Twenty-seven patients with highly active, refractory rheumatoid arthritis (RA) were treated with the new anti-rheumatic drug prospidine, in view of selecting the optimum pulse regimen and comparing its short-term use with methotrexate (MTX). Prospidine was administered intravenously 500 mg every 3–5 days in the hospital and then monthly. Fifteen patients received MTX (30 mg/week intravenously in hospital and then orally 7.5–15 mg/week). The randomisation code was 2:1. We assessed 7 clinical and 4 lab data. The clinical improvement was noticed statistically after 2–4 weeks in 85 prospidine-patients and sustained up to 6 months in 73 (cp. 40 and 57 by the MTX). Only in the prospidine patients were a significant reduction of the mean daily prednisolone dose and the levels of rheumatoid factor and immune complexes observed. Prospidine and MTX had a similar incidence of side effects (39 and 43), but all drop-outs in prospidine pulse were due to lack of response (26) and to initial intolerance (4). Drop-outs in MTX pulse were connected both with drug toxicity (14) and with lack of response (7). Alternate prospidine pulse, as highly anti-inflammatory, rapidly acting and well-tolerated regimen, may be used in treating severe forms
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