都梁软胶囊治疗偏头痛疗效与安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Duliang Soft Capsules in Treatment of Migraine

作　　者：翟微微 郭蓉娟[2] 苟金 李俊男 王荟荧 朱晓晨[2] ZHAI Weiwei;GUO Rongjuan;GOU Jin;LI Junnan;WANG Huiying;ZHU Xiaochen(Beijing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学,北京100029 [2]北京中医药大学东方医院,北京100078

出　　处：《世界中医药》2022年第3期392-399,共8页World Chinese Medicine

基　　金：国家自然科学基金面上项目(81874422);国家重点研发计划项目(2017YFC1307700);国家中医药管理局脑病重点专科建设项目。

摘　　要：目的:系统评价都梁软胶囊治疗偏头痛的有效性和安全性。方法:计算机检索Cochrane Library、PubMed、EMbase、中文科技期刊数据库(CCD)、中国学术期刊数据库(CSPD)、国家知识基础设施数据库(CNKI)、中国生物医学文献服务系统(SinoMed)及ClinicalTrials.gov临床注册系统,从建库起至2020年5月为检索期限,收集都梁软胶囊单用或联合西药治疗偏头痛的随机对照临床试验(RCT)。2名研究者各自筛选文献、提取资料、评价偏倚风险并交叉核对后,采用RevMan5.3进行Meta分析,本研究根据都梁软胶囊是否联合西药及西药种类分别进行亚组分析。结果:14个RCT被纳入,包括1325例患者。亚组分析结果显示,都梁软胶囊联合西药在提高总有效率、减轻头痛严重程度、减少头痛发作频率、缩短头痛持续时间、降低血清降钙素基因相关肽(CGRP)水平及改善脑血流动力学等方面均优于单用西药;都梁软胶囊在提高总有效率、减轻头痛严重程度、减少头痛发作频率、缩短头痛持续时间方面优于氟桂利嗪。在不良反应发生率方面,都梁软胶囊较西药低,都梁软胶囊联合西药的不良反应则与单用西药相当,且均未见严重不良反应。结论:都梁软胶囊治疗偏头痛优于氟桂利嗪,联合西药治疗较单用西药效果好,且安全性较高。由于纳入研究存在方法学质量不高、文献数量少等局限性,该研究结论所提供的临床依据尚需进一步验证。Objective:To evaluate the efficacy and safety of Duliang Soft Capsules in the treatment of migraine.Methods:Databases,such as Cochrane Library,PubMed,EMbase,CCD,CSPD,CNKI,and SinoMed and ClinicalTrials.gov were electronically searched for relevant randomized controlled trials(RCTs)on the effect of Duliang Soft Capsules alone or in combination against migraine from database inception to May 2020.After two researchers screened the literature papers independently,extracted the data,evaluated the risk of bias,and cross-checked the results,RevMan 5.3 was used for Meta-analysis.Results:Fourteen RCTs were included,involving 1325 patients.Subgroup analysis was conducted according to the combined medication of Duliang Soft Capsules with western medicine and types of western medicine,respectively.The results showed that Duliang Soft Capsules combined with western medicine were superior to western medicine alone in improving total effective rate,relieving headache,reducing headache frequency,shortening headache duration,reducing serum calcitonin gene-related peptide(CGRP)levels,and improving cerebral hemodynamics.Duliang Soft Capsules were superior to flunarizine in improving total effective rate,relieving headache,reducing headache frequency,and shortening headache duration.In terms of the incidence of adverse events,Duliang Soft Capsules were lower than western medicine,and the adverse events of Duliang Soft Capsules combined with western medicine were similar to those of western medicine alone.No serious adverse events were observed.Conclusion:Duliang Soft Capsules are superior to flunarizine in the treatment of migraine,and combined medication with western medicine was more effective and safer than western medicine alone.Due to the limitations of low methodological quality and small amount of included literature papers,the clinical evidence provided by the conclusion of this study needs to be further verified.

关 键 词：都梁软胶囊 氟桂利嗪 偏头痛 临床疗效 安全性 META分析 系统评价 随机对照试验 

分 类 号：R277.7[医药卫生—中医学]