双氯芬酸钾(久宁)治疗骨关节炎临床试验

Clinical trial of diclofenac potassium in treatment of osteoarthritis

目的 观察双氯芬酸钾片剂 (久宁 )治疗骨节炎节炎(OA)的疗效和安全性。方法 随机、单盲、平行对照研究。试验组口服久宁片每天 10 0mg ;对照组口服进口双氯芬酸钾片 (凯扶兰 )每天 10 0mg ,疗程 4周。共完成病例 6 0例 ,试验组和对照组各 30例。结果 治疗后第 1周、2周、4周时久宁组总有效率分别为 5 3 33%、86 6 7%和 90 0 0 % ;凯扶兰组总有效率为 34 48%、72 41%和 86 2 1% ,但统计学处理两药无显著差异 (P >0 0 5 ) ,均能明显改善各项临床症状和体征 (P <0 0 5或 0 0 0 1)。不良反应发生率久宁为13 33 % ,凯扶兰为 16 6 7% (P >0 0 5 ) ;除凯扶兰组有 1例因发生室早而停药 ,其余主要为轻度胃肠道不适 ,偶见水肿等。结论 久宁治疗OA的疗效与凯扶兰相近 。

Objective\ To observe the effect and safety of diclofenac potassium(DK) in treatment of osteoarthritis(OA). Methods\ Radomized and controlled single blind clinical trial was performed. 60 patients(30 pairs) were given DK or Caflam (imported DK), 100 mg·d -1 for 4 d respectively . Results The total efficacy rates of DK and Caflam were 53 33%,86 67%,90 00% and 34 48%,72 41%,86 21% after 4 weeks treatment, respectively, and no significant statistic difference between 2 drugs was found( P>0 05) . The incidences of adverse effects of DK and Caflam were 13 33% and 16 67%( P >0 05). One with Caflam ceased treatment due to ventricular etopic beats. The tolerance of DK may be better that of Caflam. Conclusion\ Diclofenac potassium, similar in efficacy with caflam is an effective,safe drug in treating osteoarthritis.