尪痹片治疗骨性关节炎临床试验研究评价

Clinical and Trial Study on the Treatment of Osteoarthritis of the Knee with Wangbi Pian

目的:观察、评价尪痹片治疗骨性关节炎的临床疗效及安全性。方法:将30例辨证为肝肾两虚、瘀血痹阻型的骨性关节炎患者随机分为两组进行双盲双模拟临床试验,治疗组20例口服尪痹片,对照组10例为双氯芬酸钠缓释片;8周为1个疗程。在治疗后第2周、5周及第8周统计两组患者各症状计分及其症状总积分变化情况;治疗后第8周评价其临床疗效及安全性。结果:在2周、5周及8周内降低骨性关节炎患者各症状计分及其症状总积分方面,治疗组和对照组治疗前后比较有显著性差异(P<0.05),8周后两组患者临床疗效比较无显著性差异(P>0.05),但在证候改善方面有显著差异性(P<0.05);各项实验室指标检测基本正常,观察期间,未出现不良反应。结论:尪痹片和双氯芬酸钠缓释片(扶他林)均能有效改善骨性关节炎患者症状,两药疗效相当。但尪痹片在改善患者证候疗效上优于双氯芬酸钠缓释片,且药物安全性好,无明显毒副作用,值得临床推广。

Objective ：To observe and evaluate the clinical curative effect and the safety of Wangbi Pian on osteoarthritis（OA） of the knee. Methods ：Thirsty cases of knee OA patients who were determined deficiency of liver and kidney ;stagnation of blood stasis were divided randomly into the control group and the treatment group,the former was treated with Wangbi Pian and diclofenae sodium extended action tablet （voharen）. 8th weeks is a course of treatment. Comparative study on clinical curative effect between the control group and the treatment group was conducted by examing the changing mark of each main and primary symptom or sign in the 2nd,5th and 8th week and the summarized marks of the main and primary symptoms or signs in the 8th week respectively in the two groups. And observed Wangbi Pian security judgedits clinical effect. Results ： The score of each main and primary symptom or sign in the 2nd,5th and 8th week and the summarized marks of the symptoms or signs comparing with those diagnosing for the first time in two groups were statistic significant（P 〈0. 05）. The two groups have no obvious difference in comparing the total clinical curativeeffect after 8 weeks （ P 〉 0.05 ）, but it have in the symptom curativeeffeet （ P 〈 0. 05 ）. No side effect is appeared and the laboratory examination indexes have not changed during the treatment. Conclusion：Wangbi Pian and diclofenae sodium extended action tablet （voharen）can effectively improve the symptoms of patients with knee osteoarthritis, a considerable effect of the two drugs. Wangbi Pian lame, but in improving the curative effect on patients with syndrome better than that of diclofenae sodium sustained-release tablets, and drug safety, no significant side effects, worthy to be popularized.