右旋布洛芬片的Ⅱ期临床研究

Phase Ⅱ clinical study of S(+)-ismer of ibuprofen on rheumatoid arthritis and osteoarthritis patients

目的评估右旋布洛芬片治疗类风湿关节炎(rheumatoid arthritis,RA)和骨关节炎(osteoarthritis,OA)的疗效及安全性。方法通过多中心及随机双盲对照试验,试验组给予右旋布洛芬0.4～0.6g/次,每日2次,对照组给予布洛芬0.4～0.6g/次,每日2次,疗程4周。结果右旋布洛芬组对RA和OA的总改善率,总有效率及关节疼痛,肿胀的改善率均高于布洛芬组,且2组不良反应发生率比较差异无显著性。结论右旋布洛芬治疗RA、OA疗效优于布洛芬,不良反应未增加,用药较为安全。

[Objective] To investigate the effect and salty of S（＋）-ismer of ibuprofen on RA and OA patients. [Method] In this randomized multi-center, double-blind, control study, those patient with RA and OA received a single dose of either S（＋）-ismer of ibuprofen （0.4-0.6 g, bid） or ibuprofen （0.4-0.6 g, bid） for four weeks. [Resuit] Besides the total effective rate and the total improvable rate, tender joint and swollen joint had been improved significantly, compared with ibuprofen treatment group. There was no difference in side-effects between the two groups. [Conclusion] Like ibuprofen, S（＋）-ismer of ibuprofen is effective, but its adverse-effects are less than ibuprofen.