通心络胶囊治疗偏头痛（气虚血瘀型）的疗效观察

目的 评价通心络胶囊治疗轻中度气虚血瘀型偏头痛的疗效和安全性。方法 将120例轻中度气虚血瘀型偏头痛患者随机分为治疗组、对照组，每组各60例。治疗组给予通心络胶囊，对照组给予布洛芬缓释胶囊（芬必得）和盐酸氟桂利嗪胶囊治疗。结果 对总体疗效而言，意向性分析（intention—to—treat，ITT）结果显示两组总有效率分别为81．67％、83．33％，方案数据分析（per—protocol population，PP）结果显示两组总有效率分别为82．00％、84．31％，疗效差异均无统计学意义，P〉0．05，两组具有临床上的非劣性，P〈0．05。ITT分析与PP分析结果一致。临床观察中未发现通心络胶囊有任何毒副作用和不良反应。结论 通心络胶囊治疗轻中度气虚血瘀型偏头痛安全有效，值得在临床上推广应用。

Clinical observation of Tongxinluo Capsules for treatment migraine of Qi blood stasis syndrome

Objective To assess the efficacy and safety of Tongxinluo Capsules for treatment the mild and moderate migraine of Qi blood stasis syndrome.Methods 120 patients of mild and moderate migraine of Qi blood stasis syndrome were randomly divided into treatment group and control group,60 patients in each group.The treatment group were treated with Tongxinluo Capsules,and control group with Ibuprofen Sustained Release Capsules(Revise their labels)and Flunarizine hydrochloride capsules.30 days later,their therapeutic effects were observed.Results All the results were analyzed on the basis of intention-to-treat(ITT)and per-protocol population(PP),the total effective rate was 81.67%or 83.33%in the treatment group and 82.00%or 84.31%in the control group with the no significant difference between the two groups,P>0.05.The efficacy of between two groups was noninferiority,P<0.05.ITT and PP analysis revealed similar results.No adverse effect was found in the observation.Conclusion Efficacy and safety of Tongxinluo Capsules in the treatment of mild and moderate migraine of Qi blood stasis syndrome.