慢性関節リウマチに対するブレディニン錠の用量比較試験 (2)

―多施設共同研究による市販後臨床試験 (長期投与成績) ―

抄録

In order to objectively compare the efficacy and the safety of Bredinin for longterm treatment of rheumatoid arthritis, a multicenter, randomized, post-marketing surveillance study was conducted using two different daily doses of 150 and 300 mg per day. One hundred and thirty-three patients participated in this study which lasted 48 weeks or longer. Efficacy was assessed with a total of 104 cases (63 cases: 150 mg/day, 41 cases: 300 mg/day) . Safety was assessed with a total of 133 cases (77 cases: 150 mg/day, 50 cases: 300 mg/day) . The following are a summary of the study.
1. In the assessment of efficacy, there were no significant differences in the clinical parameters between the 150 and 300 mg/day patient groups.
2. The combined percentages of patients with a final grobal assessment of “improved” and better in the 150 and 300 mg groups were 33.1 % and 53.7 % respectively. The percentages of patients with a final grobal assessment of “slightly improved” and better in the 150 and 300 mg groups were 00.7 % and 80.5 % respectively. Althougt the differences were not statistically significant, the percentage of patients showing improvements was higher in the 300 mg group than in the 150 mg group.
3. The overall safety rating showed the incidence of adverse reactions in the 150 and 300 mg groups to have been 1.3 % and 7.1 %, respectively, which were not statistically different.
4. As for rheumatoid arthritis activity measures which include swollen and painful joint counts, grip strength, morning stiffness, Lansbury's activity index and ADL scores, similar degrees of improvements were observed both in the 150 and 300 mg groups. However, improvement in swollen joint count was more marked in the 300 mg group than in the 150 mg group.
5. The results of the present study indicate than mizoribine (150 or 300 mg/day) is useful drug for the long-term treatment of rheumatoid arthritis.