天舒胶囊治疗偏头痛随机对照试验的系统评价

Tianshu Capsule for migraine:A systematic review of randomized controlled trial

目的:系统评价天舒胶囊治疗偏头痛的疗效和安全性。方法:通过计算机检索、手工检索及向药厂索取资料,全面收集国内已发表和未发表关于天舒胶囊治疗偏头痛的随机对照试验(RCT)的文献,按Cochrane系统评价手册进行质量评价。结果:共纳入7个试验(589例),均为非安慰剂对照试验。7个试验均为开放对照试验,6个试验(499例)的试验组均为天舒胶囊加盐酸氟桂利嗪胶囊(西比灵),对照组为西比灵。1个试验(90例)的试验组为天舒胶囊加上星状神经节阻滞(SGB),对照组为单纯SGB治疗。6个试验(527例)采用头痛发作次数及频率减少程度评估疗效的Meta分析结果显示,天舒胶囊组偏头痛疗效优于对照组(RR=1.29,95%CI[1.18,1.41]),1个试验(62例)采用治疗前后头痛程度评分评估疗效的Meta分析结果显示,天舒胶囊组偏头痛疗效优于对照组(MD=1.53,95%CI[0.85,2.21])。共5个试验报道了药品不良事件,主要是头晕、腹部不适、乏力、困倦等,无严重不良事件发生。结论:天舒胶囊联合西比灵治疗头痛效果优于单用西比灵,能有效改善偏头痛患者头痛程度,减少发作频率,且不良反应少,未见严重不良反应。

Objectives： To assess the efficacy and safety of Tianshu Capsule for patients with migraine. Methods： Randomized controlled trials which compared Tianshu Capsule with placebo or open control in patients with migraine were collected, by searching the electronic bibliographic databases, scanning references listed in articles and hand searching journals. Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration＇s Jadad quality scoring method. Results： Seven trials involving 589 patients were included, all of which were open-label controlled. Six trials involving 499 patients, test group were Tianshu Capsule plus Sibelium, control group were Sibelium. One trial involving 90 patients, test group were Tianshu Capsule plus stellate gang lion block （SGB）, control group was SGB. Meta-analysis of 6 trials （527）, in which headache healing were assessed by the reduction of degree and number of time migraine attack, suggested that there were significant differences favoring Tianshu Capsule in the rate of headache healing during the treatment period （RR=l.29, 95%CI [1.18, 1.41]）. Meta-analysis of 1 trials （62）, in which headache healing were assessed by the headache severity score, suggested that there were significant differences favoring Tianshu Capsule in the mean change of headache healing during the treatment period （MD=l.53, 95%CI [0.85, 2.21]） Adverse events （AEs） were reported in 5 trials, including dizziness, abdominal discomfort, fatigue, drowsiness. However, no severe adverse events （SAEs） were reported. Conclusion： Tianshu Capsule combined with Sibelium can improve the extent of headache, reduce seizure frequency. It appears to be safe. However, further study is needed to confirm its effects for reduce long-term recurrence.