the principle of non-maleficence by potentially causing harm both at the individual level (hindering adherence and favouring treatment failure and resistance), and at the community level (hampering control of disease transmission and transmission of HIV-1 resistance). Replacing a FDAC with the individual components of that combination should only be permitted when the substituting medication has the same qualitative and quantitative composition of active ingredients, pharmaceutical form, method of administration, dosage and presentation as the medication being replaced, and a randomized study has demonstrated its non-inferiority. Finally, a strict pharma-economic study supporting this change, comparing the effectiveness and the cost of a specific intervention with the best available alternative, should be undertaken before its potential implementation. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiolog

  3. A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

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    Blume-Peytavi, Ulrike; Hillmann, Kathrin; Dietz, Ekkehart; Canfield, Douglas; Garcia Bartels, Natalie

    2011-12-01

    Although twice-daily application of propylene glycol-containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol-free formulation may improve efficacy and reduce unpleasant side effects. We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia. A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics. After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with "the treatment does not interfere with styling my hair" (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS. Because of differences in the formulations tested, study participants were not blinded to treatment. Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  4. Once-daily dose regimen of ribavirin is interchangeable with a twice-daily dose regimen: randomized open clinical trial

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    Balk JM

    2015-08-01

    .05. No significant differences in the hematological profile were observed (P>0.05. Conclusion: The standard twice-daily RBV regimen is interchangeable with the once-daily regimen. The once-daily regimen will improve compliance and opens the opportunity to combine RBV with other drugs dosed once a day, in a single pill. Keywords: hepatitis C, dose regimen, ribavirin, pegylated interferon

  5. Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain.

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    Taber, Louise; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

    2016-01-01

    To evaluate long-term use of Hysingla(®) ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain. This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20-120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in "average pain over the last 24 h" (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use. Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks. HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of

  6. Extended Efficacy of Once-Daily Atomoxetine in ADHD

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    J Gordon Millichap

    2004-07-01

    Full Text Available The efficacy of atomoxetine administered once daily (final dose 1.3 +/- 0.3 mg/kg; mean 44.5 mg per day; range 10-80 mg per day in the morning was assessed throughout the day, including evening and early morning, in a total of 197 children, 6 to 12 years of age (71% male, diagnosed with attention-deficit/hyperactivity disorder (ADHD (69% had combined subtype ADHD, and 35% had comorbid oppositional defiant disorder.

  7. Potential benefit of dolutegravir once daily: efficacy and safety

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    Fantauzzi A

    2013-02-01

    Full Text Available Alessandra Fantauzzi,1 Ombretta Turriziani,2 Ivano Mezzaroma11Department of Clinical Medicine, 2Department of Molecular Medicine, Sapienza, University of Rome, Rome, ItalyAbstract: The viral integrase enzyme has recently emerged as a primary alternative target to block HIV-1 replication, and integrase inhibitors are considered a pivotal new class of antiretroviral drugs. Dolutegravir is an investigational next-generation integrase inhibitor showing some novel and intriguing characteristics, ie, it has a favorable pharmacokinetic profile with a prolonged intracellular half-life, rendering feasible once-daily dosing without the need for ritonavir boosting and without regard to meals. Moreover, dolutegravir is primarily metabolized via uridine diphosphate glucuronosyltranferase 1A1, with a minor component of the cytochrome P450 3A4 isoform, thereby limiting drug–drug interactions. Furthermore, its metabolic profile enables coadministration with most of the other available antiretroviral agents without dose adjustment. Recent findings also demonstrate that dolutegravir has significant activity against HIV-1 isolates with resistance mutations associated with raltegravir and/or elvitegravir. The attributes of once-daily administration and the potential to treat integrase inhibitor-resistant viruses make dolutegravir an interesting and promising investigational drug. In this review, the main concerns about the efficacy and safety of dolutegravir as well as its resistance profile are explored by analysis of currently available data from preclinical and clinical studies.Keywords: antiretroviral drugs, HIV-1 integrase, integrase inhibitors, dolutegravir, once daily

  8. Once-Daily Radiation Therapy for Inflammatory Breast Cancer

    International Nuclear Information System (INIS)

    Brown, Lindsay; Harmsen, William; Blanchard, Miran; Goetz, Matthew; Jakub, James; Mutter, Robert; Petersen, Ivy; Rooney, Jessica; Stauder, Michael; Yan, Elizabeth; Laack, Nadia

    2014-01-01

    Purpose: Inflammatory breast cancer (IBC) is a rare and aggressive breast cancer variant treated with multimodality therapy. A variety of approaches intended to escalate the intensity and efficacy of radiation therapy have been reported, including twice-daily radiation therapy, dose escalation, and aggressive use of bolus. Herein, we examine our outcomes for patients treated with once-daily radiation therapy with aggressive bolus utilization, focusing on treatment technique. Methods and Materials: A retrospective review of patients with nonmetastatic IBC treated from January 1, 2000, through December 31, 2010, was performed. Locoregional control (LRC), disease-free survival (DFS), overall survival (OS) and predictors thereof were assessed. Results: Fifty-two women with IBC were identified, 49 (94%) of whom were treated with neoadjuvant chemotherapy. All underwent mastectomy followed by adjuvant radiation therapy. Radiation was delivered in once-daily fractions of 1.8 to 2.25 Gy (median, 2 Gy). Patients were typically treated with daily 1-cm bolus throughout treatment, and 33 (63%) received a subsequent boost to the mastectomy scar. Five-year Kaplan Meier survival estimates for LRC, DFS, and OS were 81%, 56%, and 64%, respectively. Locoregional recurrence was associated with poorer OS (P<.001; hazard ratio [HR], 4.1). Extracapsular extension was associated with worse LRC (P=.02), DFS (P=.007), and OS (P=.002). Age greater than 50 years was associated with better DFS (P=.03). Pathologic complete response was associated with a trend toward improved LRC (P=.06). Conclusions: Once-daily radiation therapy with aggressive use of bolus for IBC results in outcomes consistent with previous reports using various intensified radiation therapy regimens. LRC remains a challenge despite modern systemic therapy. Extracapsular extension, age ≤50 years, and lack of complete response to chemotherapy appear to be associated with worse outcomes. Novel strategies are needed in IBC

  9. [Effectiveness of new, once-daily 5-aminosalicylic acid in the treatment of ulcerative colitis].

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    Lakatos, Péter László; Lakatos, László

    2009-03-01

    5-aminosalicylate (5-ASA) agents remain the mainstay treatment in ulcerative colitis (UC). A number of oral 5-ASA agents is commercially available, including azo-bond pro-drugs such as sulfasalazine, olsalazine and balsalazide, and delayed- and controlled-release forms of mesalazine. In addition, the effectiveness of oral therapy relies on good compliance, which may be adversely affected by frequent daily dosing and a large number of tablets. Furthermore, poor adherence has been shown to be an important barrier to successful management of patients with UC. Recently, new, once-daily formulations of mesalazine including the unique multi-matrix delivery system and mesalazine granules were proven to be efficacious in inducing and maintaining remission in mild-to-moderate UC, with a good safety profile comparable to that of other oral mesalazine formulations. In addition, they offer the advantage of low pill burden and may contribute to increased long-term compliance and treatment success in clinical practice and might potentially further contribute to a decline in the risk for UC-associated colon cancers. In this systematic review, the authors summarize the available literature on the short- and medium-term efficacy and safety of the new once-daily mesalazine formulations.

  10. Effect of sprint training: training once daily versus twice every second day.

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    Ijichi, Toshiaki; Hasegawa, Yuta; Morishima, Takuma; Kurihara, Toshiyuki; Hamaoka, Takafumi; Goto, Kazushige

    2015-01-01

    This study compared training adaptations between once daily (SINGLE) and twice every second day (REPEATED) sprint training, with same number of training sessions. Twenty physically active males (20.9 ± 1.3 yr) were assigned randomly to the SINGLE (n = 10) or REPEATED (n = 10) group. The SINGLE group trained once per day (5 days per week) for 4 weeks (20 sessions in total). The REPEATED group conducted two consecutive training sessions on the same day, separated by a rest period of 1 h (2-3 days per week) for 4 weeks (20 sessions in total). Each training session consisted of three consecutive 30-s maximal pedalling sets with a 10-min rest between sets. Before and after the training period, the power output during two bouts of 30-s maximal pedalling, exercise duration during submaximal pedalling and resting muscle phosphocreatine (PCr) levels were evaluated. Both groups showed significant increases in peak and mean power output during the two 30-s bouts of maximal pedalling after the training period (P every second day improved OBLA during endurance exercise more than the same training once daily.

  11. Treatment of streptococcal pharyngitis with once-daily compared with twice-daily amoxicillin: a noninferiority trial.

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    Clegg, Herbert W; Ryan, Amy G; Dallas, Steven D; Kaplan, Edward L; Johnson, Dwight R; Norton, H James; Roddey, Oliver F; Martin, Edward S; Swetenburg, Raymond L; Koonce, Elizabeth W; Felkner, Mary M; Giftos, P Michael

    2006-09-01

    Two relatively small previous studies comparing once-daily amoxicillin with conventional therapy for group A streptococcal (GAS) pharyngitis reported similar rates of bacteriologic success for each treatment group. The purpose of this study was to further evaluate once-daily amoxicillin for GAS pharyngitis in a larger study. In a single pediatric practice, from October through May for 2 consecutive years (2001-2003), we recruited children 3 to 18 years of age who had symptoms and signs suggestive of GAS pharyngitis. Patients with a positive rapid test for GAS were stratified by weight (or=40 kg) and then randomly assigned to receive once-daily (750 mg or 1000 mg) or twice-daily (2 doses of 375 mg or 500 mg) amoxicillin for 10 days. We determined bacteriologic failure rates for GAS in the pharynx from subsequent swabs taken at 14 to 21 (visit 2) and 28 to 35 (visit 3) days after treatment initiation. We conducted a randomized, controlled, investigator-blinded, noninferiority trial to evaluate whether amoxicillin given once daily would have a bacteriologic failure rate no worse than that of amoxicillin given twice daily within a prespecified margin of 10%. GAS isolates were characterized to distinguish bacteriologic failures from new acquisitions. Adverse events were described and adherence was evaluated by review of returned daily logs and dosage bottles. Of 2139 potential study patients during the 2-year period, we enrolled 652 patients, 326 into each treatment group. Children in the 2 groups were comparable with respect to all demographic and clinical characteristics except that children <40 kg more often presented with rash in each treatment group. At visit 2, failure rates were 20.1% (59 of 294) for the once-daily group and 15.5% (46 of 296) for the twice-daily group (difference, 4.53%; 90% confidence interval [CI], -0.6 to 9.7). At visit 3, failure rates were 2.8% (6 of 216) for the once-daily group and 7.1% (16 of 225) for the twice-daily group (difference, -4

  12. Comparison of health care resource utilization and costs among patients with GERD on once-daily or twice-daily proton pump inhibitor therapy

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    Mody R

    2013-04-01

    Full Text Available Reema Mody,1 Debra Eisenberg,2 Likun Hou,2 Siddhesh Kamat,2 Joseph Singer,2 Lauren B Gerson3 1Takeda Pharmaceuticals International Inc, Deerfield, IL, 2HealthCore Inc, Wilmington, DE, 3Stanford University School of Medicine, Stanford, CA, USA Background: The purpose of this study was to assess differences in health care resource utilization and costs associated with once-daily and twice-daily proton pump inhibitor (PPI therapy. Most patients with gastroesophageal reflux disease (GERD achieve symptom control on once-daily PPI therapy, but approximately 20%–30% require twice-daily dosing. Methods: Patients were ≥18 years of age with at least one medical claim for GERD and at least two PPI claims from HealthCore's Integrated Research Database (HIRDSM during 2004–2009. Patients were continuously eligible for 12 months before and after the index date (date of first PPI claim. Based on PPI dosing throughout the post-index period (quantity of medication dispensed/number of days supply, patients were classified as once-daily (dose ≤ 1.5 pills per day or twice-daily (≥1.5 PPI users. Results: The study cohort included 248,386 patients with GERD (mean age 52.8 ± 13.93 years, 56% females of whom 90% were once-daily and 10% were twice-daily PPI users. The Deyo-Charlson Comorbidity Index for once-daily and twice-daily PPI users was 0.70 ± 1.37 and 0.89 ± 1.54, respectively (P < 0.05. More once-daily patients had claims for Barrett's esophagus (5% versus 2%, P < 0.0001 than twice-daily patients. Post-index, higher proportions of twice-daily patients had at least one GERD-related inpatient visit (7% versus 5%, outpatient visit (60% versus 49%, and office visit (48% versus 38% versus once-daily patients (P < 0.0001. Mean total GERD-related health care costs were $2065 ± $6636 versus $3749 ± $11,081 for once-daily and twice-daily PPI users, respectively (P < 0.0001. Conclusion: Patients receiving twice-daily PPI therapy were likely to have more

  13. Effect of sprint training on resting serum irisin concentration - Sprint training once daily vs. twice every other day.

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    Tsuchiya, Yoshifumi; Ijichi, Toshiaki; Goto, Kazushige

    2016-04-01

    Exercise twice every other day has been shown to lead to increasing peroxisome proliferator receptor γ coactivator-1α (PGC-1α) expression (up-stream factor of irisin) via lowered muscle glycogen level during second of exercise compared with exercise once daily. This study determined the influence of 4weeks of sprint training (training once daily vs. twice every other day) on the serum irisin concentration. Twenty healthy males (20.9±1.3years) were assigned randomly to either the SINGLE or REPEATED group (n=10 per group). The subjects in the SINGLE group participated in a sprint training session once daily (5days per week), whereas those in the REPEATED group performed two consecutive training sessions on the same day with a 1-h rest between sessions (2-3days per week). Both groups completed 20 training sessions over 4weeks. Each training session consisted of three consecutive 30-s maximal pedaling exercises with a 10-min rest between sets. Blood samples were collected before and after training period (48h after completing the last training session). The serum irisin concentration decreased significantly after training in each group (SINGLE, 338.5±77.8 to 207.6±64.6ng/mL; REPEATED, 329.5±83.9 to 234.2±72.8ng/mL, pevery other day). Copyright © 2016 Elsevier Inc. All rights reserved.

  14. A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

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    Segura J

    2013-09-01

    Full Text Available Julian Segura, Luis Miguel Ruilope Department of Nephrology, Hospital 12 de Octubre, Madrid, Spain Abstract: This review discusses the rationale for earlier use of single-pill combinations (SPCs of antihypertensive drugs, with a focus on telmisartan/amlodipine (T/A and telmisartan/hydrochlorothiazide (T/H SPCs. Compared with the respective monotherapies, the once-daily T/A and T/H SPCs have been shown to result in significantly higher blood pressure (BP reductions, BP goal rates, and response rates in patients at all stages of hypertension. As expected, BP reductions are highest with the highest dose (T80/A10 and T80/H25 SPCs. Subgroup analyses of the telmisartan trials have reported the efficacy of both SPCs to be consistent, regardless of the patients' age, race, and coexisting diabetes, obesity, or renal impairment. In patients with mild-to-moderate hypertension, the T/A combination provides superior 24-hour BP-lowering efficacy compared with either treatment administered as monotherapy. Similarly, the T/H SPC treatment provides superior 24-hour BP-lowering efficacy, especially in the last 6 hours relative to other renin–angiotensin system inhibitor-based SPCs. The T/A SPC is associated with a lower incidence of edema than amlodipine monotherapy, and the T/H SPC with a lower incidence of hypokalemia than hydrochlorothiazide monotherapy. Existing evidence supports the use of the T/A SPC for the treatment of hypertensive patients with prediabetes, diabetes, or metabolic syndrome, due to the metabolic neutrality of both component drugs, and the use of the T/H SPC for those patients with edema or in need of volume reduction. Keywords: calcium-channel blocker, essential hypertension, diuretic, primary care physician, renin-angiotensin system inhibitor

  15. Detemir as a once-daily basal insulin in type 2 diabetes

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    Nelson SE

    2011-08-01

    Full Text Available Scott E NelsonCleveland Family Medicine, Cleveland, Mississippi, USABackground: Insulin detemir, a long-acting basal insulin analog, is labeled for once-daily or twice-daily dosing in patients with type 1 (T1DM or type 2 (T2DM diabetes mellitus. Protocols for some earlier clinical studies of detemir evaluated twice-daily dosing, which may have generated the misperception that detemir should be prescribed twice daily for most patients. This review examines pharmacokinetic and pharmacodynamic (PK/PD, observational, and controlled studies that have evaluated once-daily and twice-daily detemir in patients with T2DM to determine the efficacy and safety of once-daily dosing.Methods: PubMed was searched using the keywords “detemir,” “once daily,” “twice daily,” and “type 2 diabetes” with the limits of clinical trial, human, and English.Results: Detemir has a relatively flat time–action profile and duration of action of up to 24 hours for patients with T2DM. Once-daily dosing is the most commonly used detemir regimen reported in observational studies, and controlled clinical studies indicate that once-daily dosing controls glycosylated hemoglobin when detemir is administered alone or in combination with a prandial insulin or oral antidiabetes drugs. In comparative clinical trials, detemir had a similar time–action profile and duration of action to another long-acting insulin analog, glargine, with less within-subject variability. Once-daily detemir was associated with no weight gain or less weight gain than comparator regimens. For patients who had not achieved glycemic control with a basal dose of once-daily detemir, adding a prandial insulin provided better glycemic control, less postprandial hypoglycemia, and a lower total daily dose of detemir than twice-daily detemir. Involvement of a multidisciplinary team and the use of a holistic approach for the treatment of T2DM patients are recommended to achieve and maintain the best

  16. Cerebrospinal fluid abacavir concentrations in HIV-positive patients following once-daily administration.

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    Calcagno, A; Pinnetti, C; De Nicolò, A; Scarvaglieri, E; Gisslen, M; Tempestilli, M; D'Avolio, A; Fedele, V; Di Perri, G; Antinori, A; Bonora, S

    2018-06-01

    Abacavir is a widely used nucleotide reverse transcriptase inhibitor, for which cerebrospinal fluid (CSF) exposure has been previously assessed in twice-daily recipients. We studied abacavir CSF concentrations in 61 and nine HIV-positive patients taking abacavir once daily and twice daily, respectively. Patients on once-daily abacavir had higher plasma and CSF concentrations (96 vs. 22 ng ml -1 , P = 0.038 and 123 vs. 49 ng ml -1 , P = 0.038) but similar CSF-to-plasma ratios (0.8 vs. 0.5, P = 0.500). CSF abacavir concentrations were adequate in patients receiving once-daily treatment. © 2018 The British Pharmacological Society.

  17. Efficacy and safety of rosuvastatin every other day compared with once daily in patients with hypercholesterolemia.

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    Wongwiwatthananukit, Supakit; Sansanayudh, Nakarin; Dhummauppakorn, Rawadee; Kitiyadisai, Chutiporn

    2006-11-01

    Although most patients with hypercholesterolemia require life-long therapy with statins, these drugs are underused due to high costs. Every-other-day therapy could be one strategy to resolve this problem. To compare the efficacy and safety of rosuvastatin 10 mg administered every other day versus once daily. An 8 week, randomized, open-label, parallel trial was conducted at the outpatient department of Phramongkutklao Hospital in Bangkok, Thailand. Eighty patients with primary hypercholesterolemia were equally randomized to receive rosuvastatin 10 mg once daily or every other day; 76 patients completed the study. Laboratory data were assessed at baseline and at the end of the study. Low-density lipoprotein cholesterol (LDL-C) levels were reduced by 48% and 39% in the once-daily and every-other-day groups, respectively (p = 0.011). The percentage of patients who achieved LDL-C goals according to National Cholesterol Education Program-Adult Treatment Panel III guidelines was not significantly different between the once-daily (85%) and every-other-day (70%) groups (p = 0.180). In addition, both regimens were well tolerated, with no patient developing an elevation of more than 3 times baseline levels of aspartate aminotransferase or alanine aminotransferase or 10 times that of creatine kinase. As expected, the monthly cost per percent LDL-C reduction of the once-daily (0.72 dollars) regimen was about 38% higher than that of the every-other-day (0.44 dollars) regimen. Every-other-day dosing of rosuvastatin may be an alternative regimen for cost savings, without a major decrease in therapeutic benefit or increase in adverse events, in patients with hypercholesterolemia. The number of patients achieving their LDL-C goal using the every-other-day regimen is comparable with the number using the once-daily regimen, especially in the low-risk patient category.

  18. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    LENUS (Irish Health Repository)

    Ní Ainle, Fionnuala

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU\\/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU\\/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered

  19. Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma

    DEFF Research Database (Denmark)

    Oliver, Amanda J.; Covar, Ronina A.; Goldfrad, Caroline H.

    2016-01-01

    Objective To evaluate the dose-response, efficacy, and safety of fluticasone furoate (FF; 25 µg, 50 µg, and 100 µg), administered once daily in the evening during a 12-week treatment period to children with inadequately controlled asthma. Study design This was a Phase IIb, multicenter, stratified...

  20. Clinical efficacy of levofloxacin 500 mg once daily for 7 days for patients with non-gonococcal urethritis.

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    Takahashi, Satoshi; Ichihara, Kohji; Hashimoto, Jiro; Kurimura, Yuichiro; Iwasawa, Akihiko; Hayashi, Kenji; Sunaoshi, Kenichi; Takeda, Koichi; Suzuki, Nobukazu; Satoh, Takashi; Tsukamoto, Taiji

    2011-06-01

    To confirm the efficacy of the treatment regimen with oral levofloxacin (LVFX) 500 mg once daily for 7 days for patients with non-gonococcal urethritis (NGU), we evaluated the microbiological and clinical outcomes of the regimen in those patients. We finally evaluated 53 patients with symptomatic NGU and 5 patients with asymptomatic NGU. As a result of microbiological examinations, 19 of the symptomatic patients were diagnosed as having non-gonococcal chlamydial urethritis (NGCU); 13 had non-gonococcal non-chlamydial urethritis (NGNCU), and 21 had urethritis without any microbial detection. Five of the asymptomatic patients were diagnosed as having NGCU. Microbiological cure was achieved in 91% of the 32 patients with symptomatic NGU and in 80% of the 5 patients with asymptomatic NGCU. Clinical cure was obtained in 92% of the 53 patients with symptomatic NGU. The microbiological eradication rate for Chlamydia trachomatis was 92% in 24 patients. As for other organisms, the microbiological eradication rate for Mycoplasma genitalium was 60% in 5 patients and that for Ureaplasma urealyticum was 100% in 10. The microbiological and clinical efficacy of oral LVFX 500 mg once daily for 7 days for the patients with NGU was the same for the azithromycin (AZM) 1,000 mg single dose that we previously reported. The eradication rates of C. trachomatis and U. urealyticum in the treatment regimen with LVFX 500 mg were high enough in the clinical setting; however, for M. genitalium, the rate was relatively inferior to that with AZM.

  1. Once-daily use of inhaled corticosteroids: A new regimen in the treatment of persistent asthma

    Directory of Open Access Journals (Sweden)

    Jeffrey Leflein

    2000-01-01

    Strict patient adherence with prescribed anti-inflammatory medication is crucial for obtaining optimal therapeutic benefit for patients with asthma. Despite the proven effectiveness of inhaled corticosteroids, patient adherence to prescribed therapy is often low, resulting in increased patient morbidity. Complex dosing regimens contribute greatly to patient non-adherence. Thus, new once-daily regimens of inhaled corticosteroid treatment have been introduced as means to improve patient adherence and provide optimal therapeutic benefit. In the present review, the complex inflammatory and remodeling processes in asthma and their contributions to the clinical manifestations of the disease will be discussed. Currently available, once-daily inhaled corticosteroid treatment options and the advantages of these therapeutic options in the treatment of persistent asthma also will be discussed.

  2. The antianginal efficacy and tolerability of controlled-release metoprolol once daily

    DEFF Research Database (Denmark)

    Egstrup, K; Gundersen, T; Härkönen, R

    1988-01-01

    In a randomized, double-blind, cross-over study treatment with a new controlled-release (CR) preparation of metoprolol, given once daily, was compared with treatment with conventional metoprolol tablets, given twice daily, in 115 patients with stable effort angina pectoris. The patients were...... questionnaire. When all patients were analysed together there were no differences in antianginal efficacy between the two treatment regimens. However, when the group taking 200 mg daily was analysed separately better exercise tolerance was found during metoprolol CR therapy, as measured by onset of chest pain...... and ST-segment change, compared with conventional metoprolol therapy. The two formulations were well tolerated. When given once daily in a total daily dose of 100 mg, the CR preparation induced less adverse effects than the conventional tablets, 50 mg twice daily. It was concluded that the new metoprolol...

  3. Update on the clinical utility of once-daily tacrolimus in the management of transplantation

    Directory of Open Access Journals (Sweden)

    Revollo J

    2015-05-01

    Full Text Available Jane Revollo Department of Pharmacy, Jackson Memorial Hospital, University of Miami Leonard M Miller School of Medicine Miami, FL, USAThe review by Posadas Salas and Srinivas of the clinical utility of once-daily tacrolimus formulations in the management of transplant patients1 was timely and relevant. It is worth noting, however, the data were presented in a way that overlooked several key differences between two distinct once-daily tacrolimus formulations. These formulations differ in bioavailability, Cmax, Tmax, dose required to achieve target trough levels, and time to reach target trough. The specific formulation and dosing information of one product was detailed in this review (described as modified release 4 [MR-4]; Astagraf®, Astellas Pharma Inc., Tokyo, Japan, but no formulation or dosing details were provided for a very different once-daily tacrolimus formulation (LCP-Tacro™; Veloxis Pharmaceuticals A/S, Hørsholm, Denmark for which a thorough review was recently published.2 The latter product is currently approved in Europe and under review by the US Food and Drug Administration in the US. In presenting data in this review, the authors did not identify which product was investigated in each of the studies discussed. This could easily lead to misinterpretation of results or erroneous conclusions, ie, that both once-daily formulations are the same. In fact, a careful parsing of the data clearly demonstrates that they are not equivalent. Misunderstanding of this point could have a potentially serious impact on appropriate dosing, safety, and patient management in the post-transplant setting. Differentiation between the two products is needed to clarify what appear to be conflicting results of the studies presented in this review.View original paper by Posadas Salas and Srinivas

  4. Fixed combinations in the pragmatic management of hypertension: focus on aliskiren and hydrochlorothiazide as a single pill

    Directory of Open Access Journals (Sweden)

    Michel Burnier

    2010-05-01

    Full Text Available Michel BurnierService of Nephrology and Hypertension, University Hospital, Lausanne, SwitzerlandAbstract: A majority of hypertensive patients need more than one antihypertensive drug to control their blood pressure. For this reason, most guidelines have introduced the possibility of prescribing fixed-dose combination therapies as first-line treatment in hypertension. Today, the concept of fixed-dose combinations has evolved and the term single pill combination might become more appropriate to reflect the large choice of drug combinations available on the market. Recently, a new single pill combination has been launched which combines the first direct renin inhibitor aliskiren and low doses of hydrochlorothiazide. This paper reviews the potential advantages of single pill combinations and presents the first results obtained with the aliskiren/HCTZ single pill combination in hypertension.Keywords: hypertension, drug adherence, combination therapies, diuretics, renin inhibition

  5. Once daily, extended release ciprofloxacin for complicated urinary tract infections and acute uncomplicated pyelonephritis.

    Science.gov (United States)

    Talan, David A; Klimberg, Ira W; Nicolle, Lindsay E; Song, James; Kowalsky, Steven F; Church, Deborah A

    2004-02-01

    We assessed the efficacy and safety of 1,000 mg extended release ciprofloxacin orally once daily vs conventional 500 mg ciprofloxacin orally twice daily, each for 7 to 14 days, in patients with a complicated urinary tract infection (cUTI) or acute uncomplicated pyelonephritis (AUP). In this prospective, randomized, double-blind, North American multicenter clinical trial adults were stratified based on clinical presentation of cUTI or AUP and randomized to extended release ciprofloxacin or ciprofloxacin twice daily. Efficacy valid patients had positive pretherapy urine cultures (105 or greater cFU/ml) and pyuria within 48 hours of study entry. Bacteriological and clinical outcomes were assessed at the test of cure visit (5 to 11 days after therapy) and the late followup visit (28 to 42 days after therapy). The intent to treat population comprised 1,035 patients (extended release ciprofloxacin in 517 and twice daily in 518), of whom 435 were efficacy valid (cUTI in 343 and AUP in 92). For efficacy valid patients (cUTI and AUP combined) bacteriological eradication rates at test of cure were 89% (183 of 206) vs 85% (195 of 229) (95% CI -2.4%, 10.3%) and clinical cure rates were 97% (198 of 205) vs 94% (211 of 225) (95% CI -1.2%, 6.9%) for extended release vs twice daily ciprofloxacin. Late followup outcomes were consistent with test of cure findings. Eradication rates for Escherichia coli, which accounted for 58% of pathogens, were 97% or greater per group. Drug related adverse event rates were similar for extended release and twice daily ciprofloxacin (13% and 14%, respectively). Extended release ciprofloxacin at a dose of 1,000 mg once daily was as safe and effective as conventional treatment with 500 mg ciprofloxacin twice daily, each given orally for 7 to 14 days in adults with cUTI or AUP. It provides a convenient, once daily, empirical treatment option.

  6. Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

    Science.gov (United States)

    Lakatos, Peter Laszlo

    2009-04-21

    5-aminosalicylate (5-ASA) agents remain the mainstay treatment in ulcerative colitis (UC). A number of oral 5-ASA agents are commercially available, including azobond pro-drugs, as well as delayed- and controlled-release forms of mesalazine. However, poor adherence due to frequent daily dosing and a large number of tablets has been shown to be an important barrier to successful management of patients with UC. Recently, new, once-daily formulations of mesalazine, including the unique multi-matrix delivery system and mesalazine granules, were proven to be efficacious in inducing and maintaining remission in mild-to-moderate UC, with a good safety profile comparable to that of other oral mesalazine formulations. In addition, they offer the advantage of a low pill burden and might contribute to increased long-term compliance and treatment success in clinical practice. This editorial summarizes the available literature on the short- and medium-term efficacy and safety of the new once-daily mesalazine formulations.

  7. Effects of Tadalafil 5 mg Dosed Once Daily in Men with Premature Ejaculation.

    Science.gov (United States)

    Ozcan, Levent; Polat, Emre Can; Onen, Efe; Kocaaslan, Ramazan; Otunctemur, Alper; Cekmen, Mustafa; Eraldemir, Ceyla; Ozbek, Emin

    2017-01-01

    In this study, we evaluated the effect of 5 mg tadalafil once daily in men with premature ejaculation (PE). Thirty married men with lifelong PE and 30 healthy men as control group were included in this study. All the patients received 5 mg tadalafil once a day for a month. The international index of erectile function questionnaire and intravaginal ejaculatory latency times (IELTs) and PE profile were recorded before and after treatment. Plasma samples were collected before and after treatment. The mean baseline IELTs was 40.8 ± 8.1 s in the PE group and 196.5 ± 26.2 s in the control group. After treatment in the PE group, the mean IELTs values showed a statistically significant improvement from the baseline values. At the end of 4 weeks, in the PE group, the mean IELT values showed a statistically significant improvement from the baseline values. Baseline serum nitric oxide (NO) levels were 27.3 ± 1.7 in the PE group and in the 31.1 ± 1.4 healthy control groups. After treatment, NO levels were increased from baseline. We consider that 5 mg tadalafil once daily is safety and effective for the treatment of PE. © 2016 S. Karger AG, Basel.

  8. Efficacy and safety of terbinafine 500 mg once daily in patients with dermatophytosis

    Directory of Open Access Journals (Sweden)

    P Ravindra Babu

    2017-01-01

    Full Text Available Introduction: Dermatophytosis are the most common fungal infections globally. Terbinafine is considered to have good potency against dermatophytes, but resistance to terbinafine is on the rise. Objective: The objective of this study was to evaluate the efficacy and safety of terbinafine 500 mg given once daily in treatment of patients with superficial dermatophytosis. Materials and Methods: It was a retrospective questionnaire-based survey. Each doctor was given survey questionnaire booklet containing survey forms. Clinical response was graded according to the improvement in the affected lesion. Mycological cure was defined as negative microscopy under potassium hydroxide examination and a negative culture in Sabouraud's dextrose agar. Patients were divided into three groups depending on the duration of therapy, Group A – terbinafine 500 mg for 2 weeks, Group B – terbinafine 500 mg for 4 weeks, and Group C – terbinafine 500 mg for 6 weeks. Results: Total 50 doctors completed the survey involving 440 patients. In Group A, out of 194 patients, 87% (n = 169 patients showed very good response. In Group B, out of 211 patients, 92% (n = 194 of the patients showed very good response with >75% improvement in their lesion. In Group C, out of 35 patients, 80% (n = 30 patients showed very good response. Adverse drug reactions of mild to moderate intensity related to terbinafine were seen in 57 patients. Conclusion: Our survey indicates that terbinafine in a dose of 500 mg given once daily was efficacious and safe in the treatment of patients with dermatophytosis.

  9. Efficacy and Safety of Terbinafine 500 mg Once Daily in Patients with Dermatophytosis.

    Science.gov (United States)

    Babu, P Ravindra; Pravin, A J S; Deshmukh, Gaurav; Dhoot, Dhiraj; Samant, Aniket; Kotak, Bhavesh

    2017-01-01

    Dermatophytosis are the most common fungal infections globally. Terbinafine is considered to have good potency against dermatophytes, but resistance to terbinafine is on the rise. The objective of this study was to evaluate the efficacy and safety of terbinafine 500 mg given once daily in treatment of patients with superficial dermatophytosis. It was a retrospective questionnaire-based survey. Each doctor was given survey questionnaire booklet containing survey forms. Clinical response was graded according to the improvement in the affected lesion. Mycological cure was defined as negative microscopy under potassium hydroxide examination and a negative culture in Sabouraud's dextrose agar. Patients were divided into three groups depending on the duration of therapy, Group A - terbinafine 500 mg for 2 weeks, Group B - terbinafine 500 mg for 4 weeks, and Group C - terbinafine 500 mg for 6 weeks. Total 50 doctors completed the survey involving 440 patients. In Group A, out of 194 patients, 87% ( n = 169) patients showed very good response. In Group B, out of 211 patients, 92% ( n = 194) of the patients showed very good response with >75% improvement in their lesion. In Group C, out of 35 patients, 80% ( n = 30) patients showed very good response. Adverse drug reactions of mild to moderate intensity related to terbinafine were seen in 57 patients. Our survey indicates that terbinafine in a dose of 500 mg given once daily was efficacious and safe in the treatment of patients with dermatophytosis.

  10. Onychomycosis of Toenails and Post-hoc Analyses with Efinaconazole 10% Solution Once-daily Treatment

    Science.gov (United States)

    2016-01-01

    Topical treatment for toenail onychomycosis has been fraught with a long-standing reputation of poor efficaey, primarily due to physical properties of the nail unit that impede drug penetration. Newer topical agents have been formulated as Solution, which appear to provide better therapeutic response in properly selected patients. It is important to recognize the impact the effects that mitigating and concomitant factors can have on efficaey. These factors include disease severity, gender, presence of tinea pedis, and diabetes. This article reviews results achieved in Phase 3 pivotal studies with topical efinaconazole 10% Solution applied once daily for 48 weeks with a focus on how the aforementioned factors influenced therapeutic outcomes. It is important for clinicians treating patients for onychomycosis to evaluate severity, treat concomitant tinea pedis, address control of diabetes if present by encouraging involvement of the patient’s primary care physician, and consider longer treatment courses when clinically relevant. PMID:27047631

  11. Liraglutide: a once-daily GLP-1 analogue for the treatment of type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Vilsbøll, Tina

    2007-01-01

    properties that are suitable for once-daily dosing. Liraglutide has demonstrated lasting improvement of HbA(1c )levels, weight reduction and improved beta-cell function in patients with Type 2 diabetes mellitus. Liraglutide is well tolerated; the adverse events that are most frequently reported being...... transient nausea and diarrhoea. This article reviews the mechanisms of action and efficacy of liraglutide for the treatment of Type 2 diabetes mellitus. This agent is presently in Phase III clinical development.......The incretin hormones are intestinal peptides that enhance insulin secretion following ingestion of nutrients. Liraglutide is a glucagon-like peptide-1 receptor analogue, which is obtained by derivatising glucagon-like peptide-1 with a fatty acid, providing a compound with pharmacokinetic...

  12. Liraglutide: a once-daily GLP-1 analogue for the treatment of type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Vilsbøll, Tina

    2007-01-01

    The incretin hormones are intestinal peptides that enhance insulin secretion following ingestion of nutrients. Liraglutide is a glucagon-like peptide-1 receptor analogue, which is obtained by derivatising glucagon-like peptide-1 with a fatty acid, providing a compound with pharmacokinetic propert...... transient nausea and diarrhoea. This article reviews the mechanisms of action and efficacy of liraglutide for the treatment of Type 2 diabetes mellitus. This agent is presently in Phase III clinical development....... properties that are suitable for once-daily dosing. Liraglutide has demonstrated lasting improvement of HbA(1c )levels, weight reduction and improved beta-cell function in patients with Type 2 diabetes mellitus. Liraglutide is well tolerated; the adverse events that are most frequently reported being...

  13. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne.

    Science.gov (United States)

    Jones, Terry M; Ellman, Herman; deVries, Tina

    2017-10-01

    To characterize minocycline pharmacokinetics and relative bioavailability following multiple-dose topical administration of minocycline hydrochloride (HCl) foam 4% (FMX101 4%) as compared with single-dose oral administration of minocycline HCl extended-release tablets (Solodyn®) in subjects with moderate-to-severe acne. A Phase 1, single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment crossover clinical study. The study included 30 healthy adults (mean age, 22.6 years; 90% white, and 60% females) who had moderate-to-severe acne. Subjects were assigned to first receive a single oral dose of a minocycline HCl extended-release tablet (approximately 1 mg/kg). At 10 days after the oral minocycline dose, topical minocycline foam 4% was applied, once daily for 21 days. Serial blood samples were obtained before and after administration of oral minocycline and each topical application of minocycline foam 4% on days 1, 12, and 21. Following oral administration of minocycline (approximately 1 mg/kg), plasma minocycline concentration increased until 3 hours, followed by a log-linear decrease over the remainder of the 96-hour sampling period. Following topical application of a 4-g maximal-use dose of minocycline foam 4% for 21 days, plasma minocycline concentration was very low, with geometric mean Cmax values ranging from 1.1 ng/mL to 1.5 ng/mL. Steady state was achieved by day 6. Overall, minocycline exposure with topical minocycline foam 4% was 730 to 765 times lower than that with oral minocycline. There was no evidence of minocycline accumulation over the 21 days of topical application of minocycline foam 4%. Topical minocycline foam 4% appeared to be safe and well tolerated, with no serious treatment-emergent adverse events (TEAEs), treatment-related TEAEs, or TEAEs that led to treatment discontinuation. Once-daily topical application of minocycline foam 4% did not lead to significant systemic exposure to minocycline. It appears to be a well

  14. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release.

    Science.gov (United States)

    Fass, Ronnie; Inadomi, John; Han, Cong; Mody, Reema; O'Neil, Janet; Perez, M Claudia

    2012-03-01

    Many patients with gastroesophageal reflux disease (GERD) take a proton pump inhibitor (PPI) twice daily to control symptoms. Once-daily dexlansoprazole modified release (MR) has a dual-delayed release formulation, making it attractive for step-down management of patients whose symptoms are well controlled on twice-daily PPIs. We investigated whether step-down to once-daily dexlansoprazole controls heartburn in patients with GERD who were receiving twice-daily PPI therapy. Patients 18 years and older taking a twice-daily PPI for symptom control were enrolled (n = 178) in a single-blind, multicenter study; 163 patients completed the study and 142 patients met criteria for the efficacy analysis. During the 6-week screening and treatment periods, patients recorded the presence of heartburn symptoms twice daily in electronic diaries. Patients' heartburn was considered well controlled if they had an average of 1 symptom or fewer per week during the last 4 weeks of screening and treatment. After screening, qualified patients were switched to masked dexlansoprazole MR 30 mg and placebo for 6 weeks. The primary efficacy end point was the proportion of patients whose heartburn remained well controlled after step-down. GERD-related symptoms and quality of life (QOL) also were evaluated using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the PAGI-QOL questionnaires, respectively. After step-down to once-daily dexlansoprazole MR 30 mg, heartburn remained well controlled in 88% of patients (125 of 142). These patients were able to maintain their GERD-related symptom severity and QOL, indicated by marginal changes in the PAGI-SYM and PAGI-QOL total and subscale scores, respectively. Most patients with GERD who take twice-daily PPI to control heartburn are able to successfully step down to once-daily dexlansoprazole 30 mg. Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.

  15. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies.

    Science.gov (United States)

    Jenner, Peter; Könen-Bergmann, Michael; Schepers, Cornelia; Haertter, Sebastian

    2009-11-01

    Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily. These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation. Three Phase I studies were conducted, all in healthy adult men aged food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375-4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs). The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC(0-24h,ss) of 17.4 ng.h/mL (vs 16.0 ng.h/mL for the IR formulation), C(max,ss) of 0.967 ng/mL (vs 1.09 ng/mL), and C(min,ss) of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC(0-30h) and 4.87% for C(max), and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC(0-30h) (within the bioequivalence limits of 80%-125%) and 134.1 for C(max). At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear

  16. Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.

    Science.gov (United States)

    Orbelo, Diana M; Enders, Felicity T; Romero, Yvonne; Francis, Dawn L; Achem, Sami R; Dabade, Tushar S; Crowell, Michael D; Geno, Debra M; DeJesus, Ramona S; Namasivayam, Vikneswaran; Adamson, Steven C; Arora, Amindra S; Majka, Andrew J; Alexander, Jeffrey A; Murray, Joseph A; Lohse, Matthew; Diehl, Nancy N; Fredericksen, Mary; Jung, Kee Wook; Houston, Margaret S; O'Neil, Angela E; Katzka, David A

    2015-01-01

    Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

  17. Gabapentin for once-daily treatment of post-herpetic neuralgia: a review

    Directory of Open Access Journals (Sweden)

    Beal B

    2012-07-01

    Full Text Available Benjamin Beal,1 Tobias Moeller-Bertram,1,2 Jan M Schilling,1 Mark S Wallace11Division of Pain Medicine, Department of Anesthesiology, University of California, 2VA San Diego Healthcare System, San Diego, CA, USAAbstract: Post-herpetic neuralgia is a neuropathic pain syndrome resulting from an insult to the peripheral and central nervous systems caused by the varicella zoster virus. Spontaneous pain may result in the persistent sensation of burning, tingling, or aching and may be associated with thermally or mechanically provoked pain, resulting in hyperalgesia or allodynia. The majority of cases occur in patients over the age of 50 years. Gabapentin is a structural analog of gamma aminobutyric acid that binds to the α2-δ site of voltage-dependent calcium channels and modulates the influx of calcium, with a resulting reduction in excitatory neurotransmitter release. Gabapentin is effective in reducing neuropathic pain due to post-herpetic neuralgia when given at least three times per day, due to its short half-life, resulting in demonstrable fluctuations in plasma levels. Gabapentin has dose-limiting side effects that prevent some patients from achieving therapeutic plasma levels, such as somnolence (27.4%, dizziness (23.9%, and ataxia (7.1%. Gralise™ is a once-daily extended-release formulation of gabapentin that has been developed using AcuForm™ technology. AcuForm is a polymer-based drug delivery system that retains the tablet in the stomach and upper gastrointestinal tract for a sustained period of time. Once-daily dosing has been shown to provide comparable drug exposure with an identical daily dose of the immediate-release formulation when administered three times daily. Participants given Gralise 1800 mg daily had a statistically significant reduction in average daily pain intensity scores compared with placebo, reduced sleep interference due to pain, and a greater percent of participants reporting being much or very much improved on

  18. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Bateman Eric D

    2011-04-01

    Full Text Available Abstract Background The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD. Methods In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843 and II (n = 804, patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1/forced vital capacity ratio of ≤70% and FEV1 1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ and time to first moderate or severe COPD exacerbation. Results At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p Conclusion Aclidinium is effective and well tolerated in patients with moderate to severe COPD. Trial registration ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I and NCT00358436 (ACCLAIM/COPD II.

  19. The emergence of oral tadalafil as a once-daily treatment for pulmonary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Jeremy A Falk

    2010-04-01

    Full Text Available Jeremy A Falk, Kiran J Philip, Ernst R SchwarzCedars Sinai Women’s Guild Lung Institute, Cedars Sinai Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA, USAAbstract: Pulmonary hypertension (PH is found in a vast array of diseases, with a minority representing pulmonary arterial hypertension (PAH. Idiopathic PAH or PAH in association with other disorders has been associated with poor survival, poor exercise tolerance, progressive symptoms of dyspnea, and decreased quality of life. Left untreated, patients with PAH typically have a progressive decline in function with high morbidity ultimately leading to death. Advances in medical therapy for PAH over the past decade have made significant inroads into improved function, quality of life, and even survival in this patient population. Three classes of pulmonary artery-specific vasodilators are currently available in the United States. They include prostanoids, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE5 inhibitors. In May 2009, the FDA approved tadalafil, the first once-daily PDE5 inhibitor for PAH. This review will outline the currently available data on tadalafil and its effects in patients with PAH.Keywords: PDE-5 inhibition, pulmonary hypertension, tadalafil

  20. Tafluprost once daily for treatment of elevated intraocular pressure in patients with open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Liu Y

    2012-12-01

    Full Text Available Yang Liu, Weiming MaoDepartment of Cell Biology and Anatomy, North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TXAbstract: Glaucoma is a leading cause of visual loss worldwide. Current antiglaucoma therapy focuses on lowering intraocular pressure to a safe level. In recent years, prostaglandin analogs have become the first-line agents for treating open angle glaucoma. Tafluprost, which was first reported in 2003, is a novel prostaglandin analog, and has been shown to be a potent ocular hypotensive agent in a number of preclinical and clinical studies. Also, its unique preservative-free formulation helps to decrease preservative-associated ocular disorders and improve patient compliance. In this review, studies from 2003 to 2012 focusing on the structure, metabolism, efficacy, and safety of tafluprost are summarized. These studies suggested that application of tafluprost once daily is a safe and effective treatment for patients with open angle glaucoma.Keywords: tafluprost, prostaglandin analog, glaucoma, intraocular pressure, preservative-free formulation

  1. A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy

    Directory of Open Access Journals (Sweden)

    Samuel L Washington III

    2010-08-01

    Full Text Available Samuel L Washington III1, Alan W Shindel21School of Medicine, University of California at San Francisco, San Francisco, California, USA; 2Department of Urology, University of California at San Francisco, San Francisco, California, USAAbstract: Selective phosphodiesterase type 5 inhibitors (PDE5Is have revolutionized the ­treatment of erectile dysfunction (ED in men. As an on-demand treatment, PDE5Is have excellent efficacy and safety in the treatment of ED due to a broad spectrum of etiologies. Nevertheless, these drugs do have side-effect profiles that are troublesome to some patients, eg, headache, dyspepsia, myalgia, etc. Furthermore, many patients and their partners dislike the necessity of on-demand treatment for ED, citing a desire for greater spontaneity with sexual interactions. In 2008, approximately 10 years after the release of the first commercially available PDE5I, a paradigm shift in the management of ED occurred with the approval of once-daily dose of tadalafil by the US Food and Drug Administration for the management of ED. The prolonged half-life of tadalafil lends itself well to this dosing regimen and conveys the advantage of separating medication from sexual interactions; lower dose therapy also carries the theoretical benefit of lower incidence of side effects. In this study, we review the current state of the art with respect to this new management strategy for ED, highlighting published reports of the efficacy and tolerability of the daily dose tadalafil regimen.Keywords: PDE5 inhibitor, on-demand therapy, side effects, daily dosing

  2. Teriflunomide: a once-daily oral medication for the treatment of relapsing forms of multiple sclerosis.

    Science.gov (United States)

    Miller, Aaron E

    2015-10-01

    The purpose was to summarize US prescribing information for teriflunomide in the treatment of patients with relapsing forms of multiple sclerosis (RMS), with reference to clinical efficacy and safety outcomes. In September 2012, the US Food and Drug Administration granted approval for the use of teriflunomide, 14 mg and 7 mg once daily, to treat RMS on the basis of the results of a Phase II study and the Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) trial. After recent updates to the prescribing information (October 2014), key findings from these and 2 other Phase III clinical trials, TOWER (Teriflunomide Oral in People With Relapsing Multiple Sclerosis) and TOPIC (Oral Teriflunomide for Patients with a First Clinical Episode Suggestive of Multiple Sclerosis), and practical considerations for physicians are summarized. Teriflunomide, 14 mg and 7 mg, significantly reduced mean number of unique active lesions on magnetic resonance imaging (MRI; P treatment was also associated with significant efficacy on MRI measures of disease activity in TEMSO; both doses significantly reduced total lesion volume and number of gadolinium-enhancing T1 lesions. TOPIC evaluated patients with a first clinical event consistent with acute demyelination and brain MRI lesions characteristic of multiple sclerosis. More patients were free of relapse in the teriflunomide 14-mg and 7-mg groups than in the placebo group (P treatment are recommended to assess potential safety issues. Women of childbearing potential must use effective contraception and, in the event of pregnancy, undergo an accelerated elimination procedure to reduce plasma concentrations of teriflunomide. Clinical evidence suggests that teriflunomide is an effective therapeutic choice for patients with RMS, both as an initial treatment and as an alternative for patients who may have experienced intolerance or inadequate response to a previous or current disease-modifying therapy. Copyright © 2015 The Authors

  3. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial

    NARCIS (Netherlands)

    Eron, Joseph J.; Rockstroh, Jürgen K.; Reynes, Jacques; Andrade-Villanueva, Jaime; Ramalho-Madruga, Jose Valdez; Bekker, Linda-Gail; Young, Benjamin; Katlama, Christine; Gatell-Artigas, Jose Maria; Arribas, Jose R.; Nelson, Mark; Campbell, Havilland; Zhao, Jing; Rodgers, Anthony J.; Rizk, Matthew L.; Wenning, Larissa; Miller, Michael D.; Hazuda, Daria; DiNubile, Mark J.; Leavitt, Randi; Isaacs, Robin; Robertson, Michael N.; Sklar, Peter; Nguyen, Bach-Yen; Bloch, M. T.; Hoy, J.; Workman, C.; Madruga, J. V.; Souza, T.; Telles, F. Q.; Zajdenverg, R.; Angel, J.; Montaner, J. S.; Smith, G. H. R.; Trottier, B.; Tamara, J. R.; Velez, J. D.; Gerstoft, J.; Laursen, A. L.; Mathiesen, L.; Katlama, C.; Molina, J. M.; Raffi, F.; Reynes, J.; Yazdanpanah, Y.; Bogner, J. R.; Fatkenheuer, G.; Hartl, H.; Jaeger, H.; Geerlings, S. E.

    2011-01-01

    Twice-daily raltegravir with once-daily tenofovir-emtricitabine is an effective initial antiretroviral regimen for patients with HIV-1. On the basis of pharmacokinetic data suggesting efficacy of once-daily raltegravir and because adherence is often improved with once-daily dosing, we aimed to

  4. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

    Directory of Open Access Journals (Sweden)

    Woodcock Ashley

    2011-12-01

    Full Text Available Abstract Background Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD evening and twice-daily (BD regimens of the novel inhaled corticosteroid fluticasone furoate (FF in asthma patients. Methods Patients with moderate asthma (age ≥ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1 40-85% predicted; FEV1 reversibility of ≥ 12% and ≥ 200 ml were randomized to FF or fluticasone propionate (FP regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for ≥ 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 μg OD, FF or FP 100 μg BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough FEV1; non-inferiority of FF 200 μg OD and FF 100 μg BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs and 24-hour urinary cortisol excretion were assessed. Results The intent-to-treat population comprised 147 (FF and 43 (FP patients. On Day 28, pre-dose FEV1 showed FF 200 μg OD to be non-inferior (pre-defined limit -110 ml to FF 100 μg BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml; all FF and FP regimens were significantly superior to placebo (p ≤ 0.02. AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 μg OD, 0.75; 100 μg BD, 0.84; p ≤ 0.02. Conclusions FF 200 μg OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose. Trial registration Clinicaltrials.gov; NCT00766090.

  5. The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals

    NARCIS (Netherlands)

    van Heeswijk, R. P.; Veldkamp, A. I.; Mulder, J. W.; Meenhorst, P. L.; Wit, F. W.; Lange, J. M.; Danner, S. A.; Foudraine, N. A.; Kwakkelstein, M. O.; Reiss, P.; Beijnen, J. H.; Hoetelmans, R. M.

    2000-01-01

    OBJECTIVE: To investigate and to compare the steady-state plasma pharmacokinetics of nevirapine in a dosing regimen of 400 mg once daily versus 200 mg twice daily in HIV-1-infected individuals. DESIGN: Open-label, randomized, cross-over study. METHODS: Twenty HIV-1-infected individuals who already

  6. Once-daily dosing of saquinavir and low-dose ritonavir in HIV-1-infected individuals: a pharmacokinetic pilot study

    NARCIS (Netherlands)

    van Heeswijk, R. P.; Veldkamp, A. I.; Mulder, J. W.; Meenhorst, P. L.; Lange, J. M.; Beijnen, J. H.; Hoetelmans, R. M.

    2000-01-01

    To investigate the steady-state pharmacokinetics of a once-daily dosing regimen of saquinavir soft gelatin capsules in combination with a low dose of ritonavir in HIV-1-infected individuals. Open-label, multi-dose, pharmacokinetic pilot study. Seven HIV-1-infected individuals who were treated with

  7. Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    S Yu Vorotnikova

    2012-09-01

    Full Text Available Реферат по статье: Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus Juliana Levy, Roberta A Cobas, Marilia B Gomes. Diabetol Metab Syndr. 2010 Mar 18; 2:16.

  8. A dose-finding, placebo-controlled study on extended-release felodipine once daily in treatment of hypertension.

    Science.gov (United States)

    Cambell, L M; Ross, J R; Goves, J R; Lees, C T; McCullagh, A; Barnes, P; Timerick, S J; Richardson, P D

    1989-12-01

    Hypertensive patients received a beta-blocker plus placebo once daily for 4 weeks. If their diastolic blood pressure (DBP) was then 95-115 mm Hg, they were randomized to receive, in addition to the beta-blocker, placebo (n = 36), felodipine-extended release (ER) 10 mg (n = 36), or felodipine-ER 20 mg (n = 37) in a 4-week double-blind parallel-group trial. All medication was administered once daily and, when BP was measured 24 h after the last dose, felodipine-ER 10 mg reduced DBP by 14 +/- 9 mm Hg (mean +/- SD) from a mean of 103 mm Hg and felodipine-ER 20 mg reduced DBP by 18 +/- 9 mm Gg from 101 mm Hg. The reductions in DBP with both doses of felodipine were greater than reductions with placebo (5 +/- 8 mm Hg, from 102 mm Hg--both p less than 0.001). At the end of the study, 21% of patients receiving placebo had a DBP less than or equal to 90 mm Hg. In contrast, 69% of patients receiving felodipine-ER 10 mg and 82% receiving 20 mg attained this level. More than 90% of patients receiving 10 mg felodipine-ER once daily had a reduction in DBP greater than 5 mm Hg 24 h postdose. Felodipine-ER was well tolerated. Felodipine-ER once daily is an effective antihypertensive drug for patients who require therapy in addition to a beta-blocker; the tolerability in this study was good, and a starting dose greater than 10 mg once daily is not indicated.

  9. Comparison of once-daily versus twice-weekly terbinafine administration for the treatment of canine Malassezia dermatitis - a pilot study.

    Science.gov (United States)

    Berger, Darren J; Lewis, Thomas P; Schick, Anthea E; Stone, Richard T

    2012-10-01

    Terbinafine, an allylamine antifungal, is used in pulsatile dose regimens for superficial mycoses in human medicine. To compare the clinical efficacy of twice-weekly versus once-daily terbinafine administration to determine whether preliminary proof-of-concept evidence exists for pulsatile administration of terbinafine in the treatment of canine Malassezia dermatitis and to determine whether twice-weekly treatment results in fewer clinical and owner-perceived adverse events. Twenty client-owned dogs with Malassezia dermatitis. In this randomized, single-blinded clinical trial, dogs were randomly assigned to receive terbinafine (30 mg/kg) either once daily for 21 days (n = 10) or once daily on two consecutive days per week for six doses (n = 10). On day 0 and day 21, a mean yeast count was calculated from eight anatomical locations via adhesive tape-strip cytology, clinical lesion scores were assigned to the same locations, and owners assessed pruritus using a visual analog scale. There was no significant difference between treatment groups with respect to the reduction in mean yeast count (P = 0.343) and clinical lesion scores (P = 0.887). Pruritus measured by visual analog scale was significantly decreased in the twice-weekly treatment group compared with the daily treatment group (P = 0.047). Seven of 20 dogs had a clinically measurable or owner-reported adverse event during treatment that included gastrointestinal disturbances, excessive panting and elevated hepatic enzymes, with no significant difference noted between treatment groups. This pilot study indicates that twice-weekly terbinafine administration may be an effective alternative treatment for canine Malassezia dermatitis and merits further investigation. © 2012 The Authors. Veterinary Dermatology © 2012 ESVD and ACVD.

  10. Gender difference in the response to valsartan/amlodipine single-pill combination in essential hypertension (China Status II): An observational study.

    Science.gov (United States)

    Wang, Huan; Chen, Hui

    2016-01-01

    The China STATUS II is a prospective, multicentre, open-label, post-marketing, observational study including Chinese adults (aged ⩾ 18 years) with essential hypertension who were prescribed once-daily valsartan/amlodipine (Val/Aml 80/5 mg) single-pill combination. In order to examine gender differences in treatment response to Val/Aml, we further analysed data from the China STATUS II study. A total of 11,312 patients (6456 (57%) men and 4856 (43%) women) received the Val/Aml treatment for 8 weeks. After the treatment, we compared the proportion of patients not achieving the target systolic blood pressure (SBP: < 140 mm Hg) or diastolic blood pressure (DBP: < 90 mm Hg) in different age groups (by Fisher exact probability test) and estimated the changes in blood pressure (BP) according to age and gender, using a mixed model. At enrolment, mean SBP was higher in the female versus the male patients (160.0 ± 12.71 versus 159.3 ± 12.31 mm Hg; p = 0.003), whereas the mean DBP was higher in the male versus the female patients (96.4 ± 10.65 versus 94.5 ± 10.72 mm Hg; p < 0.001). The overall proportion of women not achieving the target BP was less than that of men (57.41% versus 59.59%; p < 0.05) at 4 weeks and (22.22% versus 23.78%; p < 0.05) at 8 weeks after the Val/Aml treatment. Among both men and women, the proportion of patients not achieving the target SBP increased with age; however, the proportion not achieving the target DBP decreased with age. The mixed-model analysis showed that the changes in SBP were closely related to gender, indicating that the SBP-lowering effect after Val/Aml treatment might be better in women. In addition, the changes in DBP were closely related to age. Gender might be a factor for consideration in the decision-making process of individualised antihypertensive therapy, in the future. © The Author(s) 2016.

  11. Is Time an Important Problem in Management of Hypertension and Hypercholesterolemia by Using an Amlodipine-Atorvastatin Single Pill Combination?

    Science.gov (United States)

    Zeng, Rui; Wang, Mian; Zhang, Li

    2016-07-26

    BACKGROUND Is the timing of dosing for amlodipine and atorvastatin important with regard to therapeutic efficacy? To answer this question, we designed an outpatient, practice-based, case-control study lasting 8 weeks. MATERIAL AND METHODS Two hundred patients were divided into 2 groups: in Group I, patients were provided with a single pill containing amlodipine/atorvastatin (5/20 mg) to be taken each night at 10 pm, and in Group II, patients were taking amlodipine (5 mg) and atorvastatin (20 mg) each morning at 7 am. RESULTS Our results indicated no obvious difference in blood pressure control between the 2 groups. Taking amlodipine at night not only lowered blood pressure, but it also provided better control during the peak blood pressure in the morning. Hypercholesterolemia control in the 2 groups was also not significantly different, taking atorvastatin in the morning was as effective as dosing at night in patients with hypercholesterolemia. While the carotid IMT, hs-CRP, and LVMI were significantly lower after treatment, no differences were found between the 2 groups. Although no obvious difference was found in adverse drug reactions between the 2 groups, compliance was much better in the single-pill group than in patients taking the 2 medications separately. CONCLUSIONS In conclusion, single-pill amlodipine-atorvastatin taken at night can lower blood pressure and reduce the morning peak blood pressure levels the next day. Additionally, this dosing method could improve patient adherence to the therapy.

  12. Bioavailability of oxycodone after administration of a new prolonged-release once-daily tablet formulation in healthy subjects, in comparison to an established twice-daily tablet
.

    Science.gov (United States)

    Scheidel, Bernhard; Maritz, Martina A; Gschwind, Yves J; Steigerwald, Kerstin; Guth, Volker; Kovacs, Peter; Rey, Helene

    2017-11-01

    To evaluate and to compare the bioavailability, the influence of food intake on the bioavailability, and the safety and tolerability of a newly-developed oxycodone once-daily (OOD) prolonged-release tablet with an established oxycodone twice-daily (OTD) prolonged-release tablet after single-dose administration under fasting or fed conditions as well as after multiple-dose administration. Three single-center, open-label, randomized, balanced, two-treatment, two-period, two-sequence crossover studies were conducted. In each study, 36 healthy volunteers were randomized to receive 10 mg oxycodone daily as OOD (oxycodone HCL 10-mg PR tablets XL (Develco Pharma Schweiz AG, Pratteln, Switzerland); administration of 1 tablet in the morning) or as OTD (reference formulation: oxygesic 5-mg tablets (Mundipharma GmbH, Limburg an der Lahn, Germany); administration of 1 tablet in the morning and 1 tablet in the evening). Tablets were administered once daily or twice daily under fasting conditions (study 1) or under fed conditions (study 2) as well as after multiple-dose administration (study 3). A sufficient number of blood samples were taken for describing plasma profiles and for calculation of pharmacokinetic parameters. Plasma concentrations of oxycodone were determined by LC-MS/MS. Safety and tolerability were monitored and assessed in all three studies. Plasma profiles of OOD reveal sustained concentrations of oxycodone over the complete dosing interval of 24 hours. In comparison to the OTD reference formulation, the OOD test formulation showed a slightly slower increase of concentrations within the absorption phase and similar plasma concentrations at the maximum and at the end of the dosing interval (24 hours). Extent of bioavailability (AUC), maximum plasma concentrations (Cmax), and plasma concentrations at the end of the dosing interval (Cτ,ss,24h) of OOD could be classified as comparable to OTD considering 90% confidence intervals (CIs) and acceptance limits of 80

  13. Clinical impact of laboratory error on therapeutic drug monitoring of once-daily tobramycin in cystic fibrosis: Case series

    Directory of Open Access Journals (Sweden)

    William A Prescott

    2014-01-01

    Full Text Available Once-daily dosing intravenous tobramycin is commonly used to treat cystic fibrosis pulmonary exacerbations. Clinicians often utilize historical therapeutic drug monitoring data to individualize the dose among patients who have been treated with tobramycin previously. This case series involves three patients with cystic fibrosis who had supra-therapeutic tobramycin levels despite use of a once-daily dosing that produced therapeutic drug levels during a previous hospital admission, raising questions about the validity of these levels. Investigation into several potential sources of error led to the discovery of an analyzer error in the laboratory. Once the laboratory’s tobramycin analyzer was recalibrated, the reported levels were comparable to historical levels. This case series emphasizes the clinical importance of critically analyzing reported levels, and specifically, the importance of utilizing past therapeutic drug monitoring data, if available, for all patients treated with intravenous tobramycin. If a patient was therapeutic on a similar dose of tobramycin during a previous admission, a dose adjustment may not be necessary, and clinicians should consider repeating levels while pursuing alternative explanations for the discrepant serum levels.

  14. Once-Daily Tacrolimus Extended-Release Formulation: 1 Year after Conversion in Stable Pediatric Kidney Transplant Recipients

    Directory of Open Access Journals (Sweden)

    Lars Pape

    2011-01-01

    Full Text Available It is speculated that a once-daily dosage of immunosuppression can increase adherence and thereby graft survival. Until now, there have been no studies on once-daily use of Tacrolimus extended-release formulation (TAC-ER in children following pediatric kidney transplantation. In 11 stable pediatric kidney recipients >10 years, efficacy, safety, and tolerability of a switch to TAC-ER were observed over one year. Adherence was determined by use of the BAASIS-Scale Interview and comparison of individual variability of Tacrolimus trough levels. Over the observation period, two acute rejections were observed in one girl with nonadherence and repeated Tacrolimus trough levels of 0 ng/m. Beside this, there were no acute rejections in this trial. TAC dose was increased in 3/11 patients and decreased in 2/11 patients within the course of the study. Six patients did not require a dose adjustment. All but one patient had a maximum of 1 dose change during therapy. Mean Tacrolimus dose, trough levels, and Glomerular filtration rates were also stable. Adherence, as measured by BAASIS-Scale Interview and coefficient of variation of Tacrolimus trough levels, was good at all times. It is concluded that conversion to Tac-ER is safe in low-risk children following pediatric kidney transplantation.

  15. Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.

    Science.gov (United States)

    Philosophe, Benjamin; Leca, Nicolae; West-Thielke, Patricia M; Horwedel, Timothy; Culkin-Gemmell, Christine; Kistler, Kristin; Stevens, Daniel R

    2018-02-20

    The majority of United States kidney transplant patients are treated with tacrolimus, a drug effective in preventing graft rejection, but with a narrow therapeutic range, necessitating close monitoring to avoid increased risks of transplant rejection or toxicity if the tacrolimus concentration is too low or too high, respectively. The trough drug concentration tests are time sensitive; patients treated on a twice-daily basis have blood draws exactly 12 hours after their previous dose. The schedule's rigidity causes problems for both patients and health care providers. Novel once-daily tacrolimus formulations such as LCPT (an extended-release tablet by Veloxis Pharmaceuticals, Inc., Cary, North Carolina) have allowed for blood draws on a once-daily basis; however, even that schedule can be restrictive. Results from tests taken either before or after that 24-hour target time may be discarded, or worse, may lead to inappropriate dose changes. Data from ASTCOFF, a phase 3B pharmacokinetic clinical trial (NCT02339246), demonstrated that the unique pharmacokinetic curve of LCPT may allow for a therapeutic monitoring window that extends for 3 hours before or after the 24-hour monitoring target. Furthermore, important tools to help clinicians interpret these levels, such as formulas to estimate the 24-hour trough level if an alternative monitoring time is used, were constructed from these data. These study results give treating clinicians access to data that allow them to safely use and monitor LCPT in their patients and expand the body of evidence surrounding differentiation and practical application of the novel LCPT tacrolimus formulation. © 2018, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  16. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.

    Science.gov (United States)

    Arnold, Lesley M; Arsenault, Pierre; Huffman, Cynthia; Patrick, Jeffrey L; Messig, Michael; Chew, Marci L; Sanin, Luis; Scavone, Joseph M; Pauer, Lynne; Clair, Andrew G

    2014-10-01

    Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design. This multicenter study included 6 week single-blind pregabalin CR treatment followed by 13 week double-blind treatment with placebo or pregabalin CR. The starting dose of 165 mg/day was escalated during the first 3 weeks, up to 495 mg/day based on efficacy and tolerability. Patients with ≥50% reduction in average daily pain score at the end of the single-blind phase were randomized to continue pregabalin CR at the optimized dose (330-495 mg/day) or to placebo. The primary endpoint was time to loss of therapeutic response (LTR), defined as treatment' (Benefit, Satisfaction, and Willingness to Continue Scale) in the pregabalin CR group; no other secondary endpoints were statistically significant. Most AEs were mild to moderate in severity (most frequent: dizziness, somnolence). The percentage of pregabalin CR patients discontinuing because of AEs was 12.2% and 4.8% in the single-blind and double-blind phases, respectively (placebo, 0%). Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well tolerated in most patients. Generalizability may be limited by study duration and selective population.

  17. Once-daily fosamprenavir with ritonavir in the treatment of HIV infection in therapy-naïve patients

    OpenAIRE

    Gisslen, Magnus; Flamholc,Leo; Gisslen,Magnus

    2008-01-01

    Leo Flamholc1, Magnus Gisslén21Department of Infectious Diseases, Malmö University Hospital, Malmö, Sweden; 2Sahlgrenska University Hospital/Östra, Gothenburg, SwedenAbstract: Treatment options for HIV patients have dramatically improved since the introduction of efficacious antiretroviral combination therapy more than a decade ago. Treatment regimens have been simplified with fewer pills and fewer daily dosages. Fosamprenavir is a protease inhibitor with...

  18. Accelerated partial breast irradiation using once-daily fractionation: analysis of 312 cases with four years median follow-up

    Directory of Open Access Journals (Sweden)

    Shaikh Arif Y

    2012-02-01

    Full Text Available Abstract Background There are limited data on accelerated partial breast irradiation (APBI using external beam techniques. Moreover, there are recent reports of increased fibrosis and unacceptable cosmesis with APBI using external beam with BID fractionation. We adopted a once daily regimen of APBI with fractionation similar to that shown to be effective in a Canadian randomized trial of whole breast irradiation. It is unclear whether patients with DCIS or invasive lobular carcinoma (ILC are suitable for APBI. Methods The retrospective cohort included 310 patients with 312 tumors of T1-T2N0-N1micM0 invasive ductal carcinoma (IDC, ILC, or Tis (DCIS treated with APBI via external beam. Most patients were treated using IMRT with 16 daily fractions of 270 cGy to a dose of 4320 cGy. The target volume included the lumpectomy cavity plus 1.0 cm to account for microscopic disease and an additional 0.5 to 1.0 cm for setup uncertainty and breathing motion. Ipsilateral breast failure (IBF was pathologically confirmed as a local failure (LF or an elsewhere failure (EF. Results Median follow-up was 49 months. Among the 312 cases, 213 were IDC, 31 ILC, and 68 DCIS. Median tumor size was 1.0 cm. There were 9 IBFs (2.9% including 5 LFs and 4 EFs. The IBF rates among patients with IDC, ILC, and DCIS were 2.4%, 3.2%, and 4.4%, respectively, with no significant difference between histologies. When patients were analyzed by the ASTRO APBI consensus statement risk groups, 32% of treated cases were considered suitable, 50% cautionary, and 18% unsuitable. The IBF rates among suitable, cautionary, and unsuitable patients were 4.0%, 2.6%, and 1.8%, respectively, with no significant difference between risk groups. Acute skin reactions were rare and long-term cosmetic outcome was very good to excellent. Conclusions External beam APBI with once daily fractionation has a low rate of IBF consistent with other published APBI studies. The ASTRO risk stratification did not

  19. Safety and Efficacy of Once-Daily Intravenous Busulfan in Allogeneic Transplantation: A Matched-Pair Analysis.

    Science.gov (United States)

    Kako, Shinichi; Fujiwara, Shinichiro; Sato, Miki; Kimura, Shun-Ichi; Nakasone, Hideki; Ohashi, Kazuteru; Kawakita, Toshiro; Maeda, Tetsuo; Morishita, Takanobu; Suzuki, Ritsuro; Fukuda, Takahiro; Ichinohe, Tatsuo; Kurata, Mio; Atsuta, Yoshiko; Kanda, Yoshinobu

    2018-04-19

    Compared with 4-times-daily infusion of intravenous busulfan (ivBU4), the safety and efficacy of once-daily infusion of ivBU (ivBU1) has not been fully clarified. We have been routinely using ivBU1 in a conditioning regimen in adult patients with myeloid malignancy who undergo allogeneic hematopoietic stem cell transplantation. In this study, a total of 91 patients who received ivBU1 for 2 days (n = 18) or 4 days (n = 73) in our institutions were compared with 273 control patients who received ivBU4, who were matched for age, sex, performance status, disease risk, conditioning regimen, and donor type, selected from the database of the Japanese Society for Hematopoietic Cell Transplantation using optimal matching algorithms. One-year overall survival (56.8% versus 57.1%, P = .94), disease-free survival (51.6% versus 50.8%, P = .73), relapse rate (28.5% versus 26.2%, P = .94), nonrelapse mortality (19.9% versus 23.0%, P = .71), and the incidence of graft-versus-host disease were not significantly different between the ivBU1 and ivBU4 groups. In patients who received ivBU1, neutrophil recovery was slower (median days: 22 versus 17, P = .001), and the incidence of veno-occlusive disease was lower (2.6% versus 17.4%, P = .04). In conclusion, ivBU1 can be safely administered with clinical outcomes similar to those with ivBU4. Copyright © 2018 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  20. Extended-Release Once-Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate-Release Tofacitinib and Impact of Food.

    Science.gov (United States)

    Lamba, Manisha; Wang, Rong; Fletcher, Tracey; Alvey, Christine; Kushner, Joseph; Stock, Thomas C

    2016-11-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. An extended-release (XR) formulation has been designed to provide a once-daily (QD) dosing option to patients to achieve comparable pharmacokinetic (PK) parameters to the twice-daily immediate-release (IR) formulation. We conducted 2 randomized, open-label, phase 1 studies in healthy volunteers. Study A characterized single-dose and steady-state PK of tofacitinib XR 11 mg QD and intended to demonstrate equivalence of exposure under single-dose and steady-state conditions to tofacitinib IR 5 mg twice daily. Study B assessed the effect of a high-fat meal on the bioavailability of tofacitinib from the XR formulation. Safety and tolerability were monitored in both studies. In study A (N = 24), the XR and IR formulations achieved time to maximum plasma concentration at 4 hours and 0.5 hours postdose, respectively; terminal half-life was 5.9 hours and 3.2 hours, respectively. Area under plasma concentration-time curve (AUC) and maximum plasma concentration (C max ) after single- and multiple-dose administration were equivalent between the XR and IR formulations. In study B (N = 24), no difference in AUC was observed for fed vs fasted conditions. C max increased by 27% under the fed state. On repeat administration, negligible accumulation (Tofacitinib administration as an XR or IR formulation was generally well tolerated in these studies. © 2016, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  1. NRPB 'pill'

    International Nuclear Information System (INIS)

    Martin, S.; Arnott, D.

    1985-01-01

    The National Radiological Protection Board circulated a leaflet entitled 'Advice for general practitioners in the event of a civil nuclear emergency' in July 1985 to doctors' surgeries in the vicinity of nuclear power stations in England and Wales. The leaflet is reviewed and the scientific background to the 'anti-radiation' potassium iodate pill is explained. (author)

  2. Can combining different risk interventions into a single formulation contribute to improved cardiovascular disease risk reduction? The single pill of amlodipine/atorvastatin

    Directory of Open Access Journals (Sweden)

    FD Richard Hobbs

    2007-11-01

    Full Text Available FD Richard HobbsUniversity of Birmingham, Edgbaston, Birmingham B15 2TT, UK.Abstract: In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program investigated the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients. The JEWEL program consisted of two 16-week, international, openlabel, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The two studies differed based on country of enrollment and certain tertiary endpoints, but the overall designs were very similar. Patients were enrolled from 255 centers across Canada and 13 European countries. The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single pill therapy in a real-world setting. Patients were initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and were uptitrated as necessary. The primary efficacy parameter was the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II and the same single goal for LDL-C across all study participants (JEWEL I and II. The program utilized a newly developed questionnaire to gain better understanding of participants’ beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850

  3. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure

    Directory of Open Access Journals (Sweden)

    Inder S Anand

    2010-06-01

    Full Text Available Inder S Anand1, Anita Deswal2, Dean J Kereiakes3, Das Purkayastha4, Dion H Zappe41Veterans Administration Medical Center, Minneapolis, MN, USA; 2Michael E DeBakey VA Medical Center, Houston, TX, USA; 3The Christ Hospital Heart and Vascular Center, Cincinnati, OH, USA; 4Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Clinical trial registration information: www.clinicaltrials.gov/ct2/show/NC T00294086 Unique identification number: NC T00294086Background: The safety of once-daily (qd dosing of valsartan in heart failure (HF patients is not known. Hypothesis: This 10-week, double-blind trial examined the relative safety and efficacy of valsartan administered qd versus twice-daily (bid.Methods: HF patients (NYHA class II–III receiving diuretics (87%, angiotensin-converting enzyme inhibitors (98%, beta-blockers (92%, aldosterone antagonists (25%, or digoxin (32% were randomized to valsartan 40 mg bid (n = 60 or 80 mg qd (n = 55 and titrated to a maximum dose of 320 mg/day; doubling the dose every 2 weeks. Clinical and biochemical parameters were measured at Weeks 2, 4, 6, and 10.Results: The average dose of valsartan at the end of study was 245 mg in the bid group vs 256 mg in the qd group (P = NS. Similar proportions of patients tolerated qd vs bid dosing (bid 67% vs qd 68%. Outcome measures including reduction in blood pressure, incidence of hypotension, renal impairment, orthostatic dizziness or fatigue, changes in serum K+, creatinine, cystatin-C, and estimated glomerular filtration rate were similar between the 2 groups at all time-points. Brain natriuretic peptide levels decreased and plasma renin activity increased from baseline by the same amount in both groups at all time-points.Conclusion: Valsartan administered qd has a similar safety and tolerability profile with comparable 24-hour RAAS blockade, as assessed by increases in PRA, as bid dosing in patients with moderate to severe (NYHA class II–III heart failure

  4. Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes.

    Science.gov (United States)

    Vora, J; Caputo, S; Damci, T; Orozco-Beltran, D; Pan, C; Svendsen, A L; Sølje, K S; Khunti, K

    2014-04-01

    There are acknowledged benefits to continuing metformin when initiating insulin, but there appears to be growing concern over the role of sulphonylureas and thiazolidinediones when used in combination with insulin. This analysis investigates the effects of continuing or discontinuing oral antidiabetic drugs (OADs) following the initiation of once-daily insulin detemir. SOLVE is a 24-week, multinational observational study of insulin detemir initiation in patients with type 2 diabetes mellitus treated with one or more OADs. In the total cohort (n = 17 374), there were significant improvements in HbA1c (-1·3%, 95% CI -1·34; -1·27%) and weight (-0·6 kg, 95% CI -0·65; -0·47 kg), with an increase in the incidence rate of minor hypoglycaemia (+0·256 events ppy, P use either prior to (n = 17 086) or during insulin initiation (n = 16 346). HbA1c reductions were significantly greater in patients continuing treatment with metformin (-1·3% vs. -1·1%, P < 0·01), thiazolidinediones (-1·3% vs. -1·0%, P < 0·01) and DPP-IV inhibitors (-1·3% vs. -0·9%, P < 0·001). Final insulin doses were significantly greater in patients discontinuing treatment with sulphonylureas (0·29 vs. 0·26 IU/kg, P < 0·001), glinides (0·28 vs. 0·26 IU/kg, P < 0·01), thiazolidinediones (0·31 vs. 0·26 IU/kg, P < 0·001) and DPP-IV inhibitors (0·35 vs. 0·29 IU/kg, P < 0·001) compared with patients continuing these respective agents. All patient subgroups had a mean weight loss irrespective of OAD continuation, apart from those continuing thiazolidinediones (+0·2 kg). The largest improvements in weight were seen following the withdrawal of sulphonylureas and thiazolidinediones (-1·1 and -1·1 kg, respectively). Discontinuation (or switching) of OADs at the time of insulin initiation appears to be governed principally by concerns about hypoglycaemia and weight. HbA1c improvements were smaller in patients discontinuing OADs at the time of insulin

  5. Tamsulosin 0.4 mg once daily: effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction

    NARCIS (Netherlands)

    Höfner, K.; Claes, H.; de Reijke, T. M.; Folkestad, B.; Speakman, M. J.

    1999-01-01

    To evaluate the effect of tamsulosin, 0.4 mg once daily, on sexual function in comparison with placebo and alfuzosin, 2.5 mg three times daily, in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). Data from 830 patients randomized into three European

  6. Pharmacodynamics and Pharmacokinetics Following Once-Daily and Twice-Daily Dosing of Tiotropium Respimat(®) in Asthma Using Standardized Sample-Contamination Avoidance

    DEFF Research Database (Denmark)

    Beeh, Kai-Michael; Kirsten, Anne-Marie; Dusser, Daniel

    2016-01-01

    BACKGROUND: This study was conducted to confirm the 24-hour bronchodilator efficacy and pharmacokinetic profile of once-daily tiotropium Respimat(®) 5 μg add-on to inhaled corticosteroids (ICS) in adults with symptomatic asthma. It used a trial protocol designed to minimize the risk of pharmacoki...

  7. Twice-daily versus once-daily applications of pimecrolimus cream 1% for the prevention of disease relapse in pediatric patients with atopic dermatitis.

    Science.gov (United States)

    Ruer-Mulard, Mireille; Aberer, Werner; Gunstone, Anthony; Kekki, Outi-Maria; López Estebaranz, Jose Luis; Vertruyen, André; Guettner, Achim; Hultsch, Thomas

    2009-01-01

    The aim of this study is to compare twice-daily and once-daily applications of pimecrolimus cream 1% for prevention of atopic dermatitis relapses in pediatric patients. This multicenter trial enrolled 300 outpatients aged 2 to 17 years, with mild-to-severe atopic dermatitis. The patients were initially treated with twice-daily topical pimecrolimus until complete clearance or for up to 6 weeks (open-label period). Those who achieved a decrease of at least 1 point in the Investigator's Global Assessment score were then randomized to double-blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of disease remission (Investigator's Global Assessment = 0). The primary efficacy end point of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by Investigator's Global Assessment score > or = 3 and pruritus score > or = 2). Of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily (n = 134 in each group). The relapse rate was lower in the twice-daily dose group (9.9%) than that in the once-daily dose group (14.7%), but analysis of the time to disease relapse, using a Cox proportional model to adjust for confounding variables, did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31-1.30). Treatment of active atopic dermatitis lesions with pimecrolimus cream 1% twice daily, followed by the once-daily dosing regimen, was sufficient to prevent subsequent atopic dermatitis relapses over 16 weeks in pediatric patients.

  8. Birth control pills - combination

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/patientinstructions/000655.htm Birth control pills - combination To use the sharing features on ... both progestin and estrogen. What Are Combination Birth Control Pills? Birth control pills help keep you from ...

  9. Three-year outcomes of a once daily fractionation scheme for accelerated partial breast irradiation (APBI) using 3-D conformal radiotherapy (3D-CRT)

    International Nuclear Information System (INIS)

    Goyal, Sharad; Daroui, Parima; Khan, Atif J; Kearney, Thomas; Kirstein, Laurie; Haffty, Bruce G

    2013-01-01

    The aim of this study was to report 3-year outcomes of toxicity, cosmesis, and local control using a once daily fractionation scheme (49.95 Gy in 3.33 Gy once daily fractions) for accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT). Between July 2008 and August 2010, women aged ≥40 years with ductal carcinoma in situ or node-negative invasive breast cancer ≤3 cm in diameter, treated with breast-conserving surgery achieving negative margins, were accrued to a prospective study. Women were treated with APBI using 3–5 photon beams, delivering 49.95 Gy over 15 once daily fractions over 3 weeks. Patients were assessed for toxicities, cosmesis, and local control rates before APBI and at specified time points. Thirty-four patients (mean age 60 years) with Tis 0 (n = 9) and T1N0 (n = 25) breast cancer were treated and followed up for an average of 39 months. Only 3% (1/34) patients experienced a grade 3 subcutaneous fibrosis and breast edema and 97% of the patients had good/excellent cosmetic outcome at 3 years. The 3-year rate of ipsilateral breast tumor recurrence (IBTR) was 0% while the rate of contralateral breast events was 6%. The 3-year disease-free survival (DFS), overall survival (OS), and breast cancer-specific survival (BCSS) was 94%, 100%, and 100%, respectively. Our novel accelerated partial breast fractionation scheme of 15 once daily fractions of 3.33 Gy (49.95 Gy total) is a remarkably well-tolerated regimen of 3D-CRT-based APBI. A larger cohort of patients is needed to further ascertain the toxicity of this accelerated partial breast regimen

  10. Conversion From Twice-Daily Tacrolimus Capsules to Once-Daily Extended-Release Tacrolimus (LCPT): A Phase 2 Trial of Stable Renal Transplant Recipients

    Science.gov (United States)

    Gaber, A. Osama; Alloway, Rita R.; Bodziak, Kenneth; Kaplan, Bruce; Bunnapradist, Suphamai

    2013-01-01

    Background LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability to twice-daily tacrolimus capsules and no new safety concerns. Methods In this phase 2 study, adult stable kidney transplant patients on tacrolimus capsules (Prograf) twice-daily were converted to tacrolimus tablets (LCP-Tacro) once-daily; patients continued on LCP-Tacro once-daily for days 8 to 21; trough levels were to be maintained between 5 and 15 ng/mL; 24-hr pharmacokinetic assessments were done on days 7 (baseline pre-switch), 14, and 21. Results Forty-seven patients completed LCP-Tacro dosing per protocol. The mean conversion ratio was 0.71. Pharmacokinetic data demonstrated consistent exposure (AUC) at the lower conversion dose. Cmax (P=0.0001), Cmax/Cmin ratio (P<0.001), percent fluctuation (P<0.0001), and swing (P=0.0004) were significantly lower and Tmax significantly (P<0.001) longer for LCP-Tacro versus Prograf. AUC24 and Cmin correlation coefficients after 7 and 14 days of therapy were 0.86 or more, demonstrating a robust correlation between LCP-Tacro tacrolimus exposure and trough levels. There were three serious adverse events; none were related to study drug and all were resolved. Conclusions Stable kidney transplant patients can be safely converted from Prograf twice-daily to LCP-Tacro. The greater bioavailability of LCP-Tacro allows for once-daily dosing and similar (AUC) exposure at a dose approximately 30% less than the total daily dose of Prograf. LCP-Tacro displays flatter kinetics characterized by significantly lower peak-trough fluctuations. PMID:23715050

  11. Adherence to and Acceptance of Once-Daily Tacrolimus After Kidney and Liver Transplant: Results From OSIRIS, a French Observational Study.

    Science.gov (United States)

    Cassuto, Elisabeth; Pageaux, Georges P; Cantarovich, Diego; Rostaing, Lionel; Loupy, Alexandre; Roche, Bruno; Duvoux, Christophe; Moreau, Karine; Thervet, Eric; Mazouz, Hakim; Bourhis, Yann; Dharancy, Sébastien; Kessler, Michèle

    2016-10-01

    Adherence to immunosuppressive treatments is a major concern in transplanted patients. This 6-month French observational, longitudinal, prospective study aimed to assess patient adherence to and acceptance of once-daily tacrolimus (Advagraf) initiation in kidney and liver transplant recipients. Data from 1106 patients initiating once-daily tacrolimus during posttransplant follow-up were analyzed. Adherence and acceptance were assessed using self-administered questionnaires at inclusion and at 3 and 6 months. Mean age was 52.4 ± 13.2 years, 61.5% were men. For 94.9% of patients, once-daily tacrolimus was prescribed after switching from twice-daily tacrolimus. At inclusion, 20.9% of patients reported good treatment adherence, 72.0% minor nonadherence, and 7.1% were nonadherent. Mean general acceptance score (range, 0-100) was 77.7 (±24.7). At 3 months, adherence was improved in 21.1%, unchanged in 69.2%, and worsened in 9.7% of patients. Mean general acceptance score was 75.4 (±26.5). General acceptance score was improved in 28.0%, unchanged in 39.4%, and worsened in 32.7% of patients. At 6 months, similar changes in adherence and acceptance were observed. Higher general acceptance score at month 3 was significantly associated with better adherence at month 6. Conversion to once-daily tacrolimus led to an improved rate of adherence at month 3 in more than 20% of patients and a worsened rate of adherence in less than 10% of patients.

  12. Comparing omeprazole with fluoxetine for treatment of patients with heartburn and normal endoscopy who failed once daily proton pump inhibitors: double-blind placebo-controlled trial.

    Science.gov (United States)

    Ostovaneh, M R; Saeidi, B; Hajifathalian, K; Farrokhi-Khajeh-Pasha, Y; Fotouhi, A; Mirbagheri, S S; Emami, H; Barzin, G; Mirbagheri, S A

    2014-05-01

    Patients with heartburn but without esophageal erosion respond less well to proton pump inhibitors (PPIs). There is a growing body of evidence implicating the role of psychological comorbidities in producing reflux symptoms. Pain modulators improve symptoms in patients with other functional gastrointestinal disorders. We aimed to compare the efficacy of fluoxetine with omeprazole and placebo to achieve symptomatic relief in patients with heartburn and normal endoscopy who failed once daily PPIs. Endoscopy-negative patients with heartburn who failed once daily PPIs were randomly allocated to receive 6 weeks treatment of fluoxetine, omeprazole, or placebo. Random allocation was stratified according to ambulatory pH monitoring study. Percentage of heartburn-free days and symptom severity was assessed. Sixty patients with abnormal and 84 patients with normal pH test were randomized. Subjects receiving fluoxetine experienced more improvement in percentage of heartburn-free days (median 35.7, IQR 21.4-57.1) than those on omeprazole (median 7.14, IQR 0-50, p heartburn-free days (median improvement, 57.1, IQR 35.7-57.1 vs 13.9, IQR, 0-45.6 and 7.14, 0-23.8, respectively, p heartburn and normal endoscopy who failed once daily PPIs. The superiority of fluoxetine was mostly attributed to those with normal esophageal pH rather than those with abnormal pH (ClinicalTrials.gov, number NCT01269788). © 2014 John Wiley & Sons Ltd.

  13. An observational study evaluating tacrolimus dose, exposure, and medication adherence after conversion from twice- to once-daily tacrolimus in liver and kidney transplant recipients.

    Science.gov (United States)

    Bäckman, Lars; Persson, Carl-Axel

    2014-03-17

    Immunosuppression regimens in transplantation medicine are complex. Drugs with extended release action have simplified medication dosing without affecting efficacy. This prospective, observational, multicenter study, conducted in a routine medical practice setting, evaluated changes in tacrolimus daily dose and trough levels and patient-reported medication adherence at day 90 after 1:1 (mg: mg) conversion to once-daily tacrolimus in adult liver and kidney transplant recipients. Data from 224 recipients of a liver (n=19) or kidney (n=205) transplant, average age 51±14.5 years, were evaluated. The mean change in tacrolimus daily dose was +0.04 mg/day. Dose remained stable after conversion in 62.5%, was lower in 15.6%, and higher in 22% of patients. Trough level after conversion was lower in 62.6% and higher in 36.5%; generally, levels were 12.8% lower than pre-conversion levels. No acute rejection, graft loss, or serious safety events were observed. Two deaths occurred due to myocardial infarction. Conversion helped 19% to less frequently forget medications and 55% reported no difference in remembering to take the once-daily dose after conversion. The change in dosing frequency was identified as "better" for 55%. Tacrolimus daily dose remained stable while trough levels were significantly lower after conversion to once-daily dosing. Safety and efficacy were maintained; reduced dosing frequency had no apparent influence on patient-reported medication adherence.

  14. Compliance, clinical outcome, and quality of life of patients with stable angina pectoris receiving once-daily betaxolol versus twice daily metoprolol: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Przemyslaw Kardas

    2007-05-01

    Full Text Available Przemyslaw KardasThe First Department of Family Medicine, Medical University of LodzBackground: A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris.Methods: One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life.Results: The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01, and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001. The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01. The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01, correct interdose intervals (77.4% v 53.1%, p < 0.0001, and therapeutic coverage (85.6% vs 73.7%, p < 0.001 were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions.Conclusions: The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris.Keywords: patient compliance, quality of life, stable angina pectoris, randomized controlled trial

  15. Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction.

    Science.gov (United States)

    Brock, Gerald; Broderick, Gregory; Roehrborn, Claus G; Xu, Lei; Wong, David; Viktrup, Lars

    2013-11-01

    To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED). To compare these with effects in men with ED. After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores. Safety was assessed using treatment-emergent adverse events. The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups. Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED. Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS -5.4 vs -3.3, P  0.68). Tadalafil was safe and well tolerated. Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED. The adverse event profile in men without ED was consistent with that observed in men with ED. © 2013 The Authors. BJU International © 2013 BJU International.

  16. Postprandial changes in methanogenic and acidogenic bacteria in the rumens of steers fed high- or low-forage diets once daily.

    OpenAIRE

    Leedle, J A; Greening, R C

    1988-01-01

    Four ruminally fistulated Hereford steers (400 kg) were fed two isocaloric diets at 1.5 x maintenance once daily in a repeated measurement crossover experiment. Postprandial changes in hydrogen-oxidizing, carbon dioxide-reducing bacterial groups were monitored. The methanogenic bacterial populations were present at densities of 4 x 10(8) to 8 x 10(8)/g of ruminal contents on either the high- or low-forage diet. Numbers remained constant postprandially on the high-forage diet but showed a dist...

  17. Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2014-01-01

    BACKGROUND AND AIM: Long-acting bronchodilators are the preferred option for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the clinical efficacy of the once-daily fixed-dose du...... for chronic Obstructive Lung Disease [GOLD] spirometric criteria). Furthermore, a very recent study has shown that fixed-dose indacaterol/glycopyrronium improves exercise endurance time compared with placebo, although no significant difference was observed between fixed-dose indacaterol...

  18. Changes in body weight, blood pressure and selected metabolic biomarkers with an energy-restricted diet including twice daily sweet snacks and once daily sugar-free beverage

    OpenAIRE

    Nickols-Richardson, Sharon M.; Piehowski, Kathryn E.; Metzgar, Catherine J.; Miller, Debra L.; Preston, Amy G.

    2014-01-01

    BACKGROUND/OBJECTIVES The type of sweet snack incorporated into an energy-restricted diet (ERD) may produce differential effects on metabolic improvements associated with body weight (BW) loss. This study compared effects of incorporating either twice daily energy-controlled dark chocolate snacks plus once daily sugar-free cocoa beverage (DC) to non-chocolate snacks plus sugar-free non-cocoa beverage (NC) into an ERD on BW loss and metabolic outcomes. MATERIALS/METHODS In an 18-week randomize...

  19. The efficacy and safety of a novel lipophilic formulation of methimazole for the once daily transdermal treatment of cats with hyperthyroidism.

    Science.gov (United States)

    Hill, K E; Gieseg, M A; Kingsbury, D; Lopez-Villalobos, N; Bridges, J; Chambers, P

    2011-01-01

    Previous studies on transdermal methimazole have used pluronic lecithin organogel as the vehicle. This might not be the most suitable vehicle for a lipophilic drug, such as methimazole. Once daily transdermal administration of a novel lipophilic formulation of methimazole is as safe and effective as oral carbimazole in treating hyperthyroidism in cats. Forty-five client-owned cats diagnosed with hyperthyroidism. Prospective study. Cats with newly diagnosed, untreated hyperthyroidism were treated with carbimazole (5 mg p.o., q12h) or methimazole (10 mg) applied to the inner pinnae q24h. Cats were examined after 0, 1, 4, 8, and 12 weeks of treatment. Clinical signs, body weight, systolic blood pressure, hematologic, serum biochemical and urine parameters, total serum thyroxine concentrations (TT4), and serum methimazole concentrations were recorded. No significant differences between groups were detected at day 0. Both formulations were effective in treating hyperthyroidism. No significant differences were detected in thyroxine concentrations, body weight, blood pressure, heart rate, alkaline phosphatase, alanine aminotransferase, creatinine, urea, and urine specific gravity (USG) between groups. The serum methimazole concentrations correlated poorly with TT4-concentrations in both groups. In this 12-week trial, once daily application of a novel formulation of transdermal methimazole applied to the pinnae was as effective and safe as twice daily oral carbimazole in the treatment of cats with hyperthyroidism. This novel formulation and transdermal application could have practical advantages to some pet owners. Copyright © 2011 by the American College of Veterinary Internal Medicine.

  20. Birth Control Pill

    Science.gov (United States)

    ... Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol School & Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español Birth Control Pill KidsHealth / For Teens / Birth Control Pill What's ...

  1. A Prospective Open-Label Multicentre Trial on the Use of 1 G, Once Daily Ceftriaxone in Lower Respiratory Tract Infections

    Directory of Open Access Journals (Sweden)

    Donald E Low

    1994-01-01

    in the study. Clinical cure and clinical improvement were achieved in 64.6 and 28.3% of the evaluable patients. respectively. Relapse of infection occurred in two patients (1.8%. and treatment failure was recorded in six cases (5.3%. Twelve patients (8.8% died clue to reasons unrelated to the sludy treatment. Three adverse event (hives, diarrhea and phlebitis at the injection site were possibly related to the study drug. A cross-Canada in vitro susceptibility surveillance study of bacterial pathogens. frequently the cause of pneumonia. found ceftriaxone to have minimal inhibitory concentrations in 90% of isolates that would support such a dosing regimen. with the exception of Enterobacter species. These rcsults support the use of 1 g, once daily ceftriaxone for the empirical treatment of pneumonia in those patients requiring hospitalization.

  2. A novel once daily microparticulate dosage form comprising lansoprazole to prevent nocturnal acid breakthrough in the case of gastro-esophageal reflux disease: preparation, pharmacokinetic and pharmacodynamic evaluation.

    Science.gov (United States)

    Alai, Milind; Lin, Wen Jen

    2013-01-01

    The objective of this study was to formulate and evaluate the lansoprazole (LPZ)-loaded microparticles to prevent nocturnal acid breakthrough in the case of gastro-esophageal reflux disease (GERD). The microparticulate delivery system was prepared by solvent evaporation method using Eudragit RS100 as a matrix polymer followed by enteric coated with Eudragit S100 and hydroxypropyl methylcellulose phthalate HP55 using spray drying method. The enteric coated microparticles were stable in gastric pH condition. In vivo pharmacokinetic and pharmacodynamic studies in male Wistar rats demonstrated that enteric coated microparticles sustained release of LPZ and promoted ulcer healing activity. In other words, the microparticulate dosage form provided effective drug concentration for a longer period as compared to conventional extended release dosage form, and showed sufficient anti-acid secretion activity to treat acid related disorders including the enrichment of nocturnal acid breakthrough event based on a once daily administration.

  3. Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy

    Directory of Open Access Journals (Sweden)

    Albertson TE

    2016-12-01

    Full Text Available Timothy E Albertson,1–3 Samuel W Bullick,1,3 Michael Schivo,1 Mark E Sutter2,3 1Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, 2Department of Emergency Medicine, School of Medicine, UC Davis, Sacramento, 3Department of Medicine, Veterans Administration Northern California Health Care System, Mather, CA, USA Abstract: The use of inhaled corticosteroids (ICSs plays a key role in the treatment of asthmatic patients, and international guidelines have designated ICSs as an early maintenance therapy in controlling asthma symptoms. When asthmatic patients remain symptomatic on ICSs, one common option is to add a long-acting beta2 agonist (LABA to the maintenance treatment. Fixed combination inhalers that contain both an ICS and a LABA have been popular for both chronic obstructive pulmonary disease (COPD and asthma. Historically, these inhalers have been dosed twice daily. However, currently, there is a once-daily combination therapy with the ICS fluticasone furoate (FF and the LABA vilanterol trifenatate (VI with indications for use in both COPD and asthma. This dry powder inhaler (DPI comes in two doses of FF (100 or 200 µg both combined with VI (25 µg. This article reviews the clinical trial data for FF, VI and FF/VI combination inhalers and documents the efficacy and safety of once-daily inhaled maintenance therapy by DPI in asthmatic patients. Keywords: fluticasone furoate/vilanterol trifenatate, asthma, long-acting beta2 agonist, inhaled corticosteroid, combined inhaler, persistent asthma, dry powder inhaler  

  4. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial

    Directory of Open Access Journals (Sweden)

    D'Urzo Anthony

    2011-12-01

    Full Text Available Abstract Background NVA237 is a once-daily dry-powder formulation of the long-acting muscarinic antagonist glycopyrronium bromide in development for the treatment of chronic obstructive pulmonary disease (COPD. The glycopyrronium bromide in COPD airways clinical study 1 (GLOW1 evaluated the efficacy, safety and tolerability of NVA237 in patients with moderate-to-severe COPD. Methods Patients with COPD with a smoking history of ≥ 10 pack-years, post-bronchodilator forced expiratory volume in 1 second (FEV1 1/forced vital capacity 1 antagonists permitted in patients stabilized on them prior to study entry. The primary outcome measure was trough FEV1 at Week 12. Results A total of 822 patients were randomized to NVA237 (n = 552 or placebo (n = 270. Least squares mean (± standard error trough FEV1 at Week 12 was significantly higher in patients receiving NVA237 (1.408 ± 0.0105 L, versus placebo (1.301 ± 0.0137 L; treatment difference 108 ± 14.8 mL, p 1 were apparent at the end of Day 1 and sustained through Week 26. FEV1 was significantly improved in the NVA237 group versus placebo throughout the 24-hour periods on Day 1 and at Weeks 12 and 26, and at all other visits and timepoints. Transition dyspnoea index focal scores and St. George's Respiratory Questionnaire scores were significantly improved with NVA237 versus placebo at Week 26, with treatment differences of 1.04 (p Conclusions Once-daily NVA237 was safe and well tolerated and provided rapid, sustained improvements in lung function, improvements in dyspnoea, and health-related quality of life, and reduced the risk of exacerbations and the use of rescue medication. Trial registration ClinicalTrials.gov: NCT01005901

  5. Lansoprazole 15 mg once daily for 14 days is effective for treatment of frequent heartburn: results of 2 randomized, placebo-controlled, double-blind studies.

    Science.gov (United States)

    Kushner, Pamela R; Snoddy, Andrew M; Gilderman, Larry; Peura, David A

    2009-07-01

    To investigate the efficacy and safety of a 14-day treatment period with lansoprazole 15 mg for frequent heartburn in patients who are likely to select a nonprescription medication before consulting a prescriber. Adults with untreated frequent heartburn > or = 2 days a week over the past month were recruited for 2 identical multicenter, double-blind studies conducted with a 1-week screening and heartburn medication washout, a 1-week placebo run-in, a 2-week placebo-controlled treatment, and a 1-week placebo follow-up. After the washout and placebo run-in, subjects were randomly assigned to receive lansoprazole 15 mg or placebo once daily for 14 days in a double-blind fashion. Antacid tablets were permitted as rescue medication. Endpoints included percentage of 24-hour days without heartburn (primary), percentage of night-times without heartburn, and percentage of subjects without heartburn during day 1 of treatment (secondary endpoints). Data were collected daily via an interactive voice response system. In studies 1 and 2, 282 and 288 subjects, respectively, were randomly assigned to lansoprazole, and 282 in each study received placebo. The mean percentage of days without heartburn was greater among lansoprazole recipients compared with placebo recipients (P heartburn and no heartburn during day 1 of the 14-day treatment. Adverse events were infrequent and were similar for lansoprazole and placebo groups. During the 14-day treatment period in a population with frequent heartburn who were likely to select a medication without consulting a prescriber, lansoprazole 15 mg once daily showed rapid and sustained effectiveness throughout a 24-hour period and was well tolerated.

  6. Impact of Statin Therapy on the Blood Pressure-Lowering Efficacy of a Single-Pill Perindopril/Amlodipine Combination in Hypertensive Patients with Hypercholesterolemia.

    Science.gov (United States)

    Sirenko, Yuriy; Radchenko, Ganna

    2017-03-01

    Several lines of research indicate that statins can lower blood pressure (BP) independently of their lipid-lowering effects when used as monotherapy and in combination with antihypertensive agents. This short-term, open-label study examined whether statin therapy had a synergistic effect on the BP-lowering efficacy of perindopril/amlodipine in a subgroup of patients in the PERSPECTIVA study with concomitant hypertension and hypercholesterolemia, with or without statin at baseline. The PERSPECTIVA study recruited 732 adults with untreated or uncontrolled hypertension. This subgroup analysis of PERSPECTIVA included 587 patients with concomitant hypertension and hypercholesterolemia (mean age 56.7 years) of whom 226 were receiving a statin at baseline (statin [+] group) and 361 were not (statin [-] group). All patients received treatment with single-pill combination perindopril/amlodipine at a dose of 5/5, 10/5 or 10/10 mg/day. The study duration was 60 days with follow-up visits for BP monitoring at 7, 15, 30 and 60 days. At day 60, BP control (statin [+] vs statin [-] group: 73 vs 64% respectively (+14%, P statin [+] group, the single-pill perindopril/amlodipine combination significantly reduced BP in patients previously untreated (n = 18), or treated with monotherapy (n = 97), dual therapy (n = 93), or triple therapy (n = 18): -38.8/-20.0, -39.1/-20.1, -38.0/-19.4, -39.9/-18.3 mmHg respectively (P statin [+] group (0.9%) vs the statin [-] group (2.5%). BP control rates in patients with uncontrolled hypertension and concomitant hypercholesterolemia are significantly improved with a treatment regimen that combines perindopril/amlodipine with statin therapy, regardless of previous antihypertensive therapy. This subanalysis of the PERSPECTIVA study supports the synergistic BP-lowering effect of statins and perindopril/amlodipine.

  7. Randomised clinical trial: alginate (Gaviscon Advance) vs. placebo as add-on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor.

    Science.gov (United States)

    Reimer, C; Lødrup, A B; Smith, G; Wilkinson, J; Bytzer, P

    2016-04-01

    Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01]. In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21). © 2016 John Wiley & Sons Ltd.

  8. Exploratory study of once-daily transcranial direct current stimulation (tDCS) as a treatment for auditory hallucinations in schizophrenia.

    Science.gov (United States)

    Fröhlich, F; Burrello, T N; Mellin, J M; Cordle, A L; Lustenberger, C M; Gilmore, J H; Jarskog, L F

    2016-03-01

    Auditory hallucinations are resistant to pharmacotherapy in about 25% of adults with schizophrenia. Treatment with noninvasive brain stimulation would provide a welcomed additional tool for the clinical management of auditory hallucinations. A recent study found a significant reduction in auditory hallucinations in people with schizophrenia after five days of twice-daily transcranial direct current stimulation (tDCS) that simultaneously targeted left dorsolateral prefrontal cortex and left temporo-parietal cortex. We hypothesized that once-daily tDCS with stimulation electrodes over left frontal and temporo-parietal areas reduces auditory hallucinations in patients with schizophrenia. We performed a randomized, double-blind, sham-controlled study that evaluated five days of daily tDCS of the same cortical targets in 26 outpatients with schizophrenia and schizoaffective disorder with auditory hallucinations. We found a significant reduction in auditory hallucinations measured by the Auditory Hallucination Rating Scale (F2,50=12.22, PtDCS for treatment of auditory hallucinations and the pronounced response in the sham-treated group in this study contrasts with the previous finding and demonstrates the need for further optimization and evaluation of noninvasive brain stimulation strategies. In particular, higher cumulative doses and higher treatment frequencies of tDCS together with strategies to reduce placebo responses should be investigated. Additionally, consideration of more targeted stimulation to engage specific deficits in temporal organization of brain activity in patients with auditory hallucinations may be warranted. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  9. Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

    Directory of Open Access Journals (Sweden)

    Vladimir Skljarevski

    2012-01-01

    Full Text Available We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE study that examine duloxetine 40 and 60 mg once daily (QD in patients with diabetic peripheral neuropathic pain (DPNP. In all placebo-controlled studies, duloxetine showed significantly (P≤.01 greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P≤.05 greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P≤.01 for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P≤.01 between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%. Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

  10. Switch from a ZDV/3TC-based regimen to a completely once daily (QD regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT

    Directory of Open Access Journals (Sweden)

    Arasteh K

    2009-05-01

    Full Text Available Abstract Objectives To assess the efficacy and safety of a treatment switch from a twice-daily (BID regimen containing zidovudine (ZDV and lamivudine (3TC plus a third agent to a once daily (QD regimen containing the fixed-dose combination of tenofovir DF/emtricitabine (TDF/FTC, Truvada® plus a divergent third QD agent in HIV-1 infected patients. Methods Prospective, 48-week, non-randomised, single-group, open-label, study. Fifty-one patients on stable ZDV/3TC-containing HAART, with HIV-1 RNA 50 cells/μl, were switched to TDF/FTC plus a third agent. Plasma HIV-1 RNA, CD4+ and CD8+ T-cell counts were assessed at baseline and weeks 4, 12, 24, 36 and 48 post-switch. Results During the 48-week study, 10 patients discontinued prematurely, including three due to adverse events (AEs. At week 48, plasma HIV-1 RNA was p Conclusions Results from this study support switching from a ZDV/3TC-containing HAART regimen to a completely QD regimen of TDF/FTC plus a third agent. Virologic and immunologic control are maintained, with apparent benefits in haemoglobin.

  11. Dapagliflozin once-daily and exenatide once-weekly dual therapy: A 24-week randomized, placebo-controlled, phase II study examining effects on body weight and prediabetes in obese adults without diabetes.

    Science.gov (United States)

    Lundkvist, Per; Sjöström, C David; Amini, Sam; Pereira, Maria J; Johnsson, Eva; Eriksson, Jan W

    2017-01-01

    To explore the effects of dual therapy with dapagliflozin and exenatide on body weight, body composition, glycaemic variables and systolic blood pressure (SBP) in obese adults without diabetes. In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m 2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or placebo. MRI was used to assess change in body composition. Participants were instructed to follow a balanced diet and exercise moderately. Of 25 dapagliflozin/exenatide- and 25 placebo-treated participants, 23 (92.0%) and 20 (80.0%) completed 24 weeks of treatment, respectively. At baseline, the mean participant age was 52 years, 61% were female, the mean body weight was 104.6 kg, and 73.5% of participants had prediabetes (impaired fasting glucose or impaired glucose tolerance). After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P prediabetes was less frequent with active treatment (34.8% vs 85.0%, respectively; P prediabetes and SBP over 24 weeks and was well tolerated in obese adults without diabetes. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  12. Birth control pills - progestin only

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/patientinstructions/000656.htm Birth control pills - progestin only To use the sharing features ... estrogen in them. What Are Progestin Only Birth Control Pills? Birth control pills help keep you from ...

  13. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study.

    Science.gov (United States)

    Blume-Peytavi, Ulrike; Shapiro, Jerry; Messenger, Andrew G; Hordinsky, Maria K; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Olsen, Elise A

    2016-07-01

    A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss. Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage. Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was -0.3 hairs/cm2 (95% CI = -6.0, 5.4). Since the lower bound of the 95% CI was less than -5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated. Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met. ClinicalTrials.gov identifier: NCT01145625 J Drugs Dermatol. 2016;15(7):883-889.

  14. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study

    Directory of Open Access Journals (Sweden)

    Vincken W

    2014-02-01

    Full Text Available Walter Vincken,1 Joseph Aumann,2 Hungta Chen,3 Michelle Henley,3 Danny McBryan,4 Pankaj Goyal4 1Respiratory Division, University Hospital, UZ Brussel, Free University of Brussels, Brussels, Belgium; 2Longartsenpraktijk, Prins Bisschopssingel, Hasselt, Belgium; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Novartis Pharma AG, Basel, Switzerland Background: Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND and the long-acting muscarinic antagonist glycopyrronium (GLY versus IND alone in patients with moderate-to-severe COPD. Materials and methods: In this randomized, double-blind, parallel group, placebo-controlled, 12-week study, patients were randomized 1:1 to IND 150 µg and GLY 50 µg daily (IND + GLY or IND 150 µg daily and placebo (IND + PBO (all delivered via separate Breezhaler® devices. The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second (FEV1 at week 12. Other end points included trough FEV1 at day 1, FEV1 area under the curve from 30 minutes to 4 hours (AUC30min–4h, peak FEV1, inspiratory capacity and trough forced vital capacity (FVC at day 1 and week 12, and transition dyspnea index (TDI focal score, COPD symptoms, and rescue medication use over 12 weeks. Results: A total of 449 patients were randomized (IND + GLY, 226; IND + PBO, 223; 94% completed the study. On day 1 and at week 12, IND + GLY significantly improved trough FEV1 versus IND + PBO, with treatment differences of 74 mL (95% CI 46–101 mL and 64 mL (95% CI 28–99 mL, respectively (both P<0.001. IND + GLY significantly improved postdose peak FEV1, FEV1 AUC30min–4h

  15. Cost effectiveness of once-daily oral chelation therapy with deferasirox versus infusional deferoxamine in transfusion-dependent thalassaemia patients: US healthcare system perspective.

    Science.gov (United States)

    Delea, Thomas E; Sofrygin, Oleg; Thomas, Simu K; Baladi, Jean-Francois; Phatak, Pradyumna D; Coates, Thomas D

    2007-01-01

    Deferasirox is a recently approved once-daily oral iron chelator that has been shown to reduce liver iron concentrations and serum ferritin levels to a similar extent as infusional deferoxamine. To determine the cost effectiveness of deferasirox versus deferoxamine in patients with beta-thalassaemia major from a US healthcare system perspective. A Markov model was used to estimate the total additional lifetime costs and QALYs gained with deferasirox versus deferoxamine in patients with beta-thalassaemia major and chronic iron overload from blood transfusions. Patients were assumed to be 3 years of age at initiation of chelation therapy and to receive prescribed dosages of deferasirox and deferoxamine that have been shown to be similarly effective in such patients. Compliance with chelation therapy and probabilities of iron overload-related cardiac disease and death by degree of compliance were estimated using data from published studies. Costs ($US, year 2006 values) of deferoxamine administration and iron overload-related cardiac disease were based on analyses of health insurance claims of transfusion-dependent thalassaemia patients. Utilities were based on a study of patient preferences for oral versus infusional chelation therapy, as well as published literature. Probabilistic and deterministic sensitivity analyses were employed to examine the robustness of the results to key assumptions. Deferasirox resulted in a gain of 4.5 QALYs per patient at an additional expected lifetime cost of $US126,018 per patient; the cost per QALY gained was $US28,255. The cost effectiveness of deferasirox versus deferoxamine was sensitive to the estimated costs of deferoxamine administration and the quality-of-life benefit associated with oral versus infusional therapy. Cost effectiveness was also relatively sensitive to the equivalent daily dose of deferasirox, and the unit costs of deferasirox and deferoxamine, and was more favourable in younger patients. Results of this analysis

  16. Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT

    Directory of Open Access Journals (Sweden)

    Ross Lisa L

    2008-03-01

    Full Text Available Abstract Background Once-daily (QD ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100 or atazanavir 300 mg (ATV/r100, plus tenofovir/emtricitabine (TDF/FTC 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3 randomly assigned to the FPV/r100 or ATV/r100 regimens. Results At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both], CD4+ count (mean, 176 vs 205 cells/mm3. At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA 3, p = 0.398 [Wilcoxon rank sum test]. Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL. FPV/r100-treated patients experienced fewer treatment-related grade 2–4 adverse events (15% vs 57%, with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to Conclusion The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2–4 adverse events.

  17. Concentrations of dapivirine in the rhesus macaque and rabbit following once daily intravaginal administration of a gel formulation of [14C]dapivirine for 7 days.

    Science.gov (United States)

    Nuttall, Jeremy P; Thake, Daryl C; Lewis, Mark G; Ferkany, John W; Romano, Joseph W; Mitchnick, Mark A

    2008-03-01

    Dapivirine is a nonnucleoside reverse transcriptase inhibitor being developed as a topical microbicide for the prevention of human immunodeficiency virus infection. The distribution of radioactivity and drug in plasma and in vaginal, cervical, and draining lymph node tissues was investigated after daily application of a vaginal gel formulation of [14C]dapivirine to rhesus macaques. This was preceded by a preliminary study with rabbits. Following the intravaginal administration of [14C]dapivirine ( approximately 0.1 mg/ml [15 microCi/ml]) to rabbits (0.5 ml/day) and macaques (1 ml/day) for 7 days, the dapivirine levels associated with vaginal and cervical tissue samples 1 h after the final dose were high (quantities of microg/g of tissue) and remained detectable at 24 h (mean, >or=2.5 ng/g in rabbits) and 48 h (mean, >80 ng/g in macaques). Radioactivity levels were low in the plasma and very low or unquantifiable in the draining lymph nodes of the macaques. Microautoradiography identified drug-related material (DRM) on the surfaces of the vaginal and cervical tissues of the rabbits and macaques. Although DRM was primarily associated with the outermost layer of shedding cells in rabbits, two animals showed some evidence of small quantities in the mucosal epithelium of the cervix. In macaques, DRM was seen within the keratinized layer of the vaginal epithelium and and was found to extend into the superficial cellular layers, and in at least one animal it appeared to be present in the deepest (germinal) layer of the epithelium and in submucosal tissues. The persistence of biologically significant concentrations of dapivirine in vaginal and cervical tissues for >24 h supports the development of dapivirine as a microbicide for once daily application.

  18. Concentrations of Dapivirine in the Rhesus Macaque and Rabbit following Once Daily Intravaginal Administration of a Gel Formulation of [14C]Dapivirine for 7 Days▿

    Science.gov (United States)

    Nuttall, Jeremy P.; Thake, Daryl C.; Lewis, Mark G.; Ferkany, John W.; Romano, Joseph W.; Mitchnick, Mark A.

    2008-01-01

    Dapivirine is a nonnucleoside reverse transcriptase inhibitor being developed as a topical microbicide for the prevention of human immunodeficiency virus infection. The distribution of radioactivity and drug in plasma and in vaginal, cervical, and draining lymph node tissues was investigated after daily application of a vaginal gel formulation of [14C]dapivirine to rhesus macaques. This was preceded by a preliminary study with rabbits. Following the intravaginal administration of [14C]dapivirine (∼0.1 mg/ml [15 μCi/ml]) to rabbits (0.5 ml/day) and macaques (1 ml/day) for 7 days, the dapivirine levels associated with vaginal and cervical tissue samples 1 h after the final dose were high (quantities of μg/g of tissue) and remained detectable at 24 h (mean, ≥2.5 ng/g in rabbits) and 48 h (mean, >80 ng/g in macaques). Radioactivity levels were low in the plasma and very low or unquantifiable in the draining lymph nodes of the macaques. Microautoradiography identified drug-related material (DRM) on the surfaces of the vaginal and cervical tissues of the rabbits and macaques. Although DRM was primarily associated with the outermost layer of shedding cells in rabbits, two animals showed some evidence of small quantities in the mucosal epithelium of the cervix. In macaques, DRM was seen within the keratinized layer of the vaginal epithelium and and was found to extend into the superficial cellular layers, and in at least one animal it appeared to be present in the deepest (germinal) layer of the epithelium and in submucosal tissues. The persistence of biologically significant concentrations of dapivirine in vaginal and cervical tissues for >24 h supports the development of dapivirine as a microbicide for once daily application. PMID:18086845

  19. Pharmacokinetics, safety and efficacy of ritonavir-boosted atazanavir (300/100 mg once daily) in HIV-1-infected pregnant women.

    Science.gov (United States)

    Lê, Minh P; Mandelbrot, Laurent; Descamps, Diane; Soulié, Cathia; Ichou, Houria; Bourgeois-Moine, Agnès; Damond, Florence; Lariven, Sylvie; Valantin, Marc-Antoine; Landman, Roland; Faucher, Philippe; Tubiana, Roland; Duro, Dominique; Meier, Françoise; Legac, Sylvie; Bourse, Patricia; Mortier, Emmanuel; Dommergues, Marc; Calvez, Vincent; Matheron, Sophie; Peytavin, Gilles

    2015-01-01

    Atazanavir/ritonavir (ATV/r) is a boosted protease inhibitor recommended to minimize the risk of mother-to-child HIV-1 transmission (MTCT). We aimed to assess the pharmacokinetics, safety and efficacy of ATV/r in HIV-1-infected pregnant women and their neonates. A multicentre, cross-sectional, non-interventional cohort of HIV-1-infected pregnant women receiving ATV/r (300/100 mg once daily) who delivered in three Paris hospitals from 2006 to 2013 was designed. We determined antiretroviral trough plasma concentrations using liquid chromatography-mass spectrometry at each of the three trimesters, delivery and post-partum. ATV concentrations at 24 h (C24h) were interpreted by the 150-850 ng/ml efficacy-tolerance thresholds. Safety data and newborn HIV status were recorded. A mother's virological failure was defined as two successive measurements of plasma HIV-1 RNA>50 copies/ml within the 2 months before delivery. 103 pregnant women were included, mostly from sub-Saharan Africa (88%). ATV C24h at each of the three trimesters and delivery remained similar to post-partum values. No dose adjustment was needed during pregnancy. The median plasma ratio of fetal/maternal ATV level was 0.19 (n=28). Only three patients showed two successive detectable viral loads but <400 copies/ml. Among 82 available newborn data, 16 were born preterm. Three in utero deaths occurred. Tolerance was good with one case of maternal grade 3 hyperbilirubinaemia, no cases in neonates at delivery and no clinically relevant adverse event. No case of MTCT was reported. In this population, an ATV/r-containing antiretroviral regimen demonstrated good pharmacokinetics, virological efficacy and safety. No significant impact of pregnancy on ATV C24h was found. No dose adjustment was required.

  20. Pill Properties that Cause Dysphagia and Treatment Failure

    Science.gov (United States)

    Fields, Jeremy; Go, Jorge T.; Schulze, Konrad S.

    2015-01-01

    texture; others cited sharp edges, odd shapes, or bad taste/smell. Extra-large pills were widely loathed, with 4 out of 5 participants preferring to take 3 or more medium-sized pills instead of a single jumbo pill. Conclusions Our survey results suggest that 4 out of 5 adult Americans take several pills daily, and do so without undue effort. It also suggests that half of today’s Americans encounter pills that are hard to swallow. Up to 4% of our participants gave up on treatments because they could not swallow the prescribed pills. Up to 7% categorically rejected taking pills that are hard to swallow. Specific material properties are widely blamed for making pills hard to swallow; extra-large capsules and tablets are universally feared, whereas medium-sized pills with a smooth coating are widely preferred. Our findings suggest that health care providers could minimize treatment failures and complications by prescribing and dispensing pills that are easy to swallow. Industry and regulatory bodies may facilitate this by making swallowability an essential criterion in the design and licensing of oral medications. Such policies could lessen the burden of pill taking for Americans and improve the adherence with prescribed treatments. PMID:26543509

  1. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol

    Directory of Open Access Journals (Sweden)

    Roskell NS

    2014-07-01

    Full Text Available Neil S Roskell,1 Antonio Anzueto,2 Alan Hamilton,3 Bernd Disse,4 Karin Becker5 1Statistics, Bresmed Health Solutions Ltd, Sheffield, UK; 2School of Medicine, University of Texas Health Science Center, San Antonio, TX, USA; 3Medical Department, Boehringer Ingelheim (Canada Ltd, Burlington, ON, Canada; 4Medical Department, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany; 5Global Health Economics and Outcomes Research, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany Purpose: In the absence of head-to-head clinical trials comparing the once-daily, long-acting beta2-agonists olodaterol and indacaterol for the treatment of chronic obstructive pulmonary disease (COPD, an indirect treatment comparison by systematic review and synthesis of the available clinical evidence was conducted. Methods: A systematic literature review of randomized, controlled clinical trials in patients with COPD was performed to evaluate the efficacy and safety of olodaterol and indacaterol. Network meta-analysis and adjusted indirect comparison methods were employed to evaluate treatment efficacy, using outcomes based on trough forced expiratory volume in 1 second (FEV1, Transition Dyspnea Index, St George’s Respiratory Questionnaire total score and response, rescue medication use, and proportion of patients with exacerbations. Results: Eighteen trials were identified for meta-analysis (eight, olodaterol; ten, indacaterol. Olodaterol trials included patients of all severities, whilst indacaterol trials excluded patients with very severe COPD. Concomitant maintenance bronchodilator use was allowed in most olodaterol trials, but not in indacaterol trials. When similarly designed trials/data were analyzed for change from baseline in trough FEV1 (liters, the following mean differences (95% confidence interval were observed: trials excluding concomitant bronchodilator: indacaterol 75 mcg versus olodaterol 5 mcg, –0.005 (–0.077 to 0.067, and indacaterol 150 mcg

  2. Once-daily milking during a feed deficit decreases milk production but improves energy status in early lactating grazing dairy cows.

    Science.gov (United States)

    Kay, J K; Phyn, C V C; Rius, A G; Morgan, S R; Grala, T M; Roche, J R

    2013-10-01

    The objective of this study was to investigate the effect of milking frequency (MF) at 2 feeding levels (FL) on milk production, body condition score, and metabolic indicators of energy status in grazing dairy cows during early lactation. Multiparous Holstein-Friesian and Holstein-Friesian × Jersey cows (n=120) grazed pasture and were milked twice daily (2×) from calving until 34 ± 6 d in milk (mean ± standard deviation). Cows were then allocated to 1 of 4 treatments in a 2 × 2 factorial arrangement. Treatments consisted of 2 FL: adequately fed [AF; 14.3 kg dry matter intake (DMI)/cow per d] or underfed (UF; 8.3 kg of DMI/cow per d) and 2 MF: 2× or once daily (1×). Treatments were imposed for 3 wk. After the treatment period, all cows were offered a generous pasture allowance (grazing residuals >1,600 kg of dry matter/ha) and milked 2×. During the 3-wk treatment period, we observed an interaction between FL and MF for energy-corrected milk (ECM), such that the decrease due to 1× milking was greater in AF than in UF cows (20 and 14% decrease, respectively). No interactions were found posttreatment. Cows previously UF produced 7% less ECM than AF cows during wk 4 to 12; however, no subsequent effect was observed of the previous underfeeding. Cows previously milked 1× produced 5% less ECM during wk 4 to 12, and differences remained during wk 13 to 23. During the 3-wk treatment period, UF cows lost 0.2 body condition score units (1-10 scale) and this was not affected by 1× milking. During the treatment period, UF cows had lower plasma glucose, insulin, and insulin-like growth factor I, and greater nonesterified fatty acids and β-hydroxybutyrate concentrations than AF cows. Cows milked 1× had greater plasma glucose, insulin, and insulin-like growth factor I, and lower nonesterified fatty acids and β-hydroxybutyrate concentrations compared with cows milked 2×. In conclusion, energy status was improved by 1× milking; however, when UF cows were milked 1

  3. Effectiveness and gastrointestinal tolerability during conversion and titration with once-daily OROS® hydromorphone extended release in opioid-tolerant patients with chronic low back pain

    Science.gov (United States)

    Hale, Martin E; Nalamachu, Srinivas R; Khan, Arif; Kutch, Michael

    2013-01-01

    Purpose To describe the efficacy and safety of hydromorphone extended-release tablets (OROS hydromorphone ER) during dose conversion and titration. Patients and methods A total of 459 opioid-tolerant adults with chronic moderate to severe low back pain participated in an open-label, 2- to 4-week conversion/titration phase of a double-blind, placebo-controlled, randomized withdrawal trial, conducted at 70 centers in the United States. Patients were converted to once-daily OROS hydromorphone ER at 75% of the equianalgesic dose of their prior total daily opioid dose (5:1 conversion ratio), and titrated as frequently as every 3 days to a maximum dose of 64 mg/day. The primary outcome measure was change in pain intensity numeric rating scale; additional assessments included the Patient Global Assessment and the Roland–Morris Disability Questionnaire scores. Safety assessments were performed at each visit and consisted of recording and monitoring all adverse events (AEs) and serious AEs. Results Mean (standard deviation) final daily dose of OROS hydromorphone ER was 37.5 (17.8) mg. Mean (standard error of the mean [SEM]) numeric rating scale scores decreased from 6.6 (0.1) at screening to 4.3 (0.1) at the final titration visit (mean [SEM] change, −2.3 [0.1], representing a 34.8% reduction). Mean (SEM) change in Patient Global Assessment was −0.6 (0.1), and mean change (SEM) in the Roland–Morris Disability Questionnaire was −2.8 (0.3). Patients achieving a stable dose showed greater improvement than patients who discontinued during titration for each of these measures (P < 0.001). Almost 80% of patients achieving a stable dose (213/268) had a ≥30% reduction in pain. Commonly reported AEs were constipation (15.4%), nausea (11.9%), somnolence (8.7%), headache (7.8%), and vomiting (6.5%); 13.0% discontinued from the study due to AEs. Conclusion The majority of opioid-tolerant patients with chronic low back pain were successfully converted to effective doses of

  4. Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection.

    Science.gov (United States)

    Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S; Dretler, Robin; Rodriguez, Allan; Ward, Douglas J; Lim, Michael L; Liao, Qiming; Reddy, Sunila; Clair, Marty St; Vila, Tania; Shaefer, Mark S

    2006-01-01

    The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA or = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA >120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir

  5. Real-world glycemic outcomes in patients with type 2 diabetes initiating exenatide once weekly and liraglutide once daily: a retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Saunders WB

    2016-07-01

    Full Text Available William B Saunders,1 Hiep Nguyen,2 Iftekhar Kalsekar2 1Department of Public Health Sciences, College of Health and Human Services, The University of North Carolina at Charlotte, Charlotte, NC, 2AstraZeneca, Fort Washington, PA, USA Aim: The glucagon-like peptide-1 receptor agonists exenatide once weekly (QW and liraglutide once daily (QD have demonstrated improvements in glycemic outcomes in patients with type 2 diabetes mellitus in randomized clinical trials. However, little is known about their real-world comparative effectiveness. This retrospective cohort study used the Quintiles Electronic Medical Record database to evaluate the 6-month change in glycated hemoglobin (A1C for patients initiating exenatide QW or liraglutide QD.Methods: Patients with type 2 diabetes mellitus prescribed exenatide QW (n=664 or liraglutide QD (n=3,283 between February 1, 2012 and May 31, 2013 were identified. Baseline A1C measures were from 75 days before to 15 days after initiating exenatide QW or liraglutide QD, with follow-up measures documented at 6 months (±45 days. Adjusted linear regression models compared the difference in mean A1C change. A priori defined sensitivity analysis was performed in the subgroup of patients with baseline A1C ≥7.0% and no prescription for insulin during the 12-month pre-index period.Results: For exenatide QW and liraglutide QD, respectively, mean (SD age of the main study cohort was 58.01 (10.97 and 58.12 (11.05 years, mean (SD baseline A1C was 8.4% (1.6 and 8.4% (1.6, and 48.2% and 54.2% of patients were women. In adjusted models, change in A1C did not differ between exenatide QW and liraglutide QD during 6 months of follow-up. Results were consistent in the subgroup analyses.Conclusion: In a real-world setting, A1C similarly improves in patients initiating exenatide QW or liraglutide QD. Keywords: diabetes, exenatide, outcomes

  6. A prospective randomized trial of hyperfractionated versus conventional once daily radiation for advanced squamous cell carcinomas of the larynx and pharynx

    International Nuclear Information System (INIS)

    Cummings, B.J.; Keane, T.J.; Pintilie, M.; O'Sullivan, B.; Payne, D.; Warde, P.; McLean, M.; Waldron, J.; Liu, F.-F.; Gullane, P.

    1996-01-01

    Purpose: To examine the effects of an increased dose of radiation therapy (RT) delivered by a hyperfractionated schedule compared to conventional once daily RT on toxicity, locoregional control and survival in the treatment of squamous cell carcinomas (SCC) of the larynx and pharynx. Materials/Methods: Between 1988 and 1995 336 patients were randomized to receive RT with curative intent. Eligible patients had biopsy proven SCC of the larynx or pharynx, with TN stages (AJC-UICC 1987) T3 or T4 N0, or any T with any N+. All patients were M0. Patients were stratified by site (larynx/oropharynx/hypopharynx), node status (clinically positive/negative), and performance status. Patients were treated with either 51 Gy TAD/20 fractions/4 wk (2.55 Gy 1x/d, conventional RT=CRT) or 58 Gy TAD/40 fractions/4 wk (1.45 Gy 2x/d, hyperfractionated RT=HFRT). Patients underwent EUA and selective biopsies 10 wk after RT; surgical salvage was performed for residual or recurrent cancer whenever possible. Results: The primary cancer arose in the oropharynx (138), larynx (133) or hypopharynx (65). T stages were distributed T1 22, T2 72, T3 133 and T4 109. N stage distribution was N0 127, N1 74, N2 117 and N3 18. The proportion of patients with acute mucosal toxicity (RTOG Grade 3 or 4) was increased by HFRT (60% versus 40%), but other acute and late toxicity was not significantly different. There was no difference in the incidence of morbidity in the two treatment groups in those who underwent surgery following RT. The locoregional control rates at 3 yrs for all cases were 45% (HFRT) vs 40% (CRT) log rank p=0.16; for primary tumors <4 cm 54% (HFRT) vs 42% (CRT) p=0.04; for primary tumors ≥ 4 cm 38% (HFRT) vs 41% (CRT) p=0.73. Local control was improved to some extent in SCC which arose in all sites, but most noticeably in hypopharyngeal cancers. The disease free survival rates at 3 yr for all cases were 37% (HFRT) vs 30% (CRT) p=0.15; for primary tumors < 4 cm 47% (HFRT) vs 34% (CRT) p=0

  7. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil.

    Science.gov (United States)

    Kim, Edward; Seftel, Allen; Goldfischer, Evan; Baygani, Simin; Burns, Patrick

    2015-02-01

    Phosphodiesterase type-5 inhibitors (PDE5Is) are first-line therapies for erectile dysfunction (ED). Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED. Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy. This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy. In this randomized, double-blind, placebo-controlled trial, men with a ≥3 month ED history received SIL 100 mg, TAD 20 mg, or VAR 20 mg during a 4 week open-label lead-in period. Those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain scores TAD 2.5 mg up-titrated to 5 mg, TAD 5 mg, or placebo (PBO) OaD for 12 weeks. MAIN OUTCOME MEASURES obtained from patients treated with TAD-OaD were compared to PBO-treated patients. Additionally, results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy. NCT01130532. International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2-5. Endpoint data was obtained from 590 men (391 TAD; 199 PBO). RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD (p TAD 2.5 mg and TAD 5 mg OaD therapy were safe and generally well tolerated. Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED. Key limitations include the lack of a PRN PDE5I study group during the double-blind period, and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period.

  8. Efficacy and Safety of a Single-Pill Combination of Vildagliptin and Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    Odawara, Masato; Yoshiki, Mika; Sano, Misako; Hamada, Izumi; Lukashevich, Valentina; Kothny, Wolfgang

    2015-01-01

    Introduction The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. Methods This was a 14-week, randomized, double-blind, parallel-group, placebo-contro...

  9. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study

    NARCIS (Netherlands)

    Pratley, Richard E.; Nauck, Michael A.; Barnett, Anthony H.; Feinglos, Mark N.; Ovalle, Fernando; Harman-Boehm, Illana; Ye, June; Scott, Rhona; Johnson, Susan; Stewart, Murray; Rosenstock, Julio; Adamson, K.; Ahmann, A.; Ahn, C. W.; Ajani, D.; Akright, L.; Alwine, L.; Alzohaili, O.; Andrawis, N.; Arbañil Huaman, H.; Arora, S.; Bailey, T.; Barnett, A.; Baron, M.; Barreda Caceres, L.; Barrera, J.; Berg, J.; Bertenshaw, R.; Bode, B.; Bolton, D.; Brito, M.; Brock, S.; Brockmyre, A.; Broker, R.; Brusco, O.; Buynak, R.; Canadas-Zizzias, R.; Canas, G.; Capo, J.; Castillo Gamarra, M.; Cathcart, H.; Catindig, E. A.; Chilka, S.; Cho, Y. W.; Choi, D. S.; Chuck, L.; Cooper, M.; Corder, C.; Hoekstra, J.; Kemp, S.

    2014-01-01

    Background As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes

  10. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial

    DEFF Research Database (Denmark)

    Bretzel, R.G.; Nuber, U.; Landgraf, W.

    2008-01-01

    BACKGROUND: As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycaemic c...

  11. Safety and Effectiveness of Once-Daily Tadalafil (5 mg Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post- Marketing Surveillance Study

    Directory of Open Access Journals (Sweden)

    Ji Eon Won

    2018-05-01

    Full Text Available Purpose: The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD among Korean men with benign prostatic hyperplasia (BPH/lower urinary tract symptoms (LUTS in a real-world clinical setting. Materials and Methods: This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs. Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS from baseline to each endpoint. Results: All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637 were included in the safety population. Two percent of patients (n=13 experienced 15 TEAEs of mild (n=10; 66.7% or moderate (n=5; 33.3% severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44. Compared with baseline, the mean IPSS total score (±standard error significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001, with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score. Conclusions: Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.

  12. Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

    Science.gov (United States)

    Won, Ji Eon; Chu, Ji Yeon; Choi, Hyunah Caroline; Chen, Yun; Park, Hyun Jun; Dueñas, Héctor José

    2018-05-01

    The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (peffective in Korean men with BPH/LUTS in a real-world clinical setting. Copyright © 2018 Korean Society for Sexual Medicine and Andrology.

  13. Birth control pills overdose

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/article/002599.htm Birth control pill overdose To use the sharing features on ... the medicine was prescribed for the person Poison Control Your local poison center can be reached directly ...

  14. Effectiveness and gastrointestinal tolerability during conversion and titration with once-daily OROS® hydromorphone extended release in opioid-tolerant patients with chronic low back pain

    Directory of Open Access Journals (Sweden)

    Hale ME

    2013-05-01

    Full Text Available Martin E Hale,1 Srinivas R Nalamachu,2 Arif Khan,3 Michael Kutch4,* 1Gold Coast Research, LLC, Weston, FL, USA; 2International Clinical Research Institute, Overland Park, KS, USA; 3MedNorthwest Clinical Research Center, Bellevue, WA, USA; Duke University Medical Center, Durham, NC, USA; 4Applied Clinical Intelligence, LLC, Bala Cynwyd, PA, USA *Affiliation at the time this work was completed. Michael Kutch is currently affiliated with Cytel Inc, Chesterbrook, PA, USA Purpose: To describe the efficacy and safety of hydromorphone extended-release tablets (OROS hydromorphone ER during dose conversion and titration. Patients and methods: A total of 459 opioid-tolerant adults with chronic moderate to severe low back pain participated in an open-label, 2- to 4-week conversion/titration phase of a double-blind, placebo-controlled, randomized withdrawal trial, conducted at 70 centers in the United States. Patients were converted to once-daily OROS hydromorphone ER at 75% of the equianalgesic dose of their prior total daily opioid dose (5:1 conversion ratio, and titrated as frequently as every 3 days to a maximum dose of 64 mg/day. The primary outcome measure was change in pain intensity numeric rating scale; additional assessments included the Patient Global Assessment and the Roland–Morris Disability Questionnaire scores. Safety assessments were performed at each visit and consisted of recording and monitoring all adverse events (AEs and serious AEs. Results: Mean (standard deviation final daily dose of OROS hydromorphone ER was 37.5 (17.8 mg. Mean (standard error of the mean [SEM] numeric rating scale scores decreased from 6.6 (0.1 at screening to 4.3 (0.1 at the final titration visit (mean [SEM] change, -2.3 [0.1], representing a 34.8% reduction. Mean (SEM change in Patient Global Assessment was -0.6 (0.1, and mean change (SEM in the Roland–Morris Disability Questionnaire was -2.8 (0.3. Patients achieving a stable dose showed greater improvement

  15. PGC-1beta is downregulated by training in human skeletal muscle: no effect of training twice every second day vs. once daily on expression of the PGC-1 family

    DEFF Research Database (Denmark)

    Mortensen, Ole Hartvig; Plomgaard, Peter; Fischer, Christian P

    2007-01-01

    We hypothesized that the peroxisome proliferator-activated receptor-gamma coactivator-1 (PGC-1) family of transcriptional coactivators (PGC-1alpha, PGC-1beta, and PRC) is differentially regulated by training once daily vs. training twice daily every second day and that this difference might...... be observed in the acute response to endurance exercise. Furthermore, we hypothesized that expression levels of the PGC-1 family differ with muscular fiber-type composition. Thus, before and after 10 wk of knee extensor endurance training, training one leg once daily and the other leg twice daily every second...... day, keeping the total amount of training for the legs equal, skeletal muscle mRNA expression levels of PGC-1alpha, PGC-1beta, and PRC were determined in young healthy men (n = 7) in response to 3 h of acute exercise. No significant difference was found between the two legs, suggesting that regulation...

  16. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.

    OpenAIRE

    Rascol, O.; Brooks, D.J.; Melamed, E.; Oertel, W.; Poewe, W.; Stocchi, F.; Tolosa, E.; LARGO study group

    2005-01-01

    Lancet. 2005 Mar 12-18;365(9463):947-54. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe W, Stocchi F, Tolosa E; LARGO study group. Clinical Investigation Centre, Department of Clinical Pharmacology, University Hospital, Toulouse, France. ...

  17. Effects of Tadalafil Once-Daily or On-Demand vs Placebo on Return to Baseline Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy - Results from a Randomized Controlled Trial (REACTT)

    DEFF Research Database (Denmark)

    Mulhall, John P; Brock, Gerald; Oelke, Matthias

    2016-01-01

    INTRODUCTION AND AIM: The multicenter, randomized, double-blind, double-dummy, placebo-controlled REACTT trial suggested that treatment with tadalafil once daily (OaD) started early after bilateral nerve-sparing radical prostatectomy (nsRP) for prostate cancer may contribute to erectile function......: REACTT included 422 men blind treatment (DBT) with tadalafil 5 mg OaD (n = 139), tadalafil 20 mg on...

  18. Comparison of therapy augmentation and deviation rates from the recommended once-daily dosing regimen between LDX and commonly prescribed long-acting stimulants for the treatment of ADHD in youth and adults.

    Science.gov (United States)

    Setyawan, Juliana; Hodgkins, Paul; Guérin, Annie; Gauthier, Geneviève; Cloutier, Martin; Wu, Eric; Erder, M Haim

    2013-10-01

    To compare therapy augmentation and deviation rates from the recommended once-daily dosing regimen in Attention Deficit Hyperactivity Disorder (ADHD) patients initiated on lisdexamfetamine (LDX) vs other once-daily Food and Drug Administration (FDA) approved stimulants. ADHD patients initiated on a long-acting ADHD stimulant medication (index medication) in/after 2007 were selected from a large U.S. administrative claims database. Patients were required to be persistent for ≥90 days and continuously enrolled in their healthcare plan for ≥12 months following treatment initiation date. Based on age and previous treatment status, patients were classified into treatment-naïve children and adolescents (6-17 years old), previously treated children and adolescents, treatment-naïve adults (≥18 years old), and previously treated adults. Furthermore, patients were classified into four mutually exclusive treatment groups, based on index medication: lisdexamfetamine (LDX), osmotic release methylphenidate hydrochloride long-acting (OROS MPH), other methylphenidate/dexmethylphenidate long-acting (MPH LA), and amphetamine/dextroamphetamine long-acting (AMPH LA). The average daily consumption was measured as the quantity of index medication supplied in the 12-month study period divided by the total number of days of supply. Therapy augmentation was defined as the use of another ADHD medication concomitantly with the index medication for ≥28 consecutive days. Therapy augmentation and deviation rates from the recommended once-daily dosing regimen were compared between treatment groups using multivariate logistic regression models. Compared to the other treatment groups, LDX patients were less likely to augment with another ADHD medication (range odds ratios [OR]; 1.28-3.30) and to deviate from the recommended once-daily dosing regimen (range OR; 1.73-4.55), except for previously treated adult patients, where therapy augmentation differences were not statistically

  19. The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

    Science.gov (United States)

    Corneli, Amy L; McKenna, Kevin; Perry, Brian; Ahmed, Khatija; Agot, Kawango; Malamatsho, Fulufhelo; Skhosana, Joseph; Odhiambo, Jacob; Van Damme, Lut

    2015-04-15

    FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills. Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively. In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent. Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.

  20. Safe pill-dispensing.

    Science.gov (United States)

    Testa, Massimiliano; Pollard, John

    2007-01-01

    Each patient is supplied with a smart-card containing a Radio Frequency IDentification (RFID) chip storing a unique identification code. The patient places the Smart-card on a pill-dispenser unit containing an RFID reader. The RFID chip is read and the code sent to a Base-station via a wireless Bluetooth link. A database containing both patient details and treatment information is queried at the Base-station using the RFID as the search key. The patient's treatment data (i.e., drug names, quantities, time, etc.) are retrieved and sent back to the pill-dispenser unit via Bluetooth. Appropriate quantities of the required medications are automatically dispensed, unless the patient has already taken his/her daily dose. Safe, confidential communication and operation is ensured.

  1. Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled with once-daily basal insulin: A randomized, phase IV study.

    Science.gov (United States)

    Ilany, Jacob; Bhandari, Hamad; Nabriski, Dan; Toledano, Yoel; Konvalina, Noa; Cohen, Ohad

    2018-05-01

    To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine. This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage. A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P = .66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P = .39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P = .08). Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  2. Pill counts and pill rental: unintended entrepreneurial opportunities.

    Science.gov (United States)

    Viscomi, Christopher M; Covington, Melissa; Christenson, Catherine

    2013-07-01

    Prescription opioid diversion and abuse are becoming increasingly prevalent in many regions of the world, particularly the United States. One method advocated to assess compliance with opioid prescriptions is occasional "pill counts." Shortly before a scheduled appointment, a patient is notified that they must bring in the unused portion of their opioid prescription. It has been assumed that if a patient has the correct number and strength of pills that should be present for that point in a prescription interval that they are unlikely to be selling or abusing their opioids. Two cases are presented where patients describe short term rental of opioids from illicit opioid dealers in order to circumvent pill counts. Pill renting appears to be an established method of circumventing pill counts. Pill counts do not assure non-diversion of opioids and provide additional cash flow to illicit opioid dealers.

  3. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Vilsbøll, Tina; Brock, Birgitte; Perrild, Hans

    2008-01-01

    To assess the effect of liraglutide, a once-daily human glucagon-like peptide-1 analogue on pancreatic B-cell function. methods: Patients with Type 2 diabetes (n = 39) were randomized to treatment with 0.65, 1.25 or 1.9 mg/day liraglutide or placebo for 14 weeks. First- and second-phase insulin...... release were measured by means of the insulin-modified frequently sampled intravenous glucose tolerance test. Arginine-stimulated insulin secretion was measured during a hyperglycaemic clamp (20 mmol/l). Glucose effectiveness and insulin sensitivity were estimated by means of the insulin...

  4. [A follow-up study on a randomized, single-blind control of King's Brain pills in treatment of memory disorder in elderly people with MCI in a Beijing community].

    Science.gov (United States)

    Tian, Jin-zhou; Zhu, Ai-hua; Zhong, Jian

    2003-10-01

    To evaluate the effect of King's Brain pills (Compound Chinese ginseng extract from herbs) on the treatment and the delaying of memory decline in the elderly with mild cognitive impairment (MCI) in a community by a year follow-up of neuropsychology. 75 patients with MCI were selected from Beixinqiao community of Beijing by a cutoff score of 0.0/0.5 on CDR and were randomly assigned into a treatment group (n = 30 cases), given 4 pills of a compound Chinese ginseng extract (King's Brain) with 2 placebo tablets, and a positive control group (n = 30 cases), given 2 tablets of Piracetam with 4 placebo tablets, as well as a placebo group (n = 15 cases), given a placebo of 4 tablets and 2 pills. All subjects took this medication 3 times a day for 3 months. Single-blind and double-moulding control were used in this study. At a baseline and a middlepoint (after 3 months), and a follow-up end (one year later) following a three months of medication therapeutics, all subjects were assessed using a battery consisting of MMSE and 5 memory items on BNPT battery. In the treatment group, MMSE score 27.50 +/- 1.68 was increased to 28.27 +/- 1.70 after 3 months but decreased to 26.90 +/- 1.90 after one year of the treatment. However, the latter score was higher than that in a placebo group 26.33 +/- 1.03 (P Brain spills and piracetam tablets have protective effect on cognitive and memory decline in elderly with MCI.

  5. Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial.

    Science.gov (United States)

    Spergel, J M; Boguniewicz, M; Paller, A S; Hebert, A A; Gallagher, P R; McCormick, C; Parneix-Spake, A; Hultsch, T

    2007-08-01

    Combination therapy with pimecrolimus cream 1%, a topical calcineurin inhibitor (TCI), and fluticasone propionate cream 0.05% (FP), a mid-potency topical corticosteroid, may have a synergistic effect for treatment of atopic dermatitis (AD) because their mechanism of action differs. To assess the efficacy of concomitant pimecrolimus twice daily/FP once daily vs. vehicle twice daily/FP once daily in patients with severe AD. An exploratory, 2-week, double-blind, randomized, within-patient study was conducted (n = 45). Two target areas of similar severity, size and location were assessed. Assessments included the modified Eczema Area and Severity Index (0-12 scale) (primary variable), localized investigator global assessment (0-4 scale) and Patients' Self-Assessment of Disease Severity (0-4 scale). Data for all variables were similar for the TCI/FP and vehicle/FP treatments. The efficacy observed for treatment of severe AD flares with this TCI/FP combination regimen was equivalent to that of vehicle/FP.

  6. Efficacy and Safety of Sarecycline, a Novel, Once-Daily, Narrow Spectrum Antibiotic for the Treatment of Moderate to Severe Facial Acne Vulgaris: Results of a Phase 2, Dose-Ranging Study.

    Science.gov (United States)

    Leyden, James J; Sniukiene, Vilma; Berk, David R; Kaoukhov, Alexandre

    2018-03-01

    There is a need for new oral antibiotics for acne with improved safety profiles and targeted antibacterial spectra. Sarecycline is a novel, tetracycline-class antibiotic specifically designed for acne, offering a narrow spectrum of activity compared with currently available tetracyclines, including less activity against enteric Gram-negative bacteria. This phase 2 study evaluated the efficacy and safety of three doses of sarecycline for moderate to severe facial acne vulgaris. In this multicenter, double-blind, placebo-controlled study, patients aged 12 to 45 years were randomized to once-daily sarecycline 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg, or placebo. Efficacy analyses included change from baseline in inflammatory and noninflammatory lesion counts at week 12, with between-group comparisons using analysis of covariance. Safety assessments included adverse events (AEs), clinical laboratories, vital signs, electrocardiograms, and physical examinations. Overall, 285 randomized patients received at least one dose of study drug. At week 12, sarecycline 1.5 mg/kg and 3.0 mg/kg groups demonstrated significantly reduced inflammatory lesions from baseline (52.7% and 51.8%, respectively) versus placebo (38.3%; P=0.02 and P=0.03, respectively). Sarecycline was safe and well tolerated, with similar gastrointestinal AE rates in sarecycline and placebo groups. Vertigo and photosensitivity AEs occurred in less than 1% of patients when pooling sarecycline groups; no vulvovaginal candidiasis AEs occurred. Discontinuation rates due to AEs were low. No serious AEs occurred. Once-daily sarecycline 1.5 mg/kg significantly reduced inflammatory lesions versus placebo and was safe and well tolerated with low rates of AEs, including gastrointestinal AEs. Sarecycline 3.0 mg/kg did not result in additional efficacy versus 1.5 mg/kg. Sarecycline may represent a novel, once-daily treatment for patients with moderate to severe acne. It offers a narrow antibacterial spectrum relative to other

  7. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

    Directory of Open Access Journals (Sweden)

    Koch A

    2014-07-01

    Full Text Available Andrea Koch,1 Emilio Pizzichini,2 Alan Hamilton,3 Lorna Hart,3 Lawrence Korducki,4 Maria Cristina De Salvo,5 Pierluigi Paggiaro6 1Medical Clinic III for Pneumology, Allergology, Sleep and Respiratory Medicine, University Hospital Bochum-Bergmannsheil, Bochum, Germany; 2NUPAIVA (Asthma Research Center, Universidade Federal de Santa Catarina, Santa Catarina, Brazil; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 5Centro Médico Dra. De Salvo, Fundación Respirar, Buenos Aires, Argentina; 6Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy Abstract: Two replicate, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III studies investigated the long-term efficacy and safety of once-daily olodaterol via Respimat® versus placebo and formoterol over 48 weeks in patients with moderate to very severe chronic obstructive pulmonary disease receiving usual-care background therapy. Patients received once-daily olodaterol 5 or 10 µg, twice-daily formoterol 12 µg, or placebo. Co-primary end points were forced expiratory volume in 1 second (FEV1 area under the curve from 0–3 hours response, FEV1 trough response, and Mahler transition dyspnea index total score after 24 weeks; secondary end points included St George's Respiratory Questionnaire. Overall, 904 (Study 1222.13 and 934 (Study 1222.14 patients received treatment. Olodaterol significantly improved FEV1 area under the curve from 0–3 hours versus placebo in both studies (with olodaterol 5 µg, 0.151 L and 0.129 L; with olodaterol 10 µg, 0.165 L and 0.154 L; for all comparisons P<0.0001 and FEV1 trough responses versus placebo (0.053–0.085 L; P<0.01, as did formoterol. Primary analysis revealed no significant difference in transition dyspnea index focal score for any active treatment versus placebo. Post hoc analysis using pattern mixture modeling (accounting for

  8. Efficacy and tolerability of a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg according to age, gender, race, hypertension severity, and previous antihypertensive use: planned analyses of a randomized trial

    Directory of Open Access Journals (Sweden)

    Zhu D

    2013-04-01

    Full Text Available Dingliang Zhu,1 Harold Bays,2 Pingjin Gao,1 Michaela Mattheus,3 Birgit Voelker,3 Luis M Ruilope4 1Shanghai Ruijin Hospital, Shanghai, People’s Republic of China; 2Louisville Metabolic and Atherosclerosis Research Center Inc, Louisville, KY, USA; 3Boehringer Ingelheim International GmbH, Ingelheim, Germany; 4Hospital 12 de Octubre, Madrid, Spain Background: The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25 single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 100 mmHg in specific patient subpopulations. Methods: This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ≥ 65 years versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP 30 mmHg and >40 mmHg. Results: Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of >30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ≥65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients

  9. Onychomycosis of Toenails and Post-hoc Analyses with Efinaconazole 10% Solution Once-daily Treatment: Impact of Disease Severity and Other Concomitant Associated Factors on Selection of Therapy and Therapeutic Outcomes.

    Science.gov (United States)

    Del Rosso, James Q

    2016-02-01

    Topical treatment for toenail onychomycosis has been fraught with a long-standing reputation of poor efficaey, primarily due to physical properties of the nail unit that impede drug penetration. Newer topical agents have been formulated as Solution, which appear to provide better therapeutic response in properly selected patients. It is important to recognize the impact the effects that mitigating and concomitant factors can have on efficaey. These factors include disease severity, gender, presence of tinea pedis, and diabetes. This article reviews results achieved in Phase 3 pivotal studies with topical efinaconazole 10% Solution applied once daily for 48 weeks with a focus on how the aforementioned factors influenced therapeutic outcomes. It is important for clinicians treating patients for onychomycosis to evaluate severity, treat concomitant tinea pedis, address control of diabetes if present by encouraging involvement of the patient's primary care physician, and consider longer treatment courses when clinically relevant.

  10. Inhalation by design: novel ultra-long-acting β(2)-adrenoreceptor agonists for inhaled once-daily treatment of asthma and chronic obstructive pulmonary disease that utilize a sulfonamide agonist headgroup.

    Science.gov (United States)

    Glossop, Paul A; Lane, Charlotte A L; Price, David A; Bunnage, Mark E; Lewthwaite, Russell A; James, Kim; Brown, Alan D; Yeadon, Michael; Perros-Huguet, Christelle; Trevethick, Michael A; Clarke, Nicholas P; Webster, Robert; Jones, Rhys M; Burrows, Jane L; Feeder, Neil; Taylor, Stefan C J; Spence, Fiona J

    2010-09-23

    A novel series of potent and selective sulfonamide derived β(2)-adrenoreceptor agonists are described that exhibit potential as inhaled ultra-long-acting bronchodilators for the treatment of asthma and chronic obstructive pulmonary disease. Analogues from this series mediate very long-lasting smooth muscle relaxation in guinea pig tracheal strips. The sulfonamide agonist headgroup confers high levels of intrinsic crystallinity that could relate to the acidic sulfonamide motif supporting a zwitterionic form in the solid state. Optimization of pharmacokinetic properties was achieved through targeted introduction of a phenolic moiety to support rapid phase II clearance, thereby minimizing systemic exposure following inhalation and reducing systemically mediated adverse events. Compound 38 (PF-610355) is identified as a clinical candidate from this series, with in vivo duration of action studies confirming its potential for once-daily use in humans. Compound 38 is currently in advanced phase II clinical studies.

  11. Morning and evening behavior in children and adolescents treated with atomoxetine once daily for Attention-Deficit/Hyperactivity Disorder (ADHD: Findings from two 24-week, open-label studies

    Directory of Open Access Journals (Sweden)

    Schacht Alexander

    2009-02-01

    Full Text Available Abstract Background The impact of once daily atomoxetine treatment on symptoms in children and adolescents with ADHD may vary over the day. In order to capture such variations, two studies were undertaken in children and adolescents with ADHD using two instruments that capture morning and evening behavior and ADHD-related difficulties over the day. This secondary measure analysis builds on two primary analyses that were conducted separately for children and adolescents and also published separately. Methods In two open-label studies, ADHD patients aged 6–17 years (n = 421, received atomoxetine in the morning (target-dose 0.5–1.2 mg/kg/day for up to 24 weeks. Morning and evening behavior was assessed using the investigator-rated Weekly Rating of Evening and Morning Behavior (WREMB-R scale. ADHD-related difficulties at various times of the day (morning, during school, during homework, evening were assessed using the Global Impression of Perceived Difficulties (GIPD scale, rated by patients, parents and physicians. Data from both studies were combined for this secondary measure analysis. Results Both WREMB-R subscores decreased significantly over time, the evening subscore from 13.7 (95% CI 13.2;14.2 at baseline to 8.0 (7.4;8.5 at week 2, the morning subscore from 4.3 (4.0;4.5 to 2.4 (2.2;2.6. Scores then remained stable until week 24. All GIPD items improved correspondingly. At all times of the day, patients rated ADHD-related difficulties as less severe than parents and physicians. Conclusion These findings from two open-label studies suggest that morning and evening behavior and ADHD-related difficulties in the mornings and evenings improve over time with once daily atomoxetine treatment.

  12. Fifteen-year results of a randomized prospective trial of hyperfractionated chest wall irradiation versus once-daily chest wall irradiation after chemotherapy and mastectomy for patients with locally advanced noninflammatory breast cancer

    International Nuclear Information System (INIS)

    Buchholz, Thomas A.; Strom, Eric A.; Oswald, Mary Jane; Perkins, George H.; Oh, Julia; Domain, Delora; Yu, Tse-Kuan; Woodward, Wendy A.; Tereffe, Welela; Singletary, S. Eva; Thomas, Eva; Buzdar, Aman U.; Hortobagyi, Gabriel N.; McNeese, Marsha D.

    2006-01-01

    Purpose: To analyze the results of a Phase III clinical trial that investigated whether a hyperfractionated radiotherapy (RT) schedule could reduce the risk of locoregional recurrence in patients with locally advanced breast cancer treated with chemotherapy and mastectomy. Methods and Materials: Between 1985 and 1989, 200 patients with clinical Stage III noninflammatory breast cancer were enrolled in a prospective study investigating neoadjuvant and adjuvant chemotherapy. Of the 179 patients treated with mastectomy after neoadjuvant chemotherapy, 108 participated in a randomized component of the trial that compared a dose-escalated, hyperfractionated (twice-daily, b.i.d.) chest wall RT schedule (72 Gy in 1.2-Gy b.i.d. fractions) with a once-daily (q.d.) schedule (60 Gy in 2-Gy q.d. fractions). In both arms of the study, the supraclavicular fossa and axillary apex were treated once daily to 50 Gy. The median follow-up period was 15 years. Results: The 15-year actuarial locoregional recurrence rate was 7% for the q.d. arm and 12% for the b.i.d. arm (p = 0.36). The rates of severe acute toxicity were similar (4% for q.d. vs. 5% for b.i.d.), but moist desquamation developed in 42% of patients in the b.i.d. arm compared with 28% of the patients in the q.d. arm (p = 0.16). The 15-year actuarial rate of severe late RT complications did not differ between the two arms (6% for q.d. vs. 11% for b.i.d., p = 0.54). Conclusion: Although the sample size of this study was small, we found no evidence that this hyperfractionation schedule of postmastectomy RT offered a clinical advantage. Therefore, we have concluded that it should not be further studied in this cohort of patients

  13. One-pill once-a-day HAART: a simplification strategy that improves adherence and quality of life of HIV-infected subjects

    Directory of Open Access Journals (Sweden)

    Monica Airoldi

    2010-05-01

    /mL and 100% <400 copies/mL. Four patients stopped therapy because they were lost to follow-up and 6 because of AEs (insomnia/nervousness 4, allergy 1, difficulties swallowing pills 1.Conclusion: By substituting a one-pill once-a-day HAART, we observed an improvement of both adherence and QoL while maintaining high virologic and immunologic efficacy. HAART simplicity is an added value that favors adherence and may improve long-term success. Keywords: EFV/FTC/TDF, single-pill regimen, once-daily antiretroviral regimen, adherence, QoL, patient preferences

  14. Pille Jänes 39

    Index Scriptorium Estoniae

    2004-01-01

    Pille Jänes sai tänavu rahvusvahelise teatripäeva peol Ugalas kunstnikuauhinna kujunduse eest Tallinna Linnateatri lavastusele "Tshapajev ja Pustota", Linnateter andis kunstnikule parima kunstniku aastaauhinna

  15. Anti-C.Diff Pill

    Energy Technology Data Exchange (ETDEWEB)

    Kumar, Anand [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2018-01-30

    The anti- C.diff pill is being developed for patients who are at high risk for Clostridium difficile, a bacterium that causes diarrhea and serious intestinal conditions like colitis. C-diff is deadly, killing over 30,000 people a year in the United States and costing an average of $42,000 per treatment. The most common treatment is a fecal transplant (FT). The anti- C.diff replaces the invasive and messy FT practice with a pill.

  16. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.

    Science.gov (United States)

    Pratley, Richard E; Nauck, Michael A; Barnett, Anthony H; Feinglos, Mark N; Ovalle, Fernando; Harman-Boehm, Illana; Ye, June; Scott, Rhona; Johnson, Susan; Stewart, Murray; Rosenstock, Julio

    2014-04-01

    As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. We undertook this 32-week, open-label, phase 3 non-inferiority study at 162 sites in eight countries: USA (121 sites), Australia (9 sites), Peru (7 sites), Philippines (7 sites), South Korea (5 sites), UK (5 sites), Israel (4 sites), and Spain (4 sites). 841 adult participants (aged ≥18 years) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m(2) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6, or liraglutide 0·6 mg once daily titrated to 1·2 mg at week 1 and 1·8 mg at week 2. The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16. Participants and investigators were unmasked to treatment. The primary endpoint was change from baseline in HbA1c for albiglutide versus liraglutide, with a 95% CI non-inferiority upper margin of 0·3%. The primary analysis was by modified intention to treat. The study is registered with ClinicalTrials.gov, number NCT01128894. 422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs. The primary endpoint analysis was done on the modified intention-to-treat population, which included 402 participants in the albiglutide group and 403 in the liraglutide group. Model-adjusted change in HbA1c from baseline to week 32 was -0·78% (95% CI -0·87 to -0·69) in the albigludite group and -0·99% (-1·08 to -0·90) in the liraglutide group; treatment difference was 0·21% (0·08-0·34; non-inferiority p value=0

  17. The safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer's disease taking cholinesterase inhibitors.

    Science.gov (United States)

    Grossberg, George T; Manes, Facundo; Allegri, Ricardo F; Gutiérrez-Robledo, Luis Miguel; Gloger, Sergio; Xie, Lei; Jia, X Daniel; Pejović, Vojislav; Miller, Michael L; Perhach, James L; Graham, Stephen M

    2013-06-01

    Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. In this 24-week, double-blind, multinational study (NCT00322153), outpatients with AD (Mini-Mental State Examination scores of 3-14) were randomized to receive once-daily, 28-mg, extended-release memantine or placebo. Co-primary efficacy parameters were the baseline-to-endpoint score change on the Severe Impairment Battery (SIB) and the endpoint score on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). The secondary efficacy parameter was the baseline-to-endpoint score change on the 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19); additional parameters included the baseline-to-endpoint score changes on the Neuropsychiatric Inventory (NPI) and verbal fluency test. Data were analyzed using a two-way analysis of covariance model, except for CIBIC-Plus (Cochran-Mantel-Haenszel test). Safety and tolerability were assessed through adverse events and physical and laboratory examinations. A total of 677 patients were randomized to receive extended-release memantine (n = 342) or placebo (n = 335); completion rates were 79.8 and 81.2 %, respectively. At endpoint (week 24, last observation carried forward), memantine-treated patients significantly outperformed placebo-treated patients on the SIB (least squares mean difference [95 % CI] 2.6 [1.0, 4.2]; p = 0.001), CIBIC-Plus (p = 0.008), NPI (p = 0.005), and verbal fluency test (p = 0.004); the effect did not achieve significance on ADCS-ADL19 (p = 0.177). Adverse events with a frequency of ≥5.0 % that were more prevalent in the memantine group were headache (5.6 vs. 5.1 %) and diarrhea (5.0 vs. 3.9

  18. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.

    Science.gov (United States)

    Rascol, O; Brooks, D J; Melamed, E; Oertel, W; Poewe, W; Stocchi, F; Tolosa, E

    Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations. In an 18-week, double-blind, multicentre (74 hospitals and academic centres in Israel, Argentina, and Europe) trial, 687 outpatients were randomly assigned to oral rasagiline (231 individuals; 1 mg once daily), entacapone (227; 200 mg with every levodopa dose), or placebo (229). Primary outcome was change in total daily off-time (intention-to-treat population). Other measures included the clinical global improvement (CGI) score and unified Parkinson's disease rating scale (UPDRS) scores. Analysis was by intention to treat. 88 (13%) patients who were assigned treatment did not complete the study (23 rasagiline, 30 entacapone, 35 placebo), mainly because of withdrawal of consent (n=34) and adverse events (n=34). Both rasagiline and entacapone reduced mean daily off-time (-1.18 h rasagiline and -1.2 h entacapone vs placebo -0.4 h; p=0.0001, prasagiline and -0.72 entacapone vs -0.37 placebo; prasagiline reduces mean daily off-time and improves symptoms of Parkinson's disease in levodopa-treated patients with motor fluctuations, an effect similar to that of entacapone.

  19. Cost-effectiveness analysis of exenatide twice daily (BID) vs insulin glargine once daily (QD) as add-on therapy in Chinese patients with Type 2 diabetes mellitus inadequately controlled by oral therapies.

    Science.gov (United States)

    Deng, Jing; Gu, Shuyan; Shao, Hui; Dong, Hengjin; Zou, Dajin; Shi, Lizheng

    2015-01-01

    To estimate cost-effectiveness of exenatide twice daily (BID) vs insulin glargine once daily (QD) as add-on therapy in Chinese type 2 diabetes patients not well controlled by oral anti-diabetic (OAD) agents. The Cardiff model was populated with data synthesized from three head-to-head randomized clinical trials of up to 30 weeks in China comparing exenatide BID vs insulin glargine as add-on therapies to oral therapies in the Chinese population. The Cardiff model generated outputs including macrovascular and microvascular complications, diabetes-specific mortality, costs, and quality-adjusted life years (QALYs). Cost and QALYs were estimated with a time horizon of 40 years at a discount rate of 3% from a societal perspective. Compared with insulin glargine plus OAD treatments, patients on exenatide BID plus OAD gained 1.88 QALYs, at an incremental cost saving of Chinese Renminbi (RMB) 114,593 (i.e., cost saving of RMB 61078/QALY). The cost-effectiveness results were robust to various sensitivity analyses including probabilistic sensitivity analysis. The variables with the most impact on incremental cost-effectiveness ratio included HbA1c level at baseline, health utilities decrement, and BMI at baseline. Compared with insulin glargine QD, exenatide BID as add-on therapy to OAD is a cost-effective treatment in Chinese patients inadequately controlled by OAD treatments.

  20. Optimization of health-care organization and perceived improvement of patient comfort by switching from intra-venous BU four-times-daily infusions to a once-daily administration scheme in adult hematopoietic stem cell recipients.

    Science.gov (United States)

    Xhaard, A; Rzepecki, P; Valcarcel, D; Santarone, S; Fürst, S; Serrano, D; De Angelis, G; Krüger, W; Scheid, C

    2014-04-01

    Previous studies have shown an equivalent pharmacokinetic profile between four-times-daily (4QD) and once-daily (QD) administration of intra-venous (IV) BU, without increased toxicity. We assess the impact of a switch in IV BU from a 4QD to a QD schedule, in terms of health-care organization, staff working conditions, quality of care dispensed and perceived patient comfort. Clinicians, nurses and pharmacists from nine allogeneic transplantation units in five European countries were interviewed face to face. Overall perception of QD versus 4QD BU was very positive. Both administration schemes were evaluated to be equally efficaciousZ. QD BU was perceived to be safer and more convenient. Clinicians and nurses perceived that patient comfort was improved, due to fewer complications associated with repeated infusions, and avoiding night infusions associated with stress, anxiety and decreased quality of sleep. Switching from 4QD to QD BU had a significant impact on health-care organization, with a better integration in the overall management and usual timelines in the pharmacies and transplantation units. Time spent to prepare and administer BU was significantly reduced, leading to potential financial savings that merit further assessment and would be of particular interest in the current economic climate.

  1. Pilling Resistance of Knitted Fabrics

    Directory of Open Access Journals (Sweden)

    Gita BUSILIENĖ

    2011-09-01

    Full Text Available Knitted fabrics with different quantity of elastane, conspicuous by high viscosity and elasticity, having one of the most important performance properties - resistance to pilling are often used in the production of high quality sportswear. During technological process imitating operating conditions, the behaviour of knitted fabrics may be changed by different industrial softeners from 12 % to 20 % of active substance, for example fatty acid condensate (Tubingal 5051 or silicone micro emulsion (Tubingal SMF. The aim of this investigation is to define the influence of fibrous composition and chemical softeners to the propensity of fuzzing and pilling of plain and plated jersey pattern knitted fabrics. The results of investigations showed that fibrous composition and thickness of materials (up to 6 % and washing as well as softening (from 33 % to 67 % change the resistance of knitted fabrics to pilling.http://dx.doi.org/10.5755/j01.ms.17.3.597

  2. Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway.

    Science.gov (United States)

    Huetson, Pernilla; Palmer, James L; Levorsen, Andrée; Fournier, Marie; Germe, Maeva; McLeod, Euan

    2015-01-01

    Lixisenatide is a potent, selective and short-acting once daily prandial glucagon-like peptide-1 receptor agonist which lowers glycohemoglobin and body weight by clinically significant amounts in patients with type 2 diabetes treated with basal insulin, with limited risk of hypoglycemia. To assess the cost-effectiveness of lixisenatide versus bolus insulin, both in combination with basal insulin, in patients with type 2 diabetes in Norway. The IMS CORE Diabetes Model, a non-product-specific and validated simulation model, was used to make clinical and cost projections. Transition probabilities, risk adjustments and the progression of complication risk factors were derived from the UK Prospective Diabetes Study, supplemented with Norwegian data. Patients were assumed to receive combination treatment with basal insulin, lixisenatide or bolus insulin therapy for 3 years, followed by intensification of a basal-bolus insulin regimen for their remaining lifetime. Simulated healthcare costs, taken from the public payer perspective, were derived from microcosting and diagnosis related groups, discounted at 4% per annum and reported in Norwegian krone (NOK). Productivity costs were also captured based on extractions from the Norwegian Labor and Welfare Administration. Health state utilities were derived from a systematic literature review. Sensitivity and scenario analyses were performed. Lixisenatide in combination with basal insulin was associated with increased quality-adjusted life years (QALYs) and reduced lifetime healthcare costs compared to bolus insulin in combination with basal insulin in patients with Type 2 diabetes, and can be considered dominant. The net monetary benefit of lixisenatide versus bolus insulin was NOK 39,369 per patient. Results were sensitive to discounting, the application of excess body weight associated disutility and uncertainty surrounding the changes in HbA1c. Lixisenatide may be considered an economically efficient therapy in combination

  3. Analysis of traditional Tibetan pills

    Science.gov (United States)

    Cesnek, Martin; Štefánik, Milan; Miglierini, Marcel; Kmječ, Tomáš; Sklenka, L'ubomír

    2017-11-01

    Traditional Tibetan medicine starts to be a very popular complementary medicine in USA and Europe. These pills contain many elements essential for the human body. However, they might also contain heavy metals such as mercury, iron, arsenic, etc. This paper focuses on elemental composition of two Tibetan pills and investigation of forms of iron in them. X-ray fluorescence spectroscopy and neutron activation analysis identified the presence of several heavy metals such as mercury, iron and copper. Mőssbauer spectroscopy revealed the possible presence of α - F e 2 O 3(hematite) and α - F e O O H(goethite) in both of the investigated samples.

  4. Rein Pill tegi fantastilise sõidu / Rein Pill

    Index Scriptorium Estoniae

    Pill, Rein

    2008-01-01

    Septembris Chernjahovskis peetud CS14 taseme rahvusvahelistel ratsutamise takistussõiduvõistlustel tegi Rein Pill ajalugu, võites hobusel A Big Boy võistluste Grand Prix 160 cm kõrgusel parkuuril ja täites Euroopa meistrivõistluste kvalifikatsiooninormi

  5. Herbal Weight Loss Pill Overdose: Sibutramine Hidden in Pepper Pill

    Directory of Open Access Journals (Sweden)

    Gul Pamukcu Gunaydin

    2015-01-01

    Full Text Available Supposedly herbal weight loss pills are sold online and are widely used in the world. Some of these products are found to contain sibutramine by FDA and their sale is prohibited. We report a case of a female patient who presented to the emergency department after taking slimming pills. 17-year-old female patient presented to the emergency room with palpitations, dizziness, anxiety, and insomnia. She stated that she had taken 3 pills named La Jiao Shou Shen for slimming purposes during the day. Her vital signs revealed tachycardia. On her physical examination, she was restless, her oropharynx was dry, her pupils were mydriatic, and no other pathological findings were found. Sibutramine intoxication was suspected. She was given 5 mg IV diazepam for restlessness. After supportive therapy and observation in emergency department for 12 hours there were no complications and the patient was discharged home. Some herbal pills that are sold online for weight loss have sibutramine hidden as an active ingredient, and their sale is prohibited for this reason. For people who use herbal weight loss drugs, sibutramine excessive intake should be kept in mind at all times.

  6. Unmarried Mother's Knowledge and Attitudes toward Emergency Contraceptive Pills

    Directory of Open Access Journals (Sweden)

    Gyeong Mi Lee

    2013-06-01

    Full Text Available PurposeThis study was conducted to identify relationships among knowledge and attitudes of unmarried mothers toward emergency contraceptive pills.MethodsData were collected through structured questionnaires from 135 unmarried mothers enrolled in 7 single mothers' facilities nationwide. Data were analyzed using the SPSS/WIN 17.0 program for descriptive statistics, t-test, ANOVA, Scheffe-test, and Pearson correlation coefficients.ResultsFor knowledge about emergency contraceptive pills, there were significant differences among who live with her before pregnancy, experience of past pregnancies, state of present pregnancy and preparation in using contraceptives. For attitude toward emergency contraceptive pills, there were significant differences according to age, education level and religion. There were significant positive relationships between knowledge and attitudes toward emergency contraceptive pills.ConclusionThe results of this study suggest that unmarried women should be better informed about emergency contraceptive pills, and reassured about their safety. Efforts are needed to disseminate up-to-date information to experts in sex education including nurses.

  7. [Effects of Betel shisanwei ingredients pill on AC-cAMP-PKA signal transduction pathways in hippocampus and prefrontal cortex of depressive rats].

    Science.gov (United States)

    Tong, Hai-Ying; Wu, Jisiguleng; Bai, Liang-Feng; Bao, Wu-Ye; Hu, Rilebagen; Li, Jing; Zhang, Yue

    2014-05-01

    To observe the effects of Mongolian pharmaceutical Betel shisanwei ingredients pill on AC-cAMP-PKA signal transduction pathways in hippocampus and prefrontal cortex of depressive rats. Sixty male Wistar rats were randomly divided into six groups according to the sugar consumption test (10 rats in each group), normal control group,model group,fluoxetine group (3.3 mg x kg(-1)) and low dose, medium dose and high dose group (0.25, 0.5, 1 g x kg(-1)) of Betel shisanwei ingredients pill. Except the normal control,the other groups were treated with the chronic unpredictable mild stress stimulation combined with lonely raising for 28 days. 10 mL x kg(-1) of drugs were given to each rat once daily,continuously for 28 days. The AC activity of the hippocampus and prefrontal cortex were determined by radiation immunity analysis (RIA), while cAMP and PKA quantity were determinated by Enzyme-linked immunosorbent (ELISA). The AC activity, cAMP and PKA quantity of hippocampus and prefrontal of mouse model of Chronic stress depression decreased significantly than those of control group (P Betel shisanwei ingredients pill group indecreased significantly than those of model group (P Betel shisanwei ingredients pill. The AC-cAMP-PKA signal transduction pathways in hippocampus and prefrontal cortex of depression model of rats is down-regulated, whereas Mongolian pharmaceutical Betel shisanwei ingredients pill could up-regulated it to resist depression.

  8. Efficacy and safety of a once-daily single-tablet regimen of tenofovir, lamivudine, and efavirenz assessed at 144 weeks among antiretroviral-naïve and experienced HIV-1-infected Thai adults

    Directory of Open Access Journals (Sweden)

    Anchalee Avihingsanon

    2017-08-01

    Conclusions: This generic STR TDF/3TC/EFV is effective and well-tolerated. These findings lend support to the use of this generic STR as first-line antiretroviral therapy in resource-limited settings.

  9. A pill for every ill?

    OpenAIRE

    Buhagiar, Marc

    2015-01-01

    In the US, non-medical use of prescription drugs is second only to marijuana. Marc Buhagiar meets up with Prof. Marilyn Clark to investigate just how dangerous this problem is around Europe. Illustrations by Sonya Hallett. http://www.um.edu.mt/think/a-pill-for-every-ill/

  10. Comparison of insulin intensification strategies with insulin lispro low mixture twice daily versus basal insulin glargine and prandial insulin lispro once daily in East Asian and Caucasian patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Jeong, In-Kyung; Chung, Choon Hee; Zhou, Zhiguang; Han, Jeong Hee; Duan, Ran; Edralin, Diana M; Rodriguez, Angel

    2017-04-01

    This analysis evaluated efficacy and safety of insulin lispro low mixture (LM25) twice daily (breakfast and dinner) versus basal insulin glargine (bedtime) plus prandial insulin lispro (IGL) once daily before the largest meal in East Asian (EA) and Caucasian patients with type 2 diabetes mellitus who failed to reach glycemic targets on basal insulin glargine with metformin and/or pioglitazone. Included patients had an HbA1c ≥7.5% and ≤10.5% and fasting plasma glucose ≤6.7 mmol/L. Primary outcome was HbA1c change at 24 weeks. Baseline mean HbA1c was numerically similar between groups in EA (n = 79) and Caucasian (n = 278) patients. Mean (± SD) HbA1c decreased significantly from baseline to 24 weeks for LM25 and IGL in both subpopulations (EA: -1.32 ± 0.96% and -0.89 ± 0.96%; Caucasian: -1.24 ± 0.98% and -1.04 ± 0.97; all P 1). The respective proportions reaching HbA1c ≤7.0% at Week 24 in the LM25 and IGL groups were 33.3% and 22.9% (EA) and 37.2% and 34.1% (Caucasian). Mean (± SD) rates of hypoglycemia per 30 days in the LM25 and IGL groups were 0.74 ± 1.16 and 1.22 ± 1.36 (EA) and 1.38 ± 2.04 and 1.65 ± 2.43 (Caucasian). Mean (± SD) weight gain changes in the LM25 and IGL groups were 0.62 ± 2.78 and 0.51 ± 2.63 kg (EA) and 1.77 ± 2.91 and 0.67 ± 3.09 kg (Caucasian). Both strategies improved glycemic control in a small group of EA and Caucasian patients not adequately controlled on insulin glargine plus metformin and/or pioglitazone. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  11. The short-term cost-effectiveness of once-daily liraglutide versus once-weekly exenatide for the treatment of type 2 diabetes mellitus in the United States.

    Directory of Open Access Journals (Sweden)

    Bruce Wang

    Full Text Available Type 2 diabetes mellitus (T2DM is a chronic metabolic disease with substantial morbidity, mortality, and economic impacts. Glucagon-like peptide-1 (GLP-1 receptor agonists, such as once-daily (QD liraglutide and once-weekly (QW exenatide, are FDA-approved treatment for T2DM. Head-to-head trials and meta-analyses comparing these agents have reported clinically meaningful improvements but small differences in glycemic control between both agents. In this study, we calculate and compare the cost-effectiveness implications of these alternative effectiveness outcomes.We developed a decision model to evaluate the short-term cost-effectiveness of exenatide QW 2 mg versus liraglutide QD 1.8 mg in T2DM patients, with effectiveness measured as reduction in glycated hemoglobin (HbA1c. In the base case, the model tracks change in HbA1c and direct medical expenditure over a 6-month time horizon. We calculated and compared the cost per 1% reduction in HbA1c of models populated with clinical data from a head-to-head randomized, controlled trial (DURATION-6 and a network meta-analysis. Expenditure inputs were derived from wholesale acquisition costs and published sources.In the base case, 6-month expenditure for the liraglutide and exenatide strategies were $3,509 and $2,618, respectively. Using clinical data from DURATION-6 and the network meta-analysis, the liraglutide strategy had an incremental cost per 1% reduction in HbA1c of $4,773 and $27,179, respectively. The most influential model parameters were drug costs, magnitude of HbA1c reduction in patients on treatment for >1 month, and liraglutide gastrointestinal adverse event rate. In probabilistic sensitivity analyses (PSA using DURATION-6 data, the exenatide strategy was optimal at willingness-to-pay levels below $4,800 per 1% reduction in HbA1c. In a PSA using meta-analysis data, the exenatide strategy was dominant.Our modeled results demonstrate that the effectiveness and cost-effectiveness of

  12. Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study.

    Directory of Open Access Journals (Sweden)

    Patricia Echeverría

    Full Text Available Etravirine (ETR was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naïve patients. However, data on the switching from protease inhibitors (PI to ETR are lacking.HIV-1-infected patients with suppressed viral load (VL during a PI-containing regimen (>12 months and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water (ETR group, n = 22 or to continue with the same regimen (control group, n = 21. Percentage of patients with VL ≤ 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.We included 43 patients [72.9% male, 46.3 (42.2; 50.6 years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation and another in the control group (simplification discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL; treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure (p = 0.58. CD4+ T-cell counts did not significantly vary [+49 cells/µL in the ETR group (p = 0.25 and -4 cells/µL in the control group (p = 0.71]. The ETR group showed significant reductions in cholesterol (p<0.001, triglycerides (p = <0.001, and glycemia (p = 0.03 and higher satisfaction (0-10 scale (p = 0.04. Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.ClinicalTrials.gov NCT01034917.

  13. Pharmacodynamic analysis and clinical trial of amoxicillin sprinkle administered once daily for 7 days compared to penicillin V potassium administered four times daily for 10 days in the treatment of tonsillopharyngitis due to Streptococcus pyogenes in children.

    Science.gov (United States)

    Pichichero, M E; Casey, J R; Block, S L; Guttendorf, R; Flanner, H; Markowitz, D; Clausen, S

    2008-07-01

    An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time above the MIC (T >MIC; based on the MIC(90) of 0.06 microg/ml for Streptococcus pyogenes reported in the literature) was shown to be achievable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle). The daily T >MIC achieved with the QD amoxicillin sprinkle formulation was comparable to that achieved with a four-times-daily (QID) penicillin VK suspension. An investigator-blinded, randomized, parallel-group, multicenter study involving 579 children 6 months to 12 years old with acute streptococcal tonsillopharyngitis was then undertaken. Children were randomly assigned 1:1 to receive either the amoxicillin sprinkle (475 mg for ages 6 months to 4 years, 775 mg for ages 5 to 12 years) QD for 7 days or 10 mg/kg of body weight of penicillin VK QID for 10 days (up to the maximum dose of 250 mg QID). Unexpectedly, the rates of bacteriological eradication at the test of cure were 65.3% (132/202) for the amoxicillin sprinkle and 68.0% (132/194) for penicillin VK (95% confidence interval, -12.0% to 6.6%). Thus, neither antibiotic regimen met the minimum criterion of > or =85% eradication ordinarily required by the U.S. FDA for first-line treatment of tonsillopharyngitis due to S. pyogenes. The results of subgroup analyses across demographic characteristics and current infection characteristics and by age/weight categories were consistent with the primary-efficacy result. The clinical cure rates for amoxicillin sprinkle and penicillin VK were 86.1% (216/251) and 91.9% (204/222), respectively (95% confidence interval, -11.6% to -0.4%). The results of a post hoc PD analysis suggested that a requirement for 60% daily T >MIC(90) more accurately predicted the observed high failure rates for bacteriologic eradication with the amoxicillin sprinkle and penicillin VK suspension studied. Based on the association between

  14. Pharmacodynamic Analysis and Clinical Trial of Amoxicillin Sprinkle Administered Once Daily for 7 Days Compared to Penicillin V Potassium Administered Four Times Daily for 10 Days in the Treatment of Tonsillopharyngitis Due to Streptococcus pyogenes in Children▿

    Science.gov (United States)

    Pichichero, M. E.; Casey, J. R.; Block, S. L.; Guttendorf, R.; Flanner, H.; Markowitz, D.; Clausen, S.

    2008-01-01

    An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time above the MIC (T >MIC; based on the MIC90 of 0.06 μg/ml for Streptococcus pyogenes reported in the literature) was shown to be achievable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle). The daily T >MIC achieved with the QD amoxicillin sprinkle formulation was comparable to that achieved with a four-times-daily (QID) penicillin VK suspension. An investigator-blinded, randomized, parallel-group, multicenter study involving 579 children 6 months to 12 years old with acute streptococcal tonsillopharyngitis was then undertaken. Children were randomly assigned 1:1 to receive either the amoxicillin sprinkle (475 mg for ages 6 months to 4 years, 775 mg for ages 5 to 12 years) QD for 7 days or 10 mg/kg of body weight of penicillin VK QID for 10 days (up to the maximum dose of 250 mg QID). Unexpectedly, the rates of bacteriological eradication at the test of cure were 65.3% (132/202) for the amoxicillin sprinkle and 68.0% (132/194) for penicillin VK (95% confidence interval, −12.0% to 6.6%). Thus, neither antibiotic regimen met the minimum criterion of ≥85% eradication ordinarily required by the U.S. FDA for first-line treatment of tonsillopharyngitis due to S. pyogenes. The results of subgroup analyses across demographic characteristics and current infection characteristics and by age/weight categories were consistent with the primary-efficacy result. The clinical cure rates for amoxicillin sprinkle and penicillin VK were 86.1% (216/251) and 91.9% (204/222), respectively (95% confidence interval, −11.6% to −0.4%). The results of a post hoc PD analysis suggested that a requirement for 60% daily T >MIC90 more accurately predicted the observed high failure rates for bacteriologic eradication with the amoxicillin sprinkle and penicillin VK suspension studied. Based on the association between longer

  15. [Spectrum-Effect Relationship of GualouXiebai Dropping Pills on Myocardial Ischemia].

    Science.gov (United States)

    Yan, Hai-yan; Zou, Chun-cai; Wei, Mei-ling; Yang, You-yun; Fei, Fu-qi; Xu, Xin-ying

    2015-09-01

    To study the relationship between HPLC characteristic spectrum and pharmacodynamics on anti-myocardial ischemia of GualouXiebai dropping pills. HPLC characteristic spectrum of GualouXiebai dropping pills was established, dropping pills were divided into five dose groups (3.75, 11.25, 22.5, 33.75 and 45 g/kg, equivalent to the crude herb g/kg), the mice were orally administered dropping pills once daily for 7 d, 90 min after the mice were given by intraperitoneal injection of isoprenaline to establish myocardial ischemia models, the level of CK in blood plasma were detected; Then, the correlation between characteristic spectrum and biochemical index CK was studied by grey relational analysis method. The correlation between each common peak and CK had gradually increased with the dose increased from 3.73 g/kg to 33.75 g/kg, but when the dose reached to 45 g/kg, the correlation between each common peak and CK had decreased. The variation trends of correlation of spectrum-effect relationship for different dose were similar,but the correlation variation trend of the efficacy on the No. 8 peak in 33.75 g/kg group with the other four groups in the opposite, the change trends of the No. 11 peak in 22.5 g/kg group, the No. 24 peak in 33. 75 g/kg group and the No. 37 peak in 45 g/ kg group with 3.75 g/kg group and 11.25 g/kg group on the contrary. The relational orders of spectrum-effect relationship were not consistent, respectively( the first 15 peaks) :11 > 37 > 24 > 30 > 8 > 21 > 2 > 16 > 1 > 3 > 20 > 15 > 12 > 19 > 7;11 > 37 > 30 > 8 > 21 > 24 > 2 > 1 > 16 > 3 > 27 > 12 > 22 > 20 >10; 8 > 30 > 1 > 2 > 21 > 27 > 31 > 22 > 16 > 12 > 3 > 10 > 9 > 20 > 4; 1 > 2 > 27 > 21 > 31 > 22 > 12 > 16 > 9 > 3 > 10 > 4 > 17 > 30 > 20; 8 > 30 > 1 > 2 > 2 > 2 > 7 > 31 > 22 > 16 > 12 > 3 > 9 > 10 > 20 > 17. Anti-myocardial ischemia effect of GualouXiebai dropping pills comes from the synergistic or antagonistic effect among various active ingredients related to the dose. With the

  16. Pill content, dose and resulting plasma concentrations of 3,4-methylendioxymethamphetamine (MDMA) in recreational 'ecstasy' users.

    Science.gov (United States)

    Morefield, Kate M; Keane, Michael; Felgate, Peter; White, Jason M; Irvine, Rodney J

    2011-07-01

    To improve our understanding of the pharmacology of 'ecstasy' in recreational environments; in particular, to describe the composition of ecstasy pills, patterns of ecstasy use and the relationship between dose of 3,4-methylendioxymethamphetamine (MDMA) and resulting plasma concentrations. A naturalistic observational study of 56 experienced 'ecstasy' users in recreational settings in Australia. Drug use patterns (number of pills consumed, other drugs consumed). drug content of pills and resultant plasma concentrations of MDMA and related drugs were assessed by gas chromatography/mass spectrometry (GC/MS). Ecstasy pills generally contained MDMA, but this was often combined with other drugs such as 3,4-ethylendioxyethylamphetamine (MDEA) and methamphetamine. The dose of MDMA per pill ranged from 0 to 245 mg and users consumed from one-half to five pills, with the total dose consumed ranging up to 280 mg. Plasma concentrations of MDMA increased with number of pills consumed and cumulative MDMA dose. Use of larger numbers of pills was associated with extended exposure to the drug. MDMA is the major active drug in ecstasy pills, but there is a high degree of variation in doses. Use of multiple pills over the course of one session is common and results in a sustained increase in MDMA plasma concentrations over a number of hours. This is likely to lead to a much greater exposure of the brain to MDMA than would be predicted from controlled single-dose pharmacokinetic studies. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  17. Ventricular tachycardia induced by weight loss pills

    DEFF Research Database (Denmark)

    Pareek, Manan; Hansson, Nils Henrik; Grove, Erik Lerkevang

    2013-01-01

    A previously healthy 29-year-old man was admitted with palpitations, dizziness, and near-syncope after he had recently started taking weight loss pills purchased on the internet. The pills contained caffeine and ephedrine. An electrocardiogram and telemetry revealed multiple episodes of non......-sustained monomorphic ventricular tachycardia, which was successfully treated with amiodarone. In conclusion, unauthorized weight loss pills can be harmful. In particular, ephedrine-containing drugs carry a risk of ventricular tachycardia and should be discouraged....

  18. Salt Pill Design and Fabrication for Adiabatic Demagnetization Refrigerators

    Science.gov (United States)

    Shirron, Peter J.; Mccammon, Dan

    2014-01-01

    The performance of an adiabatic demagnetization refrigerator (ADR) is critically dependent on the design and construction of the salt pills that produce cooling. In most cases, the primary goal is to obtain the largest cooling capacity at the low temperature end of the operating range. The realizable cooling capacity depends on a number of factors, including refrigerant mass, and how efficiently it absorbs heat from the various instrument loads. The design and optimization of "salt pills" for ADR systems depend not only on the mechanical, chemical and thermal properties of the refrigerant, but also on the range of heat fluxes that the salt pill must accommodate. Despite the fairly wide variety of refrigerants available, those used at very low temperature tend to be hydrated salts that require a dedicated thermal bus and must be hermetically sealed, while those used at higher temperature - greater than about 0.5 K - tend to be single-­- or poly-­-crystals that have much simpler requirements for thermal and mechanical packaging. This paper presents a summary of strategies and techniques for designing, optimizing and fabricating salt pills for both low-­- and mid-­-temperature applications.

  19. Patient understanding of oral contraceptive pill instructions related to missed pills: a systematic review.

    Science.gov (United States)

    Zapata, Lauren B; Steenland, Maria W; Brahmi, Dalia; Marchbanks, Polly A; Curtis, Kathryn M

    2013-05-01

    Instructions on what to do after pills are missed are critical to reducing unintended pregnancies resulting from patient non-adherence to oral contraceptive (OC) regimens. Missed pill instructions have previously been criticized for being too complex, lacking a definition of what is meant by "missed pills," and for being confusing to women who may not know the estrogen content of their formulation. To help inform the development of missed pill guidance to be included in the forthcoming US Selected Practice Recommendations, the objective of this systematic review was to evaluate the evidence on patient understanding of missed pill instructions. We searched the PubMed database for peer-reviewed articles that examined patient understanding of OC pill instructions that were published in any language from inception of the database through March 2012. We included studies that examined women's knowledge and understanding of missed pill instructions after exposure to some written material (e.g., patient package insert, brochure), as well as studies that compared different types of missed pill instructions on women's comprehension. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. From 1620 articles, nine studies met our inclusion criteria. Evidence from one randomized controlled trial (RCT) and two descriptive studies found that more women knew what to do after missing 1 pill than after missing 2 or 3 pills (Level I, good, to Level II-3, poor), and two descriptive studies found that more women knew what to do after missing 2 pills than after missing 3 pills (Level II-3, fair). Data from two descriptive studies documented the difficulty women have understanding missed pill instructions contained in patient package inserts (Level II-3, poor), and evidence from two RCTs found that providing written brochures with information on missed pill instructions in addition to contraceptive counseling significantly improved

  20. Pill organizers and pill cutters: risks and limitations.

    Science.gov (United States)

    Borja-Oliveira, Caroline Ribeiro de

    2013-02-01

    In this essay, based on documental analysis, the limitations associated with the use of pill organizers and cutters are discussed and analyzed as a matter of public health. The use of the organizers for storing and carrying tablets and capsules exposes these medications to environmental factors from which their original packaging protected them, compromising their stability and safeness. Cutters also pose the additional risk of causing loss of efficacy, adverse reactions and overdose. On the other hand, the user carrying their own medication reflects the balance between autonomy and self-care, and splitting is sometimes required to comply with certain regimens. It can be concluded that healthcare professionals should observe and guide patients and caregivers in order to avoid risks.

  1. [Mamy-boom and baby-flop, pill and pill].

    Science.gov (United States)

    Geraud, R

    1989-05-01

    Data from France's National Institute of Demographic Studies indicate that in 1986, 778,859 infants were born in France, including 80,874 to foreign mothers. France's total fertility rate was 1.83, higher than the 1.40 of the Federal Republic of Germany or the 1.35 of Italy but not high enough to ensure replacement. A 1988 survey by the National Institute of Demographic Studies indicated that almost 2/3 of fertile-aged French women used pills or IUDs. 7% had undergone sterilization, 4% were infertile, 13% had no partners, and 10% were pregnant or desired to become pregnant. All the developed countries, regardless of their form of government, have low fertility rates. The complete explanations of the trend to low fertility are not known. Economic and sociological explanations probably carry less weight than psychological factors. The desire for material goods, greater freedom of women, changing roles of men in the family and society, and fragility of marriages probably all play a part. The pill and to a lesser extent abortion have been blamed for the declining fertility, but do not furnish the complete explanation. Greater availability of RU 486 may cause further decline, but nobody can predict with assurance. Falling nuptiality, increased nonmarital cohabitation with its low fertility rates, the low rate of remarriage after divorce, and the greater life expectancy of women all affect France's population structure and prospects. By 2010, some 20% of the European population will be aged 65 and over. By 2035 almost 10 million persons will be over 70 years old in France, and nearly 2/3 of them will be female. This large cohort of elderly will require expensive care that the smaller young cohorts will be expected to finance. Intergenerational solidarity, however, already shows signs of strain. Serious conflicts will inevitably arise over the care and maintenance of this large elderly population group and will be exacerbated by the uneven population structure resulting

  2. Progestin-only pills for contraception.

    Science.gov (United States)

    Grimes, David A; Lopez, Laureen M; O'Brien, Paul A; Raymond, Elizabeth G

    2013-11-13

    The introduction of a new progestin-only oral contraceptive in Europe has renewed interest in this class of oral contraceptives. Unlike the more widely used combined oral contraceptives containing an estrogen plus progestin, these pills contain only a progestin (progestogen) and are taken without interruption. How these pills compare to others in their class or to combined oral contraceptives is not clear. This review examined randomized controlled trials of progestin-only pills for differences in efficacy, acceptability, and continuation rates. Through October 2013, we searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, and LILACS for studies of progestin-only pills. We also searched for current trials via ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE. We included all randomized controlled trials in any language that included progestin-only pills for contraception.  We incorporated any comparison with a progestin-only pill; this could include different doses, other progestin-only pills, combined oral contraceptives, or other contraceptives. The first author abstracted the data and entered the information into RevMan 5. Another author performed a second, independent data abstraction to verify the initial data entry.We attempted to extract life-table rates (actuarial or continuous) and used the rate difference as the effect measure. Where life-table rates were not published, we used the incidence rate ratio (ratio of Pearl rates). Where only the crude number of events was published, we calculated the Peto odds ratio with 95% confidence interval (CI) using a fixed-effect model. For continuous variables, the mean difference (MD) was computed with 95% CI. Because of disparate exposures, we were not able to combine studies in meta-analysis. Six trials met the inclusion criteria. We have not found any new studies since the initial review. In the trial comparing the desogestrel versus

  3. The Return of Rainbow Diet Pills

    Science.gov (United States)

    Cohen, Pieter A.; Goday, Alberto; Swann, John P.

    2012-01-01

    The US Food and Drug Administration (FDA) has recently warned consumers about the risks of weight loss supplements adulterated with multiple pharmaceutical agents. Some of these supplements combine potent anorectics, such as amphetamines derivatives, with benzodiazepines, beta-blockers, and other medications to suppress the anorectics’ adverse effects. These weight loss supplements represent the most recent generation of rainbow diet pills, named for their bright and varied colors, which date back more than 70 years. Beginning in the 1940s, several US pharmaceutical firms aggressively promoted rainbow pills to physicians and patients. By the 1960s the pills had caused dozens of deaths before the FDA began removing them from the US market. We used a variety of original resources to trace these deadly pills from their origins in the United States to their popularity in Spain and Brazil to their reintroduction to the United States as weight loss dietary supplements. PMID:22813089

  4. Salt pill design and fabrication for adiabatic demagnetization refrigerators

    Science.gov (United States)

    Shirron, Peter J.; McCammon, Dan

    2014-07-01

    The performance of an adiabatic demagnetization refrigerator (ADR) is critically dependent on the design and construction of the salt pills that produce cooling. In most cases, the primary goal is to obtain the largest cooling capacity at the low temperature end of the operating range. The realizable cooling capacity depends on a number of factors, including refrigerant mass, and how efficiently it absorbs heat from the various instrument loads. The design and optimization of “salt pills” for ADR systems depend not only on the mechanical, chemical and thermal properties of the refrigerant, but also on the range of heat fluxes that the salt pill must accommodate. Despite the fairly wide variety of refrigerants available, those used at very low temperature tend to be hydrated salts that require a dedicated thermal bus and must be hermetically sealed, while those used at higher temperature - greater than about 0.5 K - tend to be single- or poly-crystals that have much simpler requirements for thermal and mechanical packaging. This paper presents a summary of strategies and techniques for designing, optimizing and fabricating salt pills for both low- and mid-temperature applications.

  5. Missed pills: frequency, reasons, consequences and solutions.

    Science.gov (United States)

    Chabbert-Buffet, Nathalie; Jamin, Christian; Lete, Iñaki; Lobo, Paloma; Nappi, Rossella E; Pintiaux, Axelle; Häusler, Günther; Fiala, Christian

    2017-06-01

    Oral hormonal contraception is an effective contraceptive method as long as regular daily intake is maintained. However, a daily routine is a constraint for many women and can lead to missed pills, pill discontinuation and/or unintended pregnancy. This article describes the frequency of inconsistent use, the consequences, the risk factors and the possible solutions. The article comprises a narrative review of the literature. Forgetting one to three pills per cycle is a frequent problem among 15-51% of users, generally adolescents. The reasons for this are age, inability to establish a routine, pill unavailability, side effects, loss of motivation and lack of involvement in the initial decision to use oral contraceptives. The consequences are 'escape ovulations' and, possibly, unintended pregnancy. Solutions are either to use a long-acting method or, for women who prefer to take oral contraceptives, use a continuous or long-cycle regimen to reduce the risks of follicular development and thus the likelihood of ovulation and unintended pregnancy. A progestogen with a long half-life can increase ovarian suppression. For women deciding to use oral contraceptives, a shortened or eliminated hormone-free interval and a progestogen with a long half-life may be an option to reduce the negative consequences of missed oral contraceptive pills.

  6. The 2016 iodine pill distribution campaign

    International Nuclear Information System (INIS)

    Delmestre, A.; Le Guen, B.

    2016-01-01

    The last iodine pills were distributed in february 2009, they are now outdated and a new campaign has been launched. Each family will receive a voucher to recover iodine pills from the nearby pharmacy. The aim of this new campaign is of course to protect people in case of severe nuclear accident but also to develop a radiation protection culture among the population. During the previous campaign only 51% of the concerned people went to the pharmacy to get the pills. The 2016 campaign will involve the public and all the establishments open to the public in a range of 10 km around each of the 19 nuclear power plants. It concerns 500 municipalities, 375.000 households, 55.000 enterprises and public utilities and 275 pharmacies are involved in the campaign. (A.C.)

  7. "Take your pill": the role and fantasy of pills in modern medicine.

    Science.gov (United States)

    Leder, Drew; Krucoff, Mitchell W

    2014-06-01

    The pharmaceutical industry has undergone a vast expansion in the 20th and 21st centuries. This article explores the central role now played by pills in clinical practice, but also in the public imagination. First, this article analyzes four properties that, together, account for many of the promises and perils associated with pills: They are ingestible, potent, reproducible, and miniaturized. This allows them to serve as ideal consumer items for widespread distribution and sale and also as model technological "devices" capable of downloading into the body healing chemicals. As such, they seem to promise a disburdening solution to many of life's ills. In our cultural fantasy, often shared by physician and patient alike, pills can be used not only to treat and prevent disease but also raise energy, lose weight, lessen pain, lift mood, cope with stress, and enhance sexual and athletic performance. This article also explores many adverse effects not only of pills themselves but of this exaggerated cultural fantasy of the pill. It tends to distract us from other, more holistic understandings of the locus of disease and healing. It even fosters misunderstandings of the ways in which pills themselves work, which is to assist bodily processes, and the mind's "meaning response." The intent here is not to demonize all pills-many have great therapeutic potential-but to learn how to better choose and use them wisely. We propose that this process be assisted through recontextualizing the pill as a multidimensional gift. Taken in such a way, with appropriate gratitude and discernment, we may ingest fewer pills, but with greater efficacy.

  8. Smart pill dispenser for dependent people

    OpenAIRE

    Juan Grau, Guillermo de

    2015-01-01

    Many medical errors are due to the fact that people in charge of patient or elder’s medication have to deal with sorting huge amounts of pills each day. This paper consists on the conception, design and creation of a pillbox prototype intended to solve this deficiency in the medical area as it has the ability of sorting out the pills by itself as well as many other advanced features, with this device being intended to be used by hospitals or retirement homes. For the design of this device ope...

  9. Undigested Pills in Stool Mimicking Parasitic Infection.

    Science.gov (United States)

    Mir, Fazia; Achakzai, Ilyas; Ibdah, Jamal A; Tahan, Veysel

    2017-01-01

    Background . Orally ingested medications now come in both immediate release and controlled release preparations. Controlled release preparations were developed by pharmaceutical companies to improve compliance and decrease frequency of pill ingestion. Case Report . A 67-year-old obese male patient presented to our clinic with focal abdominal pain that had been present 3 inches below umbilicus for the last three years. This pain was not associated with any trauma or recent heavy lifting. Upon presentation, the patient reported that for the last two months he started to notice pearly oval structures in his stool accompanying his chronic abdominal pain. This had coincided with initiation of his nifedipine pills for his hypertension. He reported seeing these undigested pills daily in his stool. Conclusion . The undigested pills may pose a cause of concern for both patients and physicians alike, as demonstrated in this case report, because they can mimic a parasitic infection. This can result in unnecessary extensive work-up. It is important to review the medication list for extended release formulations and note that the outer shell can be excreted whole in the stool.

  10. The Administration of Tibetan Precious Pills

    Science.gov (United States)

    Czaja, Olaf

    2016-01-01

    Precious pills represent a special kind of Tibetan drug that once was, and still is, highly sought after by Tibetan, Chinese, and Mongolian patients. Such pills are generally taken as a potent prophylactic remedy, and can be used to cure various diseases. The present study seeks to discuss the dispensation and efficacy of precious pills according to the presentations of historical Tibetan medical scholars. Several treatises dealing with these instructions will be analysed, thereby revealing their underlying concepts, and highlighting their points of both general consensus and disagreement. The analysis of these detailed instructions will reveal the fact that these precious pills were not merely given to a patient but, in order to ensure their full efficacy, involved an elaborate regimen concerning three chronological periods: (1) the time of preparation, (2) the time of dispensation, and (3) the time after dispensation. Thus the present study surveys not only the ritual empowerment of drugs in Tibetan medicine, but also the importance of social relationships between doctors and patients in Tibetan medical history. PMID:27980504

  11. The Contraceptive Pill-Current Status

    African Journals Online (AJOL)

    16 Okt 1974 ... the method and a certain amount of inherent risk, and nonetheless request it. The onus is therefore on the medical profession to select the most suitable type of pill for each type of patient. An attempt must be made to assess the risks in specific indi- viduals, and to prevent prescription of oral contra-. 2085 ...

  12. the effect of oral contraceptive pills

    African Journals Online (AJOL)

    Uwaifoh

    2012-12-31

    Dec 31, 2012 ... The relationship between oral contraceptives pills (OCP) and body weight gain has long been established and remains one of the major setback of OCP. This study therefore, was designed to establish the effect of OCP in rabbits. It was a six weeks study involving 15 female rabbits that were divided into ...

  13. Evaluation of gastric and small bowel transit times in coeliac disease with the small bowel PillCam®: a single centre study in a non gluten-free diet adult Italian population with coeliac disease.

    Science.gov (United States)

    Urgesi, R; Cianci, R; Bizzotto, A; Costamagna, G; Riccioni, M E

    2013-05-01

    The mechanisms underlying bowel disturbances in coeliac disease are still relatively unclear. Past reports suggested that small bowel motor abnormalities may be involved in this pathological condition; there are no studies addressing small bowel transit in coeliac disease before and after a gluten-free diet. The objective of this study was to determine whether capsule endoscopy (CE) could serve as a test for measurement of gastric and small bowel transit times in a group of symptomatic or asymptomatic coeliac patients at the time of diagnosis with respect to a control group. Thirty coeliac untreated patients and 30 age-, sex- and BMI-matched healthy controls underwent CE assessment of whole gut transit times. All subjects completed the study per protocol and experienced natural passage of the pill. No statistical significant differences between gastric emptying and small bowel transit times both in coeliac and control group were found (p = 0.1842 and p = 0.7134; C.I. 95%, respectively). No correlation was found in coeliac patients and control group between transit times and age, sex and BMI. By using the Pearson's correlation test, significant correlation emerged between gastric emptying time and small bowel transit times in coeliac disease (r = 0.1706). CE reveals unrecognized gender differences and may be a novel outpatient technique for gut transit times' assessment without exposure to radiation and for the evaluation of upper gut dysfunction in healthy patients suffering from constipation without evidence of intestinal malabsorption. Nevertheless, CE does not seem to be the most suitable method for studying gut transit times in untreated coeliac patients; this might be ascribed to the fact that CE consists of inert (non-digestible, non-absorbable) substances.

  14. Fatal Fentanyl: One Pill Can Kill.

    Science.gov (United States)

    Sutter, Mark E; Gerona, Roy R; Davis, M Thais; Roche, Bailey M; Colby, Daniel K; Chenoweth, James A; Adams, Axel J; Owen, Kelly P; Ford, Jonathan B; Black, Hugh B; Albertson, Timothy E

    2017-01-01

    The current national opioid epidemic is a public health emergency. We have identified an outbreak of exaggerated opioid toxicity caused by fentanyl adulterated tablets purchased on the street as hydrocodone/acetaminophen. Over an 8-day period in late March 2016, a total of 18 patients presented to our institution with exaggerated opioid toxicity. The patients provided a similar history: ingesting their "normal dose" of hydrocodone/acetaminophen tablets but with more pronounced symptoms. Toxicology testing and analysis was performed on serum, urine, and surrendered pills. One of the 18 patients died in hospital. Five patients underwent cardiopulmonary resuscitation, one required extracorporeal life support, three required intubation, and two received bag-valve-mask ventilation. One patient had recurrence of toxicity after 8 hours after naloxone discontinuation. Seventeen of 18 patients required boluses of naloxone, and four required prolonged naloxone infusions (26-39 hours). All 18 patients tested positive for fentanyl in the serum. Quantitative assays conducted in 13 of the sera revealed fentanyl concentrations of 7.9 to 162 ng/mL (mean = 52.9 ng/mL). Pill analysis revealed fentanyl amounts of 600-6,900 μg/pill. The pills are virtually indistinguishable from authentic hydrocodone/acetaminophen tablets and are similar in weight. To date, our county has reported 56 cases of fentanyl opioid toxicity, with 15 fatalities. In our institution, the outbreak has stressed the capabilities and resources of the emergency department and intensive care units. A serious outbreak of exaggerated opioid toxicity caused by fentanyl-adulterated tablets purchased on the street as hydrocodone/acetaminophen is under way in California. These patients required higher dosing and prolonged infusions of naloxone. Additionally, observation periods off naloxone were extended due to delayed, recurrent toxicity. The outbreak has serious ramifications for public health and safety, law

  15. Effect of Zuogui Pill () on monoamine neurotransmitters and sex hormones in climacteric rats with panic attack.

    Science.gov (United States)

    Li, Xiao-Yu; Wang, Xiao-Yun

    2017-03-01

    To explore the effects of Chinese medicine prescription Zuogui Pill (, ZGP) on monoamine neurotransmitters and sex hormones in climacteric rats with induced panic attacks. Forty-eight climacteric female rats were randomized into 6 groups with 8 rats in each group: the control group, the model group, the low-, medium- and high-dose ZGP groups and the alprazolam group. Rats in the low-, medium- and high-dose ZGP groups were administered 4.725, 9.45, or 18.9 g/kg ZGP by gastric perfusion, respectively. The alprazolam group was treated by gastric perfusion with 0.036 mg/kg alprazolam. The control and model groups were treated with distilled water. The animals were pretreated once daily for 8 consecutive weeks. The behaviors of rats in the open fifield test and the elevated T-maze (ETM) were observed after induced panic attack, and the levels of brain monoamine neurotransmitters and the plasma levels of sex hormones were measured. Compared with the control group, the mean ETM escape time and the levels of 5-hydroxytryptamine (5-HT) and noradrenalin (NE) of the model group were signifificantly reduced (P<0.05), Compared with the model group, the mean ETM escape time and the 5-HT and NE levels of all the ZGP groups increased signifificantly (P<0.05 or P<0.01). However, no signifificant difference was observed in the levels of sex hormones between the groups. Pretreatment with ZGP in climacteric rats may improve the behavior of panic attack, which may be related to increased 5-HT and NE in the brain.

  16. Differences in harm from legal BZP/TFMPP party pills between North Island and South Island users in New Zealand: a case of effective industry self-regulation?

    Science.gov (United States)

    Wilkins, Chris; Sweetsur, Paul

    2010-01-01

    'Party' pills containing benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) were sold legally in New Zealand until early 2008. Prospective studies of hospital emergency department admissions appeared to suggest that the harm from party pills was greater among South Island than North Island users. The party pill industry association (the Social Tonics Association of New Zealand or STANZ) claimed these differences were due to the voluntary code of practice adopted by their members in the North Island. The aims of this study were to examine differences in harm from party pills between North and South Island users in New Zealand, and to investigate possible reasons for any differences in harm, including the impact of industry self-regulation. A national household survey of BZP/TFMPP party pill use was conducted in New Zealand. Information on the ingredients of party pills was provided by the National Poisons Centre. In a number of instances last year users of party pills from the South Island were more likely than last year users from the North Island to report harm from party pills. There were no differences between the North and South Island users with regard to the mean number of BZP/TFMPP party pills taken, mean total milligrams of BZP/TFMPP ingested or prevalence of use of other drug types in combination with party pills. A minority of users in the South Island reported using extremely high numbers of BZP/TFMPP party pills in a single session and using extremely high potency brands of party pills. Last year party pill users from the South Island were more likely than those from the North Island to be students. A number of factors may have contributed to the greater harm from BZP/TFMPP party pills among South Island users including a higher proportion of student users with higher consumption of alcohol and other drugs. Users from both Islands commonly exceeded the dosage of BZP/TFMPP recommended by STANZ suggesting the STANZ code of conduct was

  17. Happy-People-Pills for All

    Directory of Open Access Journals (Sweden)

    Mark Walker

    2011-01-01

    Full Text Available

    It is argued that we have a moral duty to create, and make available, advanced pharmacological agents to boost the happiness of those in the normal, i.e., the non-depressed, range of happiness. Happiness, conceived as a propensity to positive moods, is a quantitative trait with a sizeable genetic component. One means to boost the happiness of those in the normal range is to test the efficacy of antidepressants for enhancement. A second possibility is to model new pharmacologicals based on the genetics of the happiest amongst us, that is, the hyperthymic. The suggestion, in other words, is to “reverse engineer” the hyperthymic: to investigate what makes the hyperthymic genetically and physiologically different and then put what they have into pill form. To the ‘Brave New World’ objection, that there is more to wellbeing than happiness and that taking happy-people-pills will require the sacrifice of these other aspects of wellbeing, it is countered that contemporary social science research supports the view that happiness promotes achievement in the ‘higher’ endeavors of humanity, including work, love and virtue. In other words, happiness promotes acquisition of traits valued by perfectionists. Those born with genes for hyperthymia, on average, tend to be doubly blessed: they are happier and achieve more than the rest of the population. Happy-people-pills are a means to allow everyone else to share in this good

  18. Tibetan Precious Pills as Therapeutics and Rejuvenating Longevity Tonics

    Directory of Open Access Journals (Sweden)

    Barbara Gerke

    2017-12-01

    Full Text Available Tibetan precious pills are frequently attributed with a variety of efficacies, from “magical” powers, prevention of poisoning and infectious diseases, protection from harmful spirits and exposure to diseases while travelling, to rejuvenating and prolonging life through clearing the senses and promoting strength and vigor. They are prescribed as strong medicines for severe diseases, but are also advertised as rejuvenating tonics for the healthy. This paper explores the rejuvenating qualities attributed to precious pills in terms of how they are currently advertised, how rejuvenation is and has been explained in Tibetan works on precious pills, and how Tibetan physicians understand these attributes. How do these domains interact and refer to each other? I compare aspects of rejuvenation in precious pill formulas with contemporary presentations of precious pills online and on published leaflets given out to patients in India and elsewhere. In Tibetan medical texts certain precious pills that contain the complex and processed mercury-sulfide ash called tsotel in addition to a large variety of other medicinal substances are presented as “precious pills” or rinchen rilbu, and only some of those are said to have rejuvenating effects on the body; most are primarily prescribed for specific diseases. The practice of giving precious pills to the healthy emerges more prominently in eighteenth to nineteenth century manuals on administering precious pills (Czaja 2015, which parallels the establishment of influential medical and monastic networks that promoted the making of tsotel and precious pills. I argue that precious pills have more recently widened their specific therapeutic target beyond that of medicine into becoming popular pills for rejuvenation, even if they do not contain tsotel, as part of pharmaceutical commodification. I also show how presentations of precious pills as “rejuvenating” are deeply linked to their availability.

  19. Bioaccessibility and excretion of arsenic in Niu Huang Jie Du Pian pills

    International Nuclear Information System (INIS)

    Koch, Iris; Sylvester, Steven; Lai, Vivian W.-M.; Owen, Andrew; Reimer, Kenneth J.; Cullen, William R.

    2007-01-01

    Traditional Chinese medicines (TCMs) often contain significant levels of potentially toxic elements, including arsenic. Niu Huang Jie Du Pian pills were analyzed to determine the concentration, bioaccessibility (arsenic fraction soluble in the human gastrointestinal system) and chemical form (speciation) of arsenic. Arsenic excretion in urine (including speciation) and facial hair were studied after a one-time ingestion. The pills contained arsenic in the form of realgar, and although the total arsenic that was present in a single pill was high (28 mg), the low bioaccessibility of this form of arsenic predicted that only 4% of it was available for absorption into the bloodstream (1 mg of arsenic per pill). The species of arsenic that were solubilized were inorganic arsenate (As(V)) and arsenite (As(III)) but DMAA and MMAA were detected in urine. Two urinary arsenic excretion peaks were observed: an initial peak several (4-8) hours after ingestion corresponding to the excretion of predominantly As(III), and a larger peak at 14 h corresponding predominantly to DMAA and MMAA. No methylated As(III) species were observed. Facial hair analysis revealed that arsenic concentrations did not increase significantly as a result of the ingestion. Arsenic is incompletely soluble under human gastrointestinal conditions, and is metabolized from the inorganic to organic forms found in urine. Bioaccessible arsenic is comparable to the quantity excreted. Facial hair as a bio-indicator should be further tested

  20. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days.

    Science.gov (United States)

    Bell, D; Duffin, A; Jacobs, A; Pediconi, C; Gruss, H J

    2014-03-01

    The 1R,2S stereoisomer of methoxamine hydrochloride, NRL001, is a highly selective α1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone. This study investigated the steady state pharmacokinetics (PK) and safety of 2 g rectal suppositories containing NRL001 in different strengths (7.5, 10, 12.5 or 15 mg). Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo. In each dose group nine participants received NRL001 and three received placebo. Blood samples to determine NRL001 concentrations were taken on Days 1, 7 and 14. Cardiovascular parameters were collected via electrocardiograms, Holter monitoring (three lead Holter monitor) and vital signs. Forty-eight volunteers were enrolled; 43 completed the study and were included in the PK analysis population. AUC and Cmax broadly increased with increasing dose, Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional, dose proportionality analysis did not provide evidence against dose proportionality as the log(dose) coefficients were not significantly < 1. NRL001 did not accumulate over time for any dose. Increasing NRL001 concentrations were related to changes in vital sign variables, most notably decreased heart rate. The most commonly reported adverse events (AEs) in the active treatment groups were paraesthesia and piloerection. Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time. Treatment was associated with changes in vital sign variables, most notably decreased heart rate. AEs commonly reported with NRL001 treatment were events indicative of a systemic α-adrenergic effect. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  1. Iodine leaflets in chapter D5 'Distribution of iodine pills'

    International Nuclear Information System (INIS)

    1981-01-01

    Jodine leaflet A will be distributed together with iodine pills in a nuclear disaster. Iodine leaflet B is suitable for informing the public in advance. Iodine leaflet C informs physicians in a scientific way on the benefits and risk of iodine pills. (orig./HP) [de

  2. [The NHG guideline 'Sleep problems and sleeping pills'

    NARCIS (Netherlands)

    Damen-van Beek, Z.; Lucassen, P.L.; Gorgels, W.J.M.J.; Smelt, A.F.; Knuistingh Neven, A.; Bouma, M.

    2015-01-01

    - The Dutch College of General Practitioners' (NHG) guideline 'Sleep problems and sleeping pills' provides recommendations for the diagnosis and treatment of the most prevalent sleep problems and for the management of chronic users of sleeping pills.- The preferred approach for sleeplessness is not

  3. Understanding gastric forces calculated from high-resolution pill tracking.

    Science.gov (United States)

    Laulicht, Bryan; Tripathi, Anubhav; Schlageter, Vincent; Kucera, Pavel; Mathiowitz, Edith

    2010-05-04

    Although other methods exist for monitoring gastrointestinal motility and contractility, this study exclusively provides direct and quantitative measurements of the forces experienced by an orally ingested pill. We report motive forces and torques calculated from real-time, in vivo measurements of the movement of a magnetic pill in the stomachs of fasted and fed humans. Three-dimensional net force and two-dimensional net torque vectors as a function of time data during gastric residence are evaluated using instantaneous translational and rotational position data. Additionally, the net force calculations described can be applied to high-resolution pill tracking acquired by any modality. The fraction of time pills experience ranges of forces and torques are analyzed and correlate with the physiological phases of gastric digestion. We also report the maximum forces and torques experienced in vivo by pills as a quantitative measure of the amount of force pills experience during the muscular contractions leading to gastric emptying. Results calculated from human data are compared with small and large animal models with a translational research focus. The reported magnitude and direction of gastric forces experienced by pills in healthy stomachs serves as a baseline for comparison with pathophysiological states. Of clinical significance, the directionality associated with force vector data may be useful in determining the muscle groups associated with gastrointestinal dysmotility. Additionally, the quantitative comparison between human and animal models improves insight into comparative gastric contractility that will aid rational pill design and provide a quantitative framework for interpreting gastroretentive oral formulation test results.

  4. Towards Automated and Objective Assessment of Fabric Pilling

    Directory of Open Access Journals (Sweden)

    Rocco Furferi

    2014-10-01

    Full Text Available Pilling is a complex property of textile fabrics, representing, for the final user, a non-desired feature to be controlled and measured by companies working in the textile industry. Traditionally, pilling is assessed by visually comparing fabrics with reference to a set of standard images, thus often resulting in inconsistent quality control. A number of methods using machine vision have been proposed all over the world, with almost all sharing the idea that pilling can be assessed by determining the number of pills or the area occupied by the pills on the fabric surface. In the present work a different approach is proposed: instead of determining the number of pills, a machine vision-based procedure is devised with the aim of extracting a number of parameters characterizing the fabric. These are then used to train an artificial neural network to automatically grade the fabrics in terms of pilling. Tested against a set of differently pilled fabrics, the method shows its effectiveness.

  5. Improving access to emergency contraceptive pills.

    Science.gov (United States)

    1999-09-01

    This article focuses on the accessibility of emergency contraceptive pills (ECPs). The ECPs are safe, simple, and effective contraceptive agent that can reduce a woman's chance of becoming pregnant by 75%. It works by preventing or delaying ovulation, interfering with fertilization, or blocking implantation of a fertilized egg, depending on when in the menstrual cycle the pills are taken. The Population Council takes a multifaceted approach to expanding access to and knowledge on emergency contraception. Studies on innovations in service delivery are being conducted. In Mexico, one-tenth of women aged 13-55 who reported being raped during the 9-month study were counseled about ECPs. Results showed that pregnancies from reported rapes declined from 9.8% to 7.4% during the study. In Ho Chi Minh City, Vietnam, practitioners approved of the use of emergency contraception and desired more accurate knowledge so that they could provide it effectively. Moreover, in Zambia, researchers found out that giving women packages of ECPs in advance greatly reduced the length of time between having unprotected intercourse and beginning ECP treatment. Council researchers have also addressed the safety of offering ECPs without prescription. They have collaborated with leaders in the health care industry to increase method availability.

  6. Combining qualitative with quantitative approaches to study contraceptive pill use.

    Science.gov (United States)

    Oakley, D; Yu, M Y; Zhang, Y M; Zhu, X L; Chen, W H; Yao, L

    1999-03-01

    According to large-scale studies, oral contraceptive users become pregnant at rates that exceed ideal use failure rates. It is thought that a major cause is missed pills, but current research on consistent contraceptive pill taking is characterized by inadequate measures and a failure to investigate women's thinking about their own patterns of use. The purpose of this study was to gain some understanding about women's interpretations of consistency in their own pill taking through combining qualitative with quantitative data. The study was conducted in China, where contraception is free and widely available. Five urban and five rural oral contraceptive users were followed for up to three pill-taking cycles during 1996 for a total of 759 person-days. Consistency of pill taking was measured with electronic data obtained from a new blister package made by Anderson Clinical Technologies (Elmhurst, IL). Data from these devices were reviewed and interpreted by the study participants during in-depth private interviews. The users' reasons for missing pills included disruptions in their daily routines, their husband's absence, spotting, and trouble implementing the family planning program's instructions to take one pill per day for 22 days and start the next cycle on the fifth day of menses. One user gave these reasons for two cycles but denied missing numerous pills in her third cycle. Data from a series of four questionnaires showed that most demographic, psychosocial, and service system characteristics were not related to missed pills. However, results suggested that the daily routines of rural living may make consistent use more likely and that instructions for taking the pill may be associated with prolonged pill-free intervals and skipping pills during episodes of spotting. Three of the 10 women were at increased risk of pregnancy during the study period because of their pill-taking pattern. We concluded that the combination of qualitative with quantitative data

  7. The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early treatment-experienced subjects.

    Science.gov (United States)

    Ruane, P J; Brinson, C; Ramgopal, M; Ryan, R; Coate, B; Cho, M; Kakuda, T N; Anderson, D

    2015-05-01

    Following antiretroviral therapy failure, patients are often treated with a three-drug regimen that includes two nucleoside/tide reverse transcriptase inhibitors [N(t)RTIs]. An alternative two-drug nucleoside-sparing regimen may decrease the pill burden and drug toxicities associated with the use of N(t)RTIs. The Intelence aNd pRezista Once A Day Study (INROADS; NCT01199939) evaluated the nucleoside-sparing regimen of etravirine 400 mg with darunavir/ritonavir 800/100 mg once-daily in HIV-1-infected treatment-experienced subjects or treatment-naïve subjects with transmitted resistance. In this exploratory phase 2b, single-arm, open-label, multicentre, 48-week study, the primary endpoint was the proportion of subjects who achieved HIV-1 RNA treatment-experienced subjects or treatment-naïve subjects with transmitted resistance was virologically efficacious and well tolerated. © 2014 British HIV Association.

  8. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1): an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study to investigate the effect of once daily nitisinone on 24-h urinary homogentisic acid excretion in patients with alkaptonuria after 4 weeks of treatment.

    Science.gov (United States)

    Ranganath, Lakshminarayan R; Milan, Anna M; Hughes, Andrew T; Dutton, John J; Fitzgerald, Richard; Briggs, Michael C; Bygott, Helen; Psarelli, Eftychia E; Cox, Trevor F; Gallagher, James A; Jarvis, Jonathan C; van Kan, Christa; Hall, Anthony K; Laan, Dinny; Olsson, Birgitta; Szamosi, Johan; Rudebeck, Mattias; Kullenberg, Torbjörn; Cronlund, Arvid; Svensson, Lennart; Junestrand, Carin; Ayoob, Hana; Timmis, Oliver G; Sireau, Nicolas; Le Quan Sang, Kim-Hanh; Genovese, Federica; Braconi, Daniela; Santucci, Annalisa; Nemethova, Martina; Zatkova, Andrea; McCaffrey, Judith; Christensen, Peter; Ross, Gordon; Imrich, Richard; Rovensky, Jozef

    2016-02-01

    Alkaptonuria (AKU) is a serious genetic disease characterised by premature spondyloarthropathy. Homogentisate-lowering therapy is being investigated for AKU. Nitisinone decreases homogentisic acid (HGA) in AKU but the dose-response relationship has not been previously studied. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1) was an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study. The primary objective was to investigate the effect of different doses of nitisinone once daily on 24-h urinary HGA excretion (u-HGA24) in patients with AKU after 4 weeks of treatment. Forty patients were randomised into five groups of eight patients each, with groups receiving no treatment or 1 mg, 2 mg, 4 mg and 8 mg of nitisinone. A clear dose-response relationship was observed between nitisinone and the urinary excretion of HGA. At 4 weeks, the adjusted geometric mean u-HGA24 was 31.53 mmol, 3.26 mmol, 1.44 mmol, 0.57 mmol and 0.15 mmol for the no treatment or 1 mg, 2 mg, 4 mg and 8 mg doses, respectively. For the most efficacious dose, 8 mg daily, this corresponds to a mean reduction of u-HGA24 of 98.8% compared with baseline. An increase in tyrosine levels was seen at all doses but the dose-response relationship was less clear than the effect on HGA. Despite tyrosinaemia, there were no safety concerns and no serious adverse events were reported over the 4 weeks of nitisinone therapy. In this study in patients with AKU, nitisinone therapy decreased urinary HGA excretion to low levels in a dose-dependent manner and was well tolerated within the studied dose range. EudraCT number: 2012-005340-24. Registered at ClinicalTrials.gov: NCTO1828463. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. [Stability of physical state on compound hawthorn dropping pills].

    Science.gov (United States)

    Zhang, Wei; Chen, Hong-Yan; Jiang, Jian-Lan

    2008-11-01

    To evaluate the stability of physical state with accelerate test and dropping in process before and after on compound hawthorn dropping pills. Scanning electron microscope, TG-DTA, FT-IR and XRD were used. The active components presented amorphous, tiny crystal and molecular state in dropping pills, and it had no obvious reaction between PEG 4000 and active components. With time prolonging, a little of active components changed from amorphous state to tiny crystal or molecular state. Solid dispersion improved the stability and dissolution of compound hawthorn dropping pills.

  10. Oxycodone Ingestion Patterns in Acute Fracture Pain With Digital Pills.

    Science.gov (United States)

    Chai, Peter R; Carreiro, Stephanie; Innes, Brendan J; Chapman, Brittany; Schreiber, Kristin L; Edwards, Robert R; Carrico, Adam W; Boyer, Edward W

    2017-12-01

    Opioid analgesics are commonly prescribed on an as-needed (PRN) basis for acute painful conditions. Uncertainty of how patients actually take PRN opioids, coupled with a desire to completely cover pain, leads to variable and overly generous opioid prescribing practices, resulting in a surplus of opioids. This opioid surplus becomes a source for diversion and nonmedical opioid use. Understanding patterns of actual opioid ingestion after acute painful conditions can help clinicians counsel patients on safe opioid use, and allow timely recognition and intervention when escalating opioid self-dosing occurs, to prevent tolerance and addiction. We used a novel oxycodone digital pill system (ingestible biosensor within a standard gelatin capsule combined with 5-mg oxycodone) that when ingested, is activated by the chloride ion gradient in the stomach thereby emitting a radiofrequency signal captured by a wearable reader. The reader relays ingestion data to a cloud-based server that displays ingestion events to the study team. We deployed the oxycodone digital pill among opioid-naive individuals discharged from the emergency department with acute fracture pain. Participants were trained on digital pill operation and discharged with twenty-one 5-mg oxycodone digital pills. They were instructed to take digital pills PRN for pain on discharge. We conducted a brief interview 7 days after study enrollment, at which point participants returned the digital pill system. We identified oxycodone ingestion events in real time by data from the digital pill system and performed pill counts at the return visit to validate digital pill reporting of medication ingestion. In this study, 26 individuals were approached; 16 enrolled with 15 completing the study. Participants ingested a median of 6 (3-9.5) oxycodone digital pills over the course of 7 days, with 82% of the oxycodone dose ingested in the first 3 days. In individuals who required operative repair, 86% (N = 6) continued to ingest

  11. [Qilin Pills for obstructive azoospermia after ejaculatory duct reconstruction].

    Science.gov (United States)

    Zhang, Lei; Gao, Ping; Ren, Fei-Qiang; Chang, De-Gui; Yu, Xu-Jun; Zhang, Pei-Hai

    2016-09-01

    To observe the clinical effect of Qilin Pills in the treatment of severe oligozoospermia after microsurgical ejaculatory duct reconstruction for obstructive azoospermia. We retrospectively analyzed 75 cases of obstructive azoospermia treated by ejaculatory duct reconstruction followed by administration of Qilin Pills. The patients were divided into a Qilin group (n=42) and a control group (n=33) postoperatively, treated with Qilin Pills and placebo, respectively. After 3 months of medication, we compared the sperm quality between the two groups of patients. After 3 months' treatment, all the patients experienced remarkable improvement in sperm quality (P0.05). The total effectiveness rate was higher in the Qilin group than in the controls (88.1% vs 72.7%), but with no significant difference between the two groups (P>0.05). Qilin Pills are fairly effective in improving the quantity of sperm in obstructive azoospermia patients after ejaculatory duct reconstruction.

  12. Quantifying the utility of taking pills for cardiovascular prevention.

    Science.gov (United States)

    Hutchins, Robert; Viera, Anthony J; Sheridan, Stacey L; Pignone, Michael P

    2015-03-01

    The decrease in utility attributed to taking pills for cardiovascular prevention can have major effects on the cost-effectiveness of interventions but has not been well studied. We sought to measure the utility of daily pill-taking for cardiovascular prevention. We conducted a cross-sectional Internet-based survey of 1000 US residents aged ≥30 in March 2014. We calculated utility values, using time trade-off as our primary method and standard gamble and willingness-to-pay techniques as secondary analyses. Mean age of respondents was 50 years. Most were female (59%) and white (63%); 28% had less than a college degree; and 79% took ≥1 pills daily. Mean utility using the time trade-off method was 0.990 (95% confidence interval, 0.988-0.992), including ≈70% not willing to trade any amount of time to avoid taking a preventive pill daily. Using the standard gamble method, mean utility was 0.991 (0.989-0.993), with 62% not willing to risk any chance of death. Respondents were willing to pay an average of $1445 to avoid taking a pill daily, which translated to a mean utility of 0.994 (0.940-0.997), including 41% unwilling to pay any amount. Time trade-off-based utility varied by age (decreasing utility as age increased), sex, race, numeracy, difficulty with obtaining pills, and number of pills taken per day but did not vary by education level, literacy, or income. Mean utility for taking a pill daily for cardiovascular prevention is ≈0.990 to 0.994. © 2015 American Heart Association, Inc.

  13. Impact of Decontamination Therapy on Ultrasound Visualization of Ingested Pills

    Directory of Open Access Journals (Sweden)

    Jason Bothwell

    2014-03-01

    Full Text Available Introduction: Acute toxic ingestion is a common cause of morbidity and mortality. Emergency physicians (EP caring for overdose (OD patients are often required to make critical decisions with incomplete information. Point of care ultrasound (POCUS may have a role in assisting EPs manage OD patients. We evaluated the impact of different liquid adjuncts used for gastric decontamination on examiners’ ability to identify the presence of tablets using POCUS, and assessed examiners’ ability to quantify the numbers of tablets in a simulated massive OD. Methods: This prospective, blinded, pilot study was performed at an academic emergency department. Study participants were volunteer resident and staff EPs trained in POCUS. Five non-transparent, sealed bags were prepared with the following contents: 1 liter (L of water, 1 L of water with 50 regular aspirin (ASA tablets, 1 L of water with 50 enteric-coated aspirin tablets (ECA, 1 L of polyethylene glycol (PEG with 50 ECA, and 1 L of activated charcoal (AC with 50 ECA. After performing POCUS on each of the bags using a 10-5 MHz linear array transducer, participants completed a standardized questionnaire composed of the following questions: (1 Were pills present? YES/NO; (2 If tablets were identified, estimate the number (1-10, 11-25, >25. We used a single test on proportions using the binomial distribution to determine if the number of EPs who identified tablets differed from 50% chance. For those tablets identified in the different solutions, another test on proportions was used to determine whether the type of solution made a difference. Since 3 options were available, we used a probability of 33.3%. Results: Thirty-seven EPs completed the study. All (37/37 EP’s correctly identified the absence of tablets in the bag containing only water, and the presence of ECA in the bags containing water and PEG. For Part 2 of the study, most participants - 25/37 (67.5% using water, 23/37 (62.1% using PEG, and

  14. [Effect of heijiang pill on radiation skin ulcer in rats].

    Science.gov (United States)

    Fu, Qi; Yang, Yang; Xu, Yong-Mei

    2008-05-01

    To investigate the relationship between single dosage of 60Co radiation and the degree of radiation-induced skin ulcers, and to evaluate the curative effect of Heijiang Pill (HJP) on skin ulcer induced by various dosages of radiation in rats. Sixty-six Wistar female rats were randomly divided into three groups, the blank control group (n = 6) and the two radiation groups, each 30 rats, with their right hind leg exposed respectively to 60 Gy and 40 Gy of 60 Co radiation. The time of emergence and degree of skin ulcer were recorded. Then rats in the two radiation groups were subdivided into the HJP group, the Ethacridine group and the model group, 10 in each group, they received corresponding treatment after ulceration, and the incidence, pathology, cure rate and cure time of skin ulcer were observed in the 90 days of observation. The incidence of skin ulcer was higher and occurred earlier in rats radiated with 60 Gy than that with 40 Gy (P ulcer healing rate in rats treated with HJP was higher than that treated with Ethacridine (P cure time in the HJP group was shorter (P ulcers. HJP can effectively cure radiation skin ulcer, and the effect is especially significant on the ulcer induced by low dose radiation.

  15. Imported fenproporex-based diet pills from Brazil: a report of two cases.

    Science.gov (United States)

    Cohen, Pieter A

    2009-03-01

    Banned amphetamine-based anorectics are illicitly imported into the United States (US), but little is known regarding the harm these diet pills pose to US residents. A 26-year-old woman using imported diet pills presented with a two-year history of intermittent chest pains, palpitations, headaches and insomnia. Urine toxicology screen detected amphetamines and benzodiazepines. Fenproporex and chlordiazepoxide were detected in her pills. Her symptoms resolved after she stopped using diet pills. A 38-year-old man using imported diet pills presented after his occupational urine screen was significantly positive for amphetamine. Fenproporex and fluoxetine were detected in his pills. These cases illustrate the potential harm from imported prescription diet pills that combine fenproporex with benzodiazepines, antidepressants, diuretics, laxatives and other substances. Increasing physicians' awareness of imported diet pill use may improve care of patients suffering from the pills' many adverse effects.

  16. [Application of time domain reflectometry for determination of wate content in Xiangsha Yangwei pills].

    Science.gov (United States)

    Long, Feng-Lai; Sun, Xiao-Mei; Peng, Xiu-Juan; Liu, Peng; He, Fang-Hui

    2016-08-01

    Xiangsha Yangwei pill was selected as a model drug in this research, and time domain reflectometry (TDR) was used to determine the water content in the pill. The effects of five factors including the number of pill layers, pill packing density, atmospheric moisture, ambient temperature and the ratio of pill formula were investigated on water content. The results showed that the number of pill layers and ambient temperature had significant effects on water content of pills, while the pill packing density, atmospheric moisture and pill formula ratio had little effect on the determination of water content in pills. The reflection value was stable when 6 layers of pills were used. Under the condition of 25 ℃ and 45% relative humidity, the water content of pills ranged from 4.01% to 22.38%, showing good linear relationship between water content and reflection value, and the model equation was as follows: Y=0.279X-21.670 (R²=0.997 0). Verification experiment was used to explain the feasibility of this prediction model. The precision of the method complied with the methodology standard. It is concluded that TDR can be used in determination of water content in Xiangsha Yangwei pills. Additionally, TDR, as a new way to quickly and efficiently determine the water content, has a prospect application in the processing of traditional Chinese medicine pharmacy, especially for concentrated pill. Copyright© by the Chinese Pharmaceutical Association.

  17. Monitoring Location and Angular Orientation of a Pill

    Science.gov (United States)

    Schipper, John F.

    2012-01-01

    A mobile pill transmitter system moves through, or adjacent to, one or more organs in an animal or human body, while transmitting signals from its present location and/or present angular orientation. The system also provides signals from which the present roll angle of the pill, about a selected axis, can be determined. When the location coordinates angular orientation and the roll angle of the pill are within selected ranges, an aperture on the pill container releases a selected chemical into, or onto, the body. Optionally, the pill, as it moves, provides a sequence of visually perceptible images. The times for image formation may correspond to times at which the pill transmitter system location or image satisfies one of at least four criteria. This invention provides and supplies an algorithm for exact determination of location coordinates and angular orientation coordinates for a mobile pill transmitter (PT), or other similar device that is introduced into, and moves within, a GI tract of a human or animal body. A set of as many as eight nonlinear equations has been developed and applied, relating propagation of a wireless signal between either two, three, or more transmitting antennas located on the PT, to four or more non-coplanar receiving antennas located on a signal receiver appliance worn by the user. The equations are solved exactly, without approximations or iterations, and are applied in several environments: (1) association of a visual image, transmitted by the PT at each of a second sequence of times, with a PT location and PT angular orientation at that time; (2) determination of a position within the body at which a drug or chemical substance or other treatment is to be delivered to a selected portion of the body; (3) monitoring, after delivery, of the effect(s) of administration of the treatment; and (4) determination of one or more positions within the body where provision and examination of a finer-scale image is warranted.

  18. THE BEHAVIOUR OF FABRICS USED FOR ANTIMIS PRODUCTION TO PILLING

    Directory of Open Access Journals (Sweden)

    CHIRILĂ Mihai Maxim

    2016-05-01

    Full Text Available The present study about the behaviour of plain textiles used for the production of antimis (Christian-orthodox liturgical item used in the liturgy to pilling explores the functional classification of different types of antimis as a textile product made out the following different types of fabrics: natural silk, flax, viscose, polyamide 6.6. Pilling is a phenomenon which consists of the formation of small balls made out of fibre congeries on the textile’s surface due to attrition and fatigue. For textiles used as liturgical items, the process of pilling formation includes the following stages: the emergence of the pilling surfaces (the formation of fuzzy, fibre tangle (appearance of small balls, and the detachment of small balls from the fabric’s surface. The analysis method of pilling for liturgical items made out the four types of fabrics mentioned above consists of stereoscopic microscopy techniques and electronic microscopy methods (SEM. The images of textiles samples (yarns and fabrics will be captured using a video microscope. Quantitative tests have been done to determine the metric number and the tex title of the above-mentioned fabrics. The increased resistance of silk to pilling compared to nylon, flax, and viscose can be attributed to the chemical properties of fibres and structural characteristics of silk fabric. The structural compactness of the same fiber mixture of natural silk fabric with bonded fabric will have a higher resistance coefficient to pilling compared to the other mentioned fabrics. Through this, the value of use and durability of the antimis will increase.

  19. EPR study on non- and gamma-irradiated herbal pills

    International Nuclear Information System (INIS)

    Aleksieva, K.; Lagunov, O.; Dimov, K.; Yordanov, N.D.

    2011-01-01

    The results of EPR studies on herbal pills of marigold, hawthorn, yarrow, common balm, tutsan, nettle and thyme before and after gamma-irradiation are reported. Before irradiation all samples exhibit one weak singlet EPR line with a g-factor of 2.0048±0.0005. After irradiation herbal pills could be separated in two groups according to their EPR spectra. Radiation-induced free radicals in pills of marigold, yarrow, nettle, tutsan and thyme could be attributed mainly to saccharide excipients. Tablets of hawthorn and common balm show 'cellulose-like' EPR spectrum, superimposed on partly resolved carbohydrate spectrum, due to the active part (herb) and inulin, which is present in the pills as an excipient. Fading study of the radiation-induced EPR signals confirms that sugar radicals are more stable than cellulose species. The reported results show that the presence of characteristic EPR spectra of herbal pills due to excipients or active part can be used as unambiguous proof of radiation processing within 35 or more days after irradiation.

  20. EPR study on non- and gamma-irradiated herbal pills

    Energy Technology Data Exchange (ETDEWEB)

    Aleksieva, K., E-mail: katerina_bas@abv.b [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria); Lagunov, O. [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria); Dimov, K. [Institute of Cryobiology and Food Technologies, 1162 Sofia (Bulgaria); Yordanov, N.D. [Institute of Catalysis, Bulgarian Academy of Sciences, 1113 Sofia (Bulgaria)

    2011-06-15

    The results of EPR studies on herbal pills of marigold, hawthorn, yarrow, common balm, tutsan, nettle and thyme before and after gamma-irradiation are reported. Before irradiation all samples exhibit one weak singlet EPR line with a g-factor of 2.0048{+-}0.0005. After irradiation herbal pills could be separated in two groups according to their EPR spectra. Radiation-induced free radicals in pills of marigold, yarrow, nettle, tutsan and thyme could be attributed mainly to saccharide excipients. Tablets of hawthorn and common balm show 'cellulose-like' EPR spectrum, superimposed on partly resolved carbohydrate spectrum, due to the active part (herb) and inulin, which is present in the pills as an excipient. Fading study of the radiation-induced EPR signals confirms that sugar radicals are more stable than cellulose species. The reported results show that the presence of characteristic EPR spectra of herbal pills due to excipients or active part can be used as unambiguous proof of radiation processing within 35 or more days after irradiation.

  1. EPR study on non- and gamma-irradiated herbal pills

    Science.gov (United States)

    Aleksieva, K.; Lagunov, O.; Dimov, K.; Yordanov, N. D.

    2011-06-01

    The results of EPR studies on herbal pills of marigold, hawthorn, yarrow, common balm, tutsan, nettle and thyme before and after gamma-irradiation are reported. Before irradiation all samples exhibit one weak singlet EPR line with a g-factor of 2.0048±0.0005. After irradiation herbal pills could be separated in two groups according to their EPR spectra. Radiation-induced free radicals in pills of marigold, yarrow, nettle, tutsan and thyme could be attributed mainly to saccharide excipients. Tablets of hawthorn and common balm show "cellulose-like" EPR spectrum, superimposed on partly resolved carbohydrate spectrum, due to the active part (herb) and inulin, which is present in the pills as an excipient. Fading study of the radiation-induced EPR signals confirms that sugar radicals are more stable than cellulose species. The reported results show that the presence of characteristic EPR spectra of herbal pills due to excipients or active part can be used as unambiguous proof of radiation processing within 35 or more days after irradiation.

  2. Efficacy of Suxiao Jiuxin Pill on Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Li Ren

    2018-01-01

    Full Text Available Suxiao jiuxin pill is considered an effective ancillary drug in patients with coronary heart disease. Although numerous small, single-center clinical trials have been conducted, the benefits and harms of suxiao jiuxin pill remain controversial. We performed a meta-analysis to clarify the efficacy of suxiao jiuxin pill on patients with coronary heart disease. Randomized controlled trials were identified by using the Cochrane Library, PubMed, Web of Science, Embase, Wanfang, Weipu, and China Knowledge Resource Integrated databases (until June 2016. Pooled relative risks (RR, weighted mean differences (WMD, and 95% confidence intervals (95% CIs were estimated using random-effects models. Forty-one trials involving 6276 patients were included in our analysis. Administration of suxiao jiuxin pill significantly improved electrocardiogram (ECG results when compared with other therapies (RR 1.32, 95% CI 1.26 to 1.38, and P<0.001. Subgroup analyses revealed that suxiao jiuxin pills improve ECG results more than salvia tablets (RR 1.54, 95% CI 1.41 to 1.67, and P<0.001, isosorbide dinitrate (RR 1.14, 95% CI 1.21 to 1.44, and P=0.001, nitroglycerin (RR 1.35, 95% CI 1.16 to 1.56, and P<0.001, and other drugs (RR 1.32, 95% CI 1.21 to 1.44, and P<0.001. Available evidence additionally suggests that suxiao jiuxin pills could significantly reduce total cholesterol (WMD −0.62 mmol/L, 95% CI −1.06 to –0.18 mmol/L, and P=0.005 and low-density lipoprotein (LDL levels (WMD −1.12 mmol/L, 95% CI −1.42 to −0.82 mmol/L, and P<0.001 and increase high-density lipoprotein (HDL levels (WMD 0.32 mmol/L, 95% CI 0.07 to 0.58 mmol/L, and P=0.014. However, no significant differences were observed in total triglyceride levels, plasma viscosity, hematocrit, and fibrinogen. No incidences of adverse reactions were observed after administration of suxiao jiuxin pill. Improvements in ECG results and lipid profiles were also observed after suxiao jiuxin

  3. Urticarial vasculitis induced by OTC diet pills: a case report.

    Science.gov (United States)

    Chérrez Ojeda, Iván; Loayza, Enrique; Greiding, Leonardo; Calderón, Juan Carlos; Cherrez, Annia; Adum, Farid

    2015-01-01

    Urticarial Vasculitis (UV) is in most of the cases idiopathic; however it has been associated with several conditions and drugs. Over the counter (OTC) diet pills are widely available, even on-line, but they are rarely regulated by pharmaceutical control. We present the case of a 35-year-old female patient suffering of pruriginous and painful wheals more than 1 cm in diameter, with a burning sensation. The eruption lasted more than 24 hours and was accompanied by angioedema, headache and myalgia. No remarkable medical history was found, except for previous intake of OTC diet pills. UV diagnosis was confirmed by the skin biopsy of a lesion. OTC diet pills are widely available worldwide, and due to its widespread use, allergologists and dermatologist should be able to recognize symptoms and lesions of cutaneous vasculitis, which may be under reported.

  4. Levonorgestrel emergency contraceptive pills use during breastfeeding; effect on infants' health and development.

    Science.gov (United States)

    Shaaban, Omar M; Abbas, Ahmed M; Mahmoud, Hanaa R; Yones, Entsar M; Mahmoud, Ahmed; Zakherah, Mahmoud S

    2018-02-20

    The current study aims to evaluate the effect of the use of single packet of levonorgestrel emergency contraceptive pills (LNG-ECPs) during breastfeeding on the health and development of the nursing infant. The current study was an ancillary observational cohort study carried out in a university hospital. We counseled all women delivered and planning birth-space and breastfeed for at least 1 year for participation during postpartum hospital stay. Eligible participants for inclusion in the randomized controlled trial (NCT 01111929) were allocated to receive adequate Lactational Amenorrhea Method (LAM) counseling (LAM-only group) or the LAM counseling in addition to counseling about LNG-ECPs use (LAM + emergency contraception (EC) group). These pills were to be used once if unprotected intercourse did occur after expiry of any of the LAM prerequisites and before the couples started to use a reliable method of contraception. We included the first 100 women in the LAM + EC who did use the pills and the first 100 women in the control group who completed the follow-up visits for 6 months to draw the infants' outcome. The primary outcome was the difference of anthropometric measurements of the infants at 3 and 6 months postpartum. Secondary outcome was the difference in the Psycho-social, fine and gross motor, and language development using Denver development screening test. There were no statistical significant differences between both the groups regarding the infants' weight, length, head circumference, chest circumference, and mid-arm circumference at each visit (p > .05). Additionally, there were no statistically significant differences regarding all items (psycho-social, fine and gross motor, and language) of Denver development screening test between the infants in LAM-only and LAM + EC groups (p = .081). The use of single packet of LNG-ECPs during breastfeeding not objectively affects health and development of nursing infants or subjectively

  5. An Overnight Comparison of Core Temperature Using a Rectal Probe and a Radio Pill

    National Research Council Canada - National Science Library

    Paul, Michel

    1999-01-01

    Previous efforts to record core temperature with radio pills produced consistent results showing that core temperature provided by radio pill tended to be lower than that provided by rectal probe by about 0.5c to o...

  6. [ilin Pills for oligoasthenospermia: Advances in clinical studies].

    Science.gov (United States)

    Zhang, Kai-Shu; Fu, Long-Long; Shang, Xue-Jun; Gu, Yi-Qun

    2017-10-01

    Industrialization and environmental pollution are bringing more problems to human reproduction and increasing the prevalence of male infertility. Western medicine has shown its limitations in the management of male infertility, especially that of oligoasthenospermia. Traditional Chinese medicine (TCM), however, has long and rich experiences in the treatment of oligoasthenospermia, with a large variety of medicinal prescriptions based on the TCM theories, among which Qilin Pills shows a particularly significant therapeutic effect on oligoasthenospermia, especially when combined with Western medicine. At present, published studies on Qilin Pills are mainly in the stage of clinical observation, while basic researches and studies on its relevant mechanisms are rarely seen.

  7. Imported Fenproporex-based Diet Pills from Brazil: A Report of Two Cases

    OpenAIRE

    Cohen, Pieter A.

    2008-01-01

    Banned amphetamine-based anorectics are illicitly imported into the United States (US), but little is known regarding the harm these diet pills pose to US residents. A 26-year-old woman using imported diet pills presented with a two-year history of intermittent chest pains, palpitations, headaches and insomnia. Urine toxicology screen detected amphetamines and benzodiazepines. Fenproporex and chlordiazepoxide were detected in her pills. Her symptoms resolved after she stopped using diet pills...

  8. New objective system of pilling evaluation for various types of fabrics

    Czech Academy of Sciences Publication Activity Database

    Techniková, L.; Tunák, M.; Janáček, Jiří

    2017-01-01

    Roč. 108, č. 1 (2017), s. 123-131 ISSN 0040-5000 Institutional support: RVO:67985823 Keywords : objective pilling evaluation * 3D fabric surface reconstruction * image analysis * pill characteristics * pilling grade Subject RIV: JS - Reliability ; Quality Management, Testing OBOR OECD: Textiles Impact factor: 1.007, year: 2016

  9. [The NHG guideline 'Sleep problems and sleeping pills'].

    Science.gov (United States)

    Damen-van Beek, Zamire; Lucassen, Peter L B J; Gorgels, Wim; Smelt, Antonette F H; Knuistingh Neven, Arie; Bouma, Margriet

    2015-01-01

    The Dutch College of General Practitioners' (NHG) guideline 'Sleep problems and sleeping pills' provides recommendations for the diagnosis and treatment of the most prevalent sleep problems and for the management of chronic users of sleeping pills. The preferred approach for sleeplessness is not to prescribe medication but to give information and behavioural advice. Practice assistants of the Dutch Association of Mental Health and Addiction Care are also expected to be able to undertake this management. The GP may consider prescribing sleeping pills for a short period only in cases of severe insomnia with considerable distress. Chronic users of sleeping pills should be advised by the GP to stop using them or to reduce the dose gradually (controlled dose reduction). The GP may refer patients with suspected obstructive sleep apnoea (OSA) to a pulmonary or ear, nose and throat specialist or neurologist for further diagnosis depending on the regional arrangements. The GP may then consider the cardiovascular risk factors commonly present with OSA. In patients with restless legs syndrome (RLS) who continue to experience major distress despite being given advice without the prescription of medication, the GP may consider prescribing a dopamine agonist.

  10. Ectopic Pregnancy and Emergency Contraceptive Pills: A Systematic Review

    Science.gov (United States)

    Cleland, Kelly; Raymond, Elizabeth; Trussell, James; Cheng, Linan; Zhu, Haoping

    2014-01-01

    Objective To evaluate the existing data to estimate the rate of ectopic pregnancy among emergency contraceptive pill treatment failures. Data Sources Our initial reference list was generated from a 2008 Cochrane review of emergency contraception. In August 2009, we searched Biosys Previews, the Cochrane Database of Systematic Reviews, Medline, Global Health Database, Health Source: Popline, and Wanfang Data (a Chinese database). Methods of Study Selection This study included data from 136 studies which followed a defined population of women treated one time with emergency contraceptive pills (either mifepristone or levonorgestrel), and in which the number and location of pregnancies were ascertained. Results Data from each article were abstracted independently by two reviewers. In the studies of mifepristone, 3 out of 494 (0.6%) pregnancies were ectopic; in the levonorgestrel studies, 3 out of 307 (1%) were ectopic. Conclusion The rate of ectopic pregnancy when treatment with emergency contraceptive pills fails does not exceed the rate observed in the general population. Since emergency contraceptive pills are effective in lowering the risk of pregnancy, their use should reduce the chance that an act of intercourse will result in ectopic pregnancy. PMID:20502299

  11. [Qilin Pills combined with clomiphene for idiopathic oligoasthenozoospermia].

    Science.gov (United States)

    Yang, Ming-gen; Zheng, Gou-da; Xu, Zhen-qiang; Lin, Hai-li; Zhuang, Zhi-ming; Zhang, Chao-xian

    2015-06-01

    To observe the therapeutic effect of Qilin Pills combined with clomiphene on idiopathic oligoasthenospermia. We randomly assigned 300 patients with idiopathic oligoasthenospermia to a trial (n = 156) and a control group (n = 144) to be treated with Qilin Pills (6 g, tid) combined with clomiphene (50 mg, qd) and clomiphene alone (50 mg, qd), respectively, both for a course of 12 weeks. Before and after 4, 8, and 12 weeks of medication, we determined sperm concentration, the percentages of grade a and grade a + b sperm, sperm motility, and the levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone (T), followed by evaluation of the clinical efficacy of Qilin Pills with the pregnancy rate in the patients' spouses as the secondaty therapeutic indexes. Compared with the baseline, both groups of patients showed remarkably improved semen parameters and hormone levels after treatment (all P 0.05). No obvious adverse reactions were observed. Qilin Pills combined with clomiphene can evidently improve the seminal quality and hormone level of oligoasthenospermia patients with no obvious adverse events. However, its long-term efficacy and tolerance deserve further clinical investigation.

  12. Other Factors That Affect Heart Disease: Birth Control Pills

    Science.gov (United States)

    ... are considering using one, keep these guidelines in mind: Don't mix smoking and "the pill." If you smoke cigarettes, make a serious effort to quit. If you cannot quit, choose a different form of birth control. Cigarette smoking boosts the risk of serious health problems from birth ...

  13. Are we overestimating the stroke risk related to contraceptive pills?

    Science.gov (United States)

    Gompel, Anne; Plu-Bureau, Genevieve

    2014-02-01

    Hormonal contraceptives are used by million of women worldwide. Ischemic stroke is one of the major harmful effects of hormonal contraceptives, but remains a very uncommon disease before menopause. The increased risk of stroke under third and fourth-generation contraceptive pills and nonoral contraceptives has been recently highlighted. Given the benefits associated with combined hormonal contraceptives (COCs), it is important to properly evaluate their risks in order to provide a better benefit/risk balance to young women. Scarce studies addressing the rates of stroke in young women suggest that the fraction attributable to the contraceptive pill remains low. In contrast, there is abundant literature on the relative risks of stroke under COCs. The risk of arterial disease seems to be similar among users of second and third-generation pills, drospirenone-containing pills and nonoral hormonal contraceptives. Progestin-only contraceptives do not appear to be associated with an increased risk of stroke. New formulations of hormonal contraceptives are not safer than second-generation COCs. Even if the absolute numbers of strokes attributable to hormonal contraceptives is very low, stringent selection of patients should help to reduce the events still more, and progestin-only contraceptives/nonhormonal methods should be preferred in cases of associated risk factors.

  14. Urmas Ott versus Pille-Riin Purje / Andry Ervald

    Index Scriptorium Estoniae

    Ervald, Andry

    2007-01-01

    Urmas Oti intervjuuraamat väliseesti ajakirjaniku, luuletaja ja prosaisti Karin Saarseniga "Grand Hotel, Stockholm. Poola suvi" : SE&JS Kirjastus, 2006 ja Pille-Riin Purje raadiosaate "Hiirelõks" tarvis intervjuudest kokku pandud vestluste kogumik "Kuraditosin näitlejat hiirelõksus" : Varrak, 2007

  15. Contraception with combined oral contraceptive pills in Port ...

    African Journals Online (AJOL)

    Mass media was the commonest source of information, and one accidental pregnancy occurred (Pearl index 0.03 per 100 woman years). Conclusion: This study shows that combined oral contraceptives pills appear to be acceptable, safe and effective in Port Harcourt. This compares to world wide experience. Concerted ...

  16. Discussing Smart Pills versus Endorsing Smart Pills: Reply to Swanson, Wigal, and Volkow (2011) and Elliott and Elliott (2011)

    Science.gov (United States)

    Farah, Martha J.; Smith, M. Elizabeth

    2011-01-01

    We find much of interest, and little to disagree with, in the commentaries on our article. We take issue only with the suggestion that our article was provocative and submit that the attempt to understand the use of stimulants as smart pills does not imply an endorsement of the practice.

  17. Johannes Hindi tütar Pille Pae : inimlik headus ei sõltu rezhiimist / Pille Pae ; interv. Anneli Ammas

    Index Scriptorium Estoniae

    Pae, Pille

    2006-01-01

    Desintegraatori juhi Johannes Hindi tütar Pille Pae vastab küsimustele, mis puudutavad tema isa armuandmispalve esitamist, isale toetusallkirjade kogumist ning Arnold Rüütli suhteid Johannes Hindiga. Lisa: Kes oli Johannes Hint ja mis Desintegraator?

  18. Emergency contraceptive pills as a backup for lactational amenorrhea method (LAM) of contraception: a randomized controlled trial.

    Science.gov (United States)

    Shaaban, Omar M; Hassen, Shaimaa G; Nour, Sanna A; Kames, Mervat A; Yones, Entsar M

    2013-03-01

    The use of breastfeeding as a method of birth spacing occasionally ends in "unplanned pregnancy." This is due to unexpected expiration of one or more of the lactation amenorrhea method (LAM) prerequisites. The current study tests a new concept that the in-advance provision of single packet of progestogen emergency contraception (EC) pills during the postpartum LAM counseling may decrease the incidence of unplanned pregnancy during breastfeeding. This was a registered two-armed randomized controlled trial (NCT 01111929). Women intending to breastfeed and to postpone pregnancy for 1 year or more were approached. They received adequate postpartum contraceptive counseling. Women intending to use LAM were randomly assigned to one of two groups. The LAM-only group received the proper LAM counseling and did not receive counseling about EC. The LAM-EC group received counseling for both LAM and EC with in-advance provision of one packet of EC pills. They were advised to use these pills if one of the prerequisites of LAM expires and sexual relation has occurred before the initiation of another regular contraceptive protection. All the participants were advised that they need to use another regular method upon expiration of any of the LAM prerequisites. Eligible women were 1158 parturients randomized into two equal groups. Forty-four percent of the women provided with EC used them. Significantly more women in the LAM-EC group initiated regular contraception within or shortly after the first 6 months postpartum when compared with those in the LAM-only group (30.5% vs. 7.3%, respectively; p=.0004). Pregnancy occurred in 5% of the LAM-only group as compared with 0.8% in the LAM-EC group (p=.005). Minimal side effects were reported after EC use. In-advance provision of EC pills can increase the rate of initiation of regular contraception once one or more of the prerequisites of LAM expire. Consequently, the use of EC pills as a temporary backup of LAM can decrease the incidence

  19. The influence of method-related partner violence on covert pill use and pill discontinuation among women living in La Paz, El Alto and Santa Cruz, Bolivia.

    Science.gov (United States)

    McCarraher, Donna R; Martin, Sandra L; Bailey, Patricia E

    2006-03-01

    Intimate partner violence is widespread worldwide. While assumed to impact women's ability to use contraceptive methods, few data are available to support this claim. In this study, eight focus group discussions were conducted to guide questionnaire development and to provide contextual information. Participants were women who were currently using the pill and women who had used the pill previously. In addition, 300 women were interviewed who initiated oral contraceptive pill use between December 1995 and April 1996. Participants were interviewed 3-6 months later to investigate the role intimate partner violence played in covert pill use and pill discontinuation. Special study procedures for asking women questions about violence were employed. Nineteen per cent of the women interviewed were using the pill covertly. The odds of covert pill use were four times higher in El Alto and La Paz than in Santa Cruz. Women who used the pill covertly were more likely to have experienced method-related partner violence (OR = 21.27) than women whose partners knew of their pill use. One-third of the women had discontinued pill use at the time of the interview. In the final multivariate analysis, having experienced side-effects (OR = 2.37) was a significant predictor of pill discontinuation and method-related partner violence was marginally predictive (OR = 1.91; 95% CI 1.0-3.66). While efforts are ongoing to incorporate men into family planning programmes, some male partners oppose, and in some situations violently oppose, contraceptive use. The needs of women with these types of partners must not be overlooked.

  20. Does the contraceptive pill alter mate choice in humans?

    Science.gov (United States)

    Alvergne, Alexandra; Lummaa, Virpi

    2010-03-01

    Female and male mate choice preferences in humans both vary according to the menstrual cycle. Women prefer more masculine, symmetrical and genetically unrelated men during ovulation compared with other phases of their cycle, and recent evidence suggests that men prefer ovulating women to others. Such monthly shifts in mate preference have been suggested to bring evolutionary benefits in terms of reproductive success. New evidence is now emerging that taking the oral contraceptive pill might significantly alter both female and male mate choice by removing the mid-cycle change in preferences. Here, we review support for such conclusions and speculate on the consequences of pill-induced choice of otherwise less-preferred partners for relationship satisfaction, durability and, ultimately, reproductive outcomes.

  1. [Effect of osseointegration in the posterior area by Shenggu pills].

    Science.gov (United States)

    Cuifen, Luo; Guoguang, Peng

    2017-10-01

    This study aimed to investigate the osseointegration condition by measuring the implant stability quotient (ISQ) to study the effect of osseointegration in the posterior area by Shenggu pills. A total of 101 DENTIUM implants were placed in 48 patients. Fifty implants placed in 24 patients were addressed as usual, whereas 51 implants placed in 24 patients were treated with Shenggu pills. ISQ was tested on the day of surgery and consecutively at 4, 8, and 12 weeks. All data were analyzed. The efficacy of the treatment group was no much better than that of control group on the day of surgery and consecutively at 12 weeks with no significant difference (P>0.05). The efficacy of the treatment group was significantly better than that of the control group at 4 and 8 weeks (Ppills could accelerate the implant bone union, improve the implants' ISQ, and ensure the success rate of the operation.

  2. Fabric tensile strength as affected by different anti pilling agents at various concentration and ph levels

    International Nuclear Information System (INIS)

    Tusief, M.Q.; Mahmood, N.; Saleem, M.

    2013-01-01

    Pilling is a phenomenon that has a long cause trouble in textile industry. It is the formation of pills or knops on the surface of woven or knitted fabrics caused by friction and abrasion. If fabric has a pronounced tendency to pilling, their appearances suffer severely after a short period of use. The pilling of fabrics is a serious problem for the apparel industry. The use of anti pilling finishes is one of the best techniques to control the pilling of the fabric. In this method fabric is treated with special anti pilling agents to prevent pilling that promote adhesion of the fibres in the yarn or the fabric. This paper endeavors to optimize the application of different anti pilling agents at different concentration and pH levels on the Tensile Strength of P/C fabric for best results. The results exposed that different anti pilling finishes have significant effects on the Tensile Strength of fabric at different concentration level however different pH levels have no considerable effects. (author)

  3. Social constructions of the male contraception pill: When are we going to break the vicious circle?

    Science.gov (United States)

    Dismore, Lorelle; Van Wersch, Anna; Swainston, Katherine

    2016-05-01

    Social constructions of men towards the availability of a male hormonal contraceptive, the 'male pill', were explored. A qualitative approach applying semi-structured interviews and scenarios with 22 men (mean age 35 years) from the North East of England revealed two core constructs and six sub-constructs using a Thematic-Construct Analysis in line with the method of Toerien and Wilkinson and Clarke and Kitzinger. Verbal accounts were inductively used to balance the deductively created two core constructs 'Constructing the male pill norm: dominant system of sensemaking' and 'Living by the male pill norm' to represent a normative framework within a changing ideology of shared responsibility in contraceptive choice. Constructing the male pill norm was divided into two sub-constructs: 'Male pill: we are going to join the women and become responsible - too!' and 'Male pill: you look so girly - what are they going to think of me?' The 'Living by the male pill norm' was further divided into four sub-constructs 'Male pill - thank you for giving me promises not to have to become a dad as yet!'; 'Male pill: thank you for the idea of fun - sorry about my morals!'; 'Male pill: in stable relations - yes, I would have you now - sorry, I am too late!' and 'Male pill, we love you - but we are too anxious - we are not ready as yet!' From this male discourse, it is clear that discussions over the male pill follow the line of a vicious circle. In order to establish long-term side effects, Phase IV studies are necessary, and these cannot commence without the male hormonal contraception being a marketable product. So, unless this circle gets broken by some brave men, the male pill will remain a virtual rotating idea for a long time. © The Author(s) 2014.

  4. A point on the 2016 iodine pill distribution campaign

    International Nuclear Information System (INIS)

    Alfonsi, S.; Catelinois, J.M.; Bouet, P.; Ferlet, O.; Riviere, E.

    2016-01-01

    The 2016 Iodine distribution campaign involves various actors: state representatives (regional prefect) whose dedication creates a climate of trust for the population, local elected officials (in particular the mayors of the municipalities concerned who can play an important role to motivate the population), health professionals like doctors and nurses who can bring information on radiation hazards and explain the preventive role of iodine and local pharmacists who are in charge of delivering iodine pills. (A.C.)

  5. The Pill vs. the Sword: Additional Considerations; Comment on “The Pill Is Mightier Than the Sword”

    Directory of Open Access Journals (Sweden)

    Ilsa L. Lottes

    2015-12-01

    Full Text Available In this paper, I present additional information for policy-makers and researchers to consider in response to the view proposed by Potts et al that “the pill is mightier than the sword.” I identify states with both high rates of terrorism and a youth bulge and discuss correlates of both these societal characteristics. The research examined supports the view that factors other than access to family planning are more important in facilitating terrorism.

  6. [Effect and regulation of drying on quality of traditional Chinese medicine pills].

    Science.gov (United States)

    Qi, Ya-Ru; Li, Yuan-Hui; Han, Li; Wu, Zhen-Feng; Yue, Peng-Fei; Wang, Xue-Cheng; Xiong, Yao-Kun; Yang, Ming

    2017-06-01

    The dry quality of traditional Chinese medicine pills is the hot spot of pills research, because their quality has a crucial effect on the efficacy and development of dosage forms. Through literature research and statistical analysis, we would review the current problems on the drying of traditional Chinese medicine pills in this paper, and surrounding the evaluation system for traditional Chinese medicine pills, analyze the characteristics of common drying equipment and processes as well as their effect on quality of pills, discuss the problems in drying equipment and process as well as quality, and put forward the corresponding strategies, hoping to provide new ideas and new methods for the quality improvement of traditional Chinese medicine pills and quality standards. Copyright© by the Chinese Pharmaceutical Association.

  7. Poison pills and CEOs: The résumé matters

    Directory of Open Access Journals (Sweden)

    Douglas Sanford Jr.

    2012-07-01

    Full Text Available Previous research has linked poison pill to corporate governance characteristics such as ownership structure and board composition while overlooking the attributes of top managers involved in poison pill decision. Based on upper echelons perspective, we changed the focus by investigating the effect of CEO characteristics on poison pills, as measured by age, business education, and outside directorships. Using a sample of Fortune 500 manufacturing firms, we found that CEO business education is positively associated with poison pills, while CEOs’ outside directorships are negatively associated with poison pills. Furthermore, we found that CEO duality moderates the relationship between CEO business education and poison pills. We make implications for both corporate governance research and managerial practices regarding firms’ anti-takeover provisions.

  8. Knowledge and opinions of emergency contraceptive pills among female factory workers in Tijuana, Mexico.

    Science.gov (United States)

    García, Sandra G; Becker, Davida; de Castro, Marcela Martínez; Paz, Francisco; Olavarrieta, Claudia Díaz; Acevedo-García, Dolores

    2008-09-01

    Workers in Mexico's maquiladoras (assembly plants) are mainly young, single women, many of whom could benefit from emergency contraceptive pills (ECPs). Because ECPs are readily available in Mexico, women who know about the therapy can obtain it easily. Do maquiladora workers know about the method? Could worksite programs help increase awareness? To investigate these questions, we conducted a five-month intervention during which workers in three maquiladoras along the Mexico-United States border could attend educational talks on ECPs, receive pamphlets, and obtain kits containing EC supplies. Among the workers exposed to our intervention, knowledge of ECPs increased. Reported ECP use also increased. Although our intervention apparently increased workers' knowledge and use, the factory proved to be a difficult intervention setting. Problems we experienced included a factory closure and management/staff opposition to certain project elements. Future studies should continue to investigate work-site interventions and other strategies to reach workers.

  9. Repeat use of emergency contraceptive pills in urban Kenya and Nigeria.

    Science.gov (United States)

    Chin-Quee, Dawn; L'Engle, Kelly; Otterness, Conrad; Mercer, Sarah; Chen, Mario

    2014-09-01

    Little is known about the frequency and patterns of use of emergency contraceptive pills among women in urban Kenya and Nigeria. To recruit women who had used emergency contraceptive pills, individuals aged 18-49 were intercepted and interviewed at shopping venues in Nairobi, Kenya, and Lagos, Nigeria, in 2011. Information was collected on 539 Nairobi and 483 Lagos respondents' demographic and behavioral characteristics, attitudes toward the method, and frequency of use. Multinomial logistic regression analyses were used to identify associations between these characteristics and frequency of pill use. Eighteen percent of the women interviewed in Nairobi and 17% in Lagos had ever used emergency contraceptive pills. On average, these respondents had used the pills less than once per month, but greater use and acceptance were seen in Lagos. In multivariate analysis, women who had sex at least once in a typical week were generally more likely than others to have used the pills 2-5 times in the last six months, rather than once or never, or to have used them six or more times. Furthermore, Lagos respondents who said their main contraceptive method was the condom, the pill or injectable, or a natural method were generally less likely than those who did not report these methods to have used the emergency pills multiple times in the last six months. Repeated use of emergency contraceptive pills was not common in this sample.

  10. Effects of the Chinese herbal formula "Zuojin Pill" on the pharmacokinetics of dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype.

    Science.gov (United States)

    Qiu, Furong; Liu, Songcan; Miao, Ping; Zeng, Jin; Zhu, Leilei; Zhao, TongFang; Ye, Yujie; Jiang, Jian

    2016-06-01

    Zuojin Pill has been shown to inhibit the cytochrome P450 (CYP) 2D6 isoenzyme in vitro. In Chinese individuals, CYP 2D6*10 is the most common allele with reduced enzyme activity. In this study, we investigated the pharmacokinetic interaction between Zuojin Pill and the sensitive CYP2D6 probe dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype. A pharmacokinetics interaction study was carried out in three groups with CYP2D6*1/*1 (n = 6), CYP2D6*1/*10 (n = 6), and CYP2D6*10/*10 (n = 6) genotypes. Each participant received a single oral dose of dextromethorphan (15 mg) followed by Zuojin Pill (3 g twice daily) for 7 days, and received 3 g Zuojin Pill with 15 mg dextromethorphan in the last day. Blood samples (0-24 h) and urine samples (0-12 h) were collected at baseline and after the administration of Zuojin Pill, and the samples' concentration of dextromethorphan and its main metabolite dextrorphan was determined. Compared to baseline values, co-administration of Zuojin Pill (3 g twice daily) for 7 days increased the AUC0-24 of dextromethorphan [mean (90 % CI)] by 3.00-fold (2.49∼3.61) and 1.71-fold (1.42∼2.06), and decreased oral clearance(CL/F) by 0.27-fold (0.2-0.40) and 0.57-fold (0.48-0.67) in the participants with CYP2D6*1/*1 and CYP2D6*1/*10 genotypes, respectively. In contrast, no significant change was observed in these pharmacokinetic parameters of the participants with CYP2D6*10/*10 genotype. These data demonstrated that administration of Zuojin Pill inhibited moderately CYP2D6-mediated metabolism of dextromethorphan in healthy volunteers. The inhibitory influence of CYP2D6 was greater in CYP2D6*1/*1 and CYP2D6*1/*10 groups than CYP2D6 *10/*10 group.

  11. Johannes Hindi tütar Pille Pae : inimlik headus ei sõltu režiimist / Pille Pae ; interv. Anneli Ammas

    Index Scriptorium Estoniae

    Pae, Pille

    2006-01-01

    Desintegraatori juhi Johannes Hindi tütar Pille Pae vastab küsimustele, mis puudutavad tema isa armuandmispalve esitamist, isale toetusallkirjade kogumist, Arnold Rüütli suhteid Johannes Hindiga. Lisa: Kes oli Johannes Hint ja mis Desintegraator?

  12. Using Six Sigma to improve once daily gentamicin dosing and therapeutic drug monitoring performance.

    LENUS (Irish Health Repository)

    Egan, Sean

    2012-08-07

    BACKGROUND: Safe, effective therapy with the antimicrobial gentamicin requires good practice in dose selection and monitoring of serum levels. Suboptimal therapy occurs with breakdown in the process of drug dosing, serum blood sampling, laboratory processing and level interpretation. Unintentional underdosing may result. This improvement effort aimed to optimise this process in an academic teaching hospital using Six Sigma process improvement methodology. METHODS: A multidisciplinary project team was formed. Process measures considered critical to quality were defined, and baseline practice was examined through process mapping and audit. Root cause analysis informed improvement measures. These included a new dosing and monitoring schedule, and standardised assay sampling and drug administration timing which maximised local capabilities. Three iterations of the improvement cycle were conducted over a 24-month period. RESULTS: The attainment of serum level sampling in the required time window improved by 85% (p≤0.0001). A 66% improvement in accuracy of dosing was observed (p≤0.0001). Unnecessary dose omission while awaiting level results and inadvertent disruption to therapy due to dosing and monitoring process breakdown were eliminated. Average daily dose administered increased from 3.39 mg\\/kg to 4.78 mg\\/kg\\/day. CONCLUSIONS: Using Six Sigma methodology enhanced gentamicin usage process performance. Local process related factors may adversely affect adherence to practice guidelines for gentamicin, a drug which is complex to use. It is vital to adapt dosing guidance and monitoring requirements so that they are capable of being implemented in the clinical environment as a matter of routine. Improvement may be achieved through a structured localised approach with multidisciplinary stakeholder involvement.

  13. Once-daily transdermal rivastigmine in the treatment of Alzheimer’s disease

    Directory of Open Access Journals (Sweden)

    Andreas Wentrup

    2008-11-01

    Full Text Available Andreas Wentrup, Wolfgang H Oertel, Richard DodelDepartment of Neurology, Philipps-University Marburg, GermanyAbstract: During the past decade, transdermal delivery systems (TDS have become increasingly important for treating neurologic and psychiatric disorders. The rivastigmine patch was the first patch to be approved to treat Alzheimer’s disease (AD. The 9.5 mg/24 h patch has equal efficacy to the capsules and reduces gastrointestinal adverse events, such as nausea and vomiting, by two-thirds. This treatment is well tolerated by patients because drug delivery is even and continuous, reducing fluctuation in drug plasma level, and attenuating the development of centrally mediated cholinergic side effects. Furthermore, once-a-day application of the patch enables an easy treatment schedule, ease of handling, infrequent skin irritations, and a patient- and caregiver-friendly mode of administration. Improved compliance with a subsequent drug administration may contribute to better clinical efficacy, reduce caregiver burden, result in a slower rate of institutionalization, and lead to a decrease in healthcare and medical costs. Because of these advantages, the rivastigmine patch has enabled great progress in the treatment of AD, and represents an excellent alternative to the orally administered cholinesterase inhibitors.Keywords: Alzheimer’s disease, rivastigmine, patch, dementia

  14. Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2012-01-01

    Long-acting bronchodilators are central in the pharmacological management of patients with chronic obstructive pulmonary disease (COPD). The aim of this systematic review is to provide an overview of the studies evaluating the safety and clinical efficacy of inhaled glycopyrronium bromide, a novel...... long-acting muscarinic antagonist, in patients with COPD....

  15. Once Daily Valacyclovir for Reducing Viral Shedding in Subjects Newly Diagnosed with Genital Herpes

    Directory of Open Access Journals (Sweden)

    Mark G. Martens

    2009-01-01

    Results. 52 subjects had at least one PCR measurement in both treatment periods and comprised the primary efficacy population. Valacyclovir significantly reduced HSV-2 shedding during all days compared to placebo (mean 2.9% versus 13.5% of all days (P<.01, a 78% reduction. Valacyclovir significantly reduced subclinical HSV-2 shedding during all days compared to placebo (mean 2.4% versus 11.0% of all days (P<.01, a 78% reduction. However, 79% of subjects had no GH recurrences while receiving valacyclovir compared to 52% of subjects receiving placebo (P<.01. Conclusion. In this study, the frequency of total and subclinical HSV-2 shedding was greater than reported in earlier studies involving subjects with a history of symptomatic genital recurrences. Our study is the first to demonstrate a significant reduction in viral shedding with valacyclovir 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.

  16. Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Petersen, Andreas Brønden; Christensen, Mikkel

    2013-01-01

    The glucagon-like peptide (GLP)-1 receptor agonist lixisenatide (Lyxumia(®)) was approved for marketing by the European Medicines Agency in February 2013 and has been evaluated in a clinical study program called GetGoal. Lixisenatide activates the GLP-1 receptor and thereby exercises the range of...... of lixisenatide seems to be in combination with basal insulin. A large multicenter study will determine the future potential of lixisenatide in preventing cardiovascular events and mortality, in patients with type 2 diabetes and recent acute coronary syndrome....

  17. Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

    DEFF Research Database (Denmark)

    Pedersen, Søren; Engelstätter, Renate; Weber, Hans-Jochen

    2009-01-01

    BACKGROUND: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. OBJECTIVE: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the ...

  18. Development and in-vitro Evaluation of Once Daily Tablet Dosage ...

    African Journals Online (AJOL)

    Kuksal A, Tiwary AK, Jain NK, Jain S. Formulation and in vitro, in vivo evaluation of extended-release matrix tablet of zidovudine: influence of combination of hydrophilic and hydrophobic matrix formers. AAPS,. Pharm Sci Tech 2006; 7: 1-9. 6. Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Design and In vitro Evaluation ...

  19. Role of once-daily glycopyrronium bromide (NVA237 in the management of COPD

    Directory of Open Access Journals (Sweden)

    D’Urzo A

    2013-08-01

    Full Text Available Anthony D'UrzoDepartment of Family and Community Medicine, University of Toronto, Toronto, ON, CanadaAbstract: Progressive airflow limitation is a hallmark feature of chronic obstructive pulmonary disease (COPD that ultimately leads to breathlessness, impaired quality of life, and reduced exercise capacity. Pharmacotherapy is used in patients with COPD to prevent and control symptoms, reduce both the frequency and severity of exacerbations, improve health status, and increase exercise tolerance. These strategies are intended to address management issues which promote both current disease control and a reduction in the risk of disease deterioration in the future. At the present time, long-acting β2-agonists (LABAs and long-acting muscarinic antagonists (LAMAs are available for maintenance therapy in patients with persistent symptoms. Tiotropium was the first LAMA to be approved for management of COPD, and many studies have described its beneficial effects on multiple clinically relevant outcomes. Glycopyrronium bromide (NVA237, a new LAMA, has been developed and received regulatory approval for management of COPD in a number of countries around the world. Results from pivotal Phase III trials suggest that NVA237 is safe and well tolerated in patients with moderate to severe COPD, and provides rapid and sustained improvements in lung function. Further, these changes are associated with statistically and clinically meaningful improvements in dyspnea, health-related quality of life, and exercise tolerance. Treatment with NVA237 also results in a significant reduction in risk of exacerbations and the need for rescue medication, and has been comparable with tiotropium with respect to safety and efficacy outcomes. Finally, emerging data indicate that NVA237 is efficacious both as monotherapy and in combination with indacaterol.Keywords: glycopyrronium bromide, NVA237, chronic obstructive pulmonary disease, inhaled long-acting bronchodilators

  20. New developments in the treatment of rosacea – role of once-daily ivermectin cream

    Directory of Open Access Journals (Sweden)

    Cardwell LA

    2016-03-01

    Full Text Available Leah A Cardwell,1 Hossein Alinia,1 Sara Moradi Tuchayi,1 Steven R Feldman,1–31Department of Dermatology, Center for Dermatology Research, 2Department of Pathology, 3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA Abstract: Rosacea is a chronic dermatological disorder with a variety of clinical manifestations localized largely to the central face. The unclear etiology of rosacea fosters therapeutic difficulty; however, subtle clinical improvement with pharmacologic treatments of various drug categories suggests a multifactorial etiology of the disease. Factors that may contribute to disease pathogenesis include immune abnormality, vascular abnormality, neurogenic dysregulation, presence of cutaneous microorganisms, UV damage, and skin barrier dysfunction. The role of ivermectin in the treatment of rosacea may be as an anti-inflammatory and anti-parasitic agent targeting Demodex mites. In comparing topical ivermectin and metronidazole, ivermectin was more effective; this treatment modality boasted more improved quality of life, reduced lesion counts, and more favorable participant and physician assessment of disease severity. Patients who received ivermectin 1% cream had an acceptable safety profile. Ivermectin is efficacious in decreasing inflammatory lesion counts and erythema. Keywords: papulopustular rosacea, topical ivermectin, metronidazole, azelaic acid, topical

  1. Pilling evaluation of patterned fabrics based on a gradient field method

    Czech Academy of Sciences Publication Activity Database

    Techniková, L.; Tunák, M.; Janáček, Jiří

    2016-01-01

    Roč. 41, č. 1 (2016), s. 97-101 ISSN 0971-0426 Institutional support: RVO:67985823 Keywords : 3D surface reconstruction * fabric pilling * gradient field method * patterned fabric * pills detection Subject RIV: JS - Reliability ; Quality Management, Testing Impact factor: 0.430, year: 2016

  2. Sisearhitekt Pille Lausmäe - Tallinna töö- ja toidukultuuri looja / Karen Jagodin

    Index Scriptorium Estoniae

    Jagodin, Karen, 1982-

    2006-01-01

    Omanimelise arhitektuuribüroo omanik sisearhitekt Pille Lausmäe oma elust ja tööst, isast sisearhitekt Väino Tammest. Eesti Kunstiakadeemias õpib sisearhitektuuri ka Pille poeg Ville Lausmäe ja töötab ema büroos. Pillet iseloomustavad Priit Põldme, Riina Sildots, Rein Tallermo, Mari Kaljuste

  3. Study on anti-atherosclerotic effect of suxiao jiuxin pill and its ...

    African Journals Online (AJOL)

    Background: Suxiao Jiuxin Pill is composed of Ligusticum wallichii, Borneolum Syntheticum and other drugs; it has qi promoting and blood circulation activating, meridian dredging and pain relieving efficacies. The objective of this paper is to study the effect of Suxiao Jiuxin Pill (quick-acting heart reliever), in atherosclerosis ...

  4. Kino Kosmos Imax = Kosmos Imax cinema / Pille Lausmäe ; kommenteerinud Karen Jagodin

    Index Scriptorium Estoniae

    Lausmäe, Pille, 1958-

    2015-01-01

    Kino Kosmos Imax Tallinnas Pärnu mnt 45. 1964. aastal valminud hoone arhitekt Ilmar Laasi. Renoveeritud interjööri autorid Pille Lausmäe, Kerli Lepp (Pille Lausmäe Sisearhitektuuri büroo). Projekti autorid Urmas Lõoke, Riina Poopuu (Urmas Lõokese Arhitektibüroo)

  5. Access to the Birth Control Pill and the Career Plans of Young Men and Women

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    The paper explores the effect of unrestricted access to the birth control pill on young people’s career plans, using annual surveys of college freshmen from 1968 to 1980. In particular it addresses the question of who was affected by the introduction of the birth control pill by looking at career...

  6. [Estrogens and feminine brain maturation during adolescence: emergency contraceptive pill].

    Science.gov (United States)

    López Moratalla, Natalia; Errasti Alcalá, Tania; Santiago, Esteban

    2011-01-01

    In the period between puberty and maturity takes place the process of brain maturation. Hormone levels induce changes in neurons and direct the architecture and structural functionality thus affecting patterns of development of different brain areas. The onset of puberty brings with it the invasion of the female brain by high levels of hormones, cyclic surges of estrogen and progesterone in addition to steroids produced in situ. Control centers of emotions (amygdala), memory and learning (hippocampus) and sexual activity (hypothalamus) are modified according to the cyclical concentrations of both hormones. Sex hormones stimulate multimodal actions, both short and longer terms, because neurons in various brain areas have different types of receptors, membrane, cytoplasmic and nuclear. The composition of emergency contraceptive pill (postcoital pill) with high hormonal content raises the urgency of a thorough knowledge about the possible effect that the lack of control of the menstrual cycle in a time of consolidation of brain maturation, can bring in structuring and development of brain circuitry. Changes in the availability of sex steroids during puberty and adolescence underlie psychiatric disorders whose prevalence is typically feminine, such as depression, anxiety disorders. It is a fundamental ethical duty to present scientific data about the influence of estrogen in young female brain maturation, both for full information to potential users, and also to induce the appropriate public health measures.

  7. Cloxacillin: A New Cause of Pill-Induced Esophagitis

    Directory of Open Access Journals (Sweden)

    Petros Zezos

    2016-01-01

    Full Text Available A large variety of medications can cause pill-induced esophagitis. Herein we present a case of cloxacillin-induced esophagitis. A 66-year-old male presented with an acute onset of epigastric and retrosternal pain on the 5th day of a course of oral cloxacillin prescribed for erysipelas. Initial clinical and imaging assessment was negative and he was sent home. A few days later, he returned with persistent severe retrosternal pain; endoscopy at the same day revealed a normal upper esophagus, several small stellate erosions in the midesophagus, and a normal squamocolumnar junction with a small hiatus hernia. Treatment with esomeprazole 40 mg bid and MucaineR suspension resulted in complete resolution of his symptoms. Pill-induced esophagitis may be underreported by patients, when symptoms are mild and unrecognized and/or underdiagnosed by the clinicians as a cause of retrosternal pain, odynophagia, or dysphagia. Failure of early recognition may result in unnecessary diagnostic investigations and prolongation of the patient’s discomfort. This case signifies the importance of enhancing clinician awareness for drug-associated esophageal injury when assessing patients with retrosternal pain, as well as the value of prophylaxis against this unpleasant condition by universally recommending drinking enough water in an upright position during ingestion of any oral medication.

  8. Study on radiosterilization of crude drug pill involving bezoar bovis

    International Nuclear Information System (INIS)

    Kimura, Syojiro; Sasaki, Masahiro; Kondo, Yuichi; Jo, Hisanobu; Kanbashi, Toshitaka.

    1981-01-01

    Radiolysis of bilirubin and cholic acids (cholic acid, desoxycholic acid and lithocholic acid) in hydrous pellet have been investigated with following parameters, which were hydrous content, radiation dose and the dose rate, to discuss the application of gamma -irradiation for sterilization of crude drug pill involving bezoar bovis. At 774 C/kg(3.0MR) irradiation for 5% and 10% hydrous contents pellets, the radiolysis percent of those components were less than 5%. However, the higher hydrous pellet, the radiolysis percents of those are more increase. At the same irradiated condition for 20% hydrous contents pellets, the radiolysis percents of those were 15--22%. The hydrous percent of commercial crude drug pill involving bezoar bovis are about 9%, so that the radiolysis of those components will be less than 5% on the sterilization. The radiolysis percent of bilirubin are constant to variation of radiation dose rate between 51.6--722.5C/kg.hr(0.2--2.8MR/hr). But, the values of cholic acids don't definite such as that of bilirubin, because of larger analitycal error. (author)

  9. A thyrotoxicosis outbreak due to dietary pills in Paris

    Directory of Open Access Journals (Sweden)

    Vincent Ioos

    2008-10-01

    Full Text Available Vincent Ioos1, Vincent Das1, Eric Maury1,2, Jean-Luc Baudel1, Jérôme Guéchot3, Bertrand Guidet1,2, Georges Offenstadt1,21Réanimation Médicale; 2Université Pierre et Marie Curie-Paris 6, INSERM, UMR-S 707; 3Unité d’Hormonologie, APHP, Hôpital Saint Antoine, F-75012, Paris, FranceAbstract: Three women were consecutively admitted to our medical intensive care unit for thyrotoxicosis after the ingestion of dietary pills accidentally containing high levels of thyroxin. These cases were observed during an outbreak in the Paris area. Despite similar blood levels of thyroid hormones, their clinical presentation and outcome were very different. One patient developed febrile confusion and died from malignant hyperthermia. The second one had progressive confusion requiring mechanical plasma exchange therapy and had a favorable outcome. The third one had very moderate symptoms. These exceptional observations raise several issues concerning diagnosis, physiopathology and treatment of thyrotoxicosis factitia.Keywords: thyrotoxicosis, dietary pills, thyroxin

  10. Emergency contraceptive pills: knowledge and attitudes of pharmacy personnel in Managua, Nicaragua.

    Science.gov (United States)

    Ehrle, Nina; Sarker, Malabika

    2011-06-01

    As abortion is illegal in Nicaragua, postcoital contraception is an important option for preventing pregnancy. Emergency contraceptive pills are available in Nicaraguan pharmacies over the counter, but pharmacy personnel's knowledge and attitudes about this method can affect access. A cross-sectional survey was conducted in Managua, Nicaragua's capital. Interviewers administered a semistructured questionnaire to 93 pharmacy employees to determine their knowledge of and attitudes toward emergency contraceptive pills. Descriptive statistics and cross-tabulations were used to examine responses of and differences between male and female employees. All participants knew about emergency contraceptive pills and reported experience selling them. The majority sold them at least once a week (92%), usually without a prescription (97%). Of participants who were aware that emergency contraceptive pills should be taken only after sexual intercourse, 45% knew that the pills can be taken up to three days afterward; none knew that the pills are effective up to five days afterward. More than one-third of all respondents (39%) thought the pills can induce abortion, and most overestimated contraindications and side effects. Large majorities believed the availability of emergency contraceptive pills discourages use of ongoing methods (75%), encourages sexual risk-taking (82%) and increases transmission of HIV and other STIs (76%). Sixty-three participants (68%) thought emergency contraceptive pills are necessary to reduce unwanted and unplanned pregnancy; 65% were willing to provide them to all women in need, although only 13% would provide them to minors. Managuan pharmacy personnel frequently dispense emergency contraceptive pills, but need additional education to accurately counsel women about the method.

  11. The suppression effect of a periodic surface with semicircular grooves on the high power microwave long pill-box window multipactor phenomenon

    Science.gov (United States)

    Zhang, Xue; Wang, Yong; Fan, Junjie; Zhong, Yong; Zhang, Rui

    2014-09-01

    To improve the transmitting power in an S-band klystron, a long pill-box window that has a disk with grooves with a semicircular cross section is theoretically investigated and simulated. A Monte-Carlo algorithm is used to track the secondary electron trajectories and analyze the multipactor scenario in the long pill-box window and on the grooved surface. Extending the height of the long-box window can decrease the normal electric field on the surface of the window disk, but the single surface multipactor still exists. It is confirmed that the window disk with periodic semicircular grooves can explicitly suppress the multipactor and predominantly depresses the local field enhancement and the bottom continuous multipactor. The difference between semicircular and sharp boundary grooves is clarified numerically and analytically.

  12. The suppression effect of a periodic surface with semicircular grooves on the high power microwave long pill-box window multipactor phenomenon

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Xue, E-mail: zhangxue.iecas@yahoo.com; Wang, Yong; Fan, Junjie; Zhong, Yong; Zhang, Rui [Institute of Electronics, Chinese Academy of Sciences, Peking, 100190 China (China)

    2014-09-15

    To improve the transmitting power in an S-band klystron, a long pill-box window that has a disk with grooves with a semicircular cross section is theoretically investigated and simulated. A Monte-Carlo algorithm is used to track the secondary electron trajectories and analyze the multipactor scenario in the long pill-box window and on the grooved surface. Extending the height of the long-box window can decrease the normal electric field on the surface of the window disk, but the single surface multipactor still exists. It is confirmed that the window disk with periodic semicircular grooves can explicitly suppress the multipactor and predominantly depresses the local field enhancement and the bottom continuous multipactor. The difference between semicircular and sharp boundary grooves is clarified numerically and analytically.

  13. The suppression effect of a periodic surface with semicircular grooves on the high power microwave long pill-box window multipactor phenomenon

    International Nuclear Information System (INIS)

    Zhang, Xue; Wang, Yong; Fan, Junjie; Zhong, Yong; Zhang, Rui

    2014-01-01

    To improve the transmitting power in an S-band klystron, a long pill-box window that has a disk with grooves with a semicircular cross section is theoretically investigated and simulated. A Monte-Carlo algorithm is used to track the secondary electron trajectories and analyze the multipactor scenario in the long pill-box window and on the grooved surface. Extending the height of the long-box window can decrease the normal electric field on the surface of the window disk, but the single surface multipactor still exists. It is confirmed that the window disk with periodic semicircular grooves can explicitly suppress the multipactor and predominantly depresses the local field enhancement and the bottom continuous multipactor. The difference between semicircular and sharp boundary grooves is clarified numerically and analytically

  14. Pills on the World Wide Web: reducing barriers through technology.

    Science.gov (United States)

    Gawron, Lori M; Turok, David K

    2015-10-01

    Oral contraceptive pills are safe, effective, and available without a prescription in most countries. Despite support from the American Congress of Obstetricians and Gynecologists to provide oral contraceptives as an over-the-counter medication, US women are still required to have a prescription to obtain them. Use of online applications and the Internet has made most things easier to obtain in our society and this includes contraceptive methods. Several online ventures are now underway to enable US women to obtain oral contraceptives without visiting a medical provider's office. Women's health care professionals should encourage these novel approaches, as they will improve contraceptive access. As US women experiment with innovative health care models, providers will need to lead, follow, or be left behind. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. What's in a label? Ecstasy sellers' perceptions of pill brands.

    Science.gov (United States)

    Duterte, Micheline; Jacinto, Camille; Sales, Paloma; Murphy, Sheigla

    2009-03-01

    This article presents selected findings from a qualitative study of Ecstasy sellers and their sales practices, knowledge of distribution networks, buyer-seller relationships, and self-reported drug use. In-depth interviews were conducted with 80 men and women who had sold five or more hits of Ecstasy five or more times in the six months prior to the interview. Study participants described their perceptions of the various types of Ecstasy they had distributed or used themselves. The participants had experience with a variety of Ecstasy labels, from the popular "Blue Dolphin" tablets to the powdered form called "Molly." We tracked pill brand mentions on Ecstasy-related websites to compare with interviewees' descriptions of Ecstasy brands. This study examines Ecstasy sellers' ideas about the role of brand names in Ecstasy markets and their relationship to their beliefs about different types of Ecstasy's purity and quality. We demonstrate that considering Ecstasy branding increases our understanding of buyer and seller relationships.

  16. Quantifying the utility of taking pills for preventing adverse health outcomes: a cross-sectional survey.

    Science.gov (United States)

    Hutchins, Robert; Pignone, Michael P; Sheridan, Stacey L; Viera, Anthony J

    2015-05-11

    The utility value attributed to taking pills for prevention can have a major effect on the cost-effectiveness of interventions, but few published studies have systematically quantified this value. We sought to quantify the utility value of taking pills used for prevention of cardiovascular disease (CVD). Cross-sectional survey. Central North Carolina. 708 healthcare employees aged 18 years and older. Utility values for taking 1 pill/day, assessed using time trade-off, modified standard gamble and willingness-to-pay methods. Mean age of respondents was 43 years (19-74). The majority of the respondents were female (83%) and Caucasian (80%). Most (80%) took at least 2 pills/day. Mean utility values for taking 1 pill/day using the time trade-off method were: 0.9972 (95% CI 0.9962 to 0.9980). Values derived from the standard gamble and willingness-to-pay methods were 0.9967 (0.9954 to 0.9979) and 0.9989 (95% CI 0.9986 to 0.9991), respectively. Utility values varied little across characteristics such as age, sex, race, education level or number of pills taken per day. The utility value of taking pills daily in order to prevent an adverse CVD health outcome is approximately 0.997. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

    Science.gov (United States)

    Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

    2013-06-14

    To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

  18. Telemetry pill versus rectal and esophageal temperature during extreme rates of exercise-induced core temperature change

    International Nuclear Information System (INIS)

    Teunissen, L P J; Daanen, H A M; De Haan, A; De Koning, J J

    2012-01-01

    Core temperature measurement with an ingestible telemetry pill has been scarcely investigated during extreme rates of temperature change, induced by short high-intensity exercise in the heat. Therefore, nine participants performed a protocol of rest, (sub)maximal cycling and recovery at 30 °C. The pill temperature (T pill ) was compared with the rectal temperature (T re ) and esophageal temperature (T es ). T pill corresponded well to T re during the entire trial, but deviated considerably from T es during the exercise and recovery periods. During maximal exercise, the average ΔT pill −T re and ΔT pill −T es were 0.13 ± 0.26 and −0.57 ± 0.53 °C, respectively. The response time from the start of exercise, the rate of change during exercise and the peak temperature were similar for T pill and T re. T es responded 5 min earlier, increased more than twice as fast and its peak value was 0.42 ± 0.46 °C higher than T pill . In conclusion, also during considerable temperature changes at a very high rate, T pill is still a representative of T re . The extent of the deviation in the pattern and peak values between T pill and T es (up to >1 °C) strengthens the assumption that T pill is unsuited to evaluate central blood temperature when body temperatures change rapidly. (paper)

  19. [Correlation between physical characteristics of sticks and quality of traditional Chinese medicine pills prepared by plastic molded method].

    Science.gov (United States)

    Wang, Ling; Xian, Jiechen; Hong, Yanlong; Lin, Xiao; Feng, Yi

    2012-05-01

    To quantify the physical characteristics of sticks of traditional Chinese medicine (TCM) honeyed pills prepared by the plastic molded method and the correlation of adhesiveness and plasticity-related parameters of sticks and quality of pills, in order to find major parameters and the appropriate range impacting pill quality. Sticks were detected by texture analyzer for their physical characteristic parameters such as hardness and compression action, and pills were observed by visual evaluation for their quality. The correlation of both data was determined by the stepwise discriminant analysis. Stick physical characteristic parameter l(CD) can exactly depict the adhesiveness, with the discriminant equation of Y0 - Y1 = 6.415 - 41.594l(CD). When Y0 Y1, pills were adhesive with each other. Pills' physical characteristic parameters l(CD) and l(AC), Ar, Tr can exactly depict smoothness of pills, with the discriminant equation of Z0 - Z1 = -195.318 + 78.79l(AC) - 3 258. 982Ar + 3437.935Tr. When Z0 Z1, pills were rough on surface. The stepwise discriminant analysis is made to show the obvious correlation between key physical characteristic parameters l(CD) and l(AC), Ar, Tr of sticks and appearance quality of pills, defining the molding process for preparing pills by the plastic molded and qualifying ranges of key physical characteristic parameters characterizing intermediate sticks, in order to provide theoretical basis for prescription screening and technical parameter adjustment for pills.

  20. A curious abnormally developed embryo of the pill millipede Glomeris marginata (Villers, 1789

    Directory of Open Access Journals (Sweden)

    Ralf Janssen

    2013-03-01

    Full Text Available This paper reports on an abnormally developed embryo (ADE of the common pill millipede Glomeris marginata. This ADE represents a modified case of Duplicitas posterior, in which two posterior ends are present, but only one anterior end. While the major posterior germ band of the embryo appears almost normally developed, the minor posterior germ band is heavily malformed, has no clear correlation to the single head, little or no ventral tissue, and a minute amount of yolk. The anterior end of the minor germ band is fused to the ventral side of the major germ band between the first and second trunk segment. At least one appendage of the second trunk segment appears to be shared by the two germ bands. Morphology and position of the minor germ band suggest that the ADE may be the result of an incorrectly established single cumulus [the later posterior segment addition zone (SAZ]. This differs from earlier reports on D. posterior type ADEs in G. marginata that are likely the result of the early formation of two separate cumuli.

  1. Emergency contraceptive pills: what you need to know. Brochure for programs providing combined ECPs.

    Science.gov (United States)

    1998-01-01

    This informational brochure was prepared for potential users of emergency contraceptive pills. In question-and-answer format, it presents facts on the mechanism of action, effectiveness, safety, and side effects of emergency contraception. It then outlines the regimen for method use. The brochure notes that emergency contraceptive pills cannot offer protection against HIV and other sexually transmitted diseases. Finally, two other emergency contraceptive regimens--the copper T IUD and progestin-only pills--are discussed. The brochure may be reproduced by family planning and other health programs.

  2. Effect and mechanism of Qishen Yiqi Pills on adriamycin- induced cardiomyopathy in mice.

    Science.gov (United States)

    Tong, Jia-Yi; Xu, Yan-Juan; Bian, Ye-Ping; Shen, Xiang-Bo; Yan, Lei; Zhu, Xin-Yi

    2013-09-01

    To study the effect and probable mechanism of Qishen Yiqi Pills on adriamycin (ADR)-induced cardiomyopathy in mice. Sixty-four mice were randomly divided into (1) the ADR group: saline (1 mL/100 g) administered every day by intragavage, ADR (4 mg·kg(-1)) administered to each mouse by intraperitoneal injection twice a week for four weeks; (2) the ADR + Qishen Yiqi Pills I group: ADR (4 mg·kg(-1)) administered to each mouse by intraperitoneal injection twice a week for four weeks, and at the beginning of the third week Qishen Yiqi Pills (3.5 mg/100 g) administered by intragavage every day for four weeks; (3) the ADR + Qishen Yiqi Pills II group: ADR (4 mg·kg(-1)) administered to each mouse by intraperitoneal injection twice a week for four weeks, and at the same time Qishen Yiqi Pills (3.5 mg/100 g) administered by intragavage every day for four weeks; (4) the control group: saline (1 mL/100 g) administered every day by intragavage, saline (1 mL·kg(-1)) administered to each mouse by intraperitoneal injection twice a week for four weeks. Six weeks later, cardiac function, myocardial pathology, and expression of Bcl-2 and Bax were evaluated. 1. The left ventricular diastolic diameter and the left ventricular systolic diameter were significantly increased (P Pills I group and the ADR + Qishen Yiqi Pills II group improved. 2. Myocardial morphologic observation showed that the myocardial fibers were disordered, there was cell edema, and gap widening in the ADR group. The degree of myocardial cell injury was reduced in the ADR + Qishen Yiqi Pills I group and ADR + Qishen Yiqi Pills II group compared with the ADR group. 3. The expression of Bax in the ADR group was significantly up-regulated, and the expression of Bcl-2 was significantly downregulated in the ADR group compared with the ADR + Qishen Yiqi Pills I group, the ADR + Qishen Yiqi Pills II group, and the control group (P Pills can effectively improve the cardiac function of ADR-induced cardiomyopathy, and the

  3. Peripheral arterial disease in a female using high-dose combined oral contraceptive pills.

    Science.gov (United States)

    Pallavee, P; Samal, Sunita; Samal, Rupal

    2013-01-01

    The association between oral contraceptive (OC) pills and vascular diseases is well-known, although, the present generation of pills is considered to be relatively safer in this regard. Hormonal treatment for severe abnormal uterine bleeding is usually considered after ruling out malignancy, when such bleeding is resistant to all other forms of treatment. We report a case of severe peripheral arterial disease in a female, who had been on high-dose OC pills for an extended period of time for severe uterine bleeding.

  4. Is It Safe to Provide Abortion Pills over the Counter? A Study on Outcome Following Self-Medication with Abortion Pills.

    Science.gov (United States)

    Nivedita, K; Shanthini, Fatima

    2015-01-01

    Medical abortion is a safe method of termination of pregnancy when performed as per guidelines with a success rate of 92-97 %. But self-administration of abortion pills is rampant throughout the country due to over the counter availability of these drugs and complications are not uncommon due to this practice. The society perceives unsupervised medical abortion as a very safe method of termination and women use this as a method of spacing. The aim of this study was to study the implications of self-administration of abortion pills by pregnant women. Retrospective observational study done in Sri Manakula Vinayagar Medical College & Hospital between the period of July 2013 to June2014. Case sheets were analysed to obtain data regarding self-administration of abortion pills and complications secondary to its administration. The following data were collected. Age, marital status, parity, duration of pregnancy as perceived by the women, confirmation of pregnancy, duration between pill intake and visit to hospital, whether any intervention done elsewhere, any known medical or surgical complications, Hb level on admission, whether patient was in shock, USG findings, evidence of sepsis, blood transfusion, treatment given and duration of hospital stay. Descriptive analysis of the collected data was done. Among the 128 cases of abortion in the study period, 40 (31.25%) patients had self-administered abortion pills. Among these 40 patients 27.5% had consumed abortion pills after the approved time period of 63 days of which 17.5% had consumed pills after 12 weeks of gestation. The most common presentation was excessive bleeding (77.5%) Severe anaemia was found in 12.5% of the patients and 5% of patients presented with shock. The outcome was as follows : 62.5% of the patients were found to have incomplete abortion, 22.5% had failed abortion and 7.5% of patients had incomplete abortion with sepsis. Surgical evacuation was performed in 67.5% of the patients whereas 12.5% of the

  5. Highs and lows: patterns of use, positive and negative effects of benzylpiperazine-containing party pills (BZP-party pills) amongst young people in New Zealand.

    Science.gov (United States)

    Butler, Rachael A; Sheridan, Janie L

    2007-11-19

    This study aimed to investigate patterns and context of use of BZP-party pills, function of use, and positive and negative effects experienced by a sample of New Zealand young people who had used the products. A qualitative study comprised of semi-structured interviews and group discussions. The sample included 58 young people aged 17-23 years who had used BZP-party pills in the previous 12 months. Young people were using these substances in a range of settings--primarily during weekend social occasions--particularly as part of the dance party culture. They were mostly used for their stimulant properties and to enhance socialisation, and were often taken in combination with other legal and illicit drugs. Young people had suffered a range of physical and emotional negative effects, although none of these was reported as being life-threatening or long-term. Many participants had reduced the frequency with which they used BZP-party pills due to adverse effects. Potentially risky behaviours identified included taking large doses, mixing BZP-party pills with alcohol and other substances, and driving whilst under the influence of BZP-party pills. Findings suggest that young people in this study were not suffering excessive or dangerous adverse effects. However, potentially risky use of these products raises the issue of the need for developing harm reduction interventions.

  6. STRike - characteristics of HIV-1-infected patients treated with a single-tablet regimen in daily clinical practice

    OpenAIRE

    S Esser; H Heiken; L Gallo; S Schellberg; M Schlag; A Moll; R Pauli; A Stoehr; O Degen; H Jaeger; C Stephan; G Fätkenheuer

    2012-01-01

    The life-long antiretroviral treatment of HIV-1 infection requires effective and well tolerated medications complemented by high rates of adherence in order to achieve viral suppression, immunologic reconstitution and to prevent the development of resistance. Single-tablet regimens (STRs), combining a full antiretroviral regimen in one tablet taken once daily, have been designed to achieve high adherence and better long-term outcomes. “STRike” is the first cohort study, describi...

  7. Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake

    DEFF Research Database (Denmark)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique

    2016-01-01

    by four placebo tablets. A previous study showed that this new drospirenone-only pill effectively inhibited ovulation. Clinical efficacy, however, can be affected by compliance, and delayed or forgotten pill intake often occurs in daily life. The aim of this study was to investigate if inhibition.......8%; only one subject in Group A fulfilled the ovulation criteria in Cycle 2. Follicular diameters in the regular-intake and the delayed-intake cycles were similar. CONCLUSION: Despite the 4-day hormone-free period and multiple intentional 24-h delays in tablet intake, ovulation inhibition was maintained...... inhibition by the new-generation oestrogen-free pill, containing 4-mg drospirenone for 24 days followed by a 4-day treatment-free period, was maintained despite four 24-h delays in tablet intake, so the impact of delayed intake on contraceptive reliability will be low....

  8. [Studies on preparation and dissolution test in vitro of sustained-release dropping pills of curcumin].

    Science.gov (United States)

    Fang, Yu; Xiang, Bai; Pan, Zhen-Hua; Cao, De-Ying

    2010-01-01

    To study the prescription and technique of sustained-release dropping pills of curcumin and inspect their release property in vitro. The orthogonal test was used to screen the prescription and technique which were definited with the colligation evaluation of release and formation of dropping pills. The optimization of prescription and technique were as follows: stearic acid 70 mg, glycery monostearate 25 mg, solutol 6 mg, viscosity of cooling liquid was 100 mm2/s; the temperature of material liquid was 80 degrees C; the cooling temperature was 30 - 0 degrees C; the dropping speed was (21 +/- 2) dripping/min. The release behavior of sustained-release dropping pills of curcumin coincidented with Higuchi equation well and the character of sustained-release was transparent. The sustained-release dropping pills of curcumin have good property of sustained-release in vitro and their release behavior in vivo need to be inspected.

  9. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits.

    Science.gov (United States)

    Kumar, Kanupriya; Gulotta, Lawrence V; Dines, Joshua S; Allen, Answorth A; Cheng, Jennifer; Fields, Kara G; YaDeau, Jacques T; Wu, Christopher L

    2017-03-01

    In the past 16 years, the number of prescription opioids sold in the United States, as well as deaths from prescription opioids, has nearly quadrupled. However, the overall amount of pain reported by patients has not changed significantly. Specific information about opioid prescriptions in the perioperative period is lacking. Of the studies that have been published, investigators have shown that the majority of patients have unused postoperative opioid pills. Moreover, patients appear to lack information about disposal of unused opioid pills. To compare the number of pills prescribed versus the numbers left unused after outpatient shoulder surgeries at an orthopaedic surgery institution. Case series; Level of evidence, 4. In this prospective, observational study, 100 patients (age >18 years) undergoing outpatient shoulder surgery (rotator cuff repair, labral repair, stabilization/Bankart repair, debridement) were enrolled. Follow-ups were conducted via surveys on postoperative days (PODs) 7, 14, 28, and 90. The primary outcome was the number of unused pills from the originally prescribed medication. For all procedure types, the median (Q1, Q3) number of prescribed pills was 60 (40, 80). On POD 90, patients reported a median (Q1, Q3) of 13 (0, 32) unused pills; patients who underwent rotator cuff repairs had the lowest number of pills remaining (median [Q1, Q3], 0 [0, 16]), whereas patients who had stabilization/Bankart repairs had the highest number of unused pills (median [Q1, Q3], 37 [29, 50]). Patient satisfaction with pain management ranged from an average of 70% to 90%. Only 25 patients received instructions or education about opioid disposal. Most outpatient shoulder surgery patients who underwent certain operations were prescribed more opioid analgesics than they consumed. Patient education regarding the disposal of opioids was lacking.

  10. Combined Oral Contraceptive Pills: Profile of Acceptors in a Tertiary Hospital in South-South Nigeria.

    Science.gov (United States)

    Abasiattai, A M; Utuk, M N; Ojeh, S O; Eyo, U E

    2011-01-01

    BACKGROUND: Combined oral contraceptive pills were the first contraceptive method to provide sexual freedom of choice for women through reliable, personal and private control of fertility. They are the most widely used hormonal contraceptives and also the most popular non-surgical method of contraception. OBJECTIVE: To review the profile of acceptors of combined oral contraceptive pills at the University of Uyo Teaching Hospital, Uyo. METHODOLOGY: An 8 year review of all clients that accepted combined oral contraceptive pills in the family planning clinic. RESULTS: There were 1,146 new contraceptive acceptors during the period of study out of which 309 (27.9%) accepted the pills. Majority of the clients were between 20 and 29 years of age (54.0%), were multiparous (72.8%), Christians (99.7%) and 61.2% had tertiary level education. Two hundred and fifty-five women (82.5%) desired to use combined oral contraceptive pills to space births while 7.8% wanted to limit child bearing. There was a high discontinuation rate among the women (45.0%) and out of these 87.9% of the clients changed to other contraceptive methods. All the clients commenced their pills within seven days of menstruation and only the low dose monophasic preparations were available in the family planning unit and thus were given to the clients. CONCLUSION: Women who accept to initiate combined oral contraceptive pills in our center are young, well educated, multiparous women who want to space their pregnancies. However, due to the high discontinuation rate among the clients, there is need for further studies evaluating reasons for the high discontinuation rate, exploring interactions between clients and providers' and also providers' attitude towards combined pills in our environment.

  11. [Pharmacodynamics Study on Gualou Xiebai Dropping Pills and Its Medicinal Ingredients in Prescription].

    Science.gov (United States)

    Yan, Hai-yan; Zou, Chun-cai; Wei, Mei-ling; Gao, Zheng-zheng; Yang, Yang

    2015-03-01

    To study the pharmacodynamics of Gualou Xiebai Dropping Pills and its medicinal ingredients in prescription on anti-myocardial ischemia. SPF Rats were divided randomly into eleven groups with ten rats in each group and half male and half female, the rats were respectively given the physiological saline(blank group and model group), Gualou, Xiebai, Gualou Xiebai Baijiutang (all equivalent to the crude herb of 22. 5 g/kg), Gualou Xiebai. Dropping Pills in the doses of 3. 75,11. 25,22. 5,33. 75 and 45 g/kg and Compound Danshen Drop Pills of 0. 085 g/kg by gavage one time a day for seven days. Except blank group, other rats were given by intraperitoneal injection of isoproterenol to establish myocardial ischemia models, changes of ST segments in ECG were observed in all groups, and the levels of SOD, NO, HDL-C, MDA, CAT, LDH and CK in blood plasma were detected, and the pathological changes of myocardial tissues were observed under light microscope by HE staining. Compared with model group, ST segments in ECG dropped markedly at different time point which included 10,11 and 12 (P Pills groups of 22. 5, 33. 75 and 45 g/kg, time points were more than those of other groups. Gualou Xiebai Dropping Pills groups of 22. 5 and 33. 75 g/kg improved the levels of SOD, MDA, CAT, NO, HDL-C, LDH and CK in blood plasma in model rats significantly (P Pills improved the pathological changes of myocardial tissues at all dosages. Gualou Xiebai Drop Pills can effectively restrain the acute myocardial ischemia induced by isoproterenol in rats, compared with Gualou, Xiebai or Gualou Xiebai Baijiutang, Gualou Xiebai Drop Pills obtains a favourable effect.

  12. Enhanced Oral Bioavailability of Pueraria Flavones by a Novel Solid Self-microemulsifying Drug Delivery System (SMEDDS) Dropping Pills.

    Science.gov (United States)

    Guan, Qingxiang; Zhang, Guangyuan; Sun, Shilin; Fan, Hongbo; Sun, Cheng; Zhang, Shaoyuan

    2016-05-01

    To improve bioavailability of pueraria flavones (PF), a self-microemulsifying drug delivery system (SMEDDS) dropping pills composed of PF, Crodamol GTCC, Maisine 35-1, Cremophor RH 40, 1,2-propylene glycol and polyethylene glycol 6000 (PEG6000) was developed. Particle size, zeta potential, morphology and in vitro drug release were investigated, respectively. Pharmacokinetics, bioavailability of PF-SMEDDS dropping pills and commercial Yufengningxin dropping pills were also evaluated and compared in rats. Puerarin treated as the representative component of PF was analyzed. Dynamic light scattering showed the ability of PF-SMEDDS dropping pills to form a nanoemulsion droplet size in aqueous media. The type of media showed no significant effects on the release rate of PF. PF-SMEDDS dropping pills were able to improve the in vitro release rate of PF, and the in vitro release of these dropping pills was significantly faster than that of Yufengningxin dropping pills. There was a dramatic difference between the mean value of t1/2, peak concentration (Cmax), the area of concentration-time curve from 0 to 6 h (AUC0-6 h) of PF-SMEDDS dropping pills and that of commercial Yufengningxin dropping pills. A pharmacokinetic study showed that the bioavailability of PF was greatly enhanced by PF-SMEDDS dropping pills. The value of Cmax and relative bioavailability of PF-SMEDDS dropping pills were dramatically improved by an average of 1.69- and 2.36-fold compared with that of Yufengningxin dropping pills after gavage administration, respectively. It was concluded that bioavailability of PF was greatly improved and that PF-SMEDDS dropping pills might be an encouraging strategy to enhance the oral bioavailability of PF.

  13. Adolescents’ Knowledge, Attitude and Utilization of Emergency Contraceptive Pills in Nigeria’s Niger Delta Region

    Science.gov (United States)

    Onasoga, Olayinka A.; Afolayan, Joel Adeleke; Asamabiriowei, Tariebi Florence; Jibril, Umar Nda; Imam, Abubakar Ayinla

    2016-01-01

    Background and Objective: Risky sexual activity among adolescents is on the increase and contraceptive prevalence rate is low which is evidenced by high rate of teenage pregnancy in Bayelsa state, Nigeria. This study assesses the adolescents’ knowledge, attitude and utilization of emergency contraceptive pills (ECP) in Amassoma Community, Bayelsa State, in the Niger Delta region of Nigeria. Methods: The study was a descriptive cross-sectional research design. A purposive sampling technique was used to select a sample of 220 respondents from the target population. Data were collected using a self-structured questionnaire. Descriptive and inferential statistics were used to analyze the data generated. Results: Majority of the respondents had high level of knowledge and positive attitude towards emergency contraceptive pills but had low level of utilization. Concerns about what others may say, parental attitude, contraceptive availability, contraceptive accessibility, and peer influences were the major factors that influenced the utilization of contraceptive pills. There was no significant relationship between knowledge and utilization of emergency contraceptive pills, as well as level of knowledge and their utilization of emergency contraceptive pills. Conclusions and Global Health Implications: Adolescents in the study were more likely to use emergency contraceptive pills, if parents and others reaction to adolescents’ contraceptive use were positive about those. Health care professionals, especially nurses, should organize enlightenment programs to educate adolescents, parents and the public on the benefits of adolescents’ contraceptives use, especially ECP. PMID:28058193

  14. Adolescents' Knowledge, Attitude and Utilization of Emergency Contraceptive Pills in Nigeria's Niger Delta Region.

    Science.gov (United States)

    Onasoga, Olayinka A; Afolayan, Joel Adeleke; Asamabiriowei, Tariebi Florence; Jibril, Umar Nda; Imam, Abubakar Ayinla

    2016-01-01

    Risky sexual activity among adolescents is on the increase and contraceptive prevalence rate is low which is evidenced by high rate of teenage pregnancy in Bayelsa state, Nigeria. This study assesses the adolescents' knowledge, attitude and utilization of emergency contraceptive pills (ECP) in Amassoma Community, Bayelsa State, in the Niger Delta region of Nigeria. The study was a descriptive cross-sectional research design. A purposive sampling technique was used to select a sample of 220 respondents from the target population. Data were collected using a self-structured questionnaire. Descriptive and inferential statistics were used to analyze the data generated. Majority of the respondents had high level of knowledge and positive attitude towards emergency contraceptive pills but had low level of utilization. Concerns about what others may say, parental attitude, contraceptive availability, contraceptive accessibility, and peer influences were the major factors that influenced the utilization of contraceptive pills. There was no significant relationship between knowledge and utilization of emergency contraceptive pills, as well as level of knowledge and their utilization of emergency contraceptive pills. Adolescents in the study were more likely to use emergency contraceptive pills, if parents and others reaction to adolescents' contraceptive use were positive about those. Health care professionals, especially nurses, should organize enlightenment programs to educate adolescents, parents and the public on the benefits of adolescents' contraceptives use, especially ECP.

  15. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Science.gov (United States)

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  16. High order mode damping in a pill box cavity

    International Nuclear Information System (INIS)

    Voelker, F.; Lambertson, G.; Rimmer, R.

    1991-04-01

    We have substantially damped the higher order modes (HOM's) in a pill box cavity with attached beam pipe, while reducing the Q of the principal mode by less that 10%. This was accomplished by cutting slots in the cavity end wall at a radius at which the magnetic field of the lowest frequency HOM's is large. The slots couple energy from the cavity into waveguides which are below cut off for the principal mode, but which propagate energy at the HOM frequencies. Three slots 120 degrees apart couple HOM energy to three waveguides. We are concerned primarily with accelerating and deflecting modes: i.e. the TM mnp modes of order m=0 and m=1. For the strongest damping, only three m=0 and m=1 modes were detectable. These were the principal TM 010 mode, the TM 011 longitudinal mode, and the TM 110 deflecting mode. In addition the HOM Q's and the reduction of Q for the principal mode were determined by computer calculation. The principal mode Q for an actual rf cavity could not be measured because the bolted joints used in the construction of the cavity were not sufficiently good to support Q's above 6000. The measured Q of the first longitudinal mode was 31 and of the first transverse mode 37. Our maximum damping was limited by how well we could terminated the waveguides, and indeed, the computer calculations for the TM 011 and TM 110 modes give values in the range we measured. 2 refs., 2 figs

  17. Providers' knowledge, attitude and dispensing practices of e-pills in government dispensaries of South district in delhi, India.

    Science.gov (United States)

    Kishore, Vertika; Misro, Man M; Nandan, Deoki

    2010-01-01

    South Delhi is one of the well developed districts in the capital with best public health care facilities. Knowledge, attitude and dispensing practices of emergency contraceptive pills (E-pills) were assessed among health care providers of government dispensaries in South Delhi. A descriptive epidemiological study. Both medical and paramedical (n = 428) providers in 63 government health care facilities were interviewed between August to December 2007 using a semi-structured interview schedule. Among the different categories of the providers, medical officers were observed to be most knowledgeable about E-pills and the pharmacists were the least. The correct prescribed dose of E-pill was known only to 32% of the providers while 49% knew about its right time of intake. Misconceptions and apprehensions for promoting its use were very much prevalent even among medical officers as majority felt that open access to E-pills would increase promiscuity. The dispensing practice of providers was found positively (P pills.

  18. Impact of a warning CPOE system on the inappropriate pill splitting of prescribed medications in outpatients.

    Directory of Open Access Journals (Sweden)

    Chia-Chen Hsu

    Full Text Available Prescribing inappropriate pill splitting is not rare in clinical practice. To reduce inappropriate pill splitting, we developed an automatic warning system linked to a computerized physician order entry (CPOE system for special oral formulation drugs in outpatient settings. We examined the impact of the warning system on inappropriate prescribing of pill splitting and assess prescribers' responses to the warnings.Drugs with extended-release or enteric-coated formulations that were not originally intended to be split were recognized as "special oral formulations". A hard-stop system which could examine non-integer doses of drugs with special oral formulations, provide warnings to interrupt inappropriate prescriptions was integrated in CPOE in a medical center since June 2010. We designed an intervention study to compare the inappropriate splitting before and after the implementation of the warning system (baseline period 2010 January to May vs. intervention period 2010 June to 2011 August. During the intervention period, prescription changes in response to a warning were logged and analyzed.A total of 470,611 prescribed drug items with 34 different drugs with special oral formulations were prescribed in the study period. During the 15-month intervention period, 909 warnings for 26 different drugs were triggered among 354,523 prescribed drug items with special oral formulations. The warning rate of inappropriate splitting in the late intervention period was lower than those in baseline period (0.16% vs. 0.61%, incidence rate ratio 0.27, 95% CI 0.23-0.31, P<0.001. In respond to warnings, physicians had to make adjustments, of which the majority was changing to an unsplit pill (72.9%.The interruptive warning system could avoid the prescriptions with inappropriate pill splitting. Accordingly, physicians changed their behavior of prescribing special oral formulations regarding inappropriate pill splitting. We suggest the establishment of such system

  19. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis.

    Science.gov (United States)

    Wang, Steven; Alfieri, Thomas; Ramakrishnan, Karthik; Braunhofer, Peter; Newsome, Britt A

    2014-11-01

    Phosphate binders (PBs) account for about one half of the daily pill burden for US hemodialysis (HD) patients, which may reduce adherence. Adherence can be estimated by the medication possession ratio (MPR), which is defined as the proportion of time a patient had sufficient medication to have taken it as prescribed. Gaps of time between prescription fills lower the patient's MPR. We assessed the association of PB pill burden and adherence (MPR) with phosphorus goal attainment. Using pharmacy management program data, HD patients on PB monotherapy were tracked from first PB fill during 1 January 2007-30 June 2011 for 1 year, or until PB change or censoring. Data were assessed with generalized linear models. We analyzed 8616 patients. Higher pill burden was associated with lower adherence. Lower adherence tended to be associated with higher mean phosphorus levels and lower percentage of patients with serum phosphorus ≤5.5 mg/dL (P adherence and these clinical outcomes was most pronounced in the lowest and highest pill burden strata (3-6, >12-15, >15). Adherence, as measured by the MPR, was negatively related to higher pill burden and phosphorus levels and positively related to patients in the phosphorus target range. Within pill burden strata, phosphorus increased and patients in the target range generally decreased with decreasing adherence, suggesting that patients prescribed fewer PB pills are less likely to have treatment gaps, and may be more likely to achieve phosphorus targets. © The Author 2013. Published by Oxford University Press on behalf of ERA-EDTA.

  20. Pharmacokinetics, brain distribution, release and blood-brain barrier transport of Shunaoxin pills.

    Science.gov (United States)

    Wu, Kai; Wang, Zhan-Zhang; Liu, Dan; Qi, Xian-Rong

    2014-02-12

    Shunaoxin pills, a traditional Chinese medicine (TCM) product, have been used to treat cerebrovascular diseases in China since 2005. The main active components of Shunaoxin pills are ferulic acid and ligustilide from Chuanxiong (Ligusticum chuanxiong Hort, Umbelliferae) and Danggui (Angelica sinensis radix, Umbelliferae). As Shunaoxin shows excellent activity in the central nervous system (CNS), the extent to which the major constituents of Shunaoxin reach the CNS should be investigated. Moreover, the in vivo-in vitro correlations (IVIVC) of the formulation should be studied to elucidate the mechanisms of action of TCM in the CNS. However, these data have not previously been available. Thus we intended to investigate what the extent when these constituents of Shunaoxin pills reach the CNS, and evaluate the IVIVC of release and pharmacokinetics. In this study, we evaluated the release of ferulic acid and ligustilide from Shunaoxin pills, and their transport across an in vitro model of the BBB. We also evaluated their pharmacokinetics and brain distribution in vivo. High-performance liquid chromatography (HPLC) was used to quantify both compounds simultaneously. Based on the release in vitro and absorption of ferulic acid and ligustilide in vivo, IVIVC permitted prediction of the pharmacokinetics of these compounds. The release of ferulic acid and ligustilide reached a platform phase within 1h. Ferulic acid and ligustilide rapidly crossed the BBB in different patterns; the transport ratio increased over time. After intragastric (i.g.) administration of Shunaoxin pills, ferulic acid and ligustilide were rapidly absorbed and distributed into brain, which may result in a rapid onset of action. Ferulic acid and ligustilide were transported across a model BBB. After i.g. administration of Shunaoxin pills, ferulic acid and ligustilide were rapidly absorbed and distributed in brain; this may lead to rapid pharmacological onset. The IVIVC can be used to predict in vivo

  1. Improved Design and Fabrication of Hydrated-Salt Pills

    Science.gov (United States)

    Shirron, Peter J.; DiPirro, Michael J.; Canavan, Edgar R.

    2011-01-01

    A high-performance design, and fabrication and growth processes to implement the design, have been devised for encapsulating a hydrated salt in a container that both protects the salt and provides thermal conductance between the salt and the environment surrounding the container. The unitary salt/container structure is known in the art as a salt pill. In the original application of the present design and processes, the salt is, more specifically, a hydrated paramagnetic salt, for use as a refrigerant in a very-low-temperature adiabatic demagnetization refrigerator (ADR). The design and process can also be applied, with modifications, to other hydrated salts. Hydrated paramagnetic salts have long been used in ADRs because they have the desired magnetic properties at low temperatures. They also have some properties, disadvantageous for ADRs, that dictate the kind of enclosures in which they must be housed: Being hydrated, they lose water if exposed to less than 100-percent relative humidity. Because any dehydration compromises their magnetic properties, salts used in ADRs must be sealed in hermetic containers. Because they have relatively poor thermal conductivities in the temperature range of interest (<0.1 K), integral thermal buses are needed as means of efficiently transferring heat to and from the salts during refrigeration cycles. A thermal bus is typically made from a high-thermal-conductivity met al (such as copper or gold), and the salt is configured to make intimate thermal contact with the metal. Commonly in current practice (and in the present design), the thermal bus includes a matrix of wires or rods, and the salt is grown onto this matrix. The density and spacing of the conductors depend on the heat fluxes that must be accommodated during operation.

  2. A comparison of second and third generations combined oral contraceptive pills' effect on mood.

    Science.gov (United States)

    Shahnazi, Mahnaz; Farshbaf Khalili, Azizeh; Ranjbar Kochaksaraei, Fatemeh; Asghari Jafarabadi, Mohammad; Gaza Banoi, Kamal; Nahaee, Jila; Bayati Payan, Somayeh

    2014-08-01

    Most women taking combined oral contraceptives (COCs) are satisfied with their contraceptive method. However, one of the most common reasons reported for discontinuation of combined oral contraceptives (COCs) is mood deterioration. This study aimed to compare effects of the second and third generation oral contraceptive pills on the mood of reproductive women. This randomized, double-blind, controlled clinical trial was conducted in reproductive women at health centers in Tehran, Iran. Participants were randomized into the second and third generation oral contraceptive groups. Positive and negative moods were recorded using positive affect, negative affect scale (PANAS) tools at the end the second and fourth months of the study. Data analysis was carried out using ANOVA and P Values pills. The second generation oral contraceptive pills resulted in a decrease in positive mood (95% CI: 43.39 to 38.32 in second month and 43.39 to 26.05 in four month) and increase in negative mood (95% CI: 14.23 to 22.04 in second month and 14.23 to 32.26 in four month - P pills have a better effect on mood in women in reproductive ages than the second generation pills. It can be recommended as a proper combined oral contraceptive in Iran.

  3. The Optimizing Strategies for Prescription of Sleeping Pills for Insomnia Patients

    Directory of Open Access Journals (Sweden)

    Seockhoon Chung

    2017-06-01

    Full Text Available Many patients claim that they cannot sleep well despite ingestion of sleeping pills. In such cases, the physician should explore the reason why sleep disturbance persisted in patients despite administration of sleeping pills. We should consider patients’ age, gender, medical or psychiatric diseases, workplace, or sleep environment that may influence patients’ sleep and satisfaction with their hypnotics. However, prior to prescribing a hypnotic agent for patients with sleep disturbance, good sleep hygiene education should be provided first. Cognitive-behavioral therapy for insomnia is an important and effective treatment modality to improve patients’ sleep quality and reduce dosage of sleeping pills, but it is not easy for most general practitioners to learn and practice this modality. Therefore, we need to consider how to optimize the prescription of hypnotics for treating insomnia in order to prescribe hypnotics safely and appropriately at the lowest dosage. Physician should consider the mechanism of action of each hypnotic agent and prescribe proper hypnotics according to patients’ comorbid illness, insomnia types, or other underlying sleep disorders. Also, we should instruct the patients about when they should take their sleeping pills and we should monitor whether they have followed the instructions or not. Hospitalized patients are in a different sleep environment compared to outpatients, and therefore, we should also prepare modified management strategies for inpatients. In this review, strategies for optimizing the prescription of sleeping pills for insomnia patients will be discussed.

  4. The effect of Delaware law on firm value: Evidence from poison pill adoptions

    Directory of Open Access Journals (Sweden)

    Terry L. Campbell II

    2010-07-01

    Full Text Available As the leading location for firm incorporations and corporate law, Delaware occupies a unique place in corporate governance and control. In this paper, we provide fresh evidence on whether Delaware’s dominance arises from its takeover laws being in the best interest of shareholders versus managers by investigating the role of the state in which a firm is incorporated on the firm’s adoption of a poison pill. Our results indicate that announcements of adoptions of poison pills by Delaware firms are associated with returns not significantly different from those for non-Delaware firms. Moreover, Delaware firms that adopt poison pills are no more likely to receive a takeover bid, be successfully acquired, or receive better merger terms than non-Delaware firms. Overall, it appears that Delaware law, with regards to takeovers, promotes an environment consistent with a “race to the middle” philosophy, neutral to management and shareholders.

  5. Feminism, biomedicine and the 'reproductive destiny' of women in clinical texts on the birth control pill.

    Science.gov (United States)

    Carson, Andrea

    2018-07-01

    The birth control pill is one of the most popular forms of contraception in North America and has been a key player in women's rights activism for over 50 years. In this paper, I conduct a feminist deconstructive analysis of 12 biomedical texts on the birth control pill, published between 1965 and 2016. This study is situated amongst the feminist scholarship that challenges the representation of women's bodies in biomedicine. Findings suggest that clinical texts on the birth control pill continue to universalise women's lives and experiences, and essentialise them based on their reproductive capacities. One way the texts accomplish this is by making women absent or passive in the literature thereby losing concern for the diversity of their lives, interpretations and identities as more than reproductive beings. The consequence of such representations is that biomedical texts disseminate limited forms of knowledge, in particular concerning definitions of 'natural' and 'normal' behaviour, with important consequences for the embodied experiences of women.

  6. The expected and unexpected benefits of dispensing the exact number of pills.

    Science.gov (United States)

    Treibich, Carole; Lescher, Sabine; Sagaon-Teyssier, Luis; Ventelou, Bruno

    2017-01-01

    From November 2014 to November 2015, an experiment in French community pharmacies replaced traditional pre-packed boxes by per-unit dispensing of pills in the exact numbers prescribed, for 14 antibiotics. A cluster randomised control trial was carried out in 100 pharmacies. 75 pharmacies counted out the medication by units (experimental group), the other 25 providing the treatment in the existing pharmaceutical company boxes (control group). Data on patients under the two arms were compared to assess the environmental, economic and health effects of this change in drug dispensing. In particular, adherence was measured indirectly by comparing the number of pills left at the end of the prescribed treatment. Out of the 1185 patients included during 3 sessions of 4 consecutive weeks each, 907 patients experimented the personalized delivery and 278 were assigned to the control group, consistent with a 1/3 randomization-rate at the pharmacy level. 80% of eligible patients approved of the per-unit dispensing of their treatment. The initial packaging of the drugs did not match with the prescription in 60% of cases and per-unit dispensing reduced by 10% the number of pills supplied. 13.1% of patients declared that they threw away pills residuals instead of recycling-no differences between groups. Finally, per-unit dispensing appeared to improve adherence to antibiotic treatment (marginal effect 0.21, IC 95, 0.14-0.28). Supplying antibiotics per unit is not only beneficial in terms of a reduced number of pills to reimburse or for the environment (less pills wasted and non-recycled), but also has a positive and unexpected impact on adherence to treatment, and thus on both individual and public health.

  7. BZP-party pills: a review of research on benzylpiperazine as a recreational drug.

    Science.gov (United States)

    Cohen, Bruce M Z; Butler, Rachael

    2011-03-01

    BZP-party pills are yet another 'designer drug' which mimics the stimulant qualities of amphetamines and MDMA/Ecstasy. As legal markets for the substance have developed in the last decade (especially amongst young people) so has public and governmental concern. This article provides a summary of the available international research on benzylpiperazine (BZP) and its popular use in the compound form known as 'party pills'. Through performing an analysis of the available medical and social scientific literature, the review outlines current knowledge on the compound, the prevalence of usage of BZP-party pills, as well as the associated harms, risks and rationales for use of the drug. Despite moves towards legislative control of BZP-party pills, the evidence presented suggests limited social and health harms associated with the drug, although research on long term effects is a significant gap in the literature. It also remains inconclusive as to whether BZP-party pills act as a 'gateway' to illegal drugs or, conversely, play a role in harm reduction with illegal drug users turning to legal alternatives; there is some evidence for both positions. With increasing controls of BZP-party pills, and with the increasing numbers of 'legal highs' and new designer drugs on the market, we conclude that new legal alternatives will continue to surface to replace the drug in the future. Considering a harm reduction approach to drug taking, it is suggested that policy makers consider the creation of a legal holding category which restricts and regulates the market in legal highs whilst the social and health harms associated with each drug can be thoroughly investigated. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. [Effects of shoutai pills on expression of Th1/Th2 cytokine in maternal-fetal interface and pregnancy outcome].

    Science.gov (United States)

    Lai, Maohua; You, Zhaoling; Ma, Hongxia; Lei, Lei; Lu, Fangguo; He, Dongmei; Liu, Huiping; Yin, Sheng

    2010-11-01

    To evaluate its mechanism of inducing the maternal-fetal immune tolerance by studying the effects of Shoutai pills on the expression of Th1/Th2 cytokine and pregnancy in maternal-fetal interface of mice with recurrent spontaneous abortion (RSA). The normal pregnancy and RSA model were respectively induced with CBA/J x BALB/c and CBA/J x DBA/2. The mice with RSA were randomly divided into model group and low, middle and high dose groups of Shoutai pills. The mice were killed in 14 days after administration and embryo resorption rate was counted and their decidual and placental tissues were co-cultured to detect the expressions of IL-4, IL-10, IFN-gamma and TNF-alpha with ELISA. The embryo resorption rate of the model group was significantly higher than the normal pregnancy, middle and high dose groups of Shoutai pills could decreased the embryo resorption rate of the mice with RSA (P pills could decreased the expression of IFN-gamma and TNF-alpha (P pills. Middle and high doses of Shoutai pills could increased the expression of IL-4 and IL-10 (P pills. The mechanism about Shoutai pills can change Th1 /Th2 cytokine towards Th2 bias, which induced the maternal-fetal immune tolerance.

  9. Emergency contraceptive pills: Exploring the knowledge and attitudes of community health workers in a developing Muslim country.

    Science.gov (United States)

    Mir, Azeem Sultan; Malik, Raees

    2010-08-01

    Unsafe abortion is a major Public health problem in developing countries, where women make several unsafe attempts at termination of the unintended pregnancy before turning to health services. Community health workers can act as a bridge between the community and their health facilities and can use Emergency Contraceptive Pills to significantly reduce the mortality and morbidity related to unsafe abortions. This study explores the knowledge, attitudes and practices of the Lady Health Supervisor of the National Program for Family Planning, district Rawalpindi, regarding emergency contraception pills. The cross sectional survey was conducted during the monthly meeting of Lady Health Supervisors. Self administered, anonymous and voluntary questionnaire consisting of 17 items, regarding demographic profile, awareness, knowledge, attitudes and practices, was used. Insufficient knowledge, high misinformation and strongly negative attitudes were revealed. More than half did not know that emergency contraceptive pills do not cause abortion. About four fifths believed that emergency contraceptive pills will lead to 'evil' practices in society. More than four fifths recognized that the clients of National Program for Family Planning need emergency contraceptive pills. The attitudes were significantly associated with knowledge (P=0.034, Fisher's Exact Test). The awareness of emergency contraceptive pills is high. Serious gaps in knowledge have been identified. There is a clear recognition of the need of emergency contraceptive pills for the clients of National Program for Family Planning. However, any strategy to introduce emergency contraceptive pills must cater for the misplaced beliefs of the work force.

  10. New low-dose, extended-cycle pills with levonorgestrel and ethinyl estradiol: an evolutionary step in birth control.

    Science.gov (United States)

    Nelson, Anita

    2010-08-09

    To review milestones in development of oral contraceptive pills since their introduction in the US 50 years ago in order to better understand how a new formulation with low-dose estrogen in an extended-cycle pattern fits into the evolution of birth control pills. This is a review of trends in the development of various birth controls pills and includes data from phase III clinical trials for this new formulation. The first birth control pill was a very high-dose monophasic formulation with the prodrug estrogen mestranol and a first-generation progestin. Over the decades, the doses of hormones have been markedly reduced, and a new estrogen and several different progestins were developed and used in different dosing patterns. The final element to undergo change was the 7-day pill-free interval. Many of these same changes have been made in the development of extended-cycle pill formulation. The newest extended-cycle oral contraceptive formulation with 84 active pills, each containing 20 μg ethinyl estradiol and 100 μg levonorgestrel, represents an important evolution in birth control that incorporates lower doses of estrogen (to reduce side effects and possibly reduce risk of thrombosis), fewer scheduled bleeding episodes (to meet women's desires for fewer and shorter menses) and the use of low-dose estrogen in place of placebo pills (to reduce the number of days of unscheduled spotting and bleeding). Hopefully, this unique formation will motivate women to be more successful contraceptors.

  11. Kino Kosmos Imax restaureerimine = Restoration of the Kino Kosmos as an Imax cinema / Pille Lausmäe

    Index Scriptorium Estoniae

    Lausmäe, Pille, 1958-

    2015-01-01

    Kino Kosmos Imax Tallinnas Pärnu mnt 45, hoone valminud 1964, restaureeritud 2014. Hoone arhitekt Ilmar Laasi, restaureerimisprojekt Urmas Lõokese Arhitektibüroo, sisearhitektid Kerli Lepp, Pille Lausmäe (Pille Lausmäe Sisearhitektuuribüroo). 2014. aasta Kultuurkapitali Arhitektuuripreemia kandidaat

  12. Study on the effect of Huo Xue Bo Gu Pill on secretion of endogenous bFGF after fracture

    International Nuclear Information System (INIS)

    Li Qiang; Wang Xiping; Guo E; Ye Liyan; Liu Yingjie

    2006-01-01

    Objective: To study the effect of a Chinese traditional preparation Huo Xue Bo Gu Pill on the serum contents of basic fibroblast growth factor (bFGF) after forearm fractures. Method: Serum bFGF contents were measured (with ELISA) in 62 patients with forearm fractures on d1, d8, d14 and d20 after the accident. Thirty-two of the patients were treated with Huo Xue Bo Gu Pills and thirty patients were not. Results: The serum contents of bFGF on d8 and d14 were significantly higher in the patients treated with the pills than those in patients not treated with the pills (P<0.05). Conclusion: This pill could promote the secretion of endogenous bFGF with proliferation of capillaries at the fracture site. (authors)

  13. Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study.

    Science.gov (United States)

    Chai, Peter R; Carreiro, Stephanie; Innes, Brendan J; Rosen, Rochelle K; O'Cleirigh, Conall; Mayer, Kenneth H; Boyer, Edward W

    2017-01-13

    Nonadherence to prescribed regimens for opioid analgesic agents contributes to increasing opioid abuse and overdose death. Opioids are frequently prescribed on an as-needed basis, placing the responsibility to determine opioid dose and frequency with the patient. There is wide variability in physician prescribing patterns because of the lack of data describing how patients actually use as-needed opioid analgesics. Digital pill systems have a radiofrequency emitter that directly measures medication ingestion events, and they provide an opportunity to discover the dose, timing, and duration of opioid therapy. The purpose of this study was to determine the feasibility of a novel digital pill system to measure as-needed opioid ingestion patterns in patients discharged from the emergency department (ED) after an acute bony fracture. We used a digital pill with individuals who presented to a teaching hospital ED with an acute extremity fracture. The digital pill consisted of a digital radiofrequency emitter within a standard gelatin capsule that encapsulated an oxycodone tablet. When ingested, the gastric chloride ion gradient activated the digital pill, transmitting a radiofrequency signal that was received by a hip-worn receiver, which then transmitted the ingestion data to a cloud-based server. After a brief, hands-on training session in the ED, study participants were discharged home and used the digital pill system to ingest oxycodone prescribed as needed for pain for one week. We conducted pill counts to verify digital pill data and open-ended interviews with participants at their follow-up appointment with orthopedics or at one week after enrollment in the study to determine the knowledge, attitudes, beliefs, and practices regarding digital pills. We analyzed open-ended interviews using applied thematic analysis. We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants reported being able to operate all

  14. Providing innovative solutions in a single pill: Servier's portfolio in hypertension.

    Science.gov (United States)

    Mourad, Jean-Jacques; Guillerm, Jean-Christophe

    2016-09-01

    Jean-Jacques Mourad & Jean-Christophe Guillerm speak to Henry Ireland, Drug Evaluation Editor: Jean-Jacques Mourad talks about his vision of the current landscape and unmet medical needs in the field of hypertension. Jean-Christophe Guillerm describes the family of antihypertensive treatments from Servier, which were designed to address the current challenges in the management of hypertension by providing an adapted solution to doctors and to the specific needs of each patient. Jean-Jacques Mourad currently works as Professor of Medicine and is the Head of the Hypertension Unit at the Hôpital Avicenne in Bobigny, France. He completed his academic degrees at the Pierre and Marie Curie University, Paris VI in the field of internal and vascular medicine in 1996, and in the area of cardiovascular medicine and pharmacology in 2001. He is the past president of the French League Against Hypertension (since 2012), and the former General Secretary of the French Microcirculation Society. He is the actual Scientific Secretary of the French Society of Hypertension. He is also a member of the administrative council of the Collège Français de Pathologie Vasculaire. His research focuses on the epidemiology of hypertension, arterial structure and function, determinants of adherence to chronic treatment and the effects of antihypertensive agents. He was involved in several studies and surveys. He is a co-author of more than 130 publications and of 900 communications presented at national and international meetings. Jean-Christophe Guillerm, joined the pharmaceutical industry 17 years ago. He is currently the Head of the Cardiovascular Division for Servier, in charge of both cardiology and hypertension's medical strategy at a global level. Prior to this, he was in charge of the diabetes and internal medicine franchise at a global level. He also has experience in French commercial operations.

  15. Effect of Qianggan Pills combined with antiviral treatment on the fibrosis indexes, immune and inflammatory response in patients with compensated hepatitis b cirrhosis

    Directory of Open Access Journals (Sweden)

    Hong-Gang Huang

    2017-04-01

    Full Text Available Objective: To study the effect of Qianggan Pills combined with antiviral treatment on the fibrosis indexes, immune and inflammatory response in patients with compensated hepatitis b cirrhosis. Methods: A total of 88 patients with compensated hepatitis b cirrhosis treated in our hospital between April 2013 and March 2016 were collected and divided into observation group and control group according to single blind randomized control. Observation group of patients accepted Qianggan Pills combined with antiviral treatment and control group of patients received antiviral treatment alone. After 6 months of treatment, chemiluminescence method was used to detect serum fibrosis indexes, flow cytometer was used to detect peripheral blood T lymphocyte subset levels, and enzyme-linked immunosorbent assay (ELISA was used to detect serum levels of inflammatory factors. Results: Before treatment, differences in fibrosis indexes, immune and inflammatory response indexes were not statistically significant between two groups of patients; after 6 months of treatment, serum LN, HA and Ⅳ-C levels of observation group were lower than those of control group, peripheral blood CD3+ and CD4+ T lymphocyte levels as well as CD4+/CD8+ ratio were higher than those of control group, and CD8+ T lymphocyte level was lower than that of control group; serum PCT and CRP levels were lower than those of control group while IL-10 and IL-13 levels were higher than those of control group. Conclusion: Qianggan Pills combined with antiviral treatment can inhibit the fibrosis process, strengthen the body's immune function and also relieve systemic inflammatory response in patients with compensated hepatitis b cirrhosis.

  16. Multi-constituent cardiovascular pills (MCCP)--challenges and promises of population-based prophylactic drug therapy for prevention of heart attack.

    Science.gov (United States)

    Jamieson, Michael J; Naghavi, Morteza

    2007-01-01

    Risk factors for atherosclerotic cardiovascular disease (CVD) are highly co-prevalent but poorly identified and treated. The Screening for Heart Attack Prevention and Education (SHAPE) Task Force from the Association for Eradication of Heart Attack (AEHA) has recently proposed a new strategy that recommends screening for subclinical atherosclerosis and implementing aggressive treatment of "vulnerable patients". The Task Force has also envisioned future developments that may shift mass screening strategies to mass prophylactic therapy. The "Polypill" concept, introduced by Wald and Law suggests a combination of statin, low-dose antihypertensives, aspirin and folic acid, in a single pill, taken prophylactically by high risk population can cut CVD event rates by as much as 80%. In this communication, we review the challenges and promises of such a strategy. "Polypill" is but one of an astronomical number of possible multiconstituent pills (MCCP). Attractive as the MCCP concept is, it lacks evidence from randomized controlled trials, and begs numerous questions about the credibility of the concept, the design and synthesis of such complex pills, pharmacokinetics, pharmacodynamics, bioequivalence, "class" vs. unique properties, interactions, evidence of clinical efficacy and safety, regulatory approval, post-marketing surveillance, prescription vs. over-the-counter use, responsibility for initiating and monitoring therapy, patient education, counterfeiting and importation, reimbursement, advertisement, patent protection, commercial viability, etc. If these issues are favorably addressed, MCCP stand to dramatically change the manner in which CVD is prevented particularly in developing societies. Notwithstanding, assuming low commercial interests, realizing the promises of MCCP will demand serious attention from national public health policymakers. The clinical and regulatory implications of population-based secondary prevention (which rely on a different evidence base

  17. Diet Pills, Powders, and Liquids: Predictors of Use by Healthy Weight Females

    Science.gov (United States)

    Thorlton, Janet; Park, Chang; Hughes, Tonda

    2014-01-01

    About 35% of healthy weight adolescent females describe themselves as overweight, and 66% report planning to lose weight. Body weight dissatisfaction is associated with unhealthy weight loss practices including diet pill/powder/liquid (PPL) use. Few studies have examined diet PPL use in healthy weight adolescent females; therefore, Youth Risk…

  18. Biochemical composition of two giant pill-millipedes of the Western Ghats of India

    Directory of Open Access Journals (Sweden)

    Ambarish Cheviri N.

    2015-12-01

    Full Text Available Many invertebrates have an unexpected nutraceutical potential and are of nutritional or ethnomedicinal significance to many tribals throughout the world. The giant pill-millipedes of the genus Arthrosphaera are traditionally used as natural medicines by tribals in the Western Ghats of India. In this study, two species of pill-millipedes (Arthrosphaera fumosa and A. magna were subjected to proximate and biochemical analysis to ascertain their nutritional potential. Bodies of A. fumosa and A. magna (after removal of their intestines had a low protein content (8-15% and high quantity of carbohydrates (40-41%. They were rich in many essential elements, especially in calcium. The essential amino acids of pillmillipedes were in high quantities. The level of glycine was the highest, followed by lysine and serine. The fatty acid methyl esters (FAMEs of males and females consist of high quantities of unsaturated fatty acids. The mono-unsaturated fatty acids were more abundant than poly-unsaturated fatty acids. Palmitic and oleic acids were dominant saturated and unsaturated fatty acids, respectively. The study has revealed for the first time that pill-millipedes of the Western Ghats of India constitute a good source of essential minerals, essential fatty acids, and essential amino acids. Being valuable contributors of organic manure by processing recalcitrant plant lignocellulosic wastes, pill-millipedes become part and parcel of organic farming as well as future nutraceutical sources.

  19. How to illustrate science - a lesson from the 1970s / Pille-Triin Männik

    Index Scriptorium Estoniae

    Männik, Pille-Triin

    2006-01-01

    Tallinna IV rakenduskunsti triennaali Pille-Riin Männiku ja Anneli Porri kureeritud satelliitnäitusest "Teadus ja tänapäev" A-galeriis, Draakoni galeriis ja Hobusepea galeriis. Suure osa näitusest moodustavad Tõnis Vindi illustratsioonid 1979. a. ilmunud Juhan Kivi raamatule "Teadus ja tänapäev". Fotod Ene Kull

  20. [Qilin Pills for idiopathic oligoasthenospermia: A multi-centered randomized double-blind controlled clinical trial].

    Science.gov (United States)

    Mao, Jia-Ming; Jiang, Hui; Wang, Chuan-Hang; Ning, Ke-Qin; Liu, Ji-Hong; Yang, Shu-Wen; Li, Hai-Song; Zhou, Shao-Hu; Zhang, Zhi-Chao; Xu, Ji-Xiu; Huang, Yong-Han

    2017-03-01

    To evaluate the clinical efficacy and safety of Qilin Pills in the treatment of oligoasthenospermia in infertile men. This multi-centered randomized double-blind controlled clinical trial included 216 infertile males with oligoasthenospermia, 108 in the trial group and the other 108 in the control, the former treated with Qilin Pills at the dose of 6 g tid while the latter with Wuziyanzong Pills at 6 g bid, both for 12 weeks. We examined the total sperm count, sperm motility and the count of progressively motile sperm of the patients before and at 4, 8 and 12 weeks after medication and evaluated the safety of the drug based on the adverse events and the laboratory results of blood and urine routine examinations and liver and kidney function tests. Compared with the baseline, the patients in the trial group showed a significant time-dependent improvement after 4, 8 and 12 weeks of medication in sperm motility (21.75% vs 27.54%, 29.04% and 32.95%, P Pills can evidently improve the semen quality of oligoasthenospermia patients with no obvious adverse events.

  1. The Administration of Tibetan Precious Pills: Efficacy in Historical and Ritual Contexts.

    Science.gov (United States)

    Czaja, Olaf

    2015-01-01

    Precious pills represent a special kind of Tibetan drug that once was, and still is, highly sought after by Tibetan, Chinese, and Mongolian patients. Such pills are generally taken as a potent prophylactic remedy, and can be used to cure various diseases. The present study seeks to discuss the dispensation and efficacy of precious pills according to the presentations of historical Tibetan medical scholars. Several treatises dealing with these instructions will be analysed, thereby revealing their underlying concepts, and highlighting their points of both general consensus and disagreement. The analysis of these detailed instructions will reveal the fact that these precious pills were not merely given to a patient but, in order to ensure their full efficacy, involved an elaborate regimen concerning three chronological periods: (1) the time of preparation, (2) the time of dispensation, and (3) the time after dispensation. Thus the present study surveys not only the ritual empowerment of drugs in Tibetan medicine, but also the importance of social relationships between doctors and patients in Tibetan medical history.

  2. [Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills].

    Science.gov (United States)

    Nie, Li-Xing; Zhang, Ye; Zhang, Nan-Ping; Hu, Xiao-Ru; Kang, Shuai; Hou, Jian-Zhong; Dai, Zhong; Ma, Shuang-Cheng

    2016-10-01

    Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First, microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma, Saigae Tataricae Cornu, Cinnamomi Cortex and Saposhnikoviae Radix. Finally, microscopic spectroscopy was used for test of Dioscoreae Rhizoma's adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate, simple, rapid, objective and economic, which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny. Copyright© by the Chinese Pharmaceutical Association.

  3. The Role of Liuwei Dihuang Pills and Ginkgo Leaf Tablets in Treating Diabetic Complications

    Directory of Open Access Journals (Sweden)

    Yue Zhao

    2016-01-01

    Full Text Available Objective. To observe the clinical prophylactic and therapeutic efficacy of Liuwei Dihuang Pills and Ginkgo Leaf Tablets for type 2 diabetic vascular complications. Methods. It was a randomized, double-blind and placebo-controlled clinical trial. 140 outpatients with type 2 diabetes were recruited and randomly divided into the treatment group and control group. The two groups were given basic therapy (management of blood sugar, blood pressure, etc.. Additionally, the treatment group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets, while the control group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets placebos. All subjects were followed up for consecutive 36 months and observed monthly. The clinical data as urinary microalbumin to urinary creatinine ratio (Umalb/cr, carotid intima-media thickness (IMT, diabetic nephropathy (DN and diabetic retinopathy (DR prevalence, cardiovascular and cerebrovascular events, blood glucose, and blood pressure were collected and analyzed statistically. Results. After 36-month treatment, the Umalb/cr level and DN and DR prevalence in treatment group were all significantly lower than control group (P0.05. Conclusions. Liuwei Dihuang Pills and Ginkgo Leaf Tablets are beneficial to diabetic microvascular complications, while the efficacy to diabetic macrovascular complications needs more observations.

  4. The Role of Liuwei Dihuang Pills and Ginkgo Leaf Tablets in Treating Diabetic Complications.

    Science.gov (United States)

    Zhao, Yue; Yu, Jiangyi; Liu, Jingshun; An, Xiaofei

    2016-01-01

    Objective. To observe the clinical prophylactic and therapeutic efficacy of Liuwei Dihuang Pills and Ginkgo Leaf Tablets for type 2 diabetic vascular complications. Methods. It was a randomized, double-blind and placebo-controlled clinical trial. 140 outpatients with type 2 diabetes were recruited and randomly divided into the treatment group and control group. The two groups were given basic therapy (management of blood sugar, blood pressure, etc.). Additionally, the treatment group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets, while the control group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets placebos. All subjects were followed up for consecutive 36 months and observed monthly. The clinical data as urinary microalbumin to urinary creatinine ratio (Umalb/cr), carotid intima-media thickness (IMT), diabetic nephropathy (DN) and diabetic retinopathy (DR) prevalence, cardiovascular and cerebrovascular events, blood glucose, and blood pressure were collected and analyzed statistically. Results. After 36-month treatment, the Umalb/cr level and DN and DR prevalence in treatment group were all significantly lower than control group ( P 0.05). Conclusions. Liuwei Dihuang Pills and Ginkgo Leaf Tablets are beneficial to diabetic microvascular complications, while the efficacy to diabetic macrovascular complications needs more observations.

  5. [Optimize dropping process of Ginkgo biloba dropping pills by using design space approach].

    Science.gov (United States)

    Shen, Ji-Chen; Wang, Qing-Qing; Chen, An; Pan, Fang-Lai; Gong, Xing-Chu; Qu, Hai-Bin

    2017-07-01

    In this paper, a design space approach was applied to optimize the dropping process of Ginkgo biloba dropping pills. Firstly, potential critical process parameters and potential process critical quality attributes were determined through literature research and pre-experiments. Secondly, experiments were carried out according to Box-Behnken design. Then the critical process parameters and critical quality attributes were determined based on the experimental results. Thirdly, second-order polynomial models were used to describe the quantitative relationships between critical process parameters and critical quality attributes. Finally, a probability-based design space was calculated and verified. The verification results showed that efficient production of Ginkgo biloba dropping pills can be guaranteed by operating within the design space parameters. The recommended operation ranges for the critical dropping process parameters of Ginkgo biloba dropping pills were as follows: dropping distance of 5.5-6.7 cm, and dropping speed of 59-60 drops per minute, providing a reference for industrial production of Ginkgo biloba dropping pills. Copyright© by the Chinese Pharmaceutical Association.

  6. Rein Pill võitis Venemaal kõrgetasemelise võistluse / Maarja Värv

    Index Scriptorium Estoniae

    Värv, Maarja

    2008-01-01

    Ratsutaja Rein Pill tegi Venemaal Tsherjahovskis CS14* taseme rahvusvahelistel ratsutamise takistussõiduvõistlustel ajalugu, võites hobusel A Big Boy võistluste Grand Prix' 160 cm kõrgusel parkuuril ja täites seega Euroopa meistrivõistluste kvalifikatsiooninormi

  7. Birthing the Pill at the University of Vermont (1970-1976)

    Science.gov (United States)

    Christmas, William A.; Schultz, J. Donald

    2008-01-01

    The introduction of the birth control pill in 1960 precipitated 2 decades of intense social change in the United States, particularly in the area of sexuality. Colleges and universities were not immune to these changes. The author examines the struggles at 1 land-grant university to find common ground on this issue among students, faculty,…

  8. Why Did My Doctor Prescribe Birth Control Pills for My Acne?

    Science.gov (United States)

    ... Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol School & Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español Why Did My Doctor Prescribe Birth Control Pills for My Acne? KidsHealth / For Teens / Why ...

  9. Successful treatment of pill-swallowing difficulties with head posture practice.

    Science.gov (United States)

    Kaplan, Bonnie J; Steiger, Roberta A; Pope, Jamie; Marsh, Ashley; Sharp, Maegan; Crawford, Susan G

    2010-05-01

    Clinics often encounter neurologically intact patients who are unable to swallow pills. All of the interventions published previously have used traditional behavioural techniques, which are time consuming and often not helpful. To determine whether children who had never been able to swallow a whole pill could become successful as a result of an intervention based on head posture. A novel intervention was developed based on published research showing that changing head position alters swallowing dynamics. The method was developed in two studies of 240 adults and children, pilot tested in a study of 108 university students with very mild pill-swallowing discomfort, and then evaluated in a study of 41 children who had never successfully swallowed a pill in spite of much instruction and coaxing. Children were recruited from a tertiary paediatric hospital: 34 were clinic patients, four were their siblings or friends, and three were children of hospital staff. The primary intervention involved teaching five head positions (centre, up, down, left and right) followed by a two-week period of daily practice. EIGHT CHILDREN (ALL CLINIC REFERRALS) WITHDREW WITHOUT PRACTICING: four were too ill to practice (primarily due to sedation or nausea) and four simply refused to do the homework practice. All 33 of the children who were able and willing to practice daily were successful. Practice with head posture variations was successful in treating pill-swallowing difficulties in all 33 children who practiced for 14 days. A training video can be viewed at www.ucalgary.ca/research4kids/pillswallowing.

  10. Evaluating the practice of Iranian community pharmacists regarding oral contraceptive pills using simulated patients.

    Science.gov (United States)

    Foroutan, Nazanin; Dabaghzadeh, Fatemeh

    2016-01-01

    As oral contraceptive pills are available over the counter in pharmacies, pharmacists are professionally responsible for checking and informing patients about every aspect of taking these drugs. Simulated patient method is a new and robust way to evaluate professional performance of pharmacists. The aim of the present study was to evaluate the pharmacy practice of Iranian pharmacists regarding over-the-counter use of oral contraceptive pills using simulated patient method. Simulated patients visited pharmacy with a prescription containing ciprofloxacin and asked for oral contraceptive pills. The pharmacist was expected to ask important questions for using these drugs and to inform the patient about them properly. Moreover, the Pharmacists should advise patients in regard to the possible interaction. Ninety four pharmacists participated in this study. In 24 (25.3%) visits, the liable pharmacist was not present at the time of purchase. Furthermore, In 13 (18.57 %) visits by the simulated patients, the liable pharmacists did not pay any attention to the simulated patients even when they asked for consultation. Twenty nine (41.43%) pharmacists did not ask any question during dispensing. Nausea was the most frequent described side effect by pharmacists (27 (38.57%)). Yet important adverse effects of oral contraceptive pills were not mentioned by the pharmacists except for few ones. Only twelve (17.14%) pharmacists mentioned the possible interaction. There was a significant relation between the pharmacists' gender and detection of possible interaction (p value= 0.048). The quality of the pharmacists' consultations regarding the over the counter use of oral contraceptive pills was not satisfactory and required improvement.

  11. Modal analysis of wake fields and its application to elliptical pill-box cavity with finite aperture

    International Nuclear Information System (INIS)

    Kim, S.H.; Chen, K.W.; Yang, J.S.

    1990-01-01

    The potential of the wake-field produced by a bunch of relativistic charged particles passing through a pill-box cavity is expressed by using Floquet's theorem, and an obvious requirement that the energy gain over all acceleration cavity of many pill boxes must be proportional to the number of pill boxes, based on the previous modal approach (BWW theory). It is found that the wake-field is consisted of two classes of modes: the longitudinal modes which are independent of the aperture and the pill-box gap, the hybrid (pill-box) modes which are dependent of the pill-box gap. The wake field is predominated by the fundamental longitudinal mode whose wavelength is on the order of the effective diameter of the cavity, and its magnitude is inversely proportional to the cross sectional area of the cavity for practical cavities with small apertures. Both longitudinal and transverse wake fields due to the longitudinal modes in an elliptical pill box cavity are expressed analytically in a closed series form by solving exactly the longitudinal eigenmode equation in the elliptical cylindrical coordinates in terms of Mathieu functions. It is found that both longitudinal and transverse wake fields whose amplitudes per driving charge are greater than 100 MV/m/μC can be generated in an elliptical cavity

  12. SmartPill® as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study).

    Science.gov (United States)

    Vilz, Tim O; Pantelis, Dimitrios; Lingohr, Philipp; Fimmers, Rolf; Esmann, Anke; Randau, Thomas; Kalff, Jörg C; Coenen, Martin; Wehner, Sven

    2016-07-08

    Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill(®), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill(®) immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking. The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill(®) will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill(®) in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill(®) to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill(®) will be analysed. The protocol was approved by the federal authority (94

  13. Fatigue and Use of Go/Nogo Pills in F-16 Pilots Subjected to Extraordinarily Long Combat Sorties

    National Research Council Canada - National Science Library

    Schultz, Darlene

    2004-01-01

    We lack knowledge of real world pilot fatigue and use of GO/NOGO pills. To analyze this, a forward-deployed flight surgeon studied fighter pilots subjected to combat sorties often longer than 8 hours in duration. Methods...

  14. Muusajüngrid pühitsesid Kreutzwaldi 200. sünnipäeva / Toomas Pill

    Index Scriptorium Estoniae

    Pill, Toomas

    2004-01-01

    13. dets. 2003 Sydneys toimunud tähtpäevaüritusel esines Toomas Pill referaadiga "Kalevipoja" retseptsioonist, loeti ette katkendeid Kreutzwaldi ja Koidula kirjavahetusest ning deklameeriti Heidi Aedma poolt valitud katkendeid "Kalevipojast"

  15. The comparative study of side effect of the two kinds of LD combined oral contraceptive pills containing Norgestimate and Levonorgestrel

    Directory of Open Access Journals (Sweden)

    Ghazizade Sh

    1998-05-01

    Full Text Available In order to compare the new generation of oral contraceptive pills containing Norgestimate (NGM with currently available pills containing levonorgestrel (LNG a clinical trial was conducted. 413 women (age 18-35 years with no contrainindication to pill use entered the study and randomly received one type of pills. Premenstrual syndrome and depression were significantly decreased in NGM group (P=0.00016, P=0.005, on the other hand, breast tenderness, mood changes and hair loss were significantly increased in LNG group (P=0.001, P=0.042, P=0.011. Comparing two groups with each other, following variables were significantly lower in NGM group: headache (P<0.05, vertigo (P<0.05, cloasma (P<0.05, acne (P<0.04, depression (P<0.05, appetite change (P<0.03. Overall patient satisfaction was similar in two groups.

  16. Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Levy Juliana

    2010-03-01

    Full Text Available Abstract Aims To determine prospectively the efficacy, tolerability and patient satisfaction of an extended release formulation of metformin (metformin XR in hospital based outpatients with type 2 diabetes mellitus currently treated with standard metformin. Methods Patients on immediate release standard metformin either alone or combined with other oral agents were switched to extended release metformin XR 500 mg tablets and titrated to a maximum dose of 2000 mg/day Measurements to include glucose and lipid control, blood pressure, body weight, waist circumference, C-reactive protein, adverse events and patient satisfaction were recorded at baseline, three and six months. Results Complete data were obtained for 35 of the 61 patients enrolled to the study. At three and six months no changes were reported for any of the cardiovascular risk factors except for lipids where there was a modest rise in plasma triglycerides. These effects were achieved with a reduced dose of metformin XR compared to pre-study dosing with standard metformin (1500 mg +/- 402 vs 1861 +/- 711 p = 0.004. A total of 77% of patients were free of gastrointestinal side effects and 83% of patients stated a preference for metformin XR at the end of the study. Ghost tablets were reported in the faeces by the majority of the patients (54.1%. Conclusions Patients switched to extended release metformin XR derived the same clinical and metabolic benefits as for standard metformin but with reduced dosage, fewer gastrointestinal side effects and a greater sense of well being and satisfaction on medication.

  17. Once-daily glycopyrronium bromide (Seebri Breezhaler(®)) for the treatment of chronic obstructive pulmonary disease (COPD)

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2015-01-01

    INTRODUCTION: Long-acting bronchodilators are the mainstay of pharmacological therapy for patients with chronic obstructive pulmonary disease (COPD). The choice of optimal bronchodilator therapy for COPD is increasingly difficult for clinicians as new treatments are marketed. AREAS COVERED: Inhaled...... glycopyrronium bromide (Seebri Breezhaler®) is a well-tolerated long-acting anti-muscarinic agent (LAMA) with a fast onset of action. In patients with moderate to severe COPD, glycopyrronium bromide has clinically important effects on level of FEV1, use of relief medication, day-time dyspnea scores, and probably...... also on health status. Furthermore, glycopyrronium bromide also has beneficial effects on dynamic hyperinflation and, probably by that, exercise tolerance. Glycopyrronium bromide has been shown to reduce the rate of exacerbations in patients with moderate to severe COPD, although as a secondary outcome...

  18. Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy.

    NARCIS (Netherlands)

    Ananworanich, J.; Gorowara, M.; Avihingsanon, A.; Kerr, S.J.; Heesch, N. van; Khongpetch, C.; Uanithirat, A.; Hill, A.; Ruxrungtham, K.; Burger, D.M.

    2012-01-01

    Because studies showed similar viral suppression with lower raltegravir doses and because Asians usually have high antiretroviral concentrations, we explored low-dose raltegravir therapy in Thais. Nineteen adults on raltegravir at 400 mg twice daily (BID) with HIV RNA loads of <50 copies/ml were

  19. The economics of 4 grams once daily mesalazine dosing compared with 4 grams twice daily in active ulcerative colitis

    NARCIS (Netherlands)

    Connolly, M.; Kuyvenhoven, J.; Postma, M.; Nielsen, S.

    2013-01-01

    Background: Dosing frequency is an important treatment consideration that has been shown to influence adherence and outcomes when treating ulcerative colitis (UC). In this analysis we evaluate the economic consequences of outcome differences observed in the study comparing mesalazine 4g per day once

  20. Tadalafil once daily: Narrative review of a treatment option for female sexual dysfunctions (FSD in midlife and older women

    Directory of Open Access Journals (Sweden)

    Chiara Borghi

    2017-03-01

    Full Text Available Female Sexual Disorders (FSD include a complex, multidimensional, individual experience that can change as an individual age, suggesting that these problems are caused by multiple factors including psychosocial factors, personal relationships, pathologic changes caused by diseases, and pharmacologic influences. Menopause is an important time for middle aged women and postmenopausal physiological changes could have a significant role in the development of FSD. Few is still known about their correct definition and treatment. Their incidence, prevalence and risk factors are difficult to define because of a high level of overlap in the experience of problems with desire, arousal, and orgasm. Little evidences are known about the best therapeutic approach, and both non-pharmacological and pharmacological treatment options have been described. Among these, phosphodiesterase type 5 inhibitors could be an effective option for many subtypes of female sexual disorders, with an improvement in different aspects of sexual function, such as desire, arousal, orgasm and sexual satisfaction. In this paper authors reviewed what is already known about the use of these vasoactive agents, particularly tadalafil, as a treatment option for female sexual disturbances.

  1. Influence of the number of daily pills and doses on adherence to antiretroviral treatment: a 7-year study.

    Science.gov (United States)

    Hernández Arroyo, M J; Cabrera Figueroa, S E; Sepúlveda Correa, R; Valverde Merino, M P; Luna Rodrigo, G; Domínguez-Gil Hurlé, A

    2016-02-01

    Antiretroviral treatment (ART) is hampered by complicated regimens, high pill burden, drug-drug interactions, and frequent short- and long-term adverse effects, leading to decreased adherence. Over recent years, considerable effort has been directed at developing regimens that are less burdening. We undertook a 7-year retrospective study of the records of 264 HIV-infected subjects enrolled in a pharmaceutical care programme to document the progress made and to study the influence of the number of ART pills and doses on the level of treatment adherence. Antiretroviral dispensing records were analysed for the number of pills and doses administered and the ART adherence rate estimated. In 2005, the patients took a mean of 6·2 pills daily (CI 95%: 5·9-6·6), and 92·9% of them were on a twice-a-day (BID) dosage regimen. By 2012, the mean number of pills was reduced to 4·1 (CI 95%: 3·8-4·4), and only 50·9% were on a BID regimen. No statistically significant relation was observed between number of daily pills and doses and ART adherence reached by the patients in any of the analyses performed. There has been a continuous reduction in the number of pills and doses of antiretrovirals taken by individual patients over the last 7 years due largely to the introduction of improved treatments and regimens. More daily pills or doses was not associated with worse ART adherence in our pharmaceutical care programme. © 2015 John Wiley & Sons Ltd.

  2. How can a state control swallowing? The home use of abortion pills in Ireland.

    Science.gov (United States)

    Sheldon, Sally

    2016-11-01

    Evidence suggests that there is widespread home use of abortion pills in Ireland and that ending a pregnancy in this way is potentially safer than the alternatives available to many women. This paper argues that there is a strong case for women with unwanted pregnancies to be offered truthful and objective information regarding the use of abortion pills by trusted local professionals and, further, that this is possible within existing law. A move in this direction would not, however, negate the need for legal reform to address the fundamental moral incoherence of a law that treats women who terminate pregnancies within Ireland as criminals but those who travel to access services overseas as victims in need of support. In support of these arguments, the paper draws on both library research and a small number of interviews with government officials, service providers and activists. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Dragon's blood dropping pills have protective effects on focal cerebral ischemia rats model.

    Science.gov (United States)

    Xin, Nian; Yang, Fang-Ju; Li, Yan; Li, Yu-Juan; Dai, Rong-Ji; Meng, Wei-Wei; Chen, Yan; Deng, Yu-Lin

    2013-12-15

    Dragon's blood is a bright red resin obtained from Dracaena cochinchinensis (Lour.) S.C.Chen (Yunnan, China). As a traditional Chinese medicinal herb, it has great traditional medicinal value and is used for wound healing and to stop bleeding. Its main biological activity comes from phenolic compounds. In this study, phenolic compounds were made into dropping pills and their protective effects were examined by establishing focal cerebral ischemia rats model used method of Middle Cerebral Artery Occlusion (MCAO), and by investigating indexes of neurological scores, infarct volume, cerebral index, cerebral water content and oxidation stress. Compared to model group, high, middle and low groups of Dragon's blood dropping pills could improve the neurological function significantly (ppills had protective effects on focal cerebral ischemia rats. Copyright © 2013 Elsevier GmbH. All rights reserved.

  4. 'Stratified Contraception': Emergency Contraceptive Pills and Women's Differential Experiences in Contemporary India.

    Science.gov (United States)

    Sheoran, Nayantara

    2015-01-01

    Available without prescriptions in India since 2005, emergency contraceptive pills (ECPs) and their advertisements have provided women with increased contraceptive options and a vocabulary to talk about their reproductive lives. I draw on long-term fieldwork with women in urban India about ECPs, demonstrating a new form of 'stratified contraception' enabled by these pills and their advertisements. I posit that there are within India spaces that replicate the luxuries and privileges of the global North. These material conditions, I suggest, are replicated when it comes to contraception as there are hubs of women consumers of contraception and contraceptive advertising that participate in an 'imagined cosmopolitanism' within the global South in close proximity to 'contraceptive ghettos.' Moving beyond simplistic binaries, I outline three major stratifications along which women experience this medical technology and outline the implications for women and their contraceptive choices when notions of northern privilege exist in the 'South.'

  5. Swallowable smart pills for local drug delivery: present status and future perspectives.

    Science.gov (United States)

    Goffredo, Rosa; Accoto, Dino; Guglielmelli, Eugenio

    2015-01-01

    Smart pills were originally developed for diagnosis; however, they are increasingly being applied to therapy - more specifically drug delivery. In addition to smart drug delivery systems, current research is also looking into localization systems for reaching the target areas, novel locomotion mechanisms and positioning systems. Focusing on the major application fields of such devices, this article reviews smart pills developed for local drug delivery. The review begins with the analysis of the medical needs and socio-economic benefits associated with the use of such devices and moves onto the discussion of the main implemented technological solutions with special attention given to locomotion systems, drug delivery systems and power supply. Finally, desired technical features of a fully autonomous robotic capsule for local drug delivery are defined and future research trends are highlighted.

  6. The Pill and Men’s Disappearance from the Teaching Sector

    DEFF Research Database (Denmark)

    Steingrimsdottir, Herdis

    In this paper I look at the relationship between increased access to reliable fertility controls and men’s disappearance from teaching. As the pill has been found to have a substantial effect on women’s family responsibilities, career investments and labor market outcomes, men’s bargaining position...... and 1980, the ratio of male college freshmen planning to become a teacher fell from 12.4% to 2.4% and the share of males among those who aspired to teach dropped from 30.6% to 19.7%. Using nationally representative data on the career plans of college freshmen I find that unrestricted access to the birth...... control pill bears a negative relation to the likelihood that men plan to teach, while changes in the strength of teacher unions and relative wages of teachers have limited effect on their career plans. Men’s aspirations shift away from teaching towards occupations that are associated with higher average...

  7. An assessment of the quality of advice provided by patent medicine vendors to users of oral contraceptive pills in urban Nigeria.

    Science.gov (United States)

    Ujuju, Chinazo; Adebayo, Samson B; Anyanti, Jennifer; Oluigbo, Obi; Muhammad, Fatima; Ankomah, Augustine

    2014-01-01

    In Nigeria about 50% of oral contraceptive pill users obtain their products from proprietary patent medicine vendors (PPMVs). This group of service providers are poorly trained and have very limited knowledge about contraception. This paper investigated the nature of the advice offered to simulated current and potential users of oral contraceptive pills. The main objective was to assess the nature and quality of advice provided by PPMVs to pill users. This study is based on findings from a 'mystery client' approach in which three scenarios related to contraceptive pill use were simulated. Each of the 12 mystery clients simulated one of the following three scenarios: new pill users (new to family planning or switching from condom to pills); user seeking a resupply of pills; and dissatisfied pill users intending to discontinue use. Simple random sampling was used to select 410 PPMVs from a total of 1,826 in four states in Nigeria. Qualitative study using in-depth interviews was also conducted. A majority of the PPMVs had pills in stock on the day of the survey and resupplied pills to the clients. PPMVs also understood the reason and importance of referring clients who were new adopters of oral contraceptive methods to a health facility; 30% of the PPMVs referred new adopters to a health facility. However, demand from clients who do not want to go to health care facilities (for various reasons) necessitated the provision of oral contraceptive pills to 41% of the first time users. Some PPMVs prescribed treatment to mystery clients who presented with perceived complications arising from the use of pills, while 49% were referred to a health facility. The advice given by PPMVs often falls short of safety guidelines related to the use of oral contraceptive pills. There is a need to continuously update knowledge among the PPMVs to ensure that they provide quality oral contraceptive services as PPMVs bridge the gap between medical experts and users in rural communities.

  8. Offering extended use of the combined contraceptive pill: a survey of specialist family planning services

    Directory of Open Access Journals (Sweden)

    Sauer U

    2013-09-01

    Full Text Available Ulrike Sauer,1 Sue Mann,2 Nataliya Brima,3 Judith Stephenson21Reproductive and Sexual Health, Enfield Community Service, Enfield, 2Sexual and Reproductive Health Research Group, Institute for Women’s Health, 3Research Department of Infection and Population Health, University College London, London, UKBackground: The purpose of this study was to determine attitudes to, and provision of, extended regimens for taking the combined oral contraceptive pill (COC by specialist contraception practitioners from three contrasting specialist contraception services in London.Methods: An online cross-sectional survey was administered to all doctors and nurses, who counsel, provide, or prescribe the oral contraceptive pill at each clinic.Results: A total of 105 clinicians received the questionnaire and 67 (64% responded. Only one of three clinics initiated and maintained guidelines for extended COC use. In that service, 60% of staff prescribing COC advised more than 50% of patients regarding alternative COC regimens. In the other two services, this was discussed with 20% and 6% of patients, respectively (P < 0.001. The reasons for prescribing extended use included cyclic headaches, menorrhagia, patient request, menstrual-related cramps, and endometriosis, and did not differ between the three different settings. The most common extended regimens were 63 pills or continuous use until bleeding occurs, followed by a hormone-free interval. Concerns highlighted by providers and patients were “unhealthy not to have a monthly bleed”, “future fertility”, and “breakthrough bleeding”. Such comments highlight the need for further information for providers and patients.Conclusion: There is growing evidence, backed by national guidance, about extended COC use, but routine provision of this information is patchy and varies ten-fold, even within specialist family planning services. Targeted training, use of service guidelines, and implementation research will be

  9. Oral contraceptive pills: Risky or protective in case of Trichinella spiralis infection?

    Science.gov (United States)

    Hasby Saad, M A; Radi, D A; Hasby, E A

    2017-08-01

    The aim of this study was to investigate how Trichinella spiralis infection can be affected by contraceptive pills in vivo. Methods included six groups of female Wistar rats; healthy, Trichinella infected, receiving combined contraceptive pills (COCPs), receiving progestin only pills (POPs), infected receiving COCPs and infected receiving POPs. Parasite burden was measured; adult worm counts, gravidity, larvae and reproductive capacity index). Histopathological examination, immunohistochemical detection of C-kit+ mast cells and Foxp3+ T-reg. cells in intestinal sections, eosinophils muscle infiltration and CPK level were performed. Rats infected and receiving COCPs showed a significant increase in parasitic burden, and infected receiving POPs showed a significant reduction compared to infected only, with a significant increase in nongravid females (Mean total worms=964.40±55.9, 742±52.63, 686±31.68, larvae/g=5030±198.75, 2490±143.18 and 4126±152,91, respectively). Intestinal sections from infected receiving COCPs showed intact mucosa (though the high inflammatory cells infiltrate), and significant increase in C-kit+ mast cells number and intensity (30.20±4.15 and 60.40±8.29), and Foxp3+ T-reg. cells (10±1.58). Infected receiving POPs showed a significantly less CPK (5886±574.40) and eosinophilic muscle infiltration (58±13.51). Oestrogen-containing pills established a favourable intestinal environment for Trichinella by enhancing Foxp+T-reg. cells and stabilizing C-kit+mast cells, while POPs gave a potential protection with less gravidity, larval burden and eosinophilic infiltrate. © 2017 John Wiley & Sons Ltd.

  10. Knowledge about missed contraceptive pills among married women at King Abdulaziz University Hospital

    Science.gov (United States)

    Iftikhar, Rahila; Aba Al Khail, Bahaa Abdulrahman

    2015-01-01

    Background Oral contraceptive pills (OCPs) are one of the most reliable methods of contraception. However, lack of knowledge about oral contraceptive use and inconsistent pill-taking might result in decreased efficacy. The study reported here aimed to explore women’s knowledge about oral contraceptive use and assess the factors associated with knowledge about OCPs among users. Methods This cross-sectional survey was conducted at King Abdulaziz University Hospital, Jeddah, Saudi Arabia between April and June 2014. We included married, non-pregnant women >18 years old who had used a combined 21-day OCP for at least 3 months prior to recruitment. A questionnaire was used to collect the participants’ demographic information. It also assessed their knowledge about OCPs. Data were entered into and analyzed using SPSS software. Results A total of 357 women were recruited. Of these, 57.7% reported they knew what to do after missing one or two pills, but only 18.3% knew exactly what to do after missing more than two pills consecutively. Postgraduate women had a significantly higher knowledge score than illiterate women (P=0.002) and those who had completed at least primary education (P=0.001). Conversely, there was no difference in knowledge scores between Saudi and expatriate women (P=0.2). Monthly incomes (P=0.2) and mode of OCP selection (P=0.2) were also not significantly associated with knowledge scores. Conclusion Women had poor knowledge about OCP use. Appropriate measures should be taken to educate women about proper oral contraceptive use. PMID:25792813

  11. Artichoke and milk thistle pills and syrups as sources of phenolic compounds with antimicrobial activity.

    Science.gov (United States)

    Pereira, Carla; Barros, Lillian; José Alves, Maria; Santos-Buelga, Celestino; Ferreira, Isabel C F R

    2016-07-13

    Dietary supplements based on hepatoprotective plants have been increasingly used in the prevention of liver injuries. In the present work, the aim was to study the phenolic profile and possibly relate it to the in vitro antimicrobial activity of two different formulations (pills and syrups) of artichoke and milk thistle, the antioxidant and anti-hepatocellular carcinoma activities of which were previously reported by our research group. The phenolic profiles were obtained by HPLC-DAD-ESI/MS, and the antimicrobial activity evaluation was performed with the clinical isolates of multiresistant bacteria (Escherichia coli, extended spectrum β-lactamases (ESBL) producing Escherichia coli, Proteus mirabilis, methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa). Artichoke syrup revealed the presence of vanillic acid and luteolin-7-O-glucoside while the pills possessed higher concentrations of 4-O-caffeoylquinic, 5-O-caffeoylquinic and 1,3-O-dicaffeoylquinic acids, this latest being able to inhibit the growth of MRSA. Regarding milk thistle formulations, the syrup presented isorhamnetin-O-deoxyhexoside-O-dihexoside, isorhamnetin-O-deoxyhexoside-O-hexoside and isorhamnetin-3-O-rutinoside as the major phenolic constituents whereas the pills were richer in taxifolin, silymarin derivatives and hydroxylated silibinin; the syrup revealed antimicrobial activity against all the studied bacteria with the exception of Proteus mirabilis whereas the pills revealed activity against ESBL producing Escherichia coli. Overall, all of the studied formulations revealed to be a good source of phenolic compounds, among which milk thistle syrup presented the highest variety and concentration of flavonoids, which is possibly related to its strongest antimicrobial activity.

  12. Serum levels of T3 and T4 among workers of contraceptive pills industry

    International Nuclear Information System (INIS)

    Abbas, E.Z.; Emara, A.; Yassen, Y.Z.; Amr, M.M.; Jaras, M.S.

    1985-01-01

    Serum levels of thyroxine and triiodothyronine were determined in 24 workers engaged in contraceptive pills industry and 20 control subjects. Serum thyroxine in exposed subjects was significantly lower, compared to its level in controls. On the other hand, triiodothyronine was significantly higher in exposed workers. Thus, it is concluded that exposure to the dust of contraceptive drugs, namely estrogen and progesterone, produced disturbances in thyroid gland function and thyroid hormone metabolism. (author)

  13. Pill testing or drug checking in Australia: Acceptability of service design features.

    Science.gov (United States)

    Barratt, Monica J; Bruno, Raimondo; Ezard, Nadine; Ritter, Alison

    2018-02-01

    This study aimed to determine design features of a drug-checking service that would be feasible, attractive and likely to be used by Australian festival and nightlife attendees. Web survey of 851 Australians reporting use of psychostimulants and/or hallucinogens and attendance at licensed venues past midnight and/or festivals in the past year (70% male; median age 23 years). A drug-checking service located at festivals or clubs would be used by 94%; a fixed-site service external to such events by 85%. Most (80%) were willing to wait an hour for their result. Almost all (94%) would not use a service if there was a possibility of arrest, and a majority (64%) would not use a service that did not provide individual feedback of results. Drug-checking results were only slightly more attractive if they provided comprehensive quantitative results compared with qualitative results of key ingredients. Most (93%) were willing to pay up to $5, and 68% up to $10, per test. One-third (33%) reported willingness to donate a whole dose for testing: they were more likely to be male, younger, less experienced, use drugs more frequently and attend venues/festivals less frequently. In this sample, festival- or club-based drug-checking services with low wait times and low cost appear broadly attractive under conditions of legal amnesty and individualised feedback. Quantitative analysis of ecstasy pills requiring surrender of a whole pill may appeal to a minority in Australia where pills are more expensive than elsewhere. [Barratt MJ, Bruno R, Ezard N, Ritter A. Pill testing or drug checking in Australia: Acceptability of service design features. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  14. ADR salt pill design and crystal growth process for hydrated magnetic salts

    Science.gov (United States)

    Shirron, Peter J. (Inventor); DiPirro, Michael J. (Inventor); Canavan, Edgar R. (Inventor)

    2013-01-01

    A process is provided for producing a salt pill for use in very low temperature adiabatic demagnetization refrigerators (ADRs). The method can include providing a thermal bus in a housing. The thermal bus can include an array of thermally conductive metal conductors. A hydrated salt can be grown on the array of thermally conductive metal conductors. Thermal conductance can be provided to the hydrated salt.

  15. Providers′ knowledge, attitude and dispensing practices of E-Pills in government dispensaries of south district in Delhi, India

    Directory of Open Access Journals (Sweden)

    Kishore Vertika

    2010-01-01

    Full Text Available Background: South Delhi is one of the well developed districts in the capital with best public health care facilities. Knowledge, attitude and dispensing practices of emergency contraceptive pills (E-pills were assessed among health care providers of government dispensaries in South Delhi. Study Design: A descriptive epidemiological study. Materials and Methods: Both medical and paramedical (n = 428 providers in 63 government health care facilities were interviewed between August to December 2007 using a semi-structured interview schedule. Results: Among the different categories of the providers, medical officers were observed to be most knowledgeable about E-pills and the pharmacists were the least. The correct prescribed dose of E-pill was known only to 32% of the providers while 49% knew about its right time of intake. Misconceptions and apprehensions for promoting its use were very much prevalent even among medical officers as majority felt that open access to E-pills would increase promiscuity. The dispensing practice of providers was found positively ( P < 0.05 correlated with their knowledge. Training resulted a significant ( P < 0.05 improvement in knowledge, attitude and dispensing practice of the providers. Knowledge and training combined together contributed 35% to the dispensing practice (R 2 = 0.35. Conclusion: Besides knowledge, behavior change communication strategies should form a part of the training curricula of health care providers that would help to improve the dispensing practice of E-pills.

  16. 'Worth the test?' Pragmatism, pill testing and drug policy in Australia.

    Science.gov (United States)

    Groves, Andrew

    2018-04-10

    Recent deaths of young Australian music festival attendees from 'party-drug' overdoses have sparked debate about the effectiveness of drug policies. Australia is widely lauded for its harm minimisation approach to drugs, and yet, over the last 30 years, it can be argued its policies have been fragmented, sometimes inconsistent and contradictory. The present article examines the root of this inconsistency, using it as a foundation to advocate for drug policy reform. In keeping with the goals of the National Drug Strategy to promote policy innovation, there is an opportunity to learn from international studies which have shown promising findings in the reduction of party-drug use and its harms through application of pill testing. This paper evaluates Australia's National Drug Strategy and pill testing through a lens of pragmatism, to determine whether there is space for testing practices in contemporary policy. Specifically, the paper analyses current drug policy literature and research studies, examining a range of key drug use indicators, social and political debate and research evidence. The need for policy reform, attitudinal and cultural shifts and development of stronger cross-sectoral partnerships is highlighted, to ensure a rational and logical approach that genuinely tackles drug policy-making and strategy from a broad public health perspective. Using a theoretical frame of pragmatism and drawing from national and international research evidence, this paper recommends the integration of pill testing into Australia's harm minimisation strategy.

  17. Can pill placebo augment cognitive-behavior therapy for panic disorder?

    Directory of Open Access Journals (Sweden)

    Churchill Rachel

    2007-12-01

    Full Text Available Abstract Background In a number of drug and psychotherapy comparative trials, psychotherapy-placebo combination has been assumed to represent psychotherapy. Whether psychotherapy plus pill placebo is the same as psychotherapy alone is an empirical question which however has to date never been examined systematically. Methods We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs that directly compared cognitive-behavior therapy (CBT alone against CBT plus pill placebo in the treatment of panic disorder. Results Extensive literature search was able to identify three relevant RCTs. At the end of the acute phase treatment, patients who received CBT plus placebo had 26% (95%CI: 2 to 55% increased chances of responding than those who received CBT alone. At follow-up the difference was no longer statistically significant (22%, 95%CI: -10% to 64%. Conclusion The act of taking a pill placebo may enhance the placebo effect already contained in the effective psychotherapeutic intervention during the acute phase treatment. Theoretically this is an argument against the recently claimed null hypothesis of placebo effect in general and clinically it may point to some further room for enhancing the psychotherapeutic approach for panic disorder.

  18. Effect of compound radix sophorae flavescentis injection combined with Xiaoyao pill on breast cancer

    Directory of Open Access Journals (Sweden)

    Xiao-Li Li

    2016-12-01

    Full Text Available Objective: To investigate the influence of compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy on tumor markers, cytokines and lymphocyte subpopulations of breast cancer patients, thus provide relevant assistance on clinical therapy for breast cancer patients. Methods: A total of 170 breast cancer patients treated in our hospital were selected and divided to be the observe group and control group at random, 85 cases for each group. For patients in control group, AC chemotherapeutic project was utilized, and for patients in observe group, compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy were provided on the basis of AC chemotherapy. Tumor markers, cytokines and lymphocyte subpopulations of breast cancer patients in each group were detected before and after therapy. Results: Comparison of tumor markers, cytokines and lymphocyte subpopulations levels between the two groups of breast cancer patients before therapy showed no statistical significant difference (P>0.05. Compared with prior therapy, the tumor markers (CA153, CEA and CYRA21-1, CD8+ and cytokines (IL-4, IL-6 and IL-10 on both the two groups of breast cancer patients were dramatically decreased, while lymphocyte subpopulations (CD3+ , CD4+ , CD4+ /CD8+ , IFN-γ and IL-2 were significantly increased (P<0.05. Conclusions: Compound radix sophorae flavescentis injection and Xiaoyao pill combined therapy can significantly improve the tumor markers, cytokines and lymphocyte subpopulations of the breast cancer patients. It is of vital clinical significance for treatment on breast cancer patients.

  19. Quality evaluation of moluodan concentrated pill using high-performance liquid chromatography fingerprinting coupled with chemometrics.

    Science.gov (United States)

    Tao, Lingyan; Zhang, Qing; Wu, Yongjiang; Liu, Xuesong

    2016-12-01

    In this study, a fast and effective high-performance liquid chromatography method was developed to obtain a fingerprint chromatogram and quantitative analysis simultaneously of four indexes including gallic acid, chlorogenic acid, albiflorin and paeoniflorin of the traditional Chinese medicine Moluodan Concentrated Pill. The method was performed by using a Waters X-bridge C 18 reversed phase column on an Agilent 1200S high-performance liquid chromatography system coupled with diode array detection. The mobile phase of the high-performance liquid chromatography method was composed of 20 mmol/L phosphate solution and acetonitrile with a 1 mL/min eluent velocity, under a detection temperature of 30°C and a UV detection wavelength of 254 nm. After the methodology validation, 16 batches of Moluodan Concentrated Pill were analyzed by this high-performance liquid chromatography method and both qualitative and quantitative evaluation results were achieved by similarity analysis, principal component analysis and hierarchical cluster analysis. The results of these three chemometrics were in good agreement and all indicated that batch 10 and batch 16 showed significant differences with the other 14 batches. This suggested that the developed high-performance liquid chromatography method could be applied in the quality evaluation of Moluodan Concentrated Pill. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Chromatographic fingerprinting through chemometric techniques for herbal slimming pills: A way of adulterant identification.

    Science.gov (United States)

    Shekari, Nafiseh; Vosough, Maryam; Tabar Heidar, Kourosh

    2018-05-01

    In the current study, gas chromatography-mass spectrometry (GC-MS) fingerprinting of herbal slimming pills assisted by chemometric methods has been presented. Deconvolution of two-way chromatographic signals of nine herbal slimming pills into pure chromatographic and spectral patterns was performed. The peak clusters were resolved using multivariate curve resolution-alternating least squares (MCR-ALS) by employing appropriate constraints. It was revealed that more useful chemical information about the composition of the slimming pills can be obtained by employing sophisticated GC-MS method coupled with proper chemometric tools yielding the extended number of identified constituents. The thorough fingerprinting of the complex mixtures proved the presence of some toxic or carcinogen components, such as toluene, furfural, furfuryl alcohol, styrene, itaconic anhydride, citraconic anhydride, trimethyl phosphate, phenol, pyrocatechol, p-propenylanisole and pyrogallol. In addition, some samples were shown to be adulterated with undeclared ingredients, including stimulants, anorexiant and laxatives such as phenolphthalein, amfepramone, caffeine and sibutramine. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. Awareness and Perceptions of Emergency Contraceptive Pills Among Women in Kinshasa, Democratic Republic of the Congo.

    Science.gov (United States)

    Hernandez, Julie H; Muanda, Mbadu; Garcia, Mélissa; Matawa, Grace

    2017-09-01

    Despite the commitment of the Democratic Republic of the Congo (DRC) to expand the family planning method mix and increase access to services, awareness of emergency contraception is low among women, and the method remains underused and poorly integrated in family planning programming. Data from 15 focus group discussions conducted in 2016 among women aged 15-35 were used to examine awareness and perceptions of, and attitudes toward, emergency contraceptives. After facilitators explained emergency contraceptive pills' mechanism of action and other characteristics, participants were asked about the potential benefits and risks of making the method more widely available. Transcripts were analyzed using an iterative approach. Women reported employing a wide range of postcoital contraceptive behaviors, albeit often using inappropriate products, and generally agreed that emergency contraceptive pills seemed to be a potentially effective solution to their family planning needs. Perceived benefits and limitations of the method were almost always framed in reference to other, better-known contraceptives, and women expressed strong preferences for pharmacy-based provision that aligned with their usual behaviors for obtaining contraceptives. Participants were reluctant to see the method available for free. Emergency contraceptive pills have the potential to address gaps in the family planning method mix in the DRC. Assessing whether women have incomplete or erroneous information about family planning methods can provide better understanding of women's contraceptive choices in low-income countries.

  2. [Effect of compound Danshen dripping pills combined with atorvastatin on restenosis after angioplasty in rabbits].

    Science.gov (United States)

    Song, Jieli; Zeng, Jinpei; Zhang, Yongxia; Li, Pengfei; Zhang, Lihong; Chen, Cibin

    2014-08-01

    To study the effect of compound Danshen dripping pills and atorvastatin on restenosis after abdominal aorta angioplasty in rabbits. Rabbit models of abdominal aorta restenosis after angioplasty were established and treated with saline (group A), compound Danshen dripping pills (group B), atorvastatin (group C), or compound Danshen dripping pills plus atorvastatin (group D). HE staining was used to determine the thickness of arterial intimal hyperplasia and assess the morphological changes of the narrowed artery. Immunohistochemistry was employed to detect the expression of nuclear factor-κB (NF-κB) and monocyte chemoattractant protein-1 (MCP-1). Compared with group A, the 3 treatment groups showed significant increased vascular cavity area and reduced intimal area and percentage of intimal hyperplasia (Ppills combined with atorvastatin produces better effects than the drugs used alone in inhibiting vascular smooth muscle cell proliferation in rabbits after abdominal aorta angioplasty possibly due to a decreased expression of MCP-1 as a result of NF-κB inhibition.

  3. Use of birth control pills, condoms, and withdrawal among U.S. high school students.

    Science.gov (United States)

    Everett, S A; Warren, C W; Santelli, J S; Kann, L; Collins, J L; Kolbe, L J

    2000-08-01

    To examine the use of contraception at last sexual intercourse among currently sexually active adolescents. We analyzed data from national school-based Youth Risk Behavior Surveys (YRBS) conducted in 1991, 1993, 1995, and 1997. The YRBS is a self-administered, anonymous survey which uses a national probability sample of U.S. students in public and private schools from grades 9 through 12. From 1991 to 1997, condom use significantly increased (from 46% to 57%), birth control pill use decreased (from 21% to 17%), and use of withdrawal significantly decreased (from 18% to 13%). In 1997, although more students were using condoms, 13% reported using withdrawal and 15% reported using no method to prevent pregnancy at last sexual intercourse. In 1997, condom use among females was significantly lower in the 9th grade than in the 12th grade (p birth control pill use was higher (p birth control pill use by their partner increased (p schools, and other influential societal institutions should promote the correct and continued use of condoms as essential protection against sexually transmitted diseases and human immunodeficiency virus infection.

  4. Pill-Box Cavity BPM For TESLA Cryomodul

    CERN Document Server

    Sargsyan, V

    2003-01-01

    A new cavity BPM with 10 μm resolution is designed and fabricated to perform single bunch measurements at the TESLA linear collider. In order to have a low energy dissipation in the cryogenic supermodule, the inner surface of the cavity is copper plated. Cross-talk is minimised by a special polarisation design. The electronics, at 1.5 GHz, is a homodyne receiver normalised to the bunch charge. Its LO-signal for down-conversion is taken from the same cavity.

  5. Pharmaceutical Pill Counting and Inspection Using a Capacitive Sensor

    Directory of Open Access Journals (Sweden)

    Ganesan LETCHUMANAN

    2008-01-01

    Full Text Available A capacitive sensor for high-speed counting and inspection of pharmaceutical products is proposed and evaluated. The sensor is based on a patented Electrostatic Field Sensor (EFS device, previously developed by Sparc Systems Limited. However, the sensor head proposed in this work has a significantly different geometry and has been designed with a rectangular inspection aperture of 160mm × 21mm, which best meets applications where a larger count throughput is required with a single sensor. Finite element modelling has been used to simulate the electrostatic fields generated within the sensor, and as a design tool for optimising the sensor head configuration. The actual and simulated performance of the sensor is compared and analysed in terms of the sensor performance at discriminating between damaged products or detection of miscount errors.

  6. Factors affecting the decision to hospitalise children admitted to the emergency department due to non-fatal suicide attempts by pills.

    Science.gov (United States)

    Gokalp, Gamze; Anil, Murat; Bal, Alkan; Bicilioglu, Yuksel; Kamit Can, Fulya; Anil, Ayse Berna

    2016-01-01

    Suicide attempts (SAs) in the paediatric age group represent an important cause of morbidity and mortality. Our aim was to examine the factors affecting the decision to hospitalize children with a diagnosis of non-fatal SA by pills. Children pills during 2014 were evaluated retrospectively. Patients were divided into two groups: Group-I comprised hospitalised patients and Group-II included those who were discharged from the PED. These two groups were compared in terms of clinical and demographic characteristics recorded upon PED admission. A total of 196 patients were included in the study. The number of pills taken for self-poisoning in Group-I (median: 20 pills) was higher than that in Group-II (median: 12 pills) (p pills included the amount of medication taken for the suicide attempt and the presence of psychiatric disorders, as determined by a paediatric psychiatrist during the acute phase.

  7. Quantitative determination of 3,4-methylenedioxymethamphetamine by thin-layer chromatography in ecstasy illicit pills in Tehran.

    Science.gov (United States)

    Shetab Boushehri, Seyed Vahid; Tamimi, Maryam; Kebriaeezadeh, Abbas

    2009-11-01

    3,4-Methylenedioxymethamphetamine (MDMA) is the major ingredient of ecstasy illicit pills. It is a hallucinogen, central nervous system stimulant, and serotonergic neurotoxin that strongly releases serotonin from serotonergic nerves terminals. Moreover, it releases norepinephrine and dopamine from nerves terminal, but to a lesser extent than serotonin. Poisoning and even death from abusing MDMA-containing ecstasy illicit pills among abusers is usual. Thus, quantitative determination of MDMA content of ecstasy illicit pills in illicit drug bazaar must be done regularly to find the most high dose ecstasy illicit pills and removing them from illicit drug bazaar. In the present study, MDMA contents of 13 most abundant ecstasy illicit pills were determined by quantitative thin-layer chromatography (TLC). Two procedures for quantitative determination of MDMA contents of ecstasy illicit pills by TLC were used: densitometric and so-called 'scraping off' methods. The former was done in a reflection mode at 285 nm and the latter was done by absorbance measurement of eluted scraped off spots. Limit of detection (LOD), considering signal-to-noise ratio (S/N) of 2, and limit of quantification (LOQ), regarding S/N of 10, of densitometric and scraping off methods were 0.40 microg, 1.20 microg, and 6.87 mug, 20.63 microg, respectively. Repeatabilities (within-laboratory error) of densitometric and scraping off methods were 0.5% and 3.6%, respectively. The results showed that the ecstasy illicit pills contained 24-124.5 mg and 23.9-122.2 mg MDMA by densitometric and scraping off methods, respectively.

  8. Screening for the anti-inflammation quality markers of Xiaojin Pills based on HPLC-MS/MS method, COX-2 inhibition test and protein interaction network.

    Science.gov (United States)

    Xiong, Xi; He, Ya-Nan; Feng, Bi; Pan, Yuan; Zhang, Hai-Zhu; Ke, Xiu-Mei; Zhang, Yi; Yang, Ming; Han, Li; Zhang, Ding-Kun

    2018-05-10

    Nowadays, breast disorders seriously affect women's health in an increasing number. In China, Xiaojin Pills are commonly used in the treatment of breast diseases. Doctors have concluded that the combined use of Xiaojin Pills with conventional therapy can significantly improve the efficacy with fewer side effects. However, the prescription of Xiaojin Pills is complicated and their quality control methods cannot completely ensure the quality of Xiaojin Pills. On the basis of its mechanism, our study combined chemical evaluation and biological evaluation to identify the anti-inflammatory markers of Xiaojin Pills. In this manuscript, 13 compounds in Xiaojin Pills were quantified. At the same time, the cyclooxygenase-2 inhibition rates of different Xiaojin Pills were measured and the possible markers were screened by spectrum-effect relationship. Further, anti-inflammatory activities of markers were verified and protein interaction network was analyzed, identifying the components of Protocatechuate, Beta-Boswellic acid and Levistilide A as the anti-inflammatory quality markers of Xiaojin Pills. We hope our studies can provide a scientific theoretical basis for accurately quality control of Xiaojin Pills and reasonable suggestions for pharmaceutical companies and new ideas for the quality control of other medicines.

  9. Utilization of and Adherence to Oral Contraceptive Pills and Associated Disparities in the United States: A Baseline Assessment for the Impact of the Affordable Care Act of 2010.

    Science.gov (United States)

    Lin, Hsien-Chang; Lee, Hsiao-Yun

    2015-01-01

    This study investigated sociological factors that may influence women's utilization of and adherence to oral contraceptive pills. This was a retrospective cross-sectional study using the 2010-2012 Medical Expenditure Panel Survey. Female adults aged 18-50 years were included. Logistic regression was performed to discern women's decisions to use oral contraceptive pills or not. Ordinary least squares and Poisson regressions were conducted to examine the number of oral contraceptive pills received, refill frequency, and annual out-of-pocket expenditure on oral contraceptive pills. Covariates were based on the Andersen model of health care utilization. Among the study sample (weighted n = 207,007,531), 14.8% were oral contraceptive pill users. Factors positively related to oral contraceptive pill use included non-Hispanic white ethnicity, younger age, not currently married, having private insurance, residing in the Midwest, higher education level, and higher annual family income. Being non-Hispanic white and having a higher education level were positively related to oral contraceptive pill adherence. Our findings therefore demonstrate disparities in oral contraceptive pill utilization and adherence, especially according to women's race/ethnicity and educational level. This study serves as a baseline assessment for the impact of the Affordable Care Act on oral contraceptive pill utilization and adherence for future studies. © The Author(s) 2015.

  10. Quality evaluation of Shenmaidihuang Pills based on the chromatographic fingerprints and simultaneous determination of seven bioactive constituents.

    Science.gov (United States)

    Liu, Sifei; Zhang, Guangrui; Qiu, Ying; Wang, Xiaobo; Guo, Lihan; Zhao, Yanxin; Tong, Meng; Wei, Lan; Sun, Lixin

    2016-12-01

    In this study, we aimed to establish a comprehensive and practical quality evaluation system for Shenmaidihuang pills. A simple and reliable high-performance liquid chromatography coupled with photodiode array detection method was developed both for fingerprint analysis and quantitative determination. In fingerprint analysis, relative retention time and relative peak area were used to identify the common peaks in 18 samples for investigation. Twenty one peaks were selected as the common peaks to evaluate the similarities of 18 Shenmaidihuang pills samples with different manufacture dates. Furthermore, similarity analysis was applied to evaluate the similarity of samples. Hierarchical cluster analysis and principal component analysis were also performed to evaluate the variation of Shenmaidihuang pills. In quantitative analysis, linear regressions, injection precisions, recovery, repeatability and sample stability were all tested and good results were obtained to simultaneously determine the seven identified compounds, namely, 5-hydroxymethylfurfural, morroniside, loganin, paeonol, paeoniflorin, psoralen, isopsoralen in Shenmaidihuang pills. The contents of some analytes in different batches of samples indicated significant difference, especially for 5-hydroxymethylfurfural. So, it was concluded that the chromatographic fingerprint method obtained by high-performance liquid chromatography coupled with photodiode array detection associated with multiple compounds determination is a powerful and meaningful tool to comprehensively conduct the quality control of Shenmaidihuang pills. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. The effects of compound danshen dripping pills and human umbilical cord blood mononuclear cell transplant after acute myocardial infarction.

    Science.gov (United States)

    Jun, Yi; Chunju, Yuan; Qi, Ai; Liuxia, Deng; Guolong, Yu

    2014-04-01

    The low frequency of survival of stem cells implanted in the myocardium after acute myocardial infarction may be caused by inflammation and oxidative stress in the myocardial microenvironment. We evaluated the effects of a traditional Chinese medicine, Compound Danshen Dripping Pills, on the cardiac microenvironment and cardiac function when used alone or in combination with human umbilical cord blood mononuclear cell transplant after acute myocardial infarction. After surgically induced acute myocardial infarction, rabbits were treated with Compound Danshen Dripping Pills alone or in combination with human umbilical cord blood mononuclear cell transplant. Evaluation included histology, measurement of left ventricular ejection fraction and fractional shortening, leukocyte count, count of green fluorescent protein positive cells, superoxide dismutase activity, and malondialdehyde content. Combination treatment with Compound Danshen Dripping Pills and human umbilical cord blood mononuclear cell transplant significantly increased the survival of implanted cells, inhibited cardiac cell apoptosis, decreased oxidative stress, decreased the inflammatory response, and improved cardiac function. Rabbits treated with either Compound Danshen Dripping Pills or human umbilical cord blood mononuclear cells alone had improvement in these effects compared with untreated control rabbits. Combination therapy with Compound Danshen Dripping Pills and human umbilical cord blood mononuclear cells may improve cardiac function and morphology after acute myocardial infarction.

  12. Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association.

    Directory of Open Access Journals (Sweden)

    Jian Kong

    Full Text Available Placebo treatments and healing rituals have been used to treat pain throughout history. The present within-subject crossover study examines the variability in individual responses to placebo treatment with verbal suggestion and visual cue conditioning by investigating whether responses to different types of placebo treatment, as well as conditioning responses, correlate with one another. Secondarily, this study also examines whether responses to sham acupuncture correlate with responses to genuine acupuncture. Healthy subjects were recruited to participate in two sequential experiments. Experiment one is a five-session crossover study. In each session, subjects received one of four treatments: placebo pills (described as Tylenol, sham acupuncture, genuine acupuncture, or no treatment rest control condition. Before and after each treatment, paired with a verbal suggestion of positive effect, each subject's pain threshold, pain tolerance, and pain ratings to calibrated heat pain were measured. At least 14 days after completing experiment one, all subjects were invited to participate in experiment two, during which their analgesic responses to conditioned visual cues were tested. Forty-eight healthy subjects completed experiment one, and 45 completed experiment two. The results showed significantly different effects of genuine acupuncture, placebo pill and rest control on pain threshold. There was no significant association between placebo pills, sham acupuncture and cue conditioning effects, indicating that individuals may respond to unique healing rituals in different ways. This outcome suggests that placebo response may be a complex behavioral phenomenon that has properties that comprise a state, rather than a trait characteristic. This could explain the difficulty of detecting a signature for "placebo responders." However, a significant association was found between the genuine and sham acupuncture treatments, implying that the non

  13. The origins of the giant pill-millipedes from Madagascar (Diplopoda: Sphaerotheriida: Arthrosphaeridae).

    Science.gov (United States)

    Wesener, Thomas; Raupach, Michael J; Sierwald, Petra

    2010-12-01

    Giant pill-millipedes (order Sphaerotheriida) are large-bodied millipedes without poison glands which can roll-up into a complete ball. Their disconnected area of distribution spanning South Africa, Madagascar, India, SE Asia, Australia and New Zealand makes them interesting model organisms for biogeographic studies. The here presented phylogeny is based on a molecular dataset covering all areas of distribution with a special focus on Madagascar, where some species of giant pill-millipedes show island gigantism, reaching the size of a baseball. For our study, two mitochondrial genes (partial 16S rRNA and COI) as well as the complete nuclear 18S rDNA were sequenced. While many recent vertebrate studies hint that the ancestors of the recent Malagasy fauna crossed the >350 km wide Mozambique Channel several times, no such crossing was discovered in the Sphaerotheriida. For the first time in a molecular phylogenetic study of soil arthropods, a Madagascar-India group, the family Arthrosphaeridae, is recovered, hinting to a Gondwanan origin of the Sphaerotheriida. The Malagasy-Indian family Arthrosphaeridae forms a monophyletic, statistically well-supported group in all obtained trees. The giant pill-millipedes from Madagascar are paraphyletic because the Malagasy genus Sphaeromimus is the sister-taxon of the Indian Arthrosphaera. In Sphaeromimus, an ecotone shift occurred only once: the spiny forest species Sphaeromimus musicus forms the sister-clade to the species collected in rainforests and littoral rainforests. The two species of the Malagasy genus Zoosphaerium which express island gigantism form a monophyletic group in some trees, but these trees lack good statistical support. Deeper nodes inside the Sphaerotheriida, like the position of the Australian genera Procyliosoma and Epicyliosoma, the Southeast Asian family Zephroniidae and the South African genus Sphaerotherium could not be resolved. This study is the first genetic study inside the order Sphaerotheriida

  14. The Pill Really Can Be Mightier Than the Sword: A Response to Recent Commentaries

    Directory of Open Access Journals (Sweden)

    Malcolm Potts

    2016-03-01

    Full Text Available We appreciate the four commentaries that add new material and fresh perspectives to our article “The pill is mightier than the sword.” In emphasizing the role of voluntary family planning and girls’ education as achievable strategies with a potential to make the world a more peaceable place, we did not mean to oversimplify or disregard the intrinsic complexity of human conflict. On the whole, the commentators support and add to our thesis, although we question Pillai and Ya-Chien Wang’s suggestion that we may have overstated the unique human predisposition to kill our own species. We present additional data on male team aggression.

  15. Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC Drugs: Time to Take a Bitter Pill

    Directory of Open Access Journals (Sweden)

    Geetha Mani

    2016-10-01

    Full Text Available Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC drugs are an emerging public health concern in India. With one of the huge pharmaceutical sectors in the world, India has a varied prevalence of SSSFC drugs ranging from 0.04% to 34% according to various studies. Apart from severe health consequences, SSSFC drugs also weaken community's trust in the health care system. India is tackling the epidemic of SSSFC drugs through various existing and new regulatory measures. Considering the calamitous consequences of this silent epidemic, it is time to prescribe a bitter pill.

  16. How do levonorgestrel-only emergency contraceptive pills prevent pregnancy? Some considerations.

    Science.gov (United States)

    Mozzanega, Bruno; Cosmi, Erich

    2011-06-01

    Controversial opinions exist about the possible mechanisms throughout emergency contraception prevents pregnancy. Recently, the International Federation of Gynaecology and Obstetrics and the International Consortium for Emergency Contraception released a Joint Statement declaring that 'inhibition or delay of ovulation should be their primary and possibly only mechanism of action'. They still added that 'Review of the evidence suggests that LNG-ECPs cannot prevent implantation'. Concerning levonorgestrel-only emergency contraceptive pills effects on ovulation, the Statement based on seven reference papers which considered a total of only 142 patients, divided into still different subgroups. Basing on their same references we got quite different conclusions.

  17. Pill in the blister pack: a rare cause of dysphagia in an elderly adult

    Science.gov (United States)

    Laeeq, Syed Mudassir; Rai, Ayesha Aslam; Tasneem, Abbas Ali; Luck, Nasir Hassan; Majid, Zain

    2015-01-01

    Foreign body impaction in the esophagus amongst adults is not a common cause of dysphagia. Fish bone, food bolus, dentures may cause symptoms of dysphagia, odynophagia, chest pain or respiratory distress. It needs prompt evaluation along with removal of the substance either surgically or endoscopically to avoid the development of life threatening complications. Here we are reporting a case of an elderly male, who presented to us with a history of absolute dysphagia for one week, as a consequence of ingestion of a pill in blister pack. PMID:26918072

  18. Space dosimetry measurement results using the Pille instrument during the EUROMIR/NASAMIR space flights

    International Nuclear Information System (INIS)

    Hejja, I.; Apathy, J.; Deme, S.

    1997-01-01

    The Pille dosimeter developed in Hungary for space applications is described briefly, and its two versions are presented for the two space flights. The results of the EUROMIR mission in 1995-1996 are discussed for positional dosimetric applications. The characteristic dose rates at various space stations in the Salyut range are displayed. The NASAMIR4 mission between January 1997 and September 1998 are also discussed from the dosimetric point of view. The results of the measurements are presented and a preliminary analysis is reported. (R.P.)

  19. The Role of Oral Contraceptive Pills on Increased Risk of Breast Cancer in Iranian Populations: A Meta-analysis.

    Science.gov (United States)

    Soroush, Ali; Farshchian, Negin; Komasi, Saeid; Izadi, Neda; Amirifard, Nasrin; Shahmohammadi, Afshar

    2016-12-01

    Cancer is one of the main public health issues in the world. Breast cancer is one of the most common types of cancer among women. It is also the second cause of mortality in women. The association between the use of oral contraceptive pills and breast cancer is controversial and a main issue in public health. Some findings have shown that taking these pills does not have a significant effect in increasing the risk of breast cancer, while others have confirmed the carcinogenic effect of these products. These contradictory findings necessitated this meta-analysis, through of all correlated studies in Iran. All published studies were considered from June 2000 until June 2015, using reliable Latin databases like PubMed, Google Scholar, Google search, Scopus, and Science Direct, and Persian database like SID, Irandoc, IranMedex, and Magiran. Finally, 26 papers were selected: 24 studies were case control while two were population based studies. A total of 26 papers with 46,260 participants were assessed since 2001. Overall estimate of OR for the effect of oral contraceptive pills on breast cancer is 1.521 (CI = 1.25-1.85), which shows that the intervention group had more chance (52%) compared to the control group ( P = 0.001). Using these pills increased the risk of breast cancer up to 1.52 times. Because of directly increasing levels of estrogen and the role of estrogen in gaining weight indirectly, oral contraceptive pills can stimulate the occurrence of breast cancer. More studies should be conducted for controlling the period of pill use.

  20. Comparing the effects of low-dose contraceptive pills to control dysfunctional uterine bleeding by oral and vaginal methods.

    Science.gov (United States)

    Mehrabian, Ferdous; Abbassi, Fariba

    2013-09-01

    Background and Objective : Contraceptive pills are generally taken orally and can cause side effects such as nausea, vomiting and hypertension. The vaginal use of these pills can reduce such complications. Our objective was to compare the efficacy and side effects of low dose contraceptive pills by oral and vaginal route in the management of dysfunctional uterine bleeding-(DUB) Methods: This comparative observational study was conducted at Beheshti and Alzahra (SA) teaching hospitals, affiliated to Isfahan University of Medical Sciences in 2010-2011. One hundred women who presented with DUB were randomly assigned into two groups of equal number, receiving the low dose oral contraceptive pills by oral or vaginal route for three month. The amount and duration of bleeding were compared at the beginning and at the end of the study and side effects by these two methods compared. The results of this study showed that both oral and vaginal routes effectively reduced the duration and amount of bleeding due to DUB after three courses of treatment. This effect was better in the vaginal method compared with oral administration (P = 0.03). Regarding the side effects, nausea and vomiting were significantly higher in the oral group than in the vaginal group (P = 0.03). Vulvovaginitis infection was more frequent in the vaginal group than in the oral group (P = 0.03). Low dose contraceptive pills are effective in reducing the amount, time, and duration of bleeding in patients with DUB. In addition, reduction of gastrointestinal side effects by vaginal route helps to use these pills by the patient with proper training of physicians, midwives and patients.

  1. The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis

    NARCIS (Netherlands)

    van Galen, Katy A.; Nellen, Jeannine F.; Nieuwkerk, Pythia T.

    2014-01-01

    Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched

  2. A "Suicide Pill" for Older People: Attitudes of Physicians, the General Population, and Relatives of Patients Who Died after Euthanasia or Physician-Assisted Suicide in the Netherlands

    Science.gov (United States)

    Rurup, Mette L.; Onwuteaka-Philipsen, Bregje D.; van der Wal, Gerrit; van der Heide, Agnes; van Der Maas, Paul J.

    2005-01-01

    In the Netherlands there has been ongoing debate in the past 10 years about the availability of a hypothetical "suicide pill", with which older people could end their life in a dignified way if they so wished. Data on attitudes to the suicide pill were collected in the Netherlands from 410 physicians, 1,379 members of the general…

  3. Shexiang Baoxin Pills for Coronary Heart Disease in Animal Models: Preclinical Evidence and Promoting Angiogenesis Mechanism

    Directory of Open Access Journals (Sweden)

    Ke-Jian Zhang

    2017-06-01

    Full Text Available Shexiang Baoxin Pill (SBP originated from a classical TCM Fufang Suhexiang Pill for chest pain with dyspnea in the Southern Song Dynasty (1107–110 AD. Here, we aimed to evaluate preclinical evidence and possible mechanism of SBP for experimental coronary heart disease (CHD. Studies of SBP in animal models with CHD were identified from 6 databases until April 2016. Study quality for each included article was evaluated according to the CAMARADES 10-item checklist. Outcome measures were myocardial infarction area, vascular endothelial growth factor (VEGF and microvessel count (MVC. All the data were analyzed by using RevMan 5.1 software. As a consequence, 25 studies with 439 animals were identified. The quality score of studies ranged from 2 to 5, with the median of 3.6. Meta-analysis of seven studies showed more significant effects of SBP on the reduction of the myocardial infarction area than the control (P < 0.01. Meta-analysis of eight studies showed significant effects of SBP for increasing VEGF expression compared with the control (P < 0.01. Meta-analysis of 10 studies indicated that SBP significantly improved MVC compared with the control (P < 0.01. In conclusion, these findings preliminarily demonstrated that SBP can reduce myocardial infarction area, exerting cardioprotective function largely through promoting angiogenesis.

  4. Over-the-counter MTP Pills and Its Impact on Women's Health.

    Science.gov (United States)

    Sarojini; Ashakiran, T R; Bhanu, B T; Radhika

    2017-02-01

    To study the complications and consequences including maternal morbidity and mortality following indiscriminate self-consumption of abortion pills reporting to a tertiary care center. This is an observational study conducted at Vanivilas hospital between January 2012 to December 2013 for 24 months. After applying inclusion and exclusion criteria, 104 women were studied with respect to period of gestation, parity, clinical features at presentation and management in the institution. An analysis of maternal morbidity and mortality was done with respect to surgical interventions, ICU admissions, need for blood transfusions and maternal deaths. In this study, there were 75 (72.2 %) cases of incomplete abortion, 10 (9.6 %) cases of missed abortion, 2 (1.9 %) cases of ruptured ectopic and 2 (1.9 %) cases of rupture uterus. Seventy-eight (75 %) cases received blood transfusion, 7 (6.7 %) were admitted to ICU, and 2 (1.9 %) developed acute kidney injury. There were 2 (1.9 %) maternal deaths in the study group. This study shows urgent need for legislation and restriction of drugs used for medical termination of pregnancy. Drugs should be made available via health care facilities under supervision to reduce maternal mortality and morbidity due to indiscriminate use of these pills.

  5. Low-cost, high-performance nonevaporable getter pumps using nonevaporable getter pills

    International Nuclear Information System (INIS)

    Kodama, Hiraku; Ohno, Shinya; Tanaka, Masatoshi; Tanaka, Masato; Okudaira, Koji K.; Mase, Kazuhiko; Kikuchi, Takashi

    2016-01-01

    Nonevaporable getter (NEG) pumps are widely used for maintaining a clean ultrahigh vacuum (UHV) of ≤10"−"8" Pa because of their high pumping speeds for hydrogen (H_2) and active gases in the UHV region. In addition, they are oil free, evaporation free, sputtering free, sublimation free, magnetic field free, vibration free, economical, compact, lightweight, and energy saving. In the present paper, the authors report a new NEG pump which is composed of commercial 60 NEG pills (ϕ10 × 3 mm; 70 wt. % Zr, 24.6 wt. % V, and 5.4 wt. % Fe), titanium parts, a DN 40 conflat flange, and a tantalum heater. The NEG pills are vertically and radially aligned around the heater to maximize the effective area for pumping. After activation at 400 °C for 30 min, the pumping speeds of the NEG pump were measured with the orifice method. Pumping speeds of 140–130, 200–140, 190–130, and 35–17 l/s were estimated for H_2, CO, CO_2, and N_2 gasses, respectively, in a pumped-quantity range of 0.01–0.1 Pa l. Since the NEG pump is composed of a heating unit and a NEG module, the pumping speeds can be improved by increasing the number of NEG modules. These NEG pumps are favorable alternatives to sputtering ion pumps or titanium sublimation pumps.

  6. Why use of dienogest for the first contraceptive pill with estradiol?

    Science.gov (United States)

    Mueck, Alfred O; Seeger, Harald; Bühling, Kai J

    2010-02-01

    Dienogest (DNG) has the essential properties of an effective progestogen for use in a new contraceptive pill using estradiol valerate as estrogenic component -- it inhibits ovulation and protects against endometrial proliferation. DNG is a derivative of norethisterone (NET), but has a cyanomethyl- instead of an ethinyl-group in C17 position which may offer a variety of benefits regarding hepatic effects. The similarity to NET is reflected in the high endometriotropy and in similar pharmacokinetics like short plasma half-live and high bioavailability. However, DNG also elicits properties of progesterone derivatives like neutrality in metabolic and cardiovascular system and considerable antiandrogenic activity, the latter increased by lack of binding to SHBG as specific property of DNG. It has no glucocorticoid and antimineralocorticoid activity and has no antiestrogenic activity with the consequence that possible beneficial estradiol effects should not be antagonized. This may be of special importance for the tolerability and safety of the first pill with estradiol valerate instead of ethinylestradiol, although well-designed postmarketing studies are still ongoing to demonstrate what can be expected on the basis of pharmacology.

  7. When can a woman resume or initiate contraception after taking emergency contraceptive pills? A systematic review.

    Science.gov (United States)

    Salcedo, Jennifer; Rodriguez, Maria I; Curtis, Kathryn M; Kapp, Nathalie

    2013-05-01

    Hormonal emergency contraception can postpone ovulation, making a woman vulnerable to pregnancy later in the same cycle. However, concern exists as to whether concurrently administered emergency contraception pills (ECP) and other hormonal methods of contraception may affect the effectiveness of both medications. A systematic review of the literature using PubMed and the Cochrane databases was performed to identify articles concerning the resumption or initiation of regular contraception within the same cycle as ECP use. We searched for articles in any language, published between 1980 and April 2012 and included all methods of emergency contraception pills available in the USA. The search strategy identified 184 articles in the PubMed and Cochrane databases, of which none met inclusion criteria. The drug manufacturer advises continuation or initiation of routine contraception as soon as possible after use of ulipristal acetate, with concomitant use of a reliable barrier method until next menses. However, a theoretical concern exists that given ulipristal acetate's function as a selective progesterone receptor modulator, coadministration of a progestin could decrease its effectiveness as an emergency contraceptive. Initiation of hormonal contraception following levonorgestrel or the Yuzpe regimen for emergency contraception carries no similar concern for decreased method effectiveness. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Evaluation of pharmacists' services for dispensing emergency contraceptive pills in Delhi, India: A mystery shopper study

    Directory of Open Access Journals (Sweden)

    Pikee Saxena

    2016-01-01

    Full Text Available Background: Although emergency contraceptive pills are available over the counter, the quality of consultation, including key areas of contraceptive counseling and prevention of sexually transmitted infections (STI, has not been well documented. Objective: To evaluate actual pharmacist services while dispensing emergency contraception through a mystery shopper technique. Material and Methods: This cross-sectional study was conducted in 81 pharmacies situated in Delhi by 4 trained mystery shoppers posed as customers over a period of 6 months. Results: None of the pharmacists asked about the time lapsed since last unprotected sexual intercourse or last menstrual period before deciding the eligibility of the customer. The majority were unclear about side effects associated with emergency contraception (78.57% or with anticipated changes in menstrual flow (78.57%; 85.71% did not know whether subsequent unprotected intercourse would be protected. Only 15.71% counseled shoppers regarding risk of STI on asking leading questions and 88.5% did not provide any contraceptive advice. Conclusion: There is a huge gap in the technical knowledge and mindset of the pharmacists when it comes to checking for the eligibility of the client and providing advice regarding use of regular contraception and barrier for protection from STI, which needs to be addressed in order to realize the full benefit of making emergency contraceptive pills available over the counter.

  9. Methamphetamine Pills

    Science.gov (United States)

    ... Alzheimer’s disease. What are signs of use? Irritability/aggression Anxiety Nervousness Convulsions Insomnia Source : National Institute on Drug Abuse (NIDA) ; Drug Enforcement Agency (DEA) Related Drugs Methamphetamine ( ...

  10. Temperature Pill

    Science.gov (United States)

    1988-01-01

    Ingestible Thermal Monitoring System was developed at Johns Hopkins University as means of getting internal temperature readings for treatments of such emergency conditions as dangerously low (hypothermia) and dangerously high (hyperthermia) body temperatures. ITMS's accuracy is off no more than one hundredth of a degree and provides the only means of obtaining deep body temperature. System has additional applicability in fertility monitoring and some aspects of surgery, critical care obstetrics, metabolic disease treatment, gerontology (aging) and food processing research. Three-quarter inch silicone capsule contains telemetry system, micro battery, and a quartz crystal temperature sensor inserted vaginally, rectally, or swallowed.

  11. An assessment of the quality of advice provided by patent medicine vendors to users of oral contraceptive pills in urban Nigeria

    Directory of Open Access Journals (Sweden)

    Ujuju C

    2014-04-01

    Full Text Available Chinazo Ujuju,1 Samson B Adebayo,2 Jennifer Anyanti,3 Obi Oluigbo,3 Fatima Muhammad,4 Augustine Ankomah5 1Research and Evaluation Division, Society for Family Health, Abuja, Nigeria; 2Planning, Research and Statistics Directorate, National Agency for Food and Drug Administration and Control, Abuja, Nigeria; 3Technical Services Directorate, Society for Family Health, Abuja, Nigeria; 4Family Planning Directorate, Society for Family Health, Abuja, Nigeria; 5Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Legon, Accra, Ghana Introduction: In Nigeria about 50% of oral contraceptive pill users obtain their products from proprietary patent medicine vendors (PPMVs. This group of service providers are poorly trained and have very limited knowledge about contraception. This paper investigated the nature of the advice offered to simulated current and potential users of oral contraceptive pills. The main objective was to assess the nature and quality of advice provided by PPMVs to pill users. Method: This study is based on findings from a 'mystery client' approach in which three scenarios related to contraceptive pill use were simulated. Each of the 12 mystery clients simulated one of the following three scenarios: new pill users (new to family planning or switching from condom to pills; user seeking a resupply of pills; and dissatisfied pill users intending to discontinue use. Simple random sampling was used to select 410 PPMVs from a total of 1,826 in four states in Nigeria. Qualitative study using in-depth interviews was also conducted. Results: A majority of the PPMVs had pills in stock on the day of the survey and resupplied pills to the clients. PPMVs also understood the reason and importance of referring clients who were new adopters of oral contraceptive methods to a health facility; 30% of the PPMVs referred new adopters to a health facility. However, demand from clients who do not want to go

  12. Safety, tolerability and pharmacokinetics of doravirine, a novel HIV non-nucleoside reverse transcriptase inhibitor, after single and multiple doses in healthy subjects.

    Science.gov (United States)

    Anderson, Matt S; Gilmartin, Jocelyn; Cilissen, Caroline; De Lepeleire, Inge; Van Bortel, Luc; Dockendorf, Marissa F; Tetteh, Ernestina; Ancona, June K; Liu, Rachael; Guo, Ying; Wagner, John A; Butterton, Joan R

    2015-01-01

    Doravirine is a novel non-nucleoside inhibitor of HIV-1 reverse transcriptase with potent activity against wild-type virus (95% inhibitory concentration 19 nM, 50% human serum). Doravirine has low potential to cause drug-drug interactions since it is primarily eliminated by oxidative metabolism and does not inhibit or significantly induce drug-metabolizing enzymes. The pharmacokinetics and safety of doravirine were investigated in two double-blind, dose-escalation studies in healthy males. Thirty-two subjects received single doses of doravirine (6-1,200 mg) or matching placebo tablets; 40 subjects received doravirine (30-750 mg) or matching placebo tablets once daily for 10 days. In addition, the effect of doravirine (120 mg for 14 days) on single-dose pharmacokinetics of the CYP3A substrate midazolam was evaluated (10 subjects). The maximum plasma concentration (Cmax) of doravirine was achieved within 1-5 h with an apparent terminal half-life of 12-21 h. Consistent with single-dose pharmacokinetics, steady state was achieved after approximately 7 days of once daily administration, with accumulation ratios (day 10/day 1) of 1.1-1.5 in the area under the plasma concentration-time curve during the dosing interval (AUC0-24 h), Cmax and trough plasma concentration (C24 h). All dose levels produced C24 h>19 nM. Administration of 50 mg doravirine with a high-fat meal was associated with slight elevations in AUC time zero to infinity (AUC0-∞) and C24 h with no change in Cmax. Midazolam AUC0-∞ was slightly reduced by coadministration of doravirine (geometric mean ratio 0.82, 90% CI 0.70, 0.97). There was no apparent relationship between adverse event frequency or intensity and doravirine dose. No rash or significant central nervous system events other than headache were reported. Doravirine is generally well tolerated in single doses up to 1,200 mg and multiple doses up to 750 mg once daily for up to 10 days, with a pharmacokinetic profile supportive of once-daily

  13. Using Caffeine Pills for Performance Enhancement. An Experimental Study on University Students’ Willingness and Their Intention to Try Neuroenhancements

    Science.gov (United States)

    Brand, Ralf; Koch, Helen

    2016-01-01

    Recent research has indicated that university students sometimes use caffeine pills for neuroenhancement (NE; non-medical use of psychoactive substances or technology to produce a subjective enhancement in psychological functioning and experience), especially during exam preparation. In our factorial survey experiment, we manipulated the evidence participants were given about the prevalence of NE amongst peers and measured the resulting effects on the psychological predictors included in the Prototype-Willingness Model of risk behavior. Two hundred and thirty-one university students were randomized to a high prevalence condition (read faked research results overstating usage of caffeine pills amongst peers by a factor of 5; 50%), low prevalence condition (half the estimated prevalence; 5%) or control condition (no information about peer prevalence). Structural equation modeling confirmed that our participants’ willingness and intention to use caffeine pills in the next exam period could be explained by their past use of neuroenhancers, attitude to NE and subjective norm about use of caffeine pills whilst image of the typical user was a much less important factor. Provision of inaccurate information about prevalence reduced the predictive power of attitude with respect to willingness by 40-45%. This may be because receiving information about peer prevalence which does not fit with their perception of the social norm causes people to question their attitude. Prevalence information might exert a deterrent effect on NE via the attitude-willingness association. We argue that research into NE and deterrence of associated risk behaviors should be informed by psychological theory. PMID:26903909

  14. Using Caffeine Pills for Performance Enhancement. An Experimental Study on University Students' Willingness and Their Intention to Try Neuroenhancements.

    Science.gov (United States)

    Brand, Ralf; Koch, Helen

    2016-01-01

    Recent research has indicated that university students sometimes use caffeine pills for neuroenhancement (NE; non-medical use of psychoactive substances or technology to produce a subjective enhancement in psychological functioning and experience), especially during exam preparation. In our factorial survey experiment, we manipulated the evidence participants were given about the prevalence of NE amongst peers and measured the resulting effects on the psychological predictors included in the Prototype-Willingness Model of risk behavior. Two hundred and thirty-one university students were randomized to a high prevalence condition (read faked research results overstating usage of caffeine pills amongst peers by a factor of 5; 50%), low prevalence condition (half the estimated prevalence; 5%) or control condition (no information about peer prevalence). Structural equation modeling confirmed that our participants' willingness and intention to use caffeine pills in the next exam period could be explained by their past use of neuroenhancers, attitude to NE and subjective norm about use of caffeine pills whilst image of the typical user was a much less important factor. Provision of inaccurate information about prevalence reduced the predictive power of attitude with respect to willingness by 40-45%. This may be because receiving information about peer prevalence which does not fit with their perception of the social norm causes people to question their attitude. Prevalence information might exert a deterrent effect on NE via the attitude-willingness association. We argue that research into NE and deterrence of associated risk behaviors should be informed by psychological theory.

  15. Sex, tensions and pills : Young people’s use of contemporary reproductive and sexual health technologies in Addis Ababa, Ethiopia

    NARCIS (Netherlands)

    Both, R.E.C.

    2017-01-01

    This study sheds light on why some young men and women from diverse backgrounds in Addis Ababa use emergency contraceptive pills (ECs) and sildenafil citrate (Viagra) repeatedly, sometimes in a routinized manner. It unravels the reasons behind the frequent yet secretive purchasing of these two

  16. Effect of progestin vs. combined oral contraceptive pills on lactation: A double-blind randomized controlled trial

    Science.gov (United States)

    Espey, Eve; Ogburn, Tony; Leeman, Larry; Singh, Rameet; Schrader, Ronald

    2013-01-01

    Objective To estimate the effect of progestin-only vs. combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation and patient satisfaction with breastfeeding and contraceptive method. Methods In this randomized controlled trial, postpartum breastfeeding women who desired oral contraceptives were assigned to progestin-only vs. combined hormonal contraceptive pills. At two and eight weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length and head circumference were assessed at eight weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using chi-square tests, Fisher’s Exact test, or two-sample t-tests as appropriate. Results Breastfeeding continuation rates, contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Conclusions Choice of combined or progestin-only birth control pills administered two weeks postpartum did not adversely affect breastfeeding continuation. PMID:22143258

  17. 'Older peoples' attitudes towards euthanasia and an end-of-life pill in The Netherlands: 2001-2009

    NARCIS (Netherlands)

    Buiting, H.M.; Deeg, D.J.H.; Knol, D.L.; Ziegelmann, J.P.; Pasman, H.R.W.; Widdershoven, G.A.; Onwuteaka-Philipsen, B.D.

    2012-01-01

    Introduction With an ageing population, end-of-life care is increasing in importance. The present work investigated characteristics and time trends of older peoples' attitudes towards euthanasia and an end-of-life pill. Methods Three samples aged 64 years or older from the Longitudinal Ageing Study

  18. Overdose of oral contraceptive pills as a means of intentional self-poisoning amongst young women in Sri Lanka

    DEFF Research Database (Denmark)

    Weerasinghe, Manjula; Konradsen, Flemming; Eddleston, Michael

    2017-01-01

    OBJECTIVE: Oral contraceptive pills (OCPs) are one of the most popular family planning methods in Sri Lanka. As part of two hospital-based studies on self-harm, the use of OCPs was identified, from yet unpublished results, as a means of intentional self-poisoning. To inform future guidelines for ...

  19. Therapeutic effect of the compound Danshen dripping pill combined with laser acupoint irradiation on early diabetic retinopathy

    Science.gov (United States)

    Liu, Hui-Hui; Xiong, Guo-Xin; Zhang, Li-Ping

    2017-06-01

    To investigate the therapeutic effect of the compound Danshen dripping pill combined with laser acupoint irradiation on early diabetic retinopathy, 19 patients with early diabetic retinopathy were randomly divided into a treatment group and a control group. The TaiYang, YangBai, YuYao and ZanZhu acupoints of patients in the treatment group were irradiated with a semiconductor laser combined with the oral compound Danshen dropping pills, while those in the control group only used the oral compound Danshen dropping pills. The indicators of vision, mean defect of light sensitivity in the visual field, renal function and fasting blood glucose, were examined to evaluate the efficacy. After treatment, the above indicators of patients in the two groups were significantly improved and there was a significant difference between the two groups. This showed that the compound Danshen dripping pills combined with the laser acupoint irradiation can improve the ischemic and anoxic state of early diabetic retinopathy and improve the visual field.

  20. Seasonal abundance and activity of pill millipedes ( Arthrosphaera magna) in mixed plantation and semi-evergreen forest of southern India

    Science.gov (United States)

    Ashwini, Krishna M.; Sridhar, Kandikere R.

    2006-01-01

    Seasonal occurrence and activity of endemic pill millipedes ( Arthrosphaera magna) were examined in organically managed mixed plantation and semi-evergreen forest reserve in southwest India between November 1996 and September 1998. Abundance and biomass of millipedes were highest in both habitats during monsoon season. Soil moisture, conductivity, organic carbon, phosphate, potassium, calcium and magnesium were higher in plantation than in forest. Millipede abundance and biomass were about 12 and 7 times higher in plantation than in forest, respectively ( P 0.05). Millipede abundance and biomass were positively correlated with rainfall ( P = 0.01). Besides rainfall, millipedes in plantation were positively correlated with soil moisture as well as temperature ( P = 0.001). Among the associated fauna with pill millipedes, earthworms rank first followed by soil bugs in both habitats. Since pill millipedes are sensitive to narrow ecological changes, the organic farming strategies followed in mixed plantation and commonly practiced in South India seem not deleterious for the endangered pill millipedes Arthrosphaera and reduce the risk of local extinctions.

  1. Mida teie oma tervise heaks teete? / Ly Jagor, Ülle Mihhailova, Ene Pill, Katrin Käbin...[jt.

    Index Scriptorium Estoniae

    2008-01-01

    Küsimusele vastavad Pärnu Õppenõustamiskeskuse psühholoog Ly Jagor, Maasika lasteaia juhataja asetäitja Ülle Mihhailova, Tallinna Perekeskuse ja Tähetorni lastekeskuse psühholoog Ene Pill, Tallinna Nõmme Noortemaja väikelaste ringijuht Katrin Käbin, Tääksi Põhikooli õpetaja Silva Kolk

  2. Integrative description of two new species of Malagasy chirping giant pill-millipedes, genus Sphaeromimus (Diplopoda: Sphaerotheriida: Arthrosphaeridae

    Directory of Open Access Journals (Sweden)

    Leif Moritz

    2017-12-01

    Full Text Available The species-rich giant pill-millipedes (Sphaerotheriida often represent a microendemic component of Madagascar’s mega-invertebrate fauna. Of the chirping genus Sphaeromimus de Saussure & Zehntner, 1902, ten species have been described. Here, we describe two new species of Sphaeromimus integratively, combining light microscopy, scanning electron microscopy, DNA barcoding and micro-CT technology for the first time in a taxonomic description of a giant pill-millipede. S. kalambatritra sp. nov. and S. midongy sp. nov. are the first giant pill-millipedes collected and described from the mountainous rainforests of Kalambatritra and Midongy. Both species show island gigantism compared to their congeners. Our analysis of the mitochondrial COI gene shows that the two species are related to one another with a moderate genetic distance (9.4%, while they are more closely related to an undetermined specimen from the forest of Vevembe (6.3% and 8.4%. They stand in a basal position with S. ivohibe Wesener, 2014 and S. musicus (de Saussure & Zehntner, 1897. The four aforementioned species share a high number of stridulation ribs on the male harp. Our micro-CT analysis provides a look into the head of S. kalambatritra sp. nov. and shows that non-destructive CT methods are a useful tool for studying the inner morphology of giant pill-millipedes.

  3. Poison pills: A defensive measure against a hostile takeover or a demonstration of power of the target company

    Directory of Open Access Journals (Sweden)

    Jovanović-Zattila Milena

    2014-01-01

    Full Text Available The balance of power is particularly at stake in hostile takeovers, which makes the issue of establishing the balance of power one of the most controversial issues in the contemporary company law. In the circumstances of direct market competition and the need to have a dominant market position, companies are necessarily forced to constantly upgrade and advance their offensive and defensive methods, techniques and strategies. In order to prevent a hostile takeover, the target company may resort to an array of defence mechanisms, the most prominent of which are 'poison pills'. In spite of being perceived as the most powerful tool for obstructing hostile takeovers (and commonly designated as the 'Holy Grail' among the defensive mechanisms, there are many pros and cons underlying their application. One of the positive effects of using the poison pills is that the fear of takeovers makes the target company management more disciplined and efficient in business operations. The negative consequences are reflected in the relationship between the company board of directors and the shareholders. The target company management makes a unilateral decision on using a poison pill and this decision does not have to be approved by the shareholders in the General Meeting; however, this is highly inconsistent with the basic principles of corporate governance. The asymmetry of information, where the management (an agent has disproportionately more relevant information at its disposal than the shareholders (principals, generates a conflict between the management and the shareholders. In company law, this agency problem is generally known as the principal-agent problem, which is most prominent in a takeover. Poison pills are often associated with the discrimination of the target company shareholders, but not necessarily. The controversial nature of this defensive measure which can be applied by the target company has given rise to numerous debates on the need to

  4. Dosimetric properties of the 'Pille' portable, wide dose range TLD reader

    International Nuclear Information System (INIS)

    Szabo, P.P.; Feher, I.; Deme, S.; Szabo, B.; Vagvoelgyi, J.

    1986-01-01

    The dosimetric properties of a portable TLD reader are described. The TLD system named 'Pille' or 'moth' consists of a lightweight battery-operated portable TLD reader and its CaSO 4 :Dy bulb dosemeters. The reproducibility of the TLD system at constant temperature was found to be better than + -2%, and the mean time between failures exceeded 5 years. The dose range of the system is wide, covering more than 6 orders of magnitude, from 5 μGy to 10 Gy. The energy dependence of the CaSO 4 :Dy bulb dosemeters is less than + - 20% above 100 keV in the energy compensation capsules. Without additional annealing, the bulb dosemeters can be re-used at least 100 times, which is an important aspect during in situ measurements. (author)

  5. Frequency of Candidiasis and Colonization of Candida albicans in Relation to Oral Contraceptive Pills.

    Science.gov (United States)

    Aminzadeh, Atousa; Sabeti Sanat, Ali; Nik Akhtar, Saeed

    2016-10-01

    Candidiasis, the infection caused by Candida albicans , is one of the most common infections of the oral cavity in humans. Candidiasis causes irritation and is known for its carcinogenic effects. Thus, it is important to recognize the predisposing factors for this opportunistic infection. Several previous studies have demonstrated an increased frequency of vaginal candidiasis in relation to oral contraceptive consumption. Only a few studies on the relation between oral contraceptives and oral candidiasis have been previously conducted. This study aims to evaluate the possible relation between oral contraceptive pills and oral candidiasis. This analytic, case-control study included 40 non-pregnant women divided into two groups: 20 who used oral contraceptive pills and 20 who did not. The groups were matched according to age, oral health, and past and present medical history. Samples were collected from the tongue's dorsum using a cotton swab and inoculated on CHROMagar culture plates. The frequency of positive cultures and the number of Candida colonies were compared between the two groups using independent t-tests and Mann-Whitney statistical tests with SPSS18 software. The frequency of positive cultures of Candida albicans was higher (P value = 0.03) for the case group. Also, the number of C. albicans and C. krusei was significantly higher for the case group compared to the control group (P value = 0.04, P value = 0.03). The results of the present study demonstrate that oral contraceptives containing estradiol can lead to Candida colonization in the oral cavity. It is recommended that further studies comparing the influence of oral contraceptives on Candida's adherence to the epithelium is highly recommended.

  6. Low-cost, high-performance nonevaporable getter pumps using nonevaporable getter pills

    Energy Technology Data Exchange (ETDEWEB)

    Kodama, Hiraku; Ohno, Shinya; Tanaka, Masatoshi [Faculty of Engineering, Yokohama National University, 79-5 Tokiwadai, Hodogaya-ku, Yokohama 240-8501 (Japan); Tanaka, Masato; Okudaira, Koji K. [Faculty of Engineering, Chiba University, 1-33 Yayoi-cho, Inage-ku 263-8522 (Japan); Mase, Kazuhiko, E-mail: mase@post.kek.jp; Kikuchi, Takashi [Institute of Materials Structure Science, KEK, 1-1 Oho, Tsukuba 305-0801 (Japan)

    2016-09-15

    Nonevaporable getter (NEG) pumps are widely used for maintaining a clean ultrahigh vacuum (UHV) of ≤10{sup −8 }Pa because of their high pumping speeds for hydrogen (H{sub 2}) and active gases in the UHV region. In addition, they are oil free, evaporation free, sputtering free, sublimation free, magnetic field free, vibration free, economical, compact, lightweight, and energy saving. In the present paper, the authors report a new NEG pump which is composed of commercial 60 NEG pills (ϕ10 × 3 mm; 70 wt. % Zr, 24.6 wt. % V, and 5.4 wt. % Fe), titanium parts, a DN 40 conflat flange, and a tantalum heater. The NEG pills are vertically and radially aligned around the heater to maximize the effective area for pumping. After activation at 400 °C for 30 min, the pumping speeds of the NEG pump were measured with the orifice method. Pumping speeds of 140–130, 200–140, 190–130, and 35–17 l/s were estimated for H{sub 2}, CO, CO{sub 2}, and N{sub 2} gasses, respectively, in a pumped-quantity range of 0.01–0.1 Pa l. Since the NEG pump is composed of a heating unit and a NEG module, the pumping speeds can be improved by increasing the number of NEG modules. These NEG pumps are favorable alternatives to sputtering ion pumps or titanium sublimation pumps.

  7. Shexiang Baoxin pills promotes angiogenesis in myocardial infarction rats via up-regulation of 20-HETE-mediated endothelial progenitor cells mobilization.

    Science.gov (United States)

    Huang, Feifei; Liu, Yang; Yang, Xia; Che, Di; Qiu, Kaifeng; Hammock, Bruce D; Wang, Jingfeng; Wang, Mong-Heng; Chen, Jie; Huang, Hui

    2017-08-01

    Therapeutic angiogenesis is a pivotal strategy for ischemic heart disease. The aim of the present study was to determine the effect and molecular mechanism of Shexiang Baoxin pills, a widely-used traditional Chinese medicine for ischemic heart disease, on angiogenesis in a rat model of myocardial infarction (MI). We used the occlusion of left anterior descending coronary artery of Sprague-Dawley rats as a model of MI. The MI rats were treated with distilled water, Shexiang Baoxin pills, or Shexiang Baoxin pills + HET0016 (a selective blocker of the biosynthesis of 20-hydroxyeicosatetraenoic acid (20-HETE) at 10 mg/kg/day), respectively. Sham-operated rats were used as controls. Treatment with Shexiang Baoxin pills increases the level of serum 20-HETE in MI rats, which can be suppressed by HET0016 treatment. Shexiang Baoxin pills shows cardio-protective effects on MI rats, including improving cardiac function, decreasing infarction area, and promoting angiogenesis in peri-infarct area. The protective effects of Shexiang Baoxin pills are partly inhibited by HET0016. Furthermore, Shexiang Baoxin pills enhances the number of circulating endothelial progenitor cells (EPCs) and the expression of the vascular endothelial growth factor (VEGF), based on immunohistochemical analysis, in peri-infarct area of MI rats, which is partly suppressed by HET0016. Shexiang Baoxin pills may partially participate in angiogenesis in MI rats. The protective mechanism of Shexiang Baoxin pills may be mediated via up-regulation of 20-HETE, which promotes EPCs mobilization and VEGF expression. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Emmanuel eStip

    2013-08-01

    Full Text Available Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill® and the BARS, in order to verify whether the DoPill® provides reliable assessment of medication adherence. Methods: The DoPill® is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill® or Treatment As Usual group (TAU for six weeks. The BARS was used as a reference measure. Results: Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67 % after six weeks. DoPill® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. Conclusion: These results suggest that DoPill® is a valid tool that provides more reliable and objective data for the clinician about their patient’s adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  9. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia.

    Science.gov (United States)

    Stip, Emmanuel; Vincent, Philippe D; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill(®) improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill(®) and the BARS, in order to verify whether the DoPill(®) provides reliable assessment of medication adherence. The DoPill(®) is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill(®) or treatment as usual groups for 6 weeks. The BARS was used as a reference measure. Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67% after 6 weeks. DoPill(®) recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. These results suggest that DoPill(®) is a valid tool that provides more reliable and objective data for the clinician about their patient's adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  10. Simultaneous quantification of catechin, epicatechin, liquiritin, isoliquiritin, liquiritigenin, isoliquiritigenin, piperine and glycyrrhetinic acid in rat plasma by HPLC-MS/MS: application to a pharmacokinetic study of Longhu Rendan pills.

    Science.gov (United States)

    Wang, Tianming; Ding, Liqing; Jin, Huajia; Shi, Rong; Li, Yuanyuan; Wu, Jiasheng; Li, Yifei; Zhu, Li; Ma, Yueming

    2016-08-01

    A sensitive, specific, accurate HPLC-MS/MS method was developed and validated for the simultaneous quantification of catechin, epicatechin, liquiritin, isoliquiritin, liquiritigenin, isoliquiritigenin, piperine and glycyrrhetinic acid from Longhu Rendan pills in rat plasma. Chromatographic separation was performed with a Hypersil Gold C18 column using a gradient of methanol and 0.01% acetic acid containing 0.2 mm ammonium acetate as mobile phase. The analytes were quantified on a triple quadrupole mass spectrometer, operating in selected reaction monitoring mode and switching the electrospray ion source polarity between positive and negative modes in a single run. The calibration curves of catechin, epicatechin, liquiritin, isoliquiritin, liquiritigenin, isoliquiritigenin, piperine and glycyrrhetinic acid were linear over the concentration ranges of 5-2000, 5-2000, 0.5-200, 0.5-200, 0.25-100, 0.25-100, 0.025-10 and 0.50-200 ng mL(-1) , respectively. The intra- and inter-assay precisions and accuracies were pills to rats. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  11. PillCam ESO in esophageal studies: improved diagnostic yield of 14 frames per second (fps) compared with 4 fps.

    Science.gov (United States)

    Koslowsky, B; Jacob, H; Eliakim, R; Adler, S N

    2006-01-01

    Capsule endoscopy, using the PillCam ESO and sending images at a rate of 4 frames per second (fps), has a high sensitivity and specificity in diagnosing gastroesophageal reflux disease (GERD) lesions. We tested a new device which produces images at a rate of 14 fps. The diagnostic performance and esophageal visualization of these two devices were compared. 42 patients with GERD symptoms and eight patients with a history of Barrett's esophagus had an esophagogastroduodenoscopy (EGD). All patients underwent capsule endoscopy of the esophagus within 1 hour prior to EGD. The first 25 patients had a capsule endoscopy examination with the 4-fps device. The following 25 patients underwent capsule endoscopy under identical conditions but using the 14-fps device. The reader of the capsule endoscopy study was blinded to the EGD findings. A diagnosis of GERD or Barrett's esophagus was established with EGD. The findings at capsule endoscopy were compared with the EGD findings. We also examined how frequently the esophagus in its entirety was visualized by these two devices. The 4-fps device diagnosed 16/19 cases of esophageal erosions or ulcers (sensitivity 84 %) and 6/8 cases of Barrett's esophagus (sensitivity 75 %). The 14-fps capsule diagnosed 16/16 cases of esophageal ulcers or erosions and 7/7 cases of Barrett's esophagus (sensitivity 100 %). The total diagnostic miss rate in the 4-fps group was 5/27 (18 %) whereas the diagnostic miss rate in the 14-fps group was 0/23 (0 %) P fps group and in 20/25 patients (80 %) in the 14-fps group ( P fps device and in 19/25 (76 %) by the 14-fps device ( P fps PillCam ESO capsule is consistent with the data obtained from fluoroscopic studies of swallowed PillCam capsules, showing that capsule speed may reach 20 cm/s. For the 14-fps PillCam this means one image transmitted per 3-cm segment at maximal capsule speed, therefore still allowing for full visualization of the entire esophagus. Capsule endoscopy using the 14-fps PillCam ESO

  12. The effects of 60Co γ-ray irradiation on the sterilization of ready-made traditional Chinese medicine cardiac pill

    International Nuclear Information System (INIS)

    Zou Weimin; Li Lizhu; Li Xuejun

    1989-01-01

    60 Co γ-ray irradiation and epoxy-ethane treatment were used to sterilize the cardiac pill. The results showed that 60 Co γ-ray irradiation with the dosage of 4350-13050 Gy was more effective, while the epoxy-ethane treatment was not. By analyzing the sample, the bacterial number in cardiac pill treated with epoxy-ethane was more than 10,000 cells/g. The cardiac pill, however, sterilized by 60 Co γ-ray was only 0-600 cells/g, which completely correspond to the national bacteral inspect standard. In this treatment, the pharmacological analysis was done with white mice and rabbits raised with irradiated cardiac pill. The results showed that there was no abnormality in the persistence of the cardiac muscle to anemia and resistance to abnormal rhythm of the heart

  13. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Stip, Emmanuel; Vincent, Philippe D.; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR...

  14. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Emmanuel eStip; Emmanuel eStip; Emmanuel eStip; Philippe D. Vincent; Philippe D. Vincent; Philippe D. Vincent; Catherine eGuevremont; Simon eZhornitsky; Constantin eTranulis; Constantin eTranulis; Constantin eTranulis; Juliette eSablier; Juliette eSablier

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improv...

  15. Awareness and attitudes towards emergency contraceptive pills among young people in the entertainment places, Vientiane City, Lao PDR

    OpenAIRE

    Sychareun, Vanphanom; Hansana, Visanou; Phengsavanh, Alongkone; Phongsavan, Keokedthong

    2013-01-01

    Background Emergency Contraception is not officially available to the public sector in Laos. The potential of emergency contraception to prevent unwanted pregnancies is well documented in developed countries, but in Laos no studies of ECPs exist. This study aimed to assess knowledge of and attitudes towards emergency contraceptive pills (ECPs) in Vientiane, the capital city of the Lao PDR. Methods A cross-sectional survey was conducted among 500 young adults in entertainment venues by using t...

  16. [Efficacy of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation].

    Science.gov (United States)

    Li, Jian-xin; Lu, Qing-ge

    2015-05-01

    To observe the clinical effectiveness of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation (PE). A total of 120 patients with secondary non-consolidated kidney qi PE were randomly assigned to groups A (aged [35.5 ± 5.4] yr), B (aged [36.2 ± 5.7] yr), and C (aged [35.2 ± 5.3] yr) in the ratio of 1:1:1 to receive Qilin Pills (once 6 g, bid), sertraline (once 50 mg, qd), and Qilin Pills plus sertraline, respectively, all for 4 weeks. The intravaginal ejaculatory latency time (IELT) and PE diagnostic tool (PEDT) scores were obtained before and after medication and at 1 month after drug withdrawal, and comparative analyses were made among the three groups of patients. The IELT was dramatically prolonged in groups A, B, and C after treatment ([3.23 ± 1.84], [3.87 ± 2.43], and [5.92 ± 3.11] min) and at 1 month after drug withdrawal ([1.85 ± 1.27], [1.52 ± 1.06], and [ 4.26 ± 1.88 ] min) as compared with the baseline ([0.88 ± 0.45], [0.84 ± 0.47], and [0.85 ± 0.50] min) (P Pills combined with sertraline has a definite efficacy in the treatment of secondary non-consolidated kidney qi PE and therefore deserves wide clinical application.

  17. Study pertaining to the distribution of iodine pills in the event of a nuclear mishap at the Gentilly II Station

    International Nuclear Information System (INIS)

    Corriveau, R.

    1992-01-01

    This study seeks to understand how volunteers, whose task it is to distribute iodine pills in the event of a nuclear mishap, are likely to react in such a situation. Our postulate is that the uniform application of preventative measures in an emergency situation requires that volunteers adhere to the principles of the ideological apparatus (civil authority). Our findings are that current measures are inadequate for an effective emergency strategy. (author)

  18. Acceptability of the use of cellular telephone and computer pictures/video for "pill counts" in buprenorphine maintenance treatment.

    Science.gov (United States)

    Welsh, Christopher

    2016-01-01

    As part of a comprehensive plan to attempt to minimize the diversion of prescribed controlled substances, many professional organization and licensing boards are recommending the use of "pill counts." This study sought to evaluate acceptability of the use of cellular phone and computer pictures/video for "pill counts" by patients in buprenorphine maintenance treatment. Patients prescribed buprenorphine/naloxone were asked a series of questions related to the type(s) of electronic communication to which they had access as well as their willingness to use these for the purpose of performing a "pill/film count." Of the 80 patients, 4 (5 percent) did not have a phone at all. Only 28 (35 percent) had a "smart phone" with some sort of data plan and Internet access. Forty (50 percent) of the patients had a phone with no camera and 10 (12.5 percent) had a phone with a camera but no video capability. All patients said that they would be willing to periodically use the video or camera on their phone or computer to have buprenorphine/naloxone pills or film counted as long as the communication was protected from electronic tampering. With the advent of applications for smart phones that allow for Health Insurance Portability and Accountability Act of 1996-compliant picture/video communication, a number of things can now be done that can enhance patient care as well as reduce the chances of misuse/diversion of prescribed medications. This could be used in settings where a larger proportion of controlled substances are prescribed including medication assisted therapy for opioid use disorders and pain management programs.

  19. Low-FODMAP vs regular rye bread in irritable bowel syndrome: Randomized SmartPill® study.

    Science.gov (United States)

    Pirkola, Laura; Laatikainen, Reijo; Loponen, Jussi; Hongisto, Sanna-Maria; Hillilä, Markku; Nuora, Anu; Yang, Baoru; Linderborg, Kaisa M; Freese, Riitta

    2018-03-21

    To compare the effects of regular vs low-FODMAP rye bread on irritable bowel syndrome (IBS) symptoms and to study gastrointestinal conditions with SmartPill ® . Our aim was to evaluate if rye bread low in FODMAPs would cause reduced hydrogen excretion, lower intraluminal pressure, higher colonic pH, different transit times, and fewer IBS symptoms than regular rye bread. The study was a randomized, double-blind, controlled cross-over meal study. Female IBS patients ( n = 7) ate study breads at three consecutive meals during one day. The diet was similar for both study periods except for the FODMAP content of the bread consumed during the study day. Intraluminal pH, transit time, and pressure were measured by SmartPill, an indigestible motility capsule. Hydrogen excretion (a marker of colonic fermentation) expressed as area under the curve (AUC) (0-630 min) was [median (range)] 6300 (1785-10800) ppm∙min for low-FODMAP rye bread and 10 635 (4215-13080) ppm∙min for regular bread ( P = 0.028). Mean scores of gastrointestinal symptoms showed no statistically significant differences but suggested less flatulence after low-FODMAP bread consumption ( P = 0.063). Intraluminal pressure correlated significantly with total symptom score after regular rye bread (ρ = 0.786, P = 0.036) and nearly significantly after low-FODMAP bread consumption (ρ = 0.75, P = 0.052). We found no differences in pH, pressure, or transit times between the breads. Gastric residence of SmartPill was slower than expected. SmartPill left the stomach in less than 5 h only during one measurement (out of 14 measurements in total) and therefore did not follow on par with the rye bread bolus. Low-FODMAP rye bread reduced colonic fermentation vs regular rye bread. No difference was found in median values of intraluminal conditions of the gastrointestinal tract.

  20. Using caffeine pills for performance enhancement. An experimental study on university students’ willingness and their intention to try neuroenhancements.

    Directory of Open Access Journals (Sweden)

    Ralf eBrand

    2016-02-01

    Full Text Available Recent research has indicated that university students sometimes use caffeine pills for neuroenhancement (NE; non-medical, non-addictive use of psychoactive substances or technology to produce a subjective enhancement in psychological functioning and experience, especially during exam preparation. In our factorial survey experiment we manipulated the evidence participants were given about the prevalence of NE amongst peers and measured the resulting effects on the psychological predictors included in the Prototype-Willingness Model of risk behavior. Two hundred and thirty-one university students were randomized to a high prevalence condition (read faked research results overstating usage of caffeine pills amongst peers by a factor of 5; 50%, low prevalence condition (half the estimated prevalence; 5% or control condition (no information about peer prevalence. Structural equation modeling confirmed that our participants’ willingness and intention to use caffeine pills in the next exam period could be explained by their past use of neuroenhancers, attitude to NE and subjective norm about use of caffeine pills whilst image of the typical user was a much less important factor. Provision of inaccurate information about prevalence reduced the predictive power of attitude with respect to willingness by 40 45%. This may be because receiving information about peer prevalence which does not fit with their perception of the social norm causes people to question their attitude. Prevalence information might exert a deterrent effect on NE via the attitude-willingness association. We argue that research into NE and deterrence of associated risk behaviors should be informed by psychological theory.

  1. Compare Lipid Profile and Anthropometric Indices and Blood Pressure in Women with and without Low-Dose Birth Control Pills

    Directory of Open Access Journals (Sweden)

    Ali dehghani

    2017-05-01

    Full Text Available Introduction: Contraceptive Pills Are Accepted Around the World. Since the Introduction of the Pillstheir Use Increases the Risk of Venous and Arterial Complications, but There Are Doubtson Whether Low-Dose (LD Estrogen Pills Could be a Risk factor. This Study Aimed to Examine the Lipid Profile in Women Exposed to (LD Oral Contraceptives Compared to Unexposed Women. Materials and methods: In This Mix Cohort, 100 Women Aged 20-35 Years Old Referring to Health Care Centers in Yazd, Iran Were Conducted Through Face to Face Interviews by the Researcher Who Asked for Demographic and Anthropometric Characteristics and Also Took Blood Samples for Measurement of Lipid Profile. The Data Were Analyzed using SPSS Version 21 and Chi-Square Test as Well as T-test. Results: In the Exposed Group Total Cholesterol (180/7 ± 38/28 mg dl-1, Triglycerides (129/82 ± 47/92 mg dl-1, LDL (101/42 ± 30/66 mg dl-1 Were Significantly Higher than the Unexposed Group (Total Cholesterol 159 ± 30/26 mg dl-1, Triglycerides 93/60 ± 44/01 mg dl-1 and LDL 84/84±24/70 mg dl-1.  However, HDLof the Exposed Group (56/46 ± 8/42 mg dl-1 Did not Showa Significant Differencein Comparison to the Unexposed Group (56/18 ± 8/91 mg dl-1 .  Conclusion  : LD Pills Increase Levels of Cholesterol, Triglycerides and LDL, so Taking these Pills may Cause Dyslipidemia.

  2. [Effect of jiaotai pill on pancreatic fat accumulation and islet cell apoptosis in rats with type 2 diabetes].

    Science.gov (United States)

    Zou, Xin; Liu, De-Liang; Lu, Fu-Er; Dong, Hui; Xu, Li-Jun; Luo, Yun-Huan; Wang, Kai-Fu

    2014-06-01

    In this study, the rat type 2 diabetes mellitus (T2DM) model was established through tail vein injection with low dose of streptozotocin (STZ) and high fat diet for 8 weeks, and then treated with Jiaotai Pill. The oral glucose tolerance test (OGTT), fasting serum insulin (FINS), free fatty acid(FFA) levels and blood lipid were assayed. HOMA-IR was calculated. Pancreatic pathology was performed. And pancreatic triglyceride (TG) content was examined by the lipid extraction method. Pancreatic islet cell apoptosis were detected by terminal dexynucleotidyl transferase (TdT)-mediated dUTP nick end labeling (TUNEL). According to the results, the model group showed abnormal OGTT, increased FINS, HOMA-IR, FFA, lipid disorder, obvious fat accumulation and significantly increased TG content in pancreatic tissues, and enhanced pancreatic islet cell apoptosis. Compared with the model group, the Jiaotai Pill group displayed improved OGTT, reduced FINS, HOMA-IR, FFA, recovered lipid disorder, decreased fat accumulation and significantly declined TG content in pancreatic tissues, and lowered pancreatic islet cell apoptosis. In summary, Jiaotai pill could effectively treat type 2 diabetes in rats. Its mechanism may be related to the reduction in pancreatic fat accumulation and islet cell apoptosis.

  3. Yueju Pill Rapidly Induces Antidepressant-Like Effects and Acutely Enhances BDNF Expression in Mouse Brain

    Directory of Open Access Journals (Sweden)

    Wenda Xue

    2013-01-01

    Full Text Available The traditional antidepressants have a major disadvantage in delayed onset of efficacy, and the emerging fast-acting antidepressant ketamine has adverse behavioral and neurotoxic effects. Yueju pill, an herb medicine formulated eight hundred years ago by Doctor Zhu Danxi, has been popularly prescribed in China for alleviation of depression-like symptoms. Although several clinical outcome studies reported the relative short onset of antidepressant effects of Yueju, this has not been scientifically investigated. We, therefore, examined the rapid antidepressant effect of Yueju in mice and tested the underlying molecular mechanisms. We found that acute administration of ethanol extract of Yueju rapidly attenuated depressive-like symptoms in learned helpless paradigm, and the antidepressant-like effects were sustained for at least 24 hours in tail suspension test in ICR mice. Additionally, Yueju, like ketamine, rapidly increased the expression of brain-derived neurotrophic factor (BDNF in the hippocampus, whereas the BDNF mRNA expression remained unaltered. Yueju rapidly reduced the phosphorylation of eukaryotic elongation factor 2 (eEF2, leading to desuppression of BDNF synthesis. Unlike ketamine, both the BDNF expression and eEF2 phosphorylation were revered at 24 hours after Yueju administration. This study is the first to demonstrate the rapid antidepressant effects of an herb medicine, offering an opportunity to improve therapy of depression.

  4. Microscopic identification of the remnant hair or feather of five animal drug components in Shenrongbian pill

    Directory of Open Access Journals (Sweden)

    Tingguo Kang

    2012-06-01

    Full Text Available A comparative study was performed to identify the microscopic characteristics of hair or feather in the five animal drug components contained in Shenrongbian pill. Penis et Testis Canis is 40±0.07 in the medulla index, with long circular, banana or triangular circular shaped medulla cells arranged in one line or network, and the hair cuticle is in imbrication (d, m and flat wave (p shape. Penis et Testis Equi is 66±0.10 in the medulla index, with ellipse, spindle or long strip-shaped medulla cells arranged in network, and the hair cuticle is in flat wave shape. Penis et Testis Bovis is 67±0.05 in the medulla index, with rectangle, spindle or polygon-shaped medulla cells arranged in ladder or network form, and the hair cuticle is in flat wave shape. Penis et Testis Mustelae is 29±0.05 in the medulla index, with ellipse-like, square-like or circular shaped medulla cells arranged in one line generally, and the hair cuticle is in acuminate (d, m, imbrication (m,p and slightly flat wave (p shape. Musculus et Bonis Passeris is 24±0.05 in the medulla index, with bamboo joint-shaped barbs and unclear medulla cells, without hair cuticle.

  5. Safety and effectiveness data for emergency contraceptive pills among women with obesity: a systematic review.

    Science.gov (United States)

    Jatlaoui, Tara C; Curtis, Kathryn M

    2016-12-01

    This study aims to determine whether emergency contraceptive pills (ECPs) are less safe and effective for women with obesity compared with those without obesity. We searched PubMed for articles through November 2015 regarding the safety and effectiveness of ECPs [ulipristal acetate (UPA), levonorgestrel (LNG) and combined estrogen and progestin] among obese users. We assessed study quality using the United States Preventive Services Task Force evidence grading system. We identified four pooled secondary analyses (quality: poor to fair), two of which examined UPA and three examined LNG formulations. Three analyses pooled overlapping data from a total of three primary studies and demonstrated significant associations between obesity and risk of pregnancy after ECP use. One analysis reported a 4-fold increased risk of pregnancy among women with obesity (BMI≥30kg/m 2 ) compared with women within normal/underweight categories (BMIcontraception; at weights less than 75 kg, the rate of pregnancy was less than 2%. Two analyses examining UPA suggested an approximate 2-fold increased risk of pregnancy among women with obesity compared with either normal/underweight women or nonobese (BMIemergency contraception options in order for them to understand their options, to receive advanced supplies of emergency contraception as needed and to understand how to access an emergency copper intrauterine device if desired. Copyright © 2016. Published by Elsevier Inc.

  6. Severe Erosive Pill Esophagitis Induced by Crizotinib Therapy: A Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Patrick Jung

    2016-01-01

    Full Text Available Previous case reports have described esophagitis thought to be secondary to crizotinib, an oral tyrosine-kinase inhibitor used in the treatment of anaplastic lymphoma kinase- (ALK- positive non-small cell lung cancer (NSCLC. In those reports, the interval development of esophagitis was between two days and three months after initiating or reinitiating crizotinib therapy. We present a woman who developed ulcerative esophagitis ten months after beginning crizotinib therapy, which is highly unusual. We believe the provoking factor was a change in her medication administration routine, done to accommodate religious practices during the period of Ramadan. This case illustrates the mechanism of pill esophagitis and reinforces the importance of patient education when it comes to medication administration. Clinicians may consider early imaging or investigations in patients with concerning symptomatology in the context of crizotinib therapy or other offending medications. Future research may help to uncover additional risk factors for this exceedingly rare diagnosis in this patient population. Most importantly, this case highlights nonpharmacologic ways to improve tolerability and decrease adverse effects of a highly effective chemotherapeutic agent.

  7. Antiplatelet Effects of Qishen Yiqi Dropping Pill in Platelets Aggregation in Hyperlipidemic Rabbits

    Directory of Open Access Journals (Sweden)

    Yi Wang

    2012-01-01

    Full Text Available We investigated the effects of Qishen Yiqi Dropping Pill (QSYQ on platelets aggregation and its possible mechanisms. Hyperlipidemic model in rabbits was produced by a high fat/cholesterol diet for 6 weeks, the therapeutic effect of QSYQ with 2.0 g/kg, 1.0 g/kg, and 0.5 g/kg was observed. Fourteen days after drug treatment, platelet aggregation induced by adenosine diphosphate (ADP, arachidonic acid (AA, and collagen (COLL was significantly reduced in rabbits of model group. Moreover, β-thromboglobulin (β-TG level decreased obviously but no significant change in P-selectin and platelet factor 4 (PF4 level, while QSYQ significantly decreased the ratio of thromboxane B2 (TXB2 to 6-keto-prostaglandin F1α (6-Keto-PGF1α and increased cyclic adenosine monophosphate (cAMP level in rabbits. In summary, QSYQ can improve platelets aggregation and inhibit the over-release of β-TG in hyperlipidemic rabbits; and the increased cAMP level may be involved in this process. These results suggest that the antiplatelet aggregation effect of QSYQ may be due to its ability to increase cAMP level for improving cAMP metabolism.

  8. A pill-box design, flow type, gas scintillation proportional counter

    International Nuclear Information System (INIS)

    Garg, S.P.; Sharma, R.C.; Bhati, S.; Somasundaram, S.

    1982-01-01

    A gas scintillation proportional counter of 'pill-box' design operated with argon + 2.5% nitrogen gas in continuous flow, has been developed. An energy resolution of 1.6% is obtained for 239 Pu α-particles emitted from a mixed nuclide source of 239 Pu- 241 Am- 244 Cm and injected into the counter parallel to the anode. The risetime of the scintillation pulse is found to be less than 0.5 μs. Measurements have been made of charge and light gain factors as a function of anode voltage. It is found that for a given anode voltage, the scintillation pulse amplitude increases sharply with the addition of nitrogen to argon and reaches a maximum at about 2.5% and then decreases slowly, whereas the charge pulse amplitude reduces monotonically. Nitrogen improvement factors with the addition of 2.5% nitrogen to argon are found to be different for two photomultipliers with different photocathode responses. The improvement in energy resolution as a result of addition of nitrogen to argon is discussed. Comments are made on the intrinsic energy resolution capabilities of such a counter. (orig.)

  9. Oral contraceptive pills: A risk factor for retinal vascular occlusion in in-vitro fertilization patients

    Directory of Open Access Journals (Sweden)

    Rohina S Aggarwal

    2013-01-01

    Full Text Available Retinal vascular occlusion is the most common cause of retinopathy leading to severe visual loss in all age groups. Central retinal vein occlusion (CRVO is usually seen in older age group and is often associated with systemic vascular diseases. Although the exact cause and effect relationship has not been proven, central retinal vein occlusion has been associated with various systemic pathological conditions, hence a direct review of systems toward the various systemic and local factors predisposing the central retinal vein occlusion is advocated. We describe the development of central retinal venous occlusion with associated cystoid macular edema (CME in two healthy infertile women who were recruited for in vitro fertilization cycle for infertility. Predisposing risk factors associated with central retinal vein occlusion are obesity, sedentary life style, smoking, and some systemic diseases such as hyperlipidemia, hypertension, associated autoimmune disorders e.g., antiphospholipid antibody syndrome, lupus, diabetes mellitus, cardiovascular disorders, bleeding or clotting disorders, vasculitis, closed-head trauma, alcohol consumption, primary open-angle glaucoma or angle-closure glaucoma.In our patients, they were ruled out afterdoing allpertaining investigations. The cases were managed with further avoidance of oral contraceptives and intra-vitreal injections of Bevacizumab (Avastin, an anti-vascular endothelial growth factor (anti-VEGF drug and Triamcinolone acetonide (a long acting synthetic steroid. Hence, even if no systemic diseases are detected. Physical examinations are recommended periodically for young women on oral contraceptive pills.

  10. Diet pills and the cataract outbreak of 1935: reflections on the evolution of consumer protection legislation.

    Science.gov (United States)

    Margo, Curtis E; Harman, Lynn E

    2014-01-01

    An outbreak of cataracts in 1935 caused by dinitrophenol (DNP), the active ingredient of popular diet pills, highlighted the inability of the U.S. Food and Drug Administration (FDA) to prevent harmful drugs from entering the marketplace. Just two years earlier, the FDA used horrific images of ocular surface injury caused by cosmetics at the World's Fair in Chicago to garner public support for legislative reform. The FDA had to walk a fine line between a public awareness campaign and lobbying Congress while lawmakers debated the need for consumer protection. The cataract outbreak of 1935 was conspicuous in the medical literature during the height of New Deal legislation, but questions persist as to how much it affected passage of the proposed Food, Drug, and Cosmetic Act (of 1938). The legislation languished in committee for years. The cataract outbreak probably had little impact on the eventual outcome, but medical opinion concerning the safety of DNP may have contributed to the voluntary withdrawal of the diet drug from the market. We review the DNP cataract outbreak and examine it in context of the challenges facing regulatory reform at that time. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Multitarget Effects of Danqi Pill on Global Gene Expression Changes in Myocardial Ischemia

    Directory of Open Access Journals (Sweden)

    Qiyan Wang

    2018-01-01

    Full Text Available Danqi pill (DQP is a widely prescribed traditional Chinese medicine (TCM in the treatment of cardiovascular diseases. The objective of this study is to systematically characterize altered gene expression pattern induced by myocardial ischemia (MI in a rat model and to investigate the effects of DQP on global gene expression. Global mRNA expression was measured. Differentially expressed genes among the sham group, model group, and DQP group were analyzed. The gene ontology enrichment analysis and pathway analysis of differentially expressed genes were carried out. We quantified 10,813 genes. Compared with the sham group, expressions of 339 genes were upregulated and 177 genes were downregulated in the model group. The upregulated genes were enriched in extracellular matrix organization, response to wounding, and defense response pathways. Downregulated genes were enriched in fatty acid metabolism, pyruvate metabolism, PPAR signaling pathways, and so forth. This indicated that energy metabolic disorders occurred in rats with MI. In the DQP group, expressions of genes in the altered pathways were regulated back towards normal levels. DQP reversed expression of 313 of the 516 differentially expressed genes in the model group. This study provides insight into the multitarget mechanism of TCM in the treatment of complex diseases.

  12. What’s in a Label? Ecstasy Sellers’ Perceptions of Pill Brands†

    Science.gov (United States)

    Duterte, Micheline; Jacinto, Camille; Sales, Paloma; Murphy, Sheigla

    2009-01-01

    This article presents selected findings from a qualitative study of Ecstasy sellers and their sales practices, knowledge of distribution networks, buyer-seller relationships, and self-reported drug use. In-depth interviews were conducted with 80 men and women who had sold five or more hits of Ecstasy five or more times in the six months prior to the interview. Study participants described their perceptions of the various types of Ecstasy they had distributed or used themselves. The participants had experience with a variety of Ecstasy labels, from the popular “Blue Dolphin” tablets to the powdered form called “Molly.” We tracked pill brand mentions on Ecstasy-related websites to compare with interviewees’ descriptions of Ecstasy brands. This study examines Ecstasy sellers’ ideas about the role of brand names in Ecstasy markets and their relationship to their beliefs about different types of Ecstasy’s purity and quality. We demonstrate that considering Ecstasy branding increases our understanding of buyer and seller relationships. PMID:19455907

  13. [Effects of qishenyiqi gutta pills on calcium/calmodulin dependent protein kinase II in rats with renal hypertension].

    Science.gov (United States)

    Zhang, Xiao-ying; Wei, Wan-lin; Shu, Chang-cheng; Zhang, Ling; Tian, Guo-xiang

    2013-02-05

    To explore the effects of qishenyiqi gutta pills on myocardial hypertrophy of left ventricle and calcium/calmodulin dependent protein kinase II (CAMK II) in rats with renal hypertension and elucidate its intervention mechanism for myocardial hypertrophy. A total of 50 Wistar rats were randomly divided into 5 groups of sham-operation, control, high-dose qishenyiqi gutta pills, low-dose qishenyiqi gutta pills and valsartan (n = 10 each). The rat model of myocardial hypertrophy with renal hypertension was established by the 2-kidney 1-clip (2K1C) method. The experimental animals were divided into control, high-dose, low-dose and valsartan groups. At Week 5 postoperation, valsartan group received an oral dose of valsartan (30 mg×kg(-1)×d(-1)), high-dose and low-dose groups took qishenyiqi gutta pills (250 and 125 mg×kg(-1)×d(-1)) while sham-operation and control groups had the same dose of normal saline solution. Tail arterial pressure was detected weekly and continued for 8 weeks. At the end of Week 12, the animals were sacrificed to harvest myocardial tissue of left ventricle for detecting left ventricular mass index (LVMI). The collagen volume fraction (CVF) of myocardium was examined by Van Gieson staining, the activities of superoxide dismutase (SOD) and reactive oxygen species (ROS) were detected by enzyme-linked immunosorbent assay (ELISA) and the expression of CAMK II was detected by immunohistochemistry and Western blot. (1) Blood pressures were significantly higher in high-dose, low-dose and control groups than those in sham-operation and valsartan groups ((167.66 ± 11.48), (166.72 ± 13.51), (174.34 ± 14.52) vs (119.57 ± 6.30), (131.80 ± 12.49) mm Hg, P pills may retard myocardial hypertrophy of left ventricle in rats with renal hypertension. And the mechanism is probably be correlated with its antioxidant activity and inhibited expression of myocardial CAMK II.

  14. Study on preparation technology of Wuling dripping pills%五苓滴丸制备工艺研究

    Institute of Scientific and Technical Information of China (English)

    王颖

    2011-01-01

    目的 优选五苓滴丸的制备工艺.方法 通过考察滴丸的成型情况,确定冷却剂、冷却温度、滴速及冷却柱长度;采用正交试验法,以滴丸丸重差异、溶散时限和外观质量为考察指标,对基质比例、载药量、药液熔融温度和滴距4个因素进行研究.结果 优选的处方和最佳制备工艺:混合基质中PEG 6000与PEG 4000的比例为3:1,药物与基质的比例为1:1,二甲基硅油做冷却剂,冷却剂温度-5-0℃,药液熔融温度为60℃,滴距为6cm,滴速40滴/min.结论 由本工艺制备的五苓滴丸外观性状好,溶散时限短,丸重差异小,符合滴丸剂的质量标准.%Objective To optimize the preparation process of Wuling dripping pills.Methods The kind of cooler,temperature of cooler,drops distance and rate were used as affecting factors,the orthogonal test was conducted,the formulation factors in roundness,colour and lustre evenness,tail,hardness were assessed.The kind of base,ratio between drug and base,the temperature of drug solution were observed,the orthogonal test was conducted,and the appearance quality and the weight deviation of the dropping pills were assessed.Results The optinized preparation conditions were as follows:PEG 6000: PFG 4000 ( 3:1 ), optimal bases and drugs was 1: 1, temperature of mixture was 60 ℃,dropping speed was 40 drops/min, -5~0 ℃ of simethicone was optimal refrigerant of dripping pills.Conclusion Wuling dripping pills made in this process have good appearance and disintegrate rate, with low weight coefficient of vation.This process is suitable for quality control of dripping pills.

  15. Design and performance of a fast thermal response miniature Chromium Potassium Alum (CPA) salt pill for use in a millikelvin cryocooler

    Science.gov (United States)

    Bartlett, J.; Hardy, G.; Hepburn, I. D.

    2015-01-01

    The design and performance of a fast thermal response miniature (24 mm outer diameter by 30 mm long) Chromium Potassium Alum (CPA) salt pill is described. The need for a fast thermal response has been driven by the development of a continuously operating millikelvin cryocooler (mKCC) which uses 2 T superconducting magnets that can be ramped to full field in 30 s. The consequence of magnetising and demagnetising the CPA pill in such a short time is that thermal boundary resistance and eddy current heating have a significant impact on the performance of the pill, which was investigated in detail using modelling. The complete design of a prototype CPA pill is described in this paper, including the methods used to minimise thermal boundary resistance and eddy current heating as well as the manufacturing and assembly processes. The performance of the prototype CPA pill operated from a 3.6 K bath is presented, demonstrating that a complete CPA cycle (magnetising, cooling to bath and demagnetising) can be accomplished in under 2.5 min, with magnetisation and demagnetisation taking just 30 s each. The cold finger base temperature of the prototype varies with demagnetisation speed as a consequence of eddy current heating; for a 30 s demagnetisation, a base temperature of 161 mK is obtained, whilst for a 5 min demagnetisation, a base temperature of 149 mK was measured (both from a 3.6 K and 2 T starting position). The measured hold times of the CPA pill at 200 mK, 300 mK, and 1 K are given, proving that the hold time far exceeds the recycle time and demonstrating the potential for continuous operation when two ADRs are used in a tandem configuration. The ease and speed at which the CPA pill temperature can be changed and controlled when stepping between operating temperatures in the range of 200 mK to 4 K using a servo control program is also shown, once again highlighting the excellent thermal response of the pill. All of the test results are in good agreement with the

  16. Magic Learning Pill: Ontological and Instrumental Learning in Order to Speed Up Education.

    Science.gov (United States)

    Matusov, Eugene; Baker, Daniella; Fan, Yueyue; Choi, Hye Jung; L Hampel, Robert

    2017-09-01

    The purpose of this research is to investigate the phenomenology of learning - people"s attitudes toward their learning experiences that have inherent worth in themselves (i.e., ontological learning) or have value outside of the learning itself (i.e., instrumental learning). In order to explore this topic, 58 participants from the U.S., Russia, and Brazil were interviewed with a central question derived from the science fiction writer Isaac Asimov's short story "Profession": whether participants would take a "Magic Learning Pill" (MLP) to avoid the process of learning, and instead magically acquire the knowledge. The MLP would guarantee the immediate learning by skipping the process of learning while achieving the same effect of gaining skills and knowledge. Almost all participants could think of some learning experiences for which they would take MLP and others for which they would not. Many participants would not take MLP for ontological learning, which is learning experiences that have inherent value for the people, while they would take MLP for instrumental learning, which is learning that mainly serves some other non-educational purposes. The main finding suggests that both instrumental and ontological types of learning are recognized by a wide range of people from diverse cultures as present and valued in their lives. This is especially significant in light of the overwhelmingly instrumental tone of public discourse about education. In the context of formal education, ontological learning was mentioned 35 times (28.0%) while instrumental learning was mentioned 74 times (60.2%). Although ontological learning was often mentioned as taking place outside of school, incorporating pedagogy supporting ontological learning at school deserves consideration.

  17. Efficacy of a combined contraceptive regimen consisting of condoms and emergency contraception pills.

    Science.gov (United States)

    Zhao, Rui; Wu, Jun-Qing; Li, Yu-Yan; Zhou, Ying; Ji, Hong-Lei; Li, Yi-Ran

    2014-04-14

    To evaluate and compare the effectiveness of the combined regimen (consisting of condoms and emergency contraception pills (ECP)) and using condoms only for the purpose of preventing pregnancy. One-thousand-five-hundred-and-sixty-two (1,562) couples as volunteers enrolled at nine centers in Shanghai. Eight-hundred-and-twelve (812) were randomized to use male condoms and ECP (i.e., Levonorgestrel) as a back-up to condoms (the intervention group) and 750 to use male condoms only(the control group), according to their working unit. Participants were visited at admission and at the end of 1, 3, 6, 9, and 12 months. The cumulative life table rates were calculated for pregnancy and other reasons for discontinuation. The gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were 7.76 ± 0.94 and 6.61 ± 0.91, respectively, per 100 women (χ2 = 0.41, p = 0.5227). The cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were 2.17 ± 0.52 and 1.25 ± 0.41, respectively, per 100 women (χ2 = 1.93, p = 0.1645). The Pearl Index in the condoms plus emergency contraception group and the condoms only group were 2.21% and 1.26%, respectively. Male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used. In addition, the lowest pregnancy rate followed from perfect use condom.

  18. Danqi Pill regulates lipid metabolism disorder induced by myocardial ischemia through FATP-CPTI pathway.

    Science.gov (United States)

    Wang, Yong; Li, Chun; Wang, Qiyan; Shi, Tianjiao; Wang, Jing; Chen, Hui; Wu, Yan; Han, Jing; Guo, Shuzhen; Wang, Yuanyuan; Wang, Wei

    2015-02-21

    Danqi Pill (DQP), which contains Chinese herbs Salvia miltiorrhiza Bunge and Panax notoginseng, is widely used in the treatment of myocardial ischemia (MI) in China. Its regulatory effects on MI-associated lipid metabolism disorders haven't been comprehensively studied so far. We aimed to systematically investigate the regulatory mechanism of DQP on myocardial ischemia-induced lipid metabolism disorders. Myocardial ischemia rat model was induced by left anterior descending coronary artery ligation. The rat models were divided into three groups: model group with administration of normal saline, study group with administration of DanQi aqueous solution (1.5 mg/kg) and positive-control group with administration of pravastatin aqueous solution (1.2 mg/kg). In addition, another sham-operated group was set as negative control. At 28 days after treatment, cardiac function and degree of lipid metabolism disorders in rats of different groups were measured. Plasma lipid disorders were induced by myocardial ischemia, with manifestation of up-regulation of triglyceride (TG), low density lipoprotein (LDL), Apolipoprotein B (Apo-B) and 3-hydroxy-3-methyl glutaryl coenzyme A reductase (HMGCR). DQP could down-regulate the levels of TG, LDL, Apo-B and HMGCR. The Lipid transport pathway, fatty acids transport protein (FATP) and Carnitine palmitoyltransferase I (CPTI) were down-regulated in model group. DQP could improve plasma lipid metabolism by up-regulating this lipid transport pathway. The transcription factors peroxisome proliferator-activated receptor α (PPARα) and retinoid X receptors (RXRs), which regulate lipid metabolism, were also up-regulated by DQP. Furthermore, DQP was able to improve heart function and up-regulate ejection fraction (EF) by increasing the cardiac diastolic volume. Our study reveals that DQP would be an ideal alternative drug for the treatment of dyslipidemia which is induced by myocardial ischemia.

  19. Adherence to the oral contraceptive pill: a cross-sectional survey of modifiable behavioural determinants

    Directory of Open Access Journals (Sweden)

    Molloy Gerard J

    2012-10-01

    Full Text Available Abstract Background Poor adherence to the oral contraceptive pill (OCP is reported as one of the main causes of unintended pregnancy in women that rely on this form of contraception. This study aims to estimate the associations between a range of well-established modifiable psychological factors and adherence to OCP. Method A cross-sectional survey of 130 female University students currently using OCP (Mean age: 20.46 SD: 3.01, range 17–36 was conducted. An OCP specific Medication Adherence Report Scale was used to assess non-adherence. Psychological predictor measures included necessity and concern beliefs about OCP, intentions, perceived behavioural control (pbc, anticipated regret and action and coping planning. Multiple linear regression was used to analyse the data. Results Fifty-two per cent of participants reported missing their OCP once or more per month and 14% twice or more per month. In bivariate analysis intentions (r = −0.25, perceived behavioural control (r= −0.66, anticipated regret (r=0.20, concerns about OCP (r =0.31, and action (r= −0.25 and coping (r= −0.28 planning were all significantly associated with adherence to OCP in the predicted direction. In a multivariate model almost half (48% of the variation in OCP adherence could be explained. The strongest and only statistically significant predictors in this model were perceived behavioural control (β=−0.62, p Conclusion The present data point to a number of key modifiable psychological determinants of OCP use. Future work will establish whether changing these variables results in better adherence to the OCP.

  20. [Effect of Biejiajian Pills on Wnt/β-catenin signal pathway and DKK-1 and FrpHe gene expressions in hepatocellular carcinoma cells].

    Science.gov (United States)

    He, Songqi; Cheng, Yang; Zhu, Yun; Fan, Qin; Sun, Haitao; Jia, Wenyan

    2013-01-01

    To investigate the effect of Biejiajian Pills on Wnt signal pathway and its inhibitory gene (DKK-1 and FrpHe) expressions and explore the mechanism underlying the action of Biejiajian Pills to suppress the invasiveness of hepatocellular carcinoma. Twenty-four Wistar rats were randomized equally into 3 groups for gavage of normal saline and Biejiajian Pills at 20- and 10-fold clinical doses for 3 days. Blood samples were then collected from the rats, and the serum was separated and added in HepG2 cell cultures. After 48 h of culture, the cells were collected to determine the cellular content of β-catenin protein using flow cytometry and detect DKK-1 and FrpHe mRNA expressions using qRT-PCR. HepG2 cells cultured in the presence of sera from rats fed with Biejiajian Pills showed significantly lowered β-catenin protein expression and obvious down-regulation of DKK-1 mRNA expression, and the effect was correlated with the doses of the drug administered. The expression of FrpHe mRNA showed no significant differences between the 3 groups. Biejiajian Pills can effectively inhibit the invasiveness and migration of hepatocellular carcinoma cells, which is closely related to decreased expressions of β-catenin and DKK-1 to cause block of the Wnt/β-catenin signal pathway.

  1. The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    van Galen, Katy A; Nellen, Jeannine F; Nieuwkerk, Pythia T

    2014-01-01

    Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a quantitative estimate of treatment adherence, without restriction to medical condition. The odds ratio (OR) of optimal adherence with FDCs versus separate pills was used as common effect size and aggregated into a pooled effect estimate using a random effect model with inverse variance weights. Out of 1258 articles screened, only six studies fulfilled inclusion criteria. Across medical conditions, administering drugs as FDC significantly increased the likelihood of optimal adherence (OR 1.33 (95% CI, 1.03-1.71)). Within subgroups of specific medical conditions, the favourable effect of FDCs on adherence was of borderline statistical significance for HIV infection only (OR 1.46 (95% CI, 1.00-2.13)). We observed a remarkable paucity of RCTs comparing the effect on adherence of administering drugs as FDC versus as separate pills. Administering drugs as FDC improved medication adherence. However, this conclusion is based on a limited number of RCTs only.

  2. Identification and determination of the major constituents in traditional Chinese medicine Longdan Xiegan Pill by HPLC-DAD-ESI-MS

    Directory of Open Access Journals (Sweden)

    Hui Liu

    2011-02-01

    Full Text Available A novel and sensitive HPLC-UV method has been developed for the simultaneous determination of twelve major compounds in Longdan Xiegan Pill. The chemical profile of the twelve compounds, including geniposidic acid (1, geniposide(2, gentiopicroside(3, liquiritin(4, crocin(5, baicalin(6, wogonoside(7, baicalein(8, glycyrrhizic acid (9, wogonin (10, oroxylin A (11 and aristolochic acid A (12, was acquired using high-performance liquid chromatography-diode array detector coupled with an electrospray tandem mass spectrometer (HPLC-DAD-ESI-MS. The analysis was performed on a Dikma Platisil ODS C18 column (250 mm × 4. 6 mm, 5 μm with a gradient solvent system of acetonitrile-0. 1% aqueous formic acid. The validation was carried out and the linearities (r > 0. 9996, repeatability (RSD<1. 8%, intra- and inter-day precision (RSD< 1. 3%, and recoveries (ranging from 96. 6% to 103. 4% were acceptable. The limits of detection (LOD of these compounds ranged from 0.29 to 4. 17 ng. Aristolochic acid A, which is the toxic ingredient, was not detected in all the batches of Longdan Xiegan Pill. Furthermore, hierarchical cluster analysis was used to evaluate the variation of the herbal prescription. The proposed method is simple, effective and suitable for the quality control of this traditional Chinese medicine (TCM. Keywords: Longdan Xiegan Pill, high-performance liquid chromatography-diode array detector coupled with an electrospray tandem mass spectrometer (HPLC-DAD-ESI-MS, qualitative evaluation, aristolochic acid A, hierarchical cluster analysis

  3. A danger of induction of Brugada syndrome during pill-in-the-pocket therapy for paroxysmal atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Yoshiyasu Aizawa

    2010-08-01

    Full Text Available Yoshiyasu Aizawa, Tomohiro Matsuhashi, Toshiaki Sato, Seiji Takatsuki, Keiichi FukudaDivision of Cardiology, Keio University School of Medicine, Tokyo, JapanAbstract: Rhythm control therapy by sodium channel blockers is widely performed for the ­treatment of paroxysmal atrial fibrillation. Here, we present a case of acquired Brugada ­syndrome by pill-in-the-pocket treatment using pilsicainide. It is important that this therapy should be applied only after confirming the drug safety to the patients.Keywords: syncope, sudden death, drug, rhythm control, pilsicainide, atrial flutter

  4. Rethinking agency and medical adherence technology: applying Actor Network Theory to the case study of Digital Pills.

    Science.gov (United States)

    Hurtado-de-Mendoza, Alejandra; Cabling, Mark L; Sheppard, Vanessa B

    2015-12-01

    Much literature surrounding medical technology and adherence posits that technology is a mechanism for social control. This assumes that the medical establishment can take away patients' agency. Although power relationships and social control can play a key role, medical technology can also serve as an agentive tool to be utilized. We (1) offer the alternative framework of Actor Network Theory to view medical technology, (2) discuss the literature on medication adherence and technology, (3) delve into the ramifications of looking at adherence as a network and (4) use Digital Pills as a case study of dispersed agency. © 2015 John Wiley & Sons Ltd.

  5. "Pregnancy and labour cause more deaths than oral contraceptives": The debate on the pill in the Spanish press in the 1960s and 1970s.

    Science.gov (United States)

    Ortiz-Gómez, Teresa; Ignaciuk, Agata

    2015-08-01

    From 1941 to 1978, Franco's regime in Spain banned all contraceptive methods. The pill started circulating in Spain from the 1960s, officially as a drug used in gynaecological therapy. However, in the following decade it was also increasingly used and prescribed as a contraceptive. This paper analyses debates about the contraceptive pill in the Spanish daily newspaper ABC and in two magazines, Blanco y Negro and Triunfo, in the 1960s and 1970s. It concludes that the debate on this contraceptive method was much more heterogeneous than might be expected given the Catholic-conservative character of the dictatorship. The daily press focused on the adverse effects of the drug and magazines concentrated on the ethical and religious aspects of the pill and discussed it in a generally positive light. Male doctors and Catholic authors dominated the debate. © The Author(s) 2013.

  6. Low-Thermal Conductivity Suspensions Used in the Isolation of the Salt Pills Aboard the Astro-H Adiabatic Demagnetization Refrigerator

    Science.gov (United States)

    Kimball, Mark O.; Shirron, Peter J.; Wegel, Donald C.; James, Bryan L.; Galassi, Nicholas M.; Faulkner, Richard L.; San Sebastian, Marcelino

    2011-01-01

    An adiabatic demagnetization refrigerator (ADR) utilizes the magnetocholoric effect in a paramagnetic salt to produce sub-Kelvin temperatures. It is a solid-state device that has no moving parts and does not rely upon a density gradient in a working fluid. This makes it ideal for cooling space-based instruments. ·Typically the salt is enclosed in a cylindrical pill that is suspended within the bore of a magnet. The suspension between the salt pill and magnet must be robust enough to survive a launch yet have a thermal conductance that minimizes heat from the magnet that is mechanically, and thermally, anchored to a stage at a higher temperature. Here we detail such a design that uses Kevlar(Trade Mark) as the supporting media in a system that limits motion of the salt pill axial as well as laterally with respect to the magnet bore.

  7. Impact of the 2013 French Pill Crisis on Women's Behaviour Regarding Contraception.

    Science.gov (United States)

    Lemaitre, Magali; Lastennet, Glenn; Syr, David; Emmerich, Joseph; Zureik, Mahmoud

    2015-03-01

    In the last decade, several epidemiological studies have shown the increased risk of venous thromboembolism associated with third- and fourth-generation oral contraceptives (C3Gs and C4Gs) versus older combined first- and second-generation oral contraceptives (C1Gs and C2Gs). In France, in December 2012, a lawsuit filed against the National Agency for the Safety of Medicines and Health Products (ANSM) by a patient who had experienced a stroke, possibly due to the use of a C3G, triggered a national 'pill crisis'. Consequently, a 'crisis cell' was set up and pre-existing health recommendations were reinforced. The main aim of this study was to evaluate, in real time, the impact of the French health authorities' recommendations and communications on French women's behaviour regarding contraception. Real-time monthly sales data reported during 2013 were compared with monthly sales data reported in 2012. Analyses were stratified according to the type of contraceptive and age. An index corresponding to the number of months of contraception sold was developed to facilitate comparison of the different contraceptives despite their distinct features and to assess the overall trend of contraception. After a 2-year analysis (2013 versus 2012), a significant 45 % decrease (p sales was observed, compared with a significant increase of 30 % (p sales. The sharp increase in C1G-2G sales focused specifically on C2Gs with an oestrogen concentration below 20 µg. Moreover, a large (47 %) increase was reported in sales of intrauterine devices (p sales into account, a slight decrease (1 %) in overall sales was identified. Thanks to an effective national communication plan, real-time monitoring of drug sales and favourable reactions from physicians and patients, French women changed their behaviour regarding contraception. However, this study was conducted over a short period following the crisis. A longitudinal analysis is required in order to assess any real long-term changes.

  8. Investigation on the association between breast cancer and consumption patterns of combined oral contraceptive pills in the women of Isfahan in 2011.

    Science.gov (United States)

    Ehsanpour, Soheila; Nejad, Fahime Seyed Ahmadi; Rajabi, Fariborz Mokarian; Taleghani, Fariba

    2013-05-01

    Oral contraceptive pills are among the most popular contraceptive methods, but the fear of cancer and cardiovascular disease overshadows its continuous use among women. This study aimed to define the association between consumption patterns of combined oral contraceptives among women with breast cancer. This is an analytical case-control study conducted on 175 women with breast cancer, referring to Seyed al Shohada Medical Center and private clinics in Isfahan to be treated and followed up in 2011, as well as 350 healthy women who were identical with the subjects in the study group regarding age and residential location. The data were collected using a researcher-made questionnaire. Content validity and Cronbach's alpha were employed to confirm validity and scientific reliability of the questionnaire, respectively. The data were analyzed by descriptive and analytical statistical methods through SPSS. The findings showed that there was a significant association between history of contraceptive pills' consumption and incidence of breast cancer (P pills' consumption compared to those with no history of that. It was also shown that pills' consumption for 36-72 months increased the risk of breast cancer by 2.18-fold, the age of the first use being less than 20 years increased the risk by 3.28-fold, and time since the last use of less than 25 years increased the risk by 2.63-fold. There was no significant association between duration of use, age of the first and last use, and time since the first and last use in the study and control groups. The results showed that history of pills' consumption is associated with incidence of breast cancer regardless of the consumption pattern. Use of oral contraceptives pills at any age and for any duration can increase the risk of breast cancer.

  9. Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM: Crossover pilot study (J-VICTORIA study

    Directory of Open Access Journals (Sweden)

    Sakamoto Masaya

    2012-08-01

    Full Text Available Abstract Background No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM and cardiovascular parameters. Methods Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1 mean (± standard deviation 24-hour blood glucose level, 2 mean amplitude of glycemic excursions (MAGE, 3 fasting blood glucose level, 4 highest postprandial blood glucose level and time, 5 increase in blood glucose level after each meal, 6 area under the curve (AUC for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7 area over the curve (AOC for daily blood glucose level Results The mean 24-hour blood glucose level was significantly lower in patients taking vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012. In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040, the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015, the AUC (≥180 mg/dL within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025, and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008 than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin. Conclusions CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin. Trial registration UMIN000007687

  10. Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): Crossover pilot study (J-VICTORIA study)

    Science.gov (United States)

    2012-01-01

    Background No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM) and cardiovascular parameters. Methods Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1) mean (± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) fasting blood glucose level, 4) highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) area under the curve (AUC) for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7) area over the curve (AOC) for daily blood glucose level vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012). In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040), the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015), the AUC (≥180 mg/dL) within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025), and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008) than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin. Conclusions CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin. Trial registration UMIN000007687 PMID:22867630

  11. Ketoconazole is inferior to ritonavir as an alternative booster for saquinavir in a once daily regimen in Thai HIV-1 infected patients

    NARCIS (Netherlands)

    Autar, Reshma Saskia; Wit, Ferdinand W. N. M.; Sankote, Jongkol; Sutthichom, Duanghathai; Kimenai, Elly; Hassink, Elly; Hill, Andrew; Cooper, David A.; Phanuphak, Praphan; Lange, Joep M. A.; Burger, David M.; Ruxrungtham, Kiat

    2007-01-01

    OBJECTIVE: To improve the pharmacokinetics of protease inhibitors, boosting with low-dose ritonavir is performed. However, toxicity, storage conditions and high costs of antiretroviral treatment may necessitate interruption of ritonavir. Ketoconazole was investigated as a potential booster of

  12. Ketoconazole is inferior to ritonavir as an alternative booster for saquinavir in a once daily regimen in Thai HIV-1 infected patients.

    NARCIS (Netherlands)

    Autar, R.S.; Wit, F.W.; Sankote, J.; Sutthichom, D.; Kimenai, E.; Hassink, E.A.M.; Hill, A.; Cooper, D.A.; Phanuphak, P.; Lange, J.M.A.; Burger, D.M.; Ruxrungtham, K.

    2007-01-01

    OBJECTIVE: To improve the pharmacokinetics of protease inhibitors, boosting with low-dose ritonavir is performed. However, toxicity, storage conditions and high costs of antiretroviral treatment may necessitate interruption of ritonavir. Ketoconazole was investigated as a potential booster of

  13. Clinical trial: lansoprazole 15 or 30 mg once daily vs. placebo for treatment of frequent nighttime heartburn in self-treating subjects.

    Science.gov (United States)

    Peura, D A; Riff, D S; Snoddy, A M; Fennerty, M B

    2009-09-01

    Frequent nighttime heartburn is common. Lansoprazole 15 mg is indicated for treatment of heartburn and other gastro-oesophageal reflux disease-related symptoms. To evaluate the efficacy and safety of lansoprazole in self-treating subjects with frequent nocturnal heartburn. A total of 864 subjects with heartburn on >or=2 days/week over the past month were randomized to double-blind treatment with lansoprazole 15 or 30 mg or placebo each morning. Endpoints were percentage of night times without heartburn (primary), percentage of 24-h days without heartburn and percentage of subjects without heartburn on day 1. Mean percentage of night times without heartburn was significantly greater with lansoprazole 15 mg (61.3%) or lansoprazole 30 mg (61.7%) vs. placebo (47.8%) over 14 days (P heartburn and percentage of subjects without heartburn on day 1 were significantly greater with lansoprazole 15 or 30 mg vs. placebo. Both lansoprazole 15 and 30 mg were highly effective and well tolerated in reducing symptoms in subjects with frequent nighttime heartburn. The benefit of therapy on 24-h heartburn and nighttime heartburn on day 1 of treatment was also evident. Lansoprazole 15 mg is a suitable choice for management of frequent nighttime heartburn.

  14. Concentrations of Dapivirine in the Rhesus Macaque and Rabbit following Once Daily Intravaginal Administration of a Gel Formulation of [14C]Dapivirine for 7 Days▿

    OpenAIRE

    Nuttall, Jeremy P.; Thake, Daryl C.; Lewis, Mark G.; Ferkany, John W.; Romano, Joseph W.; Mitchnick, Mark A.

    2007-01-01

    Dapivirine is a nonnucleoside reverse transcriptase inhibitor being developed as a topical microbicide for the prevention of human immunodeficiency virus infection. The distribution of radioactivity and drug in plasma and in vaginal, cervical, and draining lymph node tissues was investigated after daily application of a vaginal gel formulation of [14C]dapivirine to rhesus macaques. This was preceded by a preliminary study with rabbits. Following the intravaginal administration of [14C]dapivir...

  15. Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma

    DEFF Research Database (Denmark)

    Dahl, Ronald; Engel, Michael; Dusser, Daniel

    2016-01-01

    BACKGROUND: Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma. OBJECTIVE: To evaluate safety and tolerability of tiotro...

  16. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study.

    LENUS (Irish Health Repository)

    Sreenan, S

    2008-12-01

    The PREDICTIVE study is a multinational observational study designed to follow up patients with diabetes who started insulin detemir (IDet) in routine care. Recruitment started in June 2004 and is ongoing in some countries.

  17. Long term effectiveness of once-daily unboosted atazanavir plus abacavir/lamivudine as a switch strategy in subjects with virological suppression

    DEFF Research Database (Denmark)

    Llibre, Josep M; Cozzi-Lepri, Alessandro; La Rosa, Jorge Antonio Valencia

    2014-01-01

    routine however are scant. METHODS: We evaluated treatment outcomes of ATV400+ABC/3TC in pre-treated subjects in the EuroSIDA cohort with undetectable HIV-1 RNA, and previous ABC experience or assumed previous HLA B57*01 testing. We performed a time to loss of virologic response (TLOVR below 50 c...

  18. Atomoxetine once daily for 24 weeks in adults with attention-deficit/hyperactivity disorder (ADHD): impact of treatment on family functioning.

    Science.gov (United States)

    Wietecha, Linda; Young, Joel; Ruff, Dustin; Dunn, David; Findling, Robert L; Saylor, Keith

    2012-01-01

    To assess the efficacy of atomoxetine (ATX) and impact of treatment on family functioning in adults with ADHD. Adults with attention-deficit/hyperactivity disorder (ADHD) having both a spouse/partner and child were randomized to placebo (n = 234) or ATX (n = 268) for 24 weeks. Attention-deficit/hyperactivity disorder measures included the Conners Adult ADHD Rating Scale total ADHD Symptoms score and Clinical Global Impression-ADHD-Severity. Marital measures included the Dyadic Adjustment Scale and the Family Assessment Measure Dyadic Relationship Scale (FAM III). Parenting measures included the Parenting Stress Index, Alabama Parenting Questionnaire, and Parenting Sense of Competence Scale (PSCS). Improvement was greater with ATX over placebo at 24 weeks on the Conners Adult ADHD Rating Scale (-16.43 vs -8.65; P ADHD yielded significant interaction and treatment differences for the FAM III Task Accomplishment and the FAM III and Dyadic Adjustment Scale affective expression items, PSCS total score, Alabama Parenting Questionnaire Corporal Punishment, and Parenting Stress Index attachment items. Atomoxetine demonstrated significant ADHD symptom reduction over 24 weeks. Although both groups demonstrated baseline-to-end point changes on many marital and parenting measure items, there were no treatment differences. Maladaptive behaviors of long-standing ADHD may benefit from both medication and behavioral-psychosocial intervention.

  19. A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen

    DEFF Research Database (Denmark)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique

    2015-01-01

    OBJECTIVES: Progestogen-only pills (POPs) are safer with respect to cardiovascular risks than contraceptives containing estrogens. Despite the increased contraceptive efficacy of a desogestrel-only pill compared with a traditional POP, POPs are still not widely used due to an unpredictable bleeding...... pattern. A new POP containing 4 mg drospirenone has been developed with a 24/4 intake regimen which may improve the bleeding pattern. The objectives of this study were to investigate ovulation inhibition with the new drospirenone-only pill in comparison with the desogestrel-only pill and, in addition......, to assess the effects on cervical mucus permeability and bleeding. METHODS: Sixty-four healthy volunteers with proven ovulatory cycles were randomised and treated with either the drospirenone-only or the desogestrel-only pill during two 28-day cycles. Follicular diameter, endometrial thickness, and serum...

  20. [Protective effect of Qilin Pills on the reproductive function of oligoasthenospermia rats].

    Science.gov (United States)

    Zhang, Kai-Shu; Zhou, Fang; An, Qi; Jia, Yan-Fei; Fu, Long-Long; Lu, Wen-Hong; Liang, Xiao-Wei; Shang, Xue-Jun; Gu, Yi-Qun

    2017-09-01

    To study the protective effect of Qilin Pills (QLP) on the reproductive function of rats with oligoasthenospermia (OAS) induced by tripterygium glycosides. Twenty-eight male SD rats were randomly divided into a normal control, an OAS model control, a low-dose QLP, and a high-dose QLP group of equal number. OAS models were made in the latter three groups by intragastrical administration of tripterygium glycosides at 40 mg per kg of the body weight per day, and meanwhile the animals in the low- and high-dose QLP groups were treated with QLP at 1.62 and 3.24 g per kg of the body weight per day, respectively, while those in the OAS model group with normal saline, all for 30 consecutive days. Then all the rats were executed for obtaining the testis weight, testis viscera index, epididymal sperm concentration and motility, reproductive hormone levels, and antioxidation indexes and observation of the histomorphological changes of the testis tissue by HE staining. After 30 days of intervention, the low- and high-dose QLP groups, as compared with the OAS model controls, showed significantly improved epididymal sperm concentration ([14.57 ± 3.95] and [39.71 ± 11.31] vs [4.71 ± 1.25] ×10⁶/ml, P <0.05) and motility ([3.71 ± 1.11] and [4.29 ± 1.80] vs [0.57 ± 0.53]%, P <0.05), increased levels of sex hormone binding globulin (SHBG) ([94.83 ± 11.17] and [88.05 ± 9.21] vs [56.74 ± 8.29] nmol/L, P <0.05) and free testosterone (FT) ([27.27 ± 3.63] and [32.80 ± 2.51] vs [22.81 ± 2.75] nmol/L, P <0.05), decreased level of follicle-stimulating hormone (FSH) ([1.49 ± 0.62] and [1.12 ± 0.83] vs [1.71 ± 0.52] mIU/ml, P <0.05), but no significant change in the total testosterone (TT) level. Meanwhile, the level of superoxide dismutase (SOD) was markedly elevated in the low- and high-dose QLP groups in comparison with the OAS model control group ([277.14 ± 15.84] and [299.60 ± 20.83] vs [250.04 ± 31

  1. How-To-Do-It: Snails, Pill Bugs, Mealworms, and Chi-Square? Using Invertebrate Behavior to Illustrate Hypothesis Testing with Chi-Square.

    Science.gov (United States)

    Biermann, Carol

    1988-01-01

    Described is a study designed to introduce students to the behavior of common invertebrate animals, and to use of the chi-square statistical technique. Discusses activities with snails, pill bugs, and mealworms. Provides an abbreviated chi-square table and instructions for performing the experiments and statistical tests. (CW)

  2. [Inhibitory effect of Biejiajian pills on HepG2 cell xenograft growth and expression of β-catenin and Tbx3 in nude mice].

    Science.gov (United States)

    Wen, Bin; Sun, Hai-Tao; He, Song-Qi; LA, Lei; An, Hai-Yan; Pang, Jie

    2016-02-01

    To explore the molecular mechanism by which Biejiajian pills inhibit hepatocellular carcinoma in a nude mouse model bearing HepG2 cell xenograft. The inhibitory effect of Biejiajian pills on the growth of HepG2 cell xenograft in nude mice was observed. Immunohistochemical method was used to examine proliferating cell nuclear antigen (PCNA) expression in HepG2 cell xenograft, and TUNEL method was employed to detect the cell apoptosis; the expression levels of β-catenin and Tbx3 were measured by Western blotting. Biejiajian pills significantly suppressed the growth of HepG2 cell xenograft in nude mice. The tumor-bearing mice treated with a high and a moderate dose of Biejiajian pills showed significantly increased apoptosis rate of the tumor cells [(22.9±1.220)% and (14.7±0.50)%, respectively] compared with the control group [(5.5±0.90)%, Ppills significantly decreased the expressions of PNCA, β-catenin, and Tbx3 in the cell xenograft (Ppills can inhibit the growth of HepG2 cell xenograft in nude mice and promote tumor cell apoptosis possibly by inhibiting PNCA expression and the Wnt/β-catenin signaling pathway.

  3. Assessment of sperm quality, oxidative stress injury as well as ACP, AC and PDE expression in patients with oligoasthenozoospermia before and after qilin pill treatment

    Directory of Open Access Journals (Sweden)

    Shi-Jun Zhang

    2016-09-01

    Full Text Available Objective: To analyze the sperm quality, oxidative stress injury as well as ACP, AC and PDE expression in patients with oligoasthenozoospermia before and after qilin pill treatment. Methods: A total of 60 patients with oligoasthenozoospermia were randomly divided into observation group and control group, control group received routine western medicine treatment, observation group received qilin pill + conventional western medicine treatment, and then differences in sperm quality, oxidative stress injury, ACP, AC and PDE expression, etc. were compared between two groups after treatment. Results: Semen volume and sperm density in semen samples of observation group after qilin pill treatment were higher than those of control group; serum FSH and LH levels were lower than those of control group, and the T level was higher than that of control group; ROS and MDA levels in seminal plasma were lower than those of control group, and SOD level was higher than that of control group; ACP, AC, α-Glu and Fru levels in seminal plasma were higher than those of control group, and PDE level was lower than that of control group. Conclusion: Qilin pill can improve sperm quality and optimize testicular internal environment in patients with oligoasthenozoospermia, and it has positive clinical significance.

  4. Emergency Contraceptive Pill (ECP) Use and Experiences at College Health Centers in the Mid-Atlantic United States: Changes since ECP Went Over-the-Counter

    Science.gov (United States)

    Miller, Laura M.

    2011-01-01

    Objective: To investigate the availability of emergency contraceptive pills (ECPs) at college health centers since ECP went over-the-counter (OTC) in 2006. Related issues, such as distribution procedure, existence of a written protocol, personnel involved, contraindications, follow-up procedures, methods of advertising, and staff attitudes, were…

  5. Emergency Contraceptive Pills: A 10-Year Follow-up Survey of Use and Experiences at College Health Centers in the Mid-Atlantic United States

    Science.gov (United States)

    Miller, Laura McKeller; Sawyer, Robin G.

    2006-01-01

    The authors conducted a 10-year follow-up study using a telephone survey to investigate the availability of emergency contraceptive pills (ECPs) at college health centers in the mid-Atlantic region of the United States. They also examined related issues, such as distribution procedure, existence of a written protocol, personnel involved,…

  6. How the pill became a lifestyle drug: the pharmaceutical industry and birth control in the United States since 1960.

    Science.gov (United States)

    Watkins, Elizabeth Siegel

    2012-08-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.

  7. Project Octo-Pills - A practice model engaging community pharmacists in the care of patients from a tertiary hospital.

    Science.gov (United States)

    Ong, Kheng Yong; Chung, Wing Lam; Mamun, Kaysar; Chen, Li Li

    2017-10-13

    Even while pharmacy practice evolves to a more patient-centric mode of practice, local hospitals, due to high patient load as well as space and resource constraints, find it challenging to conduct thorough medication review and physical medication reconciliation for all patients. In light of this, optimizing the local current healthcare system to involve community pharmacists in the care of patients from public hospitals could potentially better cater to the healthcare needs of the older population. Due to easy accessibility, community pharmacies are often the first point of contact in the healthcare system. Project Octo-Pills aims to engage community pharmacists in the collaborative care of patients from a tertiary hospital, providing patients with quality medication reconciliation and review services from a more convenient location within their neighborhood. This paper describes the model for this pilot initiative. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Randomized clinical trial evaluating metformin versus oral contraceptive pills in the treatment of adolescents with polycystic ovarian syndrome.

    Science.gov (United States)

    Al-Zubeidi, Hiba; Klein, Karen O

    2015-07-01

    Polycystic ovarian syndrome (PCOS) is characterized by irregular menses, elevated androgens, and insulin resistance. Little information is published about the treatment of adolescent PCOS. The aim of this study was to evaluate metformin versus oral contraceptive pills (OCP) in treating adolescent PCOS. Twenty-two girls were randomized to either treatment for 6 months. The outcomes variables included body mass index (BMI) and free testosterone (FT). BMI decreased in all patients (metformin p=0.004, OCP p=0.045). FT decreased significantly only with OCP. Insulin resistance measures decreased in all patients but did not reach significance. The only significant difference in any of the variables between the two groups was number of menses. BMI and FT remained less than baseline for 3 months off treatment. Metformin and OCP have a positive effect on BMI, which persists after treatment is discontinued. FT decreased with both treatments, but only reached significance with OCP.

  9. Using Pill Identification Calls to Poison Centers as a Marker of Drug Abuse at Three Texas Military Bases.

    Science.gov (United States)

    Ng, Patrick C; Maddry, Joseph K; Sessions, Daniel; Borys, Douglas J; Bebarta, Vikhyat S

    2017-11-01

    Opioid abuse is a growing problem in civilian communities, and it has developed in the military as well. Telephone calls to poison centers requesting pill identification (ID) is a marker of drug abuse. This study identifies the number of pill ID calls made to the poison centers from areas containing and surrounding three Texas military bases during an 8-year period. We performed a retrospective observational study identifying calls to certified poison centers in Texas from 2002 to 2009 that identified hydrocodone tablets and other pain medications. We noted the calls made from ZIP codes containing and surrounding the three largest military bases in Texas. We reviewed 75,537 drug ID calls for any drug from the ZIP codes of interest. Total drug ID calls increased 105% and the number of calls for hydrocodone increased 463%. In our study most of the drug ID calls from military communities in Texas were for hydrocodone. The rate of calls for hydrocodone increased more than the rate of calls for other analgesics from 2002 to 2009. Using drug ID calls as a surrogate of drug abuse, our results suggest that hydrocodone abuse has increased within military communities and that poison center data can be a reliable surrogate for prescription drug abuse near military bases. Future studies are needed to further understand the extent of this problem in military and civilian communities. We can use this information to heighten awareness, influence prescription practices, establish practice guidelines, and develop educational programs to mitigate the increasing rate of prescription analgesic abuse in the United States.

  10. Safety, efficacy, actions, and patient acceptability of drospirenone/ethinyl estradiol contraceptive pills in the treatment of premenstrual dysphoric disorder

    Directory of Open Access Journals (Sweden)

    Lesley L Breech

    2009-08-01

    Full Text Available Lesley L Breech, Paula K BravermanDivision of Adolescent Medicine, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USAAbstract: Premenstrual dysphoric disorder (PMDD is estimated to affect 3%–8% of reproductive age women. Multiple therapeutic modalities have been evaluated with varying efficacy for the associated somatic and mood symptoms. The majority of older studies had shown that oral contraceptive pills (OCs were most effective for the physical symptoms. However, newer OCs containing a novel progestin, drospirenone, have shown promise in alleviating both the somatic and affective/behavioral symptoms. This progestin, which is a derivative of spironolactone, has both antimineralocorticoid and antiandrogenic activity. A 24/4 formulation containing 20 µg of ethinyl estradiol has been found effective in randomized double-blind placebo-controlled trials utilizing established scales documenting symptoms associated with PMDD. Multiple studies have shown that drospirenone-containing OCs are safe without evidence of clinically adverse effects on carbohydrate metabolism, lipids, blood pressure, weight, serum potassium or increased thrombotic events compared to other low dose OCs. In addition, significant improvements have been demonstrated in acne, hirsutism, and fluid retention symptoms. Several open label studies demonstrated good patient compliance and reported satisfaction with the method. Because of the significant placebo effect demonstrated in the blinded placebo-controlled trials, additional large randomized placebo-controlled trials are needed to confirm the efficacy of the drospirenone OCs in the treatment of PMDD. However, this OC formulation appears to be a promising therapeutic modality.Keywords: drospirenone, premenstrual dysphoric disorder, premenstrual syndrome, oral contraceptive pill

  11. Pharmacokinetics of opicapone, a third-generation COMT inhibitor, after single and multiple oral administration: A comparative study in the rat

    Energy Technology Data Exchange (ETDEWEB)

    Gonçalves, Daniela [Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra (Portugal); CNC – Center for Neuroscience and Cell Biology, University of Coimbra, 3004-517 Coimbra (Portugal); Alves, Gilberto, E-mail: gilberto@fcsaude.ubi.pt [CNC – Center for Neuroscience and Cell Biology, University of Coimbra, 3004-517 Coimbra (Portugal); CICS-UBI – Health Sciences Research Centre, University of Beira Interior, Av. Infante D. Henrique, 6200-506 Covilhã (Portugal); Fortuna, Ana [Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra (Portugal); CNC – Center for Neuroscience and Cell Biology, University of Coimbra, 3004-517 Coimbra (Portugal); Soares-da-Silva, Patrício [Department of Research and Development, BIAL – Portela & Ca S.A., Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado (Portugal); MedInUP – Center for Drug Discovery and Innovative Medicines, University Porto, Porto (Portugal); Falcão, Amílcar [Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra (Portugal); CNC – Center for Neuroscience and Cell Biology, University of Coimbra, 3004-517 Coimbra (Portugal)

    2017-05-15

    Opicapone is a novel potent, reversible and purely peripheral catechol-O-methyltransferase inhibitor that has been developed to be used as an adjunct to levodopa/aromatic L-amino acid decarboxylase inhibitor therapy for Parkinson's disease. Thus, this study aimed to compare the plasma pharmacokinetics of opicapone and its active metabolite (BIA 9-1079) after the administration of single and multiple oral doses to rats. Wistar rats (n = 8 per group) were orally treated with single (30, 60 or 90 mg/kg) or multiple (30 mg/kg once-daily for seven consecutive days) oral doses of opicapone. Blood samples were collected up to 24 h post-dosing through a cannula introduced in the tail vein of rats. After quantifying opicapone and BIA 9-1079 in plasma, a non-compartmental pharmacokinetic analysis was performed. Opicapone was quickly absorbed (time to reach the maximum plasma concentration ≤ 2 h) in both dosage regimens and the extent of systemic exposure to opicapone increased approximately in a dose-proportional manner after single-dosing within the studied dose range (30–90 mg/kg). Opicapone and BIA 9-1079 showed a relatively short plasma elimination half-life (1.58–4.50 h) and a small systemic accumulation after multiple-dosing. Hence, no pharmacokinetic concerns are expected when opicapone is administered with a once-daily dosing regimen. - Highlights: • Opicapone is relatively rapid absorbed after oral administration to rats. • Systemic exposure to opicapone increases approximately in a dose-proportional manner. • Opicapone and BIA 9-1079 show a small systemic accumulation after multiple-dosing.

  12. Comparison of microbial fermentation of high- and low-forage diets in Rusitec, single-flow continuous-culture fermenters and sheep rumen.

    Science.gov (United States)

    Carro, M D; Ranilla, M J; Martín-García, A I; Molina-Alcaide, E

    2009-04-01

    Eight Rusitec and eight single-flow continuous-culture fermenters (SFCCF) were used to compare the ruminal fermentation of two diets composed of alfalfa hay and concentrate in proportions of 80 : 20 (F80) and 20 : 80 (F20). Results were validated with those obtained previously in sheep fed the same diets. Rusitec fermenters were fed once daily and SFCCF twice, but liquid dilution rates were similar in both types of fermenters. Mean values of pH over the 12 h postfeeding were higher (P 0.05) were found in any in vitro system. A more precise control of pH in both types of fermenters and a reduction of concentrate retention time in Rusitec could probably improve the simulation of in vivo fermentation.

  13. The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Qiong; Wang, Yi-Ru; Jia, Qing-Yun; Liu, Li; Xu, Chong-Qing; Wang, Xiao-Yun; Yao, Min; Cui, Xue-Jun; Shi, Qi; Wang, Yong-Jun; Liang, Qian-Qian

    2018-03-20

    Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling and painful joints, eventually leading to joint destruction. There is still a lack of effective therapy to treat RA. The Juanbi pill is a Chinese medicine that has been widely used to treat active RA in China for hundreds of years, relieving pain and protecting the affected joints from malformation. However, there is no solid evidence to show the effect of the Juanbi pill on the management of active RA. We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether the traditional Chinese medicine Juanbi pill could relieve joint pain in RA and protect the joints. A total of 120 patients with active RA will be enrolled and treated with the Juanbi pill or a placebo for 3 months. The primary outcome measures are as follows: rate of in the American College of Rheumatology (ACR)50, change in the 28-joint Disease Activity Score (DAS28) from baseline at beginning of therapy to 3 months, and a change in the van der Heijde modified Sharp score measured from baseline to 12 months. The secondary outcome measures are as follows: rate of change in ACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), and change in score in the Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, and the Athens Insomnia Scale (AIS) from baseline to 2-week, 1-month, 2-month, 3-month, 6-month, and 12-month follow up. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow up are also the secondary outcome measures. Although the Juanbi pill has been used in China for many years to treat RA, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of Juanbi pill on active RA. ClinicalTrials.gov, NCT02885597 . Registered on 30 August 2016.

  14. Reaching the end of the line: Operational issues with implementing phone-based unannounced pill counts in resource-limited settings.

    Directory of Open Access Journals (Sweden)

    Yael Hirsch-Moverman

    Full Text Available Accurate measurement of adherence is necessary to ensure that therapeutic outcomes can be attributed to the recommended treatment. Phone-based unannounced pill counts were shown to be feasible and reliable measures of adherence in developed settings; and have been further used as part of medication adherence interventions. However, it is not clear whether this method can be implemented successfully in resource-limited settings, where cellular network and mobile phone coverage may be low. Our objective is to describe operational issues surrounding the use of phone-based unannounced pill counts in Lesotho and Ethiopia.Phone-based monthly unannounced pill counts, using an adaptation of a standardized protocol from previous US-based studies, were utilized to measure anti-TB and antiretroviral medication adherence in two implementation science studies in resource-limited settings, START (Lesotho and ENRICH (Ethiopia.In START, 19.6% of calls were completed, with 71.9% of participants reached at least once; majority of failed call attempts were due to phones not being available (54.8% or because participants were away from the pills (32.7%. In ENRICH, 33.5% of calls were completed, with 86.7% of participants reached at least once; the main reasons for failed call attempts were phones being switched off (31.5%, participants not answering (27.3%, participants' discomfort speaking on the phone (15.4%, and network problems (13.2%. Structural, facility-level, participant-level, and data collection challenges were encountered in these settings.Phone-based unannounced pill counts were found to be challenging, and response rates suboptimal. While some of these challenges were specific to local contexts, most of them are generalizable to resource-limited settings. In a research study context, a possible solution to ease operational challenges may be to focus phone-based unannounced pill count efforts on a randomly selected sample from participants who are

  15. "They're legal so they're safe, right?" What did the legal status of BZP-party pills mean to young people in New Zealand?

    Science.gov (United States)

    Sheridan, Janie; Butler, Rachael

    2010-01-01

    The legislation on psychoactive substances has a role to play with regard to shaping social values and influencing the normalisation of drug use. In New Zealand from 2005 to 2008, benzylpiperazine-containing 'legal' party pills (BZP-party pills) were legally available for purchase, subject to controls around a minimum purchase age of 18 years, and prohibitions on free of charge distribution and advertising in certain media. This paper explores what their legal status communicated to young users. Interviews and group discussions with young people (n=58) who had used BZP-party pills in the preceding 6 months. Data were collected between June and December 2006 via a series of interviews with individuals, 'friendship' pairs, and groups comprised of participants known to each other. Young people saw BZP-party pills as 'safe' and of good quality as they were legal/government sanctioned, but also thus of inferior strength, suggesting they could take more of them. However, after using them they often reviewed their view of their safety and quality due to varied experiences. Being legal for some people meant they could use the substances without breaking the law, or having to go to 'dealers'. Their legal status also meant they were easily accessible and were seen to be 'socially acceptable', with some young people indicating they would be happy to discuss their use with their parents. However, social acceptability was, for some, a reason not to use them. These data provide a unique insight into the tension between positive and negative harm reduction messages relating to the legal nature of psychoactive drugs and as such begin to fill an information void in this area. The legal status of these 'party pills' conveys mixed messages to young people and whilst being seen as potentially safe and of good quality, this often leads to higher than 'recommended' doses being used. Nevertheless, not breaking the law or having to access BZP-party pills from 'dealers', and being able to

  16. [Effects of Biejiajian Pills on Wnt signal pathway signal molecules β-catenin/TCF4 complex activities and downstream proteins cyclin D1 and MMP-2 in hepatocellular carcinoma cells].

    Science.gov (United States)

    Wen, Bin; Sun, Haitao; He, Songqi; Cheng, Yang; Jia, Wenyan; Fan, Eryan; Pang, Jie

    2014-12-01

    To study the effect of Biejiajian Pills on Wnt signal pathway and the mechanisms underlying its action to suppress the invasiveness of hepatocellular carcinoma. HepG2 cells cultured in the serum of rats fed with Biejiajian Pills for 48 h were examined for β-catenin expression using immunofluorescence, β-catenin/TCF4 complex activity with luciferase, and expressions of the downstream proteins cyclin D1 and MMP-2 using qRT-PCR. Biejiajian Pills-treated sera significantly reduced the expressions of cytoplasmic and nuclear β-catenin protein, cyclin D1 and MMP-2 proteins and lowered the activities of β-catenin/TCF4 complex. Biejiajian Pills may serve as a potential anti-tumor agent, whose effect might be mediated by inhibiting the Wnt/β-catenin pathway.

  17. Two new giant pill-millipede species of the genus Zoosphaerium endemic to the Bemanevika area in northern Madagascar (Diplopoda, Sphaerotheriida, Arthrosphaeridae).

    Science.gov (United States)

    Sagorny, Christina; Wesener, Thomas

    2017-05-09

    Madagascar is one of the world's most important hotspots of biodiversity and a center for localized endemism. Among the highly endemic faunal elements are the giant pill-millipedes, order Sphaerotheriida, which are severely understudied in Madagascar. Here we provide descriptions of two new species of endemic giant-pill millipedes of the genus Zoosphaerium Pocock, 1895: Zoosphaerium bemanevika n. sp. and Zoosphaerium minutus n. sp.. Zoosphaerium bemanevika n. sp. belongs to the Z. coquerelianum species-group, while Z. minutus n. sp. is not assignable to a species-group. An updated key to the 19 species of the Z. coquerelianum group is provided. Zoosphaerium minutus n. sp. has a body length of Madagascar, an only recently protected area that represents a Malagasy center of endemism.

  18. The Influence of Pelvic Incidence and Lumbar Lordosis Mismatch on Development of Symptomatic Adjacent Level Disease Following Single-Level Transforaminal Lumbar Interbody Fusion.

    Science.gov (United States)

    Tempel, Zachary J; Gandhoke, Gurpreet S; Bolinger, Bryan D; Khattar, Nicolas K; Parry, Philip V; Chang, Yue-Fang; Okonkwo, David O; Kanter, Adam S

    2017-06-01

    Annual incidence of symptomatic adjacent level disease (ALD) following lumbar fusion surgery ranges from 0.6% to 3.9% per year. Sagittal malalignment may contribute to the development of ALD. To describe the relationship between pelvic incidence-lumbar lordosis (PI-LL) mismatch and the development of symptomatic ALD requiring revision surgery following single-level transforaminal lumbar interbody fusion for degenerative lumbar spondylosis and/or low-grade spondylolisthesis. All patients who underwent a single-level transforaminal lumbar interbody fusion at either L4/5 or L5/S1 between July 2006 and December 2012 were analyzed for pre- and postoperative spinopelvic parameters. Using univariate and logistic regression analysis, we compared the spinopelvic parameters of those patients who required revision surgery against those patients who did not develop symptomatic ALD. We calculated the predictive value of PI-LL mismatch. One hundred fifty-nine patients met the inclusion criteria. The results noted that, for a 1° increase in PI-LL mismatch (preop and postop), the odds of developing ALD requiring surgery increased by 1.3 and 1.4 fold, respectively, which were statistically significant increases. Based on our analysis, a PI-LL mismatch of >11° had a positive predictive value of 75% for the development of symptomatic ALD requiring revision surgery. A high PI-LL mismatch is strongly associated with the development of symptomatic ALD requiring revision lumbar spine surgery. The development of ALD may represent a global disease process as opposed to a focal condition. Spine surgeons may wish to consider assessment of spinopelvic parameters in the evaluation of degenerative lumbar spine pathology. Copyright © 2017 by the Congress of Neurological Surgeons

  19. The Therapeutic Effects of a Traditional Chinese Medicine Formula Wuzi Yanzong Pill for the Treatment of Oligoasthenozoospermia: A Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Shi, Xiao; Kong, Grace Wing Shan; Wu, Justin Che Yuen; Li, Tin Chiu

    2018-01-01

    Oligoasthenozoospermia is a crucial factor in male infertility. Wuzi Yanzong (WZYZ) pill is a popular traditional Chinese medicine (TCM) formula which has been used for male infertility treatment for years. However, its effects on semen quality remain controversial. We conducted a preregistered meta-analysis to assess the effect of WZYZ pill for the therapeutic effects on oligoasthenozoospermia. Five randomized controlled trials including 960 participants were selected from databases of domains in North-East Asian regions, PubMed, Embase, and Cochrane Library. WZYZ pill group yielded a greater mean increment on sperm concentration (5 trials: MD 5.99, 95% CI 2.12–9.85, P = 0.002), sperm motility (5 trials: MD 4.57, 95% CI 0.47–8.68, P = 0.03), sperm morphology (2 trials: MD −1.93, 95% CI −4.87–1.01, P = 0.20), activity of acrosomal enzyme (2 trials: MD 28.27, 95% CI 12.41–44.14, P < 0.01), volume of semen (2 trials: MD 0.56, 95% CI 0.21–0.91, P = 0.002), and a decrement of sperm DNA fragmentation index (2 trials: MD −3.82, 95% CI −6.45–−1.19, P = 0.004). However, qualities of selected studies were generally unsatisfactory, and there was inherent heterogeneity among some of the outcomes. Despite these limitations, the WZYZ pill improved sperm quality by improving several semen parameters and decreasing DNA damage in oligoasthenozoospermia patients. PMID:29576794

  20. Onboard cross-calibration of the Pille-ISS Detector System and measurement of radiation shielding effect of the water filled protective curtain in the ISS crew cabin

    International Nuclear Information System (INIS)

    Szántó, P.; Apáthy, I.; Deme, S.; Hirn, A.; Nikolaev, I.V.; Pázmándi, T.; Shurshakov, V.A.; Tolochek, R.V.; Yarmanova, E.N.

    2015-01-01

    As a preparation for long duration space missions it is important to determine and minimize the impact of space radiation on human health. One of the methods to diminish the radiation burden is using an additional local shielding in the places where the crewmembers can stay for longer time. To increase the crew cabin shielding a special protective curtain was designed and delivered to ISS in 2010 containing four layers of hygienic wipes and towels providing an additional shielding thickness of about 8 g/cm"2 water-equivalent matter. The radiation shielding effect of the protective curtain, in terms of absorbed dose, was measured with the thermoluminescent Pille-ISS Detector System. In order to verify the reliability of the Pille system an onboard cross-calibration was also performed. The measurement proved that potentially 25% reduction of the absorbed dose rate in the crew cabin can be achieved, that results in 8% (∼16 μGy/day) decrease of the total absorbed dose to the crew, assuming that they spend 8 h in the crew cabin a day. - Highlights: • The dose level in the ISS Zvezda crew quarters is higher than the average dose level in the module. • A shielding made of hygienic wipes and towels was set up onboard as additional protection. • Onboard cross calibration of the Pille-ISS space dosimeter (TL) system was performed. • The shielding effect of the protective curtain in terms of absorbed dose was measured with the onboard Pille system. • The shielding effect of the protective water curtain is approximately 24 ± 9% in absorbed dose.

  1. Sleep improvement for restless legs syndrome patients. Part IV: meta-analysis comparison of effect sizes of vibratory stimulation sham pads and placebo pills

    Directory of Open Access Journals (Sweden)

    Burbank F

    2014-02-01

    Full Text Available Fred Burbank Salt Creek International Women's Health Foundation, San Clemente, CA, USA Purpose: To determine whether sham pads used as controls in randomized clinical trials of vibratory stimulation to treat patients with sleep loss associated with restless legs syndrome perform differently than placebo pills used in comparable restless legs syndrome drug trials. Patients and methods: Sham pad effect sizes from 66 control patients in two randomized clinical trials of vibratory stimulation were compared with placebo responses from 1,024 control patients in 12 randomized clinical drug trials reporting subjective sleep measurement scales. Control patient responses were measured as the standardized difference in means corrected for correlation between beginning and ending scores and for small sample sizes. Results: For parallel randomized clinical trials, sham effects in vibratory stimulation trials were not significantly different from placebo effects in drug trials (0.37 and 0.31, respectively, Qbetween subgroups =0.25, PQ≥0.62. Placebo effect sizes were significantly smaller in crossover drug trials than sham effect sizes in parallel vibratory stimulation trials (0.07 versus 0.37, respectively, Qbetween subgroups =4.59, PQ≤0.03 and placebo effect sizes in parallel drug trials (0.07 versus 0.31, respectively, Qbetween subgroups =5.50, PQ≤0.02. Conclusion: For subjective sleep loss assessments in parallel trials, sham pads in vibratory stimulation trials performed similarly to placebo pills in drug trials. Trial design (parallel versus crossover had a large influence on control effect sizes. Placebo pills in crossover drug trials had significantly smaller effect sizes than sham pads in parallel vibratory stimulation trials or placebo pills in parallel drug trials. Keywords: sham effect, placebo effect, trial design, crossover study, parallel study, counterstimulation

  2. [Effect of Biejiajian Pills on Wnt signal pathway molecules β-catenin and GSK-3β and the target genes CD44v6 and VEGF in hepatocellular carcinoma cells].

    Science.gov (United States)

    Sun, Haitao; He, Songqi; Wen, Bin; Jia, Wenyan; Fan, Eryan; Zheng, Yan

    2014-10-01

    To investigate the effect of Biejiajian Pills on the expressions of the signal molecules and target genes of Wnt signal pathway in HepG2 cells and explore the mechanisms by which Biejiajian pills suppress the invasiveness of hepatocellular carcinoma. HepG2 cells were cultured for 48 h in the presence of serum collected from rats fed with Biejiajian Pills. The expressions of β-catenin, GSK-3β and P-GSK-3β in the cultured cells were assessed by Western blotting and the expressions of CD44v6 and VEGF were detected using immunohistochemistry. HepG2 cells cultured with the serum of rats fed with Biejiajian Pills showed lowered expressions of β-catenin protein both in the cytoplasm and the nuclei with also inhibition of phosphorylation of GSK-3β and reduced expression of CD44v6 and VEGF. Biejiajian Pills can significantly reduce the expression of β-catenin by decreasing the phosphorylation of GSK-3β and blocking the Wnt/β-catenin signaling pathway to cause down-regulation of the target genes CD44v6 and VEGF, which may be one of the molecular mechanisms by which Biejiajian Pills suppress the proliferation and invasiveness of hepatocellular carcinoma.

  3. Ultra high performance liquid chromatography coupled with electrospray ionization/quadrupole time-of-flight mass spectrometry for the rapid analysis of constituents in the traditional Chinese medicine formula Wu Ji Bai Feng Pill.

    Science.gov (United States)

    Duan, Shengnan; Qi, Wen; Zhang, Siwen; Huang, Kunkun; Yuan, Dan

    2017-10-01

    An ultra high performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight mass spectrometry method in both positive and negative ion modes was established in order to comprehensively investigate the major constituents in Wu Ji Bai Feng Pill. Briefly, a Waters ACQUITY UPLC HSS C 18 column was used to separate the aqueous extract of Wu Ji Bai Feng Pill. A total of 0.1% formic acid in acetonitrile and 0.1% aqueous formic acid v/v were used as the mobile phase. All analytes were determined using quadrupole time-of-flight mass spectrometry with electrospray ionization source in positive and negative ion modes. At length, a total of 173 components including flavones and their glycosides, monoterpene glycosides, triterpene saponins, phenethylalchohol glycosides, iridoid glycosides, phthalides, tanshinones, phenolic acids, sesquiterpenoids and cyclopeptides were identified or tentatively characterized in Wu Ji Bai Feng Pill in an analysis of 16.0 min based on the accurate mass and tandem mass spectrometry behaviors. The developed method is rapid and highly sensitive to characterize the chemical constituents of Wu Ji Bai Feng Pill, which could not only be used for chemical standardization and quality control of Wu Ji Bai Feng Pill, but also be helpful for further study in vivo metabolism of Wu Ji Bai Feng Pill. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  4. SESK ja SEKK / Toomas Pill ; T. Pill

    Index Scriptorium Estoniae

    Pill, Toomas

    2007-01-01

    3. mail toimunud koosolekul tegi Heidi Aedma ettepaneku korraldada Sydney Eesti Seenioride Koondise kokkutulekud laupäeviti ja soovituse asendada endine nimi teisiti - Sydney Eesti Kultuuriklubi (SEKK)

  5. Health education alone and health education plus advance provision of emergency contraceptive pills on knowledge and attitudes among university female students in Enugu, Nigeria.

    Science.gov (United States)

    Arinze-Onyia, S U; Aguwa, E N; Nwobodo, Ed

    2014-01-01

    This was an intervention study to compare the effects of health education alone and health education plus advance provision of emergency contraception (EC) pills on the knowledge and attitudes to EC by female students of University of Nigeria in South-East Nigeria. A structured questionnaire was used to collect data in February, 2009 from 290 female students of a tertiary educational institution (140 in the study group and 150 from the control group) who were selected by multistage sampling. Subsequently, health education was conducted among all the students. In addition, a pack containing 2 tablets of EC pills (Postinor) was given only to the students in the study group. Three months after this intervention, its effects were assessed through a survey using the same structured questionnaire employed in the baseline survey. knowledge of EC was significantly higher among the study group than the controls at post-intervention, P education plus advance provision of EC pills effectively improved knowledge and attitudes to EC among female students of tertiary institutions more than health education alone and this should be promoted.

  6. Monitoring the quality consistency of Fufang Danshen Pills using micellar electrokinetic chromatography fingerprint coupled with prediction of antioxidant activity and chemometrics.

    Science.gov (United States)

    Ji, Zhengchao; Sun, Wanyang; Sun, Guoxiang; Zhang, Jin

    2016-08-01

    A fast micellar electrokinetic chromatography fingerprint method combined with quantification was developed and validated to evaluate the quality of Fufang Danshen Pills, a traditional Chinese Medicine, which has been used in the treatment of cardiovascular system diseases, in which the tetrahedron optimization method was first used to optimize the background electrolyte solution. Subsequently, the index of the fingerprint information amount of I was performed as an excellent objective indictor to investigate the experimental conditions. In addition, a systematical quantified fingerprint method was constructed for evaluating the quality consistency of 20 batches of test samples obtained from the same drug manufacturer. The fingerprint analysis combined with quantitative determination of two components showed that the quality consistency of the test samples was quite good within the same commercial brand. Furthermore, the partial least squares model analysis was used to explore the fingerprint-efficacy relationship between active components and antioxidant activity in vitro, which can be applied for the assessment of anti-oxidant activity of Fufang Danshen pills and provide valuable medicinal information for quality control. The result illustrated that the present study provided a reliable and reasonable method for monitoring the quality consistency of Fufang Danshen pills. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  7. Neural Plasticity Associated with Hippocampal PKA-CREB and NMDA Signaling Is Involved in the Antidepressant Effect of Repeated Low Dose of Yueju Pill on Chronic Mouse Model of Learned Helplessness

    Directory of Open Access Journals (Sweden)

    Zhilu Zou

    2017-01-01

    Full Text Available Yueju pill is a traditional Chinese medicine formulated to treat syndromes of mood disorders. Here, we investigated the therapeutic effect of repeated low dose of Yueju in the animal model mimicking clinical long-term depression condition and the role of neural plasticity associated with PKA- (protein kinase A- CREB (cAMP response element binding protein and NMDA (N-methyl-D-aspartate signaling. We showed that a single low dose of Yueju demonstrated antidepressant effects in tests of tail suspension, forced swim, and novelty-suppressed feeding. A chronic learned helplessness (LH protocol resulted in a long-term depressive-like condition. Repeated administration of Yueju following chronic LH remarkably alleviated all of depressive-like symptoms measured, whereas conventional antidepressant fluoxetine only showed a minor improvement. In the hippocampus, Yueju and fluoxetine both normalized brain-derived neurotrophic factor (BDNF and PKA level. Only Yueju, not fluoxetine, rescued the deficits in CREB signaling. The chronic LH upregulated the expression of NMDA receptor subunits NR1, NR2A, and NR2B, which were all attenuated by Yueju. Furthermore, intracerebraventricular administration of NMDA blunted the antidepressant effect of Yueju. These findings supported the antidepressant efficacy of repeated routine low dose of Yueju in a long-term depression model and the critical role of CREB and NMDA signaling.

  8. Neural Plasticity Associated with Hippocampal PKA-CREB and NMDA Signaling Is Involved in the Antidepressant Effect of Repeated Low Dose of Yueju Pill on Chronic Mouse Model of Learned Helplessness.

    Science.gov (United States)

    Zou, Zhilu; Chen, Yin; Shen, Qinqin; Guo, Xiaoyan; Zhang, Yuxuan; Chen, Gang

    2017-01-01

    Yueju pill is a traditional Chinese medicine formulated to treat syndromes of mood disorders. Here, we investigated the therapeutic effect of repeated low dose of Yueju in the animal model mimicking clinical long-term depression condition and the role of neural plasticity associated with PKA- (protein kinase A-) CREB (cAMP response element binding protein) and NMDA (N-methyl-D-aspartate) signaling. We showed that a single low dose of Yueju demonstrated antidepressant effects in tests of tail suspension, forced swim, and novelty-suppressed feeding. A chronic learned helplessness (LH) protocol resulted in a long-term depressive-like condition. Repeated administration of Yueju following chronic LH remarkably alleviated all of depressive-like symptoms measured, whereas conventional antidepressant fluoxetine only showed a minor improvement. In the hippocampus, Yueju and fluoxetine both normalized brain-derived neurotrophic factor (BDNF) and PKA level. Only Yueju, not fluoxetine, rescued the deficits in CREB signaling. The chronic LH upregulated the expression of NMDA receptor subunits NR1, NR2A, and NR2B, which were all attenuated by Yueju. Furthermore, intracerebraventricular administration of NMDA blunted the antidepressant effect of Yueju. These findings supported the antidepressant efficacy of repeated routine low dose of Yueju in a long-term depression model and the critical role of CREB and NMDA signaling.

  9. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart

    2015-01-01

    This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

  10. Study of the analgesic activities, chronic toxicity and addictive potential of Jia-Yuan-Qing pill in rats.

    Science.gov (United States)

    Tian, Y E; Teng, Li-Rong; Wang, Zhen-Zuo; Zhao, Min; Meng, Qing-Fan; Lu, Jia-Hui; Tian, Jian-Ming; Zhang, Wei-Wei; Zheng, Xiaoyi; Wang, D I; Teng, LE-Sheng

    2015-06-01

    Jia-Yuan-Qing pill (JYQP) composed of Porcellio laevis Latreille, Corydalis Rhizoma and Radix Cynanchi Paniculati at a ratio of 9:7:7 has been found to be an effective analgesic agent. The present study aimed to evaluate the safety, addictive potential and anti-cancer pain activity of JYQP in a rat model. During the 6-month chronic toxicity test, no significant changes in general behavior, defecation, postural abnormalities, dietary or water intake or blood biochemical parameters were observed in male and female rats. Although a high dose of JYQP (5 g/kg) caused swelling of the liver, spleen and kidney in male and female rats, no pathological changes were observed in all organs examined via hematoxylin and eosin staining. The analgesic effect of JYQP on bone cancer pain was successfully confirmed in a rat model of Walker 256 cell-induced bone cancer. In contrast to morphine, in a physical dependence test, JYQP produced no withdrawal symptoms following chronic administration. The data from this study provide experimental evidence supporting the clinical use of JYQP as an effective, safe and non-addictive agent for the treatment of bone cancer pain.

  11. Reproductive Toxicity of Zishen Yutai Pill in Rats: The Fertility and Early Embryonic Development Study (Segment I

    Directory of Open Access Journals (Sweden)

    Li Zhou

    2016-01-01

    Full Text Available Purpose. This study was aimed to investigate the reproductive toxicity of Zishen Yutai Pill (ZYP on fertility and early embryonic development in rats. Methods. SD rats were randomly divided into 5 groups: vehicle control group (distilled water, i.g., positive control group (80 mg/kg of cyclophosphamide, i.p., and three ZYP-treated groups (3, 6, and 12 g/kg/d, i.e., 12x, 24x, and 48x clinical doses, i.g.. The high dose was set as the maximum gavage dosage. Results. Cyclophosphamide showed diverse hazards, such as decreased weight of male reproductive organs and sperm density (P<0.05. However, there were no obvious effects of ZYP on physical signs, animal behavior, and survival rate, as well as on weight and food intake during the premating and gestation periods. Importantly, there were no significant adverse effects of ZYP on indexes of copulation, fecundity and fertility indexes, weights and coefficients of male reproductive organs, epididymal sperm number and motility, estrous cycle, preimplantation loss rate, and implantation rate. Besides, the numbers of live and resorbed fetuses per litter were not significantly altered. Conclusions. ZYP had no reproductive toxicities on fertility and early embryonic development in rats at 48x equivalent clinical doses.

  12. QiShenYiQi Pills, a Compound Chinese Medicine, Prevented Cisplatin Induced Acute Kidney Injury via Regulating Mitochondrial Function

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    Li Zhou

    2017-12-01

    Full Text Available Nephrotoxicity is a serious adverse effect of cisplatin chemotherapy that limits its clinical application, to deal with which no effective management is available so far. The present study was to investigate the potential protective effect of QiShenYiQi Pills (QSYQ, a compound Chinese medicine, against cisplatin induced nephrotoxicity in mice. Pretreatment with QSYQ significantly attenuated the cisplatin induced increase in plasma urea and creatinine, along with the histological damage, such as tubular necrosis, protein cast, and desquamation of epithelial cells, improved the renal microcirculation disturbance as indicated by renal blood flow, microvascular flow velocity, and the number of adherent leukocytes. Additionally, QSYQ prevented mitochondrial dysfunction by preventing the cisplatin induced downregulation of mitochondrial complex activity and the expression of NDUFA10, ATP5D, and Sirt3. Meanwhile, the cisplatin-increased renal thiobarbituric acid-reactive substances, caspase9, cleaved-caspase9, and cleaved-caspase3 were all diminished by QSYQ pretreatment. In summary, the pretreatment with QSYQ remarkably ameliorated the cisplatin induced nephrotoxicity in mice, possibly via the regulation of mitochondrial function, oxidative stress, and apoptosis.

  13. Policy maker and provider knowledge and attitudes regarding the provision of emergency contraceptive pills within Lao PDR

    Directory of Open Access Journals (Sweden)

    Hansana Visanou

    2010-07-01

    Full Text Available Abstract Background The Ministry of Health (MOH launched the National Reproductive Health Policy in 2005, which included recommendations regarding the use of emergency contraceptive pills (ECP. However, ECP have not yet been introduced officially in the public sector of the Lao PDR. Thus, their availability is limited. Understanding the knowledge of ECP and attitudes about their provision, barriers to use, and availability among health providers and policy makers is essential to successfully incorporate ECP into reproductive health services. Methods Qualitative research methods using in-depth interviews were employed to collect data from policy makers and health providers (auxiliary medical staff, nurses, and medical doctors. Altogether, 10 policy makers, 22 public providers, and 10 providers at private clinics were interviewed. Content analysis was applied to analyze the transcribed data. Results The majority of policy makers and health care providers had heard about ECP and supported their introduction in the public sector. However, their knowledge was poor, many expressed inconsistent attitudes, and their ability to meet the demand of potential users is limited. Conclusions There is a need to train health providers and policy makers on emergency contraception and improve their knowledge about ECP, especially regarding the correct timing of use and the availability of methods. In addition, the general public must be informed of the attributes, side effects, and availability of ECP, and policy makers must facilitate the approval of ECP by the Lao Food and Drug Administration. These interventions could lead to increased access to and demand for ECP.

  14. Knowledge and use of emergency contraceptive pill: An analysis of perception and practice among unmarried urban women

    Directory of Open Access Journals (Sweden)

    Neetu Purohit

    2013-01-01

    Full Text Available Objective: The objective of this study was to collect evidence with respect to perception and practice of unmarried women toward the use of emergency contraceptive pills (ECPs. Materials and Methods: Non-probability purposive sampling was used to select respondents. A total of 250 respondents were administered the tools for the study, of which 228 were considered for analysis. Results and Discussion: Descriptive statistics showed that nearly 87% of the respondents were aware of ECPs and there was a significant difference in the knowledge of ECP of the respondents by type of the institution they had studied. More than half of the (52% respondents admitted to have boyfriends of which 16% were sexually involved and were using some form of contraception. Nearly 84% of the respondents used ECP, which superseded the use of other contraceptives. It was further found that around two-third respondents were using ECP regularly. The reason that "ECP did not hinder pleasure" and that it was handy in case of "unplanned contact" were the most cited reasons for using ECP as a regular contraceptive. Conclusion: The fact that ECPs was preferred over condom and was used regularly shows that the respondents were at a risk of sexually transmitted infection/human immunodeficiency virus. Health-care providers could be the most authentic source of information for orienting young women toward the use of safe sexual practices.

  15. [Study on mechanisms and myocardial protective effect of Qishen Yiqi dropping pills on rats with myocardial infarction].

    Science.gov (United States)

    Yang, Quan; Cao, Yunshan

    2017-06-01

    To approach the mechanisms and myocardial protective effect of Qishen Yiqi dropping pills on rats with myocardial infarction. Sixty clean healthy male Sprague-Dawley (SD) rats were randomly divided into sham operation group, model group and observation group (each n = 20). The rat model of acute myocardial infarction (AMI) was established by ligation of left anterior descent (LAD) branch of coronary artery. After modeling, the rats in observation group were given 0.135 g/kg of Qishen Yiqi dropping pills, and sham operation group and model group were administered the same amount of normal saline, once a day for consecutive 28 days. At the end of treatment, the levels of serum inflammatory factors of leukotriene B4 (LTB4), prostaglandin E 2 (PGE 2 ), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were measured by enzyme linked immunosorbent assay (ELISA); the changes of the indexes of hemodynamic [left ventricular systolic pressure (LVSP), left ventricular end-diastolic pressure (LVEDP), the maximal rate of increase/decrease in left ventricular pressure (±dp/dt max)], the ratio of the heart weight/body weight, and the ratio of the left ventricular weight/heart weight (LVW/HW), the myocardial infarction area, myocardial histopathological changes were observed in the three groups; myocardial tissues inflammatory related factors [the mRNA and protein expressions of cytosolic phospholipase A2 (cPLA2), cyclooxygenase-2 (COX-2), 5-lipoxygenase (5-LOX)], and the expression levels of transforming growth factor-β (TGF-β)/Smads signal transduction pathway related protein (TGF-β1, Smad2/3, Collagen I, Collagen III) and cell apoptosis related factors (Bcl-2, Bax) protein were measured. Compared with the sham operation group, levels of serum inflammatory factors, the index of LVEDP, the ratio of the heart weight/body weight, LVW/HW, myocardial infarction area, the mRNA and protein expression levels of inflammatory factors in myocardium, the expression levels of

  16. Metabonomic Strategy to the Evaluation of Chinese Medicine Compound Danshen Dripping Pills Interfering Myocardial Ischemia in Rats

    Directory of Open Access Journals (Sweden)

    Xue Xin

    2013-01-01

    Full Text Available Coronary heart disease (CHD is one of the highest mortality diseases in the world. Traditional Chinese medicine compound Danshen dripping pills (CDDPs have currently made a great achievement in treating CHD. However, the therapeutic mechanism of CDDP is often poorly interpreted. In this study, a GC-MS-based metabonomic study was conducted to assess the holistic efficacy of CDDP for myocardial infarction in male Sprague-Dawley rats, which were divided into the control group, the sham group, the model group, the control + CDDP group, and the model + CDDP, with CDDP at a dose of 107 mg/kg·d (equal to 1.8 mL/kg·d. The metabonomic findings demonstrated great differences of metabolic pattern among sham, model, and the model + CDDP in the orthogonal partial least squares discriminant analysis (OPLS-DA models, which coordinated well with the assessment of plasma biochemistry and histopathological assay. Differentially expressed metabolites suggested that energy metabolism, glycolysis, and lipid metabolism might be disrupted by myocardial infarction. Both the potential metabolic biomarkers and the biochemical histopathological indices were regulated effectively by CDDP.

  17. A comparative systematic review of Yasmin (drospirenone pill) versus standard treatment options for symptoms of polycystic ovary syndrome.

    Science.gov (United States)

    Li, Jing; Ren, Jing; Sun, Wenxia

    2017-03-01

    To systematically review the impact of Yasmin (drospirenone pill) compares with other standard treatments for symptoms of Polycystic Ovary Syndrome (PCOS). The relevant studies of the randomized controlled trials in women with PCOS treated with drospirenone were retrieved and the systematic evaluation was conducted. Eighteen articles were included. Compared with drospirenone (DRSP) monotherapy, DRSP plus metformin was better in reducing body mass index (BMI), luteinizing hormone (LH) and low-density lipoprotein cholesterol (LDL-C). Compared with metformin, DRSP was better in modulating serum total testosterone (T), sex hormone-binding globulin (SHBG), follicle stimulating hormone (FSH) and free androgen index (FAI), while metformin was more effective in reducing BMI, total cholesterol (TC), LDL-C and Triglyceride (TG). DRSP was superior to cyproterone acetate (CPA) in reducing TC and homeostasis model assessment of insulin resistance (HOMA-IR). DRSP shows better effect in modulating LDL-C and high-density lipoprotein cholesterol (HDL-C) compared with desogestrel (DSG). The available data suggested that DRSP was effective in modulating hormones, insulin and lipid metabolism in women with PCOS. Compared with commonly used drugs for symptoms of PCOS as CPA and DSG, DRSP shows identical or better effect in improving symptoms and protect cardiovascular system. For the PCOS patients with IR, obesity or high LH/FSH ratio, DRSP combines with metformin maybe more effective than use DRSP alone. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  18. Impact and mechanistic role of oral contraceptive pills on the number and epithelial type of ovarian cortical inclusion cysts; a clinicopathology and immunohistochemical study.

    Science.gov (United States)

    DastranjTabrizi, Ali; MostafaGharabaghi, Parvin; SheikhzadehHesari, Farzam; Sadeghi, Liela; Zamanvandi, Sharareh; Sarbakhsh, Parvin; Ghojazadeh, Morteza

    2016-03-22

    Ovarian epithelial cancers are among the most lethal women's cancers. There is no doubt about the preventive role of oral contraceptive pills (OCPs) in development of ovarian cancers. But, there are limited numbers of studies to address the effect of these agents on the number of cortical inclusion cysts (CICs), their epithelial type and suppression of the metaplastic phenomenon by these pills. The aim of this study was to clarify the role of these agents in the prevention of these cyst formation and tubal metaplasia and also examine the mesenchymal-epithelial transition theory in this context by immunohistochemical methods. The representative section(s) of ovarian cortex from a total number of 201 consecutive total abdominal hysterectomy with bilateral or unilateral salpingo-oophorectomy specimens were examined for mean number of CICs and their epithelial type between two groups of the patients. Group A included the patients who were on oral contraceptive pills for more than 5 years. All of the subjects with other contraceptive methods or a history of less than 5 years contraceptive pills usage were stratified in group B. Sections from 20 cases in which more than five inclusion cysts were found, were selected for IHC staining with calretinine and PAX8 as markers for mesothelium and mullerian epithelium respectively. The mean age of the patients was 51.67 years with no significant differences between two groups. The mean number of cysts were 1.27 and 3.23 in group A and B respectively (P =0.0001). Similarly the mean number of CICs, lined by tubal epithelium, was significantly different between two groups (0.65 vs 2.65, P =0.0001). In IHC staining 123 out of 150 CICs (82 %) were PAX+ while only 7 CICs (4.8 %) showed positive reaction for calretinin irrespective of type of epithelium. Our findings showed that the use of OCP for more than five years in women, significantly prevents development of cortical inclusion cysts in the ovaries which lined by tubal

  19. Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

    Science.gov (United States)

    Takeshita, Hideki; Moriyama, Shingo; Arai, Yoshiaki; Washino, Satoshi; Saito, Kimitoshi; Chiba, Koji; Horiuchi, Susumu; Noro, Akira

    2016-01-01

    To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score (IPSS) of ≥8 were enrolled in the randomized crossover study and divided into silodosin-preceding (S-T) and tamsulosin-preceding (T-S) groups. The S-T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks. The T-S group received the reverse treatment sequence. A washout period prior to drug crossover was not included. Subjective and objective efficacy parameters including IPSS, quality of life (QOL) index, uroflowmetry, and safety were compared between the two groups. Thirty of 34 men (S-T group n = 16; T-S group n = 14) completed the study. Both drugs significantly improved all IPSS items and QOL index in the first treatment period. Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods. Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period. Adverse events occurred more frequently with silodosin than with tamsulosin; however, none of the adverse events required treatment discontinuation. Ejaculation disorders occurred in three participants (10%) and were associated with silodosin use. Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus, may represent an effective, safe, and affordable treatment option. © 2015 Wiley Publishing Asia Pty Ltd.

  20. Wish-fulfilling jewel pills: Tibetan medicines from exclusivity to ubiquity.

    Science.gov (United States)

    Blaikie, Calum

    2015-04-01

    Despite the recent growth of social science literature concerning the traditional medicine industry in Asia, insights into the contemporary dynamics of so-called 'classical formulae' remain relatively scant, as do studies of small-scale, less capitally intensive and technologically advanced modes of production. This paper seeks to address these gaps by considering a single Sowa Rigpa (Tibetan medicine) formula known as Samphel Norbu, or 'wish-fulfilling jewel', which appears in numerous texts and is today among the most popular Tibetan medicines in the world. Drawing primarily upon long-term fieldwork in Himalayan India, the paper follows Samphel Norbu's rise from exclusivity to popularity and examines the ways it has been transformed in the process, both materially and in its economic, social and clinical significance. The paper shows how Samphel Norbu acts as a marker of inequality between different groups of healers, and examines the role the medicine played in the development of commercial pharmacy and the proliferation of complex medicines. Tracing out wide variations in the medicine's formulation, composition, mode of production and pattern of circulation places the issue of multiplicity at the centre of analysis, and leads to a questioning of the assumptions that underpin the category 'classical formula'. The paper reflects upon the repositioning of such formulae within emergent configurations of knowledge, power, industry and market, and on their transformations and transformative effects both over time and in the present moment.