养血清脑颗粒治疗紧张性头痛有效性及安全性的Meta分析

Meta-Analysis and Sequential Analysis of Efficacy and Safety of Yangxueqingnao Particles Combined with Conventional Medical Therapy in the Treatment of Tension-Type Headache

目的系统评价养血清脑颗粒联合常规西药治疗紧张性头痛的有效性及安全性。方法检索PubMed、VIP、CKNI、Wanfang等数据库,检索时限为建库起至2021年7月,收录养血清脑颗粒联合常规西药治疗紧张性头痛的临床随机对照试验(RCT),按Cochrane偏倚风险评估方法评价文献质量,分别应用RevMan 5.3和TSA 0.9.5.10 Beta软件进行Meta分析和试验序贯分析。结果最终纳入27项RCT,共计患者2905例。Meta分析结果显示,与对照组(常规西药)相比,试验组(养血清脑颗粒联合西药常规治疗或单用养血清脑颗粒)总有效率明显优于对照组[OR=6.80,95%CI=(5.31,8.71),P<0.00001];降低头痛程度(MD=-1.05,95%CI[-1.37,-0.74],P<0.00001);缩短头痛持续时间(MD=-26.93,95%CI[-38.54,-15.31],P<0.00001);减少头痛发作次数(MD=-1.64,95%CI[-2.47,-0.80],P=0.0001);缩短第1次头痛消失时间(MD=-6.56,95%CI[-9.37,-3.76],P<0.00001)及第5次头痛消失时间(MD=-9.01,95%CI[-11.73,-6.29],P<0.00001),且药物不良反应较少,安全性良好。试验序贯分析进一步明确了养血清脑颗粒联合常规西药治疗的疗效,排除假阳性。结论在临床中应用常规西药联合养血清脑颗粒治疗紧张性头痛临床疗效明确,安全可靠,但鉴于纳入文献研究质量不高,仍需更多高质量的RCT进一步验证该结论。

Objective To systematically assess the efficacy and safety of Yangxueqingnao particles combined with conventional medical therapy in the treatment of Tension-type headache(TTH).Method Retrieved Chinese and English databases,including CNKI,Wanfang,PubMed,Embase and so on,to screen out randomized controlled trials(RCT)for modified Yangxueqingnao particle combined with conventional medical therapy in the treatment of TTH from the establishment of databases to July 2021.The Cochrane system evaluation method was used to assess the quality of the literature.RevMan 5.3 was used for Meta-analysis,and TSA 0.9.5.10 Beta software was adopted for test sequential analysis.Results A total of 27 RCT were included,involving 2905 patients.The results of Meta-analysis reflected that,compared with the control group,The total effective rate was significantly better than the control group[OR=6.80,95%CI=(5.31,8.71),P<0.00001],headache severity decreased(MD=-1.05,95%CI[-1.37,-0.74],P<0.00001),headache duration reduced(MD=-26.93,95%CI[-38.54,-15.31],P<0.00001),the number of headache attacks reduced(MD=-1.64,95%CI[-2.47,-0.80],P=0.0001),the first headache disappear time reduced(MD=-6.56,95%CI[-9.37,-3.76],P<0.00001)and the fifth headache disappear time reduced(MD=-9.01,95%CI[-11.73,-6.29],P<0.00001).Meanwhile,there were no serious adverse events during the study,and Yangxueqingnao particles showed good safety.Test sequential analysis further clarified the effect of Yangxueqingnao particles combined with conventional medical therapy on the TTH,excluding false positive.Conclusion Yangxueqingnao particles combined with conventional medical therapy has a better effect than the control group on the treatment of chronic heart failure,and shows a good safety profile.Considering the limited quality of the included studies,more high quality RCT are needed to further verify the conclusion.