目的 评价腰痛宁胶囊治疗腰肌纤维炎(寒湿瘀阻证)的临床有效性及安全性。方法 采用随机、盲法、安慰剂平行对照、多中心临床试验方法,总病例数144例,其中治疗组72例,服腰痛宁胶囊;对照组72例,服用腰痛宁胶囊安慰剂。1个疗程即连续用药14 d后评价临床疗效及安全性。结果 全分析集(FAS)分析显示,治疗组临床控制+显效例数之和与总例数的比值(控显率)优于对照组(P<0.001),符合方案集(PPS)分析显示治疗组控显率优于对照组(P<0.001);FAS分析显示,治疗组疼痛改善优于对照组(P<0.001),PPS分析显示治疗组疼痛改善优于对照组(P<0.001)。本试验共发生不良事件3例(2.10%),均发生在对照组,治疗组未发生不良事件,组间不良事件发生率无统计学差异(例数/例次P=0.245)。结论 腰痛宁胶囊治疗腰肌纤维炎(寒湿瘀阻证)疗效确切,明显优于安慰剂,试验中未发现严重不良反应,安全性较好。

Objective To observe the clinical efficacy and safety of Yaotongning Capsule in acute lumbar muscle fiber inflammation (cold damp stagnation syndrome). Methods A randomized, double-blind, placebo controlled multicenter and clinical trial was performed. The 144 patients were randomly divided into two groups, 72 cases in the treatment group treated with Yaotongning Capsule and 72 cases in the control group treated with placebo, 14 d as a course of treatment. Results After one course of treatment, there was significant difference in the curative rate between treatment group and control group. According to FAS analysis, the ratio of control/effective cases and total cases (effective rate) in the treatment group was higher than that in the control group (P < 0.001). According to PPS analysis, the effective rate of the treatment group was obviously higher than that of the control group (P < 0.001). The pain relief of FAS and PPS in the treatment group also surpasses that in the control group (P < 0.001). And the differences both had statistical significance. Among 144 patients, the adverse events were found in three cases with the incidence of 2.10%. All of the adverse events were found in the control group and there were no remarkable adverse event and side effect in the treatment group. The incidence rate of adverse event in the treatment group was similar to that in the control group (P=0.245). Conclusion Yaotongning Capsule for lumbar muscle fiber inflammation has reliable efficacy, safety, and less incident of adverse effects.