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In an open multicenter trial, 90 patients with rheumatoid arthritis were treated with a daily dose of 6 mg auranofin. The duration of the treatment was 12 months. A significant improvement in the following parameters was observed: grip strength, number of swollen and painful joints after the 4th month, blood erythrocyte sedimentation rate decreased significantly after the 2nd month. Of the 90 patients, 56 (62.3%) completed the therapy, in 14 (15.5%) it was discontinued because of side effects and in 8 (8.9%) because of inefficacy. 12 patients (13.3%) stated other reasons for discontinuing the therapy (non compliance). The reported side-effects were mostly gastrointestinal, especially diarrhoea and loose stools. The evaluation of results referring to the duration of the disease shows that patients with a duration of less than 2 years reacted better to the improvement with auranofin therapy than patients with a longer sickness history.

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Experimental allergic encephalomyelitis (EAE) is an induced autoimmune disease mediated by CD4+ T lymphocytes. Analysis of T cell receptors of myelin basic protein-specific encephalitogenic T cell clones derived from six different PL/J (H-2u) or (PL/J x SJL) F1 (H-2uxs) mice revealed a limited heterogeneity in primary structure. In vivo, the majority of T lymphocytes recognize the N-terminal MBP-nonapeptide in association with I-Au and utilize the V beta 8 gene element. cDNA-sequencing showed that all T cell receptors from a panel of such T cell clones, grown in vitro, share the same V alpha gene segment. Despite heterogeneity in the D-J regions, the clones unexpectedly display a striking similarity in fine specificity. Based on these results, prevention and reversal of autoimmune disease with V beta 8-specific monoclonal antibodies was achieved.

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To verify the possibility of a concomitant therapy control in 31 patients (18 psoriatic arthritis [PA], 13 rheumatoid arthritis [RA]) the blood cell concentration of Methotrexate (MTX) was continuously measured over a period of 6 months. The determinations were carried out by using a RIA of the CIS Corp. At any time MTX was determined laboratory and clinical examinations were done and the P-III-P serum-level was measured by using a RIA of the Behringwerke. The cellular MTX showed to be statistically significantly elevated compared to baseline, whereas within ranges of total cumulative dosages only insignificant fluctuations could be noticed. Like in the treatment of Psoriasis a strict correlation between the weekly administered dose and the cellular MTX could be established, the total cumulative dose, however, had no influence on the cellular MTX-level. In the treatment of RA slightly higher weekly dosages were necessary, which caused significantly higher cellular MTX concentrations in RA patients. Some correlations between clinical as well as serological parameters of disease activity could be noticed, nevertheless they do not allow distinct interpretations. In both diseases a significant relationship between the cellular MTX-level and the P-III-P serum-level could be realized. A storage of MTX in blood cells, especially in erythrocytes, seems to be evident. To reach therapeutical benefit in RA slightly higher mean dosages may be necessary. A therapy monitoring by the means of continuous determinations of cellular MTX seems to be impossible. In contrast an approach to the early detection of liver fibrosis can be given by the correlation between cellular MTX and the P-III-P serum levels.

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Twenty patients were treated with zidometacin by either the oral or the rectal route in a double-blind, short-term, balanced cross-over study, using the techniques of the double dummy. They suffered from osteoarthritis of the hip or knee or both. Zidometacin was administered at the daily doses of 400 mg p.o., and 600 mg by rectal route. The duration of each treatment was ten days. Zidometacin either as capsules or as suppositories showed a statistically significant influence on pain and functional indices even in this short-term evaluation. The side-effects reported by patients were three cases of dizziness and one case of nausea with capsules and one case of anal burning with suppositories, none of them requiring the interruption of the treatment.

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The non-steroidal antirheumatic drug naproxen has been available in capsule form since 1974. A new formulation, a film-coated tablet, has recently been developed and has various advantages, namely rapid release and absorption of the active substance, a lower volume, and a score-line. The efficacy and safety of the new tablet in a dose of 1000 mg daily was investigated in 30 patients in an open study. The substance was well tolerated, and there was no need to discontinue treatment in any patient. In the majority of patients the efficacy of the preparation was very good to good. An unsatisfactory effect was only obtained in two cases.

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Between 1972 and 1983, 519 patients with rheumatoid arthritis according to ARA criteria underwent basic antirheumatic treatment with Tauredon (sodium aurothiamalate). Patient age was 19 to 78 years, and the disease had been active for 6 months to 8 years. Results of treatment were recorded for periods of 14 days to 8 years. After a test dose of 10 mg intramuscular, patients received weekly injections of 20 to 50 mg for 4 to 6 months and were subsequently placed on a maintenance dose of 50 mg at intervals of 2 to 4 weeks for years. Clinical examinations and laboratory tests were scheduled at weekly intervals in the first month of treatment, at 2-weekly intervals in the next two months and subsequently once every month. In the first years of this trial (up to 1975) response to treatment was evaluated by the criteria reported by Fähndrich [2] and Steinbrocker [10]. Later Ritchie's joint index [6], laboratory parameters (sedimentation rate, CRP and alpha 2 globulin) as well as the consumption of non-steroidal antirheumatics and corticosteroids were equally used. Results were found to be excellent to good in 316 patients (= 60.8%) and satisfactory in 104 (= 20.1%). 99 patients (= 19.1%) were rated as failures. The drug was well tolerated in 391 cases (= 75.37%), but had to be withdrawn in 128 (= 24.6%) because of side effects. Among these, cutaneous and mucosal symptoms, which occurred in 70 patients (= 13.47% of the total), were most prominent. Serious side effects were absent throughout.

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The phagocytic function of leukocytes from peripheral blood of patients with classical rheumatoid arthritis was investigated using nitroblue-tetrazolium reduction of formazan. One control group (A) and two groups of RA-patients were compared. Group B was treated with nonsteroidal antirheumatics, the third group C additionally with low dose steroids (5,0-7,5 mg/d). Reduction to formazan was increased in group B in relation to the control, whereas treatment with cortico-steroids produced decreased phagocytic function of peripheral leukocytes.

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60 patients with osteoarthritis of the hips or knees were selected for our randomized double blind trial comparing efficacy and safety of the two propionic acid derivates tiaprofenic acid (daily dose 600 mg) and ibuprofen (daily dose 1200 mg) for 21 days. Criterias for evaluation were different pain qualities, morning-stiffness, 15-meter-walking-time, joint circumference, heel-seat-distance, intermalleolar and intercondylardistance. The good therapeutic effect was equal for both substances, drop-outs because of side effects were necessary for 2 patients of each group.

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The effect of D-penicillamine (DPA; 150 mg/day) on plasma amino acids administered to female patients suffering from rheumatoid arthritis (RA) was observed daily during the first 9 days of the treatment. A statistically significant influence of the oral DPA administration was detected. In comparison to control, a decrease in 12 out of 18 amino acids was found on day 2. Furthermore, for 6 amino acids an increase and a peak concentration on day 6 or 7 were observed. Surprisingly, similar results were also obtained in rats after oral application of DPA. These findings give further evidence for the multifactorial action of DPA.

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Sixty-eight patients with urinary infection were allocated at random to receive treatment with either 500 mg ampicillin 4-times daily or a trimethoprim (250 mg)/sulfamethopyrazine (200 mg) combination given once daily after a double, loading dose on the first day. All patients complained of urinary symptoms and showed significant bacteriuria, E. coli being the pathogen most frequently recovered. Clinical and microbiological assessments were carried out on entry and, as a rule, after 3 to 4 days and 1 to 2 weeks of treatment. In the 35 patients receiving trimethoprim/sulfamethopyrazine, 40 (95%) of the 42 original infecting organisms were eradicated. In the 33 patients on ampicillin, the eradication rate was 32 (89%) out of 36 organisms. The course of urinary symptoms was similarly favourable in the two groups. Overall response was considered as 'excellent' or 'good' in 89% of the patients receiving the combination preparation and in 82% of those given ampicillin. Clinical and biological tolerance was satisfactory under both regimens. A longer follow-up control should confirm the value of the new combination in the treatment of urinary infections.

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One hundred and fifty patients with rheumatoid arthritis received 6 mg of auranofin daily for 2-24 months. Thirty patients were withdrawn from the study, and 82 patients were observed for 12 months. Statistical evaluation was available for 74 patients at weeks 24, 38, and 48, respectively. The major side effects observed were diarrhea, rash, and alopecia. Significant improvement was noted in the articular index, ESR, pain, and morning stiffness.

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In an open trial 15 patients with acute gout attacks were treated with Tolmetin. A statistically significant improvement of several pain values measured as well as subsidence of swellings and redness were observed. By summing up the scores "good" and "moderate", the joint judgement of physician and patients established a 90% success of treatment with regard to efficacy and tolerability. During Tolmetin treatment a statistically significant decrease of mean uric acid levels could be seen.

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In 10 female patients with classical rheumatoid arthritis D-penicillamine was administered in a daily dose of 150-150 mg for 4 months. The only additional antiphlogistic treatment was indomethacin (100-150 mg daily). At the beginning and during the trial blood (total) levels of zinc with n-activation analysis and the excretion with urine were determined using n-activationanaysis and atom absorption. By spectrometry following results were obtained: an increase of zinc excretion. By spectrometry following results were obtained: in increase of zinc excretion in urine until day 21; after 2 and 4 months decreased above levels at the original value before beginning of treatment. Blood levels of zinc decreased distinctly until the 2nd week, increase at the 3rd week and return to the original value of the controls before D-penicillamine therapy at the 2nd and 4th months.

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The effects of [1-(p-chlorobenzoyl)-5-methoxy-2-methyl-indole-3-acetoxy]-acetic acid (acemetacin, TV 1322, Rantudil) on DNA repair (unscheduled DNA synthesis) and semiconservative DNA synthesis have been investigated in vitro in mouse spleen cells and in vivo in human leukocytes. Quantitative determination of DNA repair was made possible by a computer program and additional measurement of parameters of uptake kinetics. in vitro results showed no influence on DNA synthesis and therapeutically relevant concentrations had no influence on DNA repair. 6 female patients with diagnosticized rheumatoid arthritis received acemetacin 4 x 30 mg daily for three months. During the duration of treatment there was no significant change in DNA repair capacity or in semiconservative DNA synthesis in comparison to pre-treatment values.

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In a double blind study [1-(p-chlorobenzoyl)-5-methoxy-2-methylindol-3-acetoxy] acetic acid (acemetacin, TV 1322, Rantudil¿) was compared with indometacin in 2 x 20 patients suffering from rheumatoid arthritis. The duration of the study was 3 weeks. The patients received 3 x 30 mg/d acemetacin or 3 x 50 mg indometacin in capsules. The therapy was controlled at accurately defined intervals. Statistical evaluation of the data regarding the influence on pain and motility did not reveal any significant differences between the two drugs. Neither the evaluation of the recorded side effects nor the laboratory tests showed any statistical difference between the two therapies. The gastrointestinal complaints occurred more frequently in the indometacin group (5 of 20, of these 3 withdrawals) than in the acemetacin group (3 of 20, of these 1 withdrawal). However, this difference was not statistically secured. Evaluation of the therapeutic effect did not reveal any significant differences between acemetacin and indometacin at the administered molar dose ratio of 1:2. However, the acemetacin therapy had a markedly improved gastrointestinal tolerability.

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