天舒胶囊联合氟桂利嗪治疗偏头痛的系统评价

Systematic review of Tianshu capsule combined with Flunarizine for hemicrania

目的系统评价天舒胶囊联合氟桂利嗪治疗偏头痛的疗效与安全性。方法通过检索公开发表的与天舒胶囊联合氟桂利嗪治疗偏头痛相关的随机对照临床试验研究文献,运用Cochrane图书馆系统评价方法,对纳入文献进行质量评价及Meta分析。结果符合纳入标准的文献共7篇,均为Jadad评分小于3分的低质量研究。Meta分析结果显示,天舒胶囊联合氟桂利嗪与单纯应用氟桂利嗪比较,两组总有效率差异有统计学意义[OR=2.87,95%C(I1.92,4.28),P<0.00001];且不良反应极少发生,表现轻微,使用相对安全。结论现有有限证据显示,天舒胶囊联合氟桂利嗪与单纯使用氟桂利嗪比较,可以提高偏头痛患者的临床疗效,且安全性良好,由于纳入文献研究方法学质量低,存在发表偏倚可能性大,因此天舒胶囊联合氟桂利嗪治疗偏头痛的疗效与安全性需要更多设计合理的高质量、大样本临床试验加以验证。

【Objectives】 To systematically appraise the effectiveness and safety of Tianshu capsule combined with Flunarizine for hemicrania,in order to provide an evidence based guidance for clinical practice. 【Methods】 Studies of clinical trials on Tianshu capsule combined with Flunarizine for hemicrania were retrieved by computer.Cochrane library systematic review method was applied to analyze the quality and quantity of included trials.【Results】 7 randomized controlled trials were included in the systematic review.All the studies were concluded as poor-quality ones by the methodological quality appraisal.A Meta-analysis showed that there has statistical significance in differences between Tianshu capsule combined with Flunarizine and simple Flunarizine on the treatment of hemicrania [OR=2.87,95%CI（1.92,4.28）,P 0.00001].And Tianshu capsule combined with Flunarizine holds a relatively safety for its slight adverse effect which seldom happens.【Conclusion】 Present limited evidence shows that compared with Flunarizine,Tianshu capsule combined with Flunarizine could improve the overall effectiveness power on hemicrania with fine safety.Because of quantity,quality and basis of RCTs it gets,the effectiveness and safety of Tianshu capsule combined with Flunarizine on hemicrania should be proofed by many more well-designed high quality RCTs.