腰痛宁胶囊治疗慢性风湿性关节炎(寒湿瘀阻证)多中心临床研究

Multicenter clinical study of Yaotongning Capsules in the treatment of chronic rheumatism(cold damp stagnation syndrome)

目的评价腰痛宁胶囊(马钱子粉、土鳖虫、川牛膝等)改善慢性风湿性关节炎(寒湿瘀阻证)的临床有效性及安全性。方法采用随机、双盲、安慰剂平行对照、多中心临床研究方法,入选病例数160例,其中实验组80例,服用腰痛宁胶囊;对照组80例,使用伤湿祛痛膏,连续用药14 d(即1个疗程)。结果 1个疗程治疗后,疾病疗效显进率、疼痛改善、疼痛尺改善的非劣效性检验分析显示,实验组均非劣效于对照组。共发生不良事件5例(3.14%)6例次(3.77%),其中对照组3例(3.75%)3例次(3.75%),实验组2例(2.53%)3例次(3.80%),组间不良事件发生率无统计学差异(P=1.000)。结论腰痛宁胶囊治疗慢性风湿性关节炎时具较好的疗效。与对照药伤湿祛痛膏相比,其疗效与安全性相当,未有严重不良反应发生。

AIM To evaluate the clinical efficacy and safety of Yaotongning Capsules（ Strychni Semen pulveratum,Eupolyphage seu Steleophaga,Cyathulae Radix,etc.） in improving acute chronic rheumatism（ cold damp stagnation syndrome）. METHODS A randomized,double-blind,placebo controlled trial and multicenterclinical study method was performed. One hundred and sixty patients were randomly divided into two groups,eighty cases in the treatment group were treated with Yaotongning Capsules,and another eighty cases in the control group were treated with Shangshiqutong Plasters,fourteen days as a course of treatment. RESULTS After one course of the treatment,non-inferiority test was conducted on both the treatment group and the control group. Their results showed that the efficacy,pain relief and improvement of pain scale were noninferior with the statistical significance.Among patients,the adverse events were found in 5 /6 case-times（ 3. 14% /3. 77%） of which the control group were 3 /3（ 3. 75% /3. 75%）,and the treatment group were 2 /3（ 2. 53% /3. 80%）. The incidence rate of adverse events in the treatment group was similar to that in the control group（ P = 1. 000）. CONCLUSION Compared with Shangshiqutong Plasters,Yaotongning Capsules is effective on chronic rheumatism with similar efficacy and safety,and without serious incidents of adverse effects.