抄録
In order to objectively compare the efficacy and the safety of Predinin, an immunosuppressive drug, on rheumatoid arthritis at two different dosage levels of 150 mg and 300mg, we conducted a 24-week multicenter, randomized, post-marketing surveillance study.
(1) Efficacy was assessed with a total of 499 cases (251 cases, 150mg/day group ; 248 cases, 300mg/day group) . No significant biases in the patients' background factors between the two groups were found.
(2) The final global improvement rates for the clinical evaluations of improved or better were 21.1% and 25.5/ in the 150 mg/day group and the 300mg/day group, respectively. The improvement rates for the clinical evaluations of slightly improved and better were 45.9% in the 150mg/day group and 57.5% in the 300 mg/day group. The difference were statistically significant between the 150mg/day and 300 mg/day groups (P<0.05) .
(3) Improvement in joint swelling was markedly higher in the 300mg/day group than in the 150 mg/day group. The 300 mg dose was superior to the 150mg dose in cases where a patient failed to respond to strong DMAPDs (methotre ate or salazosulfapyridine) .
(4) Safety was assessed with a total of 488 cases (252 cases ; 150mg/day group ; 230 cases ; 300mg/day group) .
(5) In the overall safety rating, the incidence of the adverse reactions in the 150mg/day group and the 300mg/day group was 15.5% and 27.1%, respectively. The difference was statistically significant (P<0.01) .
(6) The incidence and degree of the adverse reactions were dose-dependent. The type and timing of the adverse reactions were unrelated to the dose level.
