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A Zink

Publications and source records attributed to A Zink.

At least 19 recordsLinked to original sources

Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: an open, observational, extension study of a three-month, randomized, placebo-controlled trial.

OBJECTIVE: Treatment of ankylosing spondylitis (AS) with infliximab, an anti-tumor necrosis factor alpha monoclonal antibody, was shown to be efficacious in patients with active disease during a 3-month treatment period. The purpose of this study was to evaluate the efficacy and safety of infliximab treatment of AS for a 1-year period. METHODS: This study was an open, observational, extension study of a 3-month, randomized, placebo-controlled trial. All patients who had tolerated infliximab (infliximab/infliximab group) or placebo (placebo/infliximab 12-week crossover group) therapy for 3 months entered the open extension trial (n = 65). Infliximab was administered at a dosage of 5 mg/kg every 6 weeks after the induction phase (weeks 0, 2, and 6). The primary end point was a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). RESULTS: At week 54, a total of 54 of the 69 patients (78%) continued to take infliximab. The intent-to-treat primary efficacy analysis at week 54 showed that 47% of patients in the infliximab/infliximab group (95% confidence interval 31-63) and 51% of the patients in the placebo/infliximab group (95% confidence interval 36-67) achieved 50% improvement in BASDAI scores. In the analysis of those who completed the study, the mean BASDAI scores improved between weeks 0 and 54 in both treatment groups: from 6.6 to 2.4 in the infliximab/infliximab group and from 6.3 to 2.6 in the placebo/infliximab group. The dosage of nonsteroidal antiinflammatory drugs was reduced in approximately 70% of the patients. There were significant improvements in measures of functioning, metrologic parameters, and quality of life. Between weeks 12 and 54, a total of 4 patients had serious adverse events that were possibly related to infliximab and resulted in their discontinuing the study. CONCLUSION: Infliximab therapy in AS patients resulted in a rapid and significant improvement in BASDAI scores (>50% improvement) and a durable response for 1 year. The safety profile of infliximab in AS was comparable to that observed in the postmarketing experience for the approved indications.

Acute-Phase Proteins↗

[Adaption and validation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for use in Germany].

OBJECTIVE: The purpose of this study was the validation of a German translation of the Bath Ankylosing Spondylitis Index (BASDAI). PATIENTS AND METHODS: The German translation of the BASDAI was validated using data of 134 patients with ankylosing spondylitis (AS) from a spondyloarthropathy cohort. For validation the BASDAI was compared with parameters assessed by physicians (physicians global, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), spinal mobility (BASMI), swollen joints, enthesitis (yes or no)), and parameters assessed by patients themselves (pain, function (BASFI) and quality of life (SF-12)). The discriminative validity was analyzed by comparison of BASDAI scores of patients subgroups who have different levels of disease severity. The sensibility to change was analyzed by using follow-up data of a clinical trial on efficacy of the anti-tumor necrosis factor (TNF) alpha agent infliximab in 70 AS-patients with active and severe disease. RESULTS: The German translation of the BASDAI was easy to understand, the translation back to English corresponded well with the original English version. The 6 questions of the BASDAI represent different aspects of disease but correlated also well with each other (r < 0.65). There was a good internal consistency for all 6 questions (Cronbach's Alpha 0.82), strong correlations to the physician's global (r = 0.659), pain (r = 789), function (BASFI; r = 0.752) and to CRP and ESR confirming that the BASDAI assesses a comprehensive picture of patient's disease activity. For subgroups of patients with different levels of disease severity or with different manifestations the BASDAI showed good discriminative properties. The BASDAI was sensitive to change during treatment with infliximab (effect size 1.18). CONCLUSION: The German translation of the BASDAI is easy to use, reliable, and sensitive to change for the assessment of disease activity in AS.

Activities of Daily Living↗

Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study.

We conducted this prospective randomised and externally evaluated study to investigate whether the use of a navigation system during total knee arthroplasty leads to significantly better results than the hand-guided technique. A total of 240 patients was included in the study. All patients received a condylar knee prosthesis. Two surgeons performed all the operations using the Stryker knee navigation system. Exclusion criteria included the necessity for the primary use of constrained implants. The results revealed a highly significant difference between the two groups in favour of navigation with regard to the mechanical axis, the frontal and sagittal femoral axis and the frontal tibial axis (p < 0.0001). The use of a navigation system was therefore shown to improve the alignment of the implant.

Aged↗

[Paleopathology of ancient Egyptian mummies and skeletons. Investigations on the occurrence and frequency of specific diseases during various time periods in the necropolis of Thebes-West].

The scientific investigation of mummies and skeletons provides considerable data for the reconstruction of the living conditions and diseases of past populations. We describe the data on four completely analyzed tomb complexes from the huge necropolis of Thebes-West in Upper Egypt dating to different time periods. A total of 211 individuals from the so-called "Middle Kingdom" (MK, c. 2050-1750 BC) were compared to 273 individuals from the "New Kingdom" (NK) to "Late Period" (LP, in total 1550-500 BC). The age at death and the sex ratio were comparable between both groups. There was a high rate of early death with a maximum between the 2nd and 3rd decade of life but infant/adolescent burials were comparably rare. This early death is assumed to be due to an elevated prevalence of various infectious diseases. Likewise, a high rate of tuberculosis infections was seen in those individuals regardless of which time period they came from. Metabolic disorders with osseous manifestations, such as scurvy, osteomalacia and chronic anemia (cribra orbitalia, porotic hyperostosis) were found with a high frequency in the MK populations but significantly less in the NK-LP populations. On the other hand signs of trauma were comparably high, and lesions due to degenerative joint and vertebral diseases were significantly higher in LP than in MK or NK individuals suggesting a higher mechanical load in the later populations. Cases of malignant (secondary) bone tumors and various soft tissue/organ diseases indicate that "civilization" disorders were present when the living conditions assured survival into advanced age. In summary, we provide circumstantial evidence that the systematic and concise analysis of mummy and skeletal remains can allow a reconstruction of major aspects of life and disease in historic populations, although a complete reconstruction is not possible.

Bone Diseases↗

Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial.

UNLABELLED: BACKGROUND Treatment options for patients with ankylosing spondylitis are few. We aimed to assess the effectiveness of infliximab, an antibody to tumour necrosis factor (TNF)-alpha, in treatment of such patients. METHODS: In this 12-week placebo-controlled multicentre study, we randomly assigned 35 patients with active ankylosing spondylitis to intravenous infliximab (5 mg/kg) and 35 to placebo at weeks 0, 2, and 6. One patient in the infliximab group was withdrawn from the study. Our primary outcome was regression of disease activity of at least 50%. To assess response, we used validated clinical criteria from the ankylosing spondylitis assessment working group, including disease activity (BASDAI), functional indices (BASFI), metrology (BASMI), and quality of life (short form 36). Analyses were done by intention to treat. FINDINGS: 18 (53%) of 34 patients on infliximab had a regression of disease activity at week 12 of at least 50% compared with three (9%) of 35 on placebo (difference 44% [95% CI 23-61], p<0.0001). Function and quality of life also improved significantly on infliximab but not on placebo (p<0.0001 and p<0.0001, respectively). Treatment with infliximab was generally well tolerated, but three patients had to stop treatment because of systemic tuberculosis, allergic granulomatosis of the lung, or mild leucopenia. INTERPRETATION: Our results show that treatment with infliximab is effective in patients with active ankylosing spondylitis. Since there are some potentially serious adverse effects, we recommend that this treatment mainly be used in co-operation with rheumatological centres.

Adult↗

[Research in patient care in the rheumatology specialty network--what is the benefit for improving patient care?].

One of the areas of research in the Rheumatology Competence Network deals with health services research. It evaluates the structures and outcomes of rheumatological care. The paper presents selected results from the projects in the field of health services research. Data for rheumatoid arthritis are presented according to the criteria for the inclusion of diseases in new health care programs ("Disease Management"). The national database of the German Collaborative Arthritis Centers and cohort studies show the high individual and economic burden of disease in rheumatoid arthritis. Treatment by rheumatologists and non-rheumatologists differs greatly and leads to different outcomes. There is great potential for improvement. Data on practice variation within the rheumatologic subspecialty are used for quality management. The involvement of rheumatology into new concepts of care offers the chance to show the effectiveness of rheumatologic care and to enhance existing forms of cooperation.

Arthritis, Rheumatoid↗

[Preface].

Explore the source record for details and available documents.

Biomedical Research↗

Atopic disorders in ankylosing spondylitis and rheumatoid arthritis.

BACKGROUND: The prevalence of atopic disorders in ankylosing spondylitis (AS) is unknown. AS and rheumatoid arthritis (RA) exhibit divergent T helper (Th) cell cytokine patterns. OBJECTIVE: To test the hypothesis that Th2 polarised atopic disorders may be decreased in Th1 polarised RA but increased in AS, which is characterised by an impaired Th1 cytokine pattern, by assessing the prevalence of atopic disorders in AS and RA. METHODS: 2008 subjects (380 patients with AS, 728 patients with RA, 900 controls) from Berlin, Germany, were considered in this cross sectional study. A questionnaire incorporating questions from the European Community Respiratory Health Service (ECRHS) and the International Study of Asthma and Allergies in Childhood (ISAAC) protocol was mailed to all subjects. Disease severity was assessed by the modified Health Assessment Questionnaire (mHAQ). RESULTS: 1271 (63.3%) people responded to the questionnaire. The prevalence of any atopic disorder was 24.6% (61/248) in patients with AS, 20.7% (111/536) in controls, and 13.1% (64/487) in patients with RA (p=0.0009 for AS v RA; p=0.001 for controls v RA). Hay fever was reported by 40/248 (16.1%) patients with AS, 82/536 (15.3%) controls, and 42/487 (8.6%) patients with RA (p=0.002 for AS v RA; p=0.001 for controls v RA). Atopic dermatitis was reported by 19/248 (7.7%) patients with AS, 26/536 (4.9%) controls, and 14/487 (2.9%) patients with RA (p=0.003 for AS v RA), and asthma by 18/248 (7.3%) patients with AS, 35/536 (6.5%) controls, and 21/487 (4.3%) patients with RA. The differences were related neither to age nor to drugs. Disease severity was less in atopic patients with RA who had the atopic disorder before the onset of RA (median mHAQ 0.75) than in patients in whom RA preceded the atopic disorder (median mHAQ 1.75; p=0.027). CONCLUSIONS: Atopic disorders are decreased in RA but only slightly and non-significantly increased in AS. This may imply that atopy confers some protection from RA but only little if any susceptibility to AS. It may further indicate that the cytokine deviation towards an impaired Th1 pattern in AS is less strong than the cytokine deviation towards Th1 in RA, a finding which may affect future therapeutic approaches.

Adult↗

Ankylosing spondylitis: an overview.

Ankylosing spondylitis (AS) is a complex, potentially debilitating disease that is insidious in onset, progressing to radiological sacroiliitis over several years. Patients with symptomatic AS lose productivity owing to work disability and unemployment, have a substantial use of healthcare resources, and reduced quality of life. The pathogenesis of AS is poorly understood. However, immune mediated mechanisms involving human leucocyte antigen (HLA)-B27, inflammatory cellular infiltrates, cytokines (for example, tumour necrosis factor alpha and interleukin 10), and genetic and environmental factors are thought to have key roles. The detection of sacroiliitis by radiography, magnetic resonance imaging, or computed tomography in the presence of clinical manifestations is diagnostic for AS, although the presence of inflammatory back pain plus at least two other typical features of spondyloarthropathy (for example, enthesitis and uveitis) is highly predictive of early AS. Non-steroidal anti-inflammatory drugs (NSAIDs) effectively relieve inflammatory symptoms and are presently first line drug treatment. However, NSAID treatment has only a symptomatic effect and probably does not alter the disease course. For symptoms refractory to NSAIDs, second line treatments, including corticosteroids and various disease modifying antirheumatic drugs, are employed but are of limited benefit. Emerging biological therapies target the inflammatory processes underlying AS, and thus, may favourably alter the disease process, in addition to providing symptom relief.

Age of Onset↗

[National database documentation for collecting, controlling and quality assurance of new therapies in rheumatoid arthritis].

The national database of the German Collaborative Arthritis Centres is well-established in German rheumatology as a tool for the observation and assessment of treatments. The usage and spread of new drugs and treatment principles is regularly observed. Discussion about practice variations in treatment contributes to the internal quality assessment in the participating arthritis centres.

Antirheumatic Agents↗

[Outcome measurement in musculoskeletal diseases: recommendation for a core set of scales for use in rehabilitation].

By application of a standardized core set of outcome measurement instruments, comparison between studies as well as meta-analyses in rehabilitation research can be facilitated. The German Society for Rheumatology has commissioned its working group on rehabilitation with the development of a proposal for such a core set of outcome measurement instruments. In a first step, dimensions for outcome measurement in rehabilitation were defined by a group of experts which represented rehabilitation hospitals, acute care hospitals, and research groups specialized in outcome measurement. The Delphi method was used in a multiple step consensus process. In a second step, instruments and procedures to operationalize the relevant dimensions were chosen. Reliability, validity, sensitivity to change, and practicability were used as criteria for selecting measurement instruments. The main intention of the proposed core set of outcome measurement instruments is to facilitate the processes of planning and carrying out rehabilitation research studies. Furthermore, the proposed instruments can be used for clinical documentation systems as well as for internal or external quality assurance programs.

Arthritis, Rheumatoid↗

[Help status and help prospects of severely handicapped patients with rheumatoid arthritis].

UNLABELLED: Although increased efforts have been made, rheumatoid arthritis still leads to severe disability and dependence on external help in about one-third of the patients. Relatively little is known on how help-dependent RA patients manage everyday life, to what extent they need help, by whom the help is given, what the patients' future help perspectives are and what kind of patient- and resource-related characteristics are associated with unmet need. METHODS: By means of standardized interviews a representative sample of severly disabled RA patients was investigated with respect to present life situation, functional capacity, amount of help needed, relationship of caregiver and patient, health status of caregiver, stability of the help situation, housing preferences and help-seeking behaviour. The patients were classified as being either in definite need of help or independent of external help. RESULTS: Patients with comparable disabilities living on their own had only one-third of the help of those living together with others. They received help slightly more often from non-family caregivers, such as visiting nurses or privately paid household help, than from family members. Although many patients had rather uncertain perspectives for the future, the majority vehemently rejected living in a retirement home or in a home for the disabled. This refusal to live in an institution was independent of functional capacity, adequacy of the present help situation and the financial situation. Unmet need was highly associated with the age and health status of the caregiver as well as the help-seeking behaviour of the dependent person, but not with functional status or available resources. CONCLUSION: Given an appropriate home, the majority of conditions for a self-determined life for help-dependent RA patients are satisfied by the present outpatient help and care systems in Germany, but patients and their care givers need to be encouraged to take advantage of the available help and care facilities.

Activities of Daily Living↗

The national database of the German Collaborative Arthritis Centres: I. Structure, aims, and patients.

OBJECTIVE: To describe the aims, principles, and content of the German rheumatological database and to present data on patient mix and healthcare provision for the year 1998. METHODS: The German rheumatological database contains clinical and patient derived data of the outpatients with inflammatory rheumatic diseases seen at one of the 24 collaborative arthritis centres. The case mix, institutional context, and demographic features of 25 653 patients from the year 1998 were analysed. RESULTS: 51% of the patients had rheumatoid arthritis, 23% seronegative spondyloarthropathies, including ankylosing spondylitis, psoriatic arthritis, and reactive arthritis, and 19% had vasculitis, including SLE (5%). The distribution of the age at onset of patients with RA with < or = 2 years' disease duration was comparable with recent incidence data from population studies. The case mix differed between university departments and rheumatology hospitals as well as individual practices. 65% of the male and 46% of the female patients at ages 18-60 were still in gainful employment, the rates of employment were 14% below the population rates for women, and 11% below those for men. 62% of all patients had seen a rheumatologist within the first year of disease, 73% within the first two years. Ankylosing spondylitis was seen in rheumatological care much later than all other diseases (only 39% within the first year). The mean number of contacts with a rheumatologist was five a year; rheumatologists in individual practices saw their patients seven times a year on the average. Together with visits to the non-specialist doctor mainly treating the patient, the mean number of visits to the doctor for a rheumatic condition was 20 a year. CONCLUSION: Large databases like this one give information about the patient case mix in different healthcare settings, about treatment practice, and about the consequences of disease. Patients treated in specialised rheumatology units in Germany are referred earlier than in the past, which probably reflects better regional cooperation due to the implementation of arthritis centres. University departments and outpatient clinics of rheumatology hospitals contribute considerably to the specialised care of patients with arthritis and connective tissue diseases.

Adolescent↗

The national database of the German Collaborative Arthritis Centres: II. Treatment of patients with rheumatoid arthritis.

OBJECTIVE: To describe current treatment of patients with rheumatoid arthritis (RA) in German rheumatology. METHODS: Data from the German rheumatological database of 1998, comprising clinical and patient questionnaire data of 12 992 outpatients with RA seen at 24 collaborative arthritis centres in Germany, were analysed. RESULTS: At the time of documentation, 88% of the patients with RA were undergoing disease modifying antirheumatic drug (DMARD) treatment. Methotrexate (MTX) was prescribed to 56% of the patients (61% with seropositive and 45% with seronegative RA). Combination treatment was used in 15%. MTX was the drug of first choice even in patients with up to one year's disease duration (49%), followed by antimalarial drugs (21%). Patients treated by non-rheumatologists within the previous year had received DMARD treatment in only 33% of the cases. In steroid treatment, low doses (< or = 7.5 mg/day) were used by rheumatologists much more often (44%) than higher doses (12%). 16% of the patients had been inpatients during the previous year, with a median length of stay accumulated over the year of 21 days. Together with stays in inpatient rehabilitation, 22% of all patients had had some form of inpatient treatment. Comprehensive measures such as occupational therapy and patient education were prescribed to fewer than 12% of the patients, mostly during their hospital stay. CONCLUSION: German rheumatologists do follow recent recommendations about early and effective treatment. However, there are still deficits in outpatient care with non-medicinal measures like occupational therapy and patient education, which may partly explain the high hospital admission rates.

Adolescent↗

Practice variation in the treatment of rheumatoid arthritis among German rheumatologists.

OBJECTIVE: To describe practice variation in the treatment of rheumatoid arthritis (RA) among German rheumatologists with regard to drug and non-drug therapy. METHODS: We used data of 7,326 patients with RA registered in a national German rheumatological database in 1998. In the database, every patient with an inflammatory rheumatic disease seen at one of the German Collaborative Arthritis Centres is registered once a year with a standard clinical data form and a patient questionnaire. We compared health care provided by 29 rheumatological outpatient units. For drug and non-drug treatment unit prescription rates, ranges and outliers were calculated. Logistic regression analysis was used for case mix adjustment and for the identification of practice patterns. RESULTS: We observed variation concerning the frequency of use of single disease modifying antirheumatic drugs (DMARD). The median of the prescription rates in the 29 units for methotrexate (MTX) was 55% in 1998 (1st quartile: 51%, 3rd quartile: 63%); sulfasalazine had a median of 15% (quartiles: 10%/19%), antimalarials a median of 8% (quartiles: 5%/21%). Combination DMARD therapy was used in 11% (quartiles: 6%/18%). Prescriptions of low dose steroids (< or = 7.5 mg) had a median of 45% (quartiles: 35%/55%), and nonsteroidal antiinflammatory drugs (NSAID) had a median prescription rate of 58% (quartiles: 50%/70%). High variation was also found concerning active physiotherapy (median: 41%; quartiles 34%/55%) and passive physical measures (median 14%, quartiles 9%/37%). Differences in case mix (age, sex, rheumatoid factor, disease duration, severity, disability) only explained a small proportion of the total variation. When the units were grouped according to the frequency of prescription of DMARD combination therapy, treatment patterns could be identified. Units with higher rates of DMARD combination therapy used more drugs for the prevention and treatment of osteoporosis, more active physiotherapy but fewer NSAID and fewer passive physical therapies. CONCLUSION: Variation in drug and non-drug treatment indicates significant differences in health care provision. Trends in the drug management of RA are adopted differentially by the members of the rheumatology community. The large variability in non-drug therapies may, apart from differences in availability, suggest a lack of agreement on therapeutic effectiveness.

Adrenal Cortex Hormones↗