title: Prospidine versus methotrexate pulse in highly active rheumatoid arthritis: a controlled 6-month clinical trial.
abstract: 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 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 of RA.
authors.affiliation: Medical Institute, Kirov, Russia.
authors.forename: E V
authors.initials: EV
authors.lastname: Benenson
authors.forename: O B
authors.initials: OB
authors.lastname: Timina
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011447:Prospidium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011447:Prospidium; D008727:Methotrexate