天舒胶囊治疗头痛的疗效与安全性系统评价

Efficacy and Safety of Tianshu(天舒) Capsule in the Treatment of Headache:A Systematic Evaluation

目的:系统评价天舒胶囊治疗头痛的疗效和安全性,为临床用药提供循证参考。方法:计算机检索知网、万方、维普、中国生物医学文献数据库、Pubmed等数据库,收集天舒胶囊治疗头痛的随机对照试验(RCT),筛选文献、提取数据后,采用Rev Man 5.4.1软件进行Meta分析。结果:共纳入29项RCT,共计3699例患者。Meta分析结果显示:对于偏头痛患者,天舒胶囊改善VAS评分和减少头痛发作次数方面疗效优于安慰剂[MD=-1.31,95%CI(-1.51,-1.11),P<0.01;MD=-1.06,95%CI(-1.23,-0.89),P<0.01];天舒胶囊联合氟桂利嗪改善VAS评分优于氟桂利嗪[MD=1.58,95%CI(-2.80,-0.36),P<0.05]。天舒胶囊单用或联合氟桂利嗪对比氟桂利嗪能显著减少头痛发作次数[MD=-3.20,95%CI(-3.36,-3.04),P<0.01;MD=-0.70,95%CI(-1.28,-0.11),P<0.05]、持续时间[MD=-8.00,95%CI(-9.28,-6.27),P<0.01;MD=-1.31,95%CI(-2.21,-0.41),P<0.01],提高显效率[MD=1.84,95%CI(1.50,2.25),P<0.01;MD=1.66,95%CI(1.45,1.90),P<0.01],两组之间不良反应发生率相当[RR=0.86,95%CI(0.22,3.34),P>0.05;RR=0.81,95%CI(0.35,1.90),P>0.05]。与西药常规治疗相比,天舒胶囊联合西药常规治疗紧张型头痛和血管神经性头痛存在一定优势。结论:现有证据表明天舒胶囊单用或联用西药常规治疗头痛可能具有一定的疗效,最好饭后服用。

Objective:To systematically evaluate the efficacy and safety of Tianshu capsule in the treatment of headache,providing evidence-based references for clinical medication.Methods:The China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Chinese Technology Periodical Database,SinoMed,Pubmed,and other databases were retrieved by computer to collect randomized controlled trials(RCTs)about Tianshu capsule for headache.After literature screening and data extraction,meta-analysis was performed by Revman 5.4.1.Results:Twenty-nine RCTs were included,involving 3699 patients.Meta-analysis results showed that Tianshu capsule was more effective than the placebo in improving the Visual Analogue Scale(VAS)score and reducing the number of headache attacks in patients with migraine[MD=-1.31,95%CI(-1.51,-1.11),P<0.01;MD=-1.06,95%CI(-1.23,-0.89),P<0.01].Compared with flunarizine alone,the combination of Tianshu capsule with flunarizine improved the VAS score[MD=1.58,95%CI(-2.80,-0.36),P<0.05].Compared with flunarizine alone,Tianshu capsule alone or combined with flunarizine effectively reduced the number of headache attacks[MD=-3.20,95%CI(-3.36,-3.04),P<01;MD=-0.70,95%CI(-1.28,-0.11),P<0.05]and time of duration[MD=-8.00,95%CI(-9.28,-6.27),P<0.01;MD=-1.31,95%CI(-2.21,-0.41),P<0.01],and improved the effective rate[MD=1.84,95%CI(1.50,2.25),P<0.01;MD=1.66,95%CI(1.45,1.90),P<0.01].The incidence of adverse reactions between the two groups had no significant difference[RR=0.86,95%CI(0.22,3.34),P>0.05;RR=0.81,95%CI(0.35,1.90),P>0.05].Compared with conventional treatment with chemical medicines,Tianshu capsule combined with chemical medicines had certain advantages in the treatment of tension-type headache and angioneurotic headache.Conclusion:Tianshu capsule alone or combined with chemical medicines has a better effect on headache,but it is best to take the medicine after meals.