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Sample records for complicating adalimumab therapy

  1. Concurrent immunomodulator therapy is associated with higher adalimumab trough levels during scheduled maintenance therapy.

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    Bond, Ashley; Dodd, Susanna; Fisher, Gareth; Skouras, Thomas; Subramanian, Sreedhar

    2017-02-01

    Combination therapy with infliximab and immunomodulators is superior to monotherapy, resulting in better outcomes and higher trough levels of infliximab. The role of concurrent immunomodulatory therapy on adalimumab trough levels has not been adequately investigated. We evaluated the impact of concomitant immunomodulation on adalimumab trough levels in patients on scheduled maintenance therapy. We conducted a prospective observational, cross-sectional study of all inflammatory bowel disease patients on maintenance therapy who had adalimumab trough levels measured between January 2013 and January 2016. Drug level and anti-drug antibody measurements were performed on sera using a solid phase assay. Pairwise comparison of means was used to compare trough levels in patients with and without concomitant immune modulator therapy. In total, 79 patients were included. Twenty-three patients (29.1%) were on weekly dosing whereas 56 (70.9%) were on alternate weeks. Median adalimumab trough levels were comparable in patients with and without clinical remission (6.8 μg/ml (IQR 5.6-8.1) versus 6.7 μg/ml (IQR 3.9-8.1), respectively. Patients with an elevated faecal calprotectin >250 μg/g had lower adalimumab trough levels (median 6.7, IQR 3.9-8) compared to patients with faecal calprotectin <250 μg/g (median 7.7, IQR 6.1-8.1) though this did not achieve statistical significance (p = .062). Median adalimumab trough levels among patients on concurrent immunomodulators was 7.2 μg/ml (IQR 5.7-8.1) compared to those not on concurrent immunomodulator, 6.1 μg/ml (IQR 2.7-7.7, p = .0297). Adalimumab trough levels were significantly higher in patients on concurrent immunomodulators during maintenance therapy. There was a trend towards a lower adalimumab trough level in patients with elevated calprotectin.

  2. Development of sarcoidosis during adalimumab therapy for chronic plaque psoriasis.

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    Marcella, Stefanie; Welsh, Belinda; Foley, Peter

    2011-08-01

    A 38-year-old woman developed clinical, biochemical, radiological and histopathological evidence of cutaneous and pulmonary sarcoidosis 5 months after commencing adalimumab for chronic plaque psoriasis. Signs and symptoms resolved within 3 months of cessation of adalimumab. © 2010 The Authors. Australasian Journal of Dermatology © 2010 The Australasian College of Dermatologists.

  3. PHARMACOECONOMIC ISSUES OF ADALIMUMAB THERAPY IN JUVENILE IDIOPATHIC ARTHRITIS

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    K. Simpson

    2012-01-01

    Full Text Available Background. Juvenile idiopathic arthritis (JIA is the most common type of arthritis in children and is associated with reduced quality of life and increased health care costs. Objective. To evaluate the cost effectiveness of the tumour necrosis factor inhibitor adalimumab (ADA vs. non-biologic therapy for the treatment of JIA in Russian children and adolescents. Materials and Methods. A Markov model was developed on the basis of the DE038 clinical trial, which compared ADA plus methotrexate (MTX vs. placebo plus MTX for the treatment of JIA in children aged 4–17 years. Cost-effectiveness analyses were performed from the standpoint of the Russian health care system and society as a whole. Base case analyses followed 11-year-old patients with JIA for a period of 7 years (until the age of 18 years or over an expected lifetime. Additional analyses followed patients aged 7 years at treatment initiation for a period of 11 years or over a simulated lifetime. The cost of treating severe JIA was assumed to be the same as reported in a published investigation. The cost of ADA therapy was based on the expected cost assuming inclusion in the List of Vital and Essential Medicinal Products. This took into account the Value Added Tax and a 10% trade mark-up. Treatment outcomes were measured in quality-adjusted life years (QALYs. Results and Discussion. Over a 7-year time horizon, the incremental cost-utility ratio (ICUR for ADA vs. conventional nonbiologic therapy in the treatment of JIA in 11-year-old patients was 1,571,500 roubles/QALY when using a health care system perspective and 1,515,000 roubles/QALY when using a societal perspective. Over a simulated patient lifetime, the corresponding ICURs were 286,300 roubles/QALY and 275,300 roubles/QALY, respectively. Over an 11-year time horizon, the ICUR for ADA vs. conventional non-biologic therapy in the treatment of JIA in patients aged 7 years at the start of therapy was 852,400 roubles/QALY when

  4. Systemic sarcoidosis with bone marrow involvement responding to therapy with adalimumab: a case report

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    Patel Supen R

    2009-07-01

    Full Text Available Abstract Introduction Sarcoidosis is an inflammatory disorder characterized by the presence of non-caseating granulomas in affected organs. The presence of CD4-positive T lymphocytes and macrophages in affected organs suggests an ongoing immune response. Systemic corticosteroids remain the mainstay of treatment, but therapy is often limited by adverse effects. This is the first report of the use of adalimumab (HUMIRA®, Abbott Laboratories, North Chicago, IL, USA, an anti-tumor necrosis factor monoclonal antibody, in a patient with systemic sarcoidosis with bone marrow involvement. Case presentation A 42-year-old African-American man with a medical history significant for hypertension and diabetes mellitus presented with anemia and thrombocytopenia of two months duration. The patient underwent physical examination, bone marrow aspiration and biopsy, chest X-ray, acid-fast bacilli stain, computed tomography with contrast, and additional laboratory tests. He was diagnosed with systemic sarcoidosis with splenomegaly and bone marrow involvement. Drug therapy included prednisone, which had to be discontinued owing to adverse effects, and adalimumab. Conclusion This is the first report describing the use of adalimumab in a patient with systemic sarcoidosis with bone marrow involvement. Tumor necrosis factor antagonism with adalimumab was efficacious and well-tolerated in this patient and may be considered as a treatment option for similar cases.

  5. Systemic sarcoidosis with bone marrow involvement responding to therapy with adalimumab: a case report.

    Science.gov (United States)

    Patel, Supen R

    2009-07-29

    Sarcoidosis is an inflammatory disorder characterized by the presence of non-caseating granulomas in affected organs. The presence of CD4-positive T lymphocytes and macrophages in affected organs suggests an ongoing immune response. Systemic corticosteroids remain the mainstay of treatment, but therapy is often limited by adverse effects. This is the first report of the use of adalimumab (HUMIRA((R)), Abbott Laboratories, North Chicago, IL, USA), an anti-tumor necrosis factor monoclonal antibody, in a patient with systemic sarcoidosis with bone marrow involvement. A 42-year-old African-American man with a medical history significant for hypertension and diabetes mellitus presented with anemia and thrombocytopenia of two months duration. The patient underwent physical examination, bone marrow aspiration and biopsy, chest X-ray, acid-fast bacilli stain, computed tomography with contrast, and additional laboratory tests. He was diagnosed with systemic sarcoidosis with splenomegaly and bone marrow involvement. Drug therapy included prednisone, which had to be discontinued owing to adverse effects, and adalimumab. This is the first report describing the use of adalimumab in a patient with systemic sarcoidosis with bone marrow involvement. Tumor necrosis factor antagonism with adalimumab was efficacious and well-tolerated in this patient and may be considered as a treatment option for similar cases.

  6. Systemic sarcoidosis with bone marrow involvement responding to therapy with adalimumab: a case report

    OpenAIRE

    Patel, Supen R

    2009-01-01

    Abstract Introduction Sarcoidosis is an inflammatory disorder characterized by the presence of non-caseating granulomas in affected organs. The presence of CD4-positive T lymphocytes and macrophages in affected organs suggests an ongoing immune response. Systemic corticosteroids remain the mainstay of treatment, but therapy is often limited by adverse effects. This is the first report of the use of adalimumab (HUMIRA®, Abbott Laboratories, North Chicago, IL, USA), an anti-tumor necrosis facto...

  7. Complications of cancer therapy

    International Nuclear Information System (INIS)

    Moskowitz, P.S.; Parker, B.R.

    1985-01-01

    The purpose of this chapter is to review systematically the toxicity of contemporary chemotherapy and irradiation on normal tissues of growing children. Whenever possible, the separate toxicity of chemotherapy, irradiation, and combination therapy is addressed. However, it is not always possible to quantitate specifically such reactions in the face of multiple drug therapy, which may enhance radiation injury or reactivate prior radiation injury. Prior detailed reviews have provided important sources of information concerning radiation injury for this more general discussion. The information provided will assist both the clinician and the radiologist in the recognition of early and late complications of therapy in pediatric oncology

  8. Association of Trabecular Bone Score with Inflammation and Adiposity in Patients with Psoriasis: Effect of Adalimumab Therapy

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    José L. Hernández

    2016-01-01

    Full Text Available Studies on trabecular bone score (TBS in psoriasis are lacking. We aim to assess the association between TBS and inflammation, metabolic syndrome features, and serum adipokines in 29 nondiabetic patients with psoriasis without arthritis, before and after 6-month adalimumab therapy. For that purpose, adjusted partial correlations and stepwise multivariable linear regression analysis were performed. No correlation was found between TBS and disease severity. TBS was negatively associated with weight, BMI, waist perimeter, fat percentage, and systolic and diastolic blood pressure before and after adalimumab. After 6 months of therapy, a negative correlation between TBS and insulin resistance (p=0.02 and leptin (p=0.01 and a positive correlation with adiponectin were found (p=0.01. The best set of predictors for TBS values at baseline were female sex (p=0.015, age (p=0.05, and BMI (p=0.001. The best set of predictors for TBS following 6 months of biologic therapy were age (p=0.001, BMI (p<0.0001, and serum adiponectin levels (p=0.027. In conclusion, in nondiabetic patients with moderate-to-severe psoriasis, TBS correlates with metabolic syndrome features and inflammation. This association is still present after 6 months of adalimumab therapy. Moreover, serum adiponectin levels seem to be an independent variable related to TBS values, after adalimumab therapy.

  9. Adalimumab for maintenance therapy for one year in Crohn's disease: results of a Latin American single-center observational study.

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    Kotze, Paulo Gustavo; Abou-Rejaile, Vinícius Rezende; Uiema, Luciana Aparecida; Olandoski, Marcia; Sartor, Maria Cristina; Miranda, Eron Fábio; Kotze, Lorete Maria da Silva; Saad-Hossne, Rogério

    2014-01-01

    Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn's disease patients are scarce. The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients. Retrospective, single-center, observational study of a Brazilian case series of Crohn's disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (Panalysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

  10. Efficacy of Adalimumab as a long term maintenance therapy in ulcerative colitis.

    LENUS (Irish Health Repository)

    McDermott, Edel

    2013-03-01

    Adalimumab is a recombinant human IgG1 monoclonal antibody to TNF-alpha. There are limited data with regard to its efficacy in ulcerative colitis. We report experience of adalimumab in ulcerative colitis in a single centre with a focus on the ability of this agent to maintain response and avoid colectomy in the medium to long-term.

  11. Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases.

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    Gonczi, Lorant; Kurti, Zsuzsanna; Rutka, Mariann; Vegh, Zsuzsanna; Farkas, Klaudia; Lovasz, Barbara D; Golovics, Petra A; Gecse, Krisztina B; Szalay, Balazs; Molnar, Tamas; Lakatos, Peter L

    2017-08-08

    Therapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients. One hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35 years) were enrolled in this consecutive cohort from two referral centres in Hungary. Demographic data were comprehensively collected and harmonized monitoring strategy was applied. Previous and current therapy, laboratory data and clinical activity were recorded at the time of TDM. Patients were evaluated either at the time of suspected LOR or during follow-up. TDM measurements were determined by commercial ELISA (LISA TRACKER, Theradiag, France). Among 112 IBD patients, LOR/drug persistence was 25.9%/74.1%. The cumulative ADA positivity (>10 ng/mL) and low TL (<5.0 μg/mL) was 12.1% and 17.8% after 1 year and 17.3% and 29.5% after 2 years of adalimumab therapy. Dose intensification was needed in 29.5% of the patients. Female gender and ADA positivity were associated with LOR (female gender: p < 0.001, OR:7.8 CI 95%: 2.5-24.3, ADA positivity: p = 0.007 OR:3.6 CI 95%: 1.4-9.5). ADA development, low TL and need for dose intensification were frequent during adalimumab therapy and support the selective use of TDM in IBD patients treated with adalimumab. ADA positivity and gender were predictors of LOR.

  12. Adalimumab Injection

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    ... the armpits, groin, and anal area) in adults, uveitis (swelling and inflammation of different areas of the ... certain lab tests before, during, and after your treatment to check your body's response to adalimumab.Do ...

  13. Complication of radiation therapy

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    Imajo, Yoshinari; Suematsu, Toru; Narabayashi, Isamu; Gose, Kyuhei; Takimoto, Saeko

    1984-01-01

    The radiation pneumonitis is a major complication for patients recieving thoracic irradiation. This report describe the radiographic recognition, pathological change and imapired pulmonary functions of radiation pneumonitis. The 57 patients with lung cancer treated with radiation are analyzed on the pneumonitis by chest X-P. Among these, 50 patients (88%) develop radiation pneumonitis. Repeated CT scans give more detailed information than conventional radiograms as to exdative changes. The pathological analysis are made on the 35 patients of which affected lungs are resected after pre-operative irradiation. Three phases are recognized in the evolution of pneumonitis, the ongestive, the degenerative, and the fibrotic. Adding to the morphorogical damage, pulmonary functions also detrieorate both in ventilation and perfusion scans. (author)

  14. ADALIMUMAB FOR MAINTENANCE THERAPY FOR ONE YEAR IN CROHN?S DISEASE: results of a Latin American single-center observational study

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    Paulo Gustavo KOTZE

    2014-03-01

    Full Text Available Context Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn’s disease patients are scarce. Objectives The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn’s disease patients. Methods Retrospective, single-center, observational study of a Brazilian case series of Crohn’s disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05. Results Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033. Conclusions Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

  15. Oral complications of radiation therapy

    International Nuclear Information System (INIS)

    Lockhart, P.B.

    1986-01-01

    Comprehensive management of patients receiving radiotherapy to the head and neck dictates that they have a thorough dental evaluation as part of their overall treatment planning. Early and appropriate patient education and dental treatment, along with careful management during and after radiotherapy, will significantly decrease the incidence and severity of complications, improve quality of life, and increase tolerance to therapy. 49 refs.; 16 figs.; 1 table

  16. Late complications of radiation therapy

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    Masaki, Norie

    1998-01-01

    There are cases in which, although all traces of acute radiation complications seem to have disappeared, late complications may appear months or years to become apparent. Trauma, infection or chemotherapy may sometimes recall radiation damage and irreversible change. There were two cases of breast cancer that received an estimated skin dose in the 6000 cGy range followed by extirpation of the residual tumor. The one (12 y.o.) developed atrophy of the breast and severe teleangiectasis 18 years later radiotherapy. The other one (42 y.o.) developed severe skin necrosis twenty years later radiotherapy after administration of chemotherapy and received skin graft. A case (52 y.o.) of adenoidcystic carcinoma of the trachea received radiation therapy. The field included the thoracic spinal cord which received 6800 cGy. Two years and 8 months after radiation therapy she developed complete paraplegia and died 5 years later. A truly successful therapeutic outcome requires that the patient be alive, cured and free of significant treatment-related morbidity. As such, it is important to assess quality of life in long-term survivors of cancer treatment. (author)

  17. Late complications of radiation therapy

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    Masaki, Norie [Osaka Prefectural Center for Adult Diseases (Japan)

    1998-03-01

    There are cases in which, although all traces of acute radiation complications seem to have disappeared, late complications may appear months or years to become apparent. Trauma, infection or chemotherapy may sometimes recall radiation damage and irreversible change. There were two cases of breast cancer that received an estimated skin dose in the 6000 cGy range followed by extirpation of the residual tumor. The one (12 y.o.) developed atrophy of the breast and severe teleangiectasis 18 years later radiotherapy. The other one (42 y.o.) developed severe skin necrosis twenty years later radiotherapy after administration of chemotherapy and received skin graft. A case (52 y.o.) of adenoidcystic carcinoma of the trachea received radiation therapy. The field included the thoracic spinal cord which received 6800 cGy. Two years and 8 months after radiation therapy she developed complete paraplegia and died 5 years later. A truly successful therapeutic outcome requires that the patient be alive, cured and free of significant treatment-related morbidity. As such, it is important to assess quality of life in long-term survivors of cancer treatment. (author)

  18. Blockade of Tumor Necrosis Factor-Alpha: A Role for Adalimumab in Neovascular Age-Related Macular Degeneration Refractory to Anti-Angiogenesis Therapy

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    Beatriz Fernández-Vega

    2016-03-01

    Full Text Available Aims: To report a case of wet age-related macular degeneration (wet-AMD refractory to intravitreal anti-vascular endothelial growth factor (anti-VEGF therapy in a patient who showed visual and anatomical improvement and stabilization after starting a subcutaneous treatment course with adalimumab, an anti-tumor necrosis factor-alpha (TNF-α drug, for concomitant Crohn's disease. Methods: Observational case report of a female patient. Ophthalmological evaluation was performed by slit lamp and ophthalmoscopy (posterior pole and anterior segment. Best-corrected visual acuity (BCVA was determined, and imaging was performed by fluorescein angiography, indocyanine green angiography, and optical coherence tomography (OCT. Intravitreal therapies used and treatment with anti-TNF-α were recorded. Results: A 64-year-old woman with wet-AMD was treated with fourteen intravitreal injections of ranibizumab (0.5 mg for a period of 40 months with intervals of 1-6 months. She initially showed a good visual and anatomical response to periodic anti-VEGF treatment but during check visits, anatomical and functional responses deteriorated. At the 40-month follow-up, the patient had developed Crohn's disease, and her rheumatologist started treatment with adalimumab (40 mg subcutaneously every 2 weeks. During the 25 months of treatment with adalimumab, the patient did not require any additional intravitreal anti-VEGF treatments because her BCVA, clinical, and OCT findings improved and remained stable. Conclusions: We described a case of a patient with wet-AMD refractory to anti-VEGF therapy, which clinically benefited from subcutaneous adalimumab therapy. Treatment with subcutaneous anti-TNF-α in combination with anti-VEGF therapy avoids the high cost and risks related to multiple intravitreal anti-VEGF injections with good functional and anatomic outcomes.

  19. Adalimumab (TNFα Inhibitor Therapy Exacerbates IgA Glomerulonephritis Acute Renal Injury and Induces Lupus Autoantibodies in a Psoriasis Patient

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    S. S. Wei

    2013-01-01

    Full Text Available Adalimumab (Humira is a tumour necrosis factor α (TNFα inhibitor that is approved for the treatment of rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease, ankylosing spondylitis, and juvenile idiopathic arthritis (Sullivan and Preda (2009, Klinkhoff (2004, and Medicare Australia. Use of TNFα inhibitors is associated with the induction of autoimmunity (systemic lupus erythematosus, vasculitis, and sarcoidosis or sarcoid-like granulomas (Ramos-Casals et al. (2010. We report a patient with extensive psoriasis presenting with renal failure and seropositive lupus markers without classical lupus nephritis after 18 months treatment with adalimumab. He has renal biopsy proven IgA nephritis instead. Renal biopsy is the key diagnostic tool in patients presenting with adalimumab induced nephritis and renal failure. He made a remarkable recovery after adalimumab cessation and steroid treatment. To our knowledge, this is a unique case of a psoriasis patient presenting with seropositive lupus markers without classical lupus nephritis renal failure and had renal biopsy proven IgA glomerulonephritis after receiving adalimumab.

  20. Efficacy of adalimumab in young children with juvenile idiopathic arthritis and chronic uveitis: a case series.

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    La Torre, Francesco; Cattalini, Marco; Teruzzi, Barbara; Meini, Antonella; Moramarco, Fulvio; Iannone, Florenzo

    2014-05-24

    Juvenile idiopathic arthritis is a relatively common chronic disease of childhood, and is associated with persistent morbidity and extra-articular complications, one of the most common being uveitis. The introduction of biologic therapies, particularly those blocking the inflammatory mediator tumor necrosis factor-α, provided a new treatment option for juvenile idiopathic arthritis patients who were refractory to standard therapy such as non-steroidal anti-inflammatory drugs, corticosteroids and/or methotrexate. The first case was a 2-year-old girl with juvenile idiopathic arthritis and uveitis who failed to respond to treatment with anti-inflammatories, low-dose corticosteroids and methotrexate, and had growth retardation. Adalimumab 24 mg/m2 every 2 weeks and prednisone 0.5 mg/kg/day were added to methotrexate therapy; steroid tapering and withdrawal started after 1 month. After 2 months the patient showed good control of articular and ocular manifestations, and she remained in remission for 1 year, receiving adalimumab and methotrexate with no side effects, and showing significant improvement in growth. Case 2 was a 9-year-old boy with an 8-year history of juvenile idiopathic arthritis and uveitis that initially responded to infliximab, but relapse occurred after 2 years off therapy. After switching to adalimumab, and adjusting doses of both adalimumab and methotrexate based on body surface area, the patient showed good response and corticosteroids were tapered and withdrawn after 6 months; the patient remained in remission taking adalimumab and methotrexate. The final case was a 5-year-old girl with juvenile idiopathic arthritis for whom adalimumab was added to methotrexate therapy after three flares of uveitis. The patient had two subsequent episodes of uveitis that responded well to local therapy, but was then free of both juvenile idiopathic arthritis and uveitis symptoms, allowing methotrexate and then adalimumab to be stopped; the patient remained in drug

  1. Disease activity, physical function, and radiographic progression after longterm therapy with adalimumab plus methotrexate: 5-year results of PREMIER

    NARCIS (Netherlands)

    van der Heijde, Désirée; Breedveld, Ferdinand C.; Kavanaugh, Arthur; Keystone, Edward C.; Landewé, Robert; Patra, Kaushik; Pangan, Aileen L.

    2010-01-01

    To evaluate the efficacy and safety of initial combination treatment with adalimumab (ADA) and methotrexate (MTX) versus monotherapy with ADA or MTX during an open-label extension of PREMIER. Patients with early rheumatoid arthritis (RA) received blinded ADA plus MTX, ADA alone, or MTX alone for 2

  2. LVAD pannus complicating destination therapy

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    Maya Ignaszewski

    2017-11-01

    Full Text Available Despite advances in technology, ventricular assist devices still experience a number of complications limiting their long-term use. We present a 73-year-old woman implanted with a left ventricular assist device (LVAD five years prior due to end-stage dilated cardiomyopathy, who died several weeks after admission to the hospital. Post-mortem examination revealed a large obstructing pannus in the LVAD inflow. As a result of increased LVAD use, complications such as infection, device thrombosis and pannus must be promptly recognized and managed appropriately to ensure the greatest chance of patient survival.

  3. Complications of HIV Disease and Antiretroviral Therapy

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    Luetkemeyer, Anne F.; Havlir, Diane V.; Currier, Judith S.

    2010-01-01

    There is growing interest in the pathogenesis, treatment, and prevention of long-term complications of HIV disease and its therapies. Specifically, studies focused on cardiovascular, renal, bone, and fat abnormalities were prominent at the 17th Conference on Retroviruses and Opportunistic Infections. Although enthusiasm about the effectiveness of current antiretroviral therapy remains strong, collectively, the ongoing work in the area of HIV disease and treatment complications appears to refl...

  4. Oral complications of radiation therapy

    International Nuclear Information System (INIS)

    Lockhart, P.B.

    1986-01-01

    Approximately 24,000 patients are diagnosed each year with malignant tumors of the head and neck. Many of these patients will be treated with radiotherapy, surgery, or chemotherapy, either singly or in combination. Certain predictable sequelae of radiotherapy exist that may be considered consequences of treatment rather than complications; these may be unavoidable consequences of curative radiotherapy to the head and neck. There are, however, additional problems that occur as a result of radiotherapy that are preventable in both incidence and severity, and are therefore avoidable complications. Cell kinetic factors, radiosensitivity of normal tissues, radiotherapeutic doses necessary for tumor control, and the complex anatomy of the maxillofacial region often predispose patients serious treatment morbidity. The potential for pain, infection, and long-term functional disability with decreased quality of life dictate conscientious management before, during, and after radiotherapy. This chapter discusses common problems that can arise, as well as current methods utilized both to improve patient tolerance to treatment and to decrease the risk of preventable and potentially dose-limiting morbidity

  5. Efficacy and safety of the adalimumab biosimilar Exemptia as induction therapy in moderate-to-severe ulcerative colitis

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    Vandana Midha

    2018-01-01

    Full Text Available Background/Aims: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods: Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score. Results: A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%] were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%, whereas clinical remission was observed only in 1 patient (3.5%. Among the non-responders (n=21, 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8% developed extrapulmonary tuberculosis. Conclusions: The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.

  6. Effectiveness of early adalimumab therapy in psoriatic arthritis patients from Reuma.pt - EARLY PsA.

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    Santos, Helena; Eusébio, Mónica; Borges, Joana; Gonçalves, Diana; Ávila-Ribeiro, Pedro; Faria, Daniela Santos; Lopes, Carina; Rovisco, João; Águeda, Ana; Nero, Patrícia; Valente, Paula; Cravo, Ana Rita; Santos, Maria José

    2017-01-01

    Objective To compare outcomes in psoriatic arthritis (PsA) patients initiating adalimumab (ADA), with short- and long-term disease duration and to evaluate the potential effect of concomitant conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or glucocorticoids. Methods Analyses included adult PsA patients registered in the Rheumatic Diseases Portuguese Register (Reuma.pt) between June 2008-June 2016 who received ADA for ≥3 months. Psoriatic Arthritis Response Criteria (PsARC) response, tender and swollen joint count, inflammatory parameters, patient (PtGA) and physician global assessment (PhGA), Disease Activity Score-28 joints (DAS28), and Health Assessment Questionnaire Disability Index (HAQ-DI) were compared between patients with PsA) and those with ≥5 years of disease duration (late PsA). Time to achieving PsARC response was estimated using the Kaplan-Meier method. Results Of 135 PsA patients treated with ADA, 126 had information on disease duration (earlyPsA, n=41). PsARC response was achieved by 72.9% of the patients (88.0% early PsA vs 62.2% late PsA; P=0.022) after 3 months and by 85.4% after 24 months (100% early PsA vs 75.9% late PsA; P=0.044). Early PsA patients achieved significantly less painful joints (2.7 vs 6.7, p=0.006), lower mean C-reactive protein (0.5 mg/dL vs 1.3 mg/dL; P=0.011), and PhGA (18.3 vs 28.1; P=0.020) at 3 months. In the long term, early PsA patients also had fewer swollen joints (0.3 vs 1.7; P=0.030) and lower PhGA (6.3 vs 21.9; PPsA, respectively. Early PsA patients obtained PsARC response more rapidly than late PsA (3.8 and 7.4 months, respectively; P=0.008). Concomitant csDMARDs showed clinical benefit (2-year PsARC response, 88.3% vs 60.0%; P=0.044). Concomitant glucocorticoids had no effect on PsARC response over 2 years of follow-up. Persistence on ADA was similar in both groups. Conclusion Early PsA patients had a greater chance of improvement after ADA therapy and better functional outcome, and

  7. Quantification of late complications after radiation therapy

    International Nuclear Information System (INIS)

    Jung, Horst; Beck-Bornholdt, Hans-Peter; Svoboda, Vladimir; Alberti, Winfried; Herrmann, Thomas

    2001-01-01

    Background: An increasing number of patients survive cancer after having received radiation therapy. Therefore, the occurrence of late normal tissue complications among long-term survivors is of particular concern. Methods: Sixty-three patients treated by radical surgery and irradiation for rectal carcinoma were subjected to an unconventional sandwich therapy. Preoperative irradiation was given in four fractions of 5 Gy each applied within 2 or 3 days; postoperative irradiation consisted mostly of 15x2 Gy (range, 20-40 Gy). A considerable proportion of these patients developed severe late complications (Radiother Oncol 53 (1999) 177). The data allowed a detailed analysis of complication kinetics, leading to a new model which was tested using data from the literature. Results: Data on late complications were obtained for eight different organs with a follow-up of up to 10 years. For the various organs, the percentage of patients being free from late complications, plotted as a function of time after start of radiation therapy, was adequately described by exponential regression. From the fit, the parameter p a was obtained, which is the percentage of patients at risk in a given year of developing a complication in a given organ during that year. The rate p a remained about constant with time. Following sandwich therapy, the annual incidence of complications in the bladder, ileum, lymphatic and soft tissue, and ureters was about the same (p a =10-14%/year), whereas complications in bone or dermis occurred at lower rates (4.7 or 7.5%/year, respectively). Discussion: Numerous data sets collected from published reports were analyzed in the same way. Many of the data sets studied were from patients in a series where there was a high incidence of late effects. Three types of kinetics for the occurrence of late effects after radiotherapy were identified: Type 1, purely exponential kinetics; Type 2, exponential kinetics, the slope of which decreased exponentially with time

  8. Effectiveness of infliximab after adalimumab failure in Crohn's disease.

    Science.gov (United States)

    Chaparro, María; Andreu, Montserrat; Barreiro-de Acosta, Manuel; García-Planella, Esther; Ricart, Elena; Domènech, Eugeni; Esteve, María; Merino, Olga; Nos, Pilar; Peñalva, Mireia; Gisbert, Javier P

    2012-10-07

    To evaluate the effectiveness of infliximab as a second-line therapy in Crohn's disease patients after adalimumab failure. A historical cohort study in a community-based gastroenterology practice evaluated Crohn's disease patients treated with infliximab (induction plus maintenance) after adalimumab failure. Patients were identified using a large Spanish database (ENEIDA). We included 15 Crohn's disease patients who received infliximab after adalimumab failure. Five patients discontinued adalimumab due to loss of response, 3 due to adverse events and 7 due to partial response. After infliximab therapy was started, all patients who had interrupted adalimumab due to loss of efficacy regained response. All patients who discontinued adalimumab due to adverse events responded to infliximab and maintained this response; one of these patients had an uneventful course on infliximab, but 2 developed adverse events. None of the 7 patients who interrupted adalimumab due to partial response reached remission with infliximab. Switching from adalimumab to infliximab may be useful in patients who develop adverse effects or loss of response, however, the benefit of infliximab in primary nonresponders was not established.

  9. Efficacy of adalimumab in patients with crohn's disease and failure to infliximab therapy: a clinical series Eficacia de Adalimumab en pacientes con enfermedad de Crohn y fracaso previo a la terapia con Infliximab: resultados de una serie clínica

    Directory of Open Access Journals (Sweden)

    Patricia Cordero-Ruiz

    2011-06-01

    Full Text Available Background: adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn's disease. It seems to be effective in patients with resistance to infliximab, too, though the experience is more limited. Aim: to evaluate the efficacy of adalimumab, in patients with Crohn's disease (CD and failure to previous treatment with infliximab. B twenty-five patients with CD and failure to previous treatment with infliximab were enrolled; they were treated with 160/80 (24 patients and 80/40 (1 patient induction doses. We analyze clinical response to treatment with adalimumab by the Crohn's disease Activity Index (CDAI and plasma concentration of C-reactive protein (CRP, steroid sparing and complete fistula closure at week 48. Results: eighteen out of twenty-five patients (72% achieved clinical remission (CDAI score Introducción: adalimumab, un anti-TNF humano, ha demostrado ser efectivo en la inducción y tratamiento de mantenimiento de la enfermedad de Crohn moderada-grave. Existe menos experiencia, pero este fármaco parece también eficaz en los pacientes con pérdida de respuesta o intolerancia al infliximab. Objetivo: evaluar la eficacia de adalimumab durante un año, en nuestra serie de pacientes con enfermedad de Crohn (EC y fracaso en el tratamiento previo con infliximab. Métodos: se incluyen 25 pacientes con enfermedad de Crohn y fracaso previo a la terapia con infliximab, que son tratados con adalimumab. Se utilizaron dosis de inducción de 160/80 mg en 24 pacientes y dosis de 80/40 en un paciente. Analizamos la respuesta clínica al tratamiento con adalimumab mediante el Índice de actividad de la enfermedad de Crohn (CDAI y las concentraciones plasmáticas de proteína C reactiva (PCR, el cese de la corticoterapia y el cierre completo de las fistulas en la semana 48. Resultados: dieciocho de veinticinco pacientes (72% alcanzan la remisión clínica (CDAI < 150 en la semana 24 y 15

  10. Uveitis Events During Adalimumab, Etanercept, and Methotrexate Therapy in Juvenile Idiopathic Arthritis: Data From the Biologics in Pediatric Rheumatology Registry.

    Science.gov (United States)

    Foeldvari, Ivan; Becker, Ingrid; Horneff, Gerd

    2015-11-01

    Uveitis is a major extraarticular quality of life-restricting manifestation of juvenile idiopathic arthritis (JIA). The aim of the study is to describe the occurrence of uveitis in JIA patients receiving tumor necrosis factor inhibitors or methotrexate (MTX). Patients' characteristics, treatment, and the reported first occurrence of uveitis as an adverse event were searched in the Biologics in Pediatric Rheumatology Registry. The rates per exposed patients, exposure time, and time until event were calculated. Uveitis was reported as an adverse event in 75 of 3,467 patients; 51 of 2,844 patients were receiving MTX, 37 of 1,700 patients were receiving etanercept, and 13 of 364 patients were receiving adalimumab. Patients with uveitis were younger (mean ± SD age 4.6 ± 4.2 versus 7.4 ± 4.5 years; P uveitis diagnosis before starting treatment more often had a uveitis event (n = 28, 8.4%; OR 8.5, P uveitis event occurred: 11 while taking MTX (3.2 per 1,000 patient-years), 2 while taking etanercept monotherapy (1.9 per 1,000 patient-years), and 3 while taking etanercept and MTX combination (0.9 per 1,000 patient-years). A new uveitis event occurred early in the disease course after a median disease duration of 1.5 years (interquartile range [IQR] 1.3-3.8) while taking etanercept and 1.8 years (IQR 1.8-2.1) for the MTX cohort. A recurrent uveitis event was reported after a disease duration of 7.6 years (IQR 4.3-10.0) in the etanercept cohort and 4.8 years (IQR 1.0-5.8) in the MTX cohort. Univariate analysis showed that MTX, but not etanercept or adalimumab, led to a lower rate of uveitis. Patients with a history of uveitis had higher risks for uveitis events while taking both etanercept and adalimumab. Methotrexate turned out to be protective. Few patients developed a first uveitis event while taking etanercept, while the rate is comparable to that with MTX. Uveitis may not be attributed to be an adverse drug reaction to etanercept. © 2015, American

  11. Adalimumab-induced acute interstitial lung disease in a patient with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Olivia Meira Dias

    2014-01-01

    Full Text Available The use of immunobiological agents for the treatment of autoimmune diseases is increasing in medical practice. Anti-TNF therapies have been increasingly used in refractory autoimmune diseases, especially rheumatoid arthritis, with promising results. However, the use of such therapies has been associated with an increased risk of developing other autoimmune diseases. In addition, the use of anti-TNF agents can cause pulmonary complications, such as reactivation of mycobacterial and fungal infections, as well as sarcoidosis and other interstitial lung diseases (ILDs. There is evidence of an association between ILD and the use of anti-TNF agents, etanercept and infliximab in particular. Adalimumab is the newest drug in this class, and some authors have suggested that its use might induce or exacerbate preexisting ILDs. In this study, we report the first case of acute ILD secondary to the use of adalimumab in Brazil, in a patient with rheumatoid arthritis and without a history of ILD.

  12. Neuromuscular complications of immune checkpoint inhibitor therapy.

    Science.gov (United States)

    Kolb, Noah A; Trevino, Christopher R; Waheed, Waqar; Sobhani, Fatemeh; Landry, Kara K; Thomas, Alissa A; Hehir, Mike

    2018-01-17

    Immune checkpoint inhibitor (ICPI) therapy unleashes the body's natural immune system to fight cancer. ICPIs improve overall cancer survival, however, the unbridling of the immune system may induce a variety of immune-related adverse events. Neuromuscular immune complications are rare but they can be severe. Myasthenia gravis and inflammatory neuropathy are the most common neuromuscular adverse events but a variety of others including inflammatory myopathy are reported. The pathophysiologic mechanism of these autoimmune disorders may differ from that of non-ICPI-related immune diseases. Accordingly, while the optimal treatment for ICPI-related neuromuscular disorders generally follows a traditional paradigm, there are important novel considerations in selecting appropriate immunosuppressive therapy. This review presents 2 new cases, a summary of neuromuscular ICPI complications, and an approach to the diagnosis and treatment of these disorders. Muscle Nerve, 2018. © 2018 Wiley Periodicals, Inc.

  13. Towards a Possible Therapy for Diabetes Complications

    Science.gov (United States)

    2016-03-01

    AWARD NUMBER: W81XWH-10-1-1055 TITLE: Towards A Possible Therapy for Diabetes Complications PRINCIPAL INVESTIGATOR: Massimo Trucco, M.D...PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT : Approved for public release...official Department of the Army position , policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved

  14. Anti-adalimumab antibodies in juvenile idiopathic arthritis-related uveitis.

    Science.gov (United States)

    Leinonen, Sanna T; Aalto, Kristiina; Kotaniemi, Kaisu M; Kivelä, Tero T

    2017-01-01

    To evaluate the association of adalimumab trough levels and anti-adalimumab antibodies with activity of uveitis in juvenile idiopathic arthritis-related uveitis. This was a retrospective observational case series in a clinical setting at the Department of Ophthalmology, Helsinki University Hospital, Finland in 2014-2016. Thirty-one paediatric patients with chronic anterior juvenile idiopathic arthritis-related uveitis in 58 eyes and who had been on adalimumab ≥6 months were eligible for the study. Uveitis activity during adalimumab treatment, adalimumab trough levels and anti-adalimumab antibody levels were recorded. Anti-adalimumab antibody levels ≥12 AU /ml were detected in nine patients (29%). This level of anti-adalimumab antibodies was associated with a higher grade of uveitis (puveitis that was not in remission (p=0.001) and with lack of concomitant methotrexate therapy (p=0.043). In patients with anti-adalimumab antibody levels uveitis (p=0.86). Adalimumab treatment might be better guided by monitoring anti-adalimumab antibody formation in treating JIA-related uveitis.

  15. Treatment of pediatric uveitis with adalimumab: the MERSI experience.

    Science.gov (United States)

    Castiblanco, Claudia; Meese, Halea; Foster, C Stephen

    2016-04-01

    To evaluate adalimumab therapy in children with uveitis. The electronic health records of pediatric patients diagnosed with uveitis and treated with adalimumab therapy were reviewed retrospectively. Demographic information, site and degree of intraocular inflammation, visual acuity, underlying systemic disorders, duration of therapy, side effects, and ability to obtain steroid-free remission were recorded. A total of 17 patients were included, 16 patients with anterior uveitis and 1 with panuveitis; 14 patients had bilateral disease. Juvenile idiopathic arthritis had been diagnosed in 14 patients, sarcoidosis in 1 patient, and idiopathic etiology in 2 patients. Of the 17 patients, 13 (about 77%) achieved steroid-free remission, and 4 did not. Six patients flared after discontinuation of adalimumab, with evidence of inflammation noted 3-7 months later. Adalimumab therapy was of 12-64 months' duration (mean, 36 months). At the time of initiation, 14 patients were using other agents concomitantly with adalimumab; 3 patients were on adalimumab monotherapy. At 1 year's follow-up, 12 patients were using combination therapy, and 3 patients were on adalimumab monotherapy: 11 patients had no evidence of inflammation. Side effects included pain at site of injection in 3 patients, anemia in 1 patient, and depression in 1 patient. In our study cohort, adalimumab was effective in inducing steroid-free remission. It was well tolerated, especially in combination with other immunomodulatory agents. The dosing and the interval can be adjusted to further improve inflammation control. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

  16. Changes in Ultrasonographic Vascularity Upon Initiation of Adalimumab Combination Therapy in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

    Science.gov (United States)

    Kaeley, Gurjit S; Nishio, Midori J; Goyal, Janak R; MacCarter, Daryl K; Wells, Alvin F; Chen, Su; Kupper, Hartmut; Kalabic, Jasmina

    2016-11-01

    To assess joint disease activity by ultrasound (US) in patients with rheumatoid arthritis (RA) initiating treatment with adalimumab (ADA) plus methotrexate (MTX). Data for this post hoc analysis originated from the MUSICA trial (ClinicalTrials.gov identifier: NCT01185288), which evaluated the efficacy of initiating ADA (40 mg every other week) plus 7.5 or 20 mg/week MTX in 309 patients with RA with an inadequate response to MTX. Synovial vascularization over 24 weeks was assessed bilaterally at metacarpophalangeal joint 2 (MCP2), MCP3, MCP5, metatarsophalangeal joint 5, and the wrists by power Doppler US (PDUS). A semiquantitative 4-grade scale was used. Disease activity was assessed using the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) and Simplified Disease Activity Index (SDAI). The correlation between continuous variables was assessed using Pearson's correlation coefficient. After 24 weeks of treatment with ADA plus MTX, rapid improvements in the mean synovial vascularity score were observed; the greatest improvements were in MCP2 (-0.5), MCP3 (-0.4), and the wrist (-0.4). At week 24, patients with the lowest DAS28-CRP ( 0.9). Synovial vascularity scores correlated poorly with DAS28, swollen joint count in 66 joints (SJC66), SJC28, tender joint count in 68 joints (TJC68), TJC28, Clinical Disease Activity Index (CDAI), SDAI, physician's global assessment, patient's global assessment of pain, and disease duration (ρ < 0.2). Thirty-two (70%) of 46 patients with a DAS28-CRP of <2.6, and 11 (58%) of 19 patients with an SDAI indicating remission had at least 1 joint with a synovial vascularity score of ≥1. PDUS detects changes in synovial vascularity in RA patients treated with ADA plus MTX, and residual synovial vascularity in patients in whom clinical disease control has been achieved. © 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

  17. Adalimumab and Non-Arteritic Anterior Ischaemic Optic Neuropathy: A Case Report.

    Science.gov (United States)

    Kinard, Krista; Walsh, Jessica A; Penmetsa, Gopi K; Warner, Judith E A

    2014-01-01

    Sequential anterior ischaemic optic neuropathy was observed in a patient treated with a tumour necrosis factor α (TNF) inhibitor, adalimumab, for ankylosing spondylitis. He developed decreased visual acuity in the right eye after 17 months of treatment. Findings showed right optic disc oedema with haemorrhages and visual field defect. Adalimumab was discontinued and vision stabilised. After restarting adalimumab, he developed optic neuropathy in the left eye. Findings showed optic disc oedema, with haemorrhages and visual field changes in the left eye. Adalimumab may be associated with optic neuropathy; providers prescribing TNF inhibitors should be aware of optic neuropathy as a potential complication.

  18. Complications of bone tumors after multimodal therapy

    Energy Technology Data Exchange (ETDEWEB)

    Shapeero, L.G., E-mail: lshapeero@usuhs.edu [Department of Radiology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814 (United States); Bone and Soft Tissue Program, United States Military Cancer Institute, 6900 Georgia Ave, NW, Washington, DC 20307 (United States); Poffyn, B. [Department of Orthopaedic Surgery, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium); De Visschere, P.J.L. [Department of Radiology and Magnetic Resonance/MR-1K12 IB, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium); Sys, G. [Department of Orthopaedic Surgery, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium); Uyttendaele, D. [Department of Radiology and Magnetic Resonance/MR-1K12 IB, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium); Vanel, D. [Department of Radiology, Rizzoli Institute, 40136 Bologna (Italy); Forsyth, R. [Department of Pathology, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium); Verstraete, K.L. [Department of Radiology and Magnetic Resonance/MR-1K12 IB, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent (Belgium)

    2011-01-15

    Purpose: To define and compare the complications of bone tumors after resection, extracorporeal irradiation and re-implantation, with or without radiotherapy. Materials and methods: Eighty patients (40 males and 40 females, ages 4-77 years) with 61 malignant and 19 benign bone tumors were evaluated for local and distant complications after treatment. Two groups of patients were studied: (1) 53 patients had resection without (43 patients) or with external beam radiotherapy (RadRx) (10 patients) and (2) 27 patients underwent extracorporeal irradiation and re-implantation without (22 patients) or with RadRx (5 patients). Patient follow-up varied from 1 month to 13.63 years with mean follow-up of 4.7 years. Imaging studies included bone and chest radiography, spin echo T1- and T2-weighted (or STIR) magnetic resonance imaging (MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), computed tomography (CT) for thoracic and abdominopelvic metastases and 3-phase technetium-99m-labeled-methylene-diphosphonate (Tc99m MDP) scintigraphy for bone metastases. Results: DCE-MRI differentiated the rapidly enhancing recurrences, residual tumors and metastases from the slowly enhancing inflammation, and the non-enhancing seromas and fibrosis. Recurrences, metastases (mainly to lung and bone), and seromas were greater than twice as frequent in patients after resection than after ECCRI. Although 11.3% of post-resection patients had residual tumor, no ECRRI-treated patient had residual tumor. In contrast, after ECRRI, infection was almost three times as frequent and aseptic loosening twice as frequent as compared with the post-resection patients. Bones treated with RadRx and/or ECRRI showed increased prevalence of fractures and osteoporosis. In addition, muscle inflammation was more common in the externally irradiated patient as compared with the patient who did not receive this therapy. However, another soft tissue complication, heterotopic ossification, was rare in the

  19. Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation.

    Science.gov (United States)

    Di Lernia, Vito

    2017-12-01

    Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults. Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis. Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab's efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

  20. Adalimumab treatment for severe recalcitrant chronic plaque psoriasis.

    LENUS (Irish Health Repository)

    Ryan, C

    2012-02-01

    AIM: To assess the efficacy and safety profile of adalimumab in patients with severe, recalcitrant chronic plaque psoriasis, and to assess short-term overlapping of other systemic treatment with adalimumab to prevent flaring of disease. METHODS: This was a retrospective study comprising 39 patients with chronic plaque psoriasis treated with adalimumab between October 2005 and January 2008. All had failed treatment with other systemic agents, including biological therapies in 59% of patients. Patients were started on adalimumab 40 mg weekly or fortnightly, as clinically indicated. Severity of psoriasis was assessed by the Psoriasis Area and Severity Index (PASI). Therapeutic response was assessed by 75% improvement on PASI (PASI 75). All adverse events were recorded. RESULTS: Results were analysed separately for those treated with adalimumab only and those on combination treatment. PASI 75 was achieved in 38% (8 of 21 patients at week 16), 62% (13 of 21 patients) at week 24, 69% (9 of 13 patients) at week 48% and 71% (5 of 7 patients) at week 72 in the adalimumab-only group, compared with 56% (5 of 9 patients) at week 16, 50% (4 of 8 patients) at week 24, 80% (4 of 5 patients) at week 48% and 67% (2 of 3 patients) at week 72 in the combined group. Of the 39 patients, 15 (38%) achieved a PASI of 0 at some point in their treatment. Adalimumab was well tolerated; 38% of patients experienced side-effects, which were generally mild. CONCLUSION: Adalimumab was effective in a group of patients with psoriasis refractory to other systemic therapies, including biological treatments, and was well tolerated.

  1. Sinogenic intracranial complications

    DEFF Research Database (Denmark)

    Kofoed, Mikkel Seremet; Fisker, Niels; Christensen, Anne Estmann

    2018-01-01

    We present two 11-year-old girls with chronic recurrent multifocal osteomyelitis, treated with adalimumab. Both developed severe intracranial complications to sinusitis. Patient 1 had been treated with adalimumab for 15 months when she developed acute sinusitis complicated by an orbital abscess, ...

  2. Visual Loss Induced by Adalimumab Used for Plaque Psoriasis

    Directory of Open Access Journals (Sweden)

    Norman Saffra

    2017-03-01

    Full Text Available A 61-year-old Caucasian male with severe plaque psoriasis without joint involvement was initiated on adalimumab therapy. Shortly thereafter he presented to the emergency room with acute loss of vision in the right eye. A comprehensive systemic workup was instituted which included magnetic resonance imaging (MRI with and without gadolinium of the brain and orbits. MRI revealed findings that were consistent with CNS demyelination and retrobulbar optic neuritis. Immediate cessation of adalimumab was instituted without any other systemic therapy. Complete return of vision occurred within 6 weeks. No additional psoriatic or neurologic treatment was instituted, and the patient has remained stable now for 14 months.

  3. Towards a Possible Therapy for Diabetes Complications

    Science.gov (United States)

    2011-10-01

    such as endothelin Table 1. Long-Term Complications of Type 1 Diabetes (T1D)  Retinopathy Results in retinal edema, hemorrhage and loss of...fact, people with type 1 diabetes who retain a low but detectable level of C-peptide are less prone to develop microvascular complications of the eyes...induced apoptosis of pericytes in early diabetic retinopathy . J Ophthalmol 2010:746978 33. Zhao X, Carnevale KA, Cathcart MK (2003) Human monocytes use

  4. Detoxication and antiproteolytic therapy of radiation complications

    International Nuclear Information System (INIS)

    Yakhontov, N.E.; Klimov, I.A.; Lavrikova, L.P.; Martynov, A.D.; Provorova, T.P.; Serdyukov, A.S.; Shestakov, A.F.

    1984-01-01

    49 patients with uterine cervix and ovarian carcinomas were treated with detoxication and antiproteolytic therapy of radiation-induced side-effects. The therapy permits to complete without interruption the remote gamma-therapy course and to reduce patients in-hospital periods by 10+- 1 days. The prescription of hemoder intravenous injection in a dose of 450 ml and contrical intramuscular injection (10000 AtrE) in cases of pronounced manifestations of radiation-induced side-effects (asthenia, leukopenia, enterocolitis) for 3 days should be considered an efficient therapy

  5. Complications after radiation therapy for cervical carcinoma

    International Nuclear Information System (INIS)

    Saitoh, Masataka

    1981-01-01

    From 1966 to 1973, 215 patients with cervical cancer were treated at the Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University. The patients were divided into two groups. In the first group, 123 patients were treated by external radiation with Tele- 60 Co plus radium insertions (1966-1970). In the second group, 83 patients were treated with linear accelerator plus cesium insertions (1970-1973). The results on both of 5-year survival rate and appearance of radiation injuries were compared with two groups. There was no significant difference in the cure rate between those of groups. The incidence of pigmentation, edema and diarrhea (early complications) was higher and the diarrhea continued significantly longer in the second group. The incidence of rectal ulcer and rectostenosis (later complications) was significantly higher than former group. A study was made to lean the reason for the significant higher occurrence of rectal ulcer and rectostenosis. As a result, it was determined that later complication was more emphasized especially by ret dose given intracavitary radiation. In addition, it is thought that the dose rate, the dose volume and natural history such as the patients' age are also related to the severity of the complication. (J.P.N.)

  6. Complications after radiation therapy for cervical carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Saitoh, M. (Iwate Medical Coll., Morioka (Japan). School of Medicine)

    1981-04-01

    From 1966 to 1973, 215 patients with cervical cancer were treated at the Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University. The patients were divided into two groups. In the first group, 123 patients were treated by external radiation with Tele-/sup 60/Co plus radium insertions (1966-1970). In the second group, 83 patients were treated with linear accelerator plus cesium insertions (1970-1973). The results on both of 5-year survival rate and appearance of radiation injuries were compared with in the two groups. There was no significant difference in the cure rate between those groups. The incidence of pigmentation, edema and diarrhea (early complications) was higher and the diarrhea continued significantly longer in the second group. The incidence of rectal ulcer and rectostenosis (later complications) was significantly higher than former group. A study was made to learn the reason for the significantly higher occurrence of rectal ulcer and rectostenosis. As a result, it was determined that later complication was more emphasized especially by dose rate of intracavitary irradiation. In addition, it is thought that the dose rate, the dose volume and natural history such as the patients' age are also related to the severity of the complications.

  7. Postradiation therapy skin complications and aspects of their treatment

    International Nuclear Information System (INIS)

    Derveniece, A.; Hartmane, I.; Cema, I.; Strode, E.; Mikazans, I.

    2001-01-01

    X-ray is a common therapy for malignant skin cancers. 60-70 Gy is the necessary therapeutic dose for squamous cell carcinoma. Early and late postradiation complications are X-ray dermatitis, erosions, ulcers and atrophies. The therapy for complications includes topical antiseptics and antibacterial agents, debridement, dressing, and even plastic and reconstructive surgery. Capillary regrowth, immunosuppression, local ischemia and epithelialisation are to be considered. The aim of this study was to observe and compare the topical agents in treatment of postradiation skin compilations. Early compilations were treated effectively using Diaethonum ointment (prophylaxis and therapy), Fucicort cream, Linoladiol-HN cream. With late complications Chlorhexidine gluconate 0.05% solution, Iruxol and Desitin ointments showed good results, dealing with trophical ulcers. There is no universal drug for treating X-ray caused complications, in every case the therapy is to be considered individually. (authors)

  8. Oral Complications and Management Strategies for Patients Undergoing Cancer Therapy

    Science.gov (United States)

    2014-01-01

    With cancer survival rate climbing up over the past three decades, quality of life for cancer patients has become an issue of major concern. Oral health plays an important part in one's overall quality of life. However, oral health status can be severely hampered by side effects of cancer therapies including surgery, chemotherapy, radiotherapy, and hematopoietic stem cell transplantation. Moreover, prevention and treatment of these complications are often overlooked in clinical practice. The present paper aims at drawing health care professionals' attention to oral complications associated with cancer therapy by giving a comprehensive review. Brief comments on contemporary cancer therapies will be given first, followed by detailed description of oral complications associated with cancer therapy. Finally, a summary of preventive strategies and treatment options for common oral complications including oral mucositis, oral infections, xerostomia, and dysgeusia will be given. PMID:24511293

  9. Oral complications of cancer therapies. Oral complications in the pediatric population

    International Nuclear Information System (INIS)

    Leggott, P.J.

    1990-01-01

    A number of acute oral complications may be associated with cancer therapy in children, but the extent and duration of these complications, and the most effective management techniques. have not been well described. The few studies differ in design, making comparisons difficult. Well-controlled, prospective clinical studies are needed to define the most effective strategies for the management of acute oral complications in children. However, it is clear that dental intervention prior to cancer therapy is an important factor in the optimal preparation of the patient. During cancer therapy, intensive supervised oral preventive protocols appear to be of benefit to the child's oral health, overall comfort, and well-being. Furthermore, the prevention of oral infection may significantly reduce the morbidity associated with cancer therapy. Long-term preventive oral care may help prevent dental disease and infection in medically compromised children and contribute to improving the quality of life. 41 references

  10. A Rare Side Effect due to TNF-Alpha Blocking Agent: Acute Pleuropericarditis with Adalimumab

    Directory of Open Access Journals (Sweden)

    Hakan Ozkan

    2013-01-01

    Full Text Available Tumor necrosis factor-alpha antagonism is an important treatment strategy in patients with rheumatoid arthritis, psoriatic arthritis, vasculitis, and ankylosing spondylitis. Adalimumab is one of the well-known tumor necrosis factor-alpha blocking agents. There are several side effects reported in patients with adalimumab therapy. Cardiac side effects of adalimumab are rare. Only a few cardiac side effects were reported. A 61-year-old man treated with adalimumab for the last 6 months due to psoriatic arthritis presented with typically acute pleuropericarditis. Chest X-ray and echocardiography demonstrated marked pericardial effusion. Patient was successfully evaluated for the etiology of acute pleuro-pericarditis. Every etiology was excluded except the usage of adalimumab. Adalimumab was discontinued, and patient was treated with 1200 mg of ibuprofen daily. Control chest X-ray and echocardiography after three weeks demonstrated complete resolution of both pleural and pericardial effusions. This case clearly demonstrated the acute onset of pericarditis with adalimumab usage. Acute pericarditis and pericardial effusion should be kept in mind in patients with adalimumab treatment.

  11. Oral complications of cancer therapies. Mucosal alterations

    International Nuclear Information System (INIS)

    Squier, C.A.

    1990-01-01

    The initial effect of anticancer therapy, such as radiation and chemotherapy, is on the rapidly proliferating cells of the oral epithelium. As a consequence, the epithelium may show atrophy and ulceration. The sites of these alterations are related to the rate of epithelial proliferation. Regions of rapid proliferation, such as the oral lining mucosa, show a greater frequency of ulceration than masticatory mucosa or skin. Subsequent changes in the mucosa reflect damage to connective tissue, including fibroblasts and blood vessels. This results in hyalinization of collagen, hypovascularity, and ischemia. Indirect effects of anticancer therapy may include granulocytopenia and reduced salivary secretion, so that the protective mucin coating of the epithelium is compromised. These changes result in tissue with reduced barrier function and impaired ability to heal and to resist entry of pathogens, thus increasing the risk of systemic infections

  12. Intestinal infarction: A complication of endovascular therapy

    International Nuclear Information System (INIS)

    England, Andrew; Butterfield, John S.; Sukumar, Sathi; Thompson, David; Roulson, Jo-An; Pritchard, Susan; Ashleigh, Raymond J.

    2007-01-01

    This report presents a rare case of intestinal infarction following endovascular therapy. A female patient who had undergone an internal carotid artery stenting procedure presented suddenly with abdominal pain. Radiological and clinical examinations at the time suggested a picture of intestinal ischaemia, in view of the patient's general conditions and co-existing morbidities surgical intervention was not considered to be an option. The patient died 4 days after the carotid stenting procedure, post-mortem examination revealed infarction of the ileum and caecum. The learning outcomes are if performing endovascular therapy in a patient with diffuse atherosclerotic disease early consideration of intestinal ischaemia should be given to any patient who presents with acute post-procedural abdominal pain

  13. Intestinal infarction: A complication of endovascular therapy

    Energy Technology Data Exchange (ETDEWEB)

    England, Andrew [Department of Radiology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom)]. E-mail: andrew.england@smtr.nhs.uk; Butterfield, John S. [Department of Radiology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom); Sukumar, Sathi [Department of Radiology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom); Thompson, David [Department of Radiology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom); Roulson, Jo-An [Department of Histopathology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom); Pritchard, Susan [Department of Histopathology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom); Ashleigh, Raymond J. [Department of Radiology, South Manchester University Hospitals NHS Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT (United Kingdom)

    2007-08-15

    This report presents a rare case of intestinal infarction following endovascular therapy. A female patient who had undergone an internal carotid artery stenting procedure presented suddenly with abdominal pain. Radiological and clinical examinations at the time suggested a picture of intestinal ischaemia, in view of the patient's general conditions and co-existing morbidities surgical intervention was not considered to be an option. The patient died 4 days after the carotid stenting procedure, post-mortem examination revealed infarction of the ileum and caecum. The learning outcomes are if performing endovascular therapy in a patient with diffuse atherosclerotic disease early consideration of intestinal ischaemia should be given to any patient who presents with acute post-procedural abdominal pain.

  14. Predictors of Postoperative Complications After Trimodality Therapy for Esophageal Cancer

    International Nuclear Information System (INIS)

    Wang, Jingya; Wei, Caimiao; Tucker, Susan L.; Myles, Bevan; Palmer, Matthew; Hofstetter, Wayne L.; Swisher, Stephen G.; Ajani, Jaffer A.; Cox, James D.; Komaki, Ritsuko; Liao, Zhongxing; Lin, Steven H.

    2013-01-01

    Purpose: While trimodality therapy for esophageal cancer has improved patient outcomes, surgical complication rates remain high. The goal of this study was to identify modifiable factors associated with postoperative complications after neoadjuvant chemoradiation. Methods and Materials: From 1998 to 2011, 444 patients were treated at our institution with surgical resection after chemoradiation. Postoperative (pulmonary, gastrointestinal [GI], cardiac, wound healing) complications were recorded up to 30 days postoperatively. Kruskal-Wallis tests and χ 2 or Fisher exact tests were used to assess associations between continuous and categorical variables. Multivariate logistic regression tested the association between perioperative complications and patient or treatment factors that were significant on univariate analysis. Results: The most frequent postoperative complications after trimodality therapy were pulmonary (25%) and GI (23%). Lung capacity and the type of radiation modality used were independent predictors of pulmonary and GI complications. After adjusting for confounding factors, pulmonary and GI complications were increased in patients treated with 3-dimensional conformal radiation therapy (3D-CRT) versus intensity modulated radiation therapy (IMRT; odds ratio [OR], 2.018; 95% confidence interval [CI], 1.104-3.688; OR, 1.704; 95% CI, 1.03-2.82, respectively) and for patients treated with 3D-CRT versus proton beam therapy (PBT; OR, 3.154; 95% CI, 1.365-7.289; OR, 1.55; 95% CI, 0.78-3.08, respectively). Mean lung radiation dose (MLD) was strongly associated with pulmonary complications, and the differences in toxicities seen for the radiation modalities could be fully accounted for by the MLD delivered by each of the modalities. Conclusions: The radiation modality used can be a strong mitigating factor of postoperative complications after neoadjuvant chemoradiation

  15. Tracheoinnominate artery fistula as a complication of radiation therapy

    International Nuclear Information System (INIS)

    Reiter, D.; Piccone, B.R.; Littman, P.; Lisker, S.A.

    1979-01-01

    Tracheoinnominate artery fistulization is a well-known complication of tracheostomy and of tracheal resection. The first known occurrence of this problem in a patient in whom no transtracheal procedure had ever been performed is reported, and high-dose radiation therapy delivered three years before for a mediastinal malignancy is suggested as the cause. No evidence of tumor was found in or adjacent to the tracheovascular communication. The tracheoinnominate artery fistula must be considered a potential complication of radiation therapy as well as of surgery

  16. Radiation therapy for the prevention of postoperative and traumatic complications

    Energy Technology Data Exchange (ETDEWEB)

    Kishkovskij, A.N.; DudareV, A.L. (Voenno-Meditsinskaya Akademiya, Leningrad (USSR))

    1983-05-01

    An analysis of the results of radiation therapy of 587 patients with postoperative and traumatic complications has shown that special ..gamma..-therapy used at early time following trauma or surgical intervention, with the first clinical signs of an incipient inflammatory process (the so-called ''anticipating'' irradiation), makes it possible to avoid the development of serious postoperative, post-traumatic complications: wound suppuration, fistulas, secondary parotitis, postamputation pain syndrome, ''needle'' osteomyelitis, keloid cicatrix, skin graft rejection, etc. In the author opinion, this promising trend in radiotherapy of nontumorous diseases is worth a wider using in clinical practice.

  17. Herpes Simplex Encephalitis Complicated by Cerebral Hemorrhage during Acyclovir Therapy.

    Science.gov (United States)

    Harada, Yukinori; Hara, Yuuta

    2017-01-01

    Herpes simplex encephalitis (HSE) can be complicated by adverse events in the acute phase. We herein present the case of a 71-year-old woman with HSE complicated by cerebral hemorrhage. She presented with acute deterioration of consciousness and fever and was diagnosed with HSE based on the detection of herpes simplex virus-1 in the cerebrospinal fluid by a polymerase chain reaction. The cerebral hemorrhage developed during acyclovir therapy; however, its diagnosis was delayed for 2 days. After the conservative treatment of the cerebral hemorrhage, the patient made a near-complete recovery. Cerebral hemorrhage should be considered as an acute-phase complication of HSE.

  18. Adalimumab for Treatment of Noninfectious Uveitis: Immunogenicity and Clinical Relevance of Measuring Serum Drug Levels and Antidrug Antibodies.

    Science.gov (United States)

    Cordero-Coma, Miguel; Calleja-Antolín, Sara; Garzo-García, Irene; Nuñez-Garnés, Ana M; Álvarez-Castro, Carolina; Franco-Benito, Manuel; Ruiz de Morales, Jose G

    2016-12-01

    To evaluate the rate of immunogenicity induced by adalimumab and its relationship with drug serum levels and clinical responses in patients with noninfectious uveitis. Prospective observational study. Consecutive patients from 1 referral center who initiated treatment with adalimumab for active noninfectious uveitis resistant to conventional therapy. All patients received 40 mg adalimumab every other week. Patients were evaluated clinically and immunologically before and after 4, 8, and 24 weeks of treatment. Clinical evaluation included assessment of changes in visual acuity, degree of inflammation in the anterior chamber and vitreous cavity, central macular thickness, and retinal angiographic leakage. Immunologic evaluation included assessment of serum trough adalimumab and antibodies against adalimumab (AAA) levels and class II HLA typing. Twenty-five patients were enrolled. Overall, 18 of 25 patients (72%) showed a favorable clinical response to adalimumab therapy. Eleven patients (44%) achieved a complete response and 7 (28%) achieved a partial response. However, 7 of 25 patients (28%) were considered nonresponders. Median trough adalimumab serum levels were higher in responders than in nonresponders (P uveitis outcome was observed only in patients with permanent AAA+, which correlated with undetectable adalimumab trough levels (P = 0.014). Treatment of noninfectious uveitis with adalimumab is associated with high rates of favorable clinical response. Overall, adalimumab trough levels were higher in responder patients. Development of permanent AAA was associated with undetectable trough adalimumab levels and worse uveitis outcome. Immunogenicity was more common in patients in whom uveitis was associated with a systemic disease and was not influenced by concomitant immunosuppressors. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  19. Vascular Complications of Pancreatitis: Role of Interventional Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Barge, Jaideep U.; Lopera, Jorge E. [University of Texas Health Science Center, San Antonio (United States)

    2012-02-15

    Major vascular complications related to pancreatitis can cause life-threatening hemorrhage and have to be dealt with as an emergency, utilizing a multidisciplinary approach of angiography, endoscopy or surgery. These may occur secondary to direct vascular injuries, which result in the formation of splanchnic pseudoaneurysms, gastrointestinal etiologies such as peptic ulcer disease and gastroesophageal varices, and post-operative bleeding related to pancreatic surgery. In this review article, we discuss the pathophysiologic mechanisms, diagnostic modalities, and treatment of pancreatic vascular complications, with a focus on the role of minimally-invasive interventional therapies such as angioembolization, endovascular stenting, and ultrasound-guided percutaneous thrombin injection in their management.

  20. Iliopsoas haematoma: a rare complication of warfarin therapy

    International Nuclear Information System (INIS)

    Ozkan, O.F.; Guner, A.; Cekic, A.B.; Reis, E.; Turan, T.

    2012-01-01

    Iliopsoas haematoma is a rare complication that occurs in patients receiving anticoagulant therapy. The clinical manifestation of iliopsoas haematoma is non-specific. It can mimic orthopaedic or neurological disorders, including paraesthesia or paresis of the thigh and leg due to compression of the nerve plexus. Among the many available diagnostic modalities, computed tomography is the most useful radiological method for diagnosis. Treatment approaches for iliopsoas haematoma include conservative therapy, surgical intervention, or transcatheter arterial embolisation. Conservative therapy consists of bed rest, restoration of circulating volume, and drug discontinuation for correcting underlying coagulopathy. Although a conservative approach is the first choice, transcatheter arterial embolisation and surgical intervention may be required in patients with hemodynamically unstable and active bleeding. The report described a case of iliopsoas haematoma due to anticoagulant therapy with paraesthesia in the left leg who was successfully treated by conservative approach. (author)

  1. Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study.

    Science.gov (United States)

    Detert, Jacqueline; Bastian, Hans; Listing, Joachim; Weiß, Anja; Wassenberg, Siegfried; Liebhaber, Anke; Rockwitz, Karin; Alten, Rieke; Krüger, Klaus; Rau, Rolf; Simon, Christina; Gremmelsbacher, Eva; Braun, Tanja; Marsmann, Bettina; Höhne-Zimmer, Vera; Egerer, Karl; Buttgereit, Frank; Burmester, Gerd-R

    2013-06-01

    To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naïve patients with active early rheumatoid arthritis (RA). Patients with active early RA (disease duration of ≤12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg/week subcutaneously or PBO plus MTX subcutaneously at 15 mg/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28Health Assessment Questionnaire (HAQ) score and radiographic progression. 87 patients were assigned to ADA/MTX and 85 patients to PBO/MTX. At baseline, DAS28 was 6.2±0.8 in the ADA/MTX and 6.3±0.9 in the PBO/MTX groups. At week 24, treatment with ADA/MTX compared with PBO/MTX resulted in a greater reduction in DAS28 (3.0±1.2 vs 3.6±1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49±0.6 vs 0.72±0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2±1.4 vs 3.4±1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO/MTX (Sharp/van der Heijde score: ADA/MTX 2.6 vs PBO/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).

  2. CROHN'S DISEASE: GENERAL CHARACTERISTICS AND TREATMENT WITH ADALIMUMABE BIOPHARMACEUTICAL

    Directory of Open Access Journals (Sweden)

    S. A. Marques

    2018-02-01

    Full Text Available Crohn's Disease (CD is a chronic inflammatory disease that affects the gastrointestinal system. The etiology is not fully understood, however, genetic, immunological, microbiological and environmental factors are related to its genesis. The most common manifestations of this disease are diarrhea, abdominal pain, ulcers and fistulas. In the absence of adequate treatment it can evolve into extra intestinal complications and is also an important risk factor for colon and rectal cancer. The treatment of the disease is palliative and there is no cure for the disease, being considered only the period of remission of symptoms, as a good prognosis. The biopharmaceutical, Adalimumabe, produced by recombinant DNA technology has demonstrated efficacy in the treatment of this disease, as it prevents the action of TNF-α, a cytokine involved in inflammation and is abundant in individuals with CD. Although Adalimumabe has good results, its use leads to side effects that can be mild or fatal, such as the activation of tuberculosis.

  3. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis

    NARCIS (Netherlands)

    Bartelds, Geertje M.; Wijbrandts, Carla A.; Nurmohamed, Michael T.; Stapel, Steven; Lems, Willem F.; Aarden, Lucien; Dijkmans, Ben A. C.; Tak, Paul Peter; Wolbink, Gerrit Jan

    2007-01-01

    BACKGROUND: A substantial proportion of patients with rheumatoid arthritis (RA) do not respond, or lose initial response, to adalimumab treatment. One explanation for non-response is that patients develop anti-adalimumab antibodies. OBJECTIVES: To evaluate the incidence of formation of antibody

  4. Lethality of patients with rheumatoid arthritis depending on adalimumab administration: imitation modeling

    Directory of Open Access Journals (Sweden)

    D V Goryachev

    2009-01-01

    Full Text Available Lethality of pts with rheumatoid arthritis (RA exceeds mortality values in general population. Possibility of disease modifying anti-rheumatic drugs (DMARD influence on RA pts lethality has been widely discussed lately in scientific works. Objective. To determine possible lethality diminishment in Russian population of RA pts with one of biological drugs TNFα antagonist adalimumab. Material and methods. Model construction is based on the fact of lethality dependence on pt functional state assessed by HAQ. Model simulating progression of functional disability in pts with RA visiting medical institutions of Russia was made (RAISER study. 3 model variants for imitation of consecutive change of DMARDs including adalimumab were done. First consecution assessed DMARD change in the next chain: adalimumab-methotrexate-sulfasalazine-leflunomide-azathioprine-cyclosporine-palliative therapy. Second consecution: adalimumab administration after failure of first 3 DMARDs. Third consecution considered only change of synthetic DMARDs without adalimumab inclusion. Model imitated participation of 3000 pts in every consecution. Prognosis horizon was 12 years. Age of pts and initial HAQ distribution were get from results of epidemiological RAISER study. Calculation was done on the base of elevation of standardized lethality level (SLL in population of RA pts in average from 135% to 300%. SLL values from 80 to 320% were used depending on functional disability degree with converting to Russian values of age-specific lethality coefficient for 1999. Results. Lethality in treatment consecutions including adalimumab was significantly lower. To the end of 12th year in group not using adalimumab, using it at once and using it after 376 DMARDs respectively 65,1%, 71,6% and 71,1% of pts were still alive. Conclusion. Significant decrease of lethality with adalimumab inclusion in consecution of DMARD change during treatment of RA pts was demonstrated with imitation modeling

  5. Clinical experience with adalimumab in a multicenter Swiss cohort of patients with Crohn's disease.

    Science.gov (United States)

    Nichita, Cristina; Stelle, Marc; Vavricka, Stephan; El-Wafa Ali, Abdou; Ballabeni, Pierluigi; de Saussure, Philippe; Straumann, Alex; Rogler, Gerhard; Michetti, Pierre

    2010-01-01

    Controlled clinical trials have demonstrated the efficacy and safety of adalimumab in patients with moderate-to-severe Crohn's disease (CD), but there is, however, only limited long-term experience with adalimumab in daily practice. To assess the long-term effectiveness and safety of adalimumab in a multicenter cohort of practice-based patients with moderate-to-severe CD. We retrospectively reviewed the charts of CD patients who received adalimumab over a 3-year period. Disease severity was scored using the Harvey-Bradshaw index (HBI). Remission was defined as an HBI of 3 points at evaluation compared to the baseline. Univariate logistic regression analysis was used to identify the predictive variables associated with response. The charts of 55 patients were reviewed; remission and response rates observed at weeks 4-6 were 52.7 and 83.6%, respectively. Remission was maintained at weeks 12, 24 and 52 in 89.6, 72.4 and 44.7% of patients, respectively. Remission and response rates were not influenced by smoking status, disease location or duration, the first month total dose, or previous infliximab therapy. The remission rate at weeks 4-6 was significantly higher in patients intolerant of infliximab as compared to those who lost response to this drug. Adalimumab was well tolerated overall. Adalimumab can be considered a suitable option in patients with moderate-to-severe CD, demonstrating sustained long-term effectiveness. Copyright (c) 2010 S. Karger AG, Basel.

  6. Profile of adalimumab and its potential in the treatment of uveitis

    Directory of Open Access Journals (Sweden)

    Balevic SJ

    2016-09-01

    Full Text Available Stephen J Balevic, C Egla Rabinovich Department of Pediatric Rheumatology, Duke University Medical Center, Durham, NC, USA Abstract: Uveitis refers to the presence of intraocular inflammation, and as a strict definition compromises the iris and ciliary body anteriorly and the choroid posteriorly (the uvea. Untreated, uveitis can lead to visual loss or blindness. The etiology of uveitis can include both infectious and noninfectious (usually immune-mediated causes, the latter of which are often mediated predominantly by Th1 CD4+ T-cells that secrete proinflammatory cytokines. Tumor necrosis factor-alpha (TNF-α is a proinflammatory cytokine involved in the pathogenesis of uveitis, which at high concentrations can cause excess inflammation and tissue damage. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF-α. Historically, corticosteroids and methotrexate were used to treat uveitis; however, newer biologic agents such as adalimumab have revolutionized therapy for noninfectious uveitis. Adalimumab has shown efficacy in treating refractory uveitis in multiple settings, including idiopathic disease, juvenile idiopathic arthritis, sarcoidosis, Behçets disease, and uveitis secondary to spondyloarthropathies, among several other noninfectious uveitis conditions. In this paper, we will review the profile of adalimumab, the role of TNF-α in uveitis, discuss safety data, and summarize key articles evaluating the efficacy of adalimumab in treating uveitis secondary to the most commonly associated autoimmune diseases.Keywords: uveitis, autoimmune disease, adalimumab, TNF-α

  7. A Lethal Complication of Endoscopic Therapy: Duodenal Intramural Hematoma

    Directory of Open Access Journals (Sweden)

    Turan Calhan

    2015-01-01

    Full Text Available Duodenal intramural hematoma (DIH usually occurs in childhood and young adults following blunt abdominal trauma. It may also develop in the presence of coagulation disorders and may rarely be an iatrogenic outcome of endoscopic procedures. Management of DIH is usually a conservative approach. A case of intramural duodenal hematoma that developed following endoscopic epinephrine sclerotherapy and/or argon plasma coagulation and that was nonresponsive to conservative therapy in a patient with chronic renal failure who died from sepsis is being discussed in this report. Clinicians should be aware of such possible complications after endoscopic hemostasis in patients with coagulation disorders.

  8. Imaging of late complications of cancer therapy in children

    International Nuclear Information System (INIS)

    Shelmerdine, Susan C.; Chavhan, Govind B.; Babyn, Paul S.; Nathan, Paul C.; Kaste, Sue C.

    2017-01-01

    Long-term survival after childhood cancer has improved dramatically over recent decades but survivors face lifelong risks of adverse health effects. Many of these chronic conditions are a direct result of previous therapeutic exposures. Compared to their siblings, survivors face a greater than 8-fold increase in relative risk of severe or life-threatening medical conditions; the most significant of these include second malignancies and cardiovascular and pulmonary diseases. Imaging can play a key role in identifying and characterizing such complications, which can be reasonably predicted with knowledge of the child's treatment. This article highlights the varied radiologic presentations and features seen in late cancer-therapy-related conditions. (orig.)

  9. Physical methods of treatment of complications of anti tumoral therapy

    International Nuclear Information System (INIS)

    Zhukovets, A.G.; Ulashchik, V.S.

    1998-01-01

    Numerous experimental and clinical materials about expediency of the use of physical methods for lowering of frequency and heaviness of complications of radial therapy are reviewed. One of such methods, possessing most expressed radioprotection ability, is low intensity laser radiation. Some of the authors demonstrated that use of this method move aside the time of appearance of early radial reactions. Preliminary local use of laser irradiation (λ = 510 nm) permits to avoid of development of epidermis disease and such radial reactions as ulcer and skin fibrosis in cancer patients after neutron-photon therapy. There are good results of application of ultraviolet irradiation in the region of action of ionizing radiation in the case of medical treatment of skin cancer. Low frequency magnetic field can reduce the expression of radial reactions

  10. Technology evaluation: adalimumab, Abbott laboratories.

    Science.gov (United States)

    Lorenz, Hanns M

    2002-04-01

    Adalimumab (D2E7), a human monoclonal antibody that binds to and neutralizes TNFa, is being developed by Abbott (formerly Knoll), under license from Cambridge Antibody Technology (CAT), for the potential treatment of inflammatory disorders such as rheumatoid arthritis (RA) and Crohn's disease. It is also being investigated for the potential treatment of coronary heart disease. Phase II studies for Crohn's disease and phase III for RA were ongoing throughout 2001. Limited data are only available for RA. In January 2002, it was reported that phase III trials of adalimumab for RA had been completed, but details have not been published in the primary literature so far. At this time CAT and Abbott expected to file for US approval in the second quarter of 2002 with a launch date anticipated for 2003. Phase III data are expected to be presented at the European League Against Rheumatism meeting in June 2002. In November 2000, Lehman Brothers predicted a US launch in June 2002 with peak US sales of $600 million in 2007 and a launch in non-US markets in 2003 with peak sales in these markets of $300 million in 2008. In December 2000, Merrill Lynch predicted regulatory clearance in the second half of 2003. The probability of adalimumab reaching the market is estimated to be 70%. In December 2000, Merrill Lynch predicted a 2003 launch, with estimated sales of pounds sterling 3.65 million in that year rising to pounds sterling 30.14 million in 2010. In March 2001, ABN AMRO predicted sales of $73 million in 2003 rising to $392 million in 2007.

  11. Unilateral anterior uveitis complicating zoledronic acid therapy in breast cancer

    Directory of Open Access Journals (Sweden)

    El Saghir Nagi S

    2005-12-01

    Full Text Available Abstract Background Zoledronic acid is very widely used in patients with metastatic bone disease and osteoporosis. Only one case of bilateral uveitis was recently reported related to its use. Case presentation We report the first case of severe unilateral anterior uveitis in a patient with breast cancer and an intraocular lens. Following zoledronic acid infusion, the patient developed severe and dramatic right eye pain with decreased visual acuity within 24 hours and was found to have a fibrinous anterior uveitis of moderate severity The patient was treated with topical prednisone and atropine eyedrops and recovered slowly over several months. Conclusion Internists, oncologists, endocrinologists, and ophtalmologists should be aware of uveitis as a possible complication of zoledronic acid therapy. Patients should be instructed to report immediately to their physicians and treatment with topical prednisone and atropine eyedrops should be instituted immediately at the onset of symptoms. This report documents anterior uveitis as a complication of zoledronic acid therapy. This reaction could be an idiosyncratic one but further research may shed more light on the etiology.

  12. Metabolic complications associated with HIV protease inhibitor therapy.

    Science.gov (United States)

    Nolan, David

    2003-01-01

    HIV protease inhibitors were introduced into clinical practice over 7 years ago as an important component of combination antiretroviral drug regimens which in many ways revolutionised the treatment of HIV infection. The significant improvements in prognosis that have resulted from the use of these regimens, combined with the need for lifelong treatment, have increasingly focused attention on the adverse effects of antiretroviral drugs and on the metabolic complications of HIV protease inhibitors in particular. In this review, the cluster of metabolic abnormalities characterised by triglyceride-rich dyslipidaemia and insulin resistance associated with HIV protease inhibitor therapy are considered, along with implications for cardiovascular risk in patients affected by these complications. Toxicity profiles of individual drugs within the HIV protease inhibitor class are examined, as there is an increased recognition of significant intra-class differences both in terms of absolute risk of metabolic complications as well as the particular metabolic phenotype associated with these drugs. Guidelines for clinical assessment and treatment are emphasised, along with pathophysiological mechanisms that may provide a rational basis for the treatment of metabolic complications. Finally, these drug-specific effects are considered within the context of HIV-specific effects on lipid metabolism as well as lifestyle factors that have contributed to a rapidly increasing incidence of similar metabolic syndromes in the general population. These data highlight the importance of individualising patient management in terms of choice of antiretroviral regimen, assessment of metabolic outcomes and use of therapeutic interventions, based on the assessment of baseline (pre-treatment) metabolic status as well as the presence of potentially modifiable cardiovascular risk factors.

  13. Management of severe urethral complications of prostate cancer therapy.

    Science.gov (United States)

    Elliott, Sean P; McAninch, Jack W; Chi, Thomas; Doyle, Sean M; Master, Viraj A

    2006-12-01

    We present our management of urethral stenosis and rectourinary fistula resulting from prostate cancer therapy. We concentrated on cases refractory to minimally invasive treatment, such as dilation, urethrotomy, and urinary and/or fecal diversion. In our prospectively collected urethral reconstruction database we identified patients who underwent reconstruction of urethral stenosis or rectourinary fistula who also received prior treatment for prostate cancer. We documented demographics, prostate cancer pretreatment characteristics, prostate cancer therapy type, urethral reconstruction type and success. A total of 48 patients met the inclusion criteria, including 16 with rectourinary fistula and 32 with urethral stenosis. Urethral complications followed prior radical prostatectomy, brachytherapy, external beam radiotherapy, cryotherapy, thermal ablation and any combination of these procedures. Stenosis repair was successful in 23 of 32 cases (73%) and it differed little between anterior and posterior urethral stenosis. Repair was accomplished by anastomotic urethroplasty in 19 cases, flap urethroplasty in 2, perineal urethrostomy in 2 and a urethral stent in 9. Prior external beam radiotherapy was a risk factor for urethral reconstruction failure. Fistula repair was successful in 14 of 15 patients (93%), excluding 1 who died postoperatively. The complexity of fistula management was dictated by fistula size and the presence or absence of coincident urethral stenosis. Urethral stenosis or rectourethral fistula following prostate cancer therapy can be managed by urethral reconstruction, such that normal voiding via the urethra is maintained, rather than abandoning the urethral outlet and performing heterotopic diversion. This can be accomplished with an acceptable rate of failure, given the complexity of the cases.

  14. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model.

    Science.gov (United States)

    Archer, Rachel; Tappenden, Paul; Ren, Shijie; Martyn-St James, Marrissa; Harvey, Rebecca; Basarir, Hasan; Stevens, John; Carroll, Christopher; Cantrell, Anna; Lobo, Alan; Hoque, Sami

    2016-05-01

    Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities. Peer-reviewed publications, European Public Assessment Reports and manufacturers' submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals. A systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model. Ten randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade(®), Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira(®), AbbVie) or golimumab (GOL) (Simponi(®), MSD) were more likely to

  15. Imaging of late complications of cancer therapy in children

    Energy Technology Data Exchange (ETDEWEB)

    Shelmerdine, Susan C.; Chavhan, Govind B. [The Hospital for Sick Children and University of Toronto, Department of Diagnostic Imaging, Toronto, ON (Canada); Babyn, Paul S. [Royal University Hospital, Department of Medical Imaging, Saskatoon, SK (Canada); Nathan, Paul C. [The Hospital for Sick Children and University of Toronto, Division of Hematology/Oncology, Department of Pediatrics, Toronto, ON (Canada); Kaste, Sue C. [St. Jude Children' s Research Hospital, Department of Diagnostic Imaging and Department of Oncology, Memphis, TN (United States); University of Tennessee School of Health Sciences, Memphis, Department of Radiology, Memphis, TN (United States)

    2017-03-15

    Long-term survival after childhood cancer has improved dramatically over recent decades but survivors face lifelong risks of adverse health effects. Many of these chronic conditions are a direct result of previous therapeutic exposures. Compared to their siblings, survivors face a greater than 8-fold increase in relative risk of severe or life-threatening medical conditions; the most significant of these include second malignancies and cardiovascular and pulmonary diseases. Imaging can play a key role in identifying and characterizing such complications, which can be reasonably predicted with knowledge of the child's treatment. This article highlights the varied radiologic presentations and features seen in late cancer-therapy-related conditions. (orig.)

  16. Successful Use of Adalimumab for Treating Pyoderma Gangrenosum with Ulcerative Colitis under Corticosteroid-tapering Conditions.

    Science.gov (United States)

    Sagami, Shintaro; Ueno, Yoshitaka; Tanaka, Shinji; Nagai, Kenta; Hayashi, Ryohei; Chayama, Kazuaki

    2015-01-01

    A 52-year-old woman with ulcerative colitis was admitted to our hospital for an ulcerative colitis flare-up under salazosulfapyridine therapy. The symptoms improved with high-dose corticosteroids. After prednisolone was tapered to 10 mg, the frequency of diarrhea increased. The diarrhea was accompanied by joint pain and a skin ulcer with abscess formation, which was diagnosed to be pyoderma gangrenosum. The patient was started on adalimumab. A positive response to the adalimumab therapy was observed after 2 weeks, during which time the ulcerative skin lesion healed completely, however, colonic mucosal healing was achieved at 2 months. Therefore, adalimumab appears to be an effective therapeutic option for patients with ulcerative colitis-associated pyoderma gangrenosum.

  17. Vascular Complications and Diabetes: Current Therapies and Future Challenges

    Directory of Open Access Journals (Sweden)

    Abbott L. Willard

    2012-01-01

    Full Text Available Diabetic retinal complications, including macular edema (DME and proliferative diabetic retinopathy (PDR, are the leading cause of new cases of blindness among adults aged 20–74. Chronic hyperglycemia, considered the underlying cause of diabetic retinopathy, is thought to act first through violation of the pericyte-endothelial coupling. Disruption of microvascular integrity leads to pathologic consequences including hypoxia-induced imbalance in vascular endothelial growth factor (VEGF signaling. Several anti-VEGF medications are in clinical trials for use in arresting retinal angiogenesis arising from DME and PDR. Although a review of current clinical trials shows promising results, the lack of large prospective studies, head-to-head therapeutic comparisons, and potential long-term and systemic adverse events give cause for optimistic caution. Alternative therapies including targeting pathogenic specific angiogenesis and mural-cell-based therapeutics may offer innovative solutions for currently intractable clinical problems. This paper describes the mechanisms behind diabetic retinal complications, current research supporting anti-VEGF medications, and future therapeutic directions.

  18. Influence of adalimumab treatment on anastomotic strength, degree of inflammation, and collagen formation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Andersen, Kristian; Hansen, Katrine

    2013-01-01

    Adalimumab is a TNF-α inhibitor, which has gained wide use in the treatment of inflammatory bowel diseases. The potential detrimental effect of TNF-α inhibitors on postoperative complications such as anastomotic leakage is unknown. The aim of this study was to investigate the effect of a single...

  19. Profile of adalimumab and its potential in the treatment of uveitis.

    Science.gov (United States)

    Balevic, Stephen J; Rabinovich, C Egla

    2016-01-01

    Uveitis refers to the presence of intraocular inflammation, and as a strict definition compromises the iris and ciliary body anteriorly and the choroid posteriorly (the uvea). Untreated, uveitis can lead to visual loss or blindness. The etiology of uveitis can include both infectious and noninfectious (usually immune-mediated) causes, the latter of which are often mediated predominantly by Th1 CD4 + T-cells that secrete proinflammatory cytokines. Tumor necrosis factor-alpha (TNF-α) is a proinflammatory cytokine involved in the pathogenesis of uveitis, which at high concentrations can cause excess inflammation and tissue damage. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF-α. Historically, corticosteroids and methotrexate were used to treat uveitis; however, newer biologic agents such as adalimumab have revolutionized therapy for noninfectious uveitis. Adalimumab has shown efficacy in treating refractory uveitis in multiple settings, including idiopathic disease, juvenile idiopathic arthritis, sarcoidosis, Behçets disease, and uveitis secondary to spondyloarthropathies, among several other noninfectious uveitis conditions. In this paper, we will review the profile of adalimumab, the role of TNF-α in uveitis, discuss safety data, and summarize key articles evaluating the efficacy of adalimumab in treating uveitis secondary to the most commonly associated autoimmune diseases.

  20. THE EXPERIENCE OF ADALIMUMAB USE IN A PATIENT WITH PAUTSIARTICULAR JUVENILE ARTHRITIS AND UVEITIS

    Directory of Open Access Journals (Sweden)

    E.I. Alexeeva

    2011-01-01

    Full Text Available The article presents the observation of early debut and the severe course of the juvenile polyarthritis involving the eyes, refractory to treatment by classical immunosuppressants. Successful use of the genetically engineered biological drug — adalimumab is described:  by the 4th week of therapy the acute inflammatory changes in affected joints were stopped, range of motion in them fully recovered; to the 8th week uveitis remission was registered, laboratory values of the disease activity were normalized: erythrocyte sedimentation rate, serum concentration of C-reactive protein. Key words: children, juvenile rheumatoid arthritis, rheumatoid uveitis, adalimumab. (Pediatric pharmacology. — 2011; 8 (6: 119–124.

  1. Real-Life Treatment Paradigms Show Adalimumab Is Cost-Effective for the Management of Ulcerative Colitis

    Directory of Open Access Journals (Sweden)

    Candace L. Beilman

    2016-01-01

    Full Text Available Background. Adalimumab is effective for the maintenance of remission in patients with moderate-to-severe ulcerative colitis (UC. Currently, biologic therapies are used in cases where patients fail conventional medical therapies. If biologic therapies are not available, patients often choose to remain in an unwell state rather than undergo colectomy. Objective. The aim of the study was to evaluate the cost-effectiveness of adalimumab in patients with UC where adalimumab was readily available compared to not available. Methods. A previously validated Markov model was used to simulate disease progression of patients with UC who are corticosteroid-dependent and/or did not respond to thiopurine therapy. Utility scores and transition probabilities between health states were determined by using data from randomized controlled trials and real-life observational studies. Costs were obtained from the Ontario Case Costing Initiative and the Alberta Health Schedule of Medical Benefits. Results. The incremental cost-effectiveness ratios for readily available adalimumab treatment of UC were $40,000 and $59,000 per quality-adjusted life year, compared with ongoing medical therapy in an unwell state, at 5-year and 10-year treatment time horizons, respectively. Conclusion. Considering real-life patient preferences to avoid colectomy, adalimumab is cost-effective according to a willingness-to-pay threshold of $80,000 for treatment of UC.

  2. Adalimumab for the treatment of uveitis.

    Science.gov (United States)

    LaMattina, Kara C; Goldstein, Debra A

    2017-03-01

    Adalimumab, an inhibitor of tumor necrosis factor-alpha (TNFα), is the only systemic non-corticosteroid agent which has been approved by the US Food and Drug Administration (FDA) for the treatment of non-infectious uveitis. Areas covered: The aim of this review is to summarize the research which demonstrated the effectiveness of adalimumab in the treatment of intraocular inflammation and helped to establish its side effect profile, ultimately leading to its FDA approval. Expert commentary: Adalimumab is a useful second-line agent in the treatment of non-infectious uveitis. While it is only approved in the United States for use in intermediate, posterior, and panuveitis in adults, I find it to be effective in off-label treatment of pediatric uveitis and scleritis as well.

  3. Urological complications after x-ray-therapy and their treatment

    Energy Technology Data Exchange (ETDEWEB)

    Lichtenauer, P; Nentwig, N; Lobsien, I [Medizinische Hochschule Luebeck (F.R. Germany). Chirurgische Klinik und Poliklinik

    1974-10-01

    Early reactions on X-ray-therapy in the bladder region usually begin with pain. Sterile irritations are reversible under symptomatic therapy. Real bladder infections should be dealt with according to antibiogram intensively and for a long time before the X-ray-stress is continued. Late reactions on X-ray-therapy mostly are organised and irreversible. The different manifestations are referred to and the respective therapy is recommended.

  4. Oral complications of cancer therapies. Description and incidence of oral complications

    International Nuclear Information System (INIS)

    Dreizen, S.

    1990-01-01

    No part of the body reflects the complications of cancer chemotherapy as visibly and as vividly as the mouth. The infectious, hemorrhagic, cytotoxic, nutritional, and neurologic signs of drug toxicity are reflected in the mouth by changes in the color, character, comfort, and continuity of the mucosa. The stomatologic complications of radiotherapy for oral cancer are physical and physiological in nature, transient or lasting in duration, and reversible or irreversible in type. Some linger as permanent mementos long after the cancer has been destroyed. They stem from radiation injury to the salivary glands, oral mucosa, oral musculature, alveolar bone, and developing teeth. They are expressed clinically by xerostomia, trismus, radiation dermatitis, nutritional stomatitis, and dentofacial malformation. In both cancer chemotherapy and cancer radiotherapy, the oral complications vary in pattern, duration, intensity, and number, with not every patient developing every complication. 21 references

  5. Antibiotic Therapy for Acute Infiltrate-Complicated Calculous Cholecystitis

    Directory of Open Access Journals (Sweden)

    Yu. A. Nesterenko

    2007-01-01

    Full Text Available Objective: to summarize the results of treatment in 442 patients of various ages with acute calculous cholecystitis complicated by a compact perivesical infiltrate.Materials and methods. Bile from all the patients was bacteriologically studied. The implication of various antibiotics in limiting perivesical fat inflammation was determined.Results. The importance of decompressive treatments for complicated calculous cholecystitis has been ascertained. The advantages of microcholecystostomy have been revealed. There is evidence that it is expedient to use third-forth-generation cephalosporins, fluoroquinolones, and dioxidine in the combined treatment of destructive calculous cholecystitis complicated by an infiltrate. 

  6. Efficacy and Safety of Adalimumab in Canadian Patients with Moderate to Severe Crohn’s Disease: Results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn’s DiseaSe (ACCESS Trial

    Directory of Open Access Journals (Sweden)

    Remo Panaccione

    2011-01-01

    Full Text Available OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn’s disease (CD who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF therapy.

  7. Adalimumab for treatment of severe Behçet's uveitis: a retrospective long-term follow-up study.

    Science.gov (United States)

    Interlandi, Emanuela; Leccese, Pietro; Olivieri, Ignazio; Latanza, Loredana

    2014-01-01

    Behçet's disease (BD) is a chronic multisystem inflammatory disorder associated to uveitis that may represent a serious sight-threatening condition. The purpose of the present study is to assess the effectiveness of adalimumab as new strategic therapeutic approach in patients affected by severe Behçet's uveitis. Clinical data from twelve selected patients (22 eyes) were retrospectively analysed. All patients received 40 mg of adalimumab subcutaneously, once every 2 weeks, in addition to traditional immunosuppressive on-going therapy and eight of them were switched to adalimumab after failure of infliximab therapy. Primary outcome measures included ocular inflammatory activity, frequency of uveitis attacks and steroid-sparing effect. Secondary outcomes were changes of best-corrected visual acuity (BCVA), impact on traditional immunosuppressive therapy and occurrence of adalimumab-related side effects. Mean age of patients (11 males and 1 female) at the onset of disease was 24.34 years (±8.62 SD). Ocular involvement resulted bilateral in 83% of cases and mainly consisted in panuveitis (68% of eyes). After mean follow-up of 21 months (±9.63 SD) all patients but one (92%) achieved uveitis remission with BCVA improvement at least in one eye. Average uveitis attacks decreased from 2 to 0,42 during adalimumab (ptreatment of patients with severe and resistant Behçet's uveitis, providing an appropriate and long-term control of ocular inflammation.

  8. Genetic polymorphism in ATG16L1 gene influences the response to adalimumab in Crohn's disease patients

    NARCIS (Netherlands)

    Koder, Silvo; Repnik, Katja; Ferkolj, Ivan; Pernat, Cvetka; Skok, Pavel; Weersma, Rinse K.; Potocnik, Uros

    2015-01-01

    Aim: To see if SNPs could help predict response to biological therapy using adalimumab (ADA) in Crohn's disease (CD). Materials & methods: IBDQ index and CRP levels were used to monitor therapy response. We genotyped 31 CD-associated genes in 102 Slovenian CD patients. Results: The strongest

  9. Avascular necrosis of bone complicating corticosteroid replacement therapy.

    OpenAIRE

    Williams, P L; Corbett, M

    1983-01-01

    Two patients who developed widespread severe avascular necrosis of bone while on steroid replacement therapy are described. One, a diabetic, underwent yttrium-90 pituitary ablation for retinopathy and developed avascular necrosis within 18 months of starting prednisolone. The other, who had Addison's disease, developed avascular necrosis within 14 months of starting cortisol replacement therapy. Both cases came to bilateral total hip replacement.

  10. Crohn's disease complicated by Epstein-Barr virus-driven haemophagocytic lymphohistiocytosis successfully treated with rituximab.

    Science.gov (United States)

    Thompson, Grace; Pepperell, Dominic; Lawrence, Ian; McGettigan, Benjamin David

    2017-02-22

    We report a case of Epstein-Barr virus (EBV)-driven haemophagocytic lymphohistiocytosis (HLH) in a man with Crohn's disease treated with 6-mercaptopurine and adalimumab therapy who was successfully treated with rituximab therapy alone. This is the first published case in an adult patient with EBV-driven HLH in the setting of thiopurine use and inflammatory bowel disease to be successfully treated with rituximab therapy alone. Here, we will discuss putative immunological mechanisms which may contribute to this potentially life-threatening complication. 2017 BMJ Publishing Group Ltd.

  11. Complication of Intraoperative Radiation Therapy (IORT) in Gastric Cancer

    International Nuclear Information System (INIS)

    Kim, Myung Se; Kim, Sung Kyu; Song, Sung Kyo; Kim, Hong Jin; Kwan, Koing Bo; Kim, Heung Dae

    1992-01-01

    Local control is the important prognostic factor in cancer treatment because local control decrease the relative risk of metastatic spread and increase distant metastasis free survival. IORT is the modality which could increase local control without increasing complication, combined with curative operation. Even though we could achieve significant decreased local failure by IORT and curative resection, it should not be committed as a main treatment modality without proving acceptable complications. Therapeutic Radiology Department of Yeungnam University Medical Center have tried 58 IORT from June 15, 1988, and performed 53 IORT in patients with gastric cancer. No local failure has been report? by regular follow up so far. Nine cases(17%) of treatment related complication were reported including intestinal obstruction, hemorrhage, sepsis, and bone marrow depression. These complications could be comparable to Jo 25.2% (chemotherapy + operation), Kim 18% (chemotherapy only in inoperable patients), because our treatment regimen is consisted of IORT (1500 cGy), external irradiation(--4500 cGy) and extensive chemotherapy (FAM, 5FU+MMC, BACOP). Our data encouraged us to re-inforce further IORT in stomach cancer treatment

  12. Complication of Intraoperative Radiation Therapy (IORT) in Gastric Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Myung Se; Kim, Sung Kyu; Song, Sung Kyo; Kim, Hong Jin; Kwan, Koing Bo; Kim, Heung Dae [Yeungnam University College of Medicine, Taegu (Korea, Republic of)

    1992-12-15

    Local control is the important prognostic factor in cancer treatment because local control decrease the relative risk of metastatic spread and increase distant metastasis free survival. IORT is the modality which could increase local control without increasing complication, combined with curative operation. Even though we could achieve significant decreased local failure by IORT and curative resection, it should not be committed as a main treatment modality without proving acceptable complications. Therapeutic Radiology Department of Yeungnam University Medical Center have tried 58 IORT from June 15, 1988, and performed 53 IORT in patients with gastric cancer. No local failure has been report? by regular follow up so far. Nine cases(17%) of treatment related complication were reported including intestinal obstruction, hemorrhage, sepsis, and bone marrow depression. These complications could be comparable to Jo 25.2% (chemotherapy + operation), Kim 18% (chemotherapy only in inoperable patients), because our treatment regimen is consisted of IORT (1500 cGy), external irradiation(--4500 cGy) and extensive chemotherapy (FAM, 5FU+MMC, BACOP). Our data encouraged us to re-inforce further IORT in stomach cancer treatment.

  13. Long-term efficacy of adalimumab in the treatment of uveitis associated with juvenile idiopathic arthritis

    Directory of Open Access Journals (Sweden)

    Kotaniemi K

    2011-10-01

    Full Text Available Kaisu Kotaniemi1,2, Hanna Säilä2, Hannu Kautiainen31Helsinki University Hospital, Helsinki, Finland; 2Orton Orthopaedic Hospital and Rehabilitation Unit, Helsinki, Finland; 3Unit of Primary Health Care, Kuopio University Hospital, Kuopio, FinlandBackground: The purpose of this study was to investigate the long-term effects of adalimumab, a tumor necrosis factor alpha antagonist, in the treatment of uveitis associated with juvenile idiopathic arthritis.Methods: Adalimumab was initiated in 94 patients with juvenile idiopathic arthritis to treat active arthritis and/or active associated uveitis. In 18 patients, therapy was discontinued after a short period because of inefficacy or side effects. The activity of uveitis (using Standardized Uveitis Nomenclature [SUN] criteria and clinical examination and arthritis (number of swollen or active joints was evaluated at the start and at end of the study.Results: At the end of the study, uveitis was under good clinical control in two thirds of 54 patients (31% did not need any local treatment and 35% used only 1–2 corticosteroid drops a day, and one third had active uveitis (at least three corticosteroid drops a day. According to SUN criteria, adalimumab treatment for uveitis showed improved activity (a two-fold decrease in uveitis activity in 28% of patients, with a moderate response in 16 patients, no change in a further 16 patients, and worsening activity (a two-fold increase in uveitis activity in 13% of patients. The overall proportion of patients with active arthritis decreased. At the beginning of the study, 69% of patients with uveitis had more than two active joints, and at the end of the study only 27% had active joint disease. In 27 patients with juvenile idiopathic arthritis without uveitis on adalimumab, the number of active joints decreased from 93% to 59%. Systemic corticosteroid treatment could be stopped in 22% of patients with uveitis and in 11% of those without uveitis. Most of the

  14. Social and cultural efficacies of medicines: Complications for antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Hardon Anita

    2006-11-01

    Full Text Available Abstract Using ethnographic examples of medicine use, prescription, distribution and production, the authors argue that social and cultural effects of pharmaceuticals should be taken into account. Non-medical effects deeply influence the medical outcome of medicine use. Complications around the advent of anti-AIDS medicines in poor countries are taken as a point in case. The authors are medical anthropologists specialised in the social and cultural analysis of pharmaceuticals.

  15. Cardio-oncology: cardiovascular complications of cancer therapy.

    Science.gov (United States)

    Henning, Robert J; Harbison, Raymond D

    2017-07-01

    This paper focuses on three classes of commonly used anticancer drugs, which can cause cardiotoxicity: anthracyclines, monoclonal antibodies exemplified by trastuzumab and tyrosine kinase inhibitors. Anthracyclines can induce cardiomyocyte necrosis and fibrosis. Trastuzumab can cause cardiac stunning. The tyrosine kinase inhibitors can increase systemic arterial pressure and impair myocyte contractility. In addition, radiation therapy to the mediastinum or left chest can exacerbate the cardiotoxicity of these anticancer drugs and can also cause accelerated atherosclerosis, myocardial infarction, heart failure and arrhythmias. Left ventricular ejection fraction measurements are most commonly used to assess cardiac function in patients who receive chemo- or radiation-therapy. However, echocardiographic determinations of global longitudinal strain are more sensitive for detection of early left ventricular systolic dysfunction. Information on patient-risk stratification and monitoring is presented and guidelines for the medical treatment of cardiac dysfunction due to cancer therapies are summarized.

  16. The diagnosis and treatment of two kinds of pulmonary embolism complications after interventional therapy

    International Nuclear Information System (INIS)

    Su Hongying; Xiao Liang; Zhong Hongshan; Xu Ke; Zheng Yanbo; Lu Zaiming

    2008-01-01

    Objective: To summarize the different types, clinical manifestation, treatment and prognosis of pulmonary embolism after interventional therapy in order to promote the diagnosis and treatment for the severe complication. Methods: The cases of pulmonary embolism complications after interventional therapy were collected from three hospitals between 1998 and 2005. The patients were divided into two types of iodized oil and thrombus pulmonary embolism according to the different types of the embolus. The experience of the clinical manifestation, diagnosis and treatment were summarized. Results: Ten patients with pulmonary embolism complication after interventional therapy were collected, including five with thrombus pulmonary embolism and four with iodized oil pulmonary embolism. All 5 cases of the thrombus pulmonary embolism suffered burst dyspnea and apsychia, two died and the others recovered or turned better. Aggravating dyspnea without shock occurred in the five iodized oil pulmonary embolism cases, 1 to 3 days after interventional therapy. The symptoms disappeared 15 to 50 days after combined therapy including majorly oxygen supply therapy. Conclusion: Pulmonary embolism is an emergent and severe complication after interventional therapy including acute thrombus pulmonary embolism without deep vein thrombosis which can be effectively treated be effectively treated with maintaining effective circulation and thrombolysis; and iodized oil pulmonary embolism with slow onsets could disappear within 1 month after combined therapy with mainly oxygen supplying therapy. The diagnosis and antidiastole mainly rely on enhancement of CT scan. (authors)

  17. Cutaneous complication after electron beam therapy in breast cancer

    Directory of Open Access Journals (Sweden)

    M Jalilian

    2005-11-01

    Full Text Available Background: Breast cancer is the most common cancer in women and the second cause of death among them. There are several treatment methods for breast cancer, one of which is radiation therapy. There are two important methods of radiation therapy: tangential field and single oppositional field. Main goal of this study is evaluation of factors that have a role in producing acute side effects such as skin burning in breast cancer patients treated by electron beam,in order to decrease these side effects. Methods: From 1/2003 through 7/2004, 200 consecutive patients were evaluated during 18 months in seid-al-shohad hospital, whose mean age was 49 years old. In this study a questionnaire was used including some questions about personal profile such as patient's name, address, registration number, age and some other factors. All patients who were candidated to enter in this investigation filled out the questionnaire at the end of radiation therapy. The patients were examined and their skin burning grades were evaluated by RTOG scale. Data were analyzed by chi-square test using SPSS 11 software. Results: None of patients showed grades O or 4 of burning. 31.5 % of Patients showed grade 1, 64.5 % showed grade 2, 4 % showed grade 3 of burning. There was statistically significant correlation between posterior axillary field and skin burning and there wasnot any meaning between the other factors. Conclusion: It is necessary to pay more attention to posterior axillary field planning including field size, location, photon energy, depth and dose of treatment. Keywords: breast cancer, electron beam radiation therapy, skin burning

  18. Diagnostic imaging of severe rectus sheath hematoma complicating anticoagulant therapy

    International Nuclear Information System (INIS)

    Blum, A.; Bui, P.; Boccaccini, H.; Bresler, L.; Claudon, M.; Boissel, P.; Regent, D.

    1995-01-01

    CT were performed in thirteen patients (12 women, 1 man) aged from 53 to 90 (mean age, 74) with severe RSH. Five patients also underwent ultrasound examination and three MR examination. Nine patients (69%) were receiving subcutaneous injection of heparin, three (23%) oral anticoagulant therapy and one continuous IV infusion of heparin. Clinical diagnosis was reached in 6 cases. Excessive activity of anticoagulant therapy was noted in 4 cases. The location of the RSH, their densities and their signals were analysed. All the RSH were mostly developed in the lower third of the abdominal wall, had a large spreading into the Retzius space and compressed the bladder and/or the bowels. RSH were all hyperdense and in 8 cases (61%) a fluid-fluid level due to the hematocrit effect was noted. In one case, a retroperitoneal hematoma was discovered. The extension of the RSH was well delineated with MRI. The RSH showed itself with heterogeneous signal intensities with areas of high-signal-intensity on T1-weighted images. Fluid-fluid levels and a concentric ring sign were also noted. Older women with subcutaneous injection of heparin are especially prone to RSH even though there is no overall excessive activity of anticoagulant therapy. Clinical and biological diagnosis may be difficult. CT scan is the exam of choice to reach a precise and acute diagnosis of RSH. (authors). 34 refs., 8 figs

  19. Complications in skin grafts when continuing antithrombotic therapy prior to cutaneous surgery requiring skin grafting

    DEFF Research Database (Denmark)

    Jarjis, Reem Dina; Jørgensen, Lone; Finnerup, Kenneth

    2015-01-01

    Abstract The risk of postoperative bleeding and wound healing complications in skin grafts among anticoagulated patients undergoing cutaneous surgery has not been firmly established. The objective was to examine the literature and assess the risk of postoperative bleeding or wound healing...... complications in skin grafts among anticoagulated patients, compared with patients who discontinue or patients who are not receiving antithrombotic therapy prior to cutaneous surgery requiring skin grafting. A systematic review examining the effect of antithrombotic therapy on cutaneous surgery was performed...... studies were of prospective and retrospective design. Most of the reviewed studies suggest that the use of antithrombotic therapy can increase the risk of bleeding complications in skin grafts. These complications are only wound threatening and not life threatening. Therefore, this is of concern mostly...

  20. Impact of switching antiretroviral therapy on lipodystrophy and other metabolic complications: a review

    DEFF Research Database (Denmark)

    Hansen, Birgitte R; Haugaard, Steen B; Iversen, Johan

    2004-01-01

    Following the introduction of highly active antiretroviral therapy (HAART), metabolic and morphological complications known as HIV associated lipodystrophy syndrome (HALS) have been increasingly common. The approaches to target these complications span from resistance exercise, diet and use...... of the antidiabetics metformin or glitazones to high dose recombinant human growth hormone therapy or switching antiretroviral regimen. When looking at the effect of switching therapy, focus has been addressed to protease inhibitor (PI) based regimens, as PI was the first component of HAART recognized to be correlated...

  1. Rotational bed therapy to prevent and treat respiratory complications: a review and meta-analysis.

    Science.gov (United States)

    Goldhill, David R; Imhoff, Michael; McLean, Barbara; Waldmann, Carl

    2007-01-01

    Immobility is associated with complications involving many body systems. To review the effect of rotational therapy (use of therapeutic surfaces that turn on their longitudinal axes) on prevention and/or treatment of respiratory complications in critically ill patients. Published articles evaluating prophylaxis and/or treatment were reviewed. Prospective randomized controlled trials were assessed for quality and included in meta-analyses. A literature search yielded 15 nonrandomized, uncontrolled, or retrospective studies. Twenty prospective randomized controlled trials on rotational therapy were published between 1987 and 2004. Various types of beds were studied, but few details on the rotational parameters were reported. The usual control was manual turning of patients by nurses every 2 hours. One animal investigation and 12 clinical trials addressed the effectiveness of rotational therapy in preventing respiratory complications. Significant benefits were reported in the animal study and 4 of the trials. Significant benefits to patients were reported in 2 of another 4 studies focused on treatment of established complications. Researchers have examined the effects of rotational therapy on mucus transport, intrapulmonary shunt, hemodynamic effects, urine output, and intracranial pressure. Little convincing evidence is available, however, on the most effective rotation parameters (eg, degree, pause time, and amount of time per day). Meta-analysis suggests that rotational therapy decreases the incidence of pneumonia but has no effect on duration of mechanical ventilation, number of days in intensive care, or hospital mortality. Rotational therapy may be useful for preventing and treating respiratory complications in selected critically ill patients receiving mechanical ventilation.

  2. Hypertension complicating 131I-meta-iodobenzylguanidine therapy for neuroblastoma

    International Nuclear Information System (INIS)

    Kosmin, Michael A.; Cork, Nicholas J.; Gaze, Mark N.; Bomanji, Jamshed B.; Shankar, Ananth

    2012-01-01

    Radiolabelled meta-iodobenzylguanidine (mIBG), used as targeted therapy for neuroblastoma, is known to have effects on blood pressure (BP). In this study we audited BP changes in patients receiving 131 I-mIBG therapy for neuroblastoma to identify BP-related adverse events (AE) and possible predictive factors. Between 2003 and 2010, 50 patients with neuroblastoma received 110 131 I-mIBG administrations. BP measurements before and after administration were compared with age- and sex-matched centile values. AE were analysed, and possible predisposing factors identified. This population had a baseline BP distribution higher than that of their age- and sex-matched peers, with 16% of preadministration systolic BP values above the 95th centile. Changes in BP after administration showed an approximately normal distribution with similar numbers of reduced and increased values. Four AE, all related to hypertension, occurred with one patient having generalized seizures. One AE was immediate, others occurred between 20 and 25 h after administration. No significant association between AE and patient age or sex was demonstrated. However, a significant association between AE and high preadministration BP was shown, both above the 90th centile (p = 0.0022) and above the 95th centile (p = 0.0135). Clinically relevant hypertension following 131 I-mIBG therapy affected less than 5% of administrations, but was more common in those patients with preexisting hypertension. As hypertensive episodes may occur many hours after treatment, close monitoring of BP needs to be continued for at least 48 h after administration of 131 I-mIBG. (orig.)

  3. Neurologic complications of polycythemia and their impact on therapy

    International Nuclear Information System (INIS)

    Newton, L.K.

    1990-01-01

    Polycythemia vera, a clonal stem cell disorder, produces neurologic problems in 50-80% of patients. Some symptoms, such as headache and dizziness, are related to hyperviscosity, and respond immediately to reduction of cell counts. Others seem to result from an associated coagulopathy. Patients with polycythemia tend to develop both arterial and venous thrombosis and are prone to hemorrhages. Treatments for polycythemia include phlebotomy, chlorambucil supplemented with phlebotomy, and 32 P plus phlebotomy. Whatever treatment is chosen, the aim of therapy should be to reduce the hematocrit to approximately 40-45%.37 references

  4. The economics of adalimumab for ulcerative colitis.

    Science.gov (United States)

    Xie, Feng

    2015-06-01

    Ulcerative colitis is a chronic inflammatory disease, characterized by diffuse mucosal inflammation in the colon. Adalimumab, as a TNF-α blocker, offers a safe and efficacious treatment option for patients with moderate to severe ulcerative colitis and refractory or intolerant to conventional medications; however, its cost-effectiveness profile has not yet been well established. Future economic evaluations should choose appropriate comparators in the context of target-reimbursement decision making and focus on cost-effectiveness over a long time horizon.

  5. The Experience of Successful Use of Adalimumab in a Patient With Juvenile Arthritis Associated With Enthesitis and Uveitis

    Directory of Open Access Journals (Sweden)

    Aleksandra M. Chomakhidze

    2017-01-01

    Full Text Available The article describes the case of successful use of human monoclonal antibodies to the tumor necrosis factor- adalimumab in a patient with a severe course of juvenile arthritis associated with enthesitis and uveitis resistant to non-steroidal anti-inflammatory drugs, methotrexate, glucocorticosteroids that have been applied topically and retrobulbarly. After the first adalimumab administration, the pain syndrome was stopped, the duration of morning stiffness was significantly reduced, the laboratory indices of the disease activity were normalized by the 4th week of treatment, uveitis activity was stopped, the inflammatory changes in the joints regressed and the phase of inactive disease was ascertained by the 12th week. The duration of remission of articular syndrome and uveitis during treatment with adalimumab was 26 months. Adverse reactions were not registered during therapy.

  6. Vertebral fracture complications following radiation therapy. Report of two cases

    International Nuclear Information System (INIS)

    Tanaka, Hisato; Komine, Mitsunori; Kurokawa, Hiroaki

    2007-01-01

    We observed the outbreak time of a spinal compression fracture following radiation therapy and its natural course. Case 1 was a 88-year-old, woman. NTX 66.9. Underwent cobalt irradiation 54 Gy for esophageal cancer. Three months after irradiation, the first lumbar vertebra was found to de compressed, and low back pain occurred. Vacuum cleft phenomenon in X-P appeared after two weeks, but anterior callus formation appeared in eight weeks, after which the low back pain disappeared. Case 2 was a 77-year-old woman. NTX 86.5. Underwent irradiation 69 Gy for uterine carcinoma. Six months after the irradiation, the fourth/five lumbar vertebra were found to be compressed. Great collapse occurred in X-P after two weeks, but stabilized and did not aggravate thereafter. Low back pain also disappeared. Radiotherapy affects bone cells (osteoblasts, osteoclasts), inhibiting bone remodeling. As a result, deficient elastic resistance occurs. Vertebral bodies are also compressed in such a situation. After that normal callus formation starts from adjacent normal bone cells. The compression fracture observed ranged from three to six months after radiation. Natural course is well. Therefore conservative therapy is recommended. (author)

  7. Long-term use of adalimumab in the treatment of moderate to severe plaque psoriasis: a review of the literature

    Directory of Open Access Journals (Sweden)

    Angela Y Moore

    2010-04-01

    Full Text Available Angela Y Moore, Blakely S RichardsonArlington Center for Dermatology, Arlington, Texas, USAAbstract: Psoriasis is a chronic T-cell-mediated inflammatory disease that primarily affects the skin and joints. Patients with moderate to severe psoriasis constitute about 30% of the psoriasis population. Treatment of this group is challenging due to the long-term side effects, toxicities and inconvenience of conventional treatments such as phototherapy, methotrexate and cyclosporine. However, recent advances in our understanding of the pathogenesis of psoriasis have led to the popular use of biologics, which offer a safer, more convenient and effective targeted therapy. Adalimumab was originally approved for treating rheumatoid arthritis. Currently, adalimumab is also approved for treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy or when other systemic therapies are medically less appropriate. Since the onset of the use of biologics, there have been concerns over safety and efficacy when used as long-term therapy. This paper reviews all publications, posters and abstracts reporting original data on the efficacy and/or safety of adalimumab in patients treated for chronic plaque psoriasis for more than 1 year.Keywords: psoriasis, adalimumab, biologics

  8. Slipped Capital Femoral Epiphysis as a Complication of Growth Hormone Therapy

    Directory of Open Access Journals (Sweden)

    Shuo-Yu Wang

    2007-01-01

    Full Text Available Slipped capital femoral epiphysis (SCFE is a rare complication of growth hormone (GH therapy. Here, we report three patients who developed SCFE during GH therapy. The first two patients had hypopituitarism and had started GH therapy at the age of 15 years 6 months and 13 years 9 months, respectively. SCFE developed 4 years and 1 year after GH therapy, respectively. The third patient had Prader-Willi syndrome with obesity and hypogonadism and began GH therapy at the age of 12 years and 11 months. SCFE developed 2 months after starting GH therapy. Pain over the hip joints or over the knees is an early sign of SCFE. Despite recommendation, none of the three patients continued GH therapy. A high index of suspicion during GH therapy in patients at high risk of SCFE is important for early diagnosis and appropriate management. [J Formos Med Assoc 2007;106(2 Suppl:S46-S50

  9. Intracranial hemorrhage complicating thrombolytic therapy for acute myocardial infarction

    International Nuclear Information System (INIS)

    Uglietta, J.P.; Boyko, O.B.; O'Connor, C.M.; Aldrich, H.; Massey, E.W.; Heinz, E.R.

    1990-01-01

    This paper determines the incidence and types of intracranial hemorrhage (ICH) in 1,696 patients treated with thrombolytic therapy for acute myocardial infarction (AMI). Thirteen of 1,696 patients experienced ICH, and their nonenhanced brain CT scans were reviewed. Their mean age was 62 years (range, 53-74 years), and nine of 13 were male. Six patients received tissue plasminogen activator (tPA), four streptokinase, two urokinase, and one tPA and urokinase. The hemorrhages were classified according to CT location: intraparenchymal (IPH), subarachnoid (SAH), subdural (SDH), and intraventricular (IVH). The incidence of ICH was 0.76%. There were 31 hemorrhages in 13 patients. Twelve hemorrhages were IPH, 10 were SDH, seven were SAH, and two were IVH. Excluding IVH, 24 of 29 hemorrhages (83%) were supratentorial

  10. EXPERIENCE OF ADALIMUMAB ADMINISTRATION TO A PATIENT WITH JUVENILE ANKYLOSING SPONDYLOARTHRITIS AND CHRONIC VIRUS HEPATITIS B

    Directory of Open Access Journals (Sweden)

    E. A. Legostaeva

    2014-01-01

    Full Text Available The article presents a clinical case of high effectiveness of adalimumab — human monoclonal antibodies to tumor necrosis factor — in a patient with juvenile ankylosing spondyloarthritis refractory to therapy with classic immunosuppressive drugs and secondary to virus hepatitis B in the integrative phase. Joint pains and intensity of exudative alterations in interphalangeal and wrist joints attenuated as early as after as the first adalimumab injection; the authors achieved a 50% improvement in indices BASDAI (2.4 and ASDAI (1.1. Acute inflammatory alterations terminated, motion range of the affected joints completely recovered, general laboratory parameters of disease activity (erythrocyte sedimentation rate, C-reactive protein and white blood cell count normalized and inactive disease stage was registered after 6 months. Adverse events or virus hepatitis B exacerbations in the setting of adalimumab therapy were not observed. No osteochondral destruction progression was observed at computed and magnetic resonance imaging of joints 6 months after the therapy beginning. Emotional condition and quality of life of the child and his family improved considerably. 

  11. Impact of switching antiretroviral therapy on lipodystrophy and other metabolic complications: a review

    DEFF Research Database (Denmark)

    Hansen, Birgitte Rønde; Haugaard, Steen B; Iversen, Johan

    2004-01-01

    Following the introduction of highly active antiretroviral therapy (HAART), metabolic and morphological complications known as HIV associated lipodystrophy syndrome (HALS) have been increasingly common. The approaches to target these complications span from resistance exercise, diet and use...... with the disfiguring body-alterations known as HALS. More recently, however, regimens containing nucleoside reverse-transcriptase inhibitors (NRTI) have attracted attention. Reviewing switch studies regarding metabolic parameters and body shape changes, certain trends emerge. Switching from PI, the metabolic...

  12. Complications of combined radical hysterectomy-postoperative radiation therapy in women with early stage cervical cancer

    International Nuclear Information System (INIS)

    Barter, J.F.; Soong, S.J.; Shingleton, H.M.; Hatch, K.D.; Orr, J.W. Jr.

    1989-01-01

    Fifty patients with cervical cancer were treated with radical hysterectomy and lymphadenectomy followed by postoperative radiation therapy for high risk factors (nodal metastases, lymphvascular space invasion, close or involved margins) at the University of Alabama at Birmingham Medical Center from 1969 to 1984. Fifteen (30%) of the patients treated had serious complications, 8 (16%) requiring an operation, and 1 (2%) dying as a result of treatment-related problems. This combined modality approach is associated with significant complications

  13. Adalimumab (Humira) restores clinical response in patients with secondary loss of efficacy from infliximab (Remicade) or etanercept (Enbrel): results from the STURE registry at Karolinska University Hospital.

    Science.gov (United States)

    Wick, M C; Ernestam, S; Lindblad, S; Bratt, J; Klareskog, L; van Vollenhoven, R F

    2005-01-01

    To determine whether the tumour necrosis factor-alpha (TNF-alpha) antagonist adalimumab (Humira) can be efficacious after secondary loss of efficacy (i.e. loss of clinical response in patients who had initially demonstrated clinical response) to infliximab (Remicade) or etanercept (Enbrel). We studied 36 patients from the Stockholm TNF-alpha follow-up registry (STURE) who received adalimumab after secondary loss of efficacy to infliximab (group A, n = 27) or etanercept (group B, n = 9), and 26 patients who were started on adalimumab as the first TNF-alpha antagonist (group C). In group A, the baseline disease activity score 28 (DAS28) at infliximab institution was 5.5+/-0.2. During infliximab treatment, the mean best DAS28 was 3.7+/-0.2 (p<0.001), but increased to 5.2+/-0.3 when infliximab was stopped. After 3 months on adalimumab, the mean DAS28 decreased to 4.5+/-0.3 (p<0.003), and then to 4.2+/-0.2 at 6 months (p<0.001). In group B, the baseline DAS28 at etanercept institution was 6.6+/-0.5. During etanercept treatment, the mean best DAS28 was 4.6+/-0.5 (p<0.01), but increased to 5.7+/-0.4 by the time etanercept was stopped. After 3 months on adalimumab, the mean DAS28 decreased to 4.8+/-0.3 (p<0.005), and to 4.1+/-0.2 at 6 months (p<0.001). In group C, the mean baseline DAS28 was 5.6+/-0.3. After 6 months of adalimumab therapy, the DAS28 decreased to 3.5+/-0.4 (p<0.001). ACR20 responses with adalimumab in groups A, B, and C were similar (70-78%). For patients with secondary loss of efficacy from infliximab or etanercept, switching to adalimumab can restore a good clinical response.

  14. Usefulness of Adalimumab in the Treatment of Refractory Uveitis Associated with Juvenile Idiopathic Arthritis

    Science.gov (United States)

    García-De-Vicuña, Carmen; Díaz-Llopis, Manuel; Salom, David; Bou, Rosa; Díaz-Cascajosa, Jesus; Cordero-Coma, Miguel; Ortega, Gabriela; Ortego-Centeno, Norberto; Suarez-De-Figueroa, Marta; Cruz-Martínez, Juan; Fonollosa, Alex; Blanco, Ricardo; García-Aparicio, Ángel María; Benítez-Del-Castillo, Jose M.; Antón, Jordi

    2013-01-01

    Purpose. To assess the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA) and associated refractory uveitis. Design. Multicenter, prospective case series. Methods. Thirty-nine patients (mean [SD] age of 11.5 [7.9] years) with JIA-associated uveitis who were either not responsive to standard immunosuppressive therapy or intolerant to it were enrolled. Patients aged 13–17 years were treated with 40 mg of adalimumab every other week for 6 months and those aged 4–12 years received 24 mg/m2 body surface. Results. Inflammation of the anterior chamber (2.02 [1.16] versus 0.42 [0.62]) and of the posterior segment (2.38 [2.97] versus 0.35 [0.71] decreased significantly between baseline and the final visit (P treatment for JIA-associated refractory uveitis and may reduce steroid requirement. PMID:24489444

  15. Developments in the treatment of moderate to severe ulcerative colitis: focus on adalimumab

    Directory of Open Access Journals (Sweden)

    Freeman HJ

    2013-11-01

    Full Text Available Hugh J FreemanDepartment of Medicine (Gastroenterology, University of British Columbia, Vancouver, BC, Canada Abstract: In selected patients with moderate to severe active ulcerative colitis who have failed to respond or are poorly responsive to standard pharmacologic forms of treatment with corticosteroids and immunosuppressive agents, therapy with a biological agent may be considered. While infliximab is an established tumor necrosis factor blocker and has a longer history of clinical use, adalimumab is an alternative in the same class and may be employed as an initial biological agent, if indicated for treatment of the disease. Adalimumab may have special appeal to stable users able to self-inject in a home setting rather than a centralized infusion center. Short-term adverse effects have been limited, but long-term adverse events can be serious and remain less well defined. Recently, another agent, subcutaneous golimumab, has also been reported to induce and maintain clinical response and remission in clinical trials, but a large experience has not been accumulated to date in clinical practice. In the future, other biological agents with novel and distinct mechanisms of therapeutic action may become available. Keywords: ulcerative colitis, anti-tumor necrosis factor inhibitors, biological therapy, infliximab, adalimumab

  16. Modelling Gaucher disease progression: long-term enzyme replacement therapy reduces the incidence of splenectomy and bone complications

    NARCIS (Netherlands)

    van Dussen, Laura; Biegstraaten, Marieke; Dijkgraaf, Marcel Gw; Hollak, Carla Em

    2014-01-01

    Long-term complications and associated conditions of type 1 Gaucher Disease (GD) can include splenectomy, bone complications, pulmonary hypertension, Parkinson disease and malignancies. Enzyme replacement therapy (ERT) reverses cytopenia and reduces organomegaly. To study the effects of ERT on

  17. Dental complications and management of patients on bisphosphonate therapy: A review article

    OpenAIRE

    Kalra, Sandeep; Jain, Veena

    2012-01-01

    Bisphosphonates are group of drugs that inhibit bone resorption and are used to treat a range of pathologies including Paget's disease, osteoporosis, multiple myeloma and metastasis associated with breast or prostate cancer. The most common complication in patients on bisphosphonate therapy is osteonecrosis of jaw (ONJ) which can occur after any surgical dental procedure and the risk for the development of osteonecrosis of jaw is higher in patients receiving intravenous bisphosphonate therapy...

  18. Relationship between Post-kidney Transplantation Antithymocyte Globulin Therapy and Wound Healing Complications

    OpenAIRE

    Pourmand, G. R.; Dehghani, S.; Saraji, A.; Khaki, S.; Mortazavi, S. H.; Mehrsai, A.; Sajadi, H.

    2012-01-01

    Background: Wound healing disorders are probably the most common post-transplantation surgical complications. It is thought that wound healing disturbance occurs due to antiproliferative effects of immunosuppressive drugs. On the other hand, success of transplantation is dependent on immunosuppressive therapies. Antihuman thymocyte globulin (ATG) has been widely used as induction therapy but the impact of this treatment on wound healing is not fully understood. Objective: To investigate wound...

  19. Kocuria kristinae infection during adalimumab treatment.

    Science.gov (United States)

    Kolikonda, Murali K; Jayakumar, Priyanga; Sriramula, Srividya; Lippmann, Steven

    2017-03-01

    A common inhabitant of skin, the Kocuria kristinae of the Micrococcaceae family, has gained attention in recent years because it can induce pathology in humans. Reported is a Kocuria kristinae-caused abdominal abscess in a patient treated for rheumatoid arthritis with adalimumab. The tumor necrosis factor (TNF) inhibitor drugs are known to cause various bacterial, viral, and fungal infections. This is the first known case where an opportunistic infection with Kocuria has presented with an abdominal abscess in an immunocompromised individual who is on long term TNF inhibitors.

  20. Prediction of treatment response to adalimumab

    DEFF Research Database (Denmark)

    Krintel, S B; Dehlendorff, C; Hetland, M L

    2016-01-01

    At least 30% of patients with rheumatoid arthritis (RA) do not respond to biologic agents, which emphasizes the need of predictive biomarkers. We aimed to identify microRNAs (miRNAs) predictive of response to adalimumab in 180 treatment-naïve RA patients enrolled in the OPtimized treatment algori...... of low expression of miR-22 and high expression of miR-886.3p was associated with EULAR good response. Future studies to assess the utility of these miRNAs as predictive biomarkers are needed.The Pharmacogenomics Journal advance online publication, 5 May 2015; doi:10.1038/tpj.2015.30....

  1. Nursing care of the complications caused by vena cava filter placement and thrombolytic therapy

    International Nuclear Information System (INIS)

    Ma Congfeng; Tan Meifang; Fu Bing; Luo Chunhua; Jiang Fengjiao

    2011-01-01

    Objective: To discuss the nursing care and observation measures for the complications occurred after vena cava filter placement and thrombolytic therapy. Methods: During the period of July 2007-March 2010, vena cava filter placement and thrombolytic therapy were employed in 70 patients. The observation for the main procedure-related complications was made. The main complications included bleeding tendency, pulmonary embolism, filter migration or loss, thrombus formation within filter, IVC perforation due to filter, venous insufficiency and skin blisters of the affected lower extremity. Results: The total effective rate of thrombolytic treatment in 70 patients was 95.7%. As reasonable and effective nursing care measures were implemented, no major complications, such as pulmonary embolism, filter migration or loss,thrombus formation within filter, IVC perforation due to filter, infection, etc. occurred. The other complications developed in some patients,which included hematuria (n=4), bleeding at puncturing site (n=3), bleeding at abdominal incision (n=3), subcutaneous ecchymosis (n=3) and skin vesicles of diseased limb (n=3), all of which were cured after proper management. Conclusion: Postoperative nursing is a kind of prospective nursing care, the primary purpose of which is to prevent the occurrence of the potential complications after surgery. Therefore, solid fundamental knowledge, careful observation ability and strong consciousness of responsibility are most important.(authors)

  2. Kinetic therapy reduces complications and shortens hospital stay in patients with cardiogenic shock - a retrospective analysis.

    Science.gov (United States)

    Simonis, Gregor; Flemming, Kerstin; Ziegs, Enrico; Haacke, Katrin; Rauwolf, Thomas; Strasser, Ruth H

    2007-03-01

    Kinetic therapy (KT) has been shown to reduce complications and to shorten hospital stay in trauma patients. Data in non-surgical patients are inconclusive, and kinetic therapy has not been tested in patients with cardiogenic shock. The present analysis compares KT with standard care in patients with cardiogenic shock. A retrospective analysis of 133 patients with cardiogenic shock admitted to 1 academic heart center was performed. Patients with standard care (SC, turning every 2 h by the staff) were compared with kinetic therapy (KT, using oscillating air-flotation beds). 68 patients with KT were compared with 65 patients with SC. Length of ventilator therapy was 11 days in KT and 18 days in SC (p=0.048). The mortality was comparable in both groups. Pneumonia occurred in 14 patients in KT and 39 patients in SC (ppatients treated with kinetic therapy. The use of KT shortens hospital stay and reduces rates of pneumonia and pressure ulcers as compared to SC.

  3. Successful adalimumab treatment of a psoriasis vulgaris patient with hemodialysis for renal failure: A case report and a review of the previous reports on biologic treatments for psoriasis patients with hemodialysis for renal failure.

    Science.gov (United States)

    Kusakari, Yoshiyuki; Yamasaki, Kenshi; Takahashi, Toshiya; Tsuchiyama, Kenichiro; Shimada-Omori, Ryoko; Nasu-Tamabuchi, Mei; Aiba, Setsuya

    2015-07-01

    The efficacy and safety of biologic treatments have been established in patients with moderate to severe psoriasis, but there are few reports on biologic therapy for patients with psoriasis complicated by end-stage renal failure on hemodialysis (HD). In this report, we demonstrated the efficacy and safety of adalimumab for patients with severe psoriasis on HD. A 46-year-old Japanese man with a 14-year history of psoriasis was referred to our clinic in September 2009. He had developed hypertension and renal failure during a 7-year history of cyclosporin treatment. With the infliximab treatment, he achieved 75% improvement of the Psoriasis Area and Severity Index (PASI) score within 3 months from the PASI of 42.3 before the treatment. However, his renal failure gradually deteriorated, and HD was initiated at 1 year after the introduction of infliximab. Because of hydration during the i.v. injection of infliximab, he developed pulmonary edema with every infliximab treatment after starting HD. We switched to ustekinumab treatment, but his psoriasis was not improved. Then, we switched to adalimumab and achieved a PASI-100 response within 2 months. The patient received adalimumab treatment for more than a year without any adverse effects. In addition to our case, five articles reported cases of psoriasis patients with renal failure on HD who were treated with biologics. The psoriatic lesions were improved by biologics in these cases, and no severe adverse effects on the renal function were reported. Thus, biologics are a reasonable treatment option for patients with severe psoriasis with renal failure on HD. © 2015 Japanese Dermatological Association.

  4. Gastroduodenal Complications After Concurrent Chemoradiation Therapy in Patients With Hepatocellular Carcinoma: Endoscopic Findings and Risk Factors

    Energy Technology Data Exchange (ETDEWEB)

    Chon, Young Eun [Department of Internal Medicine, Yonsei University College of Medicine, Seoul (Korea, Republic of); Seong, Jinsil [Department of Radiation Oncology, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Beom Kyung [Department of Internal Medicine, Yonsei University College of Medicine, Seoul (Korea, Republic of); Cha, Jihye [Department of Radiation Oncology, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Seung Up; Park, Jun Yong; Ahn, Sang Hoon; Han, Kwang-Hyub; Chon, Chae Yoon [Department of Internal Medicine, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Gastroenterology, Yonsei University College of Medicine, Seoul (Korea, Republic of); Liver Cirrhosis Clinical Research Center, Seoul (Korea, Republic of); Shin, Sung Kwan, E-mail: kaarma@yuhs.ac [Department of Internal Medicine, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Gastroenterology, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Do Young, E-mail: dyk1025@yuhs.ac [Department of Internal Medicine, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Gastroenterology, Yonsei University College of Medicine, Seoul (Korea, Republic of); Liver Cirrhosis Clinical Research Center, Seoul (Korea, Republic of)

    2011-12-01

    Purpose: Concurrent chemoradiation therapy (CCRT) is useful in advanced hepatocellular carcinoma (HCC), but little is known about radiation-induced gastroduodenal complications following therapy. To determine risk factors, we investigated the prevalence and patterns of gastroduodenal complications following CCRT using endoscopy. Methods and Materials: Enrolled in the study were 123 patients treated with CCRT for unresectable HCC between January 1998 and December 2005. Radiation-induced gastroduodenal complications were defined as radiation gastritis/duodenitis, radiation gastric/duodenal ulcer, or other gastroduodenal toxicity associated with radiation, based on Common Terminology Criteria for Adverse Events (CTCAE 3.0). Serious gastroduodenal complications were defined as events occurring within 12 months from completion of CCRT, those requiring prompt therapeutic intervention, or symptoms equivalent to Grade 3 or 4 radiation-related gastroduodenal toxicity, including nausea or vomiting, based on CTCAE 3.0. Results: A month after completion of CCRT, 65 (52.8%) patients displayed endoscopic evidence of radiation-induced gastroduodenal complications. Radiation gastric and duodenal ulcers were found in 32 (26.0%) and 20 (16.3%) patients, respectively; radiation gastritis and duodenitis were found in 50 (40.7%) and 42 (34.1%) patients, respectively. Radiation-related bleeding was observed in 13 patients (10.6%). Serious gastroduodenal complications occurred in 18 patients (14.6%) and were significantly more frequent in patients with liver cirrhosis than in those without cirrhosis (p = 0.043). There were no radiation-related deaths. Conclusions: Endoscopically detectable radiation-induced gastroduodenal complications were common in HCC following CCRT. Although serious complications were uncommon, the frequency was higher in patients with liver cirrhosis; thus, these patients should be closely monitored when receiving CCRT.

  5. Gastroduodenal Complications After Concurrent Chemoradiation Therapy in Patients With Hepatocellular Carcinoma: Endoscopic Findings and Risk Factors

    International Nuclear Information System (INIS)

    Chon, Young Eun; Seong, Jinsil; Kim, Beom Kyung; Cha, Jihye; Kim, Seung Up; Park, Jun Yong; Ahn, Sang Hoon; Han, Kwang-Hyub; Chon, Chae Yoon; Shin, Sung Kwan; Kim, Do Young

    2011-01-01

    Purpose: Concurrent chemoradiation therapy (CCRT) is useful in advanced hepatocellular carcinoma (HCC), but little is known about radiation-induced gastroduodenal complications following therapy. To determine risk factors, we investigated the prevalence and patterns of gastroduodenal complications following CCRT using endoscopy. Methods and Materials: Enrolled in the study were 123 patients treated with CCRT for unresectable HCC between January 1998 and December 2005. Radiation-induced gastroduodenal complications were defined as radiation gastritis/duodenitis, radiation gastric/duodenal ulcer, or other gastroduodenal toxicity associated with radiation, based on Common Terminology Criteria for Adverse Events (CTCAE 3.0). Serious gastroduodenal complications were defined as events occurring within 12 months from completion of CCRT, those requiring prompt therapeutic intervention, or symptoms equivalent to Grade 3 or 4 radiation-related gastroduodenal toxicity, including nausea or vomiting, based on CTCAE 3.0. Results: A month after completion of CCRT, 65 (52.8%) patients displayed endoscopic evidence of radiation-induced gastroduodenal complications. Radiation gastric and duodenal ulcers were found in 32 (26.0%) and 20 (16.3%) patients, respectively; radiation gastritis and duodenitis were found in 50 (40.7%) and 42 (34.1%) patients, respectively. Radiation-related bleeding was observed in 13 patients (10.6%). Serious gastroduodenal complications occurred in 18 patients (14.6%) and were significantly more frequent in patients with liver cirrhosis than in those without cirrhosis (p = 0.043). There were no radiation-related deaths. Conclusions: Endoscopically detectable radiation-induced gastroduodenal complications were common in HCC following CCRT. Although serious complications were uncommon, the frequency was higher in patients with liver cirrhosis; thus, these patients should be closely monitored when receiving CCRT.

  6. Survival and Complication Rate of Radiation Therapy in Stage I and II Carcinoma of uterine Cervix

    International Nuclear Information System (INIS)

    Ma, Sun Young; Cho, Heung Lea; Sohn, Seung Chang

    1995-01-01

    Purpose : To analyze survival rate and late rectal and bladder complication for patients with stage with stage I and II carcinoma of uterine cervix treated by radiation alone or combined with chemotherapy. Materials and Methods : Between November 1984 and December 1993, 127 patients with stage I and II carcinoma of uterine cervix treated by radiation alone or combined therapy of radiation and chemotherapy. Retrospective analysis for survival rate was carried out on eligible 107 patients and review for complication was possible in 91 patients. The median follow-up was 47 months (range 3-118) and the median age of patients was 56 years (range 31-76). 26 patients were stage IB by FIGO classification. 40 were stage IIA and 41 were stage IIB. 86 cases were treated by radiation alone and 21 were treated by radiation and chemotherapy. 101 patients were treated with intracavitary radiation therapy (ICRT), of these, 80 were received low dose rate (LDR) ICRT and 21 were received high dose rate (HDR) ICRT. Of the patients who received LDR ICRT, 63 were treated by 1 intracavitary insertion and 17 were underwent 2 insertions. And we evaluated the external radiation dose and midline shield. Results : Acturial survival rate at 5 years was 92% for stage IB, 75% for stage IIA, 53% for stage IIB and 69% in all patients. Grade 1 rectal complications were developed in 20 cases(22%), grade 2 were in 22 cases (24%), 22 cases (24%) of grade 1 urinary complications and 17 cases (19%) of grade 2 urinary complications were observed But no patients had severe complications that needed surgical management or admission care. Maximum bladder dose for the group of patients with urinary complications was higher than that for the patients without urinary complications(7608cGy v 6960cGy, p<0.01). Maximum rectal dose for the group of patients with rectal complications was higher than that for the patients without urinary complications (7041cGy v 6269cGy, p<0.01). While there was no significant

  7. The effects of sequence and type of chemotherapy and radiation therapy on cosmesis and complications after breast conservation therapy

    International Nuclear Information System (INIS)

    Markiewicz, Deborah A.; Schultz, Delray J.; Haas, Jonathan A.; Harris, Eleanor E. R.; Fox, Kevin R.; Glick, John H.; Solin, Lawrence J.

    1996-01-01

    Purpose: Chemotherapy plays an increasingly important role in the treatment of both node-negative and node-positive breast cancer patients, but the optimal sequencing of chemotherapy and radiation therapy is not well established. The purpose of this study is to evaluate the interaction of sequence and type of chemotherapy and hormonal therapy given with radiation therapy on the cosmetic outcome and the incidence of complications of Stage I and II breast cancer patients treated with breast-conserving therapy. Methods and Materials: The records of 1053 Stage I and II breast cancer patients treated with curative intent with breast-conserving surgery, axillary dissection, and radiation therapy between 1977-1991 were reviewed. Median follow-up after treatment was 6.7 years. Two hundred fourteen patients received chemotherapy alone, 141 patients received hormonal therapy alone, 86 patients received both, and 612 patients received no adjuvant therapy. Patients who received chemotherapy ± hormonal therapy were grouped according to sequence of chemotherapy: (a) concurrent = concurrent chemotherapy with radiation therapy followed by chemotherapy; (b) sequential = radiation followed by chemotherapy or chemotherapy followed by radiation; and (c) sandwich = chemotherapy followed by concurrent chemotherapy and radiation followed by chemotherapy. Compared to node negative patients, node-positive patients more commonly received chemotherapy (77 vs. 9%, p < 0.0001) and/or hormonal therapy (40 vs. 14%, p < 0.0001). Among patients who received chemotherapy, the majority (243 patients) received concurrent chemotherapy and radiation therapy with two cycles of cytoxan and 5-fluorouracil (5-FU) administered during radiation followed by six cycles of chemotherapy with cytoxan, 5-fluorouracil and either methotrexate(CMF) or doxorubicin(CAF). For analysis of cosmesis, patients included were relapse free with 3 years minimum follow-up. Results: The use of chemotherapy had an adverse effect

  8. Emergency surgery due to complications during molecular targeted therapy in advanced gastrointestinal stromal tumors (GIST)

    International Nuclear Information System (INIS)

    Rutkowski, P.; Nowecki, Z. I.; Dziewirski, W.; Ruka, W.; Siedlecki, J. A.; Grzesiakowska, U.

    2010-01-01

    Aim. The aim of the study was to assess the frequency and results of disease/treatment-related emergency operations during molecular targeted therapy of advanced gastrointestinal stromal tumors (GISTs). Methods. We analyzed emergency operations in patients with metastatic/inoperable GISTs treated with 1 st -line imatinib - IM (group I: 232 patients; median follow-up time 31 months) and 2 nd -line sunitinib - SU (group II: 43 patients; median follow-up 13 months; 35 patients in trial A6181036) enrolled into the Polish Clinical GIST Registry. Results. In group I 3 patients (1.3%) underwent emergency surgery due to disease/treatment related complications: one due to bleeding from a ruptured liver tumor (1 month after IM onset) and two due to bowel perforation on the tumor with subsequent intraperitoneal abscess (both 2 months after IM onset). IM was restarted 5-8 days after surgery and no complications in wound healing were observed. In group II 4 patients (9.5%) underwent emergency operations due to disease/treatment related complications: three due to bowel perforations on the tumor (2 days, 20 days and 10 months after SU onset; 1 subsequent death) and one due to intraperitoneal bleeding from ruptured, necrotic tumor (3.5 months after SU start). SU was restarted 12-18 days after surgery and no complications in wound healing were observed. Conclusions. Emergency operations associated with disease or therapy during imatinib treatment of advanced GISTs are rare. The frequency of emergency operations during sunitinib therapy is considered to be higher than during first line therapy with imatinib which may be associated with more advanced and more resistant disease or to the direct mechanism of sunitinib action, i.e. combining cytotoxic and antiangiogenic activity and thus leading to dramatic tumor response. Molecular targeted therapy in GISTs should always be conducted in cooperation with an experienced surgeon. (authors)

  9. Adalimumab for the treatment of refractory noninfectious paediatric uveitis.

    Science.gov (United States)

    Muñoz-Gallego, Alicia; Barral, Estefanía; Enríquez, Eugenia; Tejada, Pilar; Barceló, Ana; de Inocencio, Jaime

    2017-06-01

    To report the experience of our center with the use of adalimumab (ADA) for the treatment of severe refractory noninfectious paediatric uveitis. The study is a retrospective case series of all paediatric patients with refractory uveitis who were treated with ADA at the Paediatric Uveitis Unit of our center from 2008 to 2015. We present 12 patients (6 Juvenile idiopathic arthritis-associated uveitis, 4 idiopathic panuveitis, 1 early-onset sarcoidosis-associated panuveitis, and 1 intermediate uveitis), with uveitis in 19/24 eyes. Once ADA therapy was started, all the patients presented improved activity according to Standardization of Uveitis Nomenclature (SUN) criteria. Nine out of the 12 patients had structural damage before ADA could be started: cataract (n = 4), glaucoma (n = 2), cystic macular edema (n = 1), exudative retinal detachment (n = 1), and optic disk edema (n = 5). Visual acuity improved or maintained stable in 17/19 affected eyes, and only 2 eyes decreased its visual acuity because of structural damage, which was already present before ADA therapy. In our experience, ADA presents a good safety profile and is efficacious in the treatment of paediatric patients with different forms of refractory noninfectious uveitis.

  10. Carcinoma of the vagina. [Complications following whole-pelvis. gamma. irradiation and radium implant therapy

    Energy Technology Data Exchange (ETDEWEB)

    Marcus, R.B. Jr.; Million, R.R.; Daly, J.W.

    1978-11-01

    Twenty-two patients with Stage I through IV primary vaginal squamous cell carcinomas treated for cure with radiation therapy are reviewed, with particular emphasis on the relationship of dose to complications and local control. All but 2 patients received 4000 to 6000 rad whole pelvis irradiation plus at least one radium application. Local control was 91%, with an absolute 2-year disease-free survival of 82%. The degree of anaplasia was found to influence prognosis, with all local and distant failures resulting from high-grade lesions. The complication rate was modest, with no fistulae or serious bowel complications. An analysis of total dose (external plus radium) with respect to local failure and complications showed that no major complications occurred at a combined dose below 9000 rad. An analysis of the individual contributions of external irradiation and radium implants showed that all but one very minor complication occurred at a radium dose of 4000 rad or higher. From these data, overall treatment planning and total dose recommendations are made.

  11. Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

    Directory of Open Access Journals (Sweden)

    Nagamu Inoue

    2017-07-01

    Full Text Available Background/Aims: Intestinal Behçet's disease (BD is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671.Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs were examined. The efficacy was assessed on the basis of marked improvement (MI and complete remission (CR using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years. No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

  12. Untargeted antifungal therapy in adult patients with complicated intra-abdominal infection

    DEFF Research Database (Denmark)

    Petersen, Marie Warrer; Perner, Anders; Sjövall, Fredrik

    2017-01-01

    who are critically ill have provided conflicting results, and clinical equipoise exists. Accordingly, we aim to assess patient-important benefits and harms of untargeted antifungal therapy versus placebo or no treatment in adult patients with complicated intra-abdominal infection. Methods and analysis......-cause mortality, and secondary outcomes include adverse events, duration of mechanical ventilation and inotropic support, need for renal replacement therapy, emergence of antibiotic resistance and intensive care unit and hospital length-of-stay. Conventional meta-analysis, including sensitivity and subgroup...

  13. Warfarin therapy and incidence of cerebrovascular complications in left-sided native valve endocarditis

    DEFF Research Database (Denmark)

    Snygg-Martin, U; Rasmussen, Rasmus Vedby; Hassager, C

    2011-01-01

    Anticoagulant therapy has been anticipated to increase the risk of cerebrovascular complications (CVC) in native valve endocarditis (NVE). This study investigates the relationship between ongoing oral anticoagulant therapy and the incidence of symptomatic CVC in left-sided NVE. In a prospective...... factors for CVC, while warfarin on admission (aOR 0.26, 95% CI 0.07-0.94), history of congestive heart failure (adjusted OR 0.22, 95% CI 0.1-0.52) and previous endocarditis (aOR 0.1, 95% CI 0.01-0.79) correlated with lower CVC frequency....

  14. A case of hyperthyroidism complicated with diabetic ketoacidosis following 131I therapy

    International Nuclear Information System (INIS)

    Itoh, Mitsuyasu; Funauchi, Masanori; Fukuma, Naobumi; Abe, Yohsuke; Hirooka, Yoshibumi; Nihei, Noriyuki

    1982-01-01

    The coexistence of diabetes mellitus and hyperthyroidism has long been known and, in a few cases, diabetic acidosis complicated with thyroid storm has been reported. We describe a case who developed thyroid storm and diabetic ketoacidosis following 131 I therapy for severe hyperthyroidism. A 50-yr-old man was diagnosed as having hyperthyroidism complicated with diabetes mellitus at the age of 47. After he had been unsuccessfully treated with methimazole and oral hypoglycemic agents, radioactive iodine was administered twice. However, no remarkable effect was observed. After a third treatment with 131 I, the patient showed symptoms like thyroid storm and diabetic ketoacidosis. He was hospitalized on October 3, 1980. Administration of insulin and supportive therapy including correction of dehydration alleviated his symptoms after admission. Administration inistration of methimazole normalized his thyroid function. A 75 g GTT and tolbutamide i.v. test revealed impaired secretion of endogenous insulin. The patient had a high level of serum T 3 and T 4 following 131 I therapy, indicating that the released hormone caused a transient condition like thyroid storm, which led to deterioration of glucose metabolism as indicated in high levels of hemoglobin A1c. Diabetic acidosis is the precipitating factor for thyroid storm. Prompt treatment for diabetic ketoacidosis, therefore, might prevent the complications of life-threatening thyroid storm. (author)

  15. Case of hyperthyroidism complicated with diabetic ketoacidosis following /sup 131/I therapy

    Energy Technology Data Exchange (ETDEWEB)

    Itoh, Mitsuyasu; Funauchi, Masanori; Fukuma, Naobumi; Abe, Yohsuke; Hirooka, Yoshibumi; Nihei, Noriyuki (Hamamatsu Univ. Shizuoka (Japan). School of Medicine)

    1982-10-01

    The coexistence of diabetes mellitus and hyperthyroidism has long been known and, in a few cases, diabetic acidosis complicated with thyroid storm has been reported. We describe a case who developed thyroid storm and diabetic ketoacidosis following /sup 131/I therapy for severe hyperthyroidism. A 50-yr-old man was diagnosed as having hyperthyroidism complicated with diabetes mellitus at the age of 47. After he had been unsuccessfully treated with methimazole and oral hypoglycemic agents, radioactive iodine was administered twice. However, no remarkable effect was observed. After a third treatment with /sup 131/I, the patient showed symptoms like thyroid storm and diabetic ketoacidosis. He was hospitalized on October 3, 1980. Adm of insulin and supportive therapy including correction of dehydration alleviated his symptoms after admission. Administration of methimazole normalized his thyroid function. A 75 g GTT and tolbutamide i.v. test revealed impaired secretion of endogenous insulin. The patient had a high level of serum T/sub 3/ and T/sub 4/ following /sup 131/I therapy, indicating that the released hormone caused a transient condition like thyroid storm, which led to deterioration of glucose metabolism as indicated in high levels of hemoglobin A1c. Diabetic acidosis is the precipitating factor for thyroid storm. Prompt treatment for diabetic ketoacidosis, therefore, might prevent the complications of life-threatening thyroid storm.

  16. Matrix metalloproteinase inhibitor therapy to prevent complications as well as therapy for Ehler-Danlos syndrome.

    Science.gov (United States)

    Sastry, P S R K

    2002-09-01

    Matrixmetalloproteinase inhibitors have been developed as anti-cancer agents. Their usage in pancreatic cancer and other such malignancies is under trial at present. An interesting undesired-effect of one of these agents is contracture of the hand. Ehler-Danlos syndrome is an inherited group of diseases with varying types. At present there is no known treatment or prevention for the complications associated with this inherited condition. Sometimes it is the adverse events of a drug, which provides an insight into its efficacy for another indication. It is hereby being hypothesized that the matrixmetalloproteinase inhibitors especially marimastat may be an effective drug for treatment of Ehler-Danlos syndrome and/or prevention of its major complications.

  17. Risk of post-operative complications associated with anti-TNF therapy in inflammatory bowel disease

    Institute of Scientific and Technical Information of China (English)

    Tauseef Ali; Laura Yun; David T Rubin

    2012-01-01

    There have been increasing concerns regarding the safety of perioperative antitumour necrosis factor (antiTNF) α agents. We performed a literature review to evaluate the postoperative complications associated with perioperative antiTNF use in patients with inflammatory bowel disease. A comprehensive review was performed with a literature search utilizing Pub Med, Cochrane, OVID and EMBASE databases according to published guidelines. To date, there are only data for infliximab. There are three published studies which have assessed postoperative complications with perioperative infliximab use in patients with Crohn's disease (CD), four studies in ulcerative colitis (UC) patients, and one study on both CD and UC patients. Two out of the three studies in CD patients showed no increased postoperative complications associated with perioperative infliximab. Two out of four studies in UC patients also did not show an increase in postoperative complications, and the combined study with CD and UC patients did not show an increased risk as well. Study differences in study designs, patient population and definition of their endpoints. There appears to be a risk of postoperative complications associated with TNF therapy in some patients. Based on these data, careful patient selection and prospective data collection should be performed.

  18. Complication of radiation therapy among patients with positive S. aureus culture from genital tract

    Science.gov (United States)

    Cybulski, Zefiryn; Urbaniak, Iwona; Roszak, Andrzej; Grabiec, Alicja; Talaga, Zofia; Klimczak, Piotr

    2012-01-01

    Aim The main goal of this investigation was to evaluate the influence of positive Staphylococcus aureus culture from the genital tract on patients receiving radiation therapy, suffering from carcinoma of the uterus. The other aim was to observe radiation therapy complications. Background Radiation therapy of patients suffering from cervical cancer can be connected with inflammation of the genitourinary tract. Materials and methods In years 2006–2010 vaginal swabs from 452 patients were examined. 39 women with positive S. aureus cultures were analysed. Results Complications and interruptions during radiation therapy were observed in 7 (18.9%) of 37 patients with positive vaginal S. aureus culture. One of them, a 46-year-old woman developed pelvic inflammatory disease. None of the six patients who received palliative radiotherapy showed interruption in this treatment. Isolated S. aureus strains were classified into 13 sensitivity patterns, of which 8 were represented by 1 strain, two by 2 strains and three by 13, 8 and 6 strains. One strain was diagnosed as methicillin resistant S. aureus (MRSA). Conclusions The results of the present study show that S. aureus may generally be isolated from the genital tract of female patients with neoplastic disease of uterus but is not often observed as inflammation factor of this tract. Comparison of species’ resistance patterns may be used in epidemiological studies in order to discover the source of infections and therefore be of profound significance in the prevention of nosocomial infections. PMID:24377025

  19. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

    Science.gov (United States)

    Strand, Vibeke; van Vollenhoven, Ronald F; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-06-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  20. Endoscopic therapy for chronic pancreatitis: technical success, clinical outcomes, and complications.

    Science.gov (United States)

    Kowalczyk, Lukasz M; Draganov, Peter V

    2009-04-01

    Chronic pancreatitis (CP) can cause failure of both the exocrine and endocrine portions of the gland. Pain is the most recalcitrant clinical complaint in CP. Generally, conservative measures are first attempted to manage pain. These include cessation of alcohol use and smoking, enzyme replacement therapy, and finally, opioid analgesia. Endoscopy can be employed to treat the pain and complications due to CP. The results of the only two prospective randomized controlled trials suggest that surgery has a more durable effect than endoscopic therapy in controlling pain. Both trials suffer from severe limitations, however, and endoscopy remains the preferred approach for many patients because of its minimally invasive nature. Endoscopic ultrasound celiac plexus block has limited value in helping to control pain. More randomized trials are needed, along with further technologic innovation to improve the current treatment modalities. When considering interventional therapy for a patient with CP, a tailored and multidisciplinary therapeutic approach should be taken.

  1. NUTRITIVE THERAPY OF HEPATIC ENCEPHALOPATHY AS A COMPLICATION OF LIVER CIRRHOSIS

    Directory of Open Access Journals (Sweden)

    Bojana Marković-Živković

    2012-06-01

    Full Text Available Hepatic encephalopathy is a complication of liver cirrhosis and is defined as a neuropsychiatric disease, with a reversibile character. Besides classical ways of therapy, an increasing importance is attached to nutritional therapy that is an effective prevention of the onset and leads to an ease of symptoms in hepathic encephalopathy that already exists. After the patient's nutritional status evaluation, the prescription of diet that includes adequate protein, calories and vitamins is assessed. The greatest importance is attached to the zinc intake as well as branched chain amino acids (BCAA therapy supplementation. It is believed that further development of science in terms of nutrigenomics and nutrigenetics will give detailed guidance on further developments since the possibility of clinical investigation in these patients is limited.

  2. Complications associated with pelvic intraarterial therapy in patients with recurrent and advanced gynecologic cancer

    International Nuclear Information System (INIS)

    Guo Yanjun; Shi Zhonghua

    2001-01-01

    Objective: To analyze the complications associated with pelvic intraarterial therapy in patients with recurrent and advanced gynecologic cancer and to discuss the causes, the prevention and management measures of the complications in details. Methods: One hundred and thirty procedures of pelvic intraarterial therapy were performed in 78 patients with pathologically confirmed recurrent and advanced gynecologic cancer, with one to six procedures per case. The Seldinger technique was used in all patients. The catheter was introduced via femoral artery on one side (mostly on the right side), and the combined antineoplastic agents were infused into contralateral internal iliac artery and (or) ipsilateral branches supplying the involved area. Common iliac arteries and inferior mesenteric arteries were also used in some cases. Results: Six patients (7.69%) developed severe skin and subcutaneous necrosis (erosion or ulceration) on the buttock and vulvae. Five of them recovered from the injuries after heteropathy in less than 2 months. One patient received surgical debridement 4 months after the pelvic chemotherapy, whose wound healed one month later. Conclusion: The causes of the severe complications of pelvic intraarterial therapy were as follows: the infusing chemotherapeutic agent was too large in dosage and too dense in concentration; the infusing time was too short; the internal iliac artery gave off a lot of abnormal skin branches; the catheter was placed too distal in small branches; the embolic pieces was too small; and the development of collateral arteries was poor especially in pretreated patients with pelvic surgery and (or) radiotherapy, etc. Heteropathy should be given in no time when the severe complications were encountered, and surgical debridement and (or) skin grafting was a need in some cases. So the interventional performers should be familiar with pelvic arteriograms to select the proper location of catheter, administer the suitable dosage of

  3. Adalimumab treatment in patients with rheumatoid arthritis with renal insufficiency.

    Science.gov (United States)

    Sumida, Keiichi; Ubara, Yoshifumi; Suwabe, Tatsuya; Hayami, Noriko; Hiramatsu, Rikako; Hasegawa, Eiko; Yamanouchi, Masayuki; Hoshino, Junichi; Sawa, Naoki; Takaichi, Kenmei

    2013-03-01

    To elucidate the safety of adalimumab for rheumatoid arthritis (RA) patients with renal insufficiency, including those with end-stage renal disease undergoing hemodialysis. Sixty-five RA patients, including 2 patients undergoing hemodialysis, treated with adalimumab in our hospital from December 1, 2008 to June 30, 2011 were retrospectively analyzed. Renal function was evaluated by the estimated glomerular filtration rate (eGFR) calculated from the Cockcroft-Gault formula at the start and end of followup after adalimumab treatment. The proportion of the patients who discontinued or switched adalimumab treatment and the change of the eGFR were compared between patients with (n = 39) and without (n = 26) renal insufficiency, defined as an eGFR patients who discontinued or switched adalimumab treatment (51.3% versus 50.0%; P = 0.53). The mean ± SD changes of eGFR were from 41.6 ± 13.3 to 43.4 ± 17.9 ml/minute/1.73 m(2) in patients with renal insufficiency and from 83.6 ± 17.5 to 83.0 ± 16.8 ml/minute/1.73 m(2) in patients without renal insufficiency, and the differences in each group were not statistically significant (P = 0.92 and P = 0.78, respectively). No severe infections or other severe adverse events were observed in either group during adalimumab treatment. Our data indicate that adalimumab does not worsen renal function and has no serious adverse events even for RA patients with renal insufficiency, including those undergoing hemodialysis, and suggest that it could be a potential therapeutic option for them. Copyright © 2013 by the American College of Rheumatology.

  4. A vascular necrosis of bone. A complication of agressive therapy for acute lymphoblastic leukemia

    Energy Technology Data Exchange (ETDEWEB)

    Vaidya, S.; Saika, S.; Sirohi, B.; Pai, S.; Advani, S. [Tata Memorial Hospital, Bombay (India). Dept. of Medical Oncology

    1998-09-01

    The purpose of the present paper was to report cases of avascular necrosis of bone (AVNB) arising as a complication of chemotherapy for acute lymphoblastic leukemia (ALL). X-rays and {sup 99m}technicium-MDP bone scans were performed on patients with symptoms of bone pain, whereby five patients out of 850 patients were detected to have avascular necrosis of the femoral head. All had received aggressive chemotherapy with steroids. Two patients were still on therapy for the primary disease. In these patients further chemotherapy was continued without steroids. The medium period from diagnosis of ALL to development of AVNB was 29 months. Three patients underwent corrective surgical procedures. To conclude, the data suggest that patients receiving combination chemotherapy, especially those with high cumulative doses, run a risk of developing AVNB. Awarness of this complication is important in order to have an early diagnosis so as to limit disability. (orig.)

  5. A vascular necrosis of bone. A complication of agressive therapy for acute lymphoblastic leukemia

    International Nuclear Information System (INIS)

    Vaidya, S.; Saika, S.; Sirohi, B.; Pai, S.; Advani, S.

    1998-01-01

    The purpose of the present paper was to report cases of avascular necrosis of bone (AVNB) arising as a complication of chemotherapy for acute lymphoblastic leukemia (ALL). X-rays and 99m technicium-MDP bone scans were performed on patients with symptoms of bone pain, whereby five patients out of 850 patients were detected to have avascular necrosis of the femoral he[. All h[ received aggressive chemotherapy with steroids. Two patients were still on therapy for the primary disease. In these patients further chemotherapy was continued without steroids. The medium period from diagnosis of ALL to development of AVNB was 29 months. Three patients underwent corrective surgical procedures. To conclude, the data suggest that patients receiving combination chemotherapy, especially those with high cumulative doses, run a risk of developing AVNB. Awarness of this complication is important in order to have an early diagnosis so as to limit disability. (orig.)

  6. [Application of antihelicobacter therapy in patients, suffering pyloroduodenal zone ulcers, complicated by hemorrhage].

    Science.gov (United States)

    Iaroshenko, K O

    2012-02-01

    There were examined 113 patients, suffering pyloroduodenal zone ulcers, complicated by an acute hemorrhage. H. pylori was revealed in 108 (96%) patients. To escape a false-negative results a serological method was applied, which was used to determine a content of IgG antibodies to H. pylori with the help of diagnostic panel GastroPanel (Biohit PLc firm, Finland). The H. pylori presence in patients must be considered as a risk factor for the early recurrent hemorrhage occurrence. A timely conducted examination, determination of H. pylori and timely prescription of antihelicobacter therapy promote the improvement of the treatment results in patients, suffering gastroduodenal ulcers, complicated by an acute hemorrhage due to reduction of the occurrence rate of early recurrence of hemorrhage.

  7. Investigation of rectal complication after RALS-therapy for uterine cervix cancer using multivariate analysis

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Suzuki, Takaichiro

    1983-01-01

    Rectal injury is one of the major side effects after radiation therapy for carcinoma of the uterine cervix. According to our previous reports, the cases of rectal complication were mainly related to the measured rectal dose in half of patients, and the other causes were related to the following factors; such as diabetes mellitus, hemorrhagic tendency, syphilis and so on. Concerning to rectal complication, these factors were investigated by means of the discriminant analysis, one of the multivariate analyses, in this paper. Twenty-eight factors as to radiation dose, laboratory tests and physical condition of patients were analyzed. From August 1978 through January 1980, 52 cases of previously untreated carcinoma of the uterine cervix were treated using RALS, remotely controlled high dose rate intracavitary radiotherapy, at our department. The data from 49 out of 52 cases were available for the discriminant analysis. By m eans of this analysis, it was found that these factors, such as the dose of whole pelvic irradiation, Point A dose of RALS, measured rectal dose by RALS, WGC-Z and TPHA were important factors for occurence of rectal complication. According to the discriminant score, 46 out of 49 cases (94 %) could be correctly discriminated. There were two cases of false positive and one false negative. Form February 1980 through July 1980, 27 cases of previously untreated carcinoma of the uterine cervix were treated at our department. The obtained discriminant function was applied to these 27 cases, and 24 out of 27 cases (89 %) were correctly predicted. There were two cases of false positive, and one of false negative. Discriminant analysis is useful for the prediction of rectal complication after radiation therapy for carcinoma of the uterine cervix. (J.P.N.)

  8. The relationship between cerebrovascular complications and previously established use of antiplatelet therapy in left-sided infective endocarditis

    DEFF Research Database (Denmark)

    Snygg-Martin, Ulrika; Rasmussen, Rasmus Vedby; Hassager, Christian

    2011-01-01

    Cerebrovascular complications (CVC) in infective endocarditis (IE) are common. The only established treatments to reduce the incidence of CVC in IE are antibiotics and in selected cases early cardiac surgery. Potential effects of previously established antiplatelet therapy are under debate....

  9. SMART Syndrome: Case report of a rare complication after cerebral radiation therapy

    International Nuclear Information System (INIS)

    Truntzer, P.; Salze, P.; Monjour, A.; Gaultier, C.; Ahle, G.; Guillerme, F.; Boutenbat, G.; Atlani, D.; Stilhart, B

    2012-01-01

    The authors report a 71-year-old woman case who developed, 7 years after a cerebral radiation therapy for a parieto-occipital glioblastoma, a stroke-like migraine attacks after radiotherapy syndrome (SMART syndrome), a rare complication characterized by reversible neurologic deficits with migraine described after cerebral irradiation. Transient gyri-form reversible enhancement is found on MRI during crises. This case report allows discussing the clinical, iconographic presentation and the clinical outcome of this syndrome at the light of the literature publication. (authors)

  10. New thoughts on the treatment of common complications of advanced liver cancer by external therapy of traditional Chinese medicine

    OpenAIRE

    PAN Shasha

    2017-01-01

    Cancerous pain, hepatic ascites and intractable hiccups are common complications in patients with advanced liver cancer, but clinical symptomatic treatment cannot achieve satisfactory results. This article reviews the application of external therapy of traditional Chinese medicine in the treatment of common complications in patients with advanced liver cancer and analyzes the clinical effect and feasibility of common therapeutic methods used in treatment, such as plaster sticking therapy, tum...

  11. An Alternative Treatment Strategy for Complicated Chronic Wounds: Negative Pressure Therapy over Mesh Skin Graft

    Directory of Open Access Journals (Sweden)

    Michele Maruccia

    2017-01-01

    Full Text Available Extensive skin defect represents a real problem and major challenge in plastic and reconstructive surgery. On one hand, skin grafts offer a practical method to deal with skin defects despite their unsuitability for several complicated wounds. On the other hand, negative pressure wound therapy (NPWT, applied before skin grafting, promotes granulation tissue growth. The aim of the study is to evaluate the improvement in wound healing given by the merger of these two different approaches. We treated 23 patients for large wounds of multiple factors. Of these, 15 were treated with the application of V.A.C.® Therapy (KCI Medical S.r.l., Milan, Italy, in combination with skin grafts after a prior unsuccessful treatment of 4 weeks with mesh skin grafts and dressings. Another 8 were treated with only mesh skin graft. Pain reduction and wound area reduction were found statistically significant (p<0.0009, p<0.0001. Infection was resolved in almost all patients. According to our study, the use of the negative pressure wound therapy over mesh skin grafts is significantly effective especially in wounds resistant to conventional therapies, thereby improving the rate of skin graft take.

  12. Three cases of dysphagia as a late complication after radiation therapy for nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Mesuda, Yasushi; Dohsaka, Yoshihiro; Honma, Akihiro; Nishizawa, Noriko; Oridate, Nobuhiko; Furuta, Yasushi; Fukuda, Satoshi

    2006-01-01

    Our experience of 3 cases with dysphagia due to cranial nerve palsy as a late complication after radiation therapy for nasopharyngeal carcinoma (NPC) is herein reported. The cases consisted of two males and one female, ranging in age from 20 to 41 years old at the time of radiation therapy. Two cases received conventional radiation therapy alone while one case was given a combination of chemotherapy and radiotherapy. All patients began to suffer from dysphagia from eight to fifteen weeks after the therapy. All cases had bilateral hypoglossal nerve palsy with several sensory and motor disturbances of the pharynx and larynx. The method of intermittent oral-esophageal tube feeding was performed in one case, however, the other one case had to undergo a total laryngectomy in order to prevent aspiration pneumonia. Recently, the combination of chemotherapy and radiotherapy is frequently performed in order to improve prognosis of NPC. As a result, the occurrence of dysphagia associated with this therapeutic regimen and caused by a late disturbance of the cranial nerve may therefore increase in future. (author)

  13. [Rupture of the spleen and acute pancreatitis after ESWL therapy: a rare complication].

    Science.gov (United States)

    Kastelan, Z; Derezic, D; Pasini, J; Stern-Padovan, R; Skegro, M; Mrazovac, D; Sosic, H

    2005-11-01

    ESWL is a safe and efficient method in the therapy of urolithiasis which, however, is not free of complications. ESWL was performed in a 54-year-old patient with a stone of 18 mm in size located in one of the upper calyces of the left kidney. Several hours after the ambulatory ESWL treatment the patient was admitted to the emergency room with strong pain in the left lumbar region and the upper abdomen. During examination low blood pressure, tachycardia and low Hb levels were found. Ultrasound and CAT scans revealed a subcapsular rupture of the spleen. Surgery was indicated, and a laparotomy with splenectomy was performed. Ten days after surgery the patient developed acute pancreatitis which was treated conservatively with success. Although ESWL is a safe method in the treatment of urinary stones with a relatively small number of complications, rare complications like ruptures of the spleen have to be considered. Special attention should be given to patients with kidney stones in the left upper calyces, pathological growth of the spleen, and accompanying diseases such as chronic heart failure or hypertension. In such patients ESWL should not be performed on an outpatient basis.

  14. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Kimball, A.B.; Kerdel, F.; Adams, D.

    2012-01-01

    Background: Hidradenitis suppurativa (HS) is a chronic, painful skin disease characterized by abscesses, nodules, and draining fistulas in the axilla and groin of young adults. Objective: To evaluate the efficacy and safety of adalimumab, an anti-tumor necrosis factor-αantibody, in patients......, respectively (EOW vs. placebo difference, 1.8% [CI,- 6.4% to 10.1%]; weekly vs. placebo difference, 3.9% [CI,- 5.2% to 13.0%]). Significantly greater improvements in patient-reported outcomes and pain were seen in the weekly dosing group than in the placebo group. A decrease in response was seen after...... the switch from weekly to EOW dosing in period 2. Limitations: Weeks 16 to 52 of the study were open-label. The study was not powered to assess the risk for known serious adverse effects of adalimumab, such as tuberculosis, other serious infections, and demyelinating disorders. Conclusion: Adalimumab dosed...

  15. The relationship between technical parameters of external beam radiation therapy and complications for localized prostate cancer

    International Nuclear Information System (INIS)

    Kitamura, Kei; Shirato, Hiroki; Suzuki, Keishiro

    2000-01-01

    This study was performed to review retrospectively the clinical course of chronic rectal bleeding as a complication of external beam radiation therapy for localized prostate cancer and to analyze the relationship between technical parameters of radiation therapy and the complications. Seventy-one patients with stages A2, B and C were treated with local-field radiotherapy (total dose 52.5-66 Gy, daily dose 2.0-3.28 Gy, field area 30-81 cm 2 , number of fields 3-15 ports, planning simulations X-ray or CT-based) between 1989 and 1998 at three institutions. The protocols were consistent during this same period at these institutions. Multivariate analysis revealed pretreatment PSA and Gleason sum to be statistically significant predictors of 5 year prostatic specific antigen (PSA) relapse-free rates in a median follow-up period of 42 months (range 12-119 months). The significant risk factors for higher grading of acute morbidity were a biological equivalent dose, α/β=10 (BED 10 ) ≥65 Gy, dose per fraction ≥3.0 Gy, field area ≥42 cm 2 , fewer ports and X-ray planning simulation. However, no parameter was associated with higher grading of late morbidity. Eleven patients (15.4%) experienced a late GI complication: grade 1 (4.2%), grade 2 (9.8%), grade 3 (1.4%). The median time to occurrence of rectal bleeding was 12 months after radiotherapy and the mean duration of morbidity was 11 months. Higher total dose and dose per fraction, larger field area, fewer ports and X-ray simulation increased the grades of acute morbidity. A majority of chronic rectal bleedings were transient and responded to conservative treatment. (author)

  16. Low rate of infectious complications following immunoadsorption therapy without regular substitution of intravenous immunoglobulins.

    Science.gov (United States)

    Tselmin, Sergey; Julius, Ulrich; Bornstein, Stefan R; Hohenstein, Bernd

    2017-11-01

    Immunoadsorption (IA) is increasingly used instead of plasma exchange due to lower risk of side effects and a higher selectivity. As a consequence of the reduction of immunoglobulins (Ig), the rate of infectious complications might increase in those patients. We therefore aimed to investigate the infection rate following IA without intravenous IG (IVIG) substitution in our apheresis center, where patients do not receive IVIG on a regular basis. We conducted a retrospective analysis of the IA treatments performed between 2010 and 2015 without IVIG substitution and collected data on patient age, diagnosis, number of IA treatments, serum levels of Ig, total protein, albumin, C-reactive protein (CRP) and infectious complications that occurred within 2 months after the IA treatment cycle. A total number of 52 patients (27 females) received at least 5 IA sessions using the following adsorbers: TheraSorb™-Ig (n = 3), TheraSorb™-Ig flex (n = 44), TheraSorb™ Ig pro (n = 1) and TheraSorb™-IgE (n = 5). The median number of treatment sessions was 8.8 [range 5-16], the median IgG reduction was 82 [11-99] %. Serum albumin was decreased by 8%. The median CRP levels remained normal until the end of therapy and within 2 months after that (3.10 and 4.30 mg/L respectively). Only 4 patients had infections (7.7%). Three of them received additional immunosuppressive therapy. Immunoadsorption leads to a significant reduction of IgG. CRP as inflammatory marker is not affected. Even without substitution of IVIG the complication rate directly linked with IA is low and questionable. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis.

    Science.gov (United States)

    Ramanan, Athimalaipet V; Dick, Andrew D; Jones, Ashley P; McKay, Andrew; Williamson, Paula R; Compeyrot-Lacassagne, Sandrine; Hardwick, Ben; Hickey, Helen; Hughes, Dyfrig; Woo, Patricia; Benton, Diana; Edelsten, Clive; Beresford, Michael W

    2017-04-27

    Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis. In this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either adalimumab (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every 2 weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. They were followed for up to 2 years after randomization. The primary end point was the time to treatment failure, defined according to a multicomponent intraocular inflammation score that was based on the Standardization of Uveitis Nomenclature criteria. The prespecified stopping criteria were met after the enrollment of 90 of 114 patients. We observed 16 treatment failures in 60 patients (27%) in the adalimumab group versus 18 treatment failures in 30 patients (60%) in the placebo group (hazard ratio, 0.25; 95% confidence interval [CI], 0.12 to 0.49; Ptreatment failure than placebo among children and adolescents with active JIA-associated uveitis who were taking a stable dose of methotrexate. Patients who received adalimumab had a much higher incidence of adverse events and serious adverse events than those who received placebo. (Funded by the NIHR Health Technology Assessment Programme and Arthritis Research UK; SYCAMORE EudraCT number, 2010-021141-41 .).

  18. New thoughts on the treatment of common complications of advanced liver cancer by external therapy of traditional Chinese medicine

    Directory of Open Access Journals (Sweden)

    PAN Shasha

    2017-12-01

    Full Text Available Cancerous pain, hepatic ascites and intractable hiccups are common complications in patients with advanced liver cancer, but clinical symptomatic treatment cannot achieve satisfactory results. This article reviews the application of external therapy of traditional Chinese medicine in the treatment of common complications in patients with advanced liver cancer and analyzes the clinical effect and feasibility of common therapeutic methods used in treatment, such as plaster sticking therapy, tumor thermotherapy, interventional therapy combined with traditional Chinese medicine, and sonophoresis of traditional Chinese medicine.

  19. Laser therapy in women genital Chlamydia trachomatis infection complicated with PID and infertility

    Science.gov (United States)

    Brinzan, Daniela; Paiusan, Lucian; Smeu, Claudia-Ramona

    2018-04-01

    Genital Chlamydia Trachomatis infection is one of the most common sexually transmitted infections with more than 50 million new cases occurred globally every year. Underdiagnosed and untreated, it can generate long term severe complications including PID, infertility, ectopic pregnancy and chronic pelvic pain. Among 20 patients diagnosed with PID and infertility in our medical office during one year, we selected a study group of 10 patients with genital Chlamydia Trachomatis infection. The diagnostic methods used were anamnesis, clinical examination, Pap smear, bacteriological and serological tests, ultra sound examination. The group of patients selected was monitored for one year. The treatment took into account general measures for both partners and specific measures (antibiotic treatment and focused laser therapy). The initial group was split in two, group A treated only with antibiotics and group B treated with both antibiotics and laser therapy. All the 5 patients of group B presented an improvement of the clinical manifestations and 3 of them ended up with pregnancy. On the other hand, in group B, only one patient manifested total disappearance of pains and the infertility persisted for all. It is noteworthy that the association of laser therapy in the treatment of Chlamydia Trachomatis infection has brought significant improvement in the inflammatory processes of internal genitalia (PID) and in the fertility of the couple.

  20. Antibodies Against Infliximab Are Associated with De Novo Development of Antibodies to Adalimumab and Therapeutic Failure in Infliximab-to-Adalimumab Switchers with IBD

    DEFF Research Database (Denmark)

    Frederiksen, Madeline Therese; Ainsworth, Mark Andrew; Brynskov, Jørn

    2014-01-01

    BACKGROUND: A notable proportion of patients with inflammatory bowel disease (IBD) are switched from infliximab (IFX) to adalimumab (ADL). We investigated if immunogenicity of IFX influenced immunogenicity and clinical outcomes of later ADL therapy. METHODS: Single-center cohort study including all...... patients with IBD assessed for antibodies (Abs) against IFX or ADL. RESULTS: Anti-IFX Abs were evaluated in 187 patients treated with IFX as first line anti-TNF agent. Approximately, half (49%) were positive. Detected anti-IFX Abs had functional capacity as judged by a median IFX concentration below limit...... of detection (interquartile range, 0.0-0.0 μg/mL) versus 3.8 μg/mL (IQR, 1.3-7.9) in anti-IFX Ab-negative patients, P tested positive. Patients with previous anti-IFX Ab development were...

  1. Chalazia development in multiple myeloma: a new complication associated with bortezomib therapy

    Directory of Open Access Journals (Sweden)

    Charles Yun

    2015-06-01

    Full Text Available Multiple myeloma (MM is a neoplasm of plasma cells within the bone marrow. A major impact on improving survival in MM has been the use of the boronic acid-derived proteasome inhibitor bortezomib, a first-in-class selective inhibitor of the 26S proteasome. Ocular side effects of bortezomib are rare. In this report, we present 2 patients with active MM in whom persistent chalazia became a therapy-interfering complication of treatment with bortezomib. Both patients had relapsed ISS III B kappa light chain myeloma, and they were responding to treatment with bortezomib until chalazia − which caused intolerable discomfort − started. In both patients discontinuation of bortezomib was necessary for chalazia to heal, and restarting of bortezomib was associated with relapse of chalazia.

  2. Hyperbaric oxygenation therapy for crush injuries reduces the risk of complications: research report.

    Science.gov (United States)

    Yamada, Noriaki; Toyoda, Izumi; Doi, Tomoaki; Kumada, Keisuke; Kato, Hisaaki; Yoshida, Shozo; Shirai, Kunihiro; Kanda, Norihide; Ogura, Shinji

    2014-01-01

    Hyperbaric oxygen (HBO2) therapy has been adopted for crush injuries, but there are few studies supporting its use. We therefore investigated the effects of HBO2 on management of patients with complicated crush injuries. This historic cohort study included patients with crush injuries and open fractures with severities greater than or equal to Gustilo class IIIA. We divided the patients into two groups: Control and HBO2. The control group received conventional treatment, while the HBO2 group received conventional treatment plus HBO2. We compared the groups with respect to the incidence of infection, need for additional surgery, and length of intensive care unit (ICU) and hospital stays. There were 16 patients in the HBO2 group and 13 in the control group. There were no patients with infections in the HBO2 group, whereas in the control group six patients had infections and five needed another drainage procedure. These incidences were significantly lower in the HBO2 group (p = 0.003 and 0.013). However, the durations of ICU and hospital stays were similar across the two groups. HBO2 is effective in the management of crush injuries from the viewpoint of reducing complications and reoperations. These observations should be verified in additional studies with larger sample sizes because the patient number is limited.

  3. PRES (posterior reversible encephalopathy syndrome), a rare complication of tacrolimus therapy.

    LENUS (Irish Health Repository)

    Hodnett, P

    2009-11-01

    With increasing numbers of solid organ and hematopoietic stem cell transplantations being performed, there have been significant increases in the use of immunosuppressive agents such as cyclosporine and tacrolimus. Posterior reversible encephalopathy syndrome (PRES) is a serious complication of immunosuppressive therapy use following solid organ or stem cell transplants. Clinical findings including headache, mental status changes, focal neurological deficits, and\\/or visual disturbances. Associated with these are characteristic imaging features of subcortical white matter lesions on computed tomography (CT) or magnetic resonance imaging (MRI). The changes in the subcortical white matter are secondary to potentially reversible vasogenic edema, although conversion to irreversible cytotoxic edema has been described. These imaging findings predominate in the territory of the posterior cerebral artery. Many studies have shown that the neurotoxicity associated with tacrolimus may occur at therapeutic levels. In most cases of PRES, the symptom complex is reversible by reducing the dosage or withholding the drug for a few days. While PRES is an uncommon complication, it is associated with significant morbidity and mortality if it is not expeditiously recognized. MRI represents the most sensitive imaging technique for recognizing PRES. This report highlights the value of MRI in prompt recognition of this entity, which offers the best chance of avoiding long-term sequelae.

  4. Two phase 3 trials of adalimumab for hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Kimball, Alexa Boer; Okun, Martin; Williams, David A

    2016-01-01

    BACKGROUND Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor á, showed efficacy against hidradenitis suppurativa. METHODS PIONEER I and II were similarly desi...

  5. Efficacy and safety of adalimumab in ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Mounach A

    2014-08-01

    Full Text Available Aziza Mounach, Abdellah El MaghraouiRheumatology Department, Military Hospital Mohammed V, Rabat, MoroccoAbstract: Ankylosing spondylitis (AS is the most common and most severe subtype of spondyloarthritis. It also may be an outcome of any of the other spondyloarthritis subtypes. AS preferentially affects the sacroiliac joints and the tip of the column, with a tendency to later ankylosis. Peripheral joints, enthesis, and other extra-articular involvement may be observed. Tumor necrosis factor (TNF inhibitors are now well-established, effective drugs in the treatment of AS symptoms. Adalimumab, which is a fully human monoclonal antibody that binds to and neutralizes TNF, has demonstrated efficacy in treating AS symptoms, including axial involvement, peripheral arthritis, enthesitis, uveitis, gut involvement, and psoriasis. Furthermore, adalimumab has showed an overall acceptable safety profile. In this paper, we review the efficacy and safety profile of adalimumab in the treatment of AS, and discuss its differences from the other anti-TNF drugs reported in the literature.Keywords: ankylosing spondylitis, spondyloarthritis, adalimumab, tumor necrosis factor-α

  6. Long-term treatment of rheumatoid arthritis with adalimumab

    Directory of Open Access Journals (Sweden)

    Murdaca G

    2013-05-01

    Full Text Available Giuseppe Murdaca, Francesca Spanò, Francesco PuppoDepartment of Internal Medicine, Clinical Immunology Unit, University of Genoa, Genoa, ItalyAbstract: Rheumatoid arthritis (RA is a chronic inflammatory disease that is associated with joint damage and progressive disability, an increased risk of morbidity related to comorbid conditions and substantial socioeconomic costs. Tumor necrosis factor-alpha (TNF-α is a proinflammatory cytokine known to have a central role in the initial host response to infection and in the pathogenesis of various immune-mediated diseases, such as RA, ankylosing spondylitis, psoriasis and/or psoriatic arthritis, Crohn’s disease, and systemic lupus erythematosus. Five TNF-α inhibitors are available for the clinical use: infliximab; adalimumab; etanercept; golimumab; and certolizumab pegol. Infliximab is a chimeric human/murine IgG1 monoclonal antibody (mAb; adalimumab, and golimumab are human mAbs; certolizumab pegol is composed of the fragment antigen-binding anti-binding domain of a humanized anti-TNF-α mAb, combined with polyethylene glycol to increase its half-life in the body; etanercept is a fusion protein that acts as a “decoy receptor” for TNF-α. In this paper, we will briefly review the current data on efficacy and safety of adalimumab in patients with RA, its potential beneficial effects upon comorbid conditions, such as endothelial dysfunction and accelerated atherosclerosis in RA, and the immunogenicity.Keywords: adalimumab, efficacy, safety, rheumatoid arthritis, VEGF, immunogenicity, infections

  7. Treatment changes in patients with psoriasis on etanercept or adalimumab

    DEFF Research Database (Denmark)

    Lee, Erica B; Amin, Mina; Egeberg, Alexander

    2018-01-01

    PURPOSE: To determine the frequency of and reasons for treatment changes in patients with psoriasis. MATERIALS AND METHODS: A retrospective chart review of 140 patients with psoriasis treated with adalimumab or etanercept seen at Kaiser Permanente Los Angeles Medical Center between September 20, ...

  8. Adalimumab effect in a cohort of Libyan patients with rheumatic ...

    African Journals Online (AJOL)

    Four patients had psoriatic arthritis, mean age was 40 years, two were females and two were males. One patient had AOSD; she was a female aged 58 years. All RA patients were on prednisolone and/or one or two DMARD before starting adalimumab and failed to show a response. Fourteen AS patients were on one or two ...

  9. A medicated polycarboxylate cement to prevent complications in composite resin therapy

    International Nuclear Information System (INIS)

    Okamoto, Y.; Shintani, H.; Yamaki, M.

    1990-01-01

    Preparative treatment is the preferred method to protect the dentin and pulp from complications in composite resin therapy. This study investigated the in vivo effects of the polycarboxylate cement containing zinc fluoride and tannic acid in composite resin restorations. Scanning electron micrographs established that the composite resin failed to contact the axial wall. The gaps varied from 10 to 60 microns. However, this polycarboxylate cement was shown to provide excellent adaptation to dentin when used as a base and its chemical adhesion allowed it to make close contact with the unetched dentin. The newly developed electron probe x-ray microanalyzer revealed that the in vivo penetration of fluoride and zinc occurred through the dentinal tubules. When this polycarboxylate cement was used, the orifices of dentinal tubules were partially occluded, possibly with the smear layer fixed by tannic acid. In addition, by releasing the components, this polycarboxylate cement adds acid resistance to dentin and increases the resistance of dentin collagen to proteolytic enzymes. As such this polycarboxylate cement offers advantages as a base to composite resin therapy

  10. Prediction of transfusion therapy tactics for prophylaxis of early postoperative complications in coronary surgery

    Directory of Open Access Journals (Sweden)

    И. А. Мандель

    2015-10-01

    Full Text Available The study focuses on the tactics of transfusion therapy during coronary artery bypass surgery with cardiopulmonary bypass in patients with left ventricular ejection fraction higher or lower than 40%. To predict the tactics of intraoperative transfusion therapy, hypoxic tests were preoperatively conducted in the main group of patients. A traditional approach to blood transfusion was applied in the control group of patients. The analysis of clinical and laboratory data, hemodynamics and oxygen balance, as well as follow-up data allowed to prove the possibility of decreasing allogenic blood use by 48.8% (p = 0,02. Based on the hypoxic test data, criteria for lowering the intraoperative trigger hemoglobin level down to 70 g/l, including the patients with a low left ventricular ejection fraction. It was shown that our tactics of trigger hemoglobin level calculation allows for reducing artificial lung ventilation time, frequency of gastrointestinal complications, multiple organ failure, as well as duration of stay at ICU.

  11. The causes and the nursing interventions of the complications due to repeated embolization therapy for huge cerebral arteriovenous malformations

    International Nuclear Information System (INIS)

    Sun Lingfang; Sun Ge

    2010-01-01

    Objective: To investigate the causes of the complications occurred after repeated embolization therapy for huge cerebral arteriovenous malformations and to discuss their nursing interventions. Methods: A total of 54 embolization procedures were performed in 17 patients with huge cerebral arteriovenous malformations. The clinical data were retrospectively analyzed. The causes of complications were carefully examined and the preventive measures were discussed. The prompt and necessary nursing interventions were formulated in order to prevent the complications or serious consequences. Results: Among the total 17 patients, one patient gave up the treatment because of the cerebral hemorrhage which occurred two months after receiving 3 times of embolization therapy. One patient experienced cerebral vascular spasm during the procedure, which was relieved after antispasmodic medication and no neurological deficit was left behind. Two patients developed transient dizziness and headache, which were alleviated spontaneously. One patient presented with nervousness, fear and irritability, which made him hard to cooperate with the operation and the basis intravenous anesthesia was employed. No complications occurred in the remaining cases. Conclusion: The predictive nursing interventions for the prevention of complications are very important for obtaining a successful repeated embolization therapy for huge cerebral arteriovenous malformations, which will ensure that the patients can get the best treatment and the complications can be avoided. (authors)

  12. Relationship between XRCC1 polymorphism and acute complication of chemoradiation therapy in the patients with colorectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Woo Chul; Choi, Sun Keun [Inha University College of Medicine, Incheon (Korea, Republic of); Hong, Yun Chul [Seoul National University College of Medicine, Seoul (Korea, Republic of)] (and others)

    2006-03-15

    It is well known from clinical experience that acute complications of chemoradiation therapy vary from patients to patients. However, there are no known factors to predict these acute complications before treatment starts. The human XRCC1 gene is known as a DNA base excision repair gene. We investigated the possibilities of XRCC1 gene polymorphisms as a predictor for the acute complications of chemoradiation therapy in colorectal cancer patients. From July 1997 to June 2003, 86 colorectal cancer patients (71 rectal cancer, 13 sigmoid colon cancer and 2 colon cancer patients) were treated with chemoradiation therapy at the Department of Radiation Oncology, Inha University Hospital. Twenty-two patients were in stage B, 50 were in stage C, 8 were in stage D and 6 patients were unresectable cases. External radiation therapy was delivered with 10MV X-ray at a 1.8 Gy fraction per day for a total dose of radiation of 30.6 {approx} 59.4 Gy (median: 54 Gy). All the patients received 5-FU based chemotherapy regimen. We analyzed the acute complications of upper and lower gastrointestinal tract based on the RTOG complication scale. The initial and lowest WBC and platelet count were recorded during both the RT period and the whole treatment period. Allelic variants of the XRCC1 gene at codons 194, 280 and 399 were analyzed in the lymphocyte DNA by performing PCR-RFLP. Statistical analyses were carried out with the SAS (version 6.12) statistical package. When all the variables were assessed on the multivariate analysis, recurrent disease revealed the factors that significantly correlated with upper gastrointestinal acute complications. Arg399Gln polymorphisms of the XRCC1 gene, the radiation dose and the frequencies of chemotherapy during radiation therapy were significantly correlated with lower gastrointestinal complications. Arg399Gln polymorphisms also affected the decrease of the WBC and platelet count during radiation therapy. Although the present sample size was too small

  13. Relationship between XRCC1 polymorphism and acute complication of chemoradiation therapy in the patients with colorectal cancer

    International Nuclear Information System (INIS)

    Kim, Woo Chul; Choi, Sun Keun; Hong, Yun Chul

    2006-01-01

    It is well known from clinical experience that acute complications of chemoradiation therapy vary from patients to patients. However, there are no known factors to predict these acute complications before treatment starts. The human XRCC1 gene is known as a DNA base excision repair gene. We investigated the possibilities of XRCC1 gene polymorphisms as a predictor for the acute complications of chemoradiation therapy in colorectal cancer patients. From July 1997 to June 2003, 86 colorectal cancer patients (71 rectal cancer, 13 sigmoid colon cancer and 2 colon cancer patients) were treated with chemoradiation therapy at the Department of Radiation Oncology, Inha University Hospital. Twenty-two patients were in stage B, 50 were in stage C, 8 were in stage D and 6 patients were unresectable cases. External radiation therapy was delivered with 10MV X-ray at a 1.8 Gy fraction per day for a total dose of radiation of 30.6 ∼ 59.4 Gy (median: 54 Gy). All the patients received 5-FU based chemotherapy regimen. We analyzed the acute complications of upper and lower gastrointestinal tract based on the RTOG complication scale. The initial and lowest WBC and platelet count were recorded during both the RT period and the whole treatment period. Allelic variants of the XRCC1 gene at codons 194, 280 and 399 were analyzed in the lymphocyte DNA by performing PCR-RFLP. Statistical analyses were carried out with the SAS (version 6.12) statistical package. When all the variables were assessed on the multivariate analysis, recurrent disease revealed the factors that significantly correlated with upper gastrointestinal acute complications. Arg399Gln polymorphisms of the XRCC1 gene, the radiation dose and the frequencies of chemotherapy during radiation therapy were significantly correlated with lower gastrointestinal complications. Arg399Gln polymorphisms also affected the decrease of the WBC and platelet count during radiation therapy. Although the present sample size was too small for

  14. An autopsy case of fatal acute peritonitis complicated by illegal acupuncture therapy.

    Science.gov (United States)

    Kim, DongJa; Lee, SangHan

    2017-07-01

    Acupuncture is an alternative medical therapy and widely practiced in Northeast Asia. Although it is known as a safe procedure, complications including infection, pneumothorax, hemorrhage, and cardiac tamponade have been reported. The authors present a rare case of fatal acute peritonitis due to penetration of acupuncture needles directly into the abdominal and pelvic cavity. The victim was a 55-year-old woman who had a recent history of chemo-radiotherapy due to breast cancer. She was collapsed three days after receiving acupuncture. She had symptoms of fever and chilling sensation, general myalgia, and vomiting during three days. The autopsy revealed several needle marks in the lower abdomen and 180ml of bloody exudate in the abdominal cavity. There was no visible intestinal perforation, but hemorrhagic foci in the mesentery and paracolic area of sigmoid colon were noted. The deepest portion was 13.5cm from the needle marks on the abdominal skin. The practitioner had not a Chinese medical license. He was accused of illegal medical practice and manslaughter. Acute peritonitis associated with acupuncture might be caused by inadequate sterilization of skin and needle itself and/or direct mesentery injury. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Dichorionic triamniotic triplet pregnancy complicated by twin anemia polycythemia sequence: the place of fetal therapy.

    Science.gov (United States)

    Griersmith, Thérèse H; Fung, Alison M; Walker, Susan P

    2014-12-01

    Monochorionic twins as part of a high order multiple pregnancy can be an unintended consequence of the increasingly common practice of blastocyst transfer for couples requiring in vitro fertilisation (IVF) for infertility. Dichorionic triamniotic (DCTA) triplets is the most common presentation, and these pregnancies are particularly high risk because of the additional risks associated with monochorionicity. Surveillance for twin-to-twin transfusion syndrome, including twin anemia polycythemia sequence, may be more difficult, and any intervention to treat the monochorionic pair needs to balance the proposed benefits against the risks posed to the unaffected singleton. Counseling of families with DCTA triplets is therefore complex. Here, we report a case of DCTA triplets, where the pregnancy was complicated by threatened preterm labour, and twin anemia polycythemia sequence (TAPS) was later diagnosed at 28 weeks. The TAPS was managed with a single intraperitoneal transfusion, enabling safe prolongation of the pregnancy for over 2 weeks until recurrence of TAPS and preterm labour supervened. Postnatal TAPS was confirmed, and all three infants were later discharged home at term corrected age, and were normal at follow-up. This case highlights that in utero therapy has an important role in multiple pregnancies of mixed chorionicity, and can achieve safe prolongation of pregnancy at critical gestations.

  16. EXPERIENCE OF THE ADALIMUMAB APPLICATION FOR THE PATIENT WITH EARLY DEBUT OF JUVENILE IDIOPATHIC ARTHRITIS AND UVEITIS

    Directory of Open Access Journals (Sweden)

    K. B. Isaeva

    2014-01-01

    Full Text Available The case of early debut and heavy course of juvenile idiopathic arthritis in the patient at the age of 1 year and 8 months, associated with uveitis refractory to the therapy by methotrexate and nonsteroid antiinflammatory preparations is presented. The given clinical example shows high therapeutic efficiency of the adalimumab. To the 8th week of treatment inflammatory changes in conjunctiva were stopped, to the 12th week the stage of inactive illness was registered, i.e. the patient had no inflammatory changes in joints, uveitis activity signs, increase of laboratory indicators of illness activity. Duration of remission of articulate syndrome and uveitis made 9 months.

  17. Radiation-induced brain tumours: potential late complications of radiation therapy for brain tumours

    International Nuclear Information System (INIS)

    Nishio, S.; Morioka, T.; Inamura, T.; Takeshita, I.; Fukui, M.; Sasaki, M.; Nakamura, K.; Wakisaka, S.

    1998-01-01

    The development of neoplasms subsequent to therapeutic cranial irradiation is a rare but serious and potentially fatal complication. In this study, we retrospectively reviewed the clinical and pathological aspects of 11 patients who underwent cranial irradiation (range, 24-110 cGy) to treat their primary disease and thereafter developed secondary tumours within a span of 13 years. All tumours arose within the previous radiation fields, and satisfied the widely used criteria for the definition of radiation-induced neoplasms. There was no sex predominance (M: 5, F: 6) and the patients tended to be young at irradiation (1.3 - 42 years; median age: 22 years). The median latency period before the detection of the secondary tumour was 14.5 years (range: 6.5 - 24 years). Meningiomas developed in 5 patients, sarcomas in 4, and malignant gliomas in 2. A pre-operative diagnosis of a secondary tumour was correctly obtained in 10 patients based on the neuro-imaging as well as nuclear medicine findings. All patients underwent a surgical removal of the secondary tumour, 3 underwent additional chemotherapy, and one received stereotactic secondary irradiation therapy. During a median of 2 years of follow-up review after the diagnosis of a secondary tumour, 3 patients died related to the secondary tumours (2 sarcomas, 1 glioblastoma), one died of a recurrent primary glioma, while the remaining 7 have been alive for from 10 months to 12 years after being treated for the secondary tumours (median: 3 years). Based on these data, the clinicopathological characteristics and possible role of treatment for secondary tumours are briefly discussed. (author)

  18. Severe and acute complications of biologics in psoriasis.

    Science.gov (United States)

    Oussedik, Elias; Patel, Nupur U; Cash, Devin R; Gupta, Angela S; Feldman, Steven R

    2017-12-01

    Biologic therapies have revolutionized the approach to immune-mediated diseases such as psoriasis. Due to their favorable safety profiles and excellent efficacy, biologic agents are considered the gold standard for moderate-to-severe psoriasis. The aim of this paper is to saliently review the severe and acute complications of the Food and Drug Administration (FDA) approved biologic agents for psoriasis. Reviewed agents include tumor necrosis factor alpha inhibitors (etanercept, infliximab, and adalimumab), interleukin 12/23 inhibitors (ustekinumab), and interleukin 17 (IL-17) inhibitors (secukinumab and ixekizumab). While malignancies, serious infections, and major adverse cardiovascular events have been reported, their association with biologic therapy are not hypothesized as causal. However, IL-17 inhibitors appear to cause exacerbations and new cases of inflammatory bowel disease. While more long-term studies are warranted in understanding the biologic's long-term side effect profile, short-term studies have confirmed that the biologics are some of the safest treatment options for psoriasis. Nevertheless, certain populations yield higher risk to acute complications with the biologics than others - physicians must use their judgement and vigilance when monitoring and treating patients undergoing therapy with biological agents.

  19. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial.

    Science.gov (United States)

    Fleischmann, Roy; Mysler, Eduardo; Hall, Stephen; Kivitz, Alan J; Moots, Robert J; Luo, Zhen; DeMasi, Ryan; Soma, Koshika; Zhang, Richard; Takiya, Liza; Tatulych, Svitlana; Mojcik, Christopher; Krishnaswami, Sriram; Menon, Sujatha; Smolen, Josef S

    2017-07-29

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy. Patients were randomly assigned (1:1:1) to receive oral tofacitinib (5 mg twice daily) monotherapy, oral tofacitinib (5 mg twice daily) plus methotrexate, or subcutaneous adalimumab (40 mg every other week) plus methotrexate at 194 centres in 25 countries. Eligible patients received live zoster vaccine at investigators' discretion. The primary endpoint was the proportion of patients who attained an American College of Rheumatology response of at least 50% (ACR50) at month 6 in the full analysis set (patients who were randomly assigned to a group and received at least one dose of the study treatment). Non-inferiority between groups was shown if the lower bound of the 98·34% CI of the difference between comparators was larger than -13·0%. This trial is registered with ClinicalTrials.gov, number NCT02187055. 1146 patients received treatment (384 had tofacitinib monotherapy; 376 had tofacitinib and methotrexate; and 386 had adalimumab and methotrexate). At 6 months, ACR50 response was attained in 147 (38%) of 384 patients with tofacitinib monotherapy, 173 (46%) of 376 patients with tofacitinib and methotrexate, and 169 (44%) of 386 patients with adalimumab and methotrexate. Non-inferiority was declared for tofacitinib and methotrexate versus adalimumab and methotrexate (difference 2% [98·34% CI -6 to 11]) but not for tofacitinib monotherapy versus either adalimumab and methotrexate (-6

  20. Prevention and nursing care of the complications occurred in interventional therapy for arteriosclerosis obliterans of lower extremity

    International Nuclear Information System (INIS)

    Xu Yang; Qi Yuchun; Wang Hua; Han Yajun; Fu Wenli; Fan Rui; Lv Xiaoying

    2009-01-01

    Objective: To discuss the prevention and nursing care of the perioperative complications occurred in interventional therapy for arteriosclerosis obliterans of lower extremity. Methods: During the period of July 2006 to June 2009, interventional treatment for the arteriosclerosis obliterans of lower extremity was performed in 380 cases. The clinical data and complications were reviewed and analyzed, and the prevention and nursing care of the complications were summarized. Results: Complications occurred in 41 cases. During the surgery, vascular rupture or arterial dissection occurred in 5 cases, hypoglycemia reaction in 3 cases and elevation of blood pressure in 2 cases. The complications,which occurred after the treatment,included acute arterial thrombosis (n=3), deep vein thrombosis (n=2), bleeding of different tissues or organs (n=17), acute myocardial infarction (n=2), pseudoaneurysm (n=2), excessive lower limb perfusion syndrome (n=4) and compression sores (n=1). Conclusion: Detailed information of medical history, careful observation of clinical condition, intensive care of patient, adequate preparation of medical materials, seriously handing over the duty to the next shift and taking one's turn on duty, etc. are all the effective measures to prevent and to reduce the occurrence of complications. (authors)

  1. Intramural duodenal hematoma as a complication of therapy with Warfarin: a case report and literature review

    International Nuclear Information System (INIS)

    Faria, Juliano; Pessoa, Roberta; Hudson, Marcelo; Vitoi, Silvio; Villela, Ovidio; Torres, Jose; Paula, Mara Delgado; Bemvindo, Aloisio

    2004-01-01

    We report a case of a patient receiving chronic oral anticoagulant therapy with Warfarin who presented with acute intestinal obstruction. Computed tomography showed intramural duodenal hematoma. Treatment was conservative with correction of the coagulation parameters and observation. This case exemplifies the usefulness of conservative therapy and computed tomography in patients with acute small bowel obstruction receiving anticoagulant therapy. (author)

  2. Multicenter COMPACT study of COMplications in patients with sickle cell disease and utilization of iron chelation therapy.

    Science.gov (United States)

    Jordan, Lanetta; Adams-Graves, Patricia; Kanter-Washko, Julie; Oneal, Patricia A; Sasane, Medha; Vekeman, Francis; Bieri, Christine; Magestro, Matthew; Marcellari, Andrea; Duh, Mei Sheng

    2015-03-01

    Over the past few decades, lifespans of sickle cell disease (SCD) patients have increased; hence, they encounter multiple complications. Early detection, appropriate comprehensive care, and treatment may prevent or delay onset of complications. We collected longitudinal data on sickle cell disease (SCD) complication rates and associated resource utilization relative to blood transfusion patterns and iron chelation therapy (ICT) use in patients aged ≥16 years to address a gap in the literature. Medical records of 254 SCD patients ≥16 years were retrospectively reviewed at three US tertiary care centers. We classified patients into cohorts based on cumulative units of blood transfused and ICT history: ICT (Cohort 1 [C1]), ≥15 units, no ICT (Cohort 2 [C2]), and ≥15 units with ICT (Cohort 3 [C3]). We report SCD complication rates per patient per year; cohort comparisons use rate ratios (RRs). Cohorts had 69 (C1), 91 (C2), and 94 (C3) patients. Pain led to most hospitalizations (76%) and emergency department (ED) (82%) visits. Among transfused patients (C2+C3), those receiving ICT were less likely to experience SCD complications than those who did not (RR [95% CI] C2 vs. C3: 1.33 [1.25-1.42]). Similar trends (RR [95% CI]) were observed in ED visits and hospitalizations associated with SCD complications (C2 vs. C3, ED: 1.94 [1.70-2.21]; hospitalizations: 1.61 [1.45-1.78]), but not in outpatient visits. Although the most commonly reported SCD complication among all patients was pain, patients who received ICT were less likely to experience pain and other complications than those who did not. These results highlight the need for increased patient and provider education on the importance of comprehensive disease management.

  3. IgG4 Production Against Adalimumab During Long Term Treatment of RA Patients

    NARCIS (Netherlands)

    van Schouwenburg, Pauline A.; Krieckaert, Charlotte L.; Nurmohamed, Michael; Hart, Margreet; Rispens, Theo; Aarden, Lucien; Wouters, Diana; Wolbink, Gerrit Jan

    2012-01-01

    A substantial part of rheumatoid arthritis (RA) patients is chronically treated with adalimumab. Some of these patients produce antibodies against adalimumab, which correlate with lower serum drug levels and reduced clinical response. Long term exposure to antigens may result in antigen specific

  4. Optimization of radiation therapy, III: a method of assessing complication probabilities from dose-volume histograms

    International Nuclear Information System (INIS)

    Lyman, J.T.; Wolbarst, A.B.

    1987-01-01

    To predict the likelihood of success of a therapeutic strategy, one must be able to assess the effects of the treatment upon both diseased and healthy tissues. This paper proposes a method for determining the probability that a healthy organ that receives a non-uniform distribution of X-irradiation, heat, chemotherapy, or other agent will escape complications. Starting with any given dose distribution, a dose-cumulative-volume histogram for the organ is generated. This is then reduced by an interpolation scheme (involving the volume-weighting of complication probabilities) to a slightly different histogram that corresponds to the same overall likelihood of complications, but which contains one less step. The procedure is repeated, one step at a time, until there remains a final, single-step histogram, for which the complication probability can be determined. The formalism makes use of a complication response function C(D, V) which, for the given treatment schedule, represents the probability of complications arising when the fraction V of the organ receives dose D and the rest of the organ gets none. Although the data required to generate this function are sparse at present, it should be possible to obtain the necessary information from in vivo and clinical studies. Volume effects are taken explicitly into account in two ways: the precise shape of the patient's histogram is employed in the calculation, and the complication response function is a function of the volume

  5. Delayed complications of surgical and combined therapy of mammary gland cancer

    International Nuclear Information System (INIS)

    Selivanov, I.S.; Bardychev, M.S.

    1984-01-01

    Analysis of complications of surgical and combined (operation+radiotherapy) treatment of 114 patients is carried out. 2-8 years after the treatment various complications were detected in 82 (72.0%) patients, 45(39.6%) of them complained of pains in the arm, 20(17.6%) had limitations of humeral articulation, and 78(68.5%) suffered from upper extremity edema and elephantiasis. The number of complications increased in patients who have undergone radiotherapy and in patients with excessive body mass

  6. Delayed complications of surgical and combined therapy of mammary gland cancer

    Energy Technology Data Exchange (ETDEWEB)

    Selivanov, I.S.; Bardychev, M.S. (Akademiya Meditsinskikh Nauk SSSR, Obninsk. Nauchno-Issledovatel' skij Inst. Meditsinskoj Radiologii)

    1984-01-01

    Analysis of complications of surgical and combined (operation+radiotherapy) treatment of 114 patients is carried out. 2-8 years after the treatment various complications were detected in 82 (72.0%) patients, 45 (39.6%) of them complained of pains in the arm, 20 (17.6%) had limitations of humeral articulation, and 78 (68.5%) suffered from upper extremity edema and elephantiasis. The number of complications increased in patients who have undergone radiotherapy and in patients with excessive body mass.

  7. Rectal complications in carcinoma of the uterine cervix by RALS-therapy

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Harada, Kenji

    1982-01-01

    Between July 1979 and January, 1980, we treated 24 patients with carcinoma of the uterine cervix with RALS-TRON-20B, using the rapid processing system of pretreatment dose calculation. The incidence of rectal complications (3/24) was the same as that of a historical control group (5/28). According to ROC curve analysis, 5 rectal complications were related to the measured rectal dose, not to the point A dose or mg-hrs. Our findings suggest that hemorrhagic tendency, syphilis and diabetes mellitus influence the rectal complications. (author)

  8. Pilot study of the safety and effect of adalimumab on pain, physical function, and musculoskeletal disease in mucopolysaccharidosis types I and II

    Directory of Open Access Journals (Sweden)

    Lynda E. Polgreen

    2017-03-01

    Full Text Available Mucopolysaccharidosis I and II are lysosomal storage disorders that, despite treatment with hematopoietic cell transplantation (HCT and/or enzyme replacement therapy (ERT, continue to cause significant skeletal abnormalities leading to pain, stiffness, physical dysfunction, and short stature. Tumor necrosis factor – alpha (TNF-α is elevated in individuals with MPS I and II and associated with pain and physical dysfunction. Therefore, we evaluated the safety and effects of the TNF-α inhibitor adalimumab in patients with MPS I and II in a 32-week, randomized, double blind, placebo-controlled, crossover study of adalimumab at a dose of 20 mg (weight 15–5° in seven of eight joints in Subject #1 and five of eight joints in Subject #2 (range 7.0° to 52.8°. There was no change in the PPQ, 6MWT, or hand dynamometer. Data from this small pilot study suggest that treatment with adalimumab is safe, tolerable, and may improve ROM, physical function, and possibly pain, in children with MPS I or II. However, additional clinical trials are needed before this therapy should be recommended as part of clinical care.

  9. Cost per remission and cost per response with infliximab, adalimumab, and golimumab for the treatment of moderately-to-severely active ulcerative colitis.

    Science.gov (United States)

    Toor, Kabirraaj; Druyts, Eric; Jansen, Jeroen P; Thorlund, Kristian

    2015-06-01

    To determine the short-term costs per sustained remission and sustained response of three tumor necrosis factor inhibitors (infliximab, adalimumab, and golimumab) in comparison to conventional therapy for the treatment of moderately-to-severely active ulcerative colitis. A probabilistic Markov model was developed. This included an 8-week induction period, and 22 subsequent 2-week cycles (up to 1 year). The model included three disease states: remission, response, and relapse. Costs were from a Canadian public payer perspective. Estimates for the additional cost per 1 year of sustained remission and sustained response were obtained. Golimumab 100 mg provided the lowest cost per additional remission ($935) and cost per additional response ($701) compared with conventional therapy. Golimumab 50 mg yielded slightly higher costs than golimumab 100 mg. Infliximab was associated with the largest additional number of estimated remissions and responses, but also higher cost at $1975 per remission and $1311 per response. Adalimumab was associated with the largest cost per remission ($7430) and cost per response ($2361). The cost per additional remission and cost per additional response associated with infliximab vs golimumab 100 mg was $14,659 and $4753, respectively. The results suggest that the additional cost of 1 full year of remission and response are lowest with golimumab 100 mg, followed by golimumab 50 mg. Although infliximab has the highest efficacy, it did not exhibit the lowest cost per additional remission or response. Adalimumab produced the highest cost per additional remission and response.

  10. Neoadjuvant radiation therapy prior to total mesorectal excision for rectal cancer is not associated with postoperative complications using current techniques.

    Science.gov (United States)

    Milgrom, Sarah A; Goodman, Karyn A; Nash, Garrett M; Paty, Philip B; Guillem, José G; Temple, Larissa K; Weiser, Martin R; Garcia-Aguilar, Julio

    2014-07-01

    Neoadjuvant radiation therapy (RT) downstages rectal cancer but may increase postoperative morbidity. This study aims to quantify 30-day complication rates after total mesorectal excision (TME) using current techniques and to assess for an association of these complications with neoadjuvant RT. Stage I-III rectal cancer patients who underwent TME from 2005 to 2010 were identified. Complications occurring within 30 days after TME were retrieved from a prospectively maintained institutional database of postoperative adverse events. The cohort consisted of 461 patients. Median age was 59 years (range 18-90), and 274 patients (59 %) were male. Comorbid conditions included obesity (n = 147; 32 %), coronary artery disease (n = 83; 18 %), diabetes (n = 65; 14 %), and inflammatory bowel disease (n = 19; 4 %). A low anterior resection (LAR) was performed in 383 cases (83 %), an abdominoperineal resection (APR) was performed in 72 cases (16 %), and a Hartmann's procedure was performed in 6 cases (1 %). Preoperative RT was delivered to 310 patients (67 %; median dose of 50.4 Gy, range 27-55.8 Gy). The 30-day incidence of postoperative mortality was 0.4 % (n = 2), any complication 25 % (n = 117), grade 3 or more complication 5 % (n = 24), intra-abdominal infection 3 % (n = 12), abdominal wound complication 9 % (n = 42), perineal wound complication after APR 11 % (n = 8/72), and anastomotic leak after LAR 2 % (n = 6/383). These events were not associated with neoadjuvant RT. In a cohort undergoing TME using current techniques, neoadjuvant RT was not associated with 30-day postoperative morbidity or mortality.

  11. An indirect comparison and cost per responder analysis of adalimumab, methotrexate and apremilast in the treatment of methotrexate-naïve patients with psoriatic arthritis.

    Science.gov (United States)

    Betts, Keith A; Griffith, Jenny; Friedman, Alan; Zhou, Zheng-Yi; Signorovitch, James E; Ganguli, Arijit

    2016-01-01

    Apremilast was recently approved for the treatment of active psoriatic arthritis (PsA). However, no studies compare apremilast with methotrexate or biologic therapies, so its relative comparative efficacy remains unknown. This study compared the response rates and incremental costs per responder associated with methotrexate, apremilast, and biologics for the treatment of active PsA. A systematic literature review was performed to identify phase 3 randomized controlled clinical trials of approved biologics, methotrexate, and apremilast in the methotrexate-naïve PsA population. Using Bayesian methods, a network meta-analysis was conducted to indirectly compare rates of achieving a ≥20% improvement in American College of Rheumatology component scores (ACR20). The number needed to treat (NNT) and the incremental costs per ACR20 responder (2014 US$) relative to placebo were estimated for each of the therapies. Three trials (MIPA for methotrexate, PALACE-4 for apremilast, and ADEPT for adalimumab) met all inclusion criteria. The NNTs relative to placebo were 2.63 for adalimumab, 6.69 for apremilast, and 8.31 for methotrexate. Among methotrexate-naïve PsA patients, the 16 week incremental costs per ACR20 responder were $3622 for methotrexate, $26,316 for adalimumab, and $45,808 for apremilast. The incremental costs per ACR20 responder were $222,488 for apremilast vs. methotrexate. Among methotrexate-naive PsA patients, adalimumab was found to have the lowest NNT for one additional ACR20 response and methotrexate was found to have the lowest incremental costs per ACR20 responder. There was no statistical evidence of greater efficacy for apremilast vs. methotrexate. A head-to-head trial between apremilast and methotrexate is recommended to confirm this finding.

  12. Extension of a Coronary Intramural Hematoma as a Complication of Early Percutaneous Coronary Intervention after Thrombolytic Therapy

    Directory of Open Access Journals (Sweden)

    Mohamed El-Mawardy

    2013-01-01

    Full Text Available The optimal treatment approach for coronary intramural hematomas has not been well defined, and discussion is limited to scarce data. In addition, the impact of prior thrombolytic therapy in the setting of coronary artery dissections with possible development and/or extension of an intramural hematoma is not well understood. We describe a case of iatrogenic periprocedural dissection of the left anterior descending artery (LAD with development of an intramural hematoma and the extension of this hematoma to the left main (LM and left circumflex (LCX arteries in a middle-aged female, where prior recent thrombolytic therapy may have played a role in its triggering or facilitation of its extension. This case highlights the importance of facilitation of bleeding complications by prior use of thrombolytic therapy not only peripherally but intracoronary too and the use of intravascular ultrasound for both diagnosis, followup, and percutaneous coronary intervention (PCI guidance.

  13. Pneumothorax as a complication of combination antiangiogenic therapy in children and young adults with refractory/recurrent solid tumors.

    Science.gov (United States)

    Interiano, Rodrigo B; McCarville, M Beth; Wu, Jianrong; Davidoff, Andrew M; Sandoval, John; Navid, Fariba

    2015-09-01

    Antiangiogenic agents show significant antitumor activity against various tumor types. In a study evaluating the combination of sorafenib, bevacizumab, and low-dose cyclophosphamide in children with solid tumors, an unexpectedly high incidence of pneumothorax was observed. We evaluated patient characteristics and risk factors for the development of pneumothorax in patients receiving this therapy. Demographics, clinical course, and radiographic data of 44 patients treated with sorafenib, bevacizumab and cyclophosphamide were reviewed. Risk factors associated with the development of pneumothorax were analyzed. Pneumothorax likely related to study therapy developed in 11 of 44 (25%) patients of whom 33 had pulmonary abnormalities. Median age of patients was 14.7 years (range, 1.08-24.5). Histologies associated with pneumothorax included rhabdoid tumor, synovial sarcoma, osteosarcoma, Ewing sarcoma, Wilms tumor, and renal cell carcinoma. Cavitation of pulmonary nodules in response to therapy was associated with pneumothorax development (Ppneumothorax was 5.7 weeks (range, 2.4-31). The development of cavitary pulmonary nodules in response to therapy is a risk factor for pneumothorax. As pneumothorax is a potentially life-threatening complication of antiangiogenic therapy in children with solid tumors, its risk needs to be evaluated when considering this therapy. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Evaluation of long-term cosmetic results and complications following breast conserving surgery and radiation therapy for breast cancer

    International Nuclear Information System (INIS)

    Fujishiro, Satsuki; Mitsumori, Michihide; Kokubo, Masaki; Nagata, Yasushi; Sasai, Keisuke; Hiraoka, Masahiro; Kodama, Hiroshi

    1999-01-01

    Long-term cosmetic outcomes and complications were evaluated in 109 patients with breast cancer who had been treated by breast conservation therapy. Patients received radiation therapy at Kyoto University Hospital following quadrantectomy and level II or III axillary node dissection. Factors that might influence long-term cosmetic results were also analyzed. Irradiation to the breast was administered in 2 Gy fractions, 5 times a week for a total of 50 Gy in all patients. Cobalt-60 γ-rays were used in 108 patients with the exception of 1 patient who received 6 Mev X-ray. Some patients with positive or close margins received boost irradiation of 10 Gy using electron beams to the primary tumor bed. Cosmetic outcome was assessed by both a scoring method and breast retraction assessment (BRA). Forty-seven percent of patients were assessed as excellent to good before radiation therapy. The percent of excellent to good decreased shortly after termination of radiation therapy, but gradually improved and stabilized by 3 years. Seventy percent of patients showed a score of excellent to good 5 years after treatment. The average BRA of the 109 patients was 3.0 cm. This did not change between 3 and 5 years after treatment. A significant correlation between cosmetic score and BRA was shown at all follow-up times. Factors such as age over 50 years (p=0.008), tumor location in the outer quadrant (p=0.02) and boost irradiation (p=0.03) significantly affected the cosmetic score. Arm edema and restriction of shoulder movement were observed in 22% and 49% at the start of radiation therapy, these improved within approximately 3 years and 1 year after treatment, respectively. Mild skin change was observed in 60% of patients even 5 years after treatment. The results indicate that cosmetic outcome after breast conservation therapy is clinically acceptable, and the complication rate is low. (author)

  15. The Effect of Neoadjuvant Therapy on Early Complications of Esophageal Cancer Surgery

    Directory of Open Access Journals (Sweden)

    Mohammadtaghi Rajabi Mashhadi

    2015-07-01

    Full Text Available Introduction: Early diagnosis and appropriate treatment is required in esophageal cancer due to its invasive nature. The aim of this study was to evaluate early post-esophagectomy complications in patients with esophageal cancer who received neoadjuvant chemoradiotherapy (NACR.   Materials and Methods: This randomized clinical trial was carried out between 2009 and 2011. Patients with lower-third esophageal cancer were randomly assigned to one of two groups. The first group consisted of 50 patients receiving standard chemoradiotherapy (Group A and then undergoing surgery, and the second group consisted of 50 patients undergoing surgery only (Group B. Patients were evaluated with respect to age, gender, clinical symptoms, type of pathology, time of surgery, perioperative blood loss, and number of lymph nodes resected as well as early post-operative complicate including leakage at the anastomosis site, chylothorax and pulmonary complications, hospitalization period, and mortality rate within the first 30 days after surgery.   Results: The mean age of patients was 55 years. Seventy-two patients had squamous cell carcinoma (SCC and 28 patients had adenocarcinoma (ACC. There was no significant difference between the two groups with respect to age, gender, time of surgery, complications including anastomotic leakage, chylothorax, pulmonary complications, cardiac complications, deep venous thrombosis (DVT, or mortality. However, there was a significant difference between the two groups regarding hospital stay, time of surgery, perioperative blood loss, and number of lymph nodes resected.   Conclusion:  The use of NACR did not increase early post-operative complications or mortality among patients with esophageal cancer.

  16. Complications of pacemaker therapy in adults with congenital heart disease: a multicenter study.

    Science.gov (United States)

    Opić, Petra; van Kranenburg, Matthijs; Yap, Sing-Chien; van Dijk, Arie P; Budts, Werner; Vliegen, Hubert W; van Erven, Lieselot; Can, Anil; Sahin, Gulhan; Theuns, Dominic A M J; Witsenburg, Maarten; Roos-Hesselink, Jolien W

    2013-10-09

    This study aims to investigate indications and complications of permanent cardiac pacing in adults with congenital heart disease (CHD). Two-hundred and seventy-four CHD patients were identified who underwent permanent pacemaker implantation between 1972 and 2009. The indication for pacing was acquired sinus node or AV node conduction disease (63%), sinus node or AV node conduction disease after cardiac surgery (28%), and drug/arrhythmia-related indications (9%). Patients with complex CHD received a pacemaker at younger age (23 versus 31 years, ppacemaker implantation (general population: 5.2%). The most common acute complications were lead dysfunction (4.0%), bleeding (2.6%), pocket infection (1.5%) and pneumothorax (1.5%). During a median follow-up of 12 years, pacemaker-related complications requiring intervention occurred in 95 patients (34.6%). The most common late pacemaker-related complications included lead failure (24.8%), pacemaker dysfunction/early battery depletion (5.1%), pacemaker migration (4.7%) and erosion (4.7%). Pacemaker implantation at younger age (pacemaker-related complication (adjusted hazard ratio 1.68, 95% confidence interval 1.07 to 2.63, p=0.023). The risk of periprocedural complications seems higher in the CHD population compared to the general population and more than one-third of CHD patients encountered a pacemaker-related complication during long-term follow-up. This risk increases for those who receive a pacemaker at younger age. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

  17. Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

    Science.gov (United States)

    Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare

    2017-10-01

    Biological treatments such as adalimumab (Humira ® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t -test and 80% retention

  18. Normal tissue complications after radiation therapy Las complicaciones de la radioterapia en los tejidos sanos

    Directory of Open Access Journals (Sweden)

    Jolyon H. Hendry

    2006-09-01

    Full Text Available This paper describes the biological mechanisms of normal tissue reactions after radiation therapy, with reference to conventional treatments, new treatments, and treatments in developing countries. It also describes biological reasons for the latency period before tissue complications arise, the relationship of dose to incidence, the effect of increasing the size of the irradiated volume, early and late tissue reactions, effects of changes in dose fractionation and dose rate, and combined chemotherapy and radiotherapy responses. Examples are given of increases in knowledge of clinical radiobiology from trials of new protocols. Potential modification to treatments include the use of biological response modifiers. The introduction of "response prediction" modifications to treatments might also be available in the near future. Finally, the paper points out that in some radiotherapy centers, the biologically-effective doses prescribed for combined brachytherapy and teletherapy treatment of cervix cancer are lower than those prescribed in other centers. This issue needs to be addressed further. The wealth of preclinical and clinical data has led to a much greater understanding of the biological basis to radiotherapy. This understanding has underpinned a variety of new approaches in radiotherapy, including both physical and biological strategies. There is also the important issue of treatment of a large number of cancers in developing countries, for which efficacious resource-sparing protocols are being continuously developed. A unified scoring system should be widely accepted as the new standard in reporting the adverse effects of radiation therapy. Likewise, late toxicity should be reported on an actuarial basis as a mandatory endpoint.En este artículo se describen los mecanismos biológicos que intervienen en las reacciones provocadas por la radioterapia, tanto con tratamientos convencionales como con los más nuevos, y los aplicados en países en

  19. Radiation therapy for subfoveal chroidal neovascularization complicating age-related macular degeneration

    International Nuclear Information System (INIS)

    Kawabata, Yuko; Ohara, Masae; Ishii, Kentaro

    2004-01-01

    We evaluated the effect of low-dose external beam irradiation on the visual function of 14 eyes with subfoveal chroidal neovascularization complicating age-related macular degeneration. Patient received external beam irradiation at a dose of 20 Gy in 10 fraction of 2 Gy. After treatment the visual function improved in 2 eyes, remained stable in 8 eyes and deteriorated in 4 eyes. At the last examination visual function improved in 1 eyes, remained stable in 2 eyes and deteriorated in 5 eyes. The low-dose irradiation is potentially beneficial for subfoveal chroidal neovascularization complicating age-related macular degeneration. (author)

  20. EFFICACY OF PANAVIR® AND ACYCLOVIR IN THE COMPLEX THERAPY OF HERPETIC INFECTION-COMPLICATED RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    O N Egorova

    2009-01-01

    Subjects and methods. One hundred and thirty patients with recurrent herpesvirus infection were enrolled in the prospective comparative study. The patients were divided into 3 groups: 1 in addition to the basic therapy, the patients received Panavir®; 2 those who took Acyclovir; and 3 those who had the basic therapy alone. In 90 of the 130 examinees, high titers of antiviral IgG antibodies to cytomegalovirus and Epstein-Barr virus were found in 60 and 48,8%, respectively. The interferon-deficiency syndrome was diagnosed in 72 (80,0% patients. Results. Virostatic therapy may be recommended for patients with RA concurrent with recurrent herpesvirus infection.

  1. Camel milk as a potential therapy for controlling diabetes and its complications: A review of in vivo studies

    Directory of Open Access Journals (Sweden)

    Amal Bakr Shori

    2015-12-01

    Full Text Available Diabetes is a condition in which there is an elevation of blood glucose. Insulin, which is produced by the pancreas, is an important hormone needed by the body because it enables glucose to be transported into cells. Under the diabetic condition, the cells may not respond properly to insulin or the body does not produce a sufficient amount of insulin, or both. This situation will cause glucose accumulation in the blood that leads to major complications. Oral insulin therapy has been used for many years; however, coagulation in an acidic environment decreases the efficacy of insulin by neutralizing its actions. Several researchers have found that camel milk can be an adjunct to insulin therapy. It appears to be safe and effective in improving long-term glycemic control. Therefore, the aim of this study was to review in vivo studies on the effect of camel milk as a potential therapy for controlling diabetes and its complications such as high cholesterol levels, liver and kidney disease, decreased oxidative stress, and delayed wound healing.

  2. Online Structured Writing Therapy for Post-traumatic Stress Disorder and Complicated Grief

    NARCIS (Netherlands)

    Ruwaard, J.; Lange, A.; Lindefors, N.; Andersson, G.

    2016-01-01

    Post-traumatic stress disorder (PTSD) and complicated grief are related disorders for which well-described and effective cognitive-behavioural therapeutic procedures exist that are firmly rooted in theoretical work. As a result, several research groups have been able to successfully translate these

  3. Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab.

    Science.gov (United States)

    Velayudhan, Jyoti; Chen, Yuh-Feng; Rohrbach, Amanda; Pastula, Christina; Maher, Gwen; Thomas, Heather; Brown, Ryan; Born, Teresa L

    2016-08-01

    Due to the complex molecular structure and proprietary manufacturing processes of monoclonal antibodies (mAbs), differences in structure and function may be expected during development of biosimilar mAbs. Important regulatory requirements for approval of biosimilar products involve comprehensive assessments of any potential differences between proposed biosimilars and reference mAbs, including differences in all known mechanisms of action, using sensitive and relevant methods. Any identified structural differences should not result in differences in biofunctional or clinical activity. A comprehensive assessment comparing the Amgen biosimilar candidate ABP 501 with FDA-licensed adalimumab (adalimumab [US]) and EU-authorized adalimumab (adalimumab [EU]) was conducted to demonstrate similarity in biofunctional activity. The functional similarity assessment included testing of binding kinetics to soluble tumor necrosis factor α (TNFα) and relative binding to transmembrane TNFα. The neutralization of TNFα-induced caspase activation, TNFα- and lymphotoxin-α (LTα)-induced chemokine production, and cytotoxicity was also tested. Binding to Fc-gamma receptors FcγRIa, FcγRIIa (131H), FcγRIIIa (158V and 158F), and neonatal Fc receptor (FcRn) was compared with the reference mAbs, as was antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The data demonstrate that ABP 501 is similar to both adalimumab (US) and adalimumab (EU) with respect to evaluated biofunctional activities. Similarity in biofunctional activity is a critical component of the totality of evidence required for demonstration of biosimilarity. The functional similarity demonstrated for ABP 501 comprehensively assesses the known mechanisms of action of adalimumab, supporting the conclusion that ABP 501, adalimumab (US), and adalimumab (EU) are likely to be clinically similar.

  4. Race/Ethnic differences in the risk of hemorrhagic complications among patients with ischemic stroke receiving thrombolytic therapy.

    Science.gov (United States)

    Mehta, Rajendra H; Cox, Margueritte; Smith, Eric E; Xian, Ying; Bhatt, Deepak L; Fonarow, Gregg C; Peterson, Eric D

    2014-08-01

    Race/ethnic-related differences in safety of intravenous thrombolytic therapy have been shown in patients with myocardial infarction, but not studied in ischemic stroke. Using data from the Get With The Guidelines (GWTG)-Stroke program (n=54 334), we evaluated differences in risk-adjusted bleeding rates (any, symptomatic intracerebral hemorrhage [sICH], serious life-threatening [excluding sICH], or other) and mortality in white (n=40 411), black (n=8243), Hispanic (n=4257), and Asian (n=1523) patients receiving intravenous tissue-type plasminogen activator (tPA) for acute ischemic stroke. Compared with white patients, overall adjusted hemorrhagic complications after tPA were higher in black (odds ratio, 1.14, 95% confidence interval, 1.04-1.28) and Asian (odds ratio, 1.36, 95% confidence interval, 1.14-1.61) patients. Overall adjusted bleeding complications in Hispanics were similar to those of whites. Increased risk of overall bleeding in Asians was related to higher risk of adjusted sICH (odds ratio, 1.47, 95% confidence interval, 1.19-1.82), whereas in blacks, it was related to higher risk of other bleeding. No significant race-related difference was noted in risk of serious or life-threatening bleeding or in overall mortality or death in patients with sICH or any hemorrhagic complications. In patients with stroke receiving tPA, hemorrhagic complications were slightly higher in blacks and Asians, but not in Hispanics compared with whites. Asians also faced significantly higher risk for sICH relative to other race/ethnic groups. Future studies are needed to evaluate whether reduction in tPA dose similar to that used in many Asian countries could improve the safety of tPA therapy in Asians in the United States with acute ischemic strokes while maintaining efficacy. © 2014 American Heart Association, Inc.

  5. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO : methodology and quality of the literature

    NARCIS (Netherlands)

    Brennan, Michael T.; Elting, Linda S.; Spijkervet, Fred K. L.

    Oral complications are commonly experienced by patients undergoing cancer therapies. The Oral Care Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) has completed nine systematic reviews including Bisphosphonate

  6. Impact of switching antiretroviral therapy on lipodystrophy and other metabolic complications: a review

    DEFF Research Database (Denmark)

    Hansen, Birgitte R; Haugaard, Steen B; Iversen, Johan

    2004-01-01

    with the disfiguring body-alterations known as HALS. More recently, however, regimens containing nucleoside reverse-transcriptase inhibitors (NRTI) have attracted attention. Reviewing switch studies regarding metabolic parameters and body shape changes, certain trends emerge. Switching from PI, the metabolic...... complications such as dyslipidaemia and insulin resistance seem to be partly reversible, whereas the morphologic alterations appear to be unchanged. In studies in which NRTI's are switched, dyslipidaemia appears unaffected, but a modest improvement in peripheral lipoatrophy has been reported. However...

  7. Criptosporidiose em paciente com espondilite anquilosante usando adalimumabe Cryptosporidiosis in a patient with ankylosing spondylitis treated with adalimumab

    Directory of Open Access Journals (Sweden)

    Fernando Augusto Chiuchetta

    2010-06-01

    Full Text Available A criptosporidiose é uma doença parasitária causada pelo protozoário Cryptosporidium sp. Observou-se um aumento no número de diagnósticos realizados nos últimos vinte anos, principalmente em pacientes que apresentam imunodeficiências como a síndrome da imunodeficiência humana adquirida e as imunodeficiências induzidas como em pacientes transplantados e nos que necessitam realizar hemodiálise frequentemente. Relata-se o caso de um jovem com espondilite anquilosante que, usando adalimumabe, apresentou diarreia devido à criptosporidiose.Cryptosporidiosis is a parasitic disease caused by a protozoan called Cryptosporidium sp. An increased number of diagnoses were made in the last 20 years, especially in patients with immunodeficiency like the acquired human immunodeficiency syndrome and induced immunodeficiency, such as in transplant patients and those who need frequent hemodialysis, has been observed. We report the case of a young patient with ankylosing spondylitis treated with adalimumab who developed chronic diarrhea secondary to cryptosporidiosis

  8. Amiodarone-induced hypothyroidism. A common complication of prolonged therapy: a report of eight cases

    International Nuclear Information System (INIS)

    Hawthorne, G.C.; Campbell, N.P.; Geddes, J.S.; Ferguson, W.R.; Postlethwaite, W.; Sheridan, B.; Atkinson, A.B.

    1985-01-01

    Amiodarone is a widely used antiarrhythmic drug, which contains 75 mg of iodide per 200 mg of active substance. Eight patients receiving long-term amiodarone therapy became hypothyroid. Seven of these patients had no previous history of thyroid dysfunction or goiter. Antithyroid antibodies were absent, and standard perchlorate discharge tests were positive in seven patients when hypothyroidism was diagnosed. In one patient, amiodarone therapy was withdrawn; over the next nine months, the hypothyroidism resolved, and results of the perchlorate discharge test reverted to normal. The authors conclude that amiodarone-induced hypothyroidism is similar to previously described iodide-induced hypothyroidism. It may develop in the absence of a previous history of thyroid disease, and all patients receiving long-term amiodarone therapy should therefore be regularly monitored for hypothyroidism

  9. Maggot therapy in treatment of a complex hand injury complicated by mycotic infection.

    Science.gov (United States)

    Bohac, M; Cambal, M; Zamborsky, R; Takac, P; Fedeles, J

    2015-01-01

    Complex injuries of the hand remain a therapeutic challenge for surgeons. We present the case of a male who suffered a devastating injury of the hand caused by a conveyor belt. The patient developed a progressive Absidia corymbifera infection of the affected soft tissues. Initial treatments with serial surgical debridement and topical and intravenous itraconazole were unsuccessful in eliminating the infection. We decided to use maggot debridement therapy in a new special design to debride all necrotic, devitalized tissue and preserve only healthy tissue and functioning structures. This maneuverer followed by negative pressure therapy allowed progressive healing. In such complex hand injuries, maggot debridement combined with negative pressure therapy could be considered to achieve effective and considerable results, although future functional morbidity may occur (Fig. 4, Ref. 18).

  10. Evaluation of financial burden following complications after major surgery in France: Potential return after perioperative goal-directed therapy.

    Science.gov (United States)

    Landais, Alain; Morel, Morgane; Goldstein, Jacques; Loriau, Jerôme; Fresnel, Annie; Chevalier, Corinne; Rejasse, Gilles; Alfonsi, Pascal; Ecoffey, Claude

    2017-06-01

    Perioperative goal-directed therapy (PGDT) has been demonstrated to improve postoperative outcomes and reduce the length of hospital stays. The objective of our analysis was to evaluate the cost of complications, derived from French hospital payments, and calculate the potential cost savings and length of hospital stay reductions. The billing of 2388 patients who underwent scheduled high-risk surgery (i.e. major abdominal, gynaecologic, urological, vascular, and orthopaedic interventions) over three years was retrospectively collected from three French hospitals (one public-teaching, one public, and one private hospital). A relationship between mortality, length of hospital stays, cost/patient, and severity scores, based mainly on postoperative complications but also on preoperative clinical status, were analysed. Statistical analysis was performed using Student's t-tests or Wilcoxon tests. Our analyses determined that a severity score of 3 or 4 was associated with complications in 90% of cases and this represented 36% of patients who, compared with those with a score of 1 or 2, were associated with significantly increased costs (€ 8205±3335 to € 22,081±16,090; Prisk surgeries per year), the potential financial savings ranged from € 40M to € 68M, not including the costs of PGDT and its implementation. Our analysis demonstrates that patients with complications are significantly more expensive to care for than those without complications. In our model, it was projected that implementing PGDT during high-risk surgery may significantly reduce healthcare costs and the length of hospital stays in France while probably improving patient access to care and reducing waiting times for procedures. Copyright © 2017. Published by Elsevier Masson SAS.

  11. Successful maintenance on sulphonylurea therapy and low diabetes complication rates in a HNF1A-MODY cohort.

    Science.gov (United States)

    Bacon, S; Kyithar, M P; Rizvi, S R; Donnelly, E; McCarthy, A; Burke, M; Colclough, K; Ellard, S; Byrne, M M

    2016-07-01

    HNF1A gene mutations are the most common cause of maturity-onset diabetes of the young (MODY) in the UK. Persons with HNF1A-MODY display sensitivity to sulphonylurea therapy; however, the long-term efficacy is not established. There is limited literature as to the prevalence of micro- and macrovascular complications in this unique cohort. The aim of this study was to determine the natural progression and clinical management of HNF1A-MODY diabetes in a dedicated MODY clinic. Sixty patients with HNF1A-MODY and a cohort of 60 BMI-, age-, ethnicity- and diabetes duration-matched patients with Type 1 diabetes mellitus participated in the study. All patients were phenotyped in detail. Clinical follow-up of the HNF1A-MODY cohort occurred on a bi-annual basis. Following a genetic diagnosis of MODY, the majority of the cohort treated with sulphonylurea therapy remained insulin independent at 84-month follow-up (80%). The HbA1c in the HNF1A-MODY group treated with sulphonylurea therapy alone improved significantly over the study period [from 49 (44-63) mmol/mol, 6.6 (6.2-7.9)% to 41 (31-50) mmol/mol, 5.9 (5-6.7)%; P = 0.003]. The rate of retinopathy was significantly lower than that noted in the Type 1 diabetes mellitus group (13.6 vs. 50%; P = 0.0001).There was also a lower rate of microalbuminuria and cardiovascular disease in the HNF1A-MODY group compared with the Type 1 diabetes mellitus group. This study demonstrates that the majority of patients with HNF1A-MODY can be maintained successfully on sulphonylurea therapy with good glycaemic control. We note a significantly lower rate of micro- and macrovascular complications than reported previously. The use of appropriate therapy at early stages of the disorder may decrease the incidence of complications. © 2015 Diabetes UK.

  12. Oral complications of cancer therapies. Pretherapy interventions to modify salivary dysfunction

    International Nuclear Information System (INIS)

    Wolff, A.; Atkinson, J.C.; Macynski, A.A.; Fox, P.C.

    1990-01-01

    Salivary gland dysfunction is a common side effect of cancer therapies. Salivary secretions are reduced rapidly after starting head and neck radiotherapy. Salivary gland dysfunction has also been linked to bone marrow transplantation and to cytotoxic chemotherapy. Salivary gland stimulation during radiation has been suggested as a means of reducing radiation damage. Results of an ongoing study investigating the effects of pilocarpine on radiation-induced salivary gland dysfunction suggest that parotid function was preserved, but not submandibular/sublingual function. Also, patients receiving pilocarpine had less frequent oral complaints. Further research is necessary to develop means of preventing or alleviating the salivary side effects of cancer therapies. 37 references

  13. Lacunar infarction in brain tumor patients. Chronic stage complication after radiation therapy

    International Nuclear Information System (INIS)

    Nakazaki, Kiyoshi; Titoku, Shirou; Ota, Shinzou; Sato, Mitiyoshi; Kobanawa, Satoshi; Tutida, Kazuyuki; Tanaka, Yasue; Goto, Katsuya; Ota, Taisei

    2007-01-01

    The authors reported two relatively young adults with lacunar infarction that took place many years after radiation therapy. The first case was that of a 41-year-old male presenting with a slight decrease in consciousness and right hemiparesis of sudden occurrence. MRI revealed a lacunar infarction in the left internal capsule. This patient had received radiation therapy and chemotherapy for a right basal ganglia germinoma when he was 24 years old. The tumor completely disappeared and he was able to return to work. The second case was a 24-year-old female presenting with dysesthesia in the right upper extremity and nausea of sudden occurrence. MRI disclosed a lacunar infarct in the right corona radiata. The patient had received radiation therapy for a suprasellar tumor when she was 11 years old. The tumor considerably decreased in size and the patient conducted normal social life thereafter. MRI showed a lacunar infarction in the right corona radiata. Review of the literature was made and the possibility of radiation therapy as a causative factor of the lacunar infarction in relatively young adults was discussed. (author)

  14. Musculoskeletal Complications and Bone Metastases in Breast Cancer Patients Undergoing Estrogen Deprivation Therapy

    Science.gov (United States)

    2016-10-01

    tissue (MAT) in estrogen deficient mice. Epidemiological studies have demonstrated a strong link between obesity and increased breast cancer...the accrual of MAT is dramatically accelerated with obesity , estrogen deprivation, glucocorticoid use, chemotherapy, and radiation therapy...Tucson, AZ 2005 – 2006 Graduate Research Assistant, McKnight Brain Institute, Neural Systems, Memory and Aging (NSMA), Department of Psychology

  15. Gastrocutaneous fistula as a late complication of fast neutron therapy for carcinoma of the stomach

    International Nuclear Information System (INIS)

    Griffith, C.D.M.; Arnott, S.J.

    1984-01-01

    A brief report is presented of a case of gastrocutaneous fistula in a 36-year-old housewife, who had been treated a year previously for carcinoma of the stomach with fast neutron therapy at a dose of 1500 cGy delivered in 20 daily treatments. The maximum tissue dose delivered to the skin surface was 1780 cGy. (U.K.)

  16. [Circumscribed and diffuse peritonitis: severe complications in bariatric and metabolic surgery; specifics related to their diagnosis and therapy].

    Science.gov (United States)

    Špička, P; Vaverka, P; Gryga, A; Malý, T

    Cases of localized and diffuse peritonitis are severe surgical conditions. Despite expanding possibilities for the diagnosis and therapy, patients with peritonitis, its diffuse form in particular, still suffer from high morbidity and mortality. The management of this condition, both in the healthy and especially seriously ill population, is not satisfactory. Recently, we have witnessed an increase in bariatric and metabolic surgery in response to an ever rising number of extremely obese patients worldwide. Bariatric patients belong to a group of seriously ill patients with a significant risk of post-operative complications due to an infection. Although their treatment is identical to that of the normal population, a great emphasis is put on early recognition of complications, and the decision on any potential surgical revision should be actively approached, often necessitating the absence of frequently lengthy paraclinical assessments. We conducted a retrospective analysis of 346 obese bariatric patients undergoing surgical treatment for morbid obesity between August 2011 and August 2015. A total of 6 patients experienced severe complications including two cases of diffuse peritonitis, two cases of localized peritonitis and two cases of intraperitoneal bleeding. One patient died after her discharge from hospital due to toxic shock caused by stomach perforation. We describe two case reports in greater detail to highlight the importance of early detection of complications and a timely surgical intervention. In principle, bariatric patients are a severely ill population where standard diagnostic procedures for post-operative complications often fail. Clinical findings and the surgeons experience are commonly the only diagnostic signs that trigger a surgical revision. In contrast, surgical treatment of post-operative complications in obese patients with peritonitis is virtually identical to that in patients with normal or slightly increased BMI. It involves thorough

  17. Relaxation Therapy on Fetal Outcomes in Complicated Pregnancies Suffering Sleep Disorders: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    azar nematollahi

    2016-10-01

    Full Text Available Background: Sleep disorders like snoring, mouth breathing, and insomnia are frequent in pregnancy and studies have shown that poor sleep is linked to obstetric complications. Muscle relaxation technique is an effective method used for improving sleep quality. The purpose of this study was to determine the effect of muscle relaxation technique on fetal outcomes in complicated pregnancies with sleep disorders. Methods: This study was performed as a clinical trial on 160 pregnant women who suffered from preeclampsia and gestational diabetes. The participants filled the Pittsburgh Sleep Quality Index (PSQI in order to measure the quality and patterns of their sleep. The participants with the total score of 5 or more were included in the present study. Intervention group were asked to use muscle relaxation technique twice a week at home for 8 weeks alongside the routine care. Study variables included sleep quality, Apgar scores, birth weight, levels of Interleukin- 6 (IL- 6, as well as umbilical cord PH and PO2. Results: The mean score of PSQI before the intervention was 9.28±4.16 and 9.18±3.06 in the intervention and control groups without a significant difference (P=0.6, respectively. However, PSQI global score of the experimental group was smaller than the control group at the end of the study (P<0.001. Also, birth weight (P=0.04, Apgar score (P=0.01, and umbilical cord blood po2 (P=0.03 and PH (P=0.01 were higher, and IL-6 (P=0.04 was smaller in the experimental group compared to the control group. Conclusion: The results of this study showed that muscle relaxation, as a simple, inexpensive and safe method, can improve the fetal outcomes such as birth weight, Apgar score, cord blood po2, and cord blood PH, and also it leads to lower IL-6 in complicated pregnancies.

  18. Variability of Basal Rate Profiles in Insulin Pump Therapy and Association with Complications in Type 1 Diabetes Mellitus.

    Science.gov (United States)

    Laimer, Markus; Melmer, Andreas; Mader, Julia K; Schütz-Fuhrmann, Ingrid; Engels, Heide-Rose; Götz, Gabriele; Pfeifer, Martin; Hermann, Julia M; Stettler, Christoph; Holl, Reinhard W

    2016-01-01

    Traditionally, basal rate profiles in continuous subcutaneous insulin infusion therapy are individually adapted to cover expected insulin requirements. However, whether this approach is indeed superior to a more constant BR profile has not been assessed so far. This study analysed the associations between variability of BR profiles and acute and chronic complications in adult type 1 diabetes mellitus. BR profiles of 3118 female and 2427 male patients from the "Diabetes-Patienten-Verlaufsdokumentation" registry from Germany and Austria were analysed. Acute and chronic complications were recorded 6 months prior and after the most recently documented basal rate. The "variability index" was calculated as variation of basal rate intervals in percent and describes the excursions of the basal rate intervals from the median basal rate. The variability Index correlated positively with severe hypoglycemia (r = .06; p1), hypoglycemic coma (r = .05; p = 0.002), and microalbuminuria (r = 0.05; p = 0.006). In addition, a higher variability index was associated with higher frequency of diabetic ketoacidosis (r = .04; p = 0.029) in male adult patients. Logistic regression analysis adjusted for age, gender, duration of disease and total basal insulin confirmed significant correlations of the variability index with severe hypoglycemia (β = 0.013; p1) and diabetic ketoacidosis (β = 0.012; p = 0.017). Basal rate profiles with higher variability are associated with an increased frequency of acute complications in adults with type 1 diabetes.

  19. Impact of Tailored Education on Awareness of Personal Risk for Therapy-Related Complications Among Childhood Cancer Survivors.

    Science.gov (United States)

    Landier, Wendy; Chen, Yanjun; Namdar, Golnaz; Francisco, Liton; Wilson, Karla; Herrera, Claudia; Armenian, Saro; Wolfson, Julie A; Sun, Can-Lan; Wong, F Lennie; Bhatia, Smita

    2015-11-20

    Survivors of childhood cancer carry a substantial burden of long-term morbidity; personal risk awareness is critical to ensure survivors' engagement in early detection/management of complications. The impact of education provided in survivorship clinics on survivors' understanding of their personal health risks is unclear. Patients diagnosed with cancer at age 21 years or younger and at 2 or more years off therapy completed questionnaires about awareness of personal risk for therapy-related complications at T0 (first survivorship clinic visit) and at T1 to T5 (subsequent visits). After questionnaire completion at each clinic visit, survivors received education tailored to personal risk. A total of 369 survivors completed 1,248 visits (median, three visits; range, one to six visits). The median age at cancer diagnosis was 11 years (range, 0 to 21 years); the median age at T0 was 24 years (range, 5 to 57 years); 38% were white; 45% had leukemia; and 34% received hematopoietic cell transplantation. The cohort was at risk for a median of six (range, one to nine) complications. Awareness increased from 38.6% at T0 to 66.3% at T3. Generalized estimating equations (that adjusted for diagnosis, hematopoietic cell transplantation, race/ethnicity, and patient/parent education) showed significant gains in awareness from T0 to T1 (P awareness included education less than a college degree (odds ratio [OR], 1.9; P = .02), longer time from diagnosis (OR, 1.03/year; P = .04), diagnosis of leukemia (OR, 2.1; P = .004), nonwhite race (OR, 2.8; P awareness of personal health risk through three sessions, with saturation thereafter. Vulnerable populations with minimal gain in awareness identified in this study could inform targeted interventions. © 2015 by American Society of Clinical Oncology.

  20. Successful treatment of ulcerative colitis complicated by Sweet's syndrome by corticosteroid therapy and leukocytapheresis.

    Science.gov (United States)

    Terai, Tomohiro; Sugimoto, Mitsushige; Osawa, Satoshi; Sugimoto, Ken; Furuta, Takahisa; Kanaoka, Shigeru; Ikuma, Mutsuhiro

    2011-06-01

    Ulcerative colitis is occasionally complicated by dermatological disorders presenting as extra-intestinal manifestations, including erythema nodosum and pyoderma gangrenosum. Sweet's syndrome is considered to be a rare cutaneous disease in patients with ulcerative colitis. To date, only 17 cases of Sweet's syndrome complicating ulcerative colitis have been reported in the English literature. Here, we report a case of a 41-year-old male who had been suffering from ulcerative colitis for 20 years. He was admitted to hospital with hematochezia, diarrhea and fever, and painful erythematous nodules on the face and arms. Histological examination of skin biopsies showed inflammatory cell infiltration composed mainly of neutrophils without evidence of necrotizing vasculitis, and the condition was diagnosed as Sweet's syndrome. The patient was treated with prednisolone and leukocytapheresis and the erythematous nodules on the skin, as well as the abdominal symptoms and endoscopic findings of ulcerative colitis, immediately improved. In this paper we report on this case and review the literature concerning ulcerative colitis and Sweet's syndrome.

  1. Musculoskeletal Complications and Bone Metastases in Breast Cancer Patients Undergoing Estrogen Deprivation Therapy

    Science.gov (United States)

    2017-10-01

    Laura E. Wright, Ph.D. 5e. TASK NUMBER E-Mail: laewrig@iu.edu 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) AND ADDRESS(ES...8. PERFORMING ORGANIZATION REPORT NUMBER Indiana University School of Medicine 980 West Walnut Street R3 Room C132 Indianapolis, IN 46202 9...13. SUPPLEMENTARY NOTES 14. ABSTRACT Between 25-50% of women treated with endocrine therapies develop musculoskeletal toxicities that result in

  2. Acute nonlymphocytic leukemia: a delayed complication of Hodgkin's disease therapy: analysis of 109 cases

    International Nuclear Information System (INIS)

    Cadman, E.C.; Capizzi, R.L.; Bertino, J.R.

    1977-01-01

    The use of combined modality therapy (irradiation and combinations of drugs) in the treatment of Hodgkin's disease has produced a significant improvement in survival, during which most patients lead an active and productive life. The estimated 1% incidence of leukemia in treated Hodgkin's disease patients, however, is greater than would be expected in the general population. There is a vast amount of literature which indicates that alkylating agents, procarbazine and irradiation are leukemogenic and immunosuppressive in animals and man. It is then conceivable that the current intensive treatment programs which use these agents are promoting the development of acute non-lymphocytic leukemia (ANLL). This leukemia has occurred most often in patients whose Hodgkin's disease is poorly controlled and who have received more aggressive therapy. The latent period from the diagnosis of Hodgkin's disease to the diagnosis of leukemia is significantly shorter (p < 0.0005) in those patients who have received intensive and near maximal radiotherapy (total nodal irradiation), combination chemotherapy (MOPP or equivalent) or a sequential combination of the two modalities than similar patients who were threated with less than total nodal irradiation and or single agent chemotherapy. The following characteristic features have occurred with sufficient frequency to suggest that the subsequent leukemia is a distinct clinicopathological entity: pancytopenia, megaloblastoid marrow, nucleated red blood cells in the peripheral blood, random chromosomal aberrations of the bone marrow in most patients (94%), and refractoriness to antileukemia therapy (response rate 6.5%) with a very short survival

  3. Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson s disease patients with motor complications.

    Science.gov (United States)

    Stowe, Rebecca; Ives, Natalie; Clarke, Carl E; Deane, Katherine; Wheatley, Keith; Gray, Richard; Handley, Kelly; Furmston, Alex

    2010-07-07

    One of the complications of long-term treatment of Parkinson's disease (PD) with levodopa is the development of motor complications. Generally, when motor complications develop, clinicians add in an additional drug (to the levodopa regimen) from one of three other classes of anti-Parkinsonian treatments (dopamine agonists, catechol-O-methyl transferase inhibitors (COMTIs) or monoamine oxidase type B inhibitors (MAOBIs)). However, despite trials having shown that these drugs are beneficial compared to placebo, it remains unclear as to the best way to treat patients experiencing motor complications and whether one class of drug is more effective than another. This meta-analysis aims to assess more reliably the benefits and risks of the three classes of drugs (dopamine agonists, COMTIs and MAOBIs) currently used as adjuvant treatment to levodopa in PD patients suffering from motor complications. The three drug classes were compared with the aim of determining whether one class of drug provides better symptomatic control than another. We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, PubMed, LILACS and Web of Science, plus major journals in the field, abstract books, conference proceedings and reference lists of retrieved publications. Randomised trials comparing an orally administered dopamine agonist, COMTI or MAOBI versus placebo, both on a background of levodopa therapy, in PD patients experiencing motor complications. Two authors independently extracted data on off-time, levodopa dose, motor complications, side-effects, treatment concordance, clinician-rated disability, mortality, quality of life and health economic data. Forty-four eligible trials, involving 8436 participants were identified. Compared to placebo, adjuvant therapy significantly reduced off-time (-1.05 hours/day, 95% confidence interval (CI) -1.19 to -0.90; P<0.00001), the required levodopa dose (-55.65 mg/day, CI -62.67 to -48.62; P<0.00001) and improved UPDRS scores (UPDRS ADL score

  4. Intravitreal Adalimumab in Active Noninfectious Uveitis: A Pilot Study.

    Science.gov (United States)

    Hamam, Rola N; Barikian, Anita W; Antonios, Rafic S; Abdulaal, Marwan R; Alameddine, Ramzi M; El Mollayess, Georges; Mansour, Ahmad M

    2016-06-01

    To evaluate the short-term efficacy of intravitreal adalimumab (IVA) for the treatment of eyes with active noninfectious uveitis. Consecutive eyes with active noninfectious uveitis were injected with IVA at 0, 2, then every 4 weeks for total of 26 weeks. Six out of 7 patients (12 of 13 eyes) completed 26 weeks of treatment. One patient (1 eye) failed treatment. Seven out of 12 eyes had improvement of ≥2 ETDRS lines. Three out of three eyes had resolution of anterior chamber cells. And 9 of 10 eyes with vitreous haze had zero haze at 26 weeks. Five out of 8 eyes with macular edema had complete resolution. Median fluorescein angiography score improved from 14 to 4 on last follow-up. IVA was effective in controlling the inflammation, decreasing the macular edema, and improving the best corrected visual acuity in the majority of eyes in this series.

  5. Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis.

    Science.gov (United States)

    Park, Hyoung-Chul; Kim, Min Jeong; Lee, Bong Hwa

    Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively. We enrolled 1,343 patients who underwent laparoscopic surgery for complicated appendicitis between January 2009 and December 2014. At the beginning of the new protocol, the patients were divided into two groups; 10 days of various antibiotic regimens (between January 2009 and June 2012, called the non-standardized protocol; n = 730) and five days of cefuroxime and metronidazole regimen (between July 2012 and December 2014; standardized protocol; n = 613). We compared the clinical outcomes, including surgical site infection (SSI) (superficial and deep organ/space infections) in the two groups. The standardized protocol group had a slightly shorter operative time (67 vs. 69 min), a shorter hospital stay (5 vs. 5.4 d), and lower medical cost (US$1,564 vs. US$1,654). Otherwise, there was no difference between the groups. No differences were found in the non-standardized and standard protocol groups with regard to the rate of superficial infection (10.3% vs. 12.7%; p = 0.488) or deep organ/space infection (2.3% vs. 2.1%; p = 0.797). In patients undergoing laparoscopic surgery for complicated appendicitis, five days of cefuroxime and metronidazole did not lead to more SSIs, and it decreased the medical costs compared with non-standardized antibiotic regimens.

  6. Long-term efficacy of adalimumab in the treatment of uveitis associated with juvenile idiopathic arthritis

    OpenAIRE

    Kotaniemi, Kaisu; S?il?, Hanna; Kautiainen, Hannu

    2011-01-01

    Kaisu Kotaniemi1,2, Hanna Säilä2, Hannu Kautiainen31Helsinki University Hospital, Helsinki, Finland; 2Orton Orthopaedic Hospital and Rehabilitation Unit, Helsinki, Finland; 3Unit of Primary Health Care, Kuopio University Hospital, Kuopio, FinlandBackground: The purpose of this study was to investigate the long-term effects of adalimumab, a tumor necrosis factor alpha antagonist, in the treatment of uveitis associated with juvenile idiopathic arthritis.Methods: Adalimumab was...

  7. Implantable Cardioverter-Defibrillator Therapy in Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy: Predictors of Appropriate Therapy, Outcomes, and Complications.

    Science.gov (United States)

    Orgeron, Gabriela M; James, Cynthia A; Te Riele, Anneline; Tichnell, Crystal; Murray, Brittney; Bhonsale, Aditya; Kamel, Ihab R; Zimmerman, Stephan L; Judge, Daniel P; Crosson, Jane; Tandri, Harikrishna; Calkins, Hugh

    2017-06-06

    Arrhythmogenic right ventricular dysplasia/cardiomyopathy is characterized by ventricular arrhythmias and sudden cardiac death. Once the diagnosis is established, risk stratification to determine whether implantable cardioverter-defibrillator (ICD) placement is warranted is critical. The cohort included 312 patients (163 men, age at presentation 33.6±13.9 years) with definite arrhythmogenic right ventricular dysplasia/cardiomyopathy who received an ICD. Over 8.8±7.33 years, 186 participants (60%) had appropriate ICD therapy and 58 (19%) had an intervention for ventricular fibrillation/flutter. Ventricular tachycardia at presentation (hazard ratio [HR]: 1.86; 95% confidence interval [CI], 1.38-2.49; P right ventricular dysplasia/cardiomyopathy. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  8. Hypertension complicating {sup 131}I-meta-iodobenzylguanidine therapy for neuroblastoma

    Energy Technology Data Exchange (ETDEWEB)

    Kosmin, Michael A.; Cork, Nicholas J.; Gaze, Mark N. [University College London Hospitals NHS Foundation Trust, Department of Oncology, London (United Kingdom); Bomanji, Jamshed B. [University College London Hospitals NHS Foundation Trust, Department of Nuclear Medicine, London (United Kingdom); Shankar, Ananth [University College London Hospitals NHS Foundation Trust, Department of Paediatric Oncology, London (United Kingdom)

    2012-04-15

    Radiolabelled meta-iodobenzylguanidine (mIBG), used as targeted therapy for neuroblastoma, is known to have effects on blood pressure (BP). In this study we audited BP changes in patients receiving {sup 131}I-mIBG therapy for neuroblastoma to identify BP-related adverse events (AE) and possible predictive factors. Between 2003 and 2010, 50 patients with neuroblastoma received 110 {sup 131}I-mIBG administrations. BP measurements before and after administration were compared with age- and sex-matched centile values. AE were analysed, and possible predisposing factors identified. This population had a baseline BP distribution higher than that of their age- and sex-matched peers, with 16% of preadministration systolic BP values above the 95th centile. Changes in BP after administration showed an approximately normal distribution with similar numbers of reduced and increased values. Four AE, all related to hypertension, occurred with one patient having generalized seizures. One AE was immediate, others occurred between 20 and 25 h after administration. No significant association between AE and patient age or sex was demonstrated. However, a significant association between AE and high preadministration BP was shown, both above the 90th centile (p = 0.0022) and above the 95th centile (p = 0.0135). Clinically relevant hypertension following {sup 131}I-mIBG therapy affected less than 5% of administrations, but was more common in those patients with preexisting hypertension. As hypertensive episodes may occur many hours after treatment, close monitoring of BP needs to be continued for at least 48 h after administration of {sup 131}I-mIBG. (orig.)

  9. Allergic complications of L-asparaginase therapy in children with acute lymphoblastic leukaemia

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    Konstantinidis Georgios

    2011-01-01

    Full Text Available Introduction. L-asparaginase (L-ASP is one of the most effective medications for the treatment of acute lymphoblastic leukaemia (ALL in children, and allergic reactions to the therapy are considered the most significant side effects. Objective. The aim of this study was to determine the prevalence and type of allergic reactions, as well as to identify potential risk factors for the development of allergic reactions during L-ASP therapy in children with ALL. Methods. The study encompassed 70 patients under 18 years of age, who were treated at the Institute for Child and Youth Healthcare of Vojvodina, Novi Sad in the period January 2000 - June 2009. We analyzed the frequency and type of allergic reactions during the administration of L-ASP, the onset of allergic reaction in relation to the phase of therapy of underlying disease, as well as the prevalence of allergic reactions in relation to drug administration method. Results. Allergic reaction manifested in 17 patients (24%. In 14 patients (82% allergic reaction to L-ASP manifested as urticaria, bronchospasm or anaphylaxis, whereas a mild local reaction was observed in only three patients (18%. In a group treated, according to the high-risk protocol, the prevalence of allergic reactions was statistically significantly higher in the intermediate-risk group of patients (p<0.01, i.e. statistically significantly more frequent, as compared to the standard-risk group of patients (p<0.05. The majority of patients (11; 65% developed allergic reactions to the 9th dose of L-ASP, i.e. the first dose during the reinduction phase. The time interval between the last L-ASP dose in the induction phase and the 1st dose in the reinduction phase was at least four weeks. With respect to administration method, the majority of patients (16; 94% developed allergic reaction after intravenous application of L-ASP. Conclusion. Potential risk factors for the development of allergic reaction to L-ASP are a high-risk therapy

  10. Cytotoxicity and genotoxicity of intravitreal adalimumab administration in rabbit retinal cells

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    Álcio Coutinho de Paula

    2015-04-01

    Full Text Available Purpose: To assess the cytotoxicity and genotoxicity of intravitreal adalimumab treatment in an animal experimental model using cytological and molecular techniques. Methods: Eighteen rabbits were randomly assigned to three groups: control, adalimumab treatment, and placebo. Cytotoxicity on retinal cells was evaluated using flow cytometry assays to determine the level of apoptosis and necrosis. Genotoxicity was evaluated by comet assays to assess DNA damage, and quantitative real-time polymerase chain reaction (qPCR was used to evaluate expression of apoptosis-inducing caspases (8 and 3. Results: No cytotoxicity or genotoxicity was observed in any of the two treatment groups (adalimumab and placebo following intravitreal administration compared with the control group. Flow cytometry analysis revealed that more than 90% of the cells were viable, and only a low proportion of retinal cells presented apoptotic (~10% or necrotic (<1% activity across all groups. Molecular damage was also low with a maximum of 6.4% DNA degradation observed in the comet assays. In addition, no increase in gene expression of apoptosis-inducing caspases was observed on retinal cells by qPCR in both the adalimumab and placebo groups compared with the control group. Conclusion: The use of adalimumab resulted in no detectable cytotoxicity or genotoxicity on retinal cells for up to 60 days upon administration. These results therefore indicate that adalimumab may be a safe option for intravitreal application to treat ocular inflammatory diseases in which TNF-α is involved.

  11. Topical Yunnan Baiyao administration as an adjunctive therapy for bleeding complications in adolescents with advanced cancer.

    Science.gov (United States)

    Ladas, E J; Karlik, J B; Rooney, D; Taromina, K; Ndao, D H; Granowetter, L; Kelly, K M

    2012-12-01

    Yunnan Baiyao (White Medicine from Yunnan, YNB) is a Chinese herbal medicinal powder used to stop bleeding and improve circulation in traumatic injuries. We describe the use of YNB in adolescents with cancer as an adjunct to uncontrolled bleeding in the palliative care setting. Through a retrospective chart review of all patients receiving integrative medicine consultations at the Integrative Therapies Program at Columbia University from January 1, 2007 to January 31, 2012, we describe the outcome of patients treated with YNB for management of uncontrolled bleeding. Four patients were identified who received topical YNB for uncontrolled bleeding; patients included two males and two females with diagnoses of solid tumors (n = 3) and Burkitt's lymphoma (n = 1). Mean age was 15.5 years (range 15-17). Fifty percent had life-threatening bleeding from the tumor site and 50 % experienced uncontrollable epistaxis. All patients received preceding therapy with packed red blood cells and platelet transfusions, topical thrombin, and oral aminocaproic acid. Two patients used YNB in the inpatient setting, and all four patients used YNB as outpatients. In all patients, bleeding control improved with the addition of YNB to conventional hemostatic interventions. Two patients using YNB in their home reported control of bleeding episodes. There were no adverse events reported. YNB may be an efficacious agent for uncontrolled bleeding in conjunction with conventional hemostatic agents in adolescents with advanced cancer. It is well accepted by patients. YNB may be especially valuable in the outpatient setting to prevent the recurrence of hemorrhage.

  12. Normal tissue complication probability modeling of radiation-induced hypothyroidism after head-and-neck radiation therapy.

    Science.gov (United States)

    Bakhshandeh, Mohsen; Hashemi, Bijan; Mahdavi, Seied Rabi Mehdi; Nikoofar, Alireza; Vasheghani, Maryam; Kazemnejad, Anoshirvan

    2013-02-01

    To determine the dose-response relationship of the thyroid for radiation-induced hypothyroidism in head-and-neck radiation therapy, according to 6 normal tissue complication probability models, and to find the best-fit parameters of the models. Sixty-five patients treated with primary or postoperative radiation therapy for various cancers in the head-and-neck region were prospectively evaluated. Patient serum samples (tri-iodothyronine, thyroxine, thyroid-stimulating hormone [TSH], free tri-iodothyronine, and free thyroxine) were measured before and at regular time intervals until 1 year after the completion of radiation therapy. Dose-volume histograms (DVHs) of the patients' thyroid gland were derived from their computed tomography (CT)-based treatment planning data. Hypothyroidism was defined as increased TSH (subclinical hypothyroidism) or increased TSH in combination with decreased free thyroxine and thyroxine (clinical hypothyroidism). Thyroid DVHs were converted to 2 Gy/fraction equivalent doses using the linear-quadratic formula with α/β = 3 Gy. The evaluated models included the following: Lyman with the DVH reduced to the equivalent uniform dose (EUD), known as LEUD; Logit-EUD; mean dose; relative seriality; individual critical volume; and population critical volume models. The parameters of the models were obtained by fitting the patients' data using a maximum likelihood analysis method. The goodness of fit of the models was determined by the 2-sample Kolmogorov-Smirnov test. Ranking of the models was made according to Akaike's information criterion. Twenty-nine patients (44.6%) experienced hypothyroidism. None of the models was rejected according to the evaluation of the goodness of fit. The mean dose model was ranked as the best model on the basis of its Akaike's information criterion value. The D(50) estimated from the models was approximately 44 Gy. The implemented normal tissue complication probability models showed a parallel architecture for the

  13. Normal Tissue Complication Probability Modeling of Radiation-Induced Hypothyroidism After Head-and-Neck Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Bakhshandeh, Mohsen [Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran (Iran, Islamic Republic of); Hashemi, Bijan, E-mail: bhashemi@modares.ac.ir [Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran (Iran, Islamic Republic of); Mahdavi, Seied Rabi Mehdi [Department of Medical Physics, Faculty of Medical Sciences, Tehran University of Medical Sciences, Tehran (Iran, Islamic Republic of); Nikoofar, Alireza; Vasheghani, Maryam [Department of Radiation Oncology, Hafte-Tir Hospital, Tehran University of Medical Sciences, Tehran (Iran, Islamic Republic of); Kazemnejad, Anoshirvan [Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran (Iran, Islamic Republic of)

    2013-02-01

    Purpose: To determine the dose-response relationship of the thyroid for radiation-induced hypothyroidism in head-and-neck radiation therapy, according to 6 normal tissue complication probability models, and to find the best-fit parameters of the models. Methods and Materials: Sixty-five patients treated with primary or postoperative radiation therapy for various cancers in the head-and-neck region were prospectively evaluated. Patient serum samples (tri-iodothyronine, thyroxine, thyroid-stimulating hormone [TSH], free tri-iodothyronine, and free thyroxine) were measured before and at regular time intervals until 1 year after the completion of radiation therapy. Dose-volume histograms (DVHs) of the patients' thyroid gland were derived from their computed tomography (CT)-based treatment planning data. Hypothyroidism was defined as increased TSH (subclinical hypothyroidism) or increased TSH in combination with decreased free thyroxine and thyroxine (clinical hypothyroidism). Thyroid DVHs were converted to 2 Gy/fraction equivalent doses using the linear-quadratic formula with {alpha}/{beta} = 3 Gy. The evaluated models included the following: Lyman with the DVH reduced to the equivalent uniform dose (EUD), known as LEUD; Logit-EUD; mean dose; relative seriality; individual critical volume; and population critical volume models. The parameters of the models were obtained by fitting the patients' data using a maximum likelihood analysis method. The goodness of fit of the models was determined by the 2-sample Kolmogorov-Smirnov test. Ranking of the models was made according to Akaike's information criterion. Results: Twenty-nine patients (44.6%) experienced hypothyroidism. None of the models was rejected according to the evaluation of the goodness of fit. The mean dose model was ranked as the best model on the basis of its Akaike's information criterion value. The D{sub 50} estimated from the models was approximately 44 Gy. Conclusions: The implemented

  14. A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial).

    Science.gov (United States)

    Ramanan, Athimalaipet V; Dick, Andrew D; Benton, Diana; Compeyrot-Lacassagne, Sandrine; Dawoud, Dalia; Hardwick, Ben; Hickey, Helen; Hughes, Dyfrig; Jones, Ashley; Woo, Patricia; Edelsten, Clive; Beresford, Michael W

    2014-01-09

    Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of inflammation of the uvea in the eye (uveitis). Overall, 20% to 25% of paediatric uveitis is associated with JIA. Major risk factors for development of uveitis in JIA are oligoarticular pattern of arthritis, an age at onset of arthritis of less than seven years of age, and antinuclear antibody positivity. In the initial stages of mild to moderate inflammation the uveitis is asymptomatic. This has led to current practice of screening all children with JIA for uveitis. Approximately 12% to 38% of patients with JIA develop uveitis in seven years following onset of arthritis. In 30% to 50% of children with JIA-associated uveitis structural complications are present at diagnosis. Furthermore about 50% to 75% of those with severe uveitis will eventually develop visual impairment secondary to ocular complications such as cataract and glaucoma. Defining the severity of inflammation and structural complications in uveitis patients is now possible following Standardised Uveitis Nomenclature (SUN) guidelines, and modified to incorporate the consensus of end point and outcome criteria into the design of randomised trials. Despite current screening and therapeutic options (pre-biologics) 10% to 15% of children with JIA-associated uveitis may develop bilateral visual impairment and certified legally blind. To date, there remains no controlled trial evidence of benefits of biologic therapy. This study will randomise 154 patients aged 2 to 18 years with active JIA-associated uveitis (despite methotrexate (MTX) treatment for at least 12 weeks). All participants will be treated for 18 months, with follow up of 3 years from randomisation (continuing on MTX throughout). All participants will receive a stable dose of MTX and in addition either adalimumab (20 mg/0.8 ml for patientstreatment of juvenile idiopathic arthritis associated uveitis. ISRCTN10065623.

  15. Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan

    Directory of Open Access Journals (Sweden)

    V. A. Maliyevskiy

    2015-01-01

    Full Text Available Background: Methotrexate is the first-line drug for treating patients with juvenile idiopathic arthritis (JIA. If it is ineffective or intolerable, prescription of genetically engineered biopharmaceuticals is indicated. Objective: The study was aimed at assessing effectiveness and safety of genetically engineered biopharmaceutical adalimumab for treating children with JIA. Methods: A retrospective cohort study was conducted to analyze results of treating patients with JIA aged 2–17 years. Adalimumab would be prescribed biweekly in the dose of 24 mg/m2 (body surface subcutaneously (if body weight is under 30 kg or in the dose of 40 mg/m2 (if body weight is > 30 kg. Effectiveness and safety would be assessed after 4–12–24–48–96 weeks. Results: We analyzed treatment results of 17 patients (15 children with active joint syndrome, 2 — with active uveitis. All patients with active joint syndrome had been receiving adalimumab for 12 weeks, 12 patients — for 24 weeks, 8 — for 48 weeks, 5 — for 96 weeks. 30/50/70% improvement in terms of the ACRpedi criteria was observed in 15/11/4 children after 4 weeks, after 12 weeks — in 15/13/11 patients, after 48 weeks — in 7/6/6 patients. The status of inactive disease was established in 5 patients (33% after 12 weeks, after 24 weeks — in 9 children (75%, after 48 weeks — in 7 children (70%, after 96 weeks — in 4 (80% children. Active uveitis was terminated in all 5 patients with signs of eye damage in the treatment onset. 1 patient suffered from exacerbation of the disease after 48 weeks of therapy; the drug was withdrawn. Tubercular infection without local manifestations was established in 1 patient after 96 weeks (positive Mantoux test, papule — 10 mm. Adalimumab injection was terminated for the period of chemotherapy. Conclusion: Adalimumab has a sufficiently high effectiveness and safety for long-term (up to 2 years treatment of children with JIA. 

  16. Established role of bisphosphonate therapy for prevention of skeletal complications from myeloma bone disease.

    Science.gov (United States)

    Terpos, Evangelos; Dimopoulos, Meletios A; Berenson, James

    2011-02-01

    Patients with advanced multiple myeloma (MM) often have increased osteolytic activity of osteoclasts and impaired osteogenesis by osteoblasts, resulting in osteolytic bone lesions that increase the risk of skeletal-related events (SREs) including pathologic fracture, the need for radiotherapy or surgery to bone, and spinal cord compression. Such SREs are potentially life-limiting, and can reduce patients' functional independence and quality of life. Bisphosphonates (e.g., oral clodronate and intravenous pamidronate and zoledronic acid) can inhibit osteoclast-mediated osteolysis, thereby reducing the risk of SREs, ameliorating bone pain, and potentially prolonging survival in patients with MM. Extensive clinical experience demonstrates that bisphosphonates are generally well tolerated, and common adverse events are typically mild and manageable. Studies are ongoing to optimize the timing and duration of bisphosphonate therapy in patients with bone lesions from MM. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  17. The relationship between hypomagnesemia, metformin therapy and cardiovascular disease complicating type 2 diabetes: the Fremantle Diabetes Study.

    Directory of Open Access Journals (Sweden)

    Kirsten E Peters

    Full Text Available Low serum magnesium concentrations have been associated with cardiovascular disease risk and outcomes in some general population studies but there are no equivalent studies in diabetes. Metformin may have cardiovascular benefits beyond blood glucose lowering in type 2 diabetes but its association with hypomagnesemia appears paradoxical. The aim of this study was to examine relationships between metformin therapy, magnesium homoeostasis and cardiovascular disease in well-characterized type 2 patients from the community.We studied 940 non-insulin-treated patients (mean ± SD age 63.4 ± 11.6 years, 49.0% males from the longitudinal observational Fremantle Diabetes Study Phase I (FDS1 who were followed for 12.3 ± 5.3 years. Baseline serum magnesium was measured using stored sera. Multivariate methods were used to determine associates of prevalent and incident coronary heart disease (CHD and cerebrovascular disease (CVD as ascertained from self-report and linked morbidity/mortality databases. 19% of patients were hypomagnesemic (serum magnesium <0.70 mmol/L. Patients on metformin, alone or combined with a sulfonylurea, had lower serum magnesium concentrations than those on diet alone (P<0.05. There were no independent associations between serum magnesium or metformin therapy and either CHD or CVD at baseline. Incident CVD, but not CHD, was independently and inversely associated with serum magnesium (hazard ratio (95% CI 0.28 (0.11-0.74; P=0.010, but metformin therapy was not a significant variable in these models.Since hypomagnesemia appears to be an independent risk factor for CVD complicating type 2 diabetes, the value of replacement therapy should be investigated further, especially in patients at high CVD risk.

  18. Study of qinolones usage in prevention and therapy of septic complications of radiation damage

    International Nuclear Information System (INIS)

    Petyrek, P.; Spelda, S.

    1994-01-01

    A standard model of experimental sepsis was elaborated at rats in dependence on a gamma irradiation dose and a time interval between irradiation and application infectious agents E. coli O 83:K 24:H 31. For a development of experimental sepsis was proved that it is not decisive in these laboratory animals when infectious agents is i.v. or i.p. applicated. Such amount of organisms (1-20.10 7-8 ) was applicated in particular not to develop sepsis in non-irradiated laboratory animals. Laboratory animals were irradiated with sublethal doses and approximately. LD 50-30 doses of gamma radiation. The laboratory animals were treated only in experiments and qinolone drug ofloxacin was used in the treatment of experimental sepsis. Ofloxacin perorally administrated in the dose of 40 mg/kg in an hour after application of infectious agents and its administration for 5 days in the 24-h intervals confirmed in fact 100% therapeutic effectiveness in irradiated experimental animals. In non-treated experimental groups, animals died in 24-28 hours interval after application of infectious agents and sepsis was a cause of death. In treated experimental groups, animal survived by day 30 after irradiation with sublethal doses or died during the period typical for a bone marrow syndrome of acute radiation injury after irradiation with lethal doses of gamma radiation. Acquired experimental outcomes may suggest that fluorochinolone chemotherapeuticals in the respect of their essential pharmacokinetic properties will be used for a prevention of infectious complications in acute radiation injury. (author)

  19. A successful therapy for severe malaria accompanied by malaria-related acute kidney injury (MAKI) complications: a case report

    Science.gov (United States)

    Syahputra, A.; Siregar, M. L.; Jamil, K. F.

    2018-03-01

    Indonesia is an endemic malaria country with high levels of morbidity and mortality. In Aceh, by the end of 2016, based on the data from Annual Parasite Incidence, the incidence rate was 0.1 per 1.000 population at risk of malaria. One of severe malaria complications is malaria-related acute kidney injury(MAKI). The death increasesthreefold by the presence of MAKI. A 56 years old male farmer was a resident in Buketmeuh village, Meukek, South Aceh, Indonesia, which was an endemic malaria area. He hadfever for seven days, chills, sweating, joint pain, headache, nausea, vomit, yellow eyes and raved. Concentrated tea-colored urineduring four days before hospital admission with a small amount of urine of 200 cc in 24 hours. The diagnosis established based on the Plasmodium vivax trophozoite finding in the blood smear examination, and the severe malaria clinical descriptions such as black water fever (BWF)with MAKI complications. Artemether injection therapy followed by oral primaquine, dihydroartemisinin and piperaquine phosphate (DHP) and hemodialysis provide a good outcome.

  20. Are bile acid malabsorption and bile acid diarrhoea important causes of loose stool complicating cancer therapy?

    Science.gov (United States)

    Phillips, F; Muls, A C G; Lalji, A; Andreyev, H J N

    2015-08-01

    Gastrointestinal (GI) symptoms during and after cancer therapy can significantly affect quality of life and interfere with treatment. This study assessed whether bile acid malabsorption (BAM) or bile acid diarrhoea (BAD) are important causes of diarrhoea associated with cancer treatment. A retrospective analysis was carried out of consecutive patients assessed for BAM using ((75) Se) Selenium homocholic acid taurocholate (SeHCAT) scanning, after reporting any episodes of loose stool, attending a gastroenterology clinic in a cancer centre. Between 2009 and 2013, 506 consecutive patients (54.5% male; age range: 20-91 years), were scanned. BAM/BAD was diagnosed in 215 (42.5%). It was mild in 25.6%, moderate in 29.3% and severe in 45.1%. Pelvic chemoradiation had induced BAM in > 50% of patients. BAM was also frequent after treatment for conditions not previously associated with BAM, such as anal and colorectal cancer, and was present in > 75% of patients referred after pancreatic surgery. It was also unexpectedly frequent in patients who were treated for malignancy outside the GI tract, such as breast cancer and haematological malignancy. BAM/BAD are very common and under-appreciated causes of GI symptoms after cancer treatment. Health professionals should have a low threshold in suspecting this condition, as diagnosis and treatment can significantly improve quality of life. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  1. Increased Body Mass Index during Therapy for Childhood Acute Lymphoblastic Leukemia: A Significant and Underestimated Complication

    Directory of Open Access Journals (Sweden)

    Helen C. Atkinson

    2015-01-01

    Full Text Available Objective & Design. We undertook a retrospective review of children diagnosed with acute lymphoblastic leukemia (ALL and treated with modern COG protocols (n=80 to determine longitudinal changes in body mass index (BMI and the prevalence of obesity compared with a healthy reference population. Results. At diagnosis, the majority of patients (77.5% were in the healthy weight category. During treatment, increases in BMI z-scores were greater for females than males; the prevalence of obesity increased from 10.3% to 44.8% (P<0.004 for females but remained relatively unchanged for males (9.8% to 13.7%, P=0.7. Longitudinal analysis using linear mixed-effects identified associations between BMI z-scores and time-dependent interactions with sex (P=0.0005, disease risk (P<0.0001, age (P=0.0001, and BMI z-score (P<0.0001 at diagnosis and total dose of steroid during maintenance (P=0.01. Predicted mean BMI z-scores at the end of therapy were greater for females with standard risk ALL irrespective of age at diagnosis and for males younger than 4 years of age at diagnosis with standard risk ALL. Conclusion. Females treated on standard risk protocols and younger males may be at greatest risk of becoming obese during treatment for ALL. These subgroups may benefit from intervention strategies to manage BMI during treatment for ALL.

  2. Dose-Volume Histogram Predictors of Chronic Gastrointestinal Complications After Radical Hysterectomy and Postoperative Concurrent Nedaplatin-Based Chemoradiation Therapy for Early-Stage Cervical Cancer

    International Nuclear Information System (INIS)

    Isohashi, Fumiaki; Yoshioka, Yasuo; Mabuchi, Seiji; Konishi, Koji; Koizumi, Masahiko; Takahashi, Yutaka; Ogata, Toshiyuki; Maruoka, Shintaroh; Kimura, Tadashi; Ogawa, Kazuhiko

    2013-01-01

    Purpose: The purpose of this study was to evaluate dose-volume histogram (DVH) predictors for the development of chronic gastrointestinal (GI) complications in cervical cancer patients who underwent radical hysterectomy and postoperative concurrent nedaplatin-based chemoradiation therapy. Methods and Materials: This study analyzed 97 patients who underwent postoperative concurrent chemoradiation therapy. The organs at risk that were contoured were the small bowel loops, large bowel loop, and peritoneal cavity. DVH parameters subjected to analysis included the volumes of these organs receiving more than 15, 30, 40, and 45 Gy (V15-V45) and their mean dose. Associations between DVH parameters or clinical factors and the incidence of grade 2 or higher chronic GI complications were evaluated. Results: Of the clinical factors, smoking and low body mass index (BMI) (<22) were significantly associated with grade 2 or higher chronic GI complications. Also, patients with chronic GI complications had significantly greater V15-V45 volumes and higher mean dose of the small bowel loops compared with those without GI complications. In contrast, no parameters for the large bowel loop or peritoneal cavity were significantly associated with GI complications. Results of the receiver operating characteristics (ROC) curve analysis led to the conclusion that V15-V45 of the small bowel loops has high accuracy for prediction of GI complications. Among these parameters, V40 gave the highest area under the ROC curve. Finally, multivariate analysis was performed with V40 of the small bowel loops and 2 other clinical parameters that were judged to be potential risk factors for chronic GI complications: BMI and smoking. Of these 3 parameters, V40 of the small bowel loops and smoking emerged as independent predictors of chronic GI complications. Conclusions: DVH parameters of the small bowel loops may serve as predictors of grade 2 or higher chronic GI complications after postoperative

  3. Interventional therapy of refractory hemoptysis complicated with bronchial artery to pulmonary circulation shunt

    International Nuclear Information System (INIS)

    Yang Qing; Yang Dakuan; Wang Jiaping; Guo Li; Yang Feifei; Tong Yuyun

    2010-01-01

    , for patients with bronchial artery to pulmonary artery shunt bronchial arterial embolization with fine particles is more effective and has fewer complications. (authors)

  4. Assessment of complications in a randomized controlled study on multimodality therapy for patients following breast-conserving surgery

    International Nuclear Information System (INIS)

    Hiraoka, Masahiro; Inoue, Toshihiko; Kodama, Hiroshi; Sako, Masao

    2002-01-01

    We conducted a randomized controlled study to evaluate the safety and usefulness of a combined treatment of radiotherapy and chemotherapy with doxifluridine (5'-DFUR) plus tamoxifen (TAM) as an adjuvant therapy for breast cancer patients after conservative surgery. The complications observed in this trial are reported herein. A total of 550 patients were registered and randomized (based on factors such as T, N, with/without radiotherapy) to groups A and B. Drug regimens were: group A, 5'-DFUR 600 mg/body/day for 6 months and TAM 20 mg/body/day for 2 years; group B, 5'-DFUR 600 mg/body/day for 2 years and TAM 20 mg/body/day for 2 years. Radiotherapy (2 Gy x 5 times/week, for 5 weeks) was administered to 88.6% of evaluable patients (481/543). Radiation-related acute adverse reactions occurred in 28.5% of the 481 patients and moderate to severe reactions occurred in 1.5% of the patients. Delayed radiation-related adverse reactions occurred in 17.9% of group A patients and 25.6% of group B patients. Grade 3 reactions occurred in 6 of the group A patients (2.4%) and in 5 of the group B patients (1.9%); all adverse reactions subsided after dose reduction or discontinuation. These findings suggest that the combination therapy of irradiation and 5'-DFUR with TAM is safe for patients after breast conserving surgery. (author)

  5. Long-term use of adalimumab in the treatment of rheumatic diseases

    Directory of Open Access Journals (Sweden)

    Charalampos Papagoras

    2009-05-01

    Full Text Available Charalampos Papagoras, Paraskevi V Voulgari, Alexandros A DrososRheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, GreeceAbstract: Adalimumab, a fully humanized monoclonal antibody against tumor necrosis factor-alpha (TNFα, has been evaluated in various randomized placebo-controlled trials in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. In the short time frame of these trials adalimumab has been shown to be effective in reducing disease activity, slowing radiographic disease progression and improving patients’ quality of life, while at the same time demonstrating an acceptable safety profile. Furthermore, release of adalimumab on the market, prospective observational studies, as well as open-label extensions of the original double-blind trials have provided experience and data about the long-term efficacy and safety of the drug. Initial effectiveness, in terms of reducing disease activity, is sustained, while in most cases patients treated with adalimumab experienced a slower radiographic progression and consequently less disability and improved health-related quality-of-life outcomes. Moreover, long-standing treatment of thousands of patients with adalimumab outside the controlled context of clinical trials was not related to new safety signals, with the most common adverse events being respiratory infections. The most common serious adverse events seem to be tuberculosis reactivation, while a putative association with malignant lymphoma development is not yet proven. Besides, both of these adverse reactions pertain to the whole TNFα blocker group. In conclusion, adalimumab is a safe and effective option for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. Keywords: adalimumab, tumor necrosis factor-alpha, rheumatoid arthritis, ankylosing spondylitis

  6. Targeting Tumor Necrosis Factor-α with Adalimumab: Effects on Endothelial Activation and Monocyte Adhesion.

    Directory of Open Access Journals (Sweden)

    Raghav Oberoi

    Full Text Available It is well known that atherosclerotic inflammatory vascular disease is critically driven by oxidized lipids and cytokines. In this regard, tumor necrosis factor (TNF-α is known as a crucial mediator of early pro-atherosclerotic events. Epidemiologic data suggest that blockade of TNF-α has beneficial effects on vascular outcomes in patients with rheumatoid arthritis, however, detailed mechanistic studies are still lacking. This study aims to elucidate effects of TNF-α blockade by adalimumab-which is approved for several inflammatory disorders-on endothelial activation and monocyte adhesion under pro-atherosclerotic conditions.Phorbol myristate acetate (PMA differentiated THP-1 macrophages were stimulated with oxidized low density lipoprotein and subsequent analysis of this conditioned media (oxLDL CM revealed a strong release of TNF-α. The TNF-α rich supernatant led to activation of human umbilical vein endothelial cells (HUVEC as shown by enhanced expression of major adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1, intercellular adhesion molecule-1 (ICAM-1 and E-selectin which was suppressed by the TNF-α inhibitor adalimumab. Accordingly, adalimumab effectively prevented THP-1 monocyte adhesion to endothelial cells under static as well as under flow conditions. Furthermore, adalimumab suppressed endothelial leakage as shown by Evan's blue diffusion across a confluent endothelial monolayer. Of note, after intraperitoneal injection we detected abundant deposition of fluorophore-labelled adalimumab in atherosclerotic plaques of hypercholesterolemic mice.Our results show that adalimumab prevents major inflammatory effects of TNF-α on endothelial activation, endothelial monocyte adhesion, endothelial leakage and therefore extends the therapeutic options of adalimumab to limit vascular inflammation.

  7. Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab.

    Science.gov (United States)

    Liu, Jennifer; Eris, Tamer; Li, Cynthia; Cao, Shawn; Kuhns, Scott

    2016-08-01

    ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed. The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods. Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation. ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions. Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.

  8. COMPARATIVE EVALUATION OF THE EFFICACY AND SAFETY OF TREATMENT USING ADALIMUMAB IN COMBINATION WITH METHOTREXATE AND METHOTREXATE MONOTHERAPY IN CHILDREN WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS IN COMBINATION WITH UVEITIS

    Directory of Open Access Journals (Sweden)

    V. А. Kel’tsev

    2014-01-01

    Full Text Available Juvenile idiopathic arthritis (JIA is the most common rheumatic disease in children and it is characterized by a primary lesion of the joints, organs and tissues with the formation of multiple organ failure of varying severity. The article describes the results of studying the efficacy and safety of adalimumab in combination with methotrexate (n = 26 and methotrexate monotherapy (n = 17 when treating the patients with polyarticular JIA and uveitis refractory to the basic immunosuppressive therapy. It was shown that the combination therapy induced the remission of arthritis in children with JIA in a shorter period of time. After 1 year, the disease remission was recorded in 42% of children in the treatment group and in 18% of children in the comparison group, the uveitis remission — in 26 (54% of 48 eyes and 2 (7% of 28 eyes with signs of lesions, respectively. It should be noted that adalimumab in combination with methotrexate was well tolerated and no serious adverse effects were recorded. Thus, the introduction of adalimumab in the treatment regimen of children with JIA and uveitis refractory to the basic immunosuppressive therapy allowed for the rapid disease remission while preserving the effect in a significant number of patients during the following year.

  9. Adalimumab for the treatment of Crohn’s disease

    Directory of Open Access Journals (Sweden)

    Andrea Cassinotti

    2008-09-01

    Full Text Available Andrea Cassinotti, Sandro Ardizzone, Gabriele Bianchi PorroDepartment of Clinical Sciences, Chair of Gastroenterology, “Luigi Sacco” University Hospital, Milan, ItalyIntroduction: Crohn’s disease (CD is a chronic inflammatory bowel disease characterized by a relapsing-remitting course with trans-mural inflammation of potentially any section of the digestive tract. Adalimumab (ADA is a subcutaneously administered, recombinant, fully human, IgG1 monoclonal antibody that binds with high affinity and specificity to human TNF-alpha, thus modulating its biologic functions and its proinflammatory effects.Aims: To review the available data on ADA in CD for biological properties, efficacy, and safety.Methods: Electronic searches were conducted using the Pubmed and SCOPUS databases from the earliest records to April 2008. The search terms used were “adalimumab”, “anti-TNF”, “TNF-alpha”, “biologicals”, “inflammatory bowel disease”, and “Crohn’s disease”. Reference lists of all relevant articles were searched for further studies.Results: Available studies suggest that ADA has the potential to induce and maintain clinical response and remission in moderate-severe CD, both in anti-TNF-naïve patients and in subjects who lost their response and/or became intolerant to infliximab (IFX. ADA seems also effective in maintaining corticosteroid-free remission and obtaining complete fistula closure (although no specific randomized trials are available. No concomitant immunosuppressors seem to be necessary. Side effects appear similar to IFX, while site-injection reactions are frequent and specific. Data on immunogenicity and its clinical impact are uncertain.Conclusions: ADA appears to be effective in inducing and maintain clinical remission in CD, including patients not manageable with IFX. Successive clinical practice and further on going trials will confirm a positive role for ADA as a new anti-TNF treatment in CD. The impact on

  10. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis.

    Science.gov (United States)

    Mease, Philip; Hall, Stephen; FitzGerald, Oliver; van der Heijde, Désirée; Merola, Joseph F; Avila-Zapata, Francisco; Cieślak, Dorota; Graham, Daniela; Wang, Cunshan; Menon, Sujatha; Hendrikx, Thijs; Kanik, Keith S

    2017-10-19

    Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs). In this 12-month, double-blind, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:1:1 ratio to receive one of the following regimens: tofacitinib at a 5-mg dose taken orally twice daily (107 patients), tofacitinib at a 10-mg dose taken orally twice daily (104), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106), placebo with a blinded switch to the 5-mg tofacitinib dose at 3 months (52), or placebo with a blinded switch to the 10-mg tofacitinib dose at 3 months (53). Placebo groups were pooled for analyses up to month 3. Primary end points were the proportion of patients who had an American College of Rheumatology 20 (ACR20) response (≥20% improvement from baseline in the number of tender and swollen joints and at least three of five other important domains) at month 3 and the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score (scores range from 0 to 3, with higher scores indicating greater disability) at month 3. ACR20 response rates at month 3 were 50% in the 5-mg tofacitinib group and 61% in the 10-mg tofacitinib group, as compared with 33% in the placebo group (P=0.01 for the comparison of the 5-mg dose with placebo; Ptofacitinib group and -0.40 in the 10-mg tofacitinib group, as compared with -0.18 in the placebo group (P=0.006 for the comparison of the 5-mg dose with placebo; Ptofacitinib group, 71% in the 10-mg tofacitinib group, 72% in the adalimumab group, 69% in the placebo group that switched to the 5-mg tofacitinib dose, and 64% in the placebo group that switched to the 10-mg tofacitinib dose. There were four cases of cancer, three serious

  11. Switching Therapy from Intravenous Landiolol to Transdermal Bisoprolol in a Patient with Thyroid Storm Complicated by Decompensated Heart Failure and Gastrointestinal Dysfunction.

    Science.gov (United States)

    Godo, Shigeo; Kawazoe, Yu; Ozaki, Hiroshi; Fujita, Motoo; Kudo, Daisuke; Nomura, Ryosuke; Shimokawa, Hiroaki; Kushimoto, Shigeki

    2017-10-01

    Thyroid storm is a life-threatening disorder that remains a therapeutic challenge. Although β-blockers are the mainstay for treatment, their use can be challenging in cases complicated by rapid atrial fibrillation and decompensated heart failure. We present a case of thyroid storm-associated atrial fibrillation and decompensated heart failure complicated by gastrointestinal dysfunction secondary to diffuse peritonitis that was successfully managed by a switching therapy, in which the continuous intravenous administration of landiolol was changed to bisoprolol via transdermal patch, in the acute phase treatment. This switching therapy may offer a promising therapeutic option for this potentially lethal disorder.

  12. A novel method for the detection of antibodies to adalimumab in the presence of drug reveals "hidden" immunogenicity in rheumatoid arthritis patients

    NARCIS (Netherlands)

    van Schouwenburg, Pauline A.; Bartelds, Geertje M.; Hart, Margreet H.; Aarden, Lucien; Wolbink, Gerrit Jan; Wouters, Diana

    2010-01-01

    Production of anti drug antibodies (ADA) in adalimumab treated RA patients is associated with reduced serum adalimumab levels and less clinical response. However, most current assays to measure ADA are unable to detect ADA in complex with adalimumab. Thus, ADA is only measured if antibody production

  13. Changes in bone mineral density during long-term treatment with adalimumab in patients with rheumatoid arthritis: a cohort study

    NARCIS (Netherlands)

    Krieckaert, C.L.M.; Nurmohamed, M.T.; Wolbink, G.; Lems, W.F.

    2013-01-01

    Objective. To investigate the effect of long-term adalimumab treatment on BMD of the lumbar spine, total hip and hands in patients with RA. Methods. In 184 established RA patients treated with adalimumab for at least 1 year, BMD measurements of the total hip and lumbar spine were performed using

  14. Metabolic complications in oncology

    International Nuclear Information System (INIS)

    Sycova-Mila, Z.

    2012-01-01

    Currently, a lot of space and time is devoted to the therapy of oncologic diseases itself. To reach the good therapy results, complex care of the oncologic patient is needed. Management of complications linked with the disease itself and management of complications emerged after administration of chemotherapy, radiotherapy or targeted therapy, plays a significant role. In addition to infectious, hematological, neurological, cardiac or other complications, metabolic complications are relatively extensive and serious. One of the most frequent metabolic complications in oncology is tumor lysis syndrome, hyperuricemia, hypercalcaemia and syndrome of inappropriate secretion of antidiuretic hormone. (author)

  15. Mitochondrial genomics and antiretroviral therapy-associated metabolic complications in HIV-infected Black South Africans: a pilot study.

    Science.gov (United States)

    Sinxadi, Phumla Z; Dave, Joel A; Samuels, David C; Heckmann, Jeannine M; Maartens, Gary; Levitt, Naomi S; Wester, C William; Haas, David W; Hulgan, Todd

    2013-07-01

    Studies suggest that mitochondrial DNA (mtDNA) haplogroups are associated with antiretroviral therapy (ART)-related metabolic complications and distal sensory polyneuropathy (DSP), but there have been few studies in persons of African descent. We explored such associations in South African adults. Clinical and laboratory data and DNA specimens from a cross-sectional study were used. Sequencing and Phylotree determined African mtDNA subhaplogroups. Wilcoxon and regression analyses determined associations between mtDNA subhaplogroups and ART-related complications. The 171 participants represented six major haplogroups: L0 (n=78), L1 (n=3), L2 (n=30), L3 (n=53), L4 (n=1), and L5 (n=6). Analyses were restricted to 161 participants representing L0, L2, and L3: 78% were female; the median age was 36 years. All had been exposed to thymidine analogues, 42% were on lopinavir/ritonavir (lopinavir/r), and 58% were on either efavirenz or nevirapine. Median (IQR) ART duration was 22 (14-36) months. Median fasting triglycerides were 1.60 (1.13-1.75) and 1.04 (0.83-1.45) mmol/liter among L3e1 (n=22) and other subhaplogroups, respectively (p=0.003). Subhaplogroup L3e1 [adjusted OR (aOR) 3.16 (95% CI: 1.11-8.96); p=0.03] and exposure to lopinavir/r [aOR 2.98 (95% CI: 1.02-8.96); p=0.05] were independently associated with hypertriglyceridemia, after adjusting for age, sex, and ART duration. There were no significant associations between mtDNA haplogroups and cholesterol, dysglycemia, hyperlactatemia, or lipoatrophy, or DSP. Subhaplogroup L3e1 and lopinavir/r exposure were independently associated with hypertriglyceridemia in black South Africans on ART. This is the first report to link an African mtDNA variant with hypertriglyceridemia. If replicated, these findings may provide new insights into host factors affecting metabolic complications.

  16. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial.

    Science.gov (United States)

    del Río, Ana; Gasch, Oriol; Moreno, Asunción; Peña, Carmen; Cuquet, Jordi; Soy, Dolors; Mestres, Carlos A; Suárez, Cristina; Pare, Juan C; Tubau, Fe; Garcia de la Mària, Cristina; Marco, Francesc; Carratalà, Jordi; Gatell, José M; Gudiol, Francisco; Miró, José M

    2014-10-15

    There is an urgent need for alternative rescue therapies in invasive infections caused by methicillin-resistant Staphylococcus aureus (MRSA). We assessed the clinical efficacy and safety of the combination of fosfomycin and imipenem as rescue therapy for MRSA infective endocarditis and complicated bacteremia. The trial was conducted between 2001 and 2010 in 3 Spanish hospitals. Adult patients with complicated MRSA bacteremia or endocarditis requiring rescue therapy were eligible for the study. Treatment with fosfomycin (2 g/6 hours IV) plus imipenem (1 g/6 hours IV) was started and monitored. The primary efficacy endpoints were percentage of sterile blood cultures at 72 hours and clinical success rate assessed at the test-of-cure visit (45 days after the end of therapy). The combination was administered in 12 patients with endocarditis, 2 with vascular graft infection, and 2 with complicated bacteremia. Therapy had previously failed with vancomycin in 9 patients, daptomycin in 2, and sequential antibiotics in 5. Blood cultures were negative 72 hours after the first dose of the combination in all cases. The success rate was 69%, and only 1 of 5 deaths was related to the MRSA infection. Although the combination was safe in most patients (94%), a patient with liver cirrhosis died of multiorgan failure secondary to sodium overload. There were no episodes of breakthrough bacteremia or relapse. Fosfomycin plus imipenem was an effective and safe combination when used as rescue therapy for complicated MRSA bloodstream infections and deserves further clinical evaluation as initial therapy in these infections. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  17. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications : study protocol for a randomized, double-blind, controlled trial (LASER-1)

    NARCIS (Netherlands)

    Nijenhuis-Rosien, Leonie; Kleefstra, Nanne; Wolfhagen, Maurice J.; Groenier, Klaas H.; Bilo, Henk J. G.; Landman, Gijs W. D.

    2015-01-01

    Background: In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in

  18. Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction

    DEFF Research Database (Denmark)

    Hørslev-Petersen, K; Hetland, M L; Ørnbjerg, L M

    2015-01-01

    OBJECTIVES: To study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647). METHODS: Disease-modifying antirheuma......OBJECTIVES: To study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647). METHODS: Disease.......12). Erosive progression (Δerosion score (ES)/year) was year 1:0.57/0.06 (p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (ΔES≤0) was year 1: 59%/76% (p=0.03); year 2:64%/79% (p=0.04). CONCLUSIONS: An aggressive triamcinolone and synthetic DMARD treat-to-target strategy...... was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120 mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) ≤3.2 or DAS28>3.2 without swollen joints) was achieved at all visits in ≥85% of patients in year 2; remission rates were...

  19. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation.

    Science.gov (United States)

    Duarte, Ana; Mebrahtu, Teumzghi; Goncalves, Pedro Saramago; Harden, Melissa; Murphy, Ruth; Palmer, Stephen; Woolacott, Nerys; Rodgers, Mark; Rothery, Claire

    2017-11-01

    Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA ® , AbbVie, Maidenhead, UK), etanercept (Enbrel ® , Pfizer, New York, NY, USA) and ustekinumab (STELARA ® , Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people. Searches of the literature and regulatory sources, contact with European psoriasis registries, company submissions and clinical study reports from manufacturers, and previous National Institute for Health and Care Excellence (NICE) technology appraisal documentation. Included studies were summarised and subjected to detailed critical appraisal. A network meta-analysis incorporating adult data was developed to connect the effectiveness data in children and young people and populate a de novo decision-analytic model. The model estimated the cost-effectiveness of adalimumab, etanercept and ustekinumab compared with each other and with either methotrexate or best supportive care (BSC), depending on the position of the intervention in the management pathway. Of the 2386 non-duplicate records identified, nine studies (one randomised controlled trial for each drug plus six observational studies) were included in the review of clinical effectiveness and safety. Etanercept and ustekinumab resulted in significantly greater improvements in psoriasis symptoms than placebo at 12 weeks' follow-up. The magnitude and persistence of the effects beyond 12 weeks is less certain. Adalimumab resulted in significantly greater improvements in psoriasis symptoms than methotrexate for some but not all measures at 16 weeks. Quality-of-life benefits were inconsistent across different measures. There was limited evidence of excess short

  20. Serum Transforming Growth Factor-β1 Change After Neoadjuvant Chemoradiation Therapy Is Associated With Postoperative Pulmonary Complications in Esophageal Cancer Patients Undergoing Combined Modality Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Lu, Shao-Lun; Hsu, Feng-Ming; Tsai, Chiao-Ling; Wu, Jian-Kuan [Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan (China); Lee, Jang-Ming; Huang, Pei-Ming [Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan (China); Hsu, Chih-Hung [Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan (China); Koong, Albert C.; Chang, Daniel T. [Department of Radiation Oncology, Stanford University, Stanford, California (United States); Chia-Hsien Cheng, Jason, E-mail: jasoncheng@ntu.edu.tw [Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan (China); Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan (China)

    2015-12-01

    Purpose: Our aim was to investigate the association of clinical factors, dosimetric parameters, and biomarkers with postoperative pulmonary complications (PPCs) in patients with locally advanced esophageal squamous cell carcinoma (ESCC) treated by neoadjuvant concurrent chemoradiation therapy (CCRT) under strict pulmonary dose constraints and esophagectomy. Methods and Materials: We prospectively enrolled 112 patients undergoing trimodality treatment (including radiation therapy [40 Gy], concurrent taxane-/5-fluorouracil-based regimens, and radical esophagectomy) for ESCC. A PPC was defined as pneumonia or acute respiratory distress syndrome within 30 days after surgery. Serum samples were collected before and within 1 month after CCRT. The association of serum biomarkers with PPCs was detected by proximity ligation assay (PLA) and verified by enzyme-linked immunosorbent assay. Associations of clinical factors, lung dosimetric parameters, and biomarkers with PPC were tested statistically. Results: Thirty-three patients (29.5%) had PPCs. None of the dosimetric parameters was associated with PPCs. Preoperative functional vital capacity (FVC) was significantly associated with PPCs (P=.004). Of the 15 PLA-screened biomarkers, posttreatment transforming growth factor-β1 (TGF-β1) was borderline significantly associated with PPCs (P=.087). Patients with PPCs had significantly larger pre-CCRT to post-CCRT decrease in serum TGF-β1 concentration (−11,310 vs −5332 pg/mL, P=.005) and higher pre-CCRT to post-CCRT percent decline in serum TGF-β1 concentration (−37.4% vs −25.0%, P=.009) than patients without PPCs. On multivariate analysis, preoperative FVC (P=.003) and decrease in TGF-β1 >7040 pg/mL (P=.014) were independent factors associated with PPCs. Conclusions: Preoperative FVC and decrease in serum TGF-β1 level after dose-limited CCRT to the lung are associated with the development of PPCs.

  1. EXPERIENCE OF TREATMENT OF JUVENILE POLYARTHRITIS WITH EYES LESION WITH ADALIMUMAB

    Directory of Open Access Journals (Sweden)

    A.O. Lisitsin

    2008-01-01

    Full Text Available A case report of early debut and severe course of juvenile poly arthritis with eyes lesion refractory to classic immuno suppressive agents is presented in this article. Successful application of biological agent adalimumab is described: acute inflammatory alterations in affected joints were stopped by 49 the week. Range of motions in affected joints was recovered. The remission of veitis, normalization of indicators of disease activity (ESR, concentration of creactive protein in blood plasma was registered by 89 th week.Key words: children, juvenile rheumatoid arthritis, rheumatoid uveitis, adalimumab.

  2. Periodontal and serum protein profiles in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitor adalimumab.

    Science.gov (United States)

    Kobayashi, Tetsuo; Yokoyama, Tomoko; Ito, Satoshi; Kobayashi, Daisuke; Yamagata, Akira; Okada, Moe; Oofusa, Ken; Narita, Ichiei; Murasawa, Akira; Nakazono, Kiyoshi; Yoshie, Hiromasa

    2014-11-01

    Tumor necrosis factor (TNF)-α inhibitor has been shown to affect the periodontal condition of patients with rheumatoid arthritis (RA). The aim of the present study is to assess the effect of a fully humanized anti-TNF-α monoclonal antibody, adalimumab (ADA), on the periodontal condition of patients with RA and to compare serum protein profiles before and after ADA therapy. The study participants consisted of 20 patients with RA treated with ADA. Clinical periodontal and rheumatologic parameters and serum cytokine levels were evaluated at baseline and 3 months later. Serum protein spot volume was examined with two-dimensional sodium dodecyl sulfate polyacrylamide gel electrophoresis. Proteins with significant difference in abundance before and after ADA therapy were found and identified using mass spectrometry and protein databases. The patients showed a significant decrease in gingival index (P = 0.002), bleeding on probing (P = 0.003), probing depth (P = 0.002), disease activity score including 28 joints using C-reactive protein (P protein spots obtained, nine spots were significantly decreased in abundance at reassessment, corresponding to complement factor H, phospholipase D, serum amyloid A, complement component 4, and α-1-acid glycoprotein (P periodontal condition of patients with RA, which might be related to differences in serum protein profiles before and after ADA therapy.

  3. Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus

    Science.gov (United States)

    Lee, Ai-Lin; Chen, Bor-Chyuan; Mou, Chih-Hsin; Sun, Mao-Feng; Yen, Hung-Rong

    2016-01-01

    Abstract With an increasing use of traditional Chinese medicine (TCM) in type 2 diabetes mellitus (T2DM), evidence of long-term benefit with adjunctive TCM treatment is limited. This study investigated whether the concurrent TCM treatment reduces the risk of vascular complications in T2DM patients by using a large population from National Health Insurance Research Database (NHIRD). We identified 33,457 adult patients with newly diagnosed T2DM using anti-diabetic agents from a random sample of one million beneficiaries in the NHIRD between January 1, 2000 and December 31, 2011. We recruited 1049 TCM users (received TCM over 30 days with a diagnosis of T2DM) and randomly selected 4092 controls as the non-TCM cohort at a ratio of 1:4 frequency-matched by age, sex, hypertension, hyperlipidemia, and index year. We investigated the prescription pattern of TCM and conducted a Cox proportional hazards regression to calculate the hazard ratios (HRs) of stroke, chronic kidney diseases (CKD), and diabetic foot between the 2 cohorts. In the TCM cohort, the prescription pattern of TCM was different between insulin and noninsulin patients. The most common herbs were Dan-Shen (Radix Salviae Miltiorrhizae) in noninsulin group and Da-Huang (Radix et Rhizoma Rhei) in insulin group. The most common formulae were Liu-Wei-Di-Huang-Wan in noninsulin group and Yu-Quan-Wan in insulin group. Although no significant reduction in the hazard ratio of CKD and diabetic foot, the incidence rate of stroke was 7.19 per 1000 person-years in the TCM cohort and 10.66 per 1000 person-years in the control cohort, respectively. After adjustment of age, sex, hypertension, hyperlipidemia, and antidiabetes agent use (including sulfonylureas, α-glucosidase, metformin, meglitinide, thiazolidinediones, and insulin), TCM cohorts were found to have a 33% decreased risk of stroke (95% CI = 0.46–0.97; P < 0.05). This population-based retrospective study showed that the complementary TCM therapy might

  4. The effect of pre-injury anti-platelet therapy on the development of complications in isolated blunt chest wall trauma: a retrospective study.

    Directory of Open Access Journals (Sweden)

    Ceri Battle

    Full Text Available INTRODUCTION: The difficulties in the management of the blunt chest wall trauma patient in the Emergency Department due to the development of late complications are well recognised in the literature. Pre-injury anti-platelet therapy has been previously investigated as a risk factor for poor outcomes following traumatic head injury, but not in the blunt chest wall trauma patient cohort. The aim of this study was to investigate pre-injury anti-platelet therapy as a risk factor for the development of complications in the recovery phase following blunt chest wall trauma. METHODS: A retrospective study was completed in which the medical notes were analysed of all blunt chest wall trauma patients presenting to a large trauma centre in Wales in 2012 and 2013. Using univariate and multivariable logistic regression analysis, pre-injury platelet therapy was investigated as a risk factor for the development of complications following blunt chest wall trauma. Previously identified risk factors were included in the analysis to address the influence of confounding. RESULTS: A total of 1303 isolated blunt chest wall trauma patients presented to the ED in Morriston Hospital in 2012 and 2013 with complications recorded in 144 patients (11%. On multi-variable analysis, pre-injury anti-platelet therapy was found to be a significant risk factor for the development of complications following isolated blunt chest wall trauma (odds ratio: 16.9; 95% confidence intervals: 8.2-35.2. As in previous studies patient age, number of rib fractures, chronic lung disease and pre-injury anti-coagulant use were also found to be significant risk factors. CONCLUSIONS: Pre-injury anti-platelet therapy is being increasingly used as a first line treatment for a number of conditions and there is a concurrent increase in trauma in the elderly population. Pre-injury anti-platelet therapy should be considered as a risk factor for the development of complications by clinicians managing

  5. Observational study on the efficacy of adalimumab for the treatment of ulcerative colitis and predictors of outcome.

    Science.gov (United States)

    García-Bosch, Orlando; Gisbert, Javier P; Cañas-Ventura, Alex; Merino, Olga; Cabriada, José L; García-Sánchez, Valle; Gutiérrez, Ana; Nos, Pilar; Peñalva, Mireia; Hinojosa, Joaquin; García-Planella, Esther; Muñoz, Fernando; Calvet, Xavier; Panés, Julián

    2013-10-01

    Information on efficacy and predictors of response to adalimumab in ulcerative colitis (UC) clinical practice is limited. Assessment of response to adalimumab and its predictors in an observational cohort study. Retrospective cohort study based on data obtained from ENEIDA registry. All patients diagnosed with UC treated with adalimumab were included. Response to adalimumab was evaluated at weeks 12, 28, and 54 according to the partial Mayo score, and requirement of colectomy until end of follow-up. 48 patients with UC treated with adalimumab were included; 39 (81.3%) had previously received infliximab. Response rates at weeks 12, 28 and 54 were 70.8%, 43.2% and 35% respectively. Response to prior treatment with infliximab was the only predictive factor of response to adalimumab at week 12, which was obtained in 90% of infliximab remitters, 53.8% of responders and 33.3% of primary non-responders (p=0.01). Colectomy was required in 11 patients (22.9%), after a mean time of 205 days. The only clinical independent predictor of colectomy was non-response to adalimumab at week 12: colectomy rates were 5/34 (14.7%) in responders and 6/14 (42.9%) in non-responders (p=0.035), time free of colectomy was significantly reduced in non-responders (p=0.01). Adalimumab withdrawal due to adverse events occurred in 4.2% of patients. This study shows that adalimumab is an effective treatment in patients with UC. If used as a second anti-TNF, previous achievement of remission with the first anti-TNF predicts response, and failure to achieve response at week 12 predicts colectomy. Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

  6. Treatment choices of paediatric rheumatologists for juvenile idiopathic arthritis : etanercept or adalimumab?

    NARCIS (Netherlands)

    Anink, Janneke; Otten, Marieke H; Gorter, Simone L; Prince, Femke H M; van Rossum, Marion A J; van den Berg, J Merlijn; van Pelt, Philomine A; Kamphuis, Sylvia; Brinkman, Danielle M C; Swen, Wijnand A A; Swart, Joost F; Wulffraat, Nico M; Dolman, Koert M; Koopman-Keemink, Yvonne; Hoppenreijs, Esther P A H; Armbrust, Wineke; ten Cate, Rebecca; van Suijlekom-Smit, Lisette W A

    OBJECTIVES: To evaluate differences in baseline characteristics between etanercept- and adalimumab-treated JIA patients and to reveal factors that influence the choice between these TNF inhibitors, which are considered equally effective in the recent ACR recommendations for JIA treatment. METHODS:

  7. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Genovese, Mark C.; van Vollenhoven, Ronald F.; Wilkinson, Bethanie; Wang, Lisy; Zwillich, Samuel H.; Gruben, David; Biswas, Pinaki; Riese, Richard; Takiya, Liza; Jones, Thomas V.

    2016-01-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA. Analyses included patients

  8. Adalimumab Dose Tapering in Psoriasis: Predictive Factors for Maintenance of Complete Clearance.

    Science.gov (United States)

    Hansel, Katharina; Bianchi, Leonardo; Lanza, Francesco; Bini, Vittorio; Stingeni, Luca

    2017-03-10

    Psoriasis can be managed successfully with long-term biologics. Real-life clinical practice may require dose tapering as a therapeutic option to reduce the risk of drug-exposure and to increase cost-effectiveness. The responsiveness to extended intervals between adalimumab doses and the possible predictive factors of maintenance of complete clearance were studied in a retrospective 7-year single-centre analysis. Thirty patients who achieved complete clearance with adalimumab underwent dose tapering, progressively extending between-dose intervals (to 21-28 days). Sixty percent of subjects (group A) maintained complete clearance, whereas 40.0% (group B) relapsed and were switched back to the standard dosage to re-achieve complete clearance. Body mass index (BMI) and time to achieve Psoriasis Area Severity Index (PASI-100) with adalimumab standard treatment before dose tapering were significantly lower in group A than in group B (multi-variate Cox regression: p < 0.05, Kaplan-Meier analysis: p < 0.001, respectively). This study suggests that patients with lower BMI and shorter time to achieve PASI-100 with adalimumab standard dose were significantly more likely to be candidates for dose tapering.

  9. [Economic impact of etanercept and adalimumab biosimilars on hospitals scale covered by PharmAlp'Ain, a hospitals grouping of orders for health products].

    Science.gov (United States)

    Berreur, B; Guerin, F; Christophe, B; Limido, G; Paubel, P

    2018-01-01

    To evaluate the economic impact of future prescriptions of etanercept and adalimumab biosimilars at the territorial scale covered by PharmAlp'Ain, a hospitals grouping of orders for health products. Determination of the number and status of patients (naive or in continuation of treatment) from the National Database "Datamart de Consommation Inter-Régimes" of health insurance, concerned by a dispensation in a pharmacy of etanercept or adalimumab in 2015. Calculation of potential savings in case of biosimilar requirements according to 3 hypotheses: 63% (rate observed in a previous study) of initiations are treated with biosimiliaries and the others by princeps (H 1 ); all initiations under biosimilars and continuation therapy with the princeps (H 2 ) or all patients are treated with biosimilars (H 3 ). The annual savings are estimated at 237,000 € with the H 1 hypothesis. In the case of H 2 , the expected savings would be 376,200 € per year. In the case of H 3 , savings for the community could reach almost 1,282,800 € per year. The arrival of biosimilars allows significant savings for medicines market. According to the French recommendations in 2016, the expected savings are between the H 1 and H 2 hypothesis. The rate of penetration of biosimilars depends on many factors such as the involvement of health professionals, patient adherence, or health authority recommendations. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  10. Achievement of sustained deep remission with adalimumab in a patient with both refractory ulcerative colitis and seronegative erosive rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    G. Andrisani

    2013-05-01

    Full Text Available Inflammatory bowel disease (IBD is commonly associated with peripheral inflammatory arthritis, and it has been estimated that as many as 12% of IBD patients report these manifestations. However, rheumatoid arthritis (RA is rarely associated with ulcerative colitis (UC. Among all the biological agents available, nine have been currently approved for the treatment of RA. Conversely, only Infliximab and recently Adalimumab have been approved for UC. In particular, the efficacy of Adalimumab in UC has been demonstrated by both recent randomized controlled trials and real-life studies. Moreover, Adalimumab is a well-established treatment for RA. Herein, we describe a patient with RA and UC treated successfully with ADA.

  11. Multiple cardiac complications after adjuvant therapy for breast cancer: the importance of echocardiography. A case report and review of the literature.

    Science.gov (United States)

    Gurghean, Adriana Luminita; Savulescu-Fiedler, Ilinca; Mihailescu, Anca

    2017-01-31

    Cardiovascular complications induced by adjuvant cancer therapies may become symptomatic after many years, being responsible for increased morbidity and mortality in long-term survivors. We report a case of a 54-year old female admitted for severe heart failure induced by myocardial and valvular damage after postoperative adjuvant therapy for left breast cancer 6 years ago. Her recent history revealed nonST elevation myocardial infarction in the absence of significant cardiovascular risk factors. Transthoracic echocardiography, tissue Doppler imaging and speckle-tracking imaging revealed severe biventricular systolic dysfunction, severe mitral and tricuspid regurgitation and severe pulmonary hypertension.

  12. Hemophilia A Pseudoaneurysm in a Patient with High Responding Inhibitors Complicating Total Knee Arthroplasty: Embolization: A Cost-Reducing Alternative to Medical Therapy

    International Nuclear Information System (INIS)

    Kickuth, Ralph; Anderson, Suzanne; Peter-Salonen, Kristiina; Laemmle, Bernhard; Eggli, Stefan; Triller, Juergen

    2006-01-01

    Joint hemorrhages are very common in patients with severe hemophilia. Inhibitors in patients with hemophilia are allo-antibodies that neutralize the activity of the clotting factor. After total knee replacement, rare intra-articular bleeding complications might occur that do not respond to clotting factor replacement. We report a 40-year-old male with severe hemophilia A and high responding inhibitors presenting with recurrent knee joint hemorrhage after bilateral knee prosthetic surgery despite adequate clotting factor treatment. There were two episodes of marked postoperative hemarthrosis requiring extensive use of subsititution therapy. Eleven days postoperatively, there was further hemorrhage into the right knee. Digital subtraction angiography diagnosed a complicating pseudoaneurysm of the inferior lateral geniculate artery and embolization was successfully performed. Because clotting factor replacement therapy has proved to be excessively expensive and prolonged, especially in patients with inhibitors, we recommend the use of cost-effective early angiographic embolization

  13. Immunological effects of adalimumab in rheumatoid arthritis: Results of a Russian national study

    Directory of Open Access Journals (Sweden)

    Dmitri Evgenyevich Karateev

    2013-01-01

    Full Text Available A reduction in immunological parameters during therapy for rheumatoid arthritis (RA can yield new data on the mechanisms of anti-inflammatory action and be of great practical importance since this allows judgment of the depth of impact on the immunological process and therefore may be regarded as one of the components of improvement and remission. Objective: to study the effect of the tumor necrosis factor-a (TNF-а inhibitor adalimumab (ADA on a number of key immunological parameters in RA. Subjects and methods. The study included 100 patients (11 men and 89 women diagnosed with RA from 5 research centers. The patients were observed to have high RA activity: at baseline, DAS28 6.22+0.84 scores; C-reactive protein (CRP 37.1+34.7 mg/l. The mean number of disease-modifying antirheumatic drugs (DMARDs used by a patient in the history was 2.1. During 24-week treatment, the patients took ADA in a subcutaneous dose of 40 mg every 2 weeks both alone and in combination with DMARDs. The time course of changes in the serum levels of CRP, IGM rheumatoid factor (RF and in the concentration of anti-cyclic citrullinated peptide 2 (anti-CCP2 antibodies was determined by enzyme immunoassay (EIA using the Axis-Shield Diagnostics commercial kits (United Kingdom. The levels of TNF-a, interleukin (IL 6, 12, matrix metalloproteinase 3 (MMP3 were measured in pg/ml by EIA using the Bender MedSystems commercial kits (USA according to the manufacturer's directions. Results. During ADA therapy, there was a rapid reduction in the level of CRP from 34.3 to 11.317.2 mg/l following 2 weeks (p<0.001, which thereafter remained low (11.9 mg/l, with some fluctuations, until week 24 of the study. There was a significant reduction in blood RF levels from 169.24 to 111.97 at 24 weeks (p<0.001. After 12 weeks of ADA treatment, there was virtually a two-fold decrease in IL-6 content from 8.87 to 4.87 pg/ml and later on to 4.03 pg/ml at week 24 (p>0,05. The mean levels of anti-CCP2

  14. Radiation therapy after radical prostatectomy for prostate cancer: evaluation of complications and influence of radiation timing on outcomes in a large, population-based cohort.

    Directory of Open Access Journals (Sweden)

    Sarah E Hegarty

    Full Text Available To evaluate the influence of timing of salvage and adjuvant radiation therapy on outcomes after prostatectomy for prostate cancer.Using the Surveillance, Epidemiology, and End Results-Medicare linked database, we identified prostate cancer patients diagnosed during 1995-2007 who had one or more adverse pathological features after prostatectomy. The final cohort of 6,137 eligible patients included men who received prostatectomy alone (n = 4,509 or with adjuvant (n = 894 or salvage (n = 734 radiation therapy. Primary outcomes were genitourinary, gastrointestinal, and erectile dysfunction events and survival after treatment(s.Radiation therapy after prostatectomy was associated with higher rates of gastrointestinal and genitourinary events, but not erectile dysfunction. In adjusted models, earlier treatment with adjuvant radiation therapy was not associated with increased rates of genitourinary or erectile dysfunction events compared to delayed salvage radiation therapy. Early adjuvant radiation therapy was associated with lower rates of gastrointestinal events that salvage radiation therapy, with hazard ratios of 0.80 (95% CI, 0.67-0.95 for procedure-defined and 0.70 (95% CI, 0.59, 0.83 for diagnosis-defined events. There was no significant difference between ART and non-ART groups (SRT or RP alone for overall survival (HR = 1.13 95% CI = (0.96, 1.34 p = 0.148.Radiation therapy after prostatectomy is associated with increased rates of gastrointestinal and genitourinary events. However, earlier radiation therapy is not associated with higher rates of gastrointestinal, genitourinary or sexual events. These findings oppose the conventional belief that delaying radiation therapy reduces the risk of radiation-related complications.

  15. Complications of combined surgery and neutron radiation therapy in patients with advanced carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Griffin, T.W.; Weisberger, E.C.; Laramore, G.E.; Tong, D.; Blasko, J.C.

    1979-01-01

    A total of 135 patients with advanced squamous-cell carcinoma of the head and neck were treated with cyclotron-generated fast neutrons. Thirty-eight had major surgery before or after irradiation. Major complications (fistula formation, carotid artery exposure or blowout requiring ligation, or major wound breakdown) occurred in 37%. The complication rates associated with surgery prior to irradiation, planned surgery following irradiation, and salvage surgery following irradiation were 0/12, 4/5, and 10/21, respectively. The complication rate for surgery following neutron irradiation alone was 73%; for surgery following mixed-beam irradiation it was 20%. The age of the patient and the interval between surgery and irradiation had no influence on the complication rate

  16. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Radstake, T R D J; Svenson, M; Eijsbouts, A M

    2008-01-01

    BACKGROUND: Tumour necrosis factor alpha (TNFalpha) neutralising antibody constructs are increasingly being used to treat rheumatoid arthritis (RA). OBJECTIVE: To determine potential differences in clinical responses, soluble drug levels and antibody formation between patients with RA receiving...... infliximab and adalimumab. METHODS: 69 patients with RA fulfilling the 1987 American College of Rheumatology criteria and about to start treatment with infliximab or adalimumab, were enrolled consecutively. All patients had active disease (28-joint count Disease Activity Score >3.2). Infliximab was given...... intravenously at 3 mg/kg at baseline and after 2, 6 and 14 weeks. Adalimumab was administered as 40 mg biweekly subcutaneously. Concomitant drug treatment was monitored and continued at constant dosage during the study. All serum samples were tested for infliximab/adalimumab levels and anti...

  17. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial.

    Science.gov (United States)

    Lhommée, Eugénie; Wojtecki, Lars; Czernecki, Virginie; Witt, Karsten; Maier, Franziska; Tonder, Lisa; Timmermann, Lars; Hälbig, Thomas D; Pineau, Fanny; Durif, Franck; Witjas, Tatiana; Pinsker, Marcus; Mehdorn, Maximilian; Sixel-Döring, Friederike; Kupsch, Andreas; Krüger, Rejko; Elben, Saskia; Chabardès, Stephan; Thobois, Stéphane; Brefel-Courbon, Christine; Ory-Magne, Fabienne; Regis, Jean-Marie; Maltête, David; Sauvaget, Anne; Rau, Jörn; Schnitzler, Alfons; Schüpbach, Michael; Schade-Brittinger, Carmen; Deuschl, Gunther; Houeto, Jean-Luc; Krack, Paul

    2018-03-01

    Although subthalamic stimulation is a recognised treatment for motor complications in Parkinson's disease, reports on behavioural outcomes are controversial, which represents a major challenge when counselling candidates for subthalamic stimulation. We aimed to assess changes in behaviour in patients with Parkinson's disease receiving combined treatment with subthalamic stimulation and medical therapy over a 2-year follow-up period as compared with the behavioural evolution under medical therapy alone. We did a parallel, open-label study (EARLYSTIM) at 17 surgical centres in France (n=8) and Germany (n=9). We recruited patients with Parkinson's disease who were disabled by early motor complications. Participants were randomly allocated (1:1) to either medical therapy alone or bilateral subthalamic stimulation plus medical therapy. The primary outcome was mean change in quality of life from baseline to 2 years. A secondary analysis was also done to assess behavioural outcomes. We used the Ardouin Scale of Behavior in Parkinson's Disease to assess changes in behaviour between baseline and 2-year follow-up. Apathy was also measured using the Starkstein Apathy Scale, and depression was assessed with the Beck Depression Inventory. The secondary analysis was done in all patients recruited. We used a generalised estimating equations (GEE) regression model for individual items and mixed model regression for subscores of the Ardouin scale and the apathy and depression scales. This trial is registered with ClinicalTrials.gov, number NCT00354133. The primary analysis has been reported elsewhere; this report presents the secondary analysis only. Between July, 2006, and November, 2009, 251 participants were recruited, of whom 127 were allocated medical therapy alone and 124 were assigned bilateral subthalamic stimulation plus medical therapy. At 2-year follow-up, the levodopa-equivalent dose was reduced by 39% (-363·3 mg/day [SE 41·8]) in individuals allocated bilateral

  18. Efficacy of adalimumab in young children with juvenile idiopathic arthritis and chronic uveitis: a case series

    OpenAIRE

    La Torre, Francesco; Cattalini, Marco; Teruzzi, Barbara; Meini, Antonella; Moramarco, Fulvio; Iannone, Florenzo

    2014-01-01

    Background Juvenile idiopathic arthritis is a relatively common chronic disease of childhood, and is associated with persistent morbidity and extra-articular complications, one of the most common being uveitis. The introduction of biologic therapies, particularly those blocking the inflammatory mediator tumor necrosis factor-α, provided a new treatment option for juvenile idiopathic arthritis patients who were refractory to standard therapy such as non-steroidal anti-inflammatory drugs, corti...

  19. RADIOACTIVE IODINE THERAPY WITHOUT RECENT ANTITHYROID DRUG PRETREATMENT FOR HYPERTHYROIDISM COMPLICATED BY SEVERE HYPERBILIRUBINEMIA DUE TO HEPATIC DYSFUNCTION: EXPERIENCE OF A CHINESE MEDICAL CENTER.

    Science.gov (United States)

    Ding, Yong; Xing, Jialiu; Qiu, Zewu; Wang, Yong; Zhang, Youren; Fang, Yi; Peng, Xiaobo; Long, Yahong; Deng, Pei

    2016-02-01

    The objective of this work is to report our experience with (131)I therapy without recent antithyroid drug (ATD) pretreatment for refractory severe hyperthyroidism complicated by hyperbilirubinemia due to hepatic dysfunction. Five patients with refractory severe hyperthyroidism were treated with (131)I at 90 to 120 μCi/g-thyroid (total activity, 6.2 to 10.1 mCi). The patients previously had received ATD treatment from 2 months to 12 years and discontinued ATDs from 2 months to 4 years before (131)I treatment due to treatment failure or severe jaundice. Prior to (131)I therapy, the patients were asked to take a low-iodine diet and were treated with bisoprolol fumarate, digoxin, furosemide, S-adenosylmethionine, polyene phosphatidylcholine, and plasma exchange as supportive treatment for related clinical conditions. Four of the patients also received lithium carbonate in conjunction with their (131)I treatment. The patients were followed for 4 to 9 years after (131)I therapy. After (131)I treatment, jaundice disappeared completely within 3 to 4 months in all patients, and liver function tests returned to normal. Concurrent atrial fibrillation and heart failure, leukopenia and thrombocytopenia, or thrombocytopenia and left cardiac enlargement improved remarkably in 3 patients during the follow-up period. Three to 45 months after (131)I treatment, hypothyroidism was noted in the patients and they were treated with L-thyroxine replacement therapy. (131)I therapy without recent ATD pretreatment for refractory severe hyperthyroidism complicated by serious jaundice appears to be safe and effective, with good long-term results. It may be the preferred therapy for such patients and should be used as early as possible.

  20. Triple antithrombotic therapy is the independent predictor for the occurrence of major bleeding complications: analysis of percent time in therapeutic range.

    Science.gov (United States)

    Naruse, Yoshihisa; Sato, Akira; Hoshi, Tomoya; Takeyasu, Noriyuki; Kakefuda, Yuki; Ishibashi, Mayu; Misaki, Masako; Abe, Daisuke; Aonuma, Kazutaka

    2013-08-01

    Triple antithrombotic therapy increases the risk of bleeding events in patients undergoing percutaneous coronary intervention. However, it remains unclear whether good control of percent time in therapeutic range is associated with reduced occurrence of bleeding complications in patients undergoing triple antithrombotic therapy. This study included 2648 patients (70 ± 11 years; 2037 men) who underwent percutaneous coronary intervention with stent in the Ibaraki Cardiovascular Assessment Study registry and received dual antiplatelet therapy with or without warfarin. Clinical end points were defined as the occurrence of major bleeding complications (MBC), major adverse cardiac and cerebrovascular event, and all-cause death. Among these 2648 patients, 182 (7%) patients received warfarin. After a median follow-up period of 25 months (interquartile range, 15-35 months), MBC had occurred in 48 (2%) patients, major adverse cardiac and cerebrovascular event in 484 (18%) patients, and all-cause death in 206 (8%) patients. Multivariable Cox regression analysis revealed that triple antithrombotic therapy was the independent predictor for the occurrence of MBC (hazard ratio, 7.25; 95% confidence interval, 3.05-17.21; Prange value did not differ between the patients with and without MBC occurrence (83% [interquartile range, 50%-90%] versus 75% [interquartile range, 58%-87%]; P=0.7). However, the mean international normalized ratio of prothrombin time at the time of MBC occurrence was 3.3 ± 2.1. Triple antithrombotic therapy did not have a predictive value for the occurrence of all-cause death (P=0.1) and stroke (P=0.2). Triple antithrombotic therapy predisposes patients to an increased risk of MBC regardless of the time in therapeutic range.

  1. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis.

    Science.gov (United States)

    Genovese, Mark C; van Vollenhoven, Ronald F; Wilkinson, Bethanie; Wang, Lisy; Zwillich, Samuel H; Gruben, David; Biswas, Pinaki; Riese, Richard; Takiya, Liza; Jones, Thomas V

    2016-06-23

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA. Analyses included patients treated with adalimumab 40 mg once every 2 weeks or tofacitinib 10 mg twice daily (BID) with background methotrexate (MTX) in a 12-month randomized study (NCT00853385), who subsequently received tofacitinib 10 mg BID (with/without background MTX) in an open-label extension (NCT00413699). Patients with treatment-related serious adverse events (AEs) and serious or recurrent infections in the index study were excluded from the extension study. Exposure-adjusted incidence rates of safety-related events were assessed in 3-month and 12-month periods in the year before and in the year after switching. Efficacy was assessed 3 months before, at the time of, and 3 months after switching. There were 233 (107 adalimumab to tofacitinib 10 mg BID, 126 blinded to open-label tofacitinib 10 mg BID) patients included in these analyses. Patients in both treatment sequences had similar incidence rates (per 100 patient-years) of discontinuation due to AEs, serious AEs, and serious infections in the year before and in the year after switching. Incidence rates of AEs were increased in the first 3 months after switching compared with the last 3 months before switching in both treatment groups. Switching from either blinded adalimumab or tofacitinib to open-label tofacitinib resulted in numerically higher incidence of responders for signs and symptoms of disease and improved physical function. Treatment can be directly switched from adalimumab to tofacitinib. A similar safety and efficacy profile was seen when patients received open-label tofacitinib after receiving either blinded adalimumab or tofacitinib. ClinicalTrials.gov Identifiers: NCT00853385 , registered 27 February 2009; NCT

  2. Effect of Adalimumab on Refractory Arthritis in Juvenile Idiopathic Inflammatory Myopathy with Anti-MDA5 Autoantibody

    Directory of Open Access Journals (Sweden)

    Takako Miyamae

    2018-01-01

    Full Text Available A 10-year-old girl manifested persistent fever, skin rash, leg pain, fatigue, and joint pain. Based on muscle weakness, elevated muscle-derived enzymes, magnetic resonance imaging, and skin biopsy results, the diagnosis was juvenile idiopathic inflammatory myopathies (JIIM. Chest CT was normal; the anti-melanoma differentiation-associated protein-5 (anti-MDA5 autoantibody was positive. Initial manifestations subsided after prednisolone (PSL and methotrexate treatment. After the PSL dosage was decreased, the patient presented with metacarpophalangeal (MCP joint pain and swelling in both index fingers, synovial fluid, and signals on power Doppler ultrasound. The arthritis was refractory to cyclosporine and tacrolimus. Radiography showed progressive MCP joint space narrowing and joint erosion. Adalimumab was initiated 14 months after disease onset. There was a mildly increased matrix metalloproteinase-3 (MMP3 level, an erythrocyte sedimentation ratio (ESR, and a normal CRP level. Adalimumab resulted in decreased MCP joint pain and swelling. PSL was discontinued 10 months after adalimumab initiation; after 9 more months of adalimumab, there were no significant ultrasonography findings. MMP3 and ESR levels normalized during treatment. Radiography after 2 years of adalimumab showed further progressive MCP joint space narrowing restricting dorsiflexion. This report clarified that anti-MDA5-positive JIIM joint manifestations were due to active synovitis and that adalimumab is required for severe cases. Further experience is needed to determine the pathology, severity, and prognosis of this type of arthritis.

  3. Statin therapy and clinical outcomes in myocardial infarction patients complicated by acute heart failure : insights from the EPHESUS trial

    NARCIS (Netherlands)

    Dobre, Daniela; Rossignol, Patrick; Murin, Jan; Parkhomenko, Alexander; Lamiral, Zohra; Krum, Henry; van Veldhuisen, Dirk J.; Pitt, Bertram; Zannad, Faiez

    Several clinical trials have shown that in patients with acute myocardial infarction (MI), statin therapy improves cardiovascular (CV) outcomes, but in these trials patients with acute heart failure (HF) were excluded or only a few were included. In patients with chronic HF, statin therapy does not

  4. Pulmonary complications of induction therapy for acute myeloid leukemia in adults. Findings of chest X-rays and computed tomography

    International Nuclear Information System (INIS)

    Kirchner, J.; Huettmann, C.; Jacobi, V.; Boehme, A.

    1998-01-01

    To exclude pulmonary complications, 359 chest radiographs and 50 computed tomographs of the lung were performed in 95 patients suffering from acute myeloid leukemia. The radiological findings were registered, described and correlated with clinical findings in the present study on 2395 days of observation. Results: In summary, 52 patients showed alterations of the lung. Pulmonary hyperhydration was seen in 21 cases, bacterial pneumonia was found in 18 cases, invasive pulmonary aspergillosis was documented in 14 cases, and 5 cases of severe haemorrhage were seen. An unexplained pulmonary edema in 13 patients with interstitial and alveolar infiltrates is considered to be a complication of treatment with cytosine-arabinoside. Conclusion: The results demonstrate that chest X-ray and computed tomography have a high impact in detection and treatment of pulmonary complications following intensive chemotherapy. We may expect the development of diffuse opacity following administration of cytosine-arabinoside in medium-sized doses. (orig.) [de

  5. Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

    OpenAIRE

    Weinblatt, Michael E.; Baranauskaite, Asta; Niebrzydowski, Jaroslaw; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz‐Rosiak, Krystyna; Cheong, Soo Yeon; Ghil, Jeehoon; Sokolovic, S.; Mekic, M.; Prodanovic, N.; Gajic, B.

    2017-01-01

    Objective SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). Methods In this phase III, randomized, double‐blind, parallel‐group study, patients with moderately to severely active RA despite treatment with methotrexate were randomized 1:1 to receive SB5 or reference ADA at a dosage of 40 mg subcutaneously every o...

  6. Clinical and economic consequences of failure of initial antibiotic therapy for patients with community-onset complicated intra-abdominal infections.

    Directory of Open Access Journals (Sweden)

    Yong Pil Chong

    Full Text Available Complicated intra-abdominal infection (cIAI is infection that extends beyond the hollow viscus of origin into the peritoneal space, and is associated with either abscess formation or peritonitis. There are few studies that have assessed the actual costs and outcomes associated with failure of initial antibiotic therapy for cIAI. The aims of this study were to evaluate risk factors and impact on costs and outcomes of failure of initial antibiotic therapy for community-onset cIAI.A retrospective study was performed at eleven tertiary-care hospitals. Hospitalized adults with community-onset cIAI who underwent an appropriate source control procedure between August 2008 and September 2011 were included. Failure of initial antibiotic therapy was defined as a change of antibiotics due to a lack of improvement of the clinical symptoms and signs associated with cIAI in the first week.A total of 514 patients hospitalized for community-onset cIAI were included in the analysis. The mean age of the patients was 53.3 ± 17.6 years, 72 patients (14% had health care-associated infection, and 48 (9% experienced failure of initial antibiotic therapy. Failure of initial antibiotic therapy was associated with increased costs and morbidity. After adjustment for covariates, patients with unsuccessful initial therapy received an additional 2.9 days of parenteral antibiotic therapy, were hospitalized for an additional 5.3 days, and incurred $3,287 in additional inpatient charges. Independent risk factors for failure of initial antibiotic therapy were health care-associated infection, solid cancer, and APACHE II ≥13.To improve outcomes and costs in patients with community-onset cIAI, rapid assessment of health care-associated risk factors and severity of disease, selection of an appropriate antibiotic regimen accordingly, and early infection source control should be performed.

  7. Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial.

    Science.gov (United States)

    López-Sanromán, Antonio; Vera-Mendoza, Isabel; Domènech, Eugeni; Taxonera, Carlos; Vega Ruiz, Vicente; Marín-Jiménez, Ignacio; Guardiola, Jordi; Castro, Luisa; Esteve, María; Iglesias, Eva; Ceballos, Daniel; Martínez-Montiel, Pilar; Gisbert, Javier P; Mínguez, Miguel; Echarri, Ana; Calvet, Xavier; Barrio, Jesús; Hinojosa, Joaquín; Martín-Arranz, María Dolores; Márquez-Mosquera, Lucía; Bermejo, Fernando; Rimola, Jordi; Pons, Vicente; Nos, Pilar

    2017-10-27

    Postoperative recurrence of Crohn's disease [POR-CD] is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab [ADA] and azathioprine [AZA] in this setting. We performed a phase 3, 52-week, multicentre, randomised, superiority study [APPRECIA], in which patients with ileocolonic resection were randomised either to ADA 160-80-40 mg subcutaneously [SC] or AZA 2.5 mg/kg/day, both associated with metronidazole. The primary endpoint was endoscopic recurrence at 1 year [Rutgeerts i2b, i3, i4], as evaluated by a blinded central reader. We recruited 91 patients [median age 35.0 years, disease duration 6.0 years, 23.8% smokers, 7.1% previous resections]. The study drugs were administered to 84 patients. Treatment was discontinued owing to adverse events in 11 patients [13.1%]. Discontinuation was significantly less frequent in the ADA [4.4%] than in the AZA group [23.2%] (dif.: 18.6% [95% CI 4.1-33.2], p = 0.011). According to the intention-to-treat analysis, therapy failed in 23/39 patients in the AZA group [59%] and 19/45 patients in the ADA group [42.2%] [p = 0.12]. In the per-protocol analysis [61 patients with centrally evaluable images], recurrence was recorded in 8/24 [33.3%] patients in the AZA and 11/37 [29.7%] in the ADA group [p = 0.76]. No statistically significant differences between the groups were found for recurrence in magnetic resonance images, biological markers of activity, surgical procedures, or hospital admissions. ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD in an unselected population, although tolerance to ADA is significantly better. ClinicalTrials.gov NCT01564823. Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com

  8. Cerebral tuberculoma in a patient receiving anti-TNF alpha (adalimumab) treatment.

    LENUS (Irish Health Repository)

    Lynch, Karen

    2010-10-01

    We report a case of a cerebral tuberculoma in a 60-year-old woman with rheumatoid arthritis while receiving the anti-tumor necrosis factor alpha monoclonal antibody, adalimumab (Humira), for active disease. MR brain imaging for dyspraxia revealed a left parietal ring-enhancing lesion, which on resection was shown to be a necrotizing granuloma. There were no associated pulmonary lesions, and the patient was systemically well. Sputum and urine cultures were negative for tuberculosis. The patient was treated with anti-tuberculous medications and made an excellent recovery. We consider this to be the first documented case of tuberculosis involving the central nervous system occurring in the setting of adalimumab treatment.

  9. Dual pancreas- and lung-targeting therapy for local and systemic complications of acute pancreatitis mediated by a phenolic propanediamine moiety.

    Science.gov (United States)

    Li, Jianbo; Zhang, Jinjie; Fu, Yao; Sun, Xun; Gong, Tao; Jiang, Jinghui; Zhang, Zhirong

    2015-08-28

    To inhibit both the local and systemic complications with acute pancreatitis, an effective therapy requires a drug delivery system that can efficiently overcome the blood-pancreas barrier while achieving lung-specific accumulation. Here, we report the first dual pancreas- and lung-targeting therapeutic strategy mediated by a phenolic propanediamine moiety for the treatment of acute pancreatitis. Using the proposed dual-targeting ligand, an anti-inflammatory compound Rhein has been tailored to preferentially accumulate in the pancreas and lungs with rapid distribution kinetics, excellent tissue-penetrating properties and minimum toxicity. Accordingly, the drug-ligand conjugate remarkably downregulated the proinflammatory cytokines in the target organs thus effectively inhibiting local pancreatic and systemic inflammation in rats. The dual-specific targeting therapeutic strategy may help pave the way for targeted drug delivery to treat complicated inflammatory diseases. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. Optimizing the radiation therapy dose prescription for pediatric medulloblastoma: Minimizing the life years lost attributable to failure to control the disease and late complication risk

    DEFF Research Database (Denmark)

    Brodin, N. Patrik; Vogelius, Ivan R.; Bjork-Eriksson, Thomas

    2014-01-01

    Background. A mathematical framework is presented for simultaneously quantifying and evaluating the trade-off between tumor control and late complications for risk-based radiation therapy (RT) decision-support. To demonstrate this, we estimate life years lost (LYL) attributable to tumor recurrence...... is important, with 0.75 LYL (95% CI 0.60-7.2 years) for standard uniform 24 Gy CS irradiation. However, recurrence risk dominates the total LYL with 14.2 years (95% CI 13.4-16.6 years). Compared to standard treatment, a risk-adapted strategy prescribing 12 Gy to the spinal volume encompassing the 1st-10th......, late cardiac toxicity and secondary cancers for standard-risk pediatric medulloblastoma (MB) patients and compare the effect of dose re-distribution on a common scale. Methods. Total LYL were derived, based on the LYL attributable to radiation-induced late complications and the LYL from not controlling...

  11. Intensity-modulated radiation therapy versus three-dimensional conformal radiation therapy with concurrent nedaplatin-based chemotherapy after radical hysterectomy for uterine cervical cancer: comparison of outcomes, complications, and dose-volume histogram parameters

    International Nuclear Information System (INIS)

    Isohashi, Fumiaki; Mabuchi, Seiji; Yoshioka, Yasuo; Seo, Yuji; Suzuki, Osamu; Tamari, Keisuke; Yamashita, Michiko; Unno, Hikari; Kinose, Yasuto; Kozasa, Katsumi; Sumida, Iori; Otani, Yuki; Kimura, Tadashi; Ogawa, Kazuhiko

    2015-01-01

    The purpose of this study is to report our clinical outcomes using intensity-modulated radiation therapy (IMRT) for adjuvant treatment of cervical cancer, compared with three-dimensional conformal radiation therapy (3DCRT), in terms of tumor control, complications and dose-volume histogram (DVH) parameters. Between March 2008 and February 2014, 62 patients were treated with concurrent nedaplatin-based chemotherapy and whole-pelvic external beam radiation therapy (RT). Of these patients, 32 (52 %) received 3DCRT and 30 (48 %) received IMRT. The median follow-up periods were 40 months (range 2–74 months). The 3-year overall survival rate (OS), locoregional control rate (LRC) and progression-free survival rate (PFS) were 92, 95 and 92 % in the IMRT group, and 85, 82 and 70 % in the 3DCRT group, respectively. A comparison of OS, LRC and PFS showed no significant differences between IMRT and 3DCRT. The 3-year cumulative incidences of grade 2 or higher chronic gastrointestinal (GI) complications were significantly lower with IMRT compared to 3DCRT (3 % vs. 45 %, p < .02) and in patients with V40 of the small bowel loops of ≤340 mL compared to those with >340 mL (3 % vs. 45 %, p < .001). Patients treated with IMRT had a higher incidence of grade 3 acute hematologic complications (p < .05). V40 and V45 of the small bowel loops or bowel bag were predictive for development of both acute and chronic GI complications. Our results suggest that IMRT for adjuvant treatment of cervical cancer is useful for decreasing GI complications without worsening outcomes

  12. Gastric Outlet Obstruction--An Unexpected Complication during Coca-Cola Therapy for a Gastric Bezoar: A Case Report and Literature Review.

    Science.gov (United States)

    Lu, Lei; Zhang, Xiao-Feng

    2016-01-01

    Gastric bezoars are concretions of undigested material, and Coca-Cola therapy is an easy, efficacious and safe approach for bezoar treatment. Gastric outlet obstruction due to a migratory gastric bezoar during Coca-Cola therapy is an uncommon presentation and, to the best of our knowledge, no cases have been previously reported. We herein describe one such case with no known predisposing factors that recovered via the endoscopic technique. A thorough literature search was performed, which yielded eight relevant patients from seven publications, all of who developed gastrointestinal obstruction during dissolution treatment and recovered uneventfully after surgical intervention. In conclusion, this potential complication should be kept in mind in the event that alternative treatment is necessary.

  13. Side-effects and complications of intra-arterial tumour therapy - experience gained from 577 interventions; Nebenwirkungen und Komplikationen der intraarteriellen Tumortherapie - Erfahrungen aus 577 Interventionen

    Energy Technology Data Exchange (ETDEWEB)

    Goerich, J. [Radiologische Universitaetsklinik Ulm (Germany); Hasan, I. [Radiologische Universitaetsklinik Bonn (Germany); Sittek, H. [Radiologische Universitaetsklinik Bonn (Germany); Harder, T. [Radiologische Universitaetsklinik Bonn (Germany); Rieber, A. [Radiologische Universitaetsklinik Ulm (Germany); Hartlapp, H.J. [Medizinische Universitaetsklinik Bonn (Germany); Keilholz, U. [Heidelberg Univ. (Germany). Medizinische Klinik und Poliklinik; Kunze, V. [Radiologische Universitaetsklinik Ulm (Germany); Brado, M. [Radiologische Universitaetsklinik Heidelberg (Germany); Reiser, M. [Radiologische Universitaetsklinik Bonn (Germany); Brambs, H. [Radiologische Universitaetsklinik Ulm (Germany)

    1995-05-01

    305 bearers of different types of tumour went through a total of 577 cycles of intra-arterial therapy (287 perfusions, 290 embolizations). The treatments were carried out for pelvic, hepatic, renal and mammary tumours, for bone metastization, pulmonary carcinomas as well as tumours of the gastrointestinal tract or the extremities. Except for 105 cases, all patients had previously been subjected to surgery or radiotherapy to cure the disease now treated by the intra-arterial method. Systemic chemotherapy had been performed in 58% of the patients. The cytostatic and embolization drugs used varied according to tumour histology and vascularization. Serious complications occurred in 1-2% of the patients. They were observed to be two times more frequent for tumour embolization (1.4%) as compared to intra-arterial perfusion therapy (0.7%). An invariable use of refined methods like intraarterial computerized angiotomography to monitor perfusion and a choice of cytostatic drugs also based on anatomic determinants may further diminish the number of serious complications during perfusion therapy. (orig./VHE) [Deutsch] Bei 305 Patienten mit unterschiedlichen Tumorerkrankungen wurden insgesamt 577 intraarterielle Therapiezyklen (287 Perfusionen, 290 Embolisationen) durchgefuehrt. Behandlungsursache waren Tumoren des Beckens, der Leber, der Niere, der Mamma, Knochenmetastasen, Lungenkarzinome, gastrointestinale Tumoren und Extremitaetstumoren. Mit Ausnahme von 105 Patienten war der zur intraarteriellen Therapie anstehende Befund lokal operiert und/oder strahlentherapeutisch vorbehandelt worden. Einer systemischen Chemotherapie hatten sich 58% der Patienten unterzogen. In Abhaengigkeit von der Tumorhistologie und -vaskularisation wurden unterschiedliche Zytostatika verwendet. Die Rate an schweren Komplikationen betrug 2%. Bei der Tumorembolisation waren schwerwiegende Komplikationen mit 1,4% doppelt so haeufig wie bei der intraarteriellen Perfusionstherapie. Verbesserte

  14. Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab.

    Science.gov (United States)

    Bagel, J; Tyring, S; Rice, K C; Collier, D H; Kricorian, G; Chung, J; Iles, J; Stolshek, B S; Kaliyaperumal, A; Papp, K A

    2017-08-01

    Some patients with plaque psoriasis experience secondary failure of tumour necrosis factor inhibitor therapy. To evaluate efficacy, safety and patient-reported outcomes (PROs) with etanercept in patients with secondary adalimumab failure. This phase IV open-label single-arm estimation study (NCT01543204) enrolled patients on adalimumab who had achieved static Physician's Global Assessment (sPGA) score 0/1 (clear/almost clear). Patients subsequently lost response, defined as sPGA ≥ 3 or loss of 50% improvement in Psoriasis Area and Severity Index (PASI 50). At baseline, patients had involved body surface area ≥ 10%, sPGA ≥ 3 and PASI ≥ 10. Antiadalimumab antibodies (ADAs) were measured at screening. Patients received etanercept 50 mg twice weekly for 12 weeks, followed by 50 mg weekly. The primary end point was sPGA 0/1 at week 12 (intention-to-treat analysis; no hypothesis tested). Additional outcomes included rates of sPGA 0/1, PASI responses, safety, PROs of itch, pain and flaking, Dermatology Life Quality Index, treatment satisfaction and Work Productivity and Activity Impairment questionnaire. Sixty-four patients enrolled; 67% had ADAs. sPGA 0/1 rates at week 12 were 39·7% [95% confidence interval (CI) 27·6-52·8; primary end point] and 45% (95% CI 29·3-61·5) for patients positive for ADAs and 35% (95% CI 15·4-59·2) for patients negative for ADAs. PASI 75 response rates at week 12 were 47·5% (95% CI 31·5-63·9) for patients who were positive for ADAs and 50% (95% CI 27·2-72·8) for patients negative for ADAs. No new safety signals were observed. PROs of itch, pain and flaking consistently improved at week 12 and were maintained through week 24. Patients with psoriasis who experienced secondary failure of adalimumab achieved satisfactory response to etanercept regardless of ADA status. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  15. [Posterior vitrectomy with gas endotamponade and retinal laser therapy in treatment of patients with macular complications of the optic disc pit].

    Science.gov (United States)

    Cywiński, Adam; Kałużny, Jakub; Ferda, Daniela; Piwońska-Lobermajer, Anna

    2015-01-01

    Retrospective evaluation of functional and anatomical treatment outcomes in patients with macular cornplications of optic disc pit. 9 patients (eyes) underwent central posterior vitrectomy in conjunction with posterior vitreous detachment, retinal laser therapy to the optic disc pit area and endotamponade with expansile gas. It was followed by the patient's forced positioning (recommended for a few days especially at night), which ended the treatment protocol. Improved anatomical relationships, accompanied by functional improvement were achieved in each reported case. The resolution of macular lesions was slow, lasting even for several months. Too long delay in performing the surgery (over 5 months since the onset of visual impairment) was associated with the development of retinal complications, mainly macular hole formation, most likely caused by the long-term ischemia. The central posterior vitrectomy combined with posterior vitreous detachment, laser therapy, andd expansile gas tamponade offers good outcomes in patients with retinal complications of optic disc pit. Surgery performed shortly after the onset of visual dysfunction gives the best functional outcomes. Restoration of normal anatomical relationships is a long-term process. In some cases, though, these abnormalities may not resolve completely.

  16. A Case of Acute Budd-Chiari Syndrome Complicating Primary Antiphospholipid Syndrome Presenting as Acute Abdomen and Responding to Tight Anticoagulant Therapy

    Directory of Open Access Journals (Sweden)

    Naofumi Chinen

    2016-01-01

    Full Text Available A 34-year-old woman with primary antiphospholipid syndrome was admitted to the Gastroenterology Department of our hospital with fever, acute abdomen, watery diarrhea, and extremely high levels of inflammatory parameters. She had a history of left lower limb deep vein thrombosis and pulmonary embolism and was taking warfarin potassium. Acute gastroenteritis was suspected and an antibiotic was administered, but symptoms progressed. Abdominal ultrasonography showed occlusion of the left hepatic vein and the middle hepatic vein and her D-dimer level was high. Accordingly, Budd-Chiari syndrome was diagnosed and high-dose intravenous infusion of heparin was initiated. Her abdominal symptoms improved and the levels of inflammatory parameters and D-dimer decreased rapidly. It is known that antiphospholipid syndrome can be complicated by Budd-Chiari syndrome that usually occurs as subacute or chronic onset, but acute onset is rare. It is difficult to diagnose acute Budd-Chiari syndrome complicating antiphospholipid syndrome and this complication generally has a poor outcome. However, the present case can get early diagnosis and successful treatment with tight anticoagulant therapy.

  17. Outcome of Intravenous Azithromycin Therapy in Patients with Complicated Scrub Typhus Compared with That of Doxycycline Therapy Using Propensity-Matched Analysis

    Science.gov (United States)

    Jang, Mi-Ok; Jang, Hee-Chang; Kim, Uh Jin; Ahn, Joon Hwan; Kang, Seung-Ji; Jung, Sook-In; Shin, Hee-Young

    2014-01-01

    There are no well-matched, controlled studies comparing azithromycin with doxycycline for the treatment of complicated scrub typhus. A retrospective propensity score-matched case-control study was performed for patients who presented with complicated scrub typhus and were treated with doxycycline or azithromycin between 2001 and 2011. Data on comorbidities, clinical manifestations, laboratory studies, treatments, and outcomes were extracted for analysis. The clinical characteristics and outcomes of the azithromycin-treated group (n = 73) were compared to those of the doxycycline-treated group (n = 108). Of 181 patients, 73 from each group were matched by propensity scores. There were no significant differences in baseline characteristics between the matched groups. The treatment success and survival rates were not significantly different (89% [65/73 patients] versus 96% [70/73 patients] and 96% [70/73 patients] versus 96% [70/73 patients], respectively [P > 0.05]). No difference was observed in the time to defervescence or length of hospital stay between the two groups (P > 0.05). In complicated scrub typhus patients (n = 181), multivariate analysis showed that only APACHE II score was an independent risk factor for mortality (95% confidence interval, 1.11 to 1.56; P scrub typhus. PMID:24366734

  18. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab.

    Science.gov (United States)

    Ferreiro-Iglesias, Rocio; Barreiro-de Acosta, Manuel; Lorenzo-Gonzalez, Aurelio; Dominguez-Muñoz, Juan Enrique

    2016-01-01

    Predicting relapse in Crohn's disease (CD) patients by measuring non-invasive biomarkers could allow for early changes of treatment. Data are scarce regarding the utility of monitoring calprotectin to predict relapse. The aim of the study was to evaluate the predictive value of a rapid test of faecal calprotectin (FC) to predict for flares in CD patients on maintenance treatment with adalimumab (ADA). A prospective, observational cohort study was designed. Inclusion criteria were CD patients in clinical remission on a standard dose of ADA therapy. Fresh FC was measured using a rapid test. Thirty patients were included (median age 38 years, 56.7% female). After the 4 months follow-up, 70.0% patients remained in clinical remission and 30.0% had a relapse. FC concentration at inclusion was significantly higher in those patients who relapsed during the follow-up (625 μg/g) compared to those who stayed in remission (45 μg/g). The optimal cut-off for FC to predict relapse was 204 μg/g. The area under the receiver-operating characteristic curve was 0.968. Sensitivity, specificity, positive, and negative predictive value of FC to predict relapse were 100%, 85.7%, 74.1%, and 100%, respectively. In CD patients on ADA maintenance therapy, FC levels measured with a rapid test allow relapse over the following months to be predicted with high accuracy. Low FC levels exclude relapse within at least 4 months after testing, whereas high levels are associated with relapse in three out of every four patients.

  19. Cost-effectiveness analysis of infliximab, adalimumab, golimumab and vedolizumab for moderate to severe ulcerative colitis in Spain.

    Science.gov (United States)

    Trigo-Vicente, Cristina; Gimeno-Ballester, Vicente; Montoiro-Allué, Raquel; López-Del Val, Alejandro

    2017-12-02

    Assess the efficiency of biologic treatment for moderate to severe ulcerative colitis (UC) which are indicated and financed for this pathology by Spain. A Markov model was constructed to simulate the progression in a cohort of patients with moderate to severe UC. The perspective chosen was National Health Service with an over 10 years of time horizon, with a discount rate of 3%, and established threshold of €30,000/quality-adjusted life-year (QALY). The comparison between infliximab versus adalimumab achieved an incremental cost-effectiveness ratio (ICER) of €45,582/QALY, with a 0.900 QALYs difference of efficacy and an incremental cost of €41,036. Golimumab versus adalimumab reached an ICER of €2,175,992/QALY, with a difference of 0.001 QALY in efficacy and a raising cost to €2,611. The comparison between vedolizumab with adalimumab achieved an ICER of €90,532/QALY, 0.930 QALYs of difference and an increasing cost of €84,218. The probabilistic sensitivity analysis shows that adalimumab would be cost-effective in the 65.2% of the simulations, infliximab in the 18.4%, golimumab in the 16.4% and vedulizumab for the 0%. Among all these drugs studied, adalimumab is the most cost-effective drug for the treatment of moderate to severe UC for a threshold of €30,000/QALY in Spain.

  20. Effectiveness of group cognitive therapy about opium addict complications on attitude of adolescents with drug dependent parents

    Directory of Open Access Journals (Sweden)

    Kaveh Hojjat

    2015-12-01

    Full Text Available Background and Aim: Statistics show that 30% to 40 % of  opium addicted fathers’ children are prone to substance abuse in the future. The present study aimed at assessing the effectiveness of cognitive therapy approach  to attitude changing of adolescents with substance dependent fathers. Materials and Methods:  In this controlled. field-trail randomized study. .data collection tool was “attitude to addiction questionnaire”. The study population was all male students in the first grade of high school in Maneh - Samalghan city. . Six sessions of group cognitive therapy based on the effectiveness of drug side-effects in drug-addicted fathers’ adolescent children’s attitude were held. The above-mentioned questionnaire was filled out before and after intervention. The obtained data  was fed into SPSS software (V: 16 using. Independent t-test .and paired t-test were used for analysis and P<0.05 was taken as the significant level. Results:  There were no significant differences between the two groups in pre-test regarding their attitude about drug abuse (P=.20%. Mean score variance from pre-test to post-test in the intervention group decreased, but in the control group, it showed a slight increase. This means that the intervention reduced the positive attitude towards drugs, but the changes were not statistically significant (p=0.57. Besides, among ten factors decisive in an individual’s attitude about addiction, only group cognitive therapy  was able  to decrease mean points of an individual’s attitude about drug abuse .. Significantly (P = 0.04. Conclusion: It was found that group cognitive therapy education about opium  addict complicationsdidn`t have a significant effect on the attitude of the students with addicted fathers. Thus, a change of adolescents’ attitude requires more research.

  1. Effect of the TNF-α inhibitor adalimumab in patients with recalcitrant sarcoidosis: a prospective observational study using FDG-PET

    DEFF Research Database (Denmark)

    Milman, Nils; Graudal, Niels; Loft, Annika

    2012-01-01

    -PET) in patients with recalcitrant sarcoidosis treated with adalimumab. Methods: Prospective 24-week observational study. Patients continued medication with steroids and antimetabolites and received adalimumab 40 mg subcutaneously every other week. Ten patients with biopsy-proven sarcoidosis (two men) were...

  2. Efficacy of chloroquine, amodiaquine, sulphadoxine-pyrimethamine and combination therapy with artesunate in Mozambican children with non-complicated malaria

    DEFF Research Database (Denmark)

    Abacassamo, F; Enosse, S; Aponte, J J

    2004-01-01

    This paper reports a two-phase study in Manhiça district, Mozambique: first we assessed the clinical efficacy and parasitological response of Plasmodium falciparum to chloroquine (CQ), sulphadoxine-pyrimethamine (SP) and amodiaquine (AQ), then we tested the safety and efficacy in the treatment of......% to AQ. Co-administration of AQ + SP, AR + SP and AQ + AR was safe and had 100% clinical efficacy at 14-day follow-up. The combination therapies affected rapid fever clearance time and reduced the incidence of gametocytaemia during follow-up....

  3. Identification of Patient Benefit From Proton Therapy for Advanced Head and Neck Cancer Patients Based on Individual and Subgroup Normal Tissue Complication Probability Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Jakobi, Annika, E-mail: Annika.Jakobi@OncoRay.de [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Bandurska-Luque, Anna [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden (Germany); Stützer, Kristin; Haase, Robert; Löck, Steffen [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Wack, Linda-Jacqueline [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); Mönnich, David [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); German Cancer Research Center, Heidelberg (Germany); German Cancer Consortium, Tübingen (Germany); Thorwarth, Daniela [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); and others

    2015-08-01

    Purpose: The purpose of this study was to determine, by treatment plan comparison along with normal tissue complication probability (NTCP) modeling, whether a subpopulation of patients with head and neck squamous cell carcinoma (HNSCC) could be identified that would gain substantial benefit from proton therapy in terms of NTCP. Methods and Materials: For 45 HNSCC patients, intensity modulated radiation therapy (IMRT) was compared to intensity modulated proton therapy (IMPT). Physical dose distributions were evaluated as well as the resulting NTCP values, using modern models for acute mucositis, xerostomia, aspiration, dysphagia, laryngeal edema, and trismus. Patient subgroups were defined based on primary tumor location. Results: Generally, IMPT reduced the NTCP values while keeping similar target coverage for all patients. Subgroup analyses revealed a higher individual reduction of swallowing-related side effects by IMPT for patients with tumors in the upper head and neck area, whereas the risk reduction of acute mucositis was more pronounced in patients with tumors in the larynx region. More patients with tumors in the upper head and neck area had a reduction in NTCP of more than 10%. Conclusions: Subgrouping can help to identify patients who may benefit more than others from the use of IMPT and, thus, can be a useful tool for a preselection of patients in the clinic where there are limited PT resources. Because the individual benefit differs within a subgroup, the relative merits should additionally be evaluated by individual treatment plan comparisons.

  4. Identification of Patient Benefit From Proton Therapy for Advanced Head and Neck Cancer Patients Based on Individual and Subgroup Normal Tissue Complication Probability Analysis

    International Nuclear Information System (INIS)

    Jakobi, Annika; Bandurska-Luque, Anna; Stützer, Kristin; Haase, Robert; Löck, Steffen; Wack, Linda-Jacqueline; Mönnich, David; Thorwarth, Daniela

    2015-01-01

    Purpose: The purpose of this study was to determine, by treatment plan comparison along with normal tissue complication probability (NTCP) modeling, whether a subpopulation of patients with head and neck squamous cell carcinoma (HNSCC) could be identified that would gain substantial benefit from proton therapy in terms of NTCP. Methods and Materials: For 45 HNSCC patients, intensity modulated radiation therapy (IMRT) was compared to intensity modulated proton therapy (IMPT). Physical dose distributions were evaluated as well as the resulting NTCP values, using modern models for acute mucositis, xerostomia, aspiration, dysphagia, laryngeal edema, and trismus. Patient subgroups were defined based on primary tumor location. Results: Generally, IMPT reduced the NTCP values while keeping similar target coverage for all patients. Subgroup analyses revealed a higher individual reduction of swallowing-related side effects by IMPT for patients with tumors in the upper head and neck area, whereas the risk reduction of acute mucositis was more pronounced in patients with tumors in the larynx region. More patients with tumors in the upper head and neck area had a reduction in NTCP of more than 10%. Conclusions: Subgrouping can help to identify patients who may benefit more than others from the use of IMPT and, thus, can be a useful tool for a preselection of patients in the clinic where there are limited PT resources. Because the individual benefit differs within a subgroup, the relative merits should additionally be evaluated by individual treatment plan comparisons

  5. Clinical status, quality of life, and work productivity in Crohn's disease patients after one year of treatment with adalimumab.

    Science.gov (United States)

    Saro, Cristina; Ceballos, Daniel; Muñoz, Fernando; de la Coba, Cristóbal; Aguilar, María Dolores; Lázaro, Pablo; García-Sánchez, Valle; Hernández, Mariola; Barrio, Jesús; de Francisco, Ruth; Fernández, Luis I; Barreiro-de Acosta, Manuel

    2017-02-01

    Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice. This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p work productivity impact decreased from 53% to 24% (p quality of life and work productivity.

  6. Efficacy of vitamin B complex as an adjuvant therapy for the treatment of complicated vulvovaginal candidiasis: An in vivo and in vitro study.

    Science.gov (United States)

    Sun, Mei-Guo; Huang, Ying; Xu, Yuan-Hong; Cao, Yun-Xia

    2017-04-01

    This study aimed to explore the efficacy of vitamin B complex as an adjuvant therapy for the treatment of complicated vulvovaginal candidiasis (VVC) in vitro and in vivo. One-hundred fifty-eight complicated VVC patients were randomly divided into group A (treated with suppository+oral antifungal agents), group B (treated with suppository+vaginal cream), and group C (treated with suppository+vaginal cream+oral vitamin B complex). A mouse model of VVC was established. Eighty VVC mice were randomly divided into 4 groups according to the dose of vitamin B complex (20 mice in each group): V1 group (injected with 150μL normal salin), V2 group (injected with 50μL vitamin B complex solution+100μL normal saline), V3 group (injected with 100μL vitamin B complex solution+50μL normal saline), and V4 group (injected with 150μL vitamin B complex solution). After 4 weeks of treatment, the vaginal secretion was obtained for microscopic smear examination. HE stainning was performed to observe histopathological changes of vaginal tissues. The expressions of inflammatory factors were detected by ELISA. Meanwhile, VVC model of vaginal epithelial cells was established. The effects of different concentrations of vitamin B complex on anti-fungal effect of fluconazole were detected in vitro. After the treatment, complicated patients in the group C had significantly higher effective rates than those in the group A and group B. After the intra-gastric administration, the microscopic smear examination found that obvious pseudohypha in cluster with a lot of blastospores can be seen in the vaginal secretions of mice in the V1 group under the microscope. There was significant difference between mice treated with different dosages of vitamin B complex. The inflammatory response of mice in the V1 group was significantly higher than those in other groups and the inflammation response reduced with the increase of vitamin B complex dosage. The vitamin B complex elevated the curative effects of

  7. Optimizing the radiation therapy dose prescription for pediatric medulloblastoma: minimizing the life years lost attributable to failure to control the disease and late complication risk.

    Science.gov (United States)

    Brodin, N Patrik; Vogelius, Ivan R; Björk-Eriksson, Thomas; Munck Af Rosenschöld, Per; Maraldo, Maja V; Aznar, Marianne C; Specht, Lena; Bentzen, Søren M

    2014-04-01

    A mathematical framework is presented for simultaneously quantifying and evaluating the trade-off between tumor control and late complications for risk-based radiation therapy (RT) decision-support. To demonstrate this, we estimate life years lost (LYL) attributable to tumor recurrence, late cardiac toxicity and secondary cancers for standard-risk pediatric medulloblastoma (MB) patients and compare the effect of dose re-distribution on a common scale. Total LYL were derived, based on the LYL attributable to radiation-induced late complications and the LYL from not controlling the primary disease. We compared the estimated LYL for three different treatments in 10 patients: 1) standard 3D conformal RT; 2) proton therapy; 3) risk-adaptive photon treatment lowering the dose to part of the craniospinal (CS) target volume situated close to critical risk organs. Late toxicity is important, with 0.75 LYL (95% CI 0.60-7.2 years) for standard uniform 24 Gy CS irradiation. However, recurrence risk dominates the total LYL with 14.2 years (95% CI 13.4-16.6 years). Compared to standard treatment, a risk-adapted strategy prescribing 12 Gy to the spinal volume encompassing the 1st-10th thoracic vertebrae (Th1-Th10), and 36 Gy to the remaining CS volume, estimated a LYL reduction of 0.90 years (95% CI -0.18-2.41 years). Proton therapy with 36 Gy to the whole CS volume was associated with significantly fewer LYL compared to the risk-adapted photon strategies, with a mean LYL difference of 0.50 years (95% CI 0.25-2.60 years). Optimization of RT prescription strategies considering both late complications and the risk of recurrence, an all-cause mortality dose painting approach, was demonstrated. The risk-adapted techniques compared favorably to the standard, and although in this context, the gain is small compared to estimated uncertainty, this study demonstrates a framework for all-cause mortality risk estimation, rather than evaluates direct clinical applicability of risk

  8. Low starting dosage of infliximab with possible escalating dosage in psoriatic arthritis gives the same treatment results as standard dosage of adalimumab or etanercept: results from the nationwide Icelandic ICEBIO registry

    Directory of Open Access Journals (Sweden)

    Gudbjornsson B

    2018-05-01

    Full Text Available Bjorn Gudbjornsson,1,2 Arni Jon Geirsson,3,4 Niels Steen Krogh5 1Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland; 2Faculty of Medicine, University of Iceland, Reykjavik, Iceland; 3Department of Rheumatology, University Hospital, Reykjavik, Iceland; 4Laeknasetrid - Medical Clinic, University of Iceland, Reykjavik, Iceland; 5Zitelab Aps, Copenhagen, Denmark Objective: To explore differences in response to a low dosage regimen of infliximab with an escalating dosage in comparison to a standard dosage of etanercept and adalimumab in patients with psoriatic arthritis (PsA. Methods: Biologically naïve PsA patients who were beginning anti-TNF-α therapy were selected from the ICEBIO registry. Demographics and clinical differences were compared in four treatment groups: infliximab <4 mg/kg; infliximab >4 mg/kg; etanercept or adalimumab at baseline and on follow-up (6 and 12 months, last visit. The Kruskal–Wallis rank sum test was used for comparison of the groups and the Wilcoxon test to compare the two infliximab dosage regimens. Results: One hundred and eighty-five patients (61% female were identified; 84 patients received infliximab, 66 etanercept, and 35 adalimumab. A total of 19% of the patients treated with infliximab escalated their dosage ≥4 mg/kg. No significant differences were observed at baseline in respect to visual analog scale (VAS pain, VAS fatigue, Health Assessment Questionnaire, C-reactive protein (CRP, numbers of swollen or tender joints, or Disease Activity Score (DAS 28-CRP values. A similar treatment response was observed in all four treatment groups on follow-up. Conclusion: In respect to treatment effects, a low dosage of infliximab with possible escalating dosage is acceptable for the majority of PsA patients who are in need of biological treatment. Keywords: psoriatic arthritis, outcome, biological treatment, routine care, clinical nationwide registry

  9. Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis.

    Science.gov (United States)

    Menter, Alan; Thaçi, Diamant; Papp, Kim A; Wu, Jashin J; Bereswill, Mareike; Teixeira, Henrique D; Rubant, Simone; Williams, David A

    2015-09-01

    ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis. Initial 5-year results are reported. Two populations were analyzed: the "all-treated" population received 1 or more adalimumab doses in registry, continuing adalimumab treatment from a current prescription or previous study participation, and included the "new-prescription" population initiating adalimumab 4 weeks or earlier preregistry entry. Data were collected from September 26, 2008, through November 30, 2013, for all-treated (n = 6059), which included new-prescription (n = 2580, 42.6%); median registry exposure was 765 and 677 days, respectively. In all-treated, rate (events per 100 patient-years of total adalimumab exposure [E/100PY]) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.3 E/100PY, serious infection 1.0 E/100PY, malignancies 0.9 E/100PY (nonmelanoma skin cancers 0.6 E/100PY; melanomas <0.1 E/100PY). Standardized mortality ratio was 0.30 (95% confidence interval 0.19-0.44). Physician Global Assessment clear or minimal (effectiveness parameter) was achieved by 57.0% at 12 months and 64.7% at 60 months of treatment. Observational data are subject to outcome-reporting bias. No new safety signals were observed with adalimumab treatment during this initial 5-year registry review. Observed number of deaths was below expected. As-observed effectiveness remained stable through 60 months. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  10. Chemotherapy-Induced and/or Radiation Therapy-Induced Oral Mucositis-Complicating the Treatment of Cancer

    Directory of Open Access Journals (Sweden)

    Maddireddy Umameshwar Rao Naidu

    2004-09-01

    Full Text Available The term mucositis is coined to describe the adverse effects of radiation and chemotherapy treatments. Mucositis is one of the most common adverse reactions encountered in radiation therapy for head and neck cancers, as well as in chemotherapy, in particular with drugs affecting DNA synthesis (Sphase-specific agents such as fluorouracil, methotrexate, and cytarabine. Mucositis may limit the patient's ability to tolerate chemotherapy or radiation therapy, and nutritional status is compromised. It may drastically affect cancer treatment as well as the patient's quality of life. The incidence and severity of mucositis will vary from patient to patient. It will also vary from treatment to treatment. It is estimated that there is 40% incidence of mucositis in patients treated with standard chemotherapy and this will not only increase with the number of treatment cycles but also with previous episodes. Similarly, patients who undergo bone marrow transplantation and who receive high doses of chemotherapy have a 76% chance of getting mucositis. Patients receiving radiation, in particular to head and neck cancers, have a 30% to 60% chance. The exact pathophysiology of development is not known, but it is thought to be divided into direct and indirect mucositis. Chemotherapy and/or radiation therapy will interfere with the normal turnover of epithelial, cells leading to mucosal injury; subsequently, it can also occur due to indirect invasion of Gram-negative bacteria and fungal species because most of the cancer drugs will cause changes in blood counts. With the advancement in cytology, a more precise mechanism has been established. With this understanding, we can select and target particular mediators responsible for the mucositis. Risk factors such as age, nutritional status, type of malignancy, and oral care during treatment will play important roles in the development of mucositis. Many treatment options are available to prevent and treat this

  11. The effect of customized beam shaping on normal tissue complications in radiation therapy of parotid gland tumors

    International Nuclear Information System (INIS)

    Keus, R.; Boer, R. de; Lebesque, J.; Noach, P.

    1991-01-01

    The impact of customized beam shaping was studied for 5 patients with parotid tumors treated with a paired wedged field technique. For each patient 2 plans were generated. The standard plan had unblocked portals with field sizes defined by the largest target contour found in any CT slice. In the 2nd plan customized beam's view (BEV) designed blocks were added to both beams. The differences in those distributions between the 2 types of plans were evaluated using dose-volume histograms (DVH). As expected, the dose distribution within the target volume showed no difference. However, a considerable sparing of normal tissue was observed for the plans with customized blocks. The volume of un-necessary exposed normal tissue that received more than 90 percent of the prescribed dose, was reduced by a factor of about 4: from 165 to 44 percent on an average, if the volume is expressed as a percentage of the target volume in each patient. In particular, the homolateral mandible showed a mean decrease of 21 percent of integral dose when blocks were used. Normal tissue complication probabilities (NTCP) were calculated. For a tumor dose of 70 Gy, the average bone necrosis probability was reduced from 8.4 percent (no blocks) to 4.1. percent (blocks). For other normal tissues such as nervous tissue, other soft tissues and bones a substantial reduction of integral dose was found for al patients when individual blocks were used. (author). 10 refs.; 4 figs.; 2 tabs

  12. Femoral neuropathy due to retroperitoneal bleeding. A red herring in medicine complicates anticoagulant therapy and influences the Russian Communist Revolution (Crown Prince Alexis, Rasputin).

    Science.gov (United States)

    Willbanks, O L; Willbanks, S E

    1983-02-01

    Femoral neuropathy occurs when occult retroperitoneal bleeding impinges on the appropriate nerve roots. The syndrome involves the acute onset of groin and thigh pain with characteristic flexion and external rotation of the hip. It may mimic other conditions such as acute arterial occlusion. Thorough knowledge of the anatomy of the femoral nerve explains the clinical features and leads the clinician to suspect the occurrence of this syndrome. Three cases have been reviewed that exhibited this condition as a result of retroperitoneal bleeding, a complication of systemic heparin therapy. The hemophilia that afflicted Alexis, the Crown Prince of Russia and son of Tsar Nicholas and Tsarina Alexandra, resulted in this clinical syndrome. The consequences enabled the sinister starets, Gregory Rasputin, to become intimately involved with the royal family, influencing the response of the Tsar to the political events in Russia, thereby playing an important role in setting the stage for the 1917 Russian communist revolution.

  13. [Uveitis associated with juvenile idiopathic arthritis : Optimization of immunomodulatory therapy].

    Science.gov (United States)

    Heiligenhaus, A; Tappeiner, C; Walscheid, K; Heinz, C

    2016-05-01

    Uveitis associated with juvenile idiopathic arthritis (JIA-associated uveitis) is a vision-threatening disorder with a high complication rate. Besides early diagnosis within screening programs an adequate therapy is essential for improvement of the long-term prognosis. Corticosteroid therapy is often insufficient. In addition to conventional immunosuppression, immunomodulatory drugs, so-called biologicals, are novel highly effective treatment modalities. A systematic search of the literature was carried out for biologicals currently used in the treatment of JIA-associated uveitis. Review of current publications, summary of treatment guidelines and discussion of treatment options for therapy refractive patients. In accordance with the current recommendations tumor necrosis factor (TNF) inhibitors are administered if uveitis inactivity cannot be achieved with topical corticosteroids and in the next stage with immunosuppressants (methotrexate preferred). According to the currently available data adalimumab is then preferred. When the effectiveness of TNF inhibitors ceases during long-term administration and/or recurrences, other biological response modifiers are attractive treatment options (e. g. lymphocyte inhibitors or specific receptor antagonists). The TNF inhibitors are of major importance for the treatment of JIA-associated uveitis. Prospective studies and registries would be desirable in order to be able to compare the value of TNF inhibitors and other biologicals and for optimization of treatment recommendations.

  14. [The lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome patients complicating with dyslipidemia].

    Science.gov (United States)

    Li, Xiang-ping; Gong, Hai-rong; Zhao, Shui-ping; Huang, Wen-yu

    2013-12-01

    To investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome(ACS) patients complicating with dyslipedemia. One hundred and four hospitalized patients with established ACS and increased serum triglycerides (TG) levels and/or low serum levels of high density lipoprotein cholesterol (HDL-C) were selected. Except for conventional therapy, the patients were randomly divided into 2 groups: control group (n = 52), treated with atorvastatin 20 mg qn or other statin equivalent to 20 mg atorvastatin; treatment group (n = 52), treated with the same dose statin plus bezafibrate 200 mg bid. The serum levels of total cholesterol (TC), TG, low-density lipoprotein cholesterol (LDL-C) and HDL-C were assessed before and after 6 and 12 weeks treatment, side effects and adverse events were recorded. After 6 weeks treatment, the serum levels of TC, TG and LDL-C in two groups were significantly reduced compared to baseline (all P 0.05). After 12 weeks, the rates reaching to target goals of LDL-C, TG, HDL-C, and non-HDL-C levels in the treatment group (69.2%, 88.5%, 92.3%, 46.2% and 65.4%, respectively) were significantly higher than those in the control group (34.6%, 65.4%, 46.2%, 7.7% and 42.3%, respectively, all P < 0.05). No serious side effects were observed in the two groups during the treatment period. The combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in ACS patients complicating with increased TG and (or) decreased HDL-C.

  15. Prophylactic and therapeutic management of oral complications related to chemotherapy and radiotherapy: role of dental oncology in cancer patient supportive therapy

    International Nuclear Information System (INIS)

    Buffarah, Henry Bittar

    2008-01-01

    Cancer patients under treatment of head and neck tumors as well as those under chemotherapy for hematologic cancers, such as lymphoma and leukemia, and those about to receive bone marrow grafts, do require preventive oral and dental care (prior to cancer treatment), as well as oral care during and after oncological treatment. Furthermore, chemo and radiotherapy-related adverse effects are also common in patients with other types of cancer, with an estimated frequency of 10 per cent in adjuvant chemotherapy (QT), 40 per cent in primary QT, 80 per cent in bone marrow transplantation, in which myeloablative regimens are introduced, and 100 per cent in head and neck radiotherapy, in which the targeted fields are those of the oral cavity. The dentist, specialized in dental oncology, works within the multidisciplinary team at the great centers of cancer treatment, contributing to improve the quality of life of these patients. The present review of literature and of the Guidelines for Management of Oral Complications of Chemotherapy and Head and Neck Radiation (US National Cancer Institute) aims to inform the clinical oncologist, the radio therapist, and other professionals about the resources available in Oral Supportive Therapy in both the prevention and managements of such complications. (author)

  16. Eight cases of pregnancy complicated with thyroid carcinoma and 2 cases of pregnancy after 131-I isotope therapy

    International Nuclear Information System (INIS)

    Toshimori, Hirataka; Hidaka, Hiroyuki; Ushiroda, Yoshihiko

    1997-01-01

    We experienced eight cases of thyroid tumor diagnosed during pregnancy: four papillary carcinomas, a follicular carcinoma with follicular adenoma, two adenomatous goiters, and a follicular carcinoma. The patients were 18 to 27 (mean 26.5) years of age. These tumors were found during 8 to 27 (mean±SD, 14.9±6.4) week of pregnancy, and two of the carcinomas showed rapid growth in early pregnancy, which pregnancy may facilitate. The study shows that in order to arrest the rapid advancement of the thyroid carcinoma in such patients during pregnancy, an operation should be performed even in pregnancy. In other cases, surgical treatment can be reasonably postponed until after parturition. Palpation, ultrasonography and fine needle aspiration biopsy were useful in diagnosing the tumors. Administration of a therapeutic dose of 131-I isotope was effective in all of our cases after total thyroidectomy. However, careful attention should be paid to avoid unexpected pregnancy before and after this therapy for a period sufficient to ensure complete elimination of the radionuclide effect. (author)

  17. Gigantic retroperitoneal hematoma as a complication of anticoagulation therapy with heparin in therapeutic doses: a case report

    Directory of Open Access Journals (Sweden)

    Daliakopoulos Stavros I

    2008-05-01

    Full Text Available Abstract Introduction Spontaneous retroperitoneal hemorrhage is a distinct clinical entity that can present as a rare life-threatening event characterized by sudden onset of bleeding into the retroperitoneal space, occurring in association with bleeding disorders, intratumoral bleeding, or ruptures of any retroperitoneal organ or aneurysm. The spontaneous form is the most infrequent retroperitoneal hemorrhage, causing significant morbidity and representing a diagnostic challenge. Case presentation We report the case of a patient with coronary artery disease who presented with transient ischemic attack, in whom anticoagulant therapy with heparin precipitated a massive spontaneous atraumatic retroperitoneal hemorrhage (with international normalized ratio 2.4, which was treated conservatively. Conclusion Delay in diagnosis is potentially fatal and high clinical suspicion remains crucial. Finally, it is a matter of controversy whether retroperitoneal hematomas should be surgically evacuated or conservatively treated and the final decision should be made after taking into consideration patient's general condition and the possibility of permanent femoral or sciatic neuropathy due to compression syndrome.

  18. Neurologic complications in oncology

    Directory of Open Access Journals (Sweden)

    Andrea Pace

    2010-06-01

    Full Text Available Neurologic side effects related to cancer therapy are a common problem in oncology practice. These complications can negatively affect the management of the patient, because they can inhibit treatment and diminish quality of life. Therefore specific skills are required to recognise symptoms and clinical manifestations. This review focuses on the most common neurologic complications to improve physician’s familiarity in determining the aetiology of these symptoms.

  19. Effective intravenous immunoglobulin therapy for Churg-Strauss syndrome (allergic granulomatous angiitis complicated by neuropathy of the eighth cranial nerve: a case report

    Directory of Open Access Journals (Sweden)

    Ozaki Yoshio

    2012-09-01

    Full Text Available Abstract Introduction We report the case of a patient with Churg-Strauss syndrome with eighth cranial nerve palsy. Vestibulocochlear nerve palsy is extremely rare in Churg-Strauss syndrome. To the best of our knowledge, only one case of complicated neuropathy of the eighth cranial nerve has been described in a previous report presenting an aggregate calculation, but no differentiation between polyarteritis nodosa and Churg-Strauss syndrome was made. High-dose immunoglobulin was administered to our patient, and her neuropathy of the eighth cranial nerve showed improvement. Case presentation At the age of 46, a Japanese woman developed Churg-Strauss syndrome that later became stable with low-dose prednisolone treatment. At the age of 52, she developed sudden difficulty of hearing in her left ear, persistent severe rotary vertigo, and mononeuritis multiplex. At admission, bilateral perceptive deafness of about 80dB and eosinophilia of 4123/μL in peripheral blood were found. A diagnosis of cranial neuropathy of the eighth cranial nerve associated with exacerbated Churg-Strauss syndrome was made. Although high doses of steroid therapy alleviated the inflammatory symptoms and markers, the vertigo and bilateral hearing loss remained. Addition of a high-dose immunoglobulin finally resulted in marked alleviation of the symptoms associated with neuropathy of the eighth cranial nerve. Conclusions A high dose of immunoglobulin therapy shows favorable effects in neuropathy of the eighth cranial nerve, but no reports regarding its efficacy in cranial neuropathy have been published.

  20. Dose Escalation and Healthcare Resource Use among Ulcerative Colitis Patients Treated with Adalimumab in English Hospitals: An Analysis of Real-World Data.

    Directory of Open Access Journals (Sweden)

    Christopher M Black

    Full Text Available To describe the real-world use of adalimumab for maintenance treatment of ulcerative colitis (UC and associated healthcare costs in English hospitals.Retrospective cohort study.Analysis of NHS Hospital Episode Statistics linked with pharmacy dispensing data in English hospitals.Adult UC patients receiving ≥240mg during adalimumab treatment induction, subsequently maintained on adalimumab.Frequency and pattern of adalimumab use and dose escalation during maintenance treatment and associated healthcare costs (prescriptions and hospital visits.191 UC patients completed adalimumab treatment induction. 83 (43.46% dose escalated during maintenance treatment by ≥100% (equivalent to weekly dosing (median time to dose escalation: 139 days. 56 patients (67.47% subsequently de-escalated by ≥50% (median time to dose de-escalation: 21 days. Mean all-cause healthcare costs for all patients ≤12 months of index were £13,892. Dose escalators incurred greater mean healthcare costs than non-escalators ≤12 months of index (£14,596 vs. £13,351. Prescriptions accounted for 96.49% of UC-related healthcare costs (£11,090 of £11,494 in all patients.Within the cohort, 43.46% of UC patients escalated their adalimumab dose by ≥100% and incurred greater costs than non-escalators. The apparent underestimation of adalimumab dose escalation in previous studies may have resulted in underestimated costs in healthcare systems.

  1. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection

    DEFF Research Database (Denmark)

    Julsgaard, Mette; Christensen, Lisbet Ambrosius; Gibson, Peter R.

    2016-01-01

    these correlated with drug concentrations in mothers at birth and risk of infection during the first year of life.  Methods  We performed a prospective study of 80 pregnant women with inflammatory bowel diseases at tertiary hospitals in Denmark, Australia, and New Zealand from March 2012 through November 2014: 36......) and in mothers at time of birth (adalimumab, r = -0.80; infliximab, r = -0.80; P mother drug concentration at birth was 1.21 for adalimumab (95% confidence interval [CI], 0.94–1.49) and 1.97 for infliximab (95% CI, 1.50–2.43). The mean time to drug clearance...... risk for infection was 2.7 in infants whose mothers received the combination of an anti-TNF agent and thiopurine, compared with anti-TNF monotherapy (95% CI, 1.09–6.78; P =.02).  Conclusions  In a prospective study of infants born to mothers who received anti-TNF agents during pregnancy, we detected...

  2. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.

    Science.gov (United States)

    Papp, Kim; Bachelez, Herve; Costanzo, Antonio; Foley, Peter; Gooderham, Melinda; Kaur, Primal; Narbutt, Joanna; Philipp, Sandra; Spelman, Lynda; Weglowska, Jolanta; Zhang, Nan; Strober, Bruce

    2017-06-01

    ABP 501 is a biosimilar of adalimumab. We sought to compare the efficacy and safety of ABP 501 with adalimumab. This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severity Index score from baseline on ABP 501 continued the same treatment, whereas adalimumab-treated patients were rerandomized to adalimumab or ABP 501. Clinical similarity in Psoriasis Area and Severity Index percent improvement from baseline to week 16 (primary end point) was established if the point estimate of treatment difference and its 2-sided 95% confidence interval between groups was within equivalence margin of ±15. Patients, including those undergoing a single transition at week 16, were evaluated for safety and immunogenicity. Psoriasis Area and Severity Index percent improvement at week 16 was 80.9 for ABP 501 and 83.1 for adalimumab (least-square mean difference -2.18 [95% confidence interval -7.39 to 3.02]). Adverse events (67.2% [117/174] vs 63.6% [110/173]) and antidrug antibody incidence (55.2% [96/174] vs 63.6% [110/173]) for ABP 501 vs adalimumab were similar. Safety, including immunogenicity, was similar among groups after single transition (week 20). The 52-week data are not reported here. ABP 501 was shown to be clinically similar to adalimumab. Safety and immunogenicity were not impacted immediately after single transition (adalimumab to ABP 501). Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  3. Adalimumab dose escalation and dose de-escalation success rate and predictors in a large national cohort of Crohn's patients

    NARCIS (Netherlands)

    Baert, Filip; Glorieus, Elien; Reenaers, Cathérine; D'Haens, Geert; Peeters, Harald; Franchimont, Dennis; Dewit, Olivier; Caenepeel, Philippe; Louis, Edouard; van Assche, Gert; D'Heygere, F.; George, C.; van Hootegem, P.; Ilegems, S.; Fontaine, F.; Colard, A.; Schoofs, N.; Belaiche, J.; Louis, E.; Reenaers, C.; van Kemseke, C.; Coche, J. C.; Dewit, O.; Rahier, J. F.; de Reuck, M.; Baert, F.; Decaestecker, J.; de Wulf, D.; Amininejad, L.; Franchimont, D.; van Gossum, A.; Du Ville, L.; Hendrickx, K.; Lepoutre, L.; Vandervoort, J.; van der Spek, P.; Sprengers, D.; van de Mierop, F.; Potvin, P.; Bontems, P.; Moreels, T.; van Outryve, M.; Mana, F.; de Looze, D.; de Vos, M.; Peeters, H.; Ferrante, M.; Rutgeerts, P.; van Assche, G.; Vermeire, S.

    2013-01-01

    Adalimumab is efficacious in inducing and maintaining remission in Crohn's disease but dose escalation is needed in 30-40% after 1 year. Attempts for dose de-escalation have not been studied. This study aimed to assess the need for, predictors, and outcome of dose escalation and de-escalation in a

  4. Ex vivo inhibited cytokine profiling may explain inferior treatment response to golimumab after adalimumab failure in rheumatoid arthritis

    NARCIS (Netherlands)

    Tweehuysen, L; Schraa, K.; Netea, M.G.; Hoogen, F.H.J. van den; Joosten, L.A.B.; Broeder, A.A. den

    2018-01-01

    OBJECTIVES: Clinical data suggest that the response of rheumatoid arthritis patients to treatment with golimumab is much lower among those who switched from adalimumab than among those who switched from etanercept. To elucidate the mechanism behind this difference in response to sequential biologic

  5. Rapid alleviation of signs and symptoms of rheumatoid arthritis with intravenous or subcutaneous administration of adalimumab in combination with methotrexate.

    NARCIS (Netherlands)

    Rau, R.; Simianer, S.; Riel, P.L.C.M. van; Putte, L.B.A. van de; Kruger, K.; Schattenkirchner, M.; Allaart, C.F.; Breedveld, F.C.; Kempeni, J.; Beck, K.; Kupper, H.

    2004-01-01

    OBJECTIVE: This randomized, placebo-controlled, double-blind, Phase 1 study assessed the magnitude, onset, and duration of response with intravenous (i.v.) and subcutaneous (s.c.) adalimumab (Humira, Abbott Laboratories) combined with methotrexate (MTX) in patients with active rheumatoid arthritis

  6. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

    NARCIS (Netherlands)

    Strand, Vibeke; van Vollenhoven, Ronald F.; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H.; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-01-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to

  7. Extent and consequences of antibody formation against adalimumab in patients with psoriasis: one-year follow-up

    NARCIS (Netherlands)

    Menting, S.P.; Lumig, P.P.M. van; Vries, A.C. de; Reek, J.M.P.A. van den; Kleij, D. van der; Jong, E.M.G.J. de; Spuls, P.I.; Lecluse, L.L.

    2014-01-01

    IMPORTANCE: In a previously reported cohort of 29 patients with plaque-type psoriasis followed up for 24 weeks, clinically relevant antidrug antibody (ADA) to adalimumab was frequently found. Long-term data were lacking. We now present the extension of this study: 80 patients followed up for 1 year.

  8. Extent and Consequences of Antibody Formation Against Adalimumab in Patients With Psoriasis One-Year Follow-up

    NARCIS (Netherlands)

    Menting, Stef P.; van Lümig, Paula P. M.; de Vries, Anna-Christa Q.; van den Reek, Juul M. P. A.; van der Kleij, Desiree; de Jong, Elke M. G. J.; Spuls, Phyllis I.; Lecluse, Lidian L. A.

    2014-01-01

    IMPORTANCE In a previously reported cohort of 29 patients with plaque-type psoriasis followed up for 24 weeks, clinically relevant antidrug antibody (ADA) to adalimumab was frequently found. Long-term data were lacking. We now present the extension of this study: 80 patients followed up for 1 year.

  9. Normal tissue complication probability modeling for cochlea constraints to avoid causing tinnitus after head-and-neck intensity-modulated radiation therapy

    International Nuclear Information System (INIS)

    Lee, Tsair-Fwu; Yeh, Shyh-An; Chao, Pei-Ju; Chang, Liyun; Chiu, Chien-Liang; Ting, Hui-Min; Wang, Hung-Yu; Huang, Yu-Jie

    2015-01-01

    Radiation-induced tinnitus is a side effect of radiotherapy in the inner ear for cancers of the head and neck. Effective dose constraints for protecting the cochlea are under-reported. The aim of this study is to determine the cochlea dose limitation to avoid causing tinnitus after head-and-neck cancer (HNC) intensity-modulated radiation therapy (IMRT). In total 211 patients with HNC were included; the side effects of radiotherapy were investigated for 422 inner ears in the cohort. Forty-nine of the four hundred and twenty-two samples (11.6 %) developed grade 2+ tinnitus symptoms after IMRT, as diagnosed by a clinician. The Late Effects of Normal Tissues–Subjective, Objective, Management, Analytic (LENT-SOMA) criteria were used for tinnitus evaluation. The logistic and Lyman-Kutcher-Burman (LKB) normal tissue complication probability (NTCP) models were used for the analyses. The NTCP-fitted parameters were TD 50 = 46.31 Gy (95 % CI, 41.46–52.50), γ 50 = 1.27 (95 % CI, 1.02–1.55), and TD 50 = 46.52 Gy (95 % CI, 41.91–53.43), m = 0.35 (95 % CI, 0.30–0.42) for the logistic and LKB models, respectively. The suggested guideline TD 20 for the tolerance dose to produce a 20 % complication rate within a specific period of time was TD 20 = 33.62 Gy (95 % CI, 30.15–38.27) (logistic) and TD 20 = 32.82 Gy (95 % CI, 29.58–37.69) (LKB). To maintain the incidence of grade 2+ tinnitus toxicity <20 % in IMRT, we suggest that the mean dose to the cochlea should be <32 Gy. However, models should not be extrapolated to other patient populations without further verification and should first be confirmed before clinical implementation

  10. Adalimumab impact on fatigue measured by FACIT-F: a study of rheumatoid arthritis patients in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Janoudi N

    2017-10-01

    Full Text Available Nahed Janoudi,1 Narges Omran,2 Waleed Hussain,3 Hanan Al-osaimi,4 Matouqa Baamer,5 Muhammad Irfanullah Siddiqui,6 Omar Fathaldin,7 Hani Almoallim1,4,8 1Department of Medicine, Dr. Soliman Fakeeh Hospital, Jeddah, 2Department of Medicine, Alnoor General Hospital, 3Department of Medicine, Heraa General Hospital, 4Alzaidi Chair of Research in Rheumatic Diseases, Umm Al-Qura University, Makkah, 5Department of Medicine, King Abdulaziz Hospital & Oncology Center, Jeddah, 6Department of Community Medicine and Public Health, Faculty of Medicine, Umm Al-Qura University, Makkah, 7Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, 8Department of Medicine, Faculty of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia Objective: The objective of the study was to assess the effectiveness of adalimumab as a treatment for fatigue in patients with rheumatoid arthritis (RA. Methods: Fatigue was monitored in patients with RA who were already on an adalimumab treatment regimen. Fatigue, general well-being, comorbidities, and disease activity were measured at baseline and ~8, 16, and 24 weeks, thereafter. Results: Significant reductions in fatigue scores and disease activity were observed from baseline to 6 months after. A predictive regression model of fatigue severity was proposed and was found to be significant, with RA disease activity as the most significant predictor of fatigue severity. Conclusion: This quasi-experimental study is a good starting point for research on the efficacy of adalimumab in treating fatigue in RA patients. The results here suggest that a randomized controlled trial assessing adalimumab as a treatment option for RA patients suffering from fatigue is warranted. Keywords: rheumatoid arthritis, fatigue, adalimumab, disease activity, Saudi Arabia, FACIT-F 

  11. The Timing and Frequency of Complications After Peripheral Percutaneous Transluminal Angioplasty and Iliac Stenting: Is a Change from Inpatient to Outpatient Therapy Feasible?

    International Nuclear Information System (INIS)

    Burns, Briony J.; Phillips, Andrea J.; Fox, Anthony; Boardman, Phillip; Phillips-Hughes, Jane

    2000-01-01

    Purpose: A prospective study was performed to assess the frequency and timing of complications after transluminal angioplasty and stent placement with a view to changing our practice and performing these procedures on an outpatient basis.Method: A total of 266 angioplasties and 51 stent deployments were attempted on 240 consecutive patients. Immediate complications were documented by the radiologists. The timing and nature of any complications during and beyond the first 24 hr were reported by the vascular surgeons.Results: There were 14 complications in 240 patients, giving a complication rate of 4.8% per vessel segment dilated. There were five major and nine minor complications. Eighty-six percent of complications were evident before the patient had left the angiography suite. All complications were evident within 4.5 hr of the procedure.Conclusion: The timing of complications suggests it would be reasonable to perform percutaneous transluminal angioplasties and iliac stenting on an outpatient basis in suitable patients

  12. Normal Tissue Complication Probability Analysis of Acute Gastrointestinal Toxicity in Cervical Cancer Patients Undergoing Intensity Modulated Radiation Therapy and Concurrent Cisplatin

    International Nuclear Information System (INIS)

    Simpson, Daniel R.; Song, William Y.; Moiseenko, Vitali; Rose, Brent S.; Yashar, Catheryn M.; Mundt, Arno J.; Mell, Loren K.

    2012-01-01

    Purpose: To test the hypothesis that increased bowel radiation dose is associated with acute gastrointestinal (GI) toxicity in cervical cancer patients undergoing concurrent chemotherapy and intensity-modulated radiation therapy (IMRT), using a previously derived normal tissue complication probability (NTCP) model. Methods: Fifty patients with Stage I–III cervical cancer undergoing IMRT and concurrent weekly cisplatin were analyzed. Acute GI toxicity was graded using the Radiation Therapy Oncology Group scale, excluding upper GI events. A logistic model was used to test correlations between acute GI toxicity and bowel dosimetric parameters. The primary objective was to test the association between Grade ≥2 GI toxicity and the volume of bowel receiving ≥45 Gy (V 45 ) using the logistic model. Results: Twenty-three patients (46%) had Grade ≥2 GI toxicity. The mean (SD) V 45 was 143 mL (99). The mean V 45 values for patients with and without Grade ≥2 GI toxicity were 176 vs. 115 mL, respectively. Twenty patients (40%) had V 45 >150 mL. The proportion of patients with Grade ≥2 GI toxicity with and without V 45 >150 mL was 65% vs. 33% (p = 0.03). Logistic model parameter estimates V50 and γ were 161 mL (95% confidence interval [CI] 60–399) and 0.31 (95% CI 0.04–0.63), respectively. On multivariable logistic regression, increased V 45 was associated with an increased odds of Grade ≥2 GI toxicity (odds ratio 2.19 per 100 mL, 95% CI 1.04–4.63, p = 0.04). Conclusions: Our results support the hypothesis that increasing bowel V 45 is correlated with increased GI toxicity in cervical cancer patients undergoing IMRT and concurrent cisplatin. Reducing bowel V 45 could reduce the risk of Grade ≥2 GI toxicity by approximately 50% per 100 mL of bowel spared.

  13. Increase in tumor control and normal tissue complication probabilities in advanced head-and-neck cancer for dose-escalated intensity-modulated photon and proton therapy

    Directory of Open Access Journals (Sweden)

    Annika eJakobi

    2015-11-01

    Full Text Available Introduction:Presently used radio-chemotherapy regimens result in moderate local control rates for patients with advanced head and neck squamous cell carcinoma (HNSCC. Dose escalation (DE may be an option to improve patient outcome, but may also increase the risk of toxicities in healthy tissue. The presented treatment planning study evaluated the feasibility of two DE levels for advanced HNSCC patients, planned with either intensity-modulated photon therapy (IMXT or proton therapy (IMPT.Materials and Methods:For 45 HNSCC patients, IMXT and IMPT treatment plans were created including DE via a simultaneous integrated boost (SIB in the high-risk volume, while maintaining standard fractionation with 2 Gy per fraction in the remaining target volume. Two DE levels for the SIB were compared: 2.3 Gy and 2.6 Gy. Treatment plan evaluation included assessment of tumor control probabilities (TCP and normal tissue complication probabilities (NTCP.Results:An increase of approximately 10% in TCP was estimated between the DE levels. A pronounced high-dose rim surrounding the SIB volume was identified in IMXT treatment. Compared to IMPT, this extra dose slightly increased the TCP values and to a larger extent the NTCP values. For both modalities, the higher DE level led only to a small increase in NTCP values (mean differences < 2% in all models, except for the risk of aspiration, which increased on average by 8% and 6% with IMXT and IMPT, respectively, but showed a considerable patient dependence. Conclusions:Both DE levels appear applicable to patients with IMXT and IMPT since all calculated NTCP values, except for one, increased only little for the higher DE level. The estimated TCP increase is of relevant magnitude. The higher DE schedule needs to be investigated carefully in the setting of a prospective clinical trial, especially regarding toxicities caused by high local doses that lack a sound dose response description, e.g., ulcers.

  14. Economic impact of adalimumab treatment in Japanese patients with rheumatoid arthritis from the adalimumab non-interventional trial for up-verified effects and utility (ANOUVEAU) study.

    Science.gov (United States)

    Tanaka, Yoshiya; Yamazaki, Kiyotaka; Nakajima, Ryo; Komatsu, Shuichi; Igarashi, Ataru; Tango, Toshiro; Takeuchi, Tsutomu

    2018-01-01

    The objective of this study is to evaluate the economic impact of adalimumab (ADA) on Japanese rheumatoid arthritis (RA) patients. ANOUVEAU was a 48-week multicenter, prospective, observational, single-cohort study. Work-related outcomes including absenteeism, presenteeism, overall work impairment (OWI), and activity impairment (AI) were evaluated using the RA-related work productivity and activity impairment (WPAI/RA). The amount of productivity loss was estimated via multiplication of absenteeism, presenteeism and OWI by the national average occupational wage for paid worker (PW) and part time worker (PTW), and via multiplication of AI by the estimated wage for domestic work for home maker (HM). In this analysis, 1196 patients were included. At week 48, measures of productivity loss due to absenteeism, presenteeism, OWI, and AI were significantly improved by administrating ADA to RA patients in all employment types (PW, PTW, and HM), compared to baseline (p < .01). Productivity loss of Japanese society by RA disease was estimated to be $9.80 billion. The annual decrease in productivity loss through ADA administration to Japanese RA patients was estimated to be $3.76 billion. The socioeconomic burden of RA is high, but ADA treatment may reduce productivity loss related to RA.

  15. Very low-calorie ketogenic diet may allow restoring response to systemic therapy in relapsing plaque psoriasis.

    Science.gov (United States)

    Castaldo, Giuseppe; Galdo, Giovanna; Rotondi Aufiero, Felice; Cereda, Emanuele

    2016-01-01

    Psoriasis is a chronic disease associated with overweight/obesity and related cardiometabolic complications. The link between these diseases is likely the inflammatory background associated with adipose tissue, particularly the visceral one. Accordingly, previous studies have demonstrated that in the long-term weight loss may improve the response to systemic therapies. We report a case report of a woman in her 40s suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome, in whom adequate response to ongoing treatment with biological therapy (adalimumab) was restored after only 4 weeks of very low-calorie, carbohydrate-free (ketogenic), protein-based diet. Accordingly, through rapid and consistent weight loss, very low calorie ketogenic diet may allow restoring a quick response to systemic therapy in a patient suffering from relapsing psoriasis. This intervention should be considered in overweight/obese patients before the rearrangement of systemic therapy. Nonetheless, studies are required to evaluate whether very low calorie ketogenic diets should be preferred to common low-calorie diets to improve the response to systemic therapy at least in patients with moderate-to-severe psoriasis. Copyright © 2015 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  16. PHARMACOECONOMIC ASPECTS OF TREATMENT WITH THE INHIBITORS OF TUMOR NECROSIS FACTOR OF THE CHRONIC UVEITIS REFRACTORY TO THE BASIC THERAPY (INCLUDING AN ASSOCIATED WITH JUVENILE IDIOPATHIC ARTHRITIS

    Directory of Open Access Journals (Sweden)

    A.V. Rudakova

    2011-01-01

    Full Text Available Therapy of chronic uveitis refractory to the basic treatment, in juvenile idiopathic arthritis (JIA is a very complex problem in pediatrics. Substantial progress in this area resulted after the implementation in practice of inhibitors of tumor necrosis factor (TNF, as the most effective in such clinical situation drugs adalimumab and infliximab are considered (although infliximab was not officially approved in JIA. Objective. To estimate the cost effectiveness of TNF inhibitors — adalimumab, and infliximab in chronic uveitis, refractory to the basic therapy (including associated with juvenile rheumatoid arthritis. Methods. A modeling on the basis of a comparative prospective cohort clinical study was carried out. The analysis was performed by the method «cost–effectiveness» from a position of health and social accounting perspective. Results. It was shown that the frequency and time of remission did not differ when treatment with infliximab (5 mg/kg at 0–2–6 weeks and further once in 6–8 weeks and adalimumab (24 mg/m2 once in 2 weeks. Adalimumab provides a long-term maintenance of remission (no recurrence in 60% of patients within 40 months of observation, whereas 1 year after the treatment with infliximab the frequency of exacerbations was returned to that observed before therapy. The proportion of patients without relapse in the treatment with infliximab for 40 months was 18.8%. Similar results were obtained in a subset of patients with chronic uveitis associated with JIA (with follow-up of 20 months of in a group of infliximab number patients without relapse was 11.1%, with adalimumab therapy — 63.6%. In the general population of patients with refractory chronic uveitis the factor «cost–effectiveness» calculated for a patient with the maintenance of remission for 3 years with adalimumab therapy was in 2,1–2,8 times less than in the treatment with infliximab. In chronic uveitis associated with JIA, the coefficient of

  17. Postpartum complications

    International Nuclear Information System (INIS)

    Kronthal, A.J.; Kuhlman, J.E.; Fishman, E.K.

    1990-01-01

    This paper reports the CT findings of major postpartum complications and determine what role CT plays in their evaluation. The CT scans of nine patients with major postpartum complications were retrospectively reviewed. Patients had been referred to CT for evaluation of postpartum fever, abdominal pain, and elevated results of liver function tests. Complications identified at CT included hepatic infarctions (n = 2), endometritis (n = 2), postoperative wound abscess (n = 1), massive abdominal hemorrhage (n = 1), septic thrombophlebitis (n = 1), and renal vein thrombosis (n = 1). CT findings of hepatic infarction included wedge-shaped areas of decreased enhancement conforming to a vascular distribution

  18. Hemorragia alveolar como complicación del uso de trombolíticos Alveolar hemorrhage as a complication of thrombolytic therapy

    Directory of Open Access Journals (Sweden)

    Alejandra González

    2011-12-01

    Full Text Available La trombolisis se usa como estrategia de reperfusión coronaria en el infarto agudo de miocardio. El sangrado es su principal complicación; la mayoría ocurre en los sitios de accesos venosos y es leve, pero también pueden presentarse hemorragia gastrointestinal, retroperitoneal, genitourinaria, pulmonar y a nivel del sistema nervioso central, episodios estos generalmente de mayor gravedad y a veces fatales. Se describe aquí el caso de un paciente que recibió terapia trombolítica con estreptoquinasa como tratamiento por un infarto de miocardio, y que posteriormente desarrolló insuficiencia respiratoria aguda, infiltrados pulmonares bilaterales, caída del hematocrito y aumento de la difusión de monóxido de carbono, cuadro compatible con diagnóstico de hemorragia alveolar.Coronary thrombolysis is used as a strategy for coronary reperfusion for acute myocardial infarction. Bleeding is the main complication described. Although most of these events occur at sites of vascular access and are mild, in some cases gastrointestinal, retroperitoneal, genitourinary, lung and central nervous system bleeding may occur. These episodes are usually serious and sometimes fatal. The following report describes the case of a patient who received thrombolytic therapy with streptokinase as a treatment for myocardial infarction. Subsequently he developed acute respiratory failure, bilateral pulmonary infiltrates and fall of hematocrit compatible with diagnosis of alveolar hemorrhage.

  19. A case of syndrome involving the inappropriate secretion of antidiuretic hormone developed during radiation therapy in a patient with invasive thymoma complicated with myasthenia gravis

    International Nuclear Information System (INIS)

    Chikuie, Naoki; Ishida, Simon; Sato, Tomohiko; Furutama, Daisuke; Sugino, Shyouichi; Kimura, Humihiro; Hanafusa, Toshiaki

    2007-01-01

    We present the case of a 56-year-old male with a syndrome involving the inappropriate secretion of antidiuretic hormone (SIADH), which developed during radiation therapy for invasive thymoma, complicated with myasthenia gravis (MG). Chest computed tomography revealed a huge mediastinal mass lesion spreading to the pulmonary artery, vena cava and pericardium. He was diagnosed with invasive thymoma, based on the pathological findings of a mediastinal tumor biopsy under computed tomography guidance. He received outpatient radiotherapy for the invasive thymoma, and two weeks after the initiation of radiation at a dose of 22 Gy, was admitted to our hospital because of hypercapnea due to weakness of the diaphragm and disturbance of consciousness. Laboratory examinations of the patient showed hyponatremia, plasma hypoosmolarity in the presence of concentrated urine and inappropriately increased concentration of the plasma antidiuretic hormone. He was also diagnosed as having myasthenia gravis, based on the existence of an anti-acetylcholine receptor antibody. The SIADH was treated by fluid restriction and sodium chloride, and MG was treated with plasma exchange and prednisolone. He recovered from respiratory failure, and his hyponatremia was improved. To our knowledge, this is a rare description of an invasive thymoma associated with SIADH. (author)

  20. Complications of endoscopic variceal therapy

    African Journals Online (AJOL)

    annaline

    during the initial 48 hours after injection of sclerosant, are thrombosis in ..... cumulative volume of injection and an association with pre- existing .... presence of venous and urine catheters and endotracheal tubes. ...... a meta-analytic review.

  1. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.

    Science.gov (United States)

    Kaur, Primal; Chow, Vincent; Zhang, Nan; Moxness, Michael; Kaliyaperumal, Arunan; Markus, Richard

    2017-03-01

    To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC inf ) and the maximum observed concentration (C max ). Secondary end points included safety and immunogenicity. AUC inf and C max were similar across the three groups. Geometrical mean ratio (GMR) of AUC inf was 1.11 between ABP 501 and adalimumab (USA), and 1.04 between ABP 501 and adalimumab (EU). GMR of C max was 1.04 between ABP 501 and adalimumab (USA) and 0.96 between ABP 501 and adalimumab (EU). The 90% CIs for the GMRs of AUC inf and C max were within the prespecified standard PK equivalence criteria of 0.80 to 1.25. Treatment-related adverse events were mild to moderate and were reported for 35.8%, 24.6% and 41.8% of subjects in the ABP 501, adalimumab (USA) and adalimumab (EU) groups; incidence of antidrug antibodies (ADAbs) was similar among the study groups. Results of this study demonstrated PK similarity of ABP 501 with adalimumab (USA) and adalimumab (EU) after a single 40-mg subcutaneous injection. No new safety signals with ABP 501 were identified. The safety and tolerability of ABP 501 was similar to the reference products, and similar ADAb rates were observed across the three groups. EudraCT number 2012-000785-37; Results. 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/.

  2. Skin Complications

    Science.gov (United States)

    ... Text Size: A A A Listen En Español Skin Complications Diabetes can affect every part of the ... lipoidica diabeticorum, diabetic blisters, and eruptive xanthomatosis. General Skin Conditions Bacterial Infections Several kinds of bacterial infections ...

  3. Diphtheria Complications

    Science.gov (United States)

    ... Search Form Controls Cancel Submit Search The CDC Diphtheria Note: Javascript is disabled or is not supported ... message, please visit this page: About CDC.gov . Diphtheria Home About Diphtheria Causes and Transmission Symptoms Complications ...

  4. The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomized controlled trials on established rheumatoid arthritis

    DEFF Research Database (Denmark)

    Kristensen, L E; Christensen, R; Bliddal, H

    2011-01-01

    To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods.......To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods....

  5. The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomized controlled trials on established rheumatoid arthritis

    DEFF Research Database (Denmark)

    Kristensen, L E; Christensen, R; Bliddal, H

    2007-01-01

    To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods.......To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods....

  6. A novel engineered interchain disulfide bond in the constant region enhances the thermostability of adalimumab Fab.

    Science.gov (United States)

    Nakamura, Hitomi; Oda-Ueda, Naoko; Ueda, Tadashi; Ohkuri, Takatoshi

    2018-01-01

    We constructed a system for expressing the Fab of the therapeutic human monoclonal antibody adalimumab at a yield of 20 mg/L in the methylotrophic yeast Pichia pastoris. To examine the contribution of interchain disulfide bonds to conformational stability, we prepared adalimumab Fab from which the interchain disulfide bond at the C-terminal region at both the CH 1 and CL domains was deleted by substitution of Cys with Ala (Fab ΔSS ). DSC measurements showed that the Tm values of Fab ΔSS were approximately 5 °C lower than those of wild-type Fab, suggesting that the interchain disulfide bond contributes to conformational thermostability. Using computer simulations, we designed a novel interchain disulfide bond outside the C-terminal region to increase the stability of Fab ΔSS . The resulting Fab (mutSS Fab ΔSS ) had the mutations H:V177C and L:Q160C in Fab ΔSS , confirming the formation of the disulfide bond between CH 1 and CL. The thermostability of mutSS Fab ΔSS was approximately 5 °C higher than that of Fab ΔSS . Therefore, the introduction of the designed interchain disulfide bond enhanced the thermostability of Fab ΔSS and mitigated the destabilization caused by partial reduction of the interchain disulfide bond at the C-terminal region, which occurs in site-specific modification such as PEGylation. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Introduction of a glycosylation site in the constant region decreases the aggregation of adalimumab Fab.

    Science.gov (United States)

    Nakamura, Hitomi; Oda-Ueda, Naoko; Ueda, Tadashi; Ohkuri, Takatoshi

    2018-06-18

    The production of therapeutic monoclonal antibodies is costly; therefore, antigen-binding fragments (Fabs) can be used instead. However, their tendency toward aggregation can reduce the half-life in the plasma and the therapeutic effectiveness. To examine the effect of glycosylation on the properties of the Fab of a therapeutic antibody, an N-glycosylation site was introduced at position 178 of the H-chain constant region of adalimumab Fab through site-directed mutagenesis of L178 N (H:L178 N Fab), and then H:L178 N Fab was expressed in Pichia pastoris. SDS-PAGE analysis with treatment of N-glycosidase F or periodic acid-Schiff reagent showed that H:L178 N Fab contained a relatively low glycan level. Moreover, the H:L178 N mutation did not decrease the binding activity and thermal stability of Fab, and H:L178 N Fab was more resistant to protease digestion than wild-type Fab. The aggregation of Fab induced by pH-shift stress was measured by monitoring the optical density at 350 nm. Although the wild-type Fab showed a large increase in optical density with an increase of protein concentration, no such increase of turbidity during aggregation was found in H:L178 N Fab. These results demonstrated that glycosylation at position 178 of the H-chain constant region of adalimumab Fab can prevent protein aggregation, and therefore serve as a potentially effective platform for drug development. Copyright © 2018. Published by Elsevier Inc.

  8. [Value of fractional flow reserve measurement in endovascular therapy for patients with Stanford B type aortic dissection complicated with renal blood flow injury].

    Science.gov (United States)

    Guo, Xi; Li, Peng; Liu, Guangrui; Huang, Xiaoyong; Yong, Qiang; Wang, Guoqin; Huang, Lianjun

    2015-10-01

    To analyze the value of fractional flow reserve (FFR) measurement on endovascular therapy for patients with renal artery stenosis. Clinical data of 12 patients with Stanford B type aortic dissection complicated with renal blood flow injury in Anzhen hospital hospitalized from May 2013 to February 2014 were retrospectively analyzed. Renal artery angiography was performed and fractional flow reserve (FFR) was measured before Thoracic endovascular aortic repair. After operation, renal artery FFR was measured again, and renal artery stenting was performed in patients with FFR ≤ 0.90 or average pressure difference between proximal and distal of renal artery > 20 mmHg (1 mmHg = 0.133 kPa) and not applied for patients with FFR > 0.90.The patients were then subsequently followed up clinically. Kidney function were measured after 1 month, and contrast-enhanced ultrasonography data were obtained at 1 and 3 months later, respectively. The FFR of 1 patient was 0.90, while the FFR of other patients were less than 0.90 before thoracic endovascular aortic repair. After the procedure,the angiography showed that the blood flow of renal artery in 8 patients were fluency, and the FFR index was over 0.90. There were 4 patients with FFR less than 0.90. After renal artery stenting, the FFR of these 4 patients were all above 0.90. Compared with pre-procedure, blood urea nitrogen ((8.84 ± 3.99) mmol/L vs. (5.18 ± 1.69) mmol/L, P = 0.011) and uric acid ((359.3 ± 77.3) µmol/L vs. (276.9 ± 108.3) µmol/L, P = 0.008) decreased significantly after 1 month, and there was no significant difference in serum creatinine (P = 0.760). Contrast-enhanced ultrasonography results showed that blood flow of renal artery were fluency after 1 month and 3 months. In patients with aortic dissection complicating renal blood flow injury, the FFR measurement is meaningful in evaluating the blood flow status of target organs and guide the endovascular revascularization.

  9. Impact of Chemotherapy on Normal Tissue Complication Probability Models of Acute Hematologic Toxicity in Patients Receiving Pelvic Intensity Modulated Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Bazan, Jose G.; Luxton, Gary; Kozak, Margaret M.; Anderson, Eric M.; Hancock, Steven L.; Kapp, Daniel S.; Kidd, Elizabeth A.; Koong, Albert C.; Chang, Daniel T., E-mail: dtchang@stanford.edu

    2013-12-01

    Purpose: To determine how chemotherapy agents affect radiation dose parameters that correlate with acute hematologic toxicity (HT) in patients treated with pelvic intensity modulated radiation therapy (P-IMRT) and concurrent chemotherapy. Methods and Materials: We assessed HT in 141 patients who received P-IMRT for anal, gynecologic, rectal, or prostate cancers, 95 of whom received concurrent chemotherapy. Patients were separated into 4 groups: mitomycin (MMC) + 5-fluorouracil (5FU, 37 of 141), platinum ± 5FU (Cis, 32 of 141), 5FU (26 of 141), and P-IMRT alone (46 of 141). The pelvic bone was contoured as a surrogate for pelvic bone marrow (PBM) and divided into subsites: ilium, lower pelvis, and lumbosacral spine (LSS). The volumes of each region receiving 5-40 Gy were calculated. The endpoint for HT was grade ≥3 (HT3+) leukopenia, neutropenia or thrombocytopenia. Normal tissue complication probability was calculated using the Lyman-Kutcher-Burman model. Logistic regression was used to analyze association between HT3+ and dosimetric parameters. Results: Twenty-six patients experienced HT3+: 10 of 37 (27%) MMC, 14 of 32 (44%) Cis, 2 of 26 (8%) 5FU, and 0 of 46 P-IMRT. PBM dosimetric parameters were correlated with HT3+ in the MMC group but not in the Cis group. LSS dosimetric parameters were well correlated with HT3+ in both the MMC and Cis groups. Constrained optimization (0complication probability curve compared with treatment with Cis. Dose tolerance of PBM and the LSS subsite may be lower for

  10. A COMPLICATED GRIEF INTERVENTION MODEL

    African Journals Online (AJOL)

    2010-07-29

    Jul 29, 2010 ... work approach to therapy) in an attempt to develop a model for complicated grief intervention ..... way feels right for them, thus making them equal partners with .... This question points out the benefits of success and affords the.

  11. Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.

    Science.gov (United States)

    Vallet, Hélène; Seve, Pascal; Biard, Lucie; Baptiste Fraison, Jean; Bielefeld, Philip; Perard, Laurent; Bienvenu, Boris; Abad, Sébastien; Rigolet, Aude; Deroux, Alban; Sene, Damien; Perlat, Antoinette; Marie, Isabelle; Feurer, Elodie; Hachulla, Eric; Fain, Olivier; Clavel, Gaëlle; Riviere, Sophie; Bouche, Pierre-Alban; Gueudry, Julie; Pugnet, Gregory; Le Hoang, Phuc; Resche Rigon, Matthieu; Cacoub, Patrice; Bodaghi, Bahram; Saadoun, David

    2016-06-01

    To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis. This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated. The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083). Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy.

  12. Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA).

    Science.gov (United States)

    Klotsche, Jens; Niewerth, Martina; Haas, Johannes-Peter; Huppertz, Hans-Iko; Zink, Angela; Horneff, Gerd; Minden, Kirsten

    2016-05-01

    Published evidence on the long-term safety of etanercept (ETA) and adalimumab (ADA) in patients with polyarticular juvenile idiopathic arthritis (pJIA) is still limited. To investigate the rates of serious adverse events (SAE) and of events of special interest (ESI) under ETA and ADA treatment. Patients with pJIA were prospectively observed in the national JIA biological register, Biologika in der Kinderrheumatologie, and its follow-up register, Juvenile arthritis Methotrexate/Biologics long-term Observation. We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate (MTX). Among the 1414 patients treated with ETA (n=1414; 4461 exposure years (EY)) and ADA (n=320; 493 EY), significantly more SAE, infections and medically important infections were observed (ETA: 4.5, 5.7, 0.9; ADA: 4.7, 11.4, 0.4 per 100 EY) compared with those treated with MTX alone (n=1455; 2.907 EY; 2.6, 5.5, 0.5 per 100 EY). The risk for malignancies was not significantly increased for ETA and ADA compared with MTX (0.09, 0.27 and 0.07/100 person-years). Patients under ETA monotherapy developed more frequently incident inflammatory bowel disease (IBD) and incident uveitis (0.5 and 0.8/100 EY) than patients treated by ETA in combination with MTX (0.1 and 0.2/100 EY) or MTX alone (0.03 and 0.1/100 EY). Our data confirm the acceptable long-term tolerability of ETA and ADA in pJIA. However, whether the onset of IBD and uveitis during ETA monotherapy is a paradoxical effect or an inadequate response to therapy remains unclear and requires further investigation in this growing cohort. 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/

  13. Decreasing trends in hospitalizations during anti-TNF therapy are associated with time to anti-TNF therapy: Results from two referral centres.

    Science.gov (United States)

    Mandel, Michael D; Balint, Anita; Golovics, Petra A; Vegh, Zsuzsanna; Mohas, Anna; Szilagyi, Blanka; Szabo, Agnes; Kurti, Zsuzsanna; Kiss, Lajos S; Lovasz, Barbara D; Gecse, Krisztina B; Farkas, Klaudia; Molnar, Tamas; Lakatos, Peter L

    2014-11-01

    Hospitalization is an important outcome measure and a major driver of costs in patients with inflammatory bowel disease. We analysed medical and surgical hospitalization rates and predictors of hospitalization before and during anti-TNF therapy. Data from 194 consecutive patients were analysed retrospectively (males, 45.4%, median age at diagnosis, 24.0 years, infliximab/adalimumab: 144/50) in whom anti-TNF therapy was started after January 1, 2008. Total follow-up was 1874 patient-years and 474 patient-years with anti-TNF exposure. Hospitalization rates hospitalization decreased only in Crohn's disease (odds ratio: 0.59, 95% confidence interval: 0.51-0.70, median 2-years' anti-TNF exposure) with a same trend for surgical interventions (p=0.07), but not in ulcerative colitis. Need for hospitalization decreased in Crohn's disease with early (within 3-years from diagnosis, p=0.016 by McNemar test), but not late anti-TNF exposure. At logistic regression analysis complicated disease behaviour (p=0.03), concomitant azathioprine (p=0.02) use, but not anti-TNF type, gender, perianal disease or previous surgeries were associated with the risk of hospitalization during anti-TNF therapy. Hospitalization rate decreased significantly in patients with Crohn's disease but not ulcerative colitis after the introduction of anti-TNF therapy and was associated with time to therapy. Complicated disease phenotype and concomitant azathioprine use were additional factors defining the risk of hospitalization. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  14. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S

    2011-01-01

    BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo-controlled,......BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg...... subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...

  15. Hospital variation and the impact of postoperative complications on the use of perioperative chemo(radio)therapy in resectable gastric cancer. Results from the Dutch Upper GI Cancer Audit.

    Science.gov (United States)

    Schouwenburg, M G; Busweiler, L A D; Beck, N; Henneman, D; Amodio, S; van Berge Henegouwen, M I; Cats, A; van Hillegersberg, R; van Sandick, J W; Wijnhoven, B P L; Wouters, M W J; Nieuwenhuijzen, G A P

    2018-04-01

    Dutch national guidelines on the diagnosis and treatment of gastric cancer recommend the use of perioperative chemotherapy in patients with resectable gastric cancer. However, adjuvant chemotherapy is often not administered. The aim of this study was to evaluate hospital variation on the probability to receive adjuvant chemotherapy and to identify associated factors with special attention to postoperative complications. All patients who received neoadjuvant chemotherapy and underwent an elective surgical resection for stage IB-IVa (M0) gastric adenocarcinoma between 2011 and 2015 were identified from a national database (Dutch Upper GI Cancer Audit). A multivariable linear mixed model was used to evaluate case-mix adjusted hospital variation and to identify factors associated with adjuvant therapy. Of all surgically treated gastric cancer patients who received neoadjuvant chemotherapy (n = 882), 68% received adjuvant chemo(radio)therapy. After adjusting for case-mix and random variation, a large hospital variation in the administration rates for adjuvant was observed (OR range 0.31-7.1). In multivariable analysis, weight loss, a poor health status and failure of neoadjuvant chemotherapy completion were strongly associated with an increased likelihood of adjuvant therapy omission. Patients with severe postoperative complications had a threefold increased likelihood of adjuvant therapy omission (OR 3.07 95% CI 2.04-4.65). Despite national guidelines, considerable hospital variation was observed in the probability of receiving adjuvant chemo(radio)therapy. Postoperative complications were strongly associated with adjuvant chemo(radio)therapy omission, underlining the need to further reduce perioperative morbidity in gastric cancer surgery. Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

  16. Effect of adalimumab on work productivity and indirect costs in moderate to severe Crohn’s disease: A meta-analysis

    Science.gov (United States)

    Binion, David G; Louis, Edouard; Oldenburg, Bas; Mulani, Parvez; Bensimon, Arielle G; Yang, Mei; Chao, Jingdong

    2011-01-01

    OBJECTIVE: To assess the effect of adalimumab on work productivity and indirect costs in patients with Crohn’s disease (CD) using a meta-analysis of clinical trials. METHODS: Study-level results were pooled from all clinical trials of adalimumab for moderate to severe CD in which work productivity outcomes were evaluated. Work Productivity and Activity Impairment Questionnaire outcomes (absenteeism, presenteeism and total work productivity impairment [TWPI]) were extracted from adalimumab trials. Meta-analyses were used to estimate pooled averages and 95% CIs of one-year accumulated reductions in work productivity impairment with adalimumab. Pooled averages were multiplied by the 2008 United States national average annual salary ($44,101) to estimate per-patient indirect cost savings during the year following adalimumab initiation. RESULTS: The four included trials (ACCESS, CARE, CHOICE and EXTEND) represented a total of 1202 employed adalimumab-treated patients at baseline. Each study followed patients for a minimum of 20 weeks. Pooled estimates (95% CIs) of one-year accumulated work productivity improvements were as follows: −9% (−10% to −7%) for absenteeism; −22% (−26% to −18%) for presenteeism; and −25% (−30% to −20%) for TWPI. Reductions in absenteeism and TWPI translated into per-patient indirect cost savings (95% CI) of $3,856 ($3,183 to $4,529) and $10,964 ($8,833 to $13,096), respectively. CONCLUSION: Adalimumab provided clinically meaningful improvements in work productivity among patients with moderate to severe CD, which may translate into substantial indirect cost savings from an employer’s perspective. PMID:21912760

  17. Radiotherapy of complicated diabetic osteoarthropathy

    International Nuclear Information System (INIS)

    Podlyashchuk, E.L.; Ustinova, V.F.; Machkovskaya, G.K.; Moskvicheva, G.P.; Shekhtman, L.M.

    1978-01-01

    The method of antiinflammatory X-ray therapy as a complex treatment of 50 patients with complicated diabetic osteoarthropathy is presented. High efficacy of antiinflammatory X-ray therapy was noted; it broadened the possibilities of treatment of the given pathology. There was no patient in whom a negative effect of irradiation on the course of diabetes mellitus had been observed

  18. Mulberry-like dual-drug complicated nanocarriers assembled with apogossypolone amphiphilic starch micelles and doxorubicin hyaluronic acid nanoparticles for tumor combination and targeted therapy.

    Science.gov (United States)

    Li, Ke; Liu, Hao; Gao, Wei; Chen, Mu; Zeng, Yun; Liu, Jiajun; Xu, Liang; Wu, Daocheng

    2015-01-01

    A comprehensive strategy for the preparation of mulberry-like dual-drug complicated nanocarriers (MLDC NCs) with high drug loading and adjustable dual-drug ratio was developed. First, apogossypolone (ApoG2) amphiphilic starch micelles (AASt MCs) were prepared by self-assembly process, and doxorubicin (DOX) hyaluronic acid nanoparticles (DHA NPs) were prepared by DOX absorption with excess HA by electrostatic absorption. MLDC NCs were obtained by adsorption of 8-9 DHA NPs around one AASt MC via electrostatic interaction. UV-visible and fluorescence spectrophotometers were used to measure the entrapment efficiency and loading efficiency of the two drugs. Transmission electron microscope and dynamic light scattering method were used to observe the size distribution and morphology of the particles. The tumor-targeting feature caused by HA-receptor mediation was confirmed by in vitro cell uptake and in vivo near-infrared fluorescence imaging. MLDC NCs were found to possess a mulberry-like shape with a dynamic size of 83.1 ± 6.6 nm. The final encapsulation efficiencies of ApoG2 and DOX in MLDC NCs were 94 ± 1.7% and 87 ± 5.8% with respect to drug-loading capacities of 13.3 ± 1.2% and 13.1 ± 3.7%, respectively. Almost no ApoG2 release was found within 80 h and less than 30% of DOX was released into the outer phase even after 72 h. In vivo fluorescence imaging revealed that MLDC NCs had highly efficient targeting and accumulation at the tumor in vivo and was maintained for 96 h after being injected intravenously in mice. Low LD50 for the two drugs in MLDC NCs was found after acute toxicity test. One-fifth normal dosage of the two drugs in MLDC NCs exhibited significantly higher anti-tumor efficiency in reducing tumor size compared with free drugs combination or single drug-loaded nanoparticles individually, indicating that the mulberry-like dual-drug nanoplatform has a great potential in tumor therapy. Copyright © 2014 Elsevier Ltd. All rights

  19. Complications of gynecologic and obstetric management

    International Nuclear Information System (INIS)

    Newton, M.; Newton, E.R.

    1987-01-01

    This book examines the incidence, diagnosis and management of complications associated with interventions used in gynecology and obstetrics. These are encountered in all phases of gynecologic and therapeutic procedures, radiation therapy, drug therapy and pre- and post-treatment care

  20. Transferrin Level Before Treatment and Genetic Polymorphism in HFE Gene as Predictive Markers for Response to Adalimumab in Crohn's Disease Patients.

    Science.gov (United States)

    Repnik, Katja; Koder, Silvo; Skok, Pavel; Ferkolj, Ivan; Potočnik, Uroš

    2016-08-01

    Tumor necrosis factor α inhibitors (anti-TNF) have improved treatment of several complex diseases, including Crohn's disease (CD). However, the effect varies and approximately one-third of the patients do not respond. Since blood parameters as well as genetic factors have shown a great potential to predict response during treatment, the aim of the study was to evaluate response to anti-TNF treatment with adalimumab (ADA) between genes HFE and TF and haematological parameters in Slovenian refractory CD patients. Single nucleotide polymorphisms (SNPs) rs1799852 in gene TF and rs2071303 in gene HFE were genotyped in 68 refractory CD patients for which response has been measured using inflammatory bowel disease questionnaire (IBDQ) index. Haematological parameters and IBDQ index were determined before therapy and after 4, 12, 20 and 30 weeks. We found novel strong association between SNP rs2071303 in gene HFE and response to ADA treatment, particularly patients with G allele comparing to A allele had better response after 20 weeks (p = 0.008). Further, we found strong association between transferrin level at baseline and treatment response after 12, 20 and 30 weeks, where average transferrin level before therapy was lower in responders (2.38 g/L) compared to non-responders (2.89 g/L, p = 0.005). Association was found between transferrin level in week 30 and SNP rs1799852 (p = 0.023), and between MCHC level before treatment and SNP rs2071303 (p = 0.007). Our results suggest that SNP in gene HFE as well as haematological markers serve as promising prognostic markers of response to anti-TNF treatment in CD patients.

  1. Maxillofacial prosthodontic rehabilitation of a patient with oral complications during and after multimodality therapy for the management of oral squamous cell carcinoma.

    Science.gov (United States)

    Acharya, Varun; Chambers, Mark S

    2015-06-01

    Multimodality cancer therapy involving surgical resection, chemotherapy, and radiation therapy is frequently employed in the management of head and neck cancer. Patients who have undergone such therapy face substantial challenges during and after treatment. Prosthodontic rehabilitation is essential during and after tumor ablation to restore function, esthetics, and minimize interruption in daily routine. This clinical report describes the challenges faced by a patient undergoing multimodality therapy for a squamous cell carcinoma of the maxillary sinus and the stages involved in prosthodontic rehabilitation. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  2. Complicações oculares da terapêutica com a cloroquina e derivados Ocular complications of chloroquine and derivatives therapy

    Directory of Open Access Journals (Sweden)

    Augusto Cézar Lacava

    2010-08-01

    gastrointestinal, nervous and skeletal muscular systems and the skin. Ocular adverse reactions are: photophobia, cornea verticillata, poliosis, cataract, extraocular muscle palsy, anterior uveitis, toxic maculopathy and optical neuritis. PURPOSE: Bibliography review of complications due to the use of chloroquine and its derivatives. To analyze the current practice and propedeutics' evolution. To suggest practical managements for early toxicity signs. METHODS: Bibliographic review through research on MEDLINE, PUBMED, LILACS and SciELO database. DISCUSSION: All exams that can be used to screen ocular adverse reactions are described, such as: complete ophthalmologic exam, with emphasis on biomicroscopy and indirect binocular ophthalmoscopy, computerized visual field, Amsler grid testing and color vision testing, electrophysiological exams, polarimetry and optical coherence tomography. A description of maculopathy is presented, focusing on epidemiology, risk factors, histopathology and propedeutics. Chemical structure and the differences between 4-aminoquinolone derivatives are described. CONCLUSION: All patients using chloroquine and its derivatives must be followed-up and documented since the beginning of the therapy until they reach a cumulative dose above 100 grams. The higher the cumulative dose, the more we must be concerned with patient follow-up.

  3. Similar Improvements in Patient-Reported Outcomes Among Rheumatoid Arthritis Patients Treated with Two Different Doses of Methotrexate in Combination with Adalimumab: Results From the MUSICA Trial.

    Science.gov (United States)

    Kaeley, Gurjit S; MacCarter, Daryl K; Goyal, Janak R; Liu, Shufang; Chen, Kun; Griffith, Jennifer; Kupper, Hartmut; Garg, Vishvas; Kalabic, Jasmina

    2018-06-01

    In patients with rheumatoid arthritis (RA), combination treatment with methotrexate (MTX) and adalimumab is more effective than MTX monotherapy. From the patients' perspective, the impact of reduced MTX doses upon initiating adalimumab is not known. The objective was to evaluate the effects of low and high MTX doses in combination with adalimumab initiation on patient-reported outcomes (PROs), in MTX-inadequate responders (MTX-IR) with moderate-to-severe RA. MUSICA was a randomized, double-blind, controlled trial evaluating the efficacy of 7.5 or 20 mg/week MTX, in combination with adalimumab for 24 weeks in MTX-IR RA patients receiving prior MTX ≥ 15 mg/week for ≥ 12 weeks. PROs were recorded at each visit, including physical function, health-related quality-of-life, work productivity, quality-of-sleep, satisfaction with treatment medication, sexual impairment due to RA, patient global assessment of disease activity (PGA), and patient pain. Last observation carried forward was used to account for missing values. At baseline, patients in both MTX dosage groups had similar demographics, disease characteristics, and PRO scores. Overall, initiation of adalimumab led to significant improvements from baseline in the PROs assessed for both MTX dosage groups. Improvements in presenteeism from baseline were strongly correlated with corresponding improvements in SF-36 (vitality), pain, and physical function. Physical and mental well-being had a good correlation with improvement in sleep. Overall, improvements in disease activity from baseline were correlated with improvements in several PROs. The addition of adalimumab to MTX in MTX-IR patients with moderate-to-severe RA led to improvements in physical function, quality-of-life, work productivity, quality of sleep, satisfaction with treatment medication, and sexual impairment due to RA, regardless of the concomitant MTX dosage. AbbVie. Clinicaltrials.gov identifier, NCT01185288.

  4. Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry.

    Science.gov (United States)

    Menter, Alan; Thaçi, Diamant; Wu, Jashin J; Abramovits, William; Kerdel, Francisco; Arikan, Dilek; Guo, Dianlin; Ganguli, Arijit; Bereswill, Mareike; Camez, Anne; Valdecantos, Wendell C

    2017-09-01

    ESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry. All treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed. Physician Global Assessment (PGA) and PROs (PROs for US patients only) were evaluated during registry participation. As of 30 November 2015, 6051 patients in the ESPRIT registry were analyzed, representing 23,660.1 patient-years (PY) of overall adalimumab exposure. The incidence rates for All-TE serious AEs, serious infections, and malignancies were 4.4, 1.0, and 1.0 events per 100 PY (E/100PY), respectively. The standardized mortality ratio for TE deaths in the registry was 0.27 (95% CI 0.18-0.38). During the registry's first 7 years, PGA "clear" or "minimal" was achieved by >50% of patients at each annual visit, and among US patients, the mean improvement from baseline in different PROs was maintained. No new safety signals were identified during the first 7 years of the registry, and safety was consistent with the known safety profile of adalimumab. The number of TE deaths was below the expected rate. During the registry's first 7 years, most of the patients remained free of All-TE cardiovascular events, serious infections, and malignancy. As-observed effectiveness of adalimumab and improvements from baseline in PROs were maintained through 7 years of registry participation. Abbvie. ClinicalTrials.gov identifier, NCT00799877.

  5. Anti tumor necrosis factor - alpha adalimumab for complex regional pain syndrome type 1 (CRPS-I): a case series.

    Science.gov (United States)

    Eisenberg, Elon; Sandler, Ifat; Treister, Roi; Suzan, Erica; Haddad, May

    2013-11-01

    Evidence suggests tumor necrosis factor-alpha (TNF-α) mediates, at least in part, symptoms and signs in complex regional pain syndrome (CRPS). Here, we present a case series of patients with CRPS type 1, in whom the response to the anti-TNF-α adalimumab was assessed. Ten patients with CRPS type 1 were recruited. Assessments were performed before treatment, at 1 week, and 1, 3, and 6 months following 3 biweekly subcutaneous injections (40 mg/0.8 mL) adalimumab (Humira(®) ) and included the followings: Pain intensity using a 0-10 cm visual analog scale; the Short Form of the McGill Pain Questionnaire; the Beck Depression Inventory; the SF-36 questionnaire and mechanical and thermal thresholds (Von frey hair and Thermal Sensory Analyzer, respectively). In addition to the description of individual patient responses, both intention to treat (ITT) and per-protocol (PP) analyses were performed for the entire group. Three subgroups of patients were identified (3 patients in each): "nonresponders", "partial responders", and "robust responders" in whom improvement in almost all parameters was noted. Both the ITT and PP analyses demonstrated only a trend toward improvement in mechanical pain thresholds following treatment (ITT χ² = 13.83, P = 0.008; PP χ² = 10.29, P = 0.036). These results suggest adalimumab, and possibly other anti-TNF-α, can be potentially useful in some (although not in all) patients with CRPS type 1. These preliminary results along with the growing body of evidence which points to the involvement of TNF-α in the pathogenesis of CRPS justify further studies in this area. © 2013 World Institute of Pain.

  6. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

    Science.gov (United States)

    Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

    2017-10-01

    ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Adalimumab in the induction of Crohn's disease remission: results of a Brazilian multicenter case series

    Directory of Open Access Journals (Sweden)

    Paulo Gustavo Kotze

    2011-09-01

    Full Text Available Introduction: Adalimumab (ADA is a subcutaneous fully-human anti-TNF antibody which has a significant role in the management of Crohn's disease (CD. Its efficacy has been demonstrated in several clinical trials. The main objective of this study was to evaluate the role of ADA in the induction of clinical remission in a Brazilian series of CD cases. Method: A retrospective analysis of CD patients treated with ADA was performed in three Brazilian inflammatory bowel diseases (IBD reference centers. The following characteristics were analyzed: gender, age, indication to ADA treatment, type of response, previous exposure to infliximab (IFX, concomitant use of immunomodulators and adverse events, among others. Results: 54 patients (29 females were included in this series, with mean age of 36.72 years (ranging from 15 to 62 years. After induction regimen, 26 patients (48.14% were in clinical remission, 26 (48.14% had partial response, and 2 (3.72% were primary non-responders. After a mean follow-up of 9.83 (2 to 28 months, 17 patients (31.48% presented adverse events. The most common event was pain on the injection site (7 patients - 12.96%. Conclusions: ADA was effective to induce CD remission in this Brazilian case series. The remission and response rates were similar to the literature, as well as the safety profile of this drug.Introdução: O adalimumabe (ADA é um anticorpo anti-fator de necrose tumoral alfa totalmente humano, de uso subcutâneo, com eficácia e perfil de segurança bem determinados na doença de Crohn (DC. O objetivo principal deste estudo foi determinar o papel do ADA na indução da remissão na DC, em uma série brasileira de casos. Método: Estudo retrospectivo, realizado em três centros de referência em doenças inflamatórias intestinais, com usuários do ADA para tratamento da DC. As variáveis analisadas foram: idade, sexo, indicação do tratamento, forma de apresentação da doença, tipo de resposta (total, parcial

  8. Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial.

    Science.gov (United States)

    Kaeley, Gurjit S; Evangelisto, Amy M; Nishio, Midori J; Goss, Sandra L; Liu, Shufang; Kalabic, Jasmina; Kupper, Hartmut

    2016-08-01

    To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7.5 mg/week) MTX; all patients received 40 mg open-label ADA every other week for 24 weeks. The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) to test for noninferiority of low-dosage MTX using a 15% margin. US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology, assessing synovial hypertrophy, vascularity, and bony erosions. Rapid improvement in clinical indices was observed in both groups after addition of ADA. The difference in mean DAS28-CRP (0.37, 95% CI 0.07-0.66) comparing low-dosage (4.12, 95% CI 3.88-4.34) versus high-dosage MTX (3.75, 95% CI 3.52-3.97) was statistically significant and non-inferiority was not met. Statistically significant differences were not detected for most clinical, functional, and US outcomes. Pharmacokinetic and safety profiles were similar. In MUSICA, Week 24 mean DAS28-CRP, the primary endpoint, did not meet non-inferiority for the low-dosage MTX group. Although the differences between the 2 MTX dosage groups were small, our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA.

  9. Pulmonary complications of cystic fibrosis

    International Nuclear Information System (INIS)

    Ng, M.Y.; Flight, W.; Smith, E.

    2014-01-01

    The life expectancy of patients with cystic fibrosis (CF) has steadily increased over recent decades with a corresponding increase in the frequency of complications of the disease. Radiologists are increasingly involved with managing and identifying the pulmonary complications of CF. This article reviews the common manifestations of CF lung disease as well as updating radiologists with a number of less well-known complications of the condition. Early and accurate detection of the pulmonary effects of CF are increasingly important to prevent irreversible lung damage and give patients the greatest possibility of benefiting from the new therapies becoming available, which correct the underlying defect causing CF

  10. Original paper Influence of biologic therapy on growth in children with chronic inflammatory connective tissue diseases

    Directory of Open Access Journals (Sweden)

    Joanna Świdrowska

    2015-04-01

    Full Text Available Objectives: Connective tissue diseases (CTD are a heterogeneous group of chronic inflammatory conditions. One of their complications in children is the inhibition of growth velocity. Due to direct inflammation within the musculoskeletal system as well as glucocorticoid therapy, this feature is the most essential and is mainly expressed in the course of juvenile spondyloarthropathies and juvenile idiopathic arthritis (JIA. Duration of the disease, but predominantly the activity of the inflammatory process, seems to have a significant impact on the abnormal growth profile in children. Effective biological therapy leads to improvement of the patient’s clinical condition and also, through the extinction of disease activity and reduction of daily doses of glucocorticosteroids (GCS, it gradually accelerates and normalizes the growth rate in children with CTD. Our objective was to evaluate the impact of biological therapy on growth in children with chronic inflammatory CTD. Material and methods: Data from 24 patients with CTD treated with tumor necrosis factor--blockers (etanercept, adalimumab, golimumab and an interleukin-6 receptor blocker (tocilizumab were reviewed at the time of disease onset, biological treatment initiation and at least 12 up to 24 months onwards. The rate of growth was correlated with the daily doses of GCS, and the type and duration of biological therapy. Results : Patient median height, measured as the change in height standard deviation score, was 0.36 ±1.07 at disease onset and –0.13 ±1.02 at biologic therapy initiation. The growth velocity accelerated in 17 patients (70.1% during the biological treatment. Mean height-SDS improvement between biological treatment initiation up to two years was 0.51 ±0.58. In 47% of patients daily doses of GCS were reduced to 0 mg/kg/day. Conclusions : In the treatment of CTD, biological agents restore growth velocity not only by inflammation inhibition, but also through limiting GCS

  11. Delayed Complications and Long-Term Management of Sulfur Mustard Poisoning: A Narrative Review of Recent Advances by Iranian Researchers Part ІІ: Clinical Management and Therapy

    Directory of Open Access Journals (Sweden)

    Leila Etemad

    2018-05-01

    Full Text Available The present study aimed to review and discuss the recommended and recently suggested protocols by Iranian researchers for a long-term treatment of delayed complications of sulfur mustard (DCSM in veterans. As indicated clinically, patients who suffer from delayed ocular complications of sulfur mustard (DOCS benefit from treatments for dry eyes, therapeutic contact lenses, amniotic membrane transplantation; blepharorrhaphy, tarsorrhaphy, limbal stem cell transplantation; corneal transplantation, topical steroids, and immunosuppressive. In spite of penetrating keratoplasty, lamellar keratoplasty and keratolimbal allograft had a good long-term survival. Delayed respiratory complications (DRCS are the most common effects and life-threatening in Iranian veterans. The recommended treatment protocols include regular clinical evaluations, respiratory physiotherapy and rehabilitation, N-acetyl cysteine; warm humidified air, long-acting 2-agonists, and inhaled corticosteroids. Azithromycin has also been effective in improving clinical conditions, pulmonary function tests, inflammatory indexes, and life quality of the veterans. Interferon gamma (IFN-γ and helium: oxygen combination were also used in severe DRCS with good results. Some of the delayed cutaneous complications (DCCS such as itching affects the quality of life of victims. Regular but not frequent showering and bathing, applying sunscreen compounds, topical corticosteroids, and systemic antihistamines reduce the problems of DCCS patients. Several compounds such as capsaicin cream, pimecrolimus, IFN-γ, phenol-menthol; Aloe vera/olive oil cream, cetirizine, doxepine, and hydroxyzine were evaluated in DCCS patients with some benefits. The physicians in charge of veterans emphasize the importance of a healthy lifestyle, appropriate financial/social/cultural supports, and a degree of reassurance and supportive care on the clinical improvement of patients.

  12. Role of radiation therapy in the treatment of pediatric non-Hodgkin's lymphomas. [Complications of local irradiation and chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Carabell, S.C.; Cassady, J.R.; Weinstein, H.J.; Jaff, N.

    1978-11-01

    Between 1971 and 1976, 64 patients less than 18 years of age with non-Hodgkin's lymphoma were treated at Boston's Children's Hospital Medical Center-Joint Center for Radiation Therapy. A multimodality approach was used, consisting of radiation therapy (3500 to 4500 rad), surgery, and chemotherapy. Since 1973, all patients have received a regimen initially comprising Adriamycin, Prednisone, 6-Mercaptopurine, Vincristine, and L-Asparaginase. Methotrexate was substituted for Adriamycin following a cumulative total dose of 450 mg/m/sup 2/. The 5-year actuarial survival for all patients was 61%, while relapse-free survival was 54%. The actuarial and relapse-free survival for patients presenting with localized disease was 75% and 72%, respectively. Median follow-up was 40 months and all relapses occurred within 24 months of initial therapy. A multidisciplinary approach, such as the current regimen, offers a good prognosis for this disease.

  13. Dependence of early therapy results and complications on radiation dose values and their fractionation in pre-operative ''afterloading'' technique brachyradiotherapy applied to cervix uteri carcinoma patients

    International Nuclear Information System (INIS)

    Kaminska, G.; Kawczynska, M.

    1984-01-01

    The ''afterloading'' technique with use of Curietron (41 cases) or Selectron (43 cases) apparatus was applied in 83 cervix uteri carcinoma patients in phase 1b (79 cases) and 2a (4 cases). The Wertheim-Magis operation was performed after several weeks. Post-operative histologic investigation showed complete destruction of the tumour in 72% cases; persistent cancer cells in cervix uteri were stated in 11 patients (13%), while lymphatic node metastasis was seen in 14 patients (17%). Supplementary teleradiotherapy was performed in those cases. 39 patients (95%) of the 41 observed during 3 years survived without any cancer symptoms. No explicit relationship between dose administered to vaginal disc and cancer persistence frequency in the cervix uteri was stated. However, such relationship was stated for the dose in point A. In the group of 19 patients who received point A dose of the least 6000 rads, with average TDF value of 135, presence of cancer cells in cervix uteri was not stated in any of the cases. In 7 patients (17%) observed for over 3 years light and medium heavy postradiation complications were stated; in that 5 rectum side complications were stated in patients additionally irradiated from external fields, where the dose absorbed by rectum wall exceeded 8000 rads, with TDF - 150. No complications were observed when the dose was less than 5000 rads and TDF below 100. 16 refs., 1 fig. (author)

  14. OPTIONS FOR USE OF APPROPRIATE ANTICOAGULANT THERAPY IN PATIENTS WITH THERMAL INJURY WITH A HIGH RISK OF THROMBOEMBOLIC COMPLICATIONS DEVELOPMENT ASSOCIATED WITH RECURRENT INTESTINAL BLEEDING

    Directory of Open Access Journals (Sweden)

    V. S. Borisov

    2015-01-01

    Full Text Available ABSTRACT. Patients with major thermal injury require anticoagulant therapy during almost the whole period of the burn disease, forcing the physician to balance constantly between the risk of possible bleeding associated with surgical treatment and the risk of thrombosis development in patients demonstrating a number of factors predisposing to the development of VTС. We report a clinical case of appropriate anticoagulant therapy using the new oral anticoagulants in a patient with a high risk of VTС development and recurrent bleeding from the tumor of the ascending colon. 

  15. Postoperative chest physical therapy prevents respiratory complications in patients undergoing esophagectomy Fisioterapia respiratória pós-operatória previne complicações respiratórias em pacientes submetidos à esofagectomia

    Directory of Open Access Journals (Sweden)

    Adriana C. Lunardi

    2011-04-01

    Full Text Available BACKGROUND: Esophagectomy presents the highest rate of postoperative pulmonary complications among all types of upper abdominal surgery. The benefits of chest physical therapy in patients undergoing upper abdominal surgery have been shown by many studies; however, its specific effect in patients receiving esophagectomy has been seldom investigated. OBJECTIVES: This study aimed to compare the frequency of respiratory complications in patients undergoing esophagectomy receiving chest physical therapy compared to no treatment. METHODS: 70 consecutive patients were evaluated retrospectively and allocated to two groups: control group (CG=no physical therapy; n=30 and chest physical therapy group (PTG; n=40. Patients received chest physical therapy which includes lung re-expansion and airway clearance maneuvers. They were not submitted to either noninvasive ventilation or exercises with devices that generate airways positive pressure. All patients were instructed to early mobilization. Information about pre-operative and respiratory complications were collected. Statistic analysis to compare the frequency of respiratory complications was performed by the Z test. The significance level was set to 5%. RESULTS: Patients in the CG and PTG were similar in terms of age, BMI, smoking and drinking status, malignant diseases, surgical and anesthesia duration and types of esophagectomy (p>0.05. Our results show that patients received chest physical therapy after esophagectomy had a lower frequency of respiratory complications (15% vs. 37%, pCONTEXTUALIZAÇÃO: A esofagectomia apresenta a maior taxa de complicações pulmonares pós-operatórias dentre as cirurgias abdominais altas. Os benefícios da fisioterapia respiratória em pacientes submetidos à cirurgia abdominal alta convencional têm sido mostrados na literatura, porém esse efeito na esofagectomia tem sido pouco investigado. OBJETIVOS: Comparar a frequência de complicações respiratórias em dois

  16. The Effectiveness of Family-Based Cognitive-Behavior Grief Therapy to Prevent Complicated Grief in Relatives of Suicide Victims: The Mediating Role of Suicide Ideation

    Science.gov (United States)

    de Groot, Marieke; Neeleman, Jan; van der Meer, Klaas; Burger, Huibert

    2010-01-01

    Grief interventions are more effective for high risk individuals. The presence of suicide ideation following suicide bereavement was examined to determine whether it indicates a high risk status. Using data from a randomized controlled trial (n = 122) on the effectiveness of cognitive-behavior therapy, the effect of suicide ideation on the…

  17. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.

    Science.gov (United States)

    Papp, K; Bachelez, H; Costanzo, A; Foley, P; Gooderham, M; Kaur, P; Philipp, S; Spelman, L; Zhang, N; Strober, B

    2017-12-01

    ABP 501, a U.S.A. Food and Drug Administration- and European Medicines Agency-approved biosimilar, is highly similar to adalimumab in structure, function and pharmacokinetics. To demonstrate similarity in efficacy, safety and immunogenicity of ABP 501 vs. adalimumab for moderate-to-severe plaque psoriasis (clinical trial: NCT01970488). Patients were randomized (1 : 1) to receive ABP 501 or adalimumab 40 mg every 2 weeks for 16 weeks. At week 16, patients with ≥ 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score were eligible to continue to week 52. Patients receiving ABP 501 continued; adalimumab patients were rerandomized (1 : 1) to continue adalimumab or undergo a single transition to ABP 501. Key efficacy assessments included percentage PASI improvement from baseline, PASI responders and mean change in affected body surface area from baseline to weeks 16, 32 and 50. Safety was monitored via adverse events (AEs) and antidrug antibodies (ADAs) were assessed. A total of 308 patients were rerandomized at week 16 (ABP 501/ABP 501, n = 152; adalimumab/adalimumab, n = 79; adalimumab/ABP 501, n = 77). PASI percentage improvements from baseline were similar across groups for weeks 16, 32 and 50 (range: 85·8-88·2%), with no significant differences detected across groups in percentages of PASI 50, 75, 90 and 100 responders. Changes from baseline in percentage body surface area affected were similar across groups and time points. No new safety signals were detected. AEs were balanced between groups. Percentages of patients with binding and neutralizing ADAs were similar across treatments. ABP 501 and adalimumab have similar clinical efficacy, safety and immunogenicity profiles over 52 weeks, including after single transition, in this patient population. © 2017 British Association of Dermatologists.

  18. Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial.

    Science.gov (United States)

    Elewski, Boni E; Okun, Martin M; Papp, Kim; Baker, Christopher S; Crowley, Jeffrey J; Guillet, Gérard; Sundaram, Murali; Poulin, Yves; Gu, Yihua; Geng, Ziqian; Williams, David A; Rich, Phoebe A

    2018-01-01

    Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P psoriasis versus with placebo and no new safety risks were identified. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  19. Intermittent versus every-day mesalazine therapy in preventing complications of diverticular disease: a long-term follow-up study.

    Science.gov (United States)

    Tursi, A; Di Mario, F; Brandimarte, G; Elisei, W; Picchio, M; Loperfido, S; Dal Bo', N; Ferrara, F; Marcello, R; Heras Salvat, H; Scarpignato, C

    2013-12-01

    Mesalazine seems to be effective in preventing recurrence of acute uncomplicated diverticulitis (AUD), but the optimal mesalazine scheme to achieve these results is still debated. To assess the effectiveness of two different mesalazine-based treatments in preventing recurrence of AUD and the occurrence of other complications of diverticular disease (DD) during a long-term follow-up. We reviewed 311 patients suffer from recent episode of AUD and undergoing to mesalazine treatment: 207 (group A, 105 males, median age 63 years, range 47-74 years) were treated with mesalazine 1.6 g for 10 days each month, whilst 104 (group B, 55 males, median age 65 years, range 50-72 years) were treated with mesalazine 1.6 g every day. Patients were followed-up every 6 months (median 7.5 months, range 5-13 months). Patients were followed-up for a mean time of 3 years (range 12-72 months). Overall, occurrence of complication recurred more frequently in group A than in group B (p = 0.030, log-rank test). Acute diverticulitis recurred in 17 (8.2%) patients in group A and in 3 (2.9%) in group B; diverticular bleeding occurred in 4 (1.9%) patients in group A and in 1 (0.96%) patient in group B; surgery was required in 3 (1.4%) patients in group A and in no (0%) patient in group B. This is the first study showing that long-term mesalazine treatment is significantly better that intermittent mesalazine treatment in preventing occurrence of DD complications after an attack of acute diverticulitis.

  20. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis.

    Science.gov (United States)

    Sroussi, Herve Y; Epstein, Joel B; Bensadoun, Rene-Jean; Saunders, Deborah P; Lalla, Rajesh V; Migliorati, Cesar A; Heaivilin, Natalie; Zumsteg, Zachary S

    2017-12-01

    Patients undergoing radiation therapy for the head and neck are susceptible to a significant and often abrupt deterioration in their oral health. The oral morbidities of radiation therapy include but are not limited to an increased susceptibility to dental caries and periodontal disease. They also include profound and often permanent functional and sensory changes involving the oral soft tissue. These changes range from oral mucositis experienced during and soon after treatment, mucosal opportunistic infections, neurosensory disorders, and tissue fibrosis. Many of the oral soft tissue changes following radiation therapy are difficult challenges to the patients and their caregivers and require life-long strategies to alleviate their deleterious effect on basic life functions and on the quality of life. We discuss the presentation, prognosis, and management strategies of the dental structure and oral soft tissue morbidities resulting from the administration of therapeutic radiation in head and neck patient. A case for a collaborative and integrated multidisciplinary approach to the management of these patients is made, with specific recommendation to include knowledgeable and experienced oral health care professionals in the treatment team. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  1. Esophageal stent fixation with endoscopic suturing device improves clinical outcomes and reduces complications in patients with locally advanced esophageal cancer prior to neoadjuvant therapy: a large multicenter experience.

    Science.gov (United States)

    Yang, Juliana; Siddiqui, Ali A; Kowalski, Thomas E; Loren, David E; Khalid, Ammara; Soomro, Ayesha; Mazhar, Syed M; Rosé, Julian; Isby, Laura; Kahaleh, Michel; Kalra, Ankush; Sarkisian, Alex M; Kumta, Nikhil A; Nieto, Jose; Sharaiha, Reem Z

    2017-03-01

    Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) to treat malignant dysphagia in patients with esophageal cancer significantly improves dysphagia; however, these stents have a high migration rate. To determine whether FCSEMS fixation using an endoscopic suturing device treated malignant dysphagia and prevented stent migration in patients with locally advanced esophageal cancer receiving neoadjuvant therapy when compared to patients with FCSEMS placement alone. A review of patients with locally advanced esophageal cancer who underwent FCSEMS placement at 3 centers was performed. Patients were divided into two groups: Group A (n = 26) was composed of patients who underwent FCSEMS placement with suture placement, and Group B (n = 67) was composed of patients with FCSEMS placement alone. There were no significant differences between Groups A and B in demographics, and tumor characteristics. The technical success rate for stent placement was 100 %. There was no difference between Groups A and B in the median stent diameter and stent lengths. Mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively, p esophageal FCSEMSs by using an endoscopic suturing device in patients receiving neoadjuvant therapy was shown to be feasible, safe, and relatively effective at preventing stent migration compared to those who had stent placed alone.

  2. A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis

    DEFF Research Database (Denmark)

    Axelsen, Mette Bjørndal; Eshed, Iris; Hørslev-Petersen, Kim

    2014-01-01

    To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect....

  3. Complications after cardiac implantable electronic device implantations

    DEFF Research Database (Denmark)

    Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard

    2013-01-01

    Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient...

  4. Plasma MicroRNA Profiles in Patients with Early Rheumatoid Arthritis Responding to Adalimumab plus Methotrexate vs Methotrexate Alone

    DEFF Research Database (Denmark)

    Sode, Jacob; Krintel, Sophine B; Carlsen, Anting Liu

    2018-01-01

    OBJECTIVE: The aim was to identify plasma (i.e., cell-free) microRNA (miRNA) predicting antitumor necrosis and/or methotrexate (MTX) treatment response in patients enrolled in an investigator-initiated, prospective, double-blinded, placebo-controlled trial (The OPERA study, NCT00660647). METHODS......: We included 180 disease-modifying antirheumatic drug-naive patients with early rheumatoid arthritis (RA) randomized to adalimumab (ADA; n = 89) or placebo (n = 91) in combination with MTX. Plasma samples before and 3 months after treatment initiation were analyzed for 91 specific mi...... multivariate miRNA models were able to predict response to ADA treatment after 3 and 12 months, with 63% and 82% area under the ROC curves, respectively. CONCLUSION: We identified miR-27a-3p as a potential predictive biomarker of ACR/EULAR remission in patients with early RA treated with ADA in combination...

  5. Catastrophic complication following injection and extracorporeal shock wave therapy of a medial femoral condyle subchondral cystic lesion in a 14 year old Arabian mare

    Directory of Open Access Journals (Sweden)

    Darla K. Moser

    2017-05-01

    Full Text Available This report describes fibrous cyst lining injection and extracorporeal shock wave therapy (ESWT of a medial femoral condyle (MFC subchondral cystic lesion (SCL resulting in catastrophic MFC fracture in an Arabian mare. The mare was presented for evaluation of a severe hind limb lameness of approximately 4 months duration. On presentation, a non-weight bearing lameness of the left hind limb with severe effusion and soft tissue swelling of the stifle region was noted. Radiographic evaluation of the stifle revealed a large SCL of the MFC with associated osteoarthritis. Arthroscopic guided intra-lesional injection of the SCL with corticosteroids and autologous bone marrow concentrate was performed followed by ESWT of the MFC. The mare was discharged walking comfortably 48-hours post-operatively. An acute increase in lameness was noted 14 days post-operatively. Imaging revealed catastrophic fracture of the left MFC. Possible mechanisms leading to failure of the MFC secondary to the described treatment are discussed.

  6. Prediction of radiation-induced liver disease by Lyman normal-tissue complication probability model in three-dimensional conformal radiation therapy for primary liver carcinoma

    International Nuclear Information System (INIS)

    Xu ZhiYong; Liang Shixiong; Zhu Ji; Zhu Xiaodong; Zhao Jiandong; Lu Haijie; Yang Yunli; Chen Long; Wang Anyu; Fu Xiaolong; Jiang Guoliang

    2006-01-01

    Purpose: To describe the probability of RILD by application of the Lyman-Kutcher-Burman normal-tissue complication (NTCP) model for primary liver carcinoma (PLC) treated with hypofractionated three-dimensional conformal radiotherapy (3D-CRT). Methods and Materials: A total of 109 PLC patients treated by 3D-CRT were followed for RILD. Of these patients, 93 were in liver cirrhosis of Child-Pugh Grade A, and 16 were in Child-Pugh Grade B. The Michigan NTCP model was used to predict the probability of RILD, and then the modified Lyman NTCP model was generated for Child-Pugh A and Child-Pugh B patients by maximum-likelihood analysis. Results: Of all patients, 17 developed RILD in which 8 were of Child-Pugh Grade A, and 9 were of Child-Pugh Grade B. The prediction of RILD by the Michigan model was underestimated for PLC patients. The modified n, m, TD 5 (1) were 1.1, 0.28, and 40.5 Gy and 0.7, 0.43, and 23 Gy for patients with Child-Pugh A and B, respectively, which yielded better estimations of RILD probability. The hepatic tolerable doses (TD 5 ) would be MDTNL of 21 Gy and 6 Gy, respectively, for Child-Pugh A and B patients. Conclusions: The Michigan model was probably not fit to predict RILD in PLC patients. A modified Lyman NTCP model for RILD was recommended

  7. Unilateral hypoglossal nerve atrophy as a late complication of radiation therapy of head and neck carcinoma: a report of four cases and a review of the literature on peripheral and cranial nerve damages after radiation therapy

    International Nuclear Information System (INIS)

    Cheng, V.S.T.; Schulz, M.D.

    1975-01-01

    The case histories of four patients who developed hemiatrophy of the tongue from 3 to 9 years after a course of curative radiation therapy for carcinomas of the head and neck are presented. These patients were subsequently followed from 1 1 / 2 to 6 years without local recurrence of the tumor, distant metastasis, or involvement of other cranial nerves, indicative of only a unilateral hypoglossal nerve atrophy. A review of the literature showed that peripheral and cranial nerve damages after radiation therapy have been reported for the optic nerve, hypoglossal nerve, oculomotor nerve, abducens nerve, recurrent laryngeal nerve, brachial plexus nerves, and peripheral nerves of the extremities. Review of clinical and experimental data indicated that in most cases, the damages were probably caused by extensive connective tissue fibrosis around and infiltrating the nerve trunks. Three possible types of peripheral and cranial nerve damages after radiation therapy are identified. (U.S.)

  8. Granulomas do pênis: uma complicação rara da terapia intravesical com Bacilo Calmette-Guérin Granulomas of the penis: a rare complication of intravesical therapy with Bacillus Calmette-Guerin

    Directory of Open Access Journals (Sweden)

    Sara Isabel Alcântara Lestre

    2011-08-01

    Full Text Available A imunoterapia com o Bacilo Calmette-Guérin é amplamente usada no tratamento e profilaxia da neoplasia urotelial superficial. As complicações associadas ao tratamento são comuns. Os autores relatam um caso de inflamação granulomatosa do pênis, associada à terapia intravesical com Bacilo Calmette-Guérin, com múltiplos nódulos eritematosos indolores localizados na glande. É também efetuada uma revisão da literatura. A balanopostite granulomatosa é uma complicação rara associada à imunoterapia com Bacilo Calmette-Guérin, com uma apresentação clinicamente heterogênea que pode dificultar o diagnóstico. O seu reconhecimento clínico é essencial para o início precoce de tuberculostáticos e interrupção de Bacilo Calmette-GuérinImmunotherapy with Bacillus Calmette-Guérin is widely used for treatment and prophylaxis of superficial urothelial cancer. Complications associated with Bacillus Calmette-Guérin treatment are common. The authors describe a case of granulomatous inflammation of the penis associated with intravesical Bacillus Calmette-Guérin therapy, presenting with multiple erythematous and painless nodules located on the glans. A review of the literature is also performed. Granulomatous balanoposthitis is a rare complication of Bacillus Calmette-Guérin immunotherapy, with heterogeneous clinical presentation, which can make the diagnosis difficult. Its clinical recognition is essential for early start of therapy with antitubercular agents and interruption of Bacillus Calmette-Guérin

  9. Considering photodynamic therapy as a therapeutic modality in selected cases of dome-shaped macula complicated by foveal serous retinal detachment.

    Science.gov (United States)

    Arapi, Ilir; Neri, Piergiorgio; Mariotti, Cesare; Gesuita, Rosaria; Pirani, Vittorio; Freddo, Francesco; Lutaj, Pajtim; Giovannini, Alfonso

    2015-02-01

    To study the role of photodynamic therapy (PDT) as a therapeutic modality in myopic patients with dome-shaped macula (DSM) associated with foveal serous retinal detachment (SRD). Retrospective interventional case series. The medical records of 10 consecutive myopic patients (10 eyes) with DSM associated with subfoveal SRD and treated with PDT were reviewed. Visual gain and loss were considered as increasing or decreasing of two or more lines of best corrected visual acuity (BCVA), respectively, and eyes with fluid resolution were deemed responsive to PDT. All eyes underwent several PDT treatments, with a median of three and a median follow-up time of 15.5 months. At final follow-up, six eyes (60%) showed complete resolution of the foveal SRD. The baseline hypocyanescent macular area observed during late indocyanine green angiography (ICGA) frames was significantly lower in the group of patients who responded to PDT and had an increase of at least two Snellen lines in BCVA (P = .01). Data suggest that myopic eyes associated with DSM and foveal SRD may be responsive to PDT, showing total resolution of fluid accumulation and positive BCVA changes if baseline ICGA findings show evidence of a limited hypocyanescent macular area. Copyright 2015, SLACK Incorporated.

  10. Effect of Trimetazidine Dihydrochloride Tablets adjuvant therapy on inflammatory reaction, oxidative stress, vascular endothelial function and myocardial function in patients with coronary heart disease complicated with heart failure

    Directory of Open Access Journals (Sweden)

    Cai-Wen Wei

    2017-11-01

    Full Text Available Objective: To investigate the effects of Trimetazidine Dihydrochloride Tablets on inflammatory reaction, oxidative stress, vascular endothelial function and myocardial function in patients with coronary heart disease complicated with heart failure. Methods: A total of 98 patients with coronary heart disease and heart failure who met the criteria of the study were selected as the subjects, based on the random data table they were divided into the control group (n=49 and observation group (n=49, the patients in the control group were treated with Metoprolol Tartrate Sustained-release Tablets treatment, and the patients in the observation group were treated with Metoprolol Tartrate Sustained-release Tablets combined with Trimetazidine Dihydrochloride Tablets, the levels of inflammatory reaction, oxidative stress, vascular endothelial function and myocardial function indexes were compared between the two groups before and after treatment. Results: The difference of the CRP, TNF-α, MDA, SOD, NO, ET-1, LVEF, LVEDD and LVESD levels in the two groups before treatment were not statistically significant; Compared with the levels of the two groups before treatment, the two groups of CRP, TNF-α, MDA, ET-1, LVEDD and LVESD levels after treatment were significantly decreased, and the level of the observation group after treatment was significantly lower than those levels in the control group, the difference was statistically significant; The levels of SOD, NO and LVEF of the two groups after treatment were significantly higher than those in the same group before treatment, and the observation group levels [(88.09±7.51 U/ ml, (72.58±14.64 mol/L, (48.34±5.09% ] were significantly higher than the control group [(79.44±7.27 U/ml, (61.89±11.06 mol/L, (44.19±4.58%], the difference was statistically significant. Conclusion: Trimetazidine Dihydrochloride Tablets in the treatment of coronary heart disease with heart failure can effectively inhibit the release

  11. Airway complication occurring during radioiodine treatment for Graves' disease

    International Nuclear Information System (INIS)

    Kinuya, Seigo; Yoneyama, Tatsuya; Michigishi, Takatoshi

    2007-01-01

    Airway complications rarely occur in 131 I radioiodine therapy for Graves' disease. This study presents two cases in which 131 I therapy caused this acute complication. The patients complained of the symptom 6 h and 33 h after administration of 131 I. A histamine H1 receptor antagonist and hydrocortisone rapidly resolved symptoms in both cases. These two cases remind physicians that 131 I therapy for Graves' disease may cause potentially life-threatening complications. (author)

  12. Neurological complications of renal dialysis and transplantation.

    Science.gov (United States)

    Karunaratne, Kushan; Taube, David; Khalil, Nofal; Perry, Richard; Malhotra, Paresh A

    2018-04-01

    Neurological complications from renal replacement therapy contribute significantly to morbidity and mortality in patients with renal failure. Such complications can affect either the central or peripheral nervous systems. Most neurological disturbances associated with the uraemic state do not respond fully to renal replacement therapy. There are also complications specifically associated with dialysis and transplantation. A multidisciplinary approach, involving both nephrologists and neurologists, is critical for the diagnosis and effective management of these disorders. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Neurological complications of infective endocarditis

    International Nuclear Information System (INIS)

    Khan, Sonia A.A.; Yaqub, Basim A.; Al-Deeb, Saleh M.

    1996-01-01

    We reviewed the files of 80 successive patients with native and prosthetic valve endocarditis admitted to Riyadh Armed Forces Hospital. Neurolological complications (NC) occurred in 28 (35%) patients. The valves involved were mitral in 12 (43%), aortic in eight (29%), combined mitral and aortic lesions in six (21%) and others in two (7%). The common causative organisms were Streptococci in 12 (43%), Staphylococcus aureus and Staphylococcus epidermides, both occurring in four (14%). Compared to the 52 infective endocarditis patients with no neurological complications (NNC), the NC occurred more frequently in male patients, those with aortic valve lesion, those with atrial fibrillation, those with delayed therapy and those with causative organisms being Streptococci or Staphylococci. Eleven patients died (39%), 12 (43%) recovered with motor sequelae, six (21%) had seizure disorder and five (18%) had full recovery. The frequency of neurological complications and mortality is comparable to those reported in the literature: however, the frequency was higher in our patients. (author)

  14. Oral complications in cancer patients

    International Nuclear Information System (INIS)

    Carl, W.

    1983-01-01

    Ionizing radiation used in treating the head and neck area produces oral side effects such as mucositis, salivary changes, trismus and radiation caries. Sequelae of cancer chemotherapy often include oral stomatitis, myelosuppression and immunosuppression. Infections of dental origin in compromised patients are potentially lethal. Specific programs to eliminate dental pathology before radiation and chemotherapy, and to maintain oral hygiene during and after therapy, will minimize these complications

  15. Impact of the Adalimumab Patient Support Program's Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study.

    Science.gov (United States)

    Marshall, John K; Bessette, Louis; Thorne, Carter; Shear, Neil H; Lebovic, Gerald; Gerega, Sebastien K; Millson, Brad; Oraichi, Driss; Gaetano, Tania; Gazel, Sandra; Latour, Martin G; Laliberté, Marie-Claude

    2018-03-01

    Adalimumab (ADA) is a tumor necrosis factor-α inhibitor indicated for use in various immune-mediated inflammatory diseases. Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care's Patient Support Program (PSP), which provides personalized services, including tailored interventions in the form of nurse-provided care coach calls (CCCs), with the goal of improving patients' experiences and outcomes. The primary objective of this study was to evaluate the impact of PSP services, including CCCs and patient characteristics, on persistence with and adherence to ADA for those patients enrolled in the PSP. A secondary objective was to estimate the effect of initial CCCs on treatment-initiation abandonment (ie, failure to initiate therapy after enrollment in the PSP). An observational retrospective cohort study was conducted. A patient linkage algorithm based on probabilistic matching was developed to link the AbbVie Care PSP database to the QuintilesIMS longitudinal pharmacy transaction database. Patients who started ADA therapy between July 2010 and August 2014 were selected, and their prescriptions were evaluated for 12 months after the date of ADA start to calculate days until drug discontinuation, that is, the end of persistence, defined as >90 days without therapy. Cox proportional hazards modeling was used for estimating hazard ratios for the association between persistence and patient characteristics and each PSP service. Adherence, measured by medication possession ratio, was calculated, and multivariate logistic regression provided adjusted odds ratios for the relationship between being adherent (medication possession ratio ≥80%) and patient characteristics and each PSP service. Treatment-initiation abandonment among patients who received an initial CCC compared with those who did not was analyzed using the χ 2 test. Analysis of 10,857 linked patients yielded statistically significant differences in the hazard ratio of discontinuation and

  16. Sobrevida e complicações em idosos com doenças neurológicas em nutrição enteral Occurrence of complications and survival rates in elderly with neurological disorders undergoing enteral nutrition therapy

    Directory of Open Access Journals (Sweden)

    Aline Stangherlin Martins

    2012-12-01

    Full Text Available OBJETIVO: Avaliar a sobrevida e complicações de pacientes idosos com doenças neurológicas em uso de nutrição enteral (NE. MÉTODOS: Avaliaram-se pacientes acima de 60 anos acompanhados pelo serviço de atenção domiciliar de um plano de saúde de Belo Horizonte, MG, Brasil. A avaliação ocorreu no domicílio após a alta hospitalar com NE, após três e seis meses e ao término do estudo. Foram realizadas avaliação nutricional, coleta de dados em prontuários e entrevistas com familiares ou cuidadores. RESULTADOS: Foram avaliados 79 pacientes, idade 82,9 ± 10,4 anos, 49,4% com demência e 50,6% com outros diagnósticos neurológicos, 100% com elevado grau de dependência avaliada pelo índice de Katz. A maioria dos pacientes (91,2% apresentou complicações (pneumonia, perda da sonda, diarreia, constipação, vômito, extravasamento periostomia, obstrução da sonda, refluxo e miíase. Pneumonia foi a mais frequente, ocorrendo em 55,9%. A mortalidade foi de 15,2% aos três meses, 22,8% aos 6 meses e 43% ao término do estudo. A mediana de sobrevida após iniciada a NE foi de 364 dias. Não se observaram diferenças entre mortalidade e diagnóstico neurológico, vias de acesso de NE e complicações. A sobrevida foi menor em pacientes com estado nutricional inadequado e albumina OBJECTIVE: To evaluate the occurrence of complications, as well as the survival rates, in elderly people having neurological diseases and undergoing enteral nutrition therapy (ENT. METHODS: Patients aged over 60 years, assisted by a home medical service from a healthcare plan in the city of Belo Horizonte, MG, Brazil, were thoroughly evaluated. The mentioned evaluation occurred at their homes after hospital discharge with enteral nutrition (EN after a three-month period, a six-month period, and at the end of the study. A nutritional assessment was performed along with data collection performed on the patients' electronic medical records, and interviews

  17. Predictors of adalimumab drug survival in psoriasis differ by reason for discontinuation: long-term results from the Bio-CAPTURE registry.

    Science.gov (United States)

    van den Reek, J M P A; Tummers, M; Zweegers, J; Seyger, M M B; van Lümig, P P M; Driessen, R J B; van de Kerkhof, P C M; Kievit, W; de Jong, E M G J

    2015-03-01

    Drug survival is an indicator for treatment success; insight in predictors associated with drug survival is important. To analyse the long-term drug survival for adalimumab in patients with psoriasis treated in daily practice and (II) to identify predictors of prolonged drug survival for adalimumab split for different reasons of discontinuation. Data were extracted from a prospective psoriasis cohort and analysed using Kaplan-Meier survival curves split for reasons of discontinuation. Baseline predictors associated with longer drug survival were identified using multivariate Cox-regression analysis. One hundred and sixteen patients were included with a total of 208 patient-years. Overall drug survival was 76% after 1 year and 52% after 4.5 years. In patients who stopped due to ineffectiveness, longer drug survival was associated with the absence of specific comorbidities (P = 0.03). In patients who stopped due to side-effects, longer drug survival was associated with male gender (P = 0.02). Predictors of adalimumab drug survival in psoriasis differ by reason for discontinuation. Strong, specific predictors can lead to patient-tailored treatment. © 2014 European Academy of Dermatology and Venereology.

  18. Complications of spinal manipulation : A comprehensive review of the literature

    NARCIS (Netherlands)

    Assendelft, Willem J.J.; Bouter, Lex M.; Knipschild, Paul G.

    1996-01-01

    Background. Spinal manipulative therapy (SMT) is a frequently applied therapy for back and neck pain. Serious complications of SMT are presented primarily in case reports. Many patients seen by physicians also seek care from therapists applying manipulative techniques. Therefore, background

  19. Adalimumabe no tratamento da artrite reumatoide: uma revisão sistemática e metanálise de ensaios clínicos randomizados

    Directory of Open Access Journals (Sweden)

    Marina Amaral de Ávila Machado

    2013-10-01

    Full Text Available Desde a descoberta do papel do fator de necrose tumoral no processo fisiopatológico da artrite reumatoide, cinco medicamentos bloqueadores dessa citocina têm sido empregados como opção terapêutica. Para avaliar a eficácia e a segurança do adalimumabe no tratamento da artrite reumatoide foi conduzida uma revisão sistemática com metanálise de ensaios clínicos controlados e randomizados. Foi realizada busca de estudos relevantes nas bases de dados Medline (via PubMed e LILACS em junho de 2011. A seleção dos estudos, coleta e análise de dados foram realizadas de forma pareada e independente por dois revisores e por um terceiro revisor em casos de discordância. A metanálise foi conduzida no software Review Manager® 5.1 usando o modelo de efeitos aleatórios. Onze artigos referentes ao adalimumabe foram incluídos e contemplaram nove estudos com 3461 pacientes. Dez estudos mostraram baixo risco de viés quanto ao cegamento dos participantes e pessoal e cegamento de avaliação de resultados. Os pacientes que receberam tratamento da associação de adalimumabe e metotrexato apresentam melhores resultados de eficácia e menor progressão radiográfica quando comparados ao grupo placebo + metotrexato em 24 a 104 semanas. Os pacientes que utilizaram adalimumabe em monoterapia apresentaram melhores resultados de eficácia em relação ao placebo em 24 e 26 semanas. Os resultados das metanálises de eventos adversos não foram estatisticamente significantes, exceto para reações no local de aplicação, na qual favoreceu o grupo controle. A eficácia do adalimumabe foi demonstrada em monoterapia e associado a algum MMCD, porém as evidências para o uso combinado são mais robustas.

  20. The effect of 6 and 15 MV on intensity-modulated radiation therapy prostate cancer treatment: plan evaluation, tumour control probability and normal tissue complication probability analysis, and the theoretical risk of secondary induced malignancies

    Science.gov (United States)

    Hussein, M; Aldridge, S; Guerrero Urbano, T; Nisbet, A

    2012-01-01

    Objective The aim of this study was to investigate the effect of 6 and 15-MV photon energies on intensity-modulated radiation therapy (IMRT) prostate cancer treatment plan outcome and to compare the theoretical risks of secondary induced malignancies. Methods Separate prostate cancer IMRT plans were prepared for 6 and 15-MV beams. Organ-equivalent doses were obtained through thermoluminescent dosemeter measurements in an anthropomorphic Aldersen radiation therapy human phantom. The neutron dose contribution at 15 MV was measured using polyallyl-diglycol-carbonate neutron track etch detectors. Risk coefficients from the International Commission on Radiological Protection Report 103 were used to compare the risk of fatal secondary induced malignancies in out-of-field organs and tissues for 6 and 15 MV. For the bladder and the rectum, a comparative evaluation of the risk using three separate models was carried out. Dose–volume parameters for the rectum, bladder and prostate planning target volume were evaluated, as well as normal tissue complication probability (NTCP) and tumour control probability calculations. Results There is a small increased theoretical risk of developing a fatal cancer from 6 MV compared with 15 MV, taking into account all the organs. Dose–volume parameters for the rectum and bladder show that 15 MV results in better volume sparing in the regions below 70 Gy, but the volume exposed increases slightly beyond this in comparison with 6 MV, resulting in a higher NTCP for the rectum of 3.6% vs 3.0% (p=0.166). Conclusion The choice to treat using IMRT at 15 MV should not be excluded, but should be based on risk vs benefit while considering the age and life expectancy of the patient together with the relative risk of radiation-induced cancer and NTCPs. PMID:22010028

  1. Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study.

    Science.gov (United States)

    Sasso, Ferdinando Carlo; Lascar, Nadia; Ascione, Antonella; Carbonara, Ornella; De Nicola, Luca; Minutolo, Roberto; Salvatore, Teresa; Rizzo, Maria Rosaria; Cirillo, Plinio; Paolisso, Giuseppe; Marfella, Raffaele

    2016-10-13

    Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy. Trial registration ClinicalTrials.gov Identifier NCT00535925. Date of registration: September 24, 2007, retrospectively registered.

  2. Flu Symptoms & Complications

    Science.gov (United States)

    ... Influenza Types Seasonal Avian Swine Variant Pandemic Other Flu Symptoms & Complications Language: English (US) Español Recommend on ... not everyone with flu will have a fever. Flu Complications Most people who get influenza will recover ...

  3. Pregnancy Complications: Shoulder Dystocia

    Science.gov (United States)

    ... Home > Complications & Loss > Pregnancy complications > Shoulder dystocia Shoulder dystocia Now playing: E-mail to a friend Please ... women more likely than others to have shoulder dystocia? A pregnant woman may be at risk for ...

  4. Complications and Deaths - State

    Data.gov (United States)

    U.S. Department of Health & Human Services — Complications and deaths - state data. This data set includes state-level data for the hip/knee complication measure, the Agency for Healthcare Research and Quality...

  5. Complications and Deaths - State

    Data.gov (United States)

    U.S. Department of Health & Human Services — Complications and deaths - state data. This data set includes state-level data for the hip/knee complication measure, the CMS Patient Safety Indicators, and 30-day...

  6. Skin Complications of IBD

    Science.gov (United States)

    ... Home > Resources > Skin Complications of IBD Go Back Skin Complications of IBD Email Print + Share After arthritis, ... about 5% of people with inflammatory bowel disease. SKIN DISORDERS COMMONLY SEEN IN IBD ERHTHEMA NODOSUM The ...

  7. Pregnancy Complications: Preeclampsia

    Science.gov (United States)

    ... online community Home > Complications & Loss > Pregnancy complications > Preeclampsia Preeclampsia E-mail to a friend Please fill in ... even if you’re feeling fine. What is preeclampsia? Preeclampsia is a serious blood pressure condition that ...

  8. Pregnancy Complications: Anemia

    Science.gov (United States)

    ... online community Home > Complications & Loss > Pregnancy complications > Anemia Anemia E-mail to a friend Please fill in ... anemia at a prenatal care visit . What causes anemia? Usually, a woman becomes anemic (has anemia) because ...

  9. Complications and Deaths - Hospital

    Data.gov (United States)

    U.S. Department of Health & Human Services — Complications and deaths - provider data. This data set includes provider data for the hip/knee complication measure, CMS Patient Safety Indicators of serious...

  10. Complications and Deaths - National

    Data.gov (United States)

    U.S. Department of Health & Human Services — Complications and deaths - national data. This data set includes national-level data for the hip/knee complication measure, the CMS Patient Safety Indicators, and...

  11. Outcomes of patients with coronary artery perforation complicating percutaneous coronary intervention and correlations with the type of adjunctive antithrombotic therapy: pooled analysis from REPLACE-2, ACUITY, and HORIZONS-AMI trials.

    Science.gov (United States)

    Doll, Jacob A; Nikolsky, Eugenia; Stone, Gregg W; Mehran, Roxana; Lincoff, A Michael; Caixeta, Adriano; McLaurin, Brent; Cristea, Ecaterina; Fahy, Martin; Kesanakurthy, Vijaya; Lansky, Alexandra J

    2009-10-01

    The lack of a specific counteragent to bivalirudin may complicate the management of patients with coronary artery (CA) perforation during percutaneous coronary intervention (PCI). Assess outcomes of patients with CA perforation from three PCI trials comparing intravenous bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibition versus unfractionated heparin (UFH) plus GP IIb/IIIa. A pooled analysis of patients treated with PCI in three randomized trials including REPLACE-2, ACUITY, and HORIZONS-AMI. Among a total of 12,921 patients, CA perforation occurred in 35 patients (0.27%). By multivariable analysis, baseline creatinine clearance was the only independent predictor of CA perforation (per 10 mL/min decrease, odds ratio [95% confidence interval]= 1.28 [1.11, 1.47], P = 0.0007). At 30 days, patients with versus without CA perforation had significantly (all P values therapy of bivalirudin monotherapy was not associated with worse outcomes compared to treatment with UFH plus GP IIb/IIIa inhibitors.

  12. Relapsing polychondritis associated with psoriasis vulgaris successfully treated with adalimumab: A case report with published work review.

    Science.gov (United States)

    Matsuo, Haruka; Asahina, Akihiko; Fukuda, Takeshi; Umezawa, Yoshinori; Nakagawa, Hidemi

    2017-07-01

    Relapsing polychondritis (RP) is a rare autoimmune-mediated disease characterized by inflammation involving cartilaginous tissues. We report here a case of RP in a 38-year-old Japanese man with 13-year duration of psoriasis vulgaris treated with topical steroids and vitamin D 3 . The patient presented with tender swelling and erythema of both auricles, and the antibody to type II collagen was detected. The biopsy specimen revealed a dense mixed cell infiltration over the auricular cartilage. We reviewed eight cases with the association of RP and psoriasis, and in all cases the clinical course of psoriasis did not correlate with that of RP. The severity of RP was mild in the majority of cases, and our case was unique in that the patient had no joint symptoms. Adalimumab treatment was effective for both RP and psoriasis. Fat-suppressed contrast-enhanced magnetic resonance imaging was beneficial, not only to demonstrate subclinical inflammation in the nasal septum, but also to subjectively assess the improvement of RP. © 2017 Japanese Dermatological Association.

  13. Intravenous Therapy: Hazards, Complications and Their Prevention ...

    African Journals Online (AJOL)

    Breaks in aseptic techniques, faulty handling of parenteral fluid containers, failure to discard out-dated intravenous solutions and tubings contribute to occurrence of intravenous-associated sepsis. Improper technique and lack of pharmaceutical knowledge when adding drugs into intravenous fluids contribute to ...

  14. Towards a Possible Therapy for Diabetes Complications

    Science.gov (United States)

    2012-10-01

    pancreatic beta cells. Type 2 diabetes (T2D) patients are, instead, afflicted by an heterogeneous set of sub- syndromes characterized by peripheral...military, their families , and retired military personnel. Finding a cure to T1D will provide significant healthcare savings and improved patients’ well...Circulation 2000: 101: 235–238. 60. Lehrke M, Lazar MA. The many faces of PPARgamma. Cell 2005: 123: 993–999. 61. Duan SZ, Usher MG, Mortensen RM. Peroxi- some

  15. Complications following radiation therapy to the head

    International Nuclear Information System (INIS)

    Helpin, M.L.; Krejmas, N.L.; Krolls, S.O.

    1986-01-01

    A case is presented in which a child who received therapeutic radiation as part of his treatment regimen for rhabdomyosarcoma of the infratemporal and parapharyngeal region demonstrated undesirable sequelae in the dentition and the mandible

  16. Neurologic complications of radiation therapy and chemotherapy

    International Nuclear Information System (INIS)

    Rosenfeld, Myrna

    1998-01-01

    Radiation induced toxicities are due to the effect of irradiation of normal surrounding tissue which is included in the radiation port. The mechanisms of radiation induced damage have not been completely elucidated. Hypotheses include direct damage to neural cells versus damage to the vascular endothelium with secondary effects on nervous system structures. Another hypothesis is that radiation damaged glial cells release antigens that are able to evoke and antimmune response against the nervous system resulting in both cellular necrosis and vascular damage. The clinical diagnosis of radiation induced neurotoxicity may be difficult especially in patients who had neurologic signs prior to treatment. It is helpful to determine if the clinical signs correlate with the irradiated site and to know the total dose received and the dose per fraction. Prior or concomitant chemotherapy may act to increase the toxicity produced by radiation. The age of the patient at the time of radiation is important as the very young and the elderly are more likely to develop toxicities. Finally, concurrent neurologic diseases such as demyelinating disorders appear to sensitize neural tissue to radiation damage. Radiation injury can occur at almost any time, from immediately after irradiation to years later. The side effects can generally be divided into those that are acute (within days), early -delayed (within 4 weeks to 4 months after treatment) and late- delayed (months to years after treatment). (The author)

  17. Complicated Horseshoe Kidney

    Energy Technology Data Exchange (ETDEWEB)

    Kim, K. S.; Kim, S. R.; Cha, K. S.; Park, S. S. [Chung Ang University College of Medicine, Seoul (Korea, Republic of)

    2010-05-15

    Horseshoe kidney is an important urological anomaly when it is complicated or accompanied by other diseases. Recently we have experienced four cases of horseshoe kidney which were complicated with hydronephrosis, renal stone and adrenal pheochromocytoma. With review of literatures, we emphasize the importance of detection of these complications.

  18. Complicated Horseshoe Kidney

    International Nuclear Information System (INIS)

    Kim, K. S.; Kim, S. R.; Cha, K. S.; Park, S. S.

    2010-01-01

    Horseshoe kidney is an important urological anomaly when it is complicated or accompanied by other diseases. Recently we have experienced four cases of horseshoe kidney which were complicated with hydronephrosis, renal stone and adrenal pheochromocytoma. With review of literatures, we emphasize the importance of detection of these complications.

  19. Complicated infective endocarditis: a case series.

    Science.gov (United States)

    Kim, Joo Seop; Kang, Min-Kyung; Cho, A Jin; Seo, Yu Bin; Kim, Kun Il

    2017-05-08

    Infective endocarditis is associated with not only cardiac complications but also neurologic, renal, musculoskeletal, and systemic complications related to the infection, such as embolization, metastatic infection, and mycotic aneurysm. We report three cases (the first patient is Chinese and the other two are Koreans) of complicated infective endocarditis; two of the cases were associated with a mycotic aneurysm, and one case was associated with a splenic abscess. One case of a patient with prosthetic valve endocarditis was complicated by intracerebral hemorrhage caused by mycotic aneurysm rupture. A second case of a patient with right-sided valve endocarditis associated with a central catheter was complicated by an abdominal aortic mycotic aneurysm. The third patient had a splenic infarction and abscess associated with infected cardiac thrombi. Complicated infective endocarditis is rare and is associated with cardiac, neurologic, renal, musculoskeletal, and systemic complications related to infection, such as embolization, metastatic infection, and mycotic aneurysm. Infective endocarditis caused by Staphylococcus aureus is more frequently associated with complications. Because the mortality rate increases when complications develop, aggressive antibiotic therapy and surgery, combined with specific treatments for the complications, are necessary.

  20. Focal neuronal gigantism: a rare complication of therapeutic radiation.

    Science.gov (United States)

    Gaughen, J R; Bourne, T D; Aregawi, D; Shah, L M; Schiff, D

    2009-11-01

    Radiation therapy, a mainstay in the treatment of many brain tumors, results in a variety of well-documented acute and chronic complications. Isolated cortical damage following irradiation represents an extremely rare delayed therapeutic complication, described only twice in the medical literature. We report this rare delayed complication in a patient following treatment of a right frontal anaplastic oligodendroglioma.

  1. Complications of wrist arthroscopy.

    Science.gov (United States)

    Ahsan, Zahab S; Yao, Jeffrey

    2012-06-01

    The purpose of this systematic review was to address the incidence of complications associated with wrist arthroscopy. Given the paucity of information published on this topic, an all-inclusive review of published wrist arthroscopy complications was sought. Two independent reviewers performed a literature search using PubMed, Google Scholar, EBSCO, and Academic Megasearch using the terms "wrist arthroscopy complications," "complications of wrist arthroscopy," "wrist arthroscopy injury," and "wrist arthroscopy." Inclusion criteria were (1) Levels I to V evidence, (2) "complication" defined as an adverse outcome directly related to the operative procedure, and (3) explicit description of operative complications in the study. Eleven multiple-patient studies addressing complications of wrist arthroscopy from 1994 to 2010 were identified, with 42 complications reported from 895 wrist arthroscopy procedures, a 4.7% complication rate. Four case reports were also found, identifying injury to the dorsal sensory branch of the ulnar nerve, injury to the posterior interosseous nerve, and extensor tendon sheath fistula formation. This systematic review suggests that the previously documented rate of wrist arthroscopy complications may be underestimating the true incidence. The report of various complications provides insight to surgeons for improving future surgical techniques. Level IV, systematic review of Levels I-V studies. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  2. Thoracic complications of rheumatoid disease

    International Nuclear Information System (INIS)

    Massey, H.; Darby, M.; Edey, A.

    2013-01-01

    Rheumatoid arthritis is a relatively common multisystem disease associated with significant mortality and morbidity. Thoracic disease, both pleural and pulmonary, is a frequent extra-articular manifestation of rheumatoid arthritis and responsible for approximately 20% of rheumatoid-associated mortality. Rheumatoid disease and its associated therapies can affect all compartments of the lung inciting a range of stereotyped pathological responses and it is not infrequent for multiple disease entities to co-exist. In some instances, development of pulmonary complications may precede typical rheumatological presentation of the disease and be the first indication of an underlying connective tissue disease. The spectrum of thoracic disease related to rheumatoid arthritis is reviewed

  3. Extracorporeal Membrane Oxygenation for Complicated Scrub Typhus

    Directory of Open Access Journals (Sweden)

    Eun Sun Kim

    Full Text Available Scrub typhus is a mite-borne infectious disease caused by Orientia tsutsugamushi . Although early diagnosis and appropriate antibiotic therapy improve the prognosis for the majority of patients, life-threatening complications are not uncommon. Here, we present a case of successful veno-veno-type extracorporeal membrane oxygenation for scrub typhus-induced complications, including acute respiratory distress syndrome, myocarditis and multi-organ dysfunction. To our knowledge, this is the first case report of successful extracorporeal membrane oxygenation in complicated scrub typhus in Korea.

  4. Interventional radiological treatment in complications of pancreatitis

    Energy Technology Data Exchange (ETDEWEB)

    Memis, Ahmet E-mail: ahmemis@yahoo.com; Parildar, Mustafa

    2002-09-01

    Percutaneous interventional therapy plays an important role in treating complications of acute and chronic pancreatitis. With the development of cross-sectional imaging and advanced interventional techniques, percutaneous drainage has become the preferred treatment for pancreatic fluid collections such as acute collections, pseudocysts and abscesses. Abscess and pancreatic hemorrhage are the most life threatening complications of pancreatitis. Massive hemorrhage is rare but frequently lethal. As a rule, bleeding complications of pancreatitis require prompt diagnosis and an aggressive surgical approach. In unstable patients with a severely bleeding pseudoaneurysm, hemostasis can be obtained by occlusion with mechanical devices.

  5. Interventional radiological treatment in complications of pancreatitis

    International Nuclear Information System (INIS)

    Memis, Ahmet; Parildar, Mustafa

    2002-01-01

    Percutaneous interventional therapy plays an important role in treating complications of acute and chronic pancreatitis. With the development of cross-sectional imaging and advanced interventional techniques, percutaneous drainage has become the preferred treatment for pancreatic fluid collections such as acute collections, pseudocysts and abscesses. Abscess and pancreatic hemorrhage are the most life threatening complications of pancreatitis. Massive hemorrhage is rare but frequently lethal. As a rule, bleeding complications of pancreatitis require prompt diagnosis and an aggressive surgical approach. In unstable patients with a severely bleeding pseudoaneurysm, hemostasis can be obtained by occlusion with mechanical devices

  6. Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey.

    Science.gov (United States)

    Schoepfer, Alain M; Vavricka, Stephan R; Binek, Janek; Felley, Christian; Geyer, Martin; Manz, Michael; Rogler, Gerhard; de Saussure, Philippe; Sauter, Bernhard; Seibold, Frank; Straumann, Alex; Michetti, Pierre

    2010-06-01

    Switzerland was the first country to approve certolizumab pegol (Cimzia, CZP) for the treatment of patients with moderate to severe Crohn's disease (CD) in September 2007. This phase IV study aimed to evaluate the efficacy and safety of CZP in a Swiss multicenter cohort of practice-based patients. Baseline and Week 6 evaluation questionnaires were sent to all Swiss gastroenterologists in hospitals and private practices. Disease activity was assessed with the Harvey-Bradshaw Index (HBI) and adverse events were evaluated according to WHO guidelines. Fifty patients (31 women, 19 men) were included; 56% had complicated disease (stricture or fistula) and 52% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 78% to infliximab, and 50% to adalimumab. A significant decrease in HBI was observed at Week 6 (versus Week 0) following induction therapy with CZP 400 mg subcutaneously at Weeks 0, 2, and 4 (12.6 +/- 4.7 Week 0 versus 6.2 +/- 4.4 Week 6, P < 0.001). Response and remission rates at Week 6 were 54% and 40%, respectively. We identified 8/11 CD patients undergoing a 50% fistula response (P = 0.021). The frequency of adverse drug reactions attributed to CZP was 6%. CZP was continued in 80% of patients beyond Week 6. In a population of CD patients with complicated disease behavior, CZP induced a response and remission in 54% and 40% of patients, respectively. This series provides the first evidence of the effectiveness of CZP in perianal fistulizing CD.

  7. Neurological complication in HIV patients

    Science.gov (United States)

    Ritarwan, K.

    2018-03-01

    Human Immunodeficiency Virus (HIV) is neurotropic and immunotropic, making themassive destruction of both systems. Although their amount has been reduced, there is still neurological presentations and complications of HIV remain common in the era of combination antiretroviral therapy (cART). Neurological opportunistic infections (OI) occur in advanced HIV diseases such as primary cerebral lymphoma, cryptococcal meningitis, cerebral toxoplasmosis, and progressive multifocal encephalopathy. Neurological problem directly related to HIV appear at any stage in the progress of HIV disease, from AIDS-associated dementia to the aseptic meningitis of primary HIV infection observed in subjects with an immune deficiency. The replication of peripheral HIV viral is able to be controlled in the era of effective antiretroviral therapy. Non-HIV-related neurological disease such as stroke increased important as the HIV population ages.

  8. Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival.

    Science.gov (United States)

    Flouri, Irini; Markatseli, Theodora E; Voulgari, Paraskevi V; Boki, Kyriaki A; Papadopoulos, Ioannis; Settas, Loukas; Zisopoulos, Dimitrios; Skopouli, Fotini N; Iliopoulos, Alexios; Bertsias, George K; Geborek, Pierre; Drosos, Alexandros A; Boumpas, Dimitrios T; Sidiropoulos, Prodromos

    2014-02-01

    To compare effectiveness, drug survival, and safety between infliximab, adalimumab, and etanercept, in a nationwide cohort of rheumatoid arthritis (RA) patients. This study is a prospective cohort study of 1208 active RA patients. Effectiveness, drug survival, and serious adverse events during entire follow-up (median 2.9 years) were monitored. EULAR and CDAI responses were comparable between the three agents (EULAR good/moderate responses at 12 months ranged 76-79%). At 12 months, 15-23% achieved remission. For adalimumab and etanercept, adjusted hazard rate (HR) for EULAR/ACR remission (reference: infliximab) was 2.7 and 2.1 (95% confidence interval was 1.7-4.1 and 1.3-3.4, respectively); males (HR 1.6; 1.1-2.4), use of glucocorticoids (HR 2.0; 1.3-3.0), and swollen joint count >7 (HR 0.36; 0.24-0.55) were independent predictors. Five-year drug survival was 31%, 43%, and 49% for infliximab, adalimumab, and etanercept, respectively (p = 0.010). Infliximab was associated with significantly more withdrawals due to adverse events. Disease activity, CRP, and use of glucocorticoids predicted efficacy-related drug survival; age, use of methotrexate, and prior DMARDs failures predicted safety-related survival. Risk for serious infections was lower with adalimumab (odds ratio [OR] 0.62; 0.38-1.00) or etanercept (OR 0.39; 0.21-0.72) than infliximab, independent of the effects of age (OR 1.65; 1.37-2.00 per 10 years), tender joint count >10 (OR 1.86; 1.21-2.86), and glucocorticoids >35mg/week (OR 1.83; 1.12-2.99). Response rates were comparable among anti-TNF agents. Overall, 5-year drug survival was below 50%, with infliximab demonstrating increased safety-related discontinuations. Remission rates are low in clinical practice. Strategies to increase effectiveness and long-term survival of anti-TNF agents in RA are needed. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Cardiovascular complications of cirrhosis

    DEFF Research Database (Denmark)

    Møller, S; Henriksen, Jens Henrik Sahl

    2008-01-01

    Cardiovascular complications of cirrhosis include cardiac dysfunction and abnormalities in the central, splanchnic and peripheral circulation, and haemodynamic changes caused by humoral and nervous dysregulation. Cirrhotic cardiomyopathy implies systolic and diastolic dysfunction and electrophysi......Cardiovascular complications of cirrhosis include cardiac dysfunction and abnormalities in the central, splanchnic and peripheral circulation, and haemodynamic changes caused by humoral and nervous dysregulation. Cirrhotic cardiomyopathy implies systolic and diastolic dysfunction....... The clinical significance of cardiovascular complications and cirrhotic cardiomyopathy is an important topic for future research, and the initiation of new randomised studies of potential treatments for these complications is needed....

  10. Complications of mechanical ventilation

    Directory of Open Access Journals (Sweden)

    Drašković Biljana

    2011-01-01

    Full Text Available Mechanical ventilation of the lungs, as an important therapeutic measure, cannot be avoided in critically ill patients. However, when machines take over some of vital functions there is always a risk of complications and accidents. Complications associated with mechanical ventilation can be divided into: 1 airway-associated complications; 2 complications in the response of patients to mechanical ventilation; and 3 complications related to the patient’s response to the device for mechanical ventilation. Complications of artificial airway may be related to intubation and extubation or the endotracheal tube. Complications of mechanical ventilation, which arise because of the patient’s response to mechanical ventilation, may primarily cause significant side effects to the lungs. During the last two decades it was concluded that mechanical ventilation can worsen or cause acute lung injury. Mechanical ventilation may increase the alveolar/capillary permeability by overdistension of the lungs (volutrauma, it can exacerbate lung damage due to the recruitment/derecruitment of collapsed alveoli (atelectrauma and may cause subtle damages due to the activation of inflammatory processes (biotrauma. Complications caused by mechanical ventilation, beside those involving the lungs, can also have significant effects on other organs and organic systems, and can be a significant factor contributing to the increase of morbidity and mortality in critically ill of mechanically ventilated patients. Complications are fortunately rare and do not occur in every patient, but due to their seriousness and severity they require extensive knowledge, experience and responsibility by health-care workers.

  11. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab.

    Science.gov (United States)

    Burmester, Gerd R; Kaeley, Gurjit S; Kavanaugh, Arthur F; Gabay, Cem; MacCarter, Daryl K; Nash, Peter; Takeuchi, Tsutomu; Goss, Sandra L; Rodila, Ramona; Chen, Kun; Kupper, Hartmut; Kalabic, Jasmina

    2017-01-01

    Treatment of rheumatoid arthritis (RA) with a combination of methotrexate (MTX)+adalimumab (ADA) is more effective than ADA monotherapy. We assessed the toxicity of different doses of MTX and treatment efficacy of ADA+MTX in two trials. Data originated from CONCERTO, in patients with early RA initiating ADA+ 2.5, 5, 10 or 20 mg/week MTX for 26 weeks; and MUSICA, in patients with an inadequate response to MTX initiating ADA+ 7.5 or 20 mg/week MTX for 24 weeks. Efficacy was assessed by the American College of Rheumatology 50 (ACR50). Patient-reported MTX-related toxicity information was collected at each visit on 18 prespecified MTX-related adverse events (AE) in the MTX label. In CONCERTO, ACR50 rates increased over time, ranging from 54% to 68% at week 26, while AE rates remained steady, ranging from 2.4% to 17.8% at week 26. Of 395 patients, 113 (28.6%) reported 345 MTX-related AEs, including one serious AE (SAE, excessive fatigue and/or malaise); 10 AEs (in two patients) led to study discontinuation. In MUSICA, ACR50 rates increased over time, and were 32.3% and 37.5% at week 24, while MTX-related AE rates remained steady and were 6.5% at week 24. Of 309 patients, 71 (23%) reported 185 MTX-related AEs, including 5 SAEs (four infections and one fever/chills); six AEs (in four patients) led to study discontinuation. In patients with RA initiating ADA+MTX combination, treatment efficacy was achieved and increased throughout both trials, while rates of MTX-related AEs remained steady. MTX-related AEs were observed in up to 30% of patients and most were mild. MTX was discontinued by 0.5%-1.3% of patients. MUSICA (NCT01185288), CONCERTO (NCT01185301), Post results.

  12. Acute toxoplasmosis infection in a patient with ankylosing spondylitis treated with adalimumab: a case report

    Directory of Open Access Journals (Sweden)

    M. de Almeida Santos Jr

    2011-06-01

    Full Text Available Ankylosing spondylitis (AS is a chronic inflammatory disease that affects the axial skeleton, often beginning in the sacroiliac joints, but accompanied also by other signs, including enthesitis, lung fibrosis and eye involvement. AS generally occurs in the second or third decade of life with inflammatory low back pain and has a strong relation with HLA-B27. The objective of the treatment until the end of the 90’s was to ameliorate pain and stiffness and preserve function (1. Nonselective nonsteroidal antiinflammatory drugs (NSAIDs, cyclooxygenase-2 selective inhibitors, and nonpharmalogic interventions, such as physiotherapy, exercise, education, and lifestyle modifications were the basis of the management. Therapy with agents like sulphasalazine was administered for peripheral arthritis (1, 2...

  13. [Complications in pediatric anesthesia].

    Science.gov (United States)

    Becke, K

    2014-07-01

    As in adult anesthesia, morbidity and mortality could be significantly reduced in pediatric anesthesia in recent decades. This fact cannot conceal the fact that the incidence of anesthetic complications in children is still much more common than in adults and sometimes with a severe outcome. Newborns and infants in particular but also children with emergency interventions and severe comorbidities are at increased risk of potential complications. Typical complications in pediatric anesthesia are respiratory problems, medication errors, difficulties with the intravenous puncture and pulmonal aspiration. In the postoperative setting, nausea and vomiting, pain, and emergence delirium can be mentioned as typical complications. In addition to the systematic prevention of complications in pediatric anesthesia, it is important to quickly recognize disturbances of homeostasis and treat them promptly and appropriately. In addition to the expertise of the performing anesthesia team, the institutional structure in particular can improve quality and safety in pediatric anesthesia.

  14. Airway Complications of Total Artificial Heart.

    Science.gov (United States)

    Pathak, Vikas; Donovan, Colin; Malhotra, Rajiv

    2017-02-01

    The total artificial heart is the mechanical device which is used as a bridge to the heart transplant in patients with biventricular failure. Due to the mechanical nature of the device, patients receiving total artificial heart (TAH) require to be on anticoagulation therapy. Hemorrhage and coagulopathy are few of the known complications of TAH.

  15. Intramural duodenal hematoma as a complication of therapy with Warfarin: a case report and literature review; Hematoma intramural duodenal como complicacao de terapia anticoagulante com Warfarin: relato de caso e revisao da literatura

    Energy Technology Data Exchange (ETDEWEB)

    Faria, Juliano [Universidade Federal de Sao Paulo (UNIFESP/EPM), SP (Brazil). Dept. de Diagnostico por Imagem]. E-mail: drjuliano@uol.com.br; Pessoa, Roberta; Hudson, Marcelo; Vitoi, Silvio; Villela, Ovidio; Torres, Jose; Paula, Mara Delgado [Hospital Marcio Cunha, Ipatinga, MG (Brazil). Servico de Diagnostico por Imagem; Bemvindo, Aloisio [Hospital Marcio Cunha, Ipatinga, MG (Brazil). Servico de Terapia Intensiva

    2004-12-01

    We report a case of a patient receiving chronic oral anticoagulant therapy with Warfarin who presented with acute intestinal obstruction. Computed tomography showed intramural duodenal hematoma. Treatment was conservative with correction of the coagulation parameters and observation. This case exemplifies the usefulness of conservative therapy and computed tomography in patients with acute small bowel obstruction receiving anticoagulant therapy. (author)

  16. [Surgical complications of colostomies].

    Science.gov (United States)

    Ben Ameur, Hazem; Affes, Nejmeddine; Rejab, Haitham; Abid, Bassem; Boujelbene, Salah; Mzali, Rafik; Beyrouti, Mohamed Issam

    2014-07-01

    The colostomy may be terminal or lateral, temporary or permanent. It may have psychological, medical or surgical complications. reporting the incidence of surgical complications of colostomies, their therapeutic management and trying to identify risk factors for their occurrence. A retrospective study for a period of 5 years in general surgery department, Habib Bourguiba hospital, Sfax, including all patients operated with confection of a colostomy. Were then studied patients reoperated for stoma complication. Among the 268 patients who have had a colostomy, 19 patients (7%) developed surgical stoma complications. They had a mean age of 59 years, a sex ratio of 5.3 and a 1-ASA score in 42% of cases. It was a prolapse in 9 cases (reconfection of the colostomy: 6 cases, restoration of digestive continuity: 3 cases), a necrosis in 5 cases (reconfection of the colostomy), a plicature in 2 cases (reconfection of the colostomy) a peristomal abscess in 2 cases (reconfection of the colostomy: 1 case, restoration of digestive continuity: 1 case) and a strangulated parastomal hernia in 1 case (herniorrhaphy). The elective incision and the perineal disease were risk factors for the occurrence of prolapse stomial. Surgical complications of colostomies remain a rare event. Prolapse is the most common complication, and it is mainly related to elective approach. Reoperation is often required especially in cases of early complications, with usually uneventful postoperative course.

  17. Imaging of osteochondroma complications

    International Nuclear Information System (INIS)

    Gomes, Fernando Santos Emerich; Lewin, Fabio; Mariotti, Guilherme Cayres; Capasso Filho, Mauro; Yamaguchi, Claudia Kazue; Cruz, Rafael O.; Baptista, Pedro Pericles Ribeiro; Yonamine, Eduardo Sadao; Prospero, Jose Donato

    2007-01-01

    Osteochondroma is the most common entity beyond all the known osseous tumors. It is a lesion with a high enlargement capacity and a continuous growing in some cases, and it may determine complications, mainly due to mass effect. It may be present in a solitary or multiple forms, and the last one is related with a higher tendency to sarcomatous transformation, which is the most frightening complication. The purpose of the present study is to demonstrate, through an iconographic assay, the most common complications caused by the osteochondromas, making the correlation of its clinical and radiological aspects. (author)

  18. Postoperative rectal anastomotic complications

    Czech Academy of Sciences Publication Activity Database

    Polanecký, O.; Adámek, S.; Šedý, Jiří; Skořepa, J.; Hladík, P.; Šmejkal, M.; Pafko, P.; Lischke, R.

    2014-01-01

    Roč. 115, č. 12 (2014), s. 781-785 ISSN 0006-9248 Institutional support: RVO:67985823 Keywords : human * complication * anastomosis * rectum Subject RIV: FJ - Surgery incl. Transplants Impact factor: 0.439, year: 2014

  19. Complications of Circumcision

    Directory of Open Access Journals (Sweden)

    Aaron J. Krill

    2011-01-01

    Full Text Available In the United States, circumcision is a commonly performed procedure. It is a relatively safe procedure with a low overall complication rate. Most complications are minor and can be managed easily. Though uncommon, complications of circumcision do represent a significant percentage of cases seen by pediatric urologists. Often they require surgical correction that results in a significant cost to the health care system. Severe complications are quite rare, but death has been reported as a result in some cases. A thorough and complete preoperative evaluation, focusing on bleeding history and birth history, is imperative. Proper selection of patients based on age and anatomic considerations as well as proper sterile surgical technique are critical to prevent future circumcision-related adverse events.

  20. Complications of shoulder dystocia.

    Science.gov (United States)

    Dajani, Nafisa K; Magann, Everett F

    2014-06-01

    Complications of shoulder dystocia are divided into fetal and maternal. Fetal brachial plexus injury (BPI) is the most common fetal complication occurring in 4-40% of cases. BPI has also been reported in abdominal deliveries and in deliveries not complicated by shoulder dystocia. Fractures of the fetal humerus and clavicle occur in about 10.6% of cases of shoulder dystocia and usually heal with no sequel. Hypoxic ischemic brain injury is reported in 0.5-23% of cases of shoulder dystocia. The risk correlates with the duration of head-to-body delivery and is especially increased when the duration is >5 min. Fetal death is rare and is reported in 0.4% of cases. Maternal complications of shoulder dystocia include post-partum hemorrhage, vaginal lacerations, anal tears, and uterine rupture. The psychological stress impact of shoulder dystocia is under-recognized and deserves counseling prior to home discharge. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Pertussis (Whooping Cough) Complications

    Science.gov (United States)

    ... of Search Controls Search Form Controls Cancel Submit Pertussis (Whooping Cough) Note: Javascript is disabled or is not supported ... message, please visit this page: About CDC.gov . Pertussis Home About Pertussis Causes & Transmission Signs & Symptoms Complications ...

  2. Evaluación económica de la monoterapia con tocilizumab frente a adalimumab en artritis reumatoide

    Directory of Open Access Journals (Sweden)

    Federico Navarro Sarabia

    2013-01-01

    Full Text Available Fundamento: Tocilizumab (TCZ fue superior a adalimumab (ADA en monoterapia en la reducción de los signos y síntomas de la artritis reumatoide del adulto (AR en pacientes intolerantes o con respuesta inadecuada a metotrexato (MTX. El objetivo del estudio fue analizar el costeefectividad de TCZ vs ADA en estos pacientes. Métodos: Evaluación económica del coste por respuesta o remisión con TCZ vs ADAa partir del estudioADACTA(horizonte temporal: 24 semanas. Criterios de respuesta clínica ACR o de remisión de la enfermedad, índice DAS28. Ámbito: Sistema Nacional de Salud. Los costes incluidos (adquisición, administración y monitorización de los medicamentos en € de 2012 se obtuvieron de fuentes españolas. Se efectuaron análisis de sensibilidad simples univariantes. Resultados: Las tasas de respuestaACR20,ACR50 yACR70 con TCZ y ADA se obtuvieron en el 65% y 49,4% (p <0,01; 47,2% y 27,8% (p <0,01; y en el 32,5% y 17,9% (p <0,01 de los pacientes, respectivamente. La remisión DAS28 se produjo en el 39,9% y 10,5%, respectivamente (p <0,0001. El coste por respuesta fue menor con TCZ que con ADA (ACR20: 8.105 y 11.553 €; ACR50: 11.162 y 20.529 €; ACR70: 16.211 y 31.882 € respectivamente. El coste de la remisión DAS28 fue de 13.204 € y 54.352 € respectivamente. En todos los escenarios el tratamiento con TCZ tuvo mayor eficacia y menores costes que con ADA . Conclusiones: Según este análisis, en España la monoterapia con TCZ es una estrategia eficiente frente a ADA para el tratamiento de los pacientes con AR intolerantes o con respuesta inadecuada a MTX.

  3. Neurologic complications of vaccinations.

    Science.gov (United States)

    Miravalle, Augusto A; Schreiner, Teri

    2014-01-01

    This chapter reviews the most common neurologic disorders associated with common vaccines, evaluates the data linking the disorder with the vaccine, and discusses the potential mechanism of disease. A literature search was conducted in PubMed using a combination of the following terms: vaccines, vaccination, immunization, and neurologic complications. Data were also gathered from publications of the American Academy of Pediatrics Committee on Infectious Diseases, the World Health Organization, the US Centers for Disease Control and Prevention, and the Vaccine Adverse Event Reporting System. Neurologic complications of vaccination are rare. Many associations have been asserted without objective data to support a causal relationship. Rarely, patients with a neurologic complication will have a poor outcome. However, most patients recover fully from the neurologic complication. Vaccinations have altered the landscape of infectious disease. However, perception of risk associated with vaccinations has limited the success of disease eradication measures. Neurologic complications can be severe, and can provoke fear in potential vaccines. Evaluating whether there is causal link between neurologic disorders and vaccinations, not just temporal association, is critical to addressing public misperception of risk of vaccination. Among the vaccines available today, the cost-benefit analysis of vaccinations and complications strongly argues in favor of vaccination. © 2014 Elsevier B.V. All rights reserved.

  4. Complications in Hip Arthroscopy

    Science.gov (United States)

    Nakano, Naoki; Khanduja, Vikas

    2016-01-01

    Summary Background Recent developments in hip arthroscopic techniques and technology have made it possible in many cases to avoid open surgical dislocation for treating a variety of pathology in the hip. Although early reports suggest favourable results’ using hip arthroscopy and it has been shown to be a relatively safe procedure, complications do exist and can sometimes lead to significant morbidity. Methods This is a review article. The aim of this manuscript is to present the most frequent and/or serious complications that could occur at or following hip arthroscopy and some guidelines to avoid these complications. Conclusion Most complications of hip arthroscopy are minor or transient but serious complications can occur as well. A lot of complication e.g. acetabular labral puncture go unreported. Appropriate education and training, precise and meticulous surgical technique with correct instrumentation, the right indication in the right patient and adherence to advice from mentors and experienced colleagues are all essential factors for a successful outcome. Level of evidence: V. PMID:28066747

  5. On complicity theory.

    Science.gov (United States)

    Kline, A David

    2006-04-01

    The received account of whistleblowing, developed over the last quarter century, is identified with the work of Norman Bowie and Richard DeGeorge. Michael Davis has detailed three anomalies for the received view: the paradoxes of burden, missing harm and failure. In addition, he has proposed an alternative account of whistleblowing, viz., the Complicity Theory. This paper examines the Complicity Theory. The supposed anomalies rest on misunderstandings of the received view or misreadings of model cases of whistleblowing, for example, the Challenger disaster and the Ford Pinto. Nevertheless, the Complicity Theory is important for as in science the contrast with alternative competing accounts often helps us better understand the received view. Several aspects of the received view are reviewed and strengthened through comparison with Complicity Theory, including why whistleblowing needs moral justification. Complicity Theory is also critiqued. The fundamental failure of Complicity Theory is its failure to explain why government and the public encourage and protect whistleblowers despite the possibility of considerable harm to the relevant company in reputation, lost jobs, and lost shareholder value.

  6. The intensity modulated radiation therapy (IMRT) reduces rectal complications arising radiotherapy treatment of prostate cancer; La Radioterapia con modulacion de intensidad (LMRT) reduce . Las complicaciones rectales derivadas del tratamiento radioterapico del cancer prostata

    Energy Technology Data Exchange (ETDEWEB)

    Garcia Vicente, F.; Zapatero Lobarda, A.; Rodriguez Martinez, G.; Martin de Vidales, C.; Bermudez Luna, R.; Leaman Alcibar, O.; Perez Gonzalez, L.; Cruz Conde, A.; Linan Diaz, O.; Torres Escobar, J. J.

    2013-07-01

    The objective of this analysis is to assess with adequate follow the incidence of rectal complications and know quantitatively and statistical evidence if the pattern of gastrointestinal toxicity allows us to continue with the next level of dose escalation. (Author)

  7. Thrombophilia in complicated pregnancies

    Directory of Open Access Journals (Sweden)

    Ayşe Şahin

    2013-12-01

    Full Text Available Objective: To investigate the incidence and etiology of pregnancy complications associated with thrombophilic factors. Methods: Fifty-four patients with complicated pregnancy and 40 healthy pregnant subjects were included the study. Factor V Leiden (FVL mutation, protein S, protein C, anti-thrombin deficiency levels were investigated. Results: Of the 54 patients with complicated pregnancy, 29 had preeclampsia, 18 had intra uterine growth retardation, and 7 had intrauterine fetal loss. The most common defect was FVL mutation. FVL mutations in patient group and the control group were 27.2% and 10%, respectively, which were statistically significant. The protein S, protein C, and anti-thrombin deficiencies were found higher in the patient group compared to control (p>0.05 for each. Conclusion: FVL mutation was found higher in patient group compared to the control group, Protein C deficiency and anti-thrombin deficiency were related to preeclampsia but not other pregnancy complications. Clinicians should take into account the thrombophilia in complicated pregnancy, especially preeclampsia. J Clin Exp Invest 2013; 4 (4: 497-502

  8. Complications of shoulder arthroscopy.

    Science.gov (United States)

    Moen, Todd C; Rudolph, Glen H; Caswell, Kyle; Espinoza, Christopher; Burkhead, Wayne Z; Krishnan, Sumant G

    2014-07-01

    Over the past 20 to 30 years, arthroscopic shoulder techniques have become increasingly popular. Although these techniques have several advantages over open surgery, surgical complications are no less prevalent or devastating than those associated with open techniques. Some of the complications associated with arthroscopic shoulder surgery include recurrent instability, soft-tissue injury, and neurapraxia. These complications can be minimized with thoughtful consideration of the surgical indications, careful patient selection and positioning, and a thorough knowledge of the shoulder anatomy. Deep infection following arthroscopic shoulder surgery is rare; however, the shoulder is particularly susceptible to Propionibacterium acnes infection, which is mildly virulent and has a benign presentation. The surgeon must maintain a high index of suspicion for this infection. Thromboemoblic complications associated with arthroscopic shoulder techniques are also rare, and studies have shown that pharmacologic prophylaxis has minimal efficacy in preventing these complications. Because high-quality studies on the subject are lacking, minimal evidence is available to suggest strategies for prevention. Copyright 2014 by the American Academy of Orthopaedic Surgeons.

  9. Post dengue neurological complication

    Directory of Open Access Journals (Sweden)

    Hizlinda Tohid

    2015-12-01

    Full Text Available Dengue infection is highly endemic in many tropical countries including Malaysia. However, neurological complications arising from dengue infection is not common; Gullain–Barre syndrome (GBS is one of these infrequent complications. In this paper, we have reported a case in which a 39-year-old woman presented with a neurological complication of dengue infection without typical symptoms and signs of dengue fever. She had a history of acute gastroenteritis (AGE followed by an upper respiratory tract infection (URTI weeks prior to her presentation rendering GBS secondary to the post viral URTI and AGE as the most likely diagnosis. Presence of thrombocytopenia was the only clue for dengue in this case.

  10. Neuromuscular complications of thyrotoxicosis.

    Science.gov (United States)

    Kung, Annie W C

    2007-11-01

    Thyroid hormones exert multiple effects on the neuromuscular system and the brain, with the most important being their role in stimulating the development and differentiation of the neuromuscular system and brain in foetal and neonatal life. In the presence of hyperthyroidism, muscular and neurological symptoms may be the presenting clinical features of the disease. The frequency and severity of neuromuscular complications vary considerably and are probably related to the degree of hyperthyroidism, although in some patients the neuromuscular dysfunction is caused by associated disorders rather than by hyperthyroidism per se. This update focuses on the most common neurological and muscular disorders that occur in patients with thyrotoxicosis. It is beyond the scope of this paper to discuss thyroid eye disease and cardiac complications, in themselves separate complications of specific myocytes.

  11. Imaging of postpartum complications

    International Nuclear Information System (INIS)

    Rooholamini, S.A.; Au, A.H.; Hansen, G.C.; Kioumehr, F.; Yaghmai, I.

    1991-01-01

    The purpose of this paper is to evaluate the efficacy of various imaging modalities in the detection of postpartum complications. Nineteen cases of postpartum complications, studied radiologically, form the basis of this exhibit. Plain abdominal radiography, US, CT, and MR imaging were performed alone or in combination. The abnormalities detected included uterine rupture, intramural uterine hematoma, hematomas of the broad ligaments and the abdominal rectus muscles, ovarian vein thrombosis, HELLP syndrome, pyometrium, retained placenta and blood clots, periappendiceal abscess, superior sagittal sinus thrombosis, and cerebral edema. Representative cases will be illustrated; and the effective value of each technique will be stressed

  12. Complications of cosmetic tattoos.

    Science.gov (United States)

    De Cuyper, Christa

    2015-01-01

    Cosmetic tattoos, which are better known as permanent make-up, have become popular in the last decades. This same procedure can be used to camouflage pathological skin conditions, to mask scars and to complete the aesthetic results of plastic and reconstructive surgeries. The risks and complications of tattooing procedures include infections and allergic reactions. Scarring can occur. Fanning and fading of the colorants and dissatisfaction with colour and shape are not unusual. Different lasers can offer solutions for the removal of unwanted cosmetic tattoos, but complications due to the laser treatment, such as paradoxical darkening and scarring, can arise. © 2015 S. Karger AG, Basel.

  13. Efficacy of cardiovascular complications correction in patients with breast cancer

    International Nuclear Information System (INIS)

    Savchenko, A.S.

    2011-01-01

    The work was performed with the purpose to assess the efficacy of cardiovascular complications correction at combination treatment for breast cancer (BC). Timely diagnosis and correction of cardiovascular diseases in BC with the use of inhalation cardioactive drugs (nitrates and calcium antagonists) improved the efficacy of accompanying therapy, prevented progress of early and late RT complications, improved the quality of life.

  14. Complication with intraosseous access

    DEFF Research Database (Denmark)

    Hallas, Peter; Brabrand, Mikkel; Folkestad, Lars

    2013-01-01

    with aspiration of bone marrow (12.3%), and bended/broken needle (4.0%). When using an established IO access the reported complications were difficulties with injection fluid and drugs after IO insertion (7.4%), slow infusion (despite use of pressure bag) (8.8%), displacement after insertion (8...

  15. Anticoagulation in pregnancy complications

    NARCIS (Netherlands)

    Middeldorp, Saskia

    2014-01-01

    Women with acquired and inherited thrombophilia are thought to be at increased risk for pregnancy complications, including recurrent pregnancy loss and, depending on the type of thrombophilia, severe preeclampsia. This review discusses the associations between the types of thrombophilia and types of

  16. Cardiovascular Complications of Pregnancy

    Science.gov (United States)

    Gongora, Maria Carolina; Wenger, Nanette K.

    2015-01-01

    Pregnancy causes significant metabolic and hemodynamic changes in a woman’s physiology to allow for fetal growth. The inability to adapt to these changes might result in the development of hypertensive disorders of pregnancy (hypertension, preeclampsia or eclampsia), gestational diabetes and preterm birth. Contrary to previous beliefs these complications are not limited to the pregnancy period and may leave permanent vascular and metabolic damage. There is in addition, a direct association between these disorders and increased risk of future cardiovascular disease (CVD, including hypertension, ischemic heart disease, heart failure and stroke) and diabetes mellitus. Despite abundant evidence of this association, women who present with these complications of pregnancy do not receive adequate postpartum follow up and counseling regarding their increased risk of future CVD. The postpartum period in these women represents a unique opportunity to intervene with lifestyle modifications designed to reduce the development of premature cardiovascular complications. In some cases it allows early diagnosis and treatment of chronic hypertension or diabetes mellitus. The awareness of this relationship is growing in the medical community, especially among obstetricians and primary care physicians, who play a pivotal role in detecting these complications and assuring appropriate follow up. PMID:26473833

  17. Extraintestinal Complications: Kidney Disorders

    Science.gov (United States)

    ... the ureters, bladder, and urethra for the passage, storage, and voiding of urine. Serious kidney complications associated with IBD are rare, ... Proteinuria, an elevated level of protein in the urine, is one sign of amyloidosis. A biopsy (tissue sample) of the kidney can confirm the diagnosis. Various ...

  18. Atrial Fibrillation: Complications

    Science.gov (United States)

    ... of this page please turn JavaScript on. Feature: Atrial Fibrillation Atrial Fibrillation: Complications Past Issues / Winter 2015 Table of Contents ... has two major complications—stroke and heart failure. Atrial Fibrillation and Stroke Click to enlarge image This illustration ...

  19. Complicating Methodological Transparency

    Science.gov (United States)

    Bridges-Rhoads, Sarah; Van Cleave, Jessica; Hughes, Hilary E.

    2016-01-01

    A historical indicator of the quality, validity, and rigor of qualitative research has been the documentation and disclosure of the behind-the-scenes work of the researcher. In this paper, we use what we call "methodological data" as a tool to complicate the possibility and desirability of such transparency. Specifically, we draw on our…

  20. Complications in ankle arthroscopy

    NARCIS (Netherlands)

    Zengerink, Maartje; van Dijk, C. Niek

    2012-01-01

    To determine the complication rate for ankle arthroscopy. A review of a consecutive series of patients undergoing ankle arthroscopy in our hospital between 1987 and 2006 was undertaken. Anterior ankle arthroscopy was performed by means of a 2-portal dorsiflexion method with intermittent soft tissue

  1. Cardiovascular Complications of Pregnancy

    Directory of Open Access Journals (Sweden)

    Maria Carolina Gongora

    2015-10-01

    Full Text Available Pregnancy causes significant metabolic and hemodynamic changes in a woman’s physiology to allow for fetal growth. The inability to adapt to these changes might result in the development of hypertensive disorders of pregnancy (hypertension, preeclampsia or eclampsia, gestational diabetes and preterm birth. Contrary to previous beliefs these complications are not limited to the pregnancy period and may leave permanent vascular and metabolic damage. There is in addition, a direct association between these disorders and increased risk of future cardiovascular disease (CVD, including hypertension, ischemic heart disease, heart failure and stroke and diabetes mellitus. Despite abundant evidence of this association, women who present with these complications of pregnancy do not receive adequate postpartum follow up and counseling regarding their increased risk of future CVD. The postpartum period in these women represents a unique opportunity to intervene with lifestyle modifications designed to reduce the development of premature cardiovascular complications. In some cases it allows early diagnosis and treatment of chronic hypertension or diabetes mellitus. The awareness of this relationship is growing in the medical community, especially among obstetricians and primary care physicians, who play a pivotal role in detecting these complications and assuring appropriate follow up.

  2. Medical complications following splenectomy.

    Science.gov (United States)

    Buzelé, R; Barbier, L; Sauvanet, A; Fantin, B

    2016-08-01

    Splenectomy is attended by medical complications, principally infectious and thromboembolic; the frequency of complications varies with the conditions that led to splenectomy (hematologic splenectomy, trauma, presence of portal hypertension). Most infectious complications are caused by encapsulated bacteria (Meningococcus, Pneumococcus, Hemophilus). These occur mainly in children and somewhat less commonly in adults within the first two years following splenectomy. Post-splenectomy infections are potentially severe with overwhelming post-splenectomy infection (OPSI) and this justifies preventive measures (prophylactic antibiotics, appropriate immunizations, patient education) and demands prompt antibiotic management with third-generation cephalosporins for any post-splenectomy fever. Thromboembolic complications can involve both the caval system (deep-vein thrombophlebitis, pulmonary embolism) and the portal system. Portal vein thrombosis occurs more commonly in patients with myeloproliferative disease and cirrhosis. No thromboembolic prophylaxis is recommended apart from perioperative low molecular weight heparin. However, some authors choose to prescribe a short course of anti-platelet medication if the post-splenectomy patient develops significant thrombocytosis. Thrombosis of the portal or caval venous system requires prolonged warfarin anticoagulation for 3 to 6 months. Finally, some studies have suggested an increase in the long-term incidence of cancer in splenectomized patients. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  3. Pregnancy Complications: Placental Abruption

    Science.gov (United States)

    ... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how to help reduce ... high blood pressure, not smoking or using street drugs, and always wearing a seatbelt when riding in a car. ... complications Preterm labor & premature birth The newborn intensive ...

  4. Treatment of complicated grief

    Directory of Open Access Journals (Sweden)

    Rita Rosner

    2011-11-01

    Full Text Available Following the death of a loved one, a small group of grievers develop an abnormal grieving style, termed complicated or prolonged grief. In the effort to establish complicated grief as a disorder in DSM and ICD, several attempts have been made over the past two decades to establish symptom criteria for this form of grieving. Complicated grief is different from depression and PTSD yet often comorbid with other psychological disorders. Meta-analyses of grief interventions show small to medium effect sizes, with only few studies yielding large effect sizes. In this article, an integrative cognitive behavioral treatment manual for complicated grief disorder (CG-CBT of 25 individual sessions is described. Three treatment phases, each entailing several treatment strategies, allow patients to stabilize, explore, and confront the most painful aspects of the loss, and finally to integrate and transform their grief. Core aspects are cognitive restructuring and confrontation. Special attention is given to practical exercises. This article includes the case report of a woman whose daughter committed suicide.

  5. Renal posttransplant's vascular complications

    Directory of Open Access Journals (Sweden)

    Bašić Dragoslav

    2003-01-01

    Full Text Available INTRODUCTION Despite high graft and recipient survival figures worldwide today, a variety of technical complications can threaten the transplant in the postoperative period. Vascular complications are commonly related to technical problems in establishing vascular continuity or to damage that occurs during donor nephrectomy or preservation [13]. AIM The aim of the presenting study is to evaluate counts and rates of vascular complications after renal transplantation and to compare the outcome by donor type. MATERIAL AND METHODS A total of 463 kidneys (319 from living related donor LD and 144 from cadaveric donor - CD were transplanted during the period between June 1975 and December 1998 at the Urology & Nephrology Institute of Clinical Centre of Serbia in Belgrade. Average recipients' age was 33.7 years (15-54 in LD group and 39.8 (19-62 in CD group. Retrospectively, we analyzed medical records of all recipients. Statistical analysis is estimated using Hi-squared test and Fischer's test of exact probability. RESULTS Major vascular complications including vascular anastomosis thrombosis, internal iliac artery stenosis, internal iliac artery rupture obliterant vasculitis and external iliac vein rupture were analyzed. In 25 recipients (5.4% some of major vascular complications were detected. Among these cases, 22 of them were from CD group vs. three from LD group. Relative rate of these complications was higher in CD group vs. LD group (p<0.0001. Among these complications dominant one was vascular anastomosis thrombosis which occurred in 18 recipients (17 from CD vs. one from LD. Of these recipients 16 from CD lost the graft, while the rest of two (one from each group had lethal outcome. DISCUSSION Thrombosis of renal allograft vascular anastomosis site is the most severe complication following renal transplantation. In the literature, renal allograft thrombosis is reported with different incidence rates, from 0.5-4% [14, 15, 16]. Data from the

  6. Complications of presumed ocular tuberculosis.

    Science.gov (United States)

    Hamade, Issam H; Tabbara, Khalid F

    2010-12-01

    To determine the effect of steroid treatment on visual outcome and ocular complications in patients with presumed ocular tuberculosis. Retrospective review of patients with presumptive ocular tuberculosis. The clinical diagnosis was made based on ocular findings, positive purified protein derivative (PPD) testing of more than 15 mm induration, exclusion of other causes of uveitis and positive ocular response to anti-tuberculous therapy (ATT) within 4 weeks. Group 1 included patients who had received oral prednisone or subtenon injection of triamcinolone acetonide prior to ATT. Group 2 included patients who did not receive corticosteroid therapy prior to administration of ATT.   Among 500 consecutive new cases of uveitis encountered in 1997-2007 there were 49 (10%) patients with presumed ocular tuberculosis. These comprised 28 (57%) male and 21 (43%) female patients with a mean age of 45 years (range 12-76 years). Four (20%) patients in group 1 had initial visual acuity of 20/40 or better, in comparison to eight (28%) patients in group 2. At 1-year follow-up, six (30%) patients in group 1 had a visual acuity of 20/40 or better compared with 20 (69%) patients in group 2 (p = 0.007). Of 20 eyes (26%) in group 1 that had visual acuity of < 20/50 at 1-year follow up, 14 (70%) eyes developed severe chorioretinal lesion (p = 0.019). Early administration of corticosteroids without anti-tuberculous therapy in presumed ocular tuberculosis may lead to poor visual outcome compared with patients who did not receive corticosteroids prior to presentation. Furthermore, the severity of chorioretinitis lesion in the group of patients given corticosteroid prior to ATT may account for the poor visual outcome. © 2009 The Authors. Journal compilation © 2009 Acta Ophthalmol.

  7. Nocardia brasiliensis Infection Complicating Cryptogenic Organizing Pneumonia.

    Science.gov (United States)

    Fernandes, Alison M; Sluzevich, Jason C; Mira-Avendano, Isabel

    2017-01-01

    Pulmonary nocardiosis is a severe and uncommon opportunistic infection caused by Nocardia species. We present a patient with cryptogenic organizing pneumonia who was receiving long-term immunosuppressive therapy, whose treatment course was complicated by cutaneous and pulmonary nocardiosis. Tissue cultures confirmed Nocardia brasiliensis . Nocardiosis should be a diagnostic consideration for patients treated with long-term immunosuppression who have worsening pulmonary symptoms and relapsing pustular skin lesions.

  8. Nocardia brasiliensis Infection Complicating Cryptogenic Organizing Pneumonia

    OpenAIRE

    Fernandes, Alison M.; Sluzevich, Jason C.; Mira-Avendano, Isabel

    2017-01-01

    Pulmonary nocardiosis is a severe and uncommon opportunistic infection caused by Nocardia species. We present a patient with cryptogenic organizing pneumonia who was receiving long-term immunosuppressive therapy, whose treatment course was complicated by cutaneous and pulmonary nocardiosis. Tissue cultures confirmed Nocardia brasiliensis. Nocardiosis should be a diagnostic consideration for patients treated with long-term immunosuppression who have worsening pulmonary symptoms and relapsing p...

  9. Nocardia brasiliensis Infection Complicating Cryptogenic Organizing Pneumonia

    Directory of Open Access Journals (Sweden)

    Alison M. Fernandes

    2017-01-01

    Full Text Available Pulmonary nocardiosis is a severe and uncommon opportunistic infection caused by Nocardia species. We present a patient with cryptogenic organizing pneumonia who was receiving long-term immunosuppressive therapy, whose treatment course was complicated by cutaneous and pulmonary nocardiosis. Tissue cultures confirmed Nocardia brasiliensis. Nocardiosis should be a diagnostic consideration for patients treated with long-term immunosuppression who have worsening pulmonary symptoms and relapsing pustular skin lesions.

  10. Neurological complications of alcoholism

    Directory of Open Access Journals (Sweden)

    I. I. Nikiforov

    2017-01-01

    Full Text Available Nervous system lesions associated with chronic alcohol intoxication are common in clinical practice. They lead to aggravated alcoholic disease, its more frequent recurrences, and intensified pathological craving for alcohol. Neurological pathology in turn occurs with frequent exacerbations. The interaction of diseases, age, and medical  pathomorphism modifies the clinical presentation and course of the  major pathology, as well as comorbidity, the nature and severity of  complications, worsens quality of life in a patient, and makes the  diagnostic and treatment process difficult. The paper discusses the  classification, clinical variants, biochemical and molecular biological  aspects of various complications of alcoholic disease. It considers its  most common form, in particular alcoholic polyneuropathy, as well as its rarer variants, such as hemorrhagic encephalopathy with a subacute course (Gayet–Wernicke encephalopathy.

  11. Gastrointestinal Complications of Obesity

    Science.gov (United States)

    Camilleri, Michael; Malhi, Harmeet; Acosta, Andres

    2017-01-01

    Obesity usually is associated with morbidity related to diabetes mellitus and cardiovascular diseases. However, there are many gastrointestinal and hepatic diseases for which obesity is the direct cause (eg, nonalcoholic fatty liver disease) or is a significant risk factor, such as reflux esophagitis and gallstones. When obesity is a risk factor, it may interact with other mechanisms and result in earlier presentation or complicated diseases. There are increased odds ratios or relative risks of several gastrointestinal complications of obesity: gastroesophageal reflux disease, erosive esophagitis, Barrett’s esophagus, esophageal adenocarcinoma, erosive gastritis, gastric cancer, diarrhea, colonic diverticular disease, polyps, cancer, liver disease including nonalcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma, gallstones, acute pancreatitis, and pancreatic cancer. Gastroenterologists are uniquely poised to participate in the multidisciplinary management of obesity as physicians caring for people with obesity-related diseases, in addition to their expertise in nutrition and endoscopic interventions. PMID:28192107

  12. Thrombophilia and Pregnancy Complications

    Directory of Open Access Journals (Sweden)

    Louise E. Simcox

    2015-11-01

    Full Text Available There is a paucity of strong evidence associated with adverse pregnancy outcomes and thrombophilia in pregnancy. These problems include both early (recurrent miscarriage and late placental vascular-mediated problems (fetal loss, pre-eclampsia, placental abruption and intra-uterine growth restriction. Due to poor quality case-control and cohort study designs, there is often an increase in the relative risk of these complications associated with thrombophilia, particularly recurrent early pregnancy loss, late fetal loss and pre-eclampsia, but the absolute risk remains very small. It appears that low-molecular weight heparin has other benefits on the placental vascular system besides its anticoagulant properties. Its use is in the context of antiphospholipid syndrome and recurrent pregnancy loss and also in women with implantation failure to improve live birth rates. There is currently no role for low-molecular weight heparin to prevent late placental-mediated complications in patients with inherited thrombophilia and this may be due to small patient numbers in the studies involved in summarising the evidence. There is potential for low-molecular weight heparin to improve pregnancy outcomes in women with prior severe vascular complications of pregnancy such as early-onset intra-uterine growth restriction and pre-eclampsia but further high quality randomised controlled trials are required to answer this question.

  13. The potential mechanisms for motor complications of Parkinson's disease

    Directory of Open Access Journals (Sweden)

    SUN Sheng-gang

    2013-08-01

    Full Text Available Parkinson's disease (PD is a common neurodegenerative disease. Dopaminergic replacement therapy is still considered as a major treatment for PD. However, long-term dopaminergic replacement therapy for PD patients is frequently associated with the development of motor complications. To date, the mechanisms underlying motor complications have not been completely understood yet. Moreover, parts of motor complications are lack of therapeutic alternatives. All these characters make this disorder difficult and challenging to manage. Increasing number of researches have been proposed in recent years for elucidating the underlying mechanisms of levodopa-related motor complications, resulting in much progression. For better understanding the management of motor complications, here we provide an overview of the current knowledge of the potential mechanisms, including the pharmacodynamic and pharmacokinetic mechanisms of levodopa and levodopa-associated neurotransmitter systems.

  14. Central venous catheters: detection of catheter complications and therapeutical options

    International Nuclear Information System (INIS)

    Gebauer, B.; Beck, A.; Wagner, H.J.; Vivantes-Kliniken, Hellersdorf und Prenzlauer Berg

    2008-01-01

    For modern medicine central venous catheters play an important role for diagnostic and therapeutic options. Catheter implantation, complication detection and therapy of catheter complications are an increasing demand for the radiologist. The review article provides an overview of different catheter types, their indications, advantages and disadvantages. Catheter malpositions are usually detectable in conventional X-ray. Most malpositions are correctable using interventional-radiological techniques. In addition therapeutical options for thrombotic complications (venous thrombosis, catheter occlusion, fibrin sheath) are discussed. In case of an infectious catheter complication, usually a catheter extraction and re-implantation is necessary

  15. Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial

    Science.gov (United States)

    2018-01-16

    Complications Wounds; Negative Pressure Wound Therapy; Wound Healing Delayed; Incisional; Panniculectomy; Incisional Negative Pressure Wound Therapy; Incisional Vac; Wound Vac; Obese; Renal Failure; Kidney Transplant; Complications; Wound Healing Complication

  16. Repeatability and response to therapy of dynamic contrast-enhanced magnetic resonance imaging biomarkers in rheumatoid arthritis in a large multicentre trial setting

    Energy Technology Data Exchange (ETDEWEB)

    Waterton, John C. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Personalised Healthcare and Biomarkers, AstraZeneca, Macclesfield (United Kingdom); Ho, Meilien [AstraZeneca, Global Medicines Development, Macclesfield (United Kingdom); Nordenmark, Lars H. [AstraZeneca, Global Medicines Development, Moelndal (Sweden); Jenkins, Martin [AstraZeneca, Global Medicines Development, Cambridge (United Kingdom); DiCarlo, Julie; Peterfy, Charles [Spire Sciences Inc, Boca Raton, FL (United States); Guillard, Gwenael; Bowes, Michael A. [Imorphics, Manchester (United Kingdom); Roberts, Caleb; Buonaccorsi, Giovanni [Bioxydyn, Manchester (United Kingdom); Parker, Geoffrey J.M. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Bioxydyn, Manchester (United Kingdom); Kellner, Herbert [Private Practice and Division of Rheumatology KHI Neuwittelsbach, Muenchen (Germany); Taylor, Peter C. [University of Oxford, Kennedy Institute, Oxford (United Kingdom)

    2017-09-15

    To determine the repeatability and response to therapy of dynamic contrast-enhanced (DCE) MRI biomarkers of synovitis in the hand and wrist of rheumatoid arthritis (RA) patients, and in particular the performance of the transfer constant K{sup trans}, in a multicentre trial setting. DCE-MRI and RA MRI scoring (RAMRIS) were performed with meticulous standardisation at baseline and 6 and 24 weeks in a substudy of fostamatinib monotherapy in reducing synovitis compared with placebo or adalimumab. Analysis employed statistical shape modelling to avoid biased regions-of-interest, kinetic modelling and heuristic analyses. Repeatability was also evaluated. At early study termination, DCE-MRI data had been acquired from 58 patients in 19 imaging centres. K{sup trans} intra-subject coefficient of variation (N = 14) was 30%. K{sup trans} change demonstrated inferiority of fostamatinib (N = 11) relative to adalimumab (N = 10) after 6 weeks (treatment ratio = 1.92, p = 0.003), and failed to distinguish fostamatinib from placebo (N = 10, p = 0.79). RAMRIS showed superiority of fostamatinib relative to placebo at 6 weeks (p = 0.023), and did not distinguish fostamatinib from adalimumab at either 6 (p = 0.175) or 24 (p = 0.230) weeks. This demonstrated repeatability of K{sup trans} and its ability to distinguish treatment groups show that DCE-MRI biomarkers are suitable for use in multicentre RA trials. (orig.)

  17. Pulmonary aspergillosis and central nervous system hemorrhage as complications of autoimmune hemolytic anemia treated with corticosteroids.

    Science.gov (United States)

    Cleri, Dennis J; Moser, Robert L; Villota, Francisco J; Wang, Yue; Husain, Syed A; Nadeem, Shahzinah; Anjari, Tarek; Sajed, Mohammad

    2003-06-01

    Warm, active antibody adult autoimmune hemolytic anemia is the most common form of hemolytic anemia not related to drug therapy. Mortality in adult autoimmune hemolytic anemia is related to the inability to successfully treat patients' underlying disease, or the infectious complications of splenectomy and prolonged steroid therapy. Predisposing factors for invasive aspergillosis are neutropenia and steroid therapy. We present a fatal case of aspergillosis complicating a nonneutropenic case of warm active antibody adult autoimmune hemolytic anemia treated with prolonged steroid therapy.

  18. How do patients with inflammatory bowel disease want their biological therapy administered?

    Directory of Open Access Journals (Sweden)

    Lindsay Hannah

    2010-01-01

    Full Text Available Abstract Background Infliximab is usually administered by two monthly intravenous (iv infusions, therefore requiring visits to hospital. Adalimumab is administered by self subcutaneous (sc injections every other week. Both of these anti-TNF drugs appear to be equally efficacious in the treatment of Crohn's Disease and therefore the decision regarding which drug to choose will depend to some extent on patient choice, which may be based on the mode of administration. The aims of this study were to compare preferences in Inflammatory Bowel Disease (IBD patients for two currently available anti-TNF agents and the reasons for their choices. Methods An anonymous questionnaire was distributed to IBD patients who had attended the Gastroenterology service (Ulster Hospital, Dundonald, Belfast, N. Ireland. UK between January 2007 and December 2007. The patients were asked in a hypothetical situation if the following administering methods of anti-TNF drugs (intravenous or subcutaneous were available, which drug route of administration would they choose. Results One hundred and twenty-five patients fulfilled the inclusion criteria and were issued questionnaires, of these 78 questionnaires were returned (62 percent response. The mean age of respondent was 44 years. Of the total number of respondents, 33 patients (42 percent preferred infliximab and 19 patients (24 percent preferred adalimumab (p = 0.07. Twenty-six patients (33 percent did not indicate a preference for either biological therapy and were not included in the final analysis. The commonest reason cited for those who chose infliximab (iv was: "I do not like the idea of self-injecting," (67 percent. For those patients who preferred adalimumab (sc the commonest reason cited was: "I prefer the convenience of injecting at home," (79 percent. Of those patients who had previously been treated with an anti-TNF therapy (n = 10, all infliximab six patients stated that they would prefer infliximab if given

  19. Preventing microvascular complications in type 1 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Vijay Viswanathan

    2015-01-01

    Full Text Available Patients with complications of diabetes such as retinopathy, nephropathy, and cardiovascular complications have increased hospital stay with greater economic burden. Prevention of complications should be started before the onset of type 1 diabetes mellitus (T1DM by working on risk factors and thereafter by intervention upon confirmatory diagnosis which can prevent further damage to β-cells. The actual risk of getting microvascular complications like microalbuminuria and retinopathy progression starts at glycated hemoglobin (HbA1c level of 7%. As per the American Diabetes Association, a new pediatric glycemic control target of HbA1c 20 years as compared to patients <10 years of age. Screening of these complications should be done regularly, and appropriate preventive strategies should be followed. Angiotensin converting enzyme inhibitors and angiotensin II receptor blocker reduce progression from microalbuminuria to macroalbuminuria and increase the regression rate to normoalbuminuria. Diabetic microvascular complications can be controlled with tight glycemic therapy, dyslipidemia management and blood pressure control along with renal function monitoring, lifestyle changes, including smoking cessation and low-protein diet. An integrated and personalized care would reduce the risk of development of microvascular complications in T1DM patients. The child with diabetes who receives limited care is more likely to develop long-term complications at an earlier age. Screening for subclinical complications and early interventions with intensive therapy is the need of the hour.

  20. Preventing microvascular complications in type 1 diabetes mellitus

    Science.gov (United States)

    Viswanathan, Vijay

    2015-01-01

    Patients with complications of diabetes such as retinopathy, nephropathy, and cardiovascular complications have increased hospital stay with greater economic burden. Prevention of complications should be started before the onset of type 1 diabetes mellitus (T1DM) by working on risk factors and thereafter by intervention upon confirmatory diagnosis which can prevent further damage to β-cells. The actual risk of getting microvascular complications like microalbuminuria and retinopathy progression starts at glycated hemoglobin (HbA1c) level of 7%. As per the American Diabetes Association, a new pediatric glycemic control target of HbA1c 20 years as compared to patients <10 years of age. Screening of these complications should be done regularly, and appropriate preventive strategies should be followed. Angiotensin converting enzyme inhibitors and angiotensin II receptor blocker reduce progression from microalbuminuria to macroalbuminuria and increase the regression rate to normoalbuminuria. Diabetic microvascular complications can be controlled with tight glycemic therapy, dyslipidemia management and blood pressure control along with renal function monitoring, lifestyle changes, including smoking cessation and low-protein diet. An integrated and personalized care would reduce the risk of development of microvascular complications in T1DM patients. The child with diabetes who receives limited care is more likely to develop long-term complications at an earlier age. Screening for subclinical complications and early interventions with intensive therapy is the need of the hour. PMID:25941647

  1. Complications of decorative tattoo.

    Science.gov (United States)

    Shinohara, Michi M

    2016-01-01

    Decorative tattoo is a popular practice that is generally safe when performed in the professional setting but can be associated with a variety of inflammatory, infectious, and neoplastic complications, risks that may be increased with current trends in home tattooing. Modern tattoo inks contain azo dyes and are often of unknown composition and not currently regulated for content or purity. Biopsy of most (if not all) tattoo reactions presenting to the dermatologist is recommended, given recent clusters of nontuberculous mycobacterial infections occurring within tattoo, as well as associations between tattoo reactions and systemic diseases such as sarcoidosis. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Lemierre's Syndrome Complicating Pregnancy

    Directory of Open Access Journals (Sweden)

    M. Thompson

    2007-01-01

    Full Text Available Lemierre's syndrome is an anaerobic suppurative thrombophlebitis involving the internal jugular vein secondary to oropharyngeal infection. There is only one previous case report in pregnancy which was complicated by premature delivery of an infant that suffered significant neurological damage. We present an atypical case diagnosed in the second trimester with a live birth at term. By reporting this case, we hope to increase the awareness of obstetricians to the possibility of Lemierre's syndrome when patients present with signs of unabating oropharyngeal infection and pulmonary symptoms.

  3. [Complications of hemorrhoids].

    Science.gov (United States)

    Slauf, P; Antoš, F; Marx, J

    2014-04-01

    The most common and serious complications of haemorrhoids include perianal thrombosis and incarcerated prolapsed internal haemorrhoids with subsequent thrombosis. They are characterised by severe pain in the perianal region possibly with bleeding. In a short history of the perianal thrombosis, acute surgical incision or excision is indicated, which can result in rapid relief of the painful symptoms. In incarcerated prolapsed internal haemorrhoids, emergency haemorrhoidectomy may also be indicated. Segmental haemorrhoidectomy in the most affected quadrants followed by further elective surgery for haemorrhoids in the next stage is preferred.

  4. Complications of Macular Peeling

    Science.gov (United States)

    Asencio-Duran, Mónica; Manzano-Muñoz, Beatriz; Vallejo-García, José Luis; García-Martínez, Jesús

    2015-01-01

    Macular peeling refers to the surgical technique for the removal of preretinal tissue or the internal limiting membrane (ILM) in the macula for several retinal disorders, ranging from epiretinal membranes (primary or secondary to diabetic retinopathy, retinal detachment…) to full-thickness macular holes, macular edema, foveal retinoschisis, and others. The technique has evolved in the last two decades, and the different instrumentations and adjuncts have progressively advanced turning into a safer, easier, and more useful tool for the vitreoretinal surgeon. Here, we describe the main milestones of macular peeling, drawing attention to its associated complications. PMID:26425351

  5. Complications associated with orthognathic surgery

    Science.gov (United States)

    2017-01-01

    While most patients undergo orthognathic surgery for aesthetic purposes, aesthetic improvements are most often followed by postoperative functional complications. Therefore, patients must carefully decide whether their purpose of undergoing orthognathic surgery lies on the aesthetic side or the functional side. There is a wide variety of complications associated with orthognathic surgery. There should be a clear distinction between malpractice and complications. Complications can be resolved without any serious problems if the cause is detected early and adequate treatment provided. Oral and maxillofacial surgeons must have a full understanding of the types, causes, and treatment of complications, and should deliver this information to patients who develop these complications. PMID:28280704

  6. Significant sE-Selectin levels reduction after 6 months of anti-TNF-α therapy in non-diabetic patients with moderate-to-severe psoriasis.

    Science.gov (United States)

    Genre, Fernanda; Armesto, Susana; Corrales, Alfonso; López-Mejías, Raquel; Remuzgo-Martínez, Sara; Pina, Trinitario; Ubilla, Begoña; Mijares, Verónica; Martín-Varillas, José Luis; Rueda-Gotor, Javier; Portilla, Virginia; Dierssen-Sotos, Trinidad; González-López, Marcos Antonio; González-Vela, María Del Carmen; Blanco, Ricardo; Llorca, Javier; Hernández, José Luis; González-Gay, Miguel Ángel

    2017-12-01

    Psoriasis patients have high risk of atherosclerosis, characterized by endothelial dysfunction. We aimed to study the association of the endothelial activation biomarkers monocyte chemoattractant protein 1 (MCP-1), soluble (s) E-selectin and P-selectin with disease activity and severity in psoriasis patients treated with anti-TNF-α therapy. Also, to evaluate the relationship of metabolic syndrome features with these biomarkers and the effect of anti-TNF-α therapy on these molecules. Twenty-nine consecutive non-diabetic patients with moderate-to-severe psoriasis who underwent 6 months of anti-TNF-α-adalimumab therapy were studied. Metabolic and clinical evaluation was performed prior to anti-TNF-α treatment (time 0) and 6 months later. MCP-1, sE-selectin and sP-selectin serum levels were determined by ELISA. Dyslipidemic and obese patients showed higher MCP-1 levels at month 6 from the onset of anti-TNF-α therapy (p = .05 and .01, respectively). sE-selectin positively correlated with pro-inflammatory molecules such as asymmetric dimethylarginine, sP-selectin and resistin at baseline and month 6 (p psoriasis. Adalimumab therapy led to a reduction in sE-selectin levels, supporting the beneficial effect of anti-TNF-α therapy on mechanisms associated with the development of atherosclerosis in psoriasis.

  7. Long term complications of diabetes

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000327.htm Long-term complications of diabetes To use the sharing features on this page, ... other tests. All these may help you keep complications of diabetes away. You will need to check your blood ...

  8. Tattoo complaints and complications

    DEFF Research Database (Denmark)

    Serup, Jørgen; Carlsen, Katrina Hutton; Sepehri, Mitra

    2015-01-01

    Tattoos cause a broad range of clinical problems. Mild complaints, especially sensitivity to sun, are very common and seen in 1/5 of cases. Medical complications are dominated by allergy to tattoo pigment haptens or haptens generated in the skin, especially in red tattoos but also in blue and green...... tattoos. Symptoms are major and can be compared to cumbersome pruritic skin diseases. Tattoo allergies and local reactions show distinct clinical manifestations, with plaque-like, excessive hyperkeratotic, ulcero-necrotic, lymphopathic, neuro-sensory, and scar patterns. Reactions in black tattoos......) transferred by tattooing remain a significant risk needing active prevention. It is noteworthy that cancer arising in tattoos, in regional lymph nodes, and in other organs due to tattoo pigments and ingredients has not been detected or noted as a significant clinical problem hitherto, despite millions...

  9. Hip complications following chemoradiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Jenkins, P.J.; Sebag Montefiore, D.J.; Arnott, S.J. [Saint Bartholomew`s Hospital, London (United Kingdom)

    1995-12-01

    Chemoradiotherapy protocols are a recent development in the management of tumours where preservation of organ function is important. It is now recognized that such combined treatment may produce adverse effects below the accepted dose thresholds for either modality. This enhancement of toxicity is generally thought to reflect depletion of stem cells within the tissue concerned. We report four patients who have developed avascular necrosis or fractures of the hip following chemoradiotherapy for carcinoma of the vulva or anus. These complications developed after a radiation dose of 4500 cGy in 20 fractions. The possible role of cytotoxic agents in sensitizing bone to radiation damage is discussed, and a novel mechanism is proposed to account for this phenomenon. (author).

  10. Neurologic Complications of Transplantation.

    Science.gov (United States)

    Dhar, Rajat

    2018-02-01

    Neurologic disturbances including encephalopathy, seizures, and focal deficits complicate the course 10-30% of patients undergoing organ or stem cell transplantation. While much or this morbidity is multifactorial and often associated with extra-cerebral dysfunction (e.g., graft dysfunction, metabolic derangements), immunosuppressive drugs also contribute significantly. This can either be through direct toxicity (e.g., posterior reversible encephalopathy syndrome from calcineurin inhibitors such as tacrolimus in the acute postoperative period) or by facilitating opportunistic infections in the months after transplantation. Other neurologic syndromes such as akinetic mutism and osmotic demyelination may also occur. While much of this neurologic dysfunction may be reversible if related to metabolic factors or drug toxicity (and the etiology is recognized and reversed), cases of multifocal cerebral infarction, hemorrhage, or infection may have poor outcomes. As transplant patients survive longer, delayed infections (such as progressive multifocal leukoencephalopathy) and post-transplant malignancies are increasingly reported.

  11. Hip complications following chemoradiotherapy

    International Nuclear Information System (INIS)

    Jenkins, P.J.; Sebag Montefiore, D.J.; Arnott, S.J.

    1995-01-01

    Chemoradiotherapy protocols are a recent development in the management of tumours where preservation of organ function is important. It is now recognized that such combined treatment may produce adverse effects below the accepted dose thresholds for either modality. This enhancement of toxicity is generally thought to reflect depletion of stem cells within the tissue concerned. We report four patients who have developed avascular necrosis or fractures of the hip following chemoradiotherapy for carcinoma of the vulva or anus. These complications developed after a radiation dose of 4500 cGy in 20 fractions. The possible role of cytotoxic agents in sensitizing bone to radiation damage is discussed, and a novel mechanism is proposed to account for this phenomenon. (author)

  12. Postviral Complications: Bacterial Pneumonia.

    Science.gov (United States)

    Prasso, Jason E; Deng, Jane C

    2017-03-01

    Secondary bacterial pneumonia after viral respiratory infection remains a significant source of morbidity and mortality. Susceptibility is mediated by a variety of viral and bacterial factors, and complex interactions with the host immune system. Prevention and treatment strategies are limited to influenza vaccination and antibiotics/antivirals respectively. Novel approaches to identifying the individuals with influenza who are at increased risk for secondary bacterial pneumonias are urgently needed. Given the threat of further pandemics and the heightened prevalence of these viruses, more research into the immunologic mechanisms of this disease is warranted with the hope of discovering new potential therapies. Published by Elsevier Inc.

  13. Assessment of complications due to intratympanic injections

    Directory of Open Access Journals (Sweden)

    Yu-Chuan Liu

    2016-03-01

    Full Text Available Objective: The purpose of the study is to report and to analyze the complications following intratympanic injections (ITI of steroids. The occurrence rate of complications at different ITI sites, four quadrants of eardrum, was also compared. Methods: A retrospective clinical review in a medical center. Each patient received ITI twice in a week for 2–3 consecutive weeks as a salvage therapy for sudden sensorineural hearing loss. Post-injection complications, especially transient dizziness and vertigo, were recorded. Patients with acute or chronic vertigo episodes in 1 month were excluded. Results: A total of 59 patients with sudden sensorineural hearing loss and a total of 278 times of ITI were performed in 1 year. The post-injection complications included pain, tongue numbness, transient dizziness, vertigo, tinnitus, and a small persistent perforation. There was no significant difference in the occurrence of these complications between the injections sites on the 4 quadrants of the tympanic membrane. However, there was statistical significance in the post-injection vertiginous episode after IT injections to posterior-inferior quadrant (Q3 and posterior-superior quadrant (Q4 compared to anterior-superior quadrant (Q1 and anterior-inferior quadrant (Q2 (P = 0.0113. Conclusion: IT injection is recommended to be applied to the Q2 since the Q1 and Q4 injections are more likely to induce the adverse effect of tongue numbness, while the Q3 and Q4 areas are more likely to induce post-injection vertigo. Keywords: Intratympanic injection, Sudden deafness, Complications, Vertigo

  14. Late complications after radiotherapy for prostate cancer

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    Jung, H. [University Hospital Hamburg-Eppendorf (Germany). Inst. of Biophysics and Radiobiology; University Hospital Hamburg-Eppendorf (Germany). Lab. of Radiobiology and Experimental Radiooncology; Beck-Bornholdt, H.P. [University Hospital Hamburg-Eppendorf (Germany). Inst. of Biophysics and Radiobiology; Svoboda, V. [University Hospital Hamburg-Eppendorf (Germany). Inst. of Biophysics and Radiobiology; Portsmouth Oncology Centre, Saint Mary' s Hospital (United Kingdom). Dept. of Radiotherapy; Alberti, W. [University Hospital Hamburg-Eppendorf (Germany). Dept. of Radiotherapy and Radiooncology; Herrmann, T. [Technical Univ. Dresden (Germany). Dept. of Radiotherapy and Radiooncology

    2012-11-15

    Background: The aim of the present study was to analyze in detail the time course of the incidence of radiation-induced late effects. For this purpose, unpublished data of patients treated by radiation therapy in Hamburg in the late 1980s were analyzed. Relatively large volumes were exposed to comparatively high doses, thus leading to a high rate of treatment-related side effects. Patients and methods: A total of 180 consecutive patients received radiotherapy for prostate cancer. The median age was 66 years (range 41-88 years). The median of the maximum dose was 77.5 Gy (range 56.3-95 Gy) and overall treatment time was 51 days (range 28-128 days). Endpoints analyzed were late complications of grade 3 or higher, overall and disease-free survival, local tumor control, and distant metastases. Data analysis was actuarial and the log-rank test was used to compare the various subgroups. Results After 2 years, 80.5 {+-} 3.2% of the patients were without any complications of grade 3 or higher, and after 5 years a constant level of 70.3 {+-} 4.0% was approached. When multiple lesions occurred per patient, the later events were disregarded. A total of 66 complications occurred in 42 patients. The percentage of patients being free from late complications, plotted as a function of time after start of radiation therapy, was adequately described by an exponential function and a constant fraction. Complications approached a constant level of 70.3% at a rate of 5.3% per month. This means that patients who will develop a complication do so at exponential kinetics and at a relatively high rate, whereas about 70% of the patients will never experience a late effect even over long observation periods. After subdividing the maximum dose into three equal dose groups of 55 patients each (< 73.3 Gy, 73.3-80 Gy, > 80 Gy), the constant fraction decreased from 85.7 to 72.8% and 52.2%, whereas the incidence rate was 4.3%, 7.7%, and 5.6% per month and, thus, almost independent of radiation dose

  15. How do patients with inflammatory bowel disease want their biological therapy administered?

    LENUS (Irish Health Repository)

    Allen, Patrick B

    2010-01-01

    BACKGROUND: Infliximab is usually administered by two monthly intravenous (iv) infusions, therefore requiring visits to hospital. Adalimumab is administered by self subcutaneous (sc) injections every other week. Both of these anti-TNF drugs appear to be equally efficacious in the treatment of Crohn\\'s Disease and therefore the decision regarding which drug to choose will depend to some extent on patient choice, which may be based on the mode of administration.The aims of this study were to compare preferences in Inflammatory Bowel Disease (IBD) patients for two currently available anti-TNF agents and the reasons for their choices. METHODS: An anonymous questionnaire was distributed to IBD patients who had attended the Gastroenterology service (Ulster Hospital, Dundonald, Belfast, N. Ireland. UK) between January 2007 and December 2007. The patients were asked in a hypothetical situation if the following administering methods of anti-TNF drugs (intravenous or subcutaneous) were available, which drug route of administration would they choose. RESULTS: One hundred and twenty-five patients fulfilled the inclusion criteria and were issued questionnaires, of these 78 questionnaires were returned (62 percent response). The mean age of respondent was 44 years. Of the total number of respondents, 33 patients (42 percent) preferred infliximab and 19 patients (24 percent) preferred adalimumab (p = 0.07). Twenty-six patients (33 percent) did not indicate a preference for either biological therapy and were not included in the final analysis. The commonest reason cited for those who chose infliximab (iv) was: "I do not like the idea of self-injecting," (67 percent). For those patients who preferred adalimumab (sc) the commonest reason cited was: "I prefer the convenience of injecting at home," (79 percent). Of those patients who had previously been treated with an anti-TNF therapy (n = 10, all infliximab) six patients stated that they would prefer infliximab if given the choice

  16. Complications associated with cutaneous aesthetic procedures.

    Science.gov (United States)

    Hartmann, Daniela; Ruzicka, Thomas; Gauglitz, Gerd G

    2015-08-01

    In recent years, a plethora of novel therapeutic approaches to fight signs of aging and to influence external body appearance have become available in aesthetic dermatology. Extensive research in this field has led to advanced understanding of the anatomy and physiology of the aging face. To successfully address the complex age-related alterations anti-aging treatment nowadays calls for a multi-faceted approach. Most frequently utilized aesthetic procedures include the use of botulinum toxin, a variety of filling substances, microneedling (collagen induction therapy), chemical peeling, lasers, radiofrequency, thread facelift and injectional lipolysis with phosphatidylcholine/deoxycholate among others. Unfortunately, many clinicians still lack in-depth understanding of potential complications, risk factors and side effects associated with minimal-invasive procedures. The following review aims to give a broad overview of nowadays most frequently used approaches in the dermato-aesthetic field and their related complications. © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by