PubMed | Leiden University, Klinikum Bielefeld, UCB Pharma, University of Oregon and 4 more.
Type: Journal Article | Journal: Arthritis care & research | Year: 2016
Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA.The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years.At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years).The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.
PubMed | Hospital Universitario La Paz, Diakonhjemmet Hospital, Semmelweis University, University of Toronto and 17 more.
Type: | Journal: Annals of the rheumatic diseases | Year: 2017
To update and integrate the recommendations for ankylosing spondylitis and the recommendations for the use of tumour necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) into one set applicable to the full spectrum of patients with axSpA. Following the latest version of the European League Against Rheumatism (EULAR) Standardised Operating Procedures, two systematic literature reviews first collected the evidence regarding all treatment options (pharmacological and non-pharmacological) that were published since 2009. After a discussion of the results in the steering group and presentation to the task force, overarching principles and recommendations were formulated, and consensus was obtained by informal voting. A total of 5 overarching principles and 13 recommendations were agreed on. The first three recommendations deal with personalised medicine including treatment target and monitoring. Recommendation 4 covers non-pharmacological management. Recommendation 5 describes the central role of non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice drug treatment. Recommendations 6-8 define the rather modest role of analgesics, and disprove glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for axSpA patents with predominant axial involvement. Recommendation 9 refers to biological DMARDs (bDMARDs) including TNFi and IL-17 inhibitors (IL-17i) for patients with high disease activity despite the use (or intolerance/contraindication) of at least two NSAIDs. In addition, they should either have an elevated C reactive protein and/or definite inflammation on MRI and/or radiographic evidence of sacroiliitis. Current practice is to start with a TNFi. Switching to another TNFi or an IL-17i is recommended in case TNFi fails (recommendation 10). Tapering, but not stopping a bDMARD, can be considered in patients in sustained remission (recommendation 11). The final two recommendations (12, 13) deal with surgery and spinal fractures. The 2016 Assessment of SpondyloArthritis international Society-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA.
Fansa H.,Reconstructive and Aesthetic Surgery |
Schirmer S.,Reconstructive and Aesthetic Surgery |
Cervelli A.,Breast Center |
Gehl H.B.,Klinikum Bielefeld
Annals of Plastic Surgery | Year: 2013
The internal mammary artery (IMA) is the standard recipient vessel for autologous breast reconstruction. To save the IMA for bypass surgery, to keep flap pedicles short, and to allow better flap positioning, the IMA perforators were used. Forty-six flaps for immediate breast reconstructions were performed in 39 patients. In the first 22 patients, the decision to use the perforators was clinically based. In the second group of 17 patients, all patients received a thoracic computed tomographic angiography (CTA) to determine the perforators. In 13 flaps (6 deep inferior epigastric artery perforator, 3 superficial inferior epigastric artery, and 4 transverse myocutaneous gracilis), the perforators were used as recipient vessels. Of these flaps, 5 were anastomosed to perforators before the CTA was applied and 8 after the CTA was established. The CTA revealed the IMA and the perforators in detail. In immediate reconstructions, the IMA perforators can be used as recipient vessels. They allow better flap positioning for superficial inferior epigastric artery and transverse myocutaneous gracilis flaps in particular; moreover, it decreases donor site and recipient site morbidity. After introducing the CTA, the perforators were used more frequently for anastomosis. © 2013 Lippincott Williams & Wilkins.
Schirmer S.,Reconstructive and Aesthetic Surgery |
Ritter R.-G.,Klinikum Bielefeld |
Fansa H.,Reconstructive and Aesthetic Surgery
PLoS ONE | Year: 2013
Introduction:Diabetic foot ulcers occur in approximately 2,5% of patients suffering from diabetes and may lead to major infections and amputation. Such ulcers are responsible for a prolonged period of hospitalization and co- morbidities caused by infected diabetic foot ulcers. Small, superficial ulcers can be treated by special conservative means. However, exposed bones or tendons require surgical intervention in order to prevent osteomyelitis. In many cases reconstructive surgery is necessary, sometimes in combination with revascularization of the foot.There are studies on non surgical treatment of the diabetic foot ulcer. Most of them include patients, classified Wagner 1-2 without infection. Patients presenting Wagner 3D and 4D however are at a higher risk of amputation. The evolution of microsurgery has extended the possibilities of limb salvage. Perforator based flaps can minimize the donorsite morbidity.Patients and Methods:41 patients were treated with free tissue transfer for diabetic foot syndrome and chronic defects. 44 microvascular flaps were needed. The average age of patients was 64.3 years. 18 patients needed revascularization. 3 patients needed 2 microvascular flaps. In 6 cases supramicrosurgical technique was used.Results:There were 2 flap losses leading to amputation. 4 other patients required amputation within 6 months postoperatively due to severe infection or bypass failure. Another 4 patients died within one year after reconstruction. The remaining patients were ambulated.Discussion:Large defects of the foot can be treated by free microvascular myocutaneous or fasciocutaneous tissue transfer. If however, small defects, exposing bones or tendons, are not eligible for local flaps, small free microvascular flaps can be applied. These flaps cause a very low donor site morbidity. Arterialized venous flaps are another option for defect closure.Amputation means reduction of quality of life and can lead to an increased mortality postoperatively. © 2013 schirmer et al.
Lawrenz T.,Klinikum Bielefeld |
Lawrenz T.,Witten/Herdecke University |
Borchert B.,Klinikum Bielefeld |
Leuner C.,Klinikum Bielefeld |
And 9 more authors.
Journal of the American College of Cardiology | Year: 2011
Objectives The purpose of this study was to examine the efficacy and safety of endocardial radiofrequency ablation of septal hypertrophy (ERASH) for left ventricular outflow tract (LVOT) gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM). Background Anatomic variability of the vessels supplying the obstructing septal bulge can limit the efficacy of transcoronary ablation of septal hypertrophy in HOCM. Previous studies showed that inducing a local contraction disorder without reducing septal mass results in effective gradient reduction. We examined an alternative endocardial approach to transcoronary ablation of septal hypertrophy by using ERASH. Methods Nineteen patients with HOCM were enrolled; in 9 patients, the left ventricular septum was ablated, and in 10 patients, the right ventricular septum was ablated. Follow-up examinations (echocardiography, 6-min walk test, bicycle ergometry) were performed 3 days and 6 months after ERASH. Results After 31.2 ± 10 radiofrequency pulses, a significant and sustained LVOT gradient reduction could be achieved (62% reduction of resting gradients and 60% reduction of provoked gradients, p = 0.0001). The 6-min walking distance increased significantly from 412.9 ± 129 m to 471.2 ± 139 m after 6 months, p = 0.019); and New York Heart Association functional class was improved from 3.0 ± 0.0 to 1.6 ± 0.7 (p = 0.0001). Complete atrioventricular block requiring permanent pacemaker implantation occurred in 4 patients (21%); 1 patient had cardiac tamponade. Conclusions ERASH is a new therapeutic option in the treatment of HOCM, allowing significant and sustained reduction of the LVOT gradient as well as symptomatic improvement with acceptable safety by inducing a discrete septal contraction disorder. It may be suitable for patients not amenable to transcoronary ablation of septal hypertrophy or myectomy. © 2011 American College of Cardiology Foundation.
Riesenberg H.,Klinikum Bielefeld |
Lubbe A.S.,Cecilien Klinik
Supportive Care in Cancer | Year: 2010
Purpose It has not previously been shown whether there is any benefit to multi-morbid patients with lung cancer who participate in complex interdisciplinary rehabilitation programmes after primary therapy. The purpose of this prospective study was to assess changes in exercise capacity and quality of life before and after an in-patient training programme. Patients and methods Forty-five patients with lung cancer (WHO I-III after surgery and/or radiotherapy and/or chemotherapy) were enrolled in a 28-day in-patient rehabilitation programme that included standardised aerobic training. Functional status and health-related quality of life (QLQ-C30, QLQ-LC13, SF-36, and MFI-20) were examined at the beginning of the study and at day 28. Results A substantial increase in work performance (bicycle ergometry from 68±3 to 86±4 W, p<0.001, and 6-minute walk test from 322±11 to 385±13 m, p<0.001) was registered. In addition, heart rate at rest was reduced (from 84±2 to 80± 1 beats per minute, p<0.05) and heart rate variability (indicator of the efficacy of endurance training) was significantly increased (from 9.7±1 to 12.9±1 root mean square of successive differences, p<0.001). Moreover, there was also a significant improvement in quality of life (48±3to62±2, p<0.001) while fatigue was reduced from 66±3 to 41±4, p<0.001. Conclusion A standardised, aerobic endurance training programme as part of the in-patient oncological rehabilitation of patients with lung cancer results in improvements in both physiological and psychological parameters after therapy. A follow-on study in order to determine to what extent this benefit persists over the long-term, particularly, in comparison with patients who have not participated in a rehabilitation programme, is currently being conducted. © Springer-Verlag 2009.
Yoon U.,Charité - Medical University of Berlin |
Kwok L.L.,Columbia University |
Magkidis A.,Klinikum Bielefeld
Metabolism: Clinical and Experimental | Year: 2013
Objective: Every year over 3.8 million people are dying of diabetes and its complications. Lifestyle intervention was suggested to have beneficial effects in preventing and reducing diabetes incidence. Interventions in patients with impaired glucose tolerance (IGT), who belong to a high risk group in developing diabetes, are supposed to be especially effective. According to the evidence hierarchy, a 1a level of evidence is missing and therefore a systematic review verifying the efficacy of lifestyle intervention is needed. Materials/Methods: Systematic review: The electronic database PubMed, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Health Technology Assessment database were searched. Main inclusion criteria were randomized controlled trials, impaired glucose tolerance, lifestyle intervention with control group and observation time > 6 months. Outcome measures were all diabetes events, as defined by the authors of each study, all-cause mortality, diabetes mortality, and quality adjusted life years (QALY). Two independent reviewers abstracted the studies by title, abstract and full-text analysis. Furthermore the reporting quality of each study was assessed by using the CONSORT criteria (Consolidated Standards of Reporting Trials) and the methodological quality by SIGN 50 instrument (Scottish Intercollegiate Guidelines Network methodology checklist for randomized controlled trials). The primary outcome measure was diabetes incidence. Secondary outcome measures were overall mortality, disease-specific mortality, quality adjusted life years (QALY), and clinical parameters; body mass index (BMI), weight change, blood pressure, blood parameter, smoking, alcohol consumption. Results: 7 trials which included 25 relevant publications were identified. Kappa Cohens for title-analysis were K = 0.77, (CI = 0.71-0.83), abstract-analysis K = 0.81 (CI = 0.64-0.92) and full-text analysis K = 0.78 (CI = 0.57-0.98). Overall 5663 patients were analyzed with primary follow-up time: India (3 y), Japan (4 y), Sweden (5 y), Da Qing (6 y), SIM (3 y), DPP (5 y), DPS (4 y) and drop-out rate ranges from 5% to 28%. Diabetes incidence ranges from 3% to 46% in the intervention group and 9.3% to 67.7% in the control group. The India study reported ARR = 16%, RRR = 29% (p = 0.018), Japan: ARR = 6.3%, RRR = 65% (p < 0.001), Sweden: ARR = 4%, RRR = 25% (p = not significant), Da Qing: ARR = 22%, RRR = 32% (p < 0.05), SLIM: ARR = 20%, RRR = 53% (p = 0.025), DPP: ARR = 15%, RRR = 58% (significant, no p-value reported), and DPS: ARR = 12%, RRR = 52% (significant, no p-value reported). Mortality and morbidity were only analyzed in Da Qing study which showed no statistical differences (overall mortality: HRR 0.96, CI 0.65-1.41, CVD-mortality: HRR 0.83; CI 0.48-1.40, CVD event: HRR 0.98; CI 0.71-1.37). Conclusion: Under consideration of heterogeneity in lifestyle interventions and follow up time of the included studies, this systematic review illustrated that lifestyle intervention can have a beneficial effect on the incidence of diabetes in patients with impaired glucose tolerance. However, several studies found the effect of lifestyle intervention decreased after intervention was terminated. No long-term benefit in mortality and morbidity was found. Development of standardized lifestyle intervention program is strongly needed and further long-term intervention trials using this program are crucial in evidencing the long-term efficacy. © 2013 Elsevier Inc.
PubMed | Rheumazentrum Herne, Klinikum Bielefeld, Charité - Medical University of Berlin and German Rheumatology Research Center
Type: Journal Article | Journal: Annals of the rheumatic diseases | Year: 2016
To date, only a single controlled trial provided evidence that non-steroidal anti-inflammatory drugs (NSAIDs) given continuously reduce radiographic progression compared with an on-demand therapy over 2years in patients with ankylosing spondylitis (AS). In the current study, we tested whether such an effect of NSAIDs could be confirmed in another randomised trial.Patients with AS were randomised for treatment with either continuous (150mg/day) or on-demand diclofenac for 2years. Tumour necrosis factor-blocker treatment was not allowed during the entire study period. The primary outcome was the difference in radiographic progression in the spine as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scored by two readers blinded to treatment arm and time point.62 of 85 patients enrolled in the continuous arm and 60 of 82 enrolled in the on-demand arm completed the study. The mSASSS progression was numerically higher in the continuous group (1.28 (0.7 to 1.9) vs 0.79 (0.2 to 1.4)) (p=0.39). If only patients were analysed who were either C reactive protein positive or had syndesmophytes at baseline, there was again a higher radiographic progression in the continuous versus the on-demand group: 1.68 (0.7 to 2.6) vs 0.96 (0.0 to 1.9) and 2.11 (1.1 to 3.1) vs 0.95 (0.0 to 1.9), respectively. There was no difference between the two treatment groups regarding adverse events.In our study, continuous treatment with diclofenac over 2years did not reduce radiographic progression compared with on-demand treatment in AS.EudraCt-no 2007-007637-39; ClinicalTrials.gov NCT00715091.
Heidemann J.,Klinikum Bielefeld |
Bartels C.,University of Munster |
Berssenbrugge C.,University of Munster |
Schmidt H.,University of Munster |
Meister T.,University of Gottingen
Gastroenterology Research and Practice | Year: 2015
Aim. Treatment of hepatorenal syndrome (HRS) in patients with liver cirrhosis is still challenging and characterized by a very high mortality. This study aimed to delineate treatment patterns and clinical outcomes of patients with HRS intravenously treated with terlipressin. Methods. In this retrospective single-center cohort study, 119 patients (median [IQR]; 56.50 [50.75-63.00] years of age) with HRS were included. All patients were treated with terlipressin and human albumin intravenously. Those with response to treatment (n = 65) were compared to the patient cohort without improvement (n = 54). Patient characteristics and clinical parameters (Child stage, ascites, hepatic encephalopathy, HRS type I/II, and initial MELD score) were retrieved. Univariate analysis of factors influencing the success of terlipressin therapy and Cox regression analysis of factors influencing survival was carried out. Results. One-month survival was significantly longer in the group of responders (p = 0.048). Cox regression analysis identified age [Hazard ratio, 95% confidence interval (CI); 1.05, 1.01-1.09, resp.], alcohol abuse [HR 3.05, 95% CI 1.11-8.38], duration of treatment [HR 0.92, 95% CI 0.88-0.96], and MELD score [HR 1.08, 95% CI 1.02-1.14] to be independent predictors of survival. Conclusions. Survival of HRS patients after treatment depends on age, etiology of liver disease, and the duration of treatment. © 2015 Jan Heidemann et al.
Vollbach F.H.,Klinikum Bielefeld |
Walle L.,Klinikum Bielefeld |
Fansa H.,Klinikum Bielefeld
Handchirurgie Mikrochirurgie Plastische Chirurgie | Year: 2013
Introduction: The gold standard in the treatment of Dupuytren's disease is the partial fasciectomy (PF). Injection of a collagenase directly into the Dupuytren cord is an alternative method. In contrast to needle fasciotomy, destruction of the cord is achieved enzymatically and not mechanically. 24 h after injection, the treated finger can be extended passively to disrupt the Dupuytren cord. Patients and Methods: Functional outcome and patient satisfaction were prospectively analysed in 2 comparable groups of patients with the same stage of disease. Follow-up was one year. Patients in the first group underwent partial fasciectomy (PF) (n=13), whereas patients in the second group were treated by an injection of collagenase (CG) in the diseased tissue (n=14). Besides clinical examination, outcome was evaluated by validated questionnaires (DASH/MHQ) and a customised questionnaire. Results: Extension after PF (mean residual contracture 7.5°) was better than after collagenase injection (mean residual contracture 13.2°). Side-effects like numbness, impaired blood circulation and pain were less after injection of collagenase than after PF and of shorter duration. Recovery of grip strength was faster in the CG than after PF and collagenase injection was regarded as less discomforting. The results of the questionnaires showed a reduction of hand function 1 month after surgery, whereas better results were observed 1 month after collagenase injection. Recovery in the CG was significantly faster than after PF. Discussion: Collagenase injection, as a less invasive technique, has less and milder side-effects than surgery and demonstrated a better total reduction of Dupuytren's contracture initially, although the residual contractures were higher in the CG after follow-up of 1 year. Patient satisfaction was higher after collagenase injection due to subjectively perceived less negative impact and a comparable functional outcome. © 2013 Georg Thieme Verlag KG Stuttgart New York.