三七通舒胶囊治疗轻中度偏头痛疗效观察

目的评价三七通舒胶囊治疗轻中度气滞血淤型偏头痛的疗效和安全性。方法将120例轻中度气滞血淤型偏头痛患者随机分为治疗组、对照组。每组各60例。治疗组给予三七通舒胶囊，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。结果就总体疗效而言，ITT结果显示2组总有效率分别为81．67％，83．33％，PP结果显示2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），2组具有临床上的非劣性（P〈0．05）。ITT分析与PP分析结果一致。临床观察中未发现三七通舒胶囊有任何毒副作用和不良反应。结论三七通舒胶囊治疗轻中度气滞血淤型偏头痛安全有效，值得在临床上推广应用。

Clinical observation of Sanqitongshu capsules for treating migraine with qi stagnation and blood stasis syndrome

Objective To assess the efficacy and safety of sanqitongshu capsules for treating the mild and moderate migraine with qi stagnation and blood stasis syndrome.Methods 120 patients of mild and moderate migraine with qi stagnation and blood stasis syndrome were randomly divided into treatment group and control group,there were 60 patients in each group. The patients in treatment group were treated with sanqitongshu capsules, and in control group with ibuprofen sustained release capsules（Fenbid） 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 82.00% in the treatment group and 83.33% or 84.31% in the control group,there was no significant difference between the two groups,P〉0.05.The efficacy rates in two groups were not significant different,P〈0.05.ITT and PP analysis revealed similar results. No adverse effect was found in the observatian.Conclusion It was efficacy and safely for sanqitongshu capsules to treat mild and moderate migraine of qi stagnation and blood stasis syndrome, which was worthy of being widely used.