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Biomedical subjects

R Rau

Publications and source records attributed to R Rau.

At least 73 records · Page 4Linked to original sources
PubMed1998

A 36 month comparative trial of methotrexate and gold sodium thiomalate in the treatment of early active and erosive rheumatoid arthritis.

OBJECTIVE: To compare the safety and efficacy of methotrexate (MTX) and gold sodium thiomalate (GSTM) in patients with active early erosive rheumatoid arthritis (RA) during 3 yr. METHODS: A total of 174 patients from two centres were randomly assigned to receive weekly i.m. injections of either 15 mg MTX or 50 mg GSTM for 1 yr in a double-blind fashion. Thereafter, the study was continued as an open prospective trial for an additional 2 yr with the same dose of MTX and half of the GSTM dose. Clinical and laboratory evaluations were carried out at baseline and at months 6, 12, 18, 24 and 36 in all patients, including withdrawals. RESULTS: An intention-to-treat analysis revealed inactivation ['clinical remission': no swollen/tender joints, erythrocyte sedimentation rate (ESR) of < 20 mm/h in males and < 30 mm in females, no corticosteroids within the last 4 weeks] in 33.3% of MTX patients and 37.9% of GSTM patients. The mean time to inactivation was insignificantly shorter with GSTM (MTX: 12.1 months; GSTM: 9.1 months; P = 0.06). At least marked improvement (> 50% reduction of the number of swollen/tender joints and of the ESR) was found in 78.2% (MTX) and 87.4% (GSTM). Withdrawal from the study due to toxicity was recorded in 16.1% of MTX and 52.9% of GSTM patients after a mean time of 30.6 and 6.1 months, respectively (P = 0.0001). In MTX and GSTM non-completers, inactivation was recorded in 24.2 and 54.7% of all patients. Among completers (54 and 34 patients, respectively), significant improvement compared to baseline was noted in all seven clinical variables (morning stiffness, overall joint pain, count of tender/swollen joints, Lansbury articular score, functional score and grip strength), ESR and C-reactive protein without significant intergroup differences. The steroid-sparing effect appeared more pronounced with GSTM. CONCLUSION: Over 36 months, treatment with MTX or GSTM induces inactivation ('clinical remission') of early and erosive RA in about one-third and at least marked improvement in four-fifths of patients (intention-to-treat analysis). Patients withdrawn from MTX or GSTM due to toxicity develop a clinical remission from the disease; this occurred more often with GSTM. Tolerability is significantly better with MTX.

Adolescent↗
PubMed1998

Progression in early erosive rheumatoid arthritis: 12 month results from a randomized controlled trial comparing methotrexate and gold sodium thiomalate.

OBJECTIVE: To compare radiographic outcomes in patients with active early erosive rheumatoid arthritis (RA) who were treated with methotrexate (MTX) and gold sodium thiomalate (GSTM). METHODS: A total of 174 patients from two centres were randomly assigned to receive weekly i.m. injections for 12 months of either 15 mg MTX or 50 mg GSTM in a double-blind fashion. Radiographic evaluations including standardized scoring of 38 joints of the hands, wrists and forefeet, and count of eroded joints, were carried out at baseline and after 6 and 12 months in all patients, including withdrawals. RESULTS: An intention-to-treat analysis revealed no statistically significant difference in the progression of radiographic scores between treatment groups after 6 months (3.4 with MTX vs 2.6 with GSTM, P = 0.66) and after 12 months (6.0 vs 4.8, P = 0.44). A similar pattern was observed for the number of joints with erosions. The slope of radiographic progression was significantly reduced in the second half-year compared to the first 6 months in both groups. Erythrocyte sedimentation rate and C-reactive protein at baseline, and the presence of rheumatoid factor (RF), were the main predictors of progression in bivariate analysis. RF remained as the only predictor for radiographic outcome in multivariable analysis. CONCLUSION: In parallel to clinical improvement, both GSTM and MTX reduce the slope of radiographic progression in patients with active erosive RA.

Aged↗
PubMed1998

Methotrexate treatment in Felty's syndrome.

Felty's syndrome is a rare disorder characterized as a systemic manifestation of severe rheumatoid arthritis associated with granulocytopenia and splenomegaly. We report a retrospective analysis of a series of seven patients treated successfully with low-dose methotrexate. leading to sustained clinical improvement (number of swollen joints) and normalization of the granulocyte count for an observation period of 1 yr. Our cohort is the largest ever published with methotrexate treatment of this rare condition. Our results confirm earlier single case reports suggesting methotrexate to be the first-choice treatment nowadays in Felty's syndrome.

Aged↗
PubMed1998

Spectral analysis of electroencephalography changes after choking in judo (juji-jime).

PURPOSE: The present study was carried out to investigate possible electroencephalographic changes induced by choking in judo (shime-waza) by means of spectral analysis and brain mapping. METHODS: Power spectral changes in Electroencephalography (EEG) were recorded in six experienced judoka who underwent a choking trial with a "shime-waza choking" technique called juji-jime. RESULTS: A significant increase of global field power in the delta- and theta-range occurred, while physiological alpha-power decreased. These changes in the low-frequency range reached a statistically significant level within a time span up to 20 s after choking, which was performed at an average choking time of 8 s. In no case did choking provoke neuropsychological symptoms. Yet, spectral EEG-analysis revealed subclinical changes of brain function. CONCLUSIONS: Choking in judo may induce subclinical electroencephalographic perturbations. The extent and duration can be objectified by means of spectral analysis of EEG data, global field power computation, and brain-mapping representation.

Airway Obstruction↗
PubMed1998

Longterm combination therapy of refractory and destructive rheumatoid arthritis with methotrexate (MTX) and intramuscular gold or other disease modifying antirheumatic drugs compared to MTX monotherapy.

OBJECTIVE: To evaluate tolerability and efficacy of combination therapy with methotrexate (MTX)/parenteral gold or MTX/other disease modifying antirheumatic drug (DMARD, d-penicillamine or chloroquine) in comparison with MTX monotherapy in patients with longstanding destructive active rheumatoid arthritis (RA). METHODS: In an open prospective trial all consecutive MTX-naive patients with active RA starting MTX treatment alone or in combination between January 1980 and December 1987, after failing one or more DMARD, were followed at regular intervals up to 108 months. Evaluations included the number of swollen joints (0-32), grip strength, patient assessment of pain and mobility, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hemoglobin. Group 1, treated with MTX monotherapy (n = 97), was compared with Group 2, with combination therapy MTX/parenteral gold (n = 126) and Group 3 with MTX + other DMARD (n = 48). RESULTS: There were no significant differences between the groups in mean age (59/57/56 yrs), disease duration (9.6/7.7/8.3 yrs), seropositivity (80/88/82%), or ACR anatomical disease stage (2/3 in stage III and IV). The number of swollen joints (16.8/19.3/16.1 of 32) and the CRP (4.4/5.1/4.7 mg/dl) was significantly greater in Group 2; other disease activity variables were not significantly different. The mean MTX dose at baseline (mostly parenteral) was 16.8/17.0/12.8 mg and could be reduced to around 12 mg (predominantly oral) in the 3 groups. Frequency of adverse events (80/83/88%), nature of clinical (nausea, hair loss, stomatitis) and laboratory (liver enzyme elevation, slight proteinuria) side effects, and withdrawal rate for side effects (20.6/15.0/12.5%) were not significantly different between the groups. After 5 years 54/54/80% of patients continued their treatment. All efficacy variables improved significantly (p < 0.001) in all groups without significant intergroup difference. Improvement > 50% in the ESR was achieved in 63/68/41% and in the swollen joint count in 70/85/48% of patients after 3 years. The number of patients taking oral steroids decreased from 63/59/65% to 22/31/48% after 3 years. In half the patients hemoglobin increased by at least 1 g/dl. CONCLUSION: Combination therapy of MTX with parenteral gold or other DMARD is effective in reducing clinical and biochemical disease activity in patients with longstanding destructive RA with no greater risk of toxicity compared with MTX alone; our study however, did not show clear advantages of combination therapy versus monotherapy for effectiveness.

Antirheumatic Agents↗
PubMed1998

A new method of scoring radiographic change in rheumatoid arthritis.

OBJECTIVE: To test the reliability and to define the minimal detectable change of a new radiographic scoring method in rheumatoid arthritis (RA). METHODS: Following the recommendations of an expert panel a new radiographic scoring method was defined. It scores 38 joints [all proximal interphalangeal (PIP) and metacarpophalangeal joints, 4 sites in the wrists, IP of the great toes, and metatarsophalangeals 2 to 5], regarding only the amount of joint surface destruction on a 0 to 5 scale for each joint. Each grade represents 20% of joint surface destruction. The method was tested by 5 readers on a set of 7 serial radiographs of hands and forefeet of 20 patients with progressive and destructive RA. Analysis of variance was performed, as it provides the best information about the capability of a method to detect real change and to define its sensitivity according to the minimal detectable change. RESULTS: Analysis of variance proved a high probability that the readers found real change with a ratio of intrapatient to intrareader standard deviation of 2.6. It also confirmed that one reader could detect a change of 3.5% of the total score with a probability of 95% and that different readers agreed upon a change of 4.6%. Inexperienced readers performed with comparable results to experienced readers. The time required for the reading averaged less than 10 minutes for the scoring of one set. CONCLUSION: The new radiographic scoring method proved to be reliable, precise, and easy to learn, with reasonable cost. Compared to published data, it may provide better results than the widely used Larsen score. These features favor our new method for use in clinical trials and in longterm observational studies in RA.

Adult↗
PubMed1998

Clinical trials on biologics in rheumatoid arthritis.

BACKGROUND: Cytokines and T cells play a major role in the pathogenesis of rheumatoid arthritis (RA). Biologic targeting is a novel therapeutic approach. Published trials in humans are discussed in this paper. METHODS: CD4-positive T cells, proinflammatory cytokines like TNF-alpha, IL-1, IL-6 and gamma-IFN were major targets for therapy. Biologics were constructed of monoclonal human and non-human antibodies, chimerics of both, antiinflammatory regulatory proteins like IL-1 receptor antagonist, IL-10, and fusion proteins consisting of receptors and immunoglobulins. RESULTS: More than 2000 humans with RA were exposed to biologics in the last decade. Both, toxic and safe, efficient and non-efficient drugs were tested. Phase II data could not confirm preliminary phase I data in several drugs tested. The pharmacokinetic profile of biologics is influenced by frequent induction of human anti drug antibodies. CONCLUSION: The major role of cytokines in RA has been confirmed. Due to the limited long-term experience immunomodulation does not replace conventional pharmacotherapy.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1997

Comparison of intramuscular methotrexate and gold sodium thiomalate in the treatment of early erosive rheumatoid arthritis: 12 month data of a double-blind parallel study of 174 patients.

The objective was to compare the safety and efficacy of methotrexate (MTX) and gold sodium thiomalate (GSTM) in patients with early erosive rheumatoid arthritis (RA). A total of 174 patients with active early erosive RA without deformities were enrolled in a 12 month, two-centre double-blind randomized trial. They received a weekly i.m. dose of 15 mg MTX (n = 87) or 50 mg GSTM (n = 87), respectively. Clinical and laboratory evaluations were carried out every 3 months in all patients, including the withdrawals. Ten patients (11.5%) in the MTX group and 21 patients (24.1%) in the GSTM group achieved a clinical remission of the disease [no swollen joints, erythrocyte sedimentation rate (ESR) < 20 mm, no steroids] within the study period (P < 0.05). An at least marked improvement (> 50% reduction of the number of swollen and tender joints and the ESR) was assessed in 59/87 (68%) and 66/87 (76%) patients treated with MTX or GSTM, respectively (P > 0.05). Significantly more patients in the GSTM group were withdrawn due to toxicity (six MTX/32 GSTM). A total of 126 patients (73 on MTX and 53 on GSTM) completed 12 months on their original medication. In the completers, a significant improvement of > 50% compared to baseline was noted in all six clinical variables [morning stiffness, joint count of swollen and tender joints, Lansbury index, grip strength and activities of daily living (ADL) score], the ESR and the C-reactive protein, without intergroup differences. The number of patients taking prednisone was reduced from 21 to 7% in the MTX group and from 15 to 4% in the GSTM group. While significantly more patients achieved a clinical remission with GSTM treatment, tolerability was significantly better with MTX.

Antirheumatic Agents↗
PubMed1997

Lack of pharmacokinetic interaction of meloxicam with methotrexate in patients with rheumatoid arthritis.

OBJECTIVE: To investigate the pharmacokinetic interaction of oral meloxicam with intravenous (i.v.) methotrexate (MTX) in patients with rheumatoid arthritis (RA). METHODS: Thirteen patients with RA received MTX 15 mg i.v. in the absence of nonsteroidal antiinflammatory drugs (NSAID) and after one week in the presence of steady state levels of meloxicam. Plasma concentrations of MTX and meloxicam were determined using validated high performance liquid chromatography methods. One patient did not complete the study. The interaction of meloxicam and MTX was examined by equivalence testing. The endpoints AUCMTX, VssMTX, CltotMTX, and CmaxMTX were analyzed parametrically, whereas endpoints MRTMTX, CltotMTX, t1/2MTX, and tmaxMTX were analyzed nonparametrically. RESULTS: The MTX plasma concentrations over time, with and without meloxicam, did not differ significantly. The point estimator for the ratio of log transformed data of the primary endpoint AUCMTX was 108%; the lower 95% confidence limit was 100% and the upper 95% confidence limit was 117%. Clinical laboratory values and adverse events revealed no increased MTX toxicity during concomitant treatment with meloxicam. CONCLUSION: In this short term interaction study there was no statistically significantly effect of meloxicam on the pharmacokinetics of MTX. The combination of MTX and meloxicam did not lead to increased MTX toxicity.

Adolescent↗
PubMed1997

Long-term treatment of destructive rheumatoid arthritis with methotrexate.

OBJECTIVE: To evaluate the tolerability and efficacy of methotrexate (MTX) treatment in patients with longstanding, progressive, active rheumatoid arthritis (RA) who had failed one or more disease modifying antirheumatic drugs (DMARD). METHODS: Two hundred seventy-one consecutive patients with RA in whom MTX treatment was introduced were followed at regular intervals for up to 108 months. Evaluations included the number of swollen joints, grip strength, patient assessment of pain and mobility, erythrocyte sedimentation rate (ESR), and hemoglobin. Radiographs of hands and feet were taken once a year and 32 joints were evaluated according to a modified Larsen score. RESULTS: Of the 271 patients, 269 had prior treatment with one DMARD, primarily parenteral gold, and 58% with 2 or more DMARD. MTX was started parenterally in all patients in doses between 15 and 25 mg weekly and continued by oral medication in most of the cases. Eighty-three percent of patients complained of adverse events. The most common side effects were nausea, hair loss, transaminase increase, and stomatitis. In 45 patients (16.5%), MTX was withdrawn because of side effects, mostly during the first year. Sixteen patients (5.9%) died during followup, mainly due to myocardial infarction, heart failure, stroke, or cancer. After one year, 78.7% and after 5 years 60.3% of the patients were still taking MTX. Number of swollen joints, ESR, grip strength, patient assessment of pain, and mobility improved significantly at all measurement points. Improvement in the swollen joint count and the ESR of over 50% was seen in more than 50% of patients. Inactivation of the disease, defined as < 2 swollen joints, ESR < 20 mm, and no concomitant steroid use, occurred in 8-14% of patients. Steroid intake was significantly reduced. In spite of clinical improvement the modified Larsen score showed a progression in the vast majority of patients. CONCLUSION: Even in patients with longstanding, active, destructive RA who failed one or more DMARD, MTX treatment is well tolerated and improves clinical and biochemical disease activity significantly, while radiographic progression is still present.

Adult↗
PubMed1996

Psychophysiological assessment of human reliability in a simulated complex system.

Stress-strain processes affect human reliability in operators in control of highly automated systems. Job demand and decision latitude play an important role in the modification of these processes. Objective methods of task analysis involving the study of 50 operators controlling an electroenergy network were used to define three "typical' tasks. The present study was carried out at simulated computer work places with the same equipment and the same relations of information transfer as in the work settings. During the 3-h activity HR, BP and motor activity were recorded with an ambulatory monitoring system. The operators answered questions concerning subjective strain, emotion, motivation, perceived control, and success by means of a pocket computer. The study revealed marked increases in strain with increasing job demand and increased decision latitude. The results partly contradict Karasek's (1979) model. The operator in a dyadic team having decision authority showed significantly higher systolic blood pressure, heart rate, and self-reported strain compared to the co-operator. Human reliability cannot be increased by means of increasing decision latitude in order to enrich the job. It is suggested that human reliability can be improved by spreading decision authority over the whole team. Further psychophysiological investigations will be necessary, testing not only Karasek's but also alternative assumptions for the design of complex systems in order to reduce strain and boredom induced decrements in human reliability.

Adult↗
PubMed1996

Healing phenomena of erosive changes in rheumatoid arthritis patients undergoing disease-modifying antirheumatic drug therapy.

OBJECTIVE: To describe radiographic healing phenomena and reparative changes of joint destruction in rheumatoid arthritis (RA). METHODS: Serial radiographs of 6 patients with erosive RA undergoing long-term treatment with disease-modifying antirheumatic drugs (DMARDs) were studied. Radiographs showing healing phenomena were reproduced, and examples of single joints are shown. RESULTS: The examples show recortication of erosions, filling in of erosions with new bone, and secondary osteoarthrosis with bone sclerosis and osteophyte formation. Commonly use radiographic scoring methods do not have the capacity to account for these reparative changes. CONCLUSION: Healing phenomena can be observed in RA patients undergoing long-term DMARD treatment. These phenomena can be regarded as clinical end points, and their assessment should be incorporated into existing standardized methods for radiologic evaluation and scoring of RA.

Adult↗
PubMed1996

Thrombocytopenia in patients with rheumatoid arthritis on long-term treatment with low dose methotrexate.

We reviewed the records of 315 patients with rheumatoid arthritis (RA) treated with low-dose methotrexate (MTX) and evaluated the conditions contributing to thrombocytopenia. Thirteen out of 315 patients with RA presented with low platelet counts (< or = 100,000/mm3). The age of these patients (51 +/- 12.6 years) did not correlate with thrombocytopenia (r = 0.211, p > 0.05). Thrombocytopenia resulted from coadministration of MTX and NSAID or multiple drug interactions. We observed a significant (r = 0.48, p < 0.05) increase of discontinuation of NSAID's but not of MTX therapy (r = 0.42, p > 0.05) with a mounting weekly dosage of MTX (12.5 +/- 5 mg orally). There was a significant correlation between this weekly dosage of MTX coadministered on the same day with NSAID and thrombocytopenia (r = 0.6, p < 0.05). In most cases (9/13) MTX was not or just temporarily withdrawn. Three of the remaining patients had multiple drug interactions. Reintroduction of low dose MTX treatment in patients having had thrombocytopenia could be performed safely, if thrombocytopenia occurred as a result of concomitant application of MTX and NSAID and no other multiple drug interactions. Preferably, MTX and NSAID should be given to these risk patients on separate days or intervals considering half time clearance of NSAIDs. This procedure has prevented the reoccurrence of thrombocytopenia and controlled further drug interactions of NSAIDs and MTX in our patients.

Adult↗
PubMed1996

Thrombocytopenia in patients with rheumatoid arthritis on long-term treatment with low dose methotrexate.

We reviewed the records of 315 patients with rheumatoid arthritis (RA) treated with low-dose methotrexate (MTX) and evaluated the conditions contributing to thrombocytopenia. Thirteen out of 315 patients with RA presented with low platelet counts (< or = 100.000/mm3). The age of these patients (51 +/- 12.6 years) did not correlate with thrombocytopenia (r = 0.211, p > 0.05). Thrombocytopenia resulted from coadministration of MTX and NSAID or multiple drug interactions. We observed a significant (r = 0.48, p < 0.05) increase of discontinuation of NSAID's but not of MTX therapy (r = 0.42, p > 0.05) with a mounting weekly dosage of MTX (12.5 +/- 5 mg orally). There was a significant correlation between this weekly dosage of MTX coadministered on the same day with NSAID and thrombocytopenia (r = 0.6, p < 0.05). In most cases (9/13) MTX was not or just temporarily withdrawn. Three of the remaining patients had multiple drug interactions. Reintroduction of low dose MTX treatment in patients having had thrombocytopenia could be performed safely, if thrombocytopenia occurred as a result of concomitant application of MTX and NSAID and no other multiple drug interactions. Preferably, MTX and NSAID should be given to these risk patients on separate days or intervals considering half time clearance of NSAIDs. This procedure has avoided the reoccurrence of thrombocytopenia and controlled further drug interactions of NSAIDs and MTX in our patients.

Adult↗
PubMed1995

A modified version of Larsen's scoring method to assess radiologic changes in rheumatoid arthritis.

We describe the development and application of a modified version of the radiologic scoring method proposed by Larsen in patients with rheumatoid arthritis (RA). We modified Larsen's method adding a semiquantitative description of the loss of joint surface area and provide standardized reference films for all stages at different anatomical sites (metacarpophalangeal joints, proximal interphalangeal joints, wrists, metatarsophalangeal joints). To evaluate the method, standard anteroposterior radiographs of hands, wrists and forefeet of 24 patients with early erosive RA taken at baseline (t0) and after 36 months (t1) were read by 2 raters in a blinded fashion. The interrater difference was compared with the interpatient (t0 to t1) difference using a hierarchical analysis of variance. Moreover, the method was applied to patients included in a 2 year clinical trial to evaluate the efficacy of intramuscular methotrexate (MTX) and gold sodium thiomalate (GSTM) with radiographs taken at baseline and after 6, 12, and 24 months. There was a good agreement between the 2 raters and the change could be well documented. The estimation of the intrapatient variance (at t0 and t1) was 8 times higher than the estimation of the interreader variance. The method was easily applicable in 57 patients treated with MTX and 53 patients under treatment with GSTM, showing a slowing of radiologic progression after Month 6 with both drugs. The modification of Larsen's scoring method is a reliable measure to assess baseline status and radiologic progression in patients with RA.

Arthritis, Rheumatoid↗
PubMed1995

Problems in evaluating radiographic findings in rheumatoid arthritis using different methods of radiographic scoring: examples of difficult cases and a study design to develop an improved scoring method.

Radiographic scoring is generally accepted as the "gold standard" to follow the course of rheumatoid arthritis (RA). Several methods have been developed to quantify radiographic changes due to RA. The most widely used methods have been proposed by Larsen and Sharp. Problems of the interpretation of the radiograph and the design of the scoring methods are not resolved. The design of established scoring methods lacks correct correlation to the amount of change on radiographs, leading to confounding of the results of the radiographic analysis. Concerns arise about the correct interpretation of findings on plain radiographs that are caused by having a 2-dimensional picture of a 3 dimensional object. There is no agreement which of the different changes caused by RA on the radiograph have to be considered and which can be neglected. Examples for these problems are given. We compared the established scoring methods of Larsen and Sharp on the same set of radiographs with longterm followup using the correct data analysis to provide the information needed to design an improved scoring method. Details of the study design are reported.

Arthritis, Rheumatoid↗
PubMed1994

[Error ratio in International Classification of Diseases coding and implementation of the nursing personnel regulation of the Health Organization Law].

Since 1 January, 1993, it has been a legal requirement to enter, for identification of the main diagnosis, the appropriate code from the International Classification of Diseases (ICD) on the documentation forms of the Nursing Personnel Regulation as prescribed under the (German Federal Government's) Health Organization Law. This study was undertaken to analyse the frequency of errors in this coding and the reasons for it. The data of the Nursing Personnel Regulations during the first 6 months of 1993 were compared with the corresponding entries in the diagnostic archives. In 671 of 2308 analysed forms (29%) coding errors were discovered. The rate of errors was especially high in the areas of cardiology (39%), angiology (37%), nephrology (36%) and neurology (35%). However, a high percentage of the wrong codings for cardiological and nephrological diseases were still within the same diagnostic field.--These findings indicate that, to ensure quality, those doctors who do the coding should be fully informed about the potential consequences regarding staffing of such errors. All coding must be done by experienced doctors, be locally checked and, if technically possible, compared with the diagnostic archive entries. Also, the registration of only one main diagnosis is not sensible in the case of patients with multi-organ disease.

Disease↗