精氨洛芬治疗膝骨关节炎和类风湿关节炎的疗效和安全性的多中心随机开放对照研究

目的 研究精氨洛芬对骨关节炎(OA)和类风湿关节炎(RA)的疗效及安全性,并与布洛芬进行比较. 方法 171例OA和RA患者随机分成精氨洛芬组(400 mg,每日3次)和布洛芬组(400 mg,每日3次)治疗,疗程为4周.对两药治疗前后关节疼痛、压痛、肿胀指数和研究者、患者的总体疗效评价进行比较. 结果 精氨洛芬和布洛芬在治疗4周后平均关节疼痛、压痛和肿胀指数的变化差异无统计学意义,但精氨洛芬组起效时间较布洛芬早,差异有统计学意义;两组的不良事件发生率差异无统计学意义,两组皆无严重不良事件发生. 结论 精氨洛芬与布洛芬对膝OA和RA的止痛作用和副作用一致,精氨洛芬起效更快.

A multicenter,random,open,parallel controlled study on the efficacy and safety of ibuprofen arginate in treating rheumatoid arthritis and knee osteoarthritis

Objective To compare the clinical efficacy of ibuprofen arginate,a new nonsteroidal antiinflammatory drug,with that of ibuprofen,in patients with rheumatoid arthritis or knee osteoarthritis and to evaluate the safety and tolerability of ibuprofen argihate.Methods This is a muhicenter,random,open,active comparator-controlled,parallel clinical trail in which 171 patients with rheumatoid arthritis or knee osteoarthritis were enrolled.Patients were randomized to 2 groups:400 mg of ibuprofen arginate three times daily and 400 mg of ibuprofen three times daily respectively.Clinical efficacy and safety were evaluated after 4-week treatment.Results Ibuprofen arginate,at dosages of 400 mg three times daily,had shown significant efficacy in relieving pain,tenderness and swelling of joints and there was no significant difference when compared to that of ibuprofen.There was no difference in clinical adverse effects between the two groups and no serious adverse effects were repofled.But ibuprofen arginate could initiate effectiveness more rapidly than ibuprofen in both rheumatoid arthritisand osteoarthritis patients.Conclusion Ibuprofen arginate has the same clinical efficacy and safety profiles as itmprofen in treating rheumatoid arthritis and osteoarthritis.However,its onset is more rapid than ibuprofen.