目的 以安慰剂为对照评价腰痛宁胶囊治疗坐骨神经痛(寒湿瘀阻证)的临床有效性及安全性。方法 对2008年10月-2009年5月符合试验纳入标准的144例坐骨神经痛患者采用随机双盲安慰剂对照试验进行研究。随机分为两组,治疗组(腰痛宁胶囊组)72例,对照组(腰痛宁胶囊安慰剂组)72例;治疗方法:两组患者分别服用相应药物,每次5粒,黄酒兑少量温开水送服,每日1次,睡前半小时服。连续用药14 d为1个疗程。结果 入选受试者144例,主要疗效指标治疗组疾病控显率明显优于对照组(U=4.138,P<0.001);疼痛改善方面:治疗组的疾病(中医证候)控显率明显优于对照组(U=6.330,P<0.001)。安全性评价方面:试验过程中无不良事件发生;其他生命体征、实验室及辅助检查项目的组间差异无统计学意义。结论 腰痛宁胶囊治疗坐骨神经痛(寒湿瘀阻证)具有较好的疗效,明显优于安慰剂,试验期间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 sciatica suffered form cold dampness and blood stasis. Methods A randomized, double-blind, and placebo controlled trial was performed. One hundred and forty-four patients with sciatica, who were in accordance with the accepting criteria from October 2008 to May 2009, were randomly divided into two groups, 72 cases treated with Yaotongning Capsule in the treatment group and 72 cases treated with placebo in the control group. Patients took five capsules with warm boiled water added yellow rice wine orally half an hour before sleep. The treatment course lasted for 2 weeks. Results After one course of the treatment, there were significant differences in the curative rate between treatment group and control group. Compared with the control group, the disease control rate in the treatment group was obvious (U=4.138, P<0.001); So did the pain relief (U=6.330, P<0.001). And the differences both had statistical significance. There were no remarkable adverse event and side effect in the both groups. Conclusion Yaotongning Capsule for sciatica suffered form cold dampness and blood stasis has reliable efficacy, safety, and less incident of adverse effects.