摘要
目的:系统评价通心络胶囊在脑梗死恢复期应用的临床疗效及安全性。方法:计算机检索中国知网(CNKI)、万方数据知识服务平台(WanFang)、维普中文期刊(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase和the Cochrane Library数据库,检索时限为数据库建库至2022年3月1日,收集通心络胶囊治疗脑梗死恢复期的临床随机对照试验。应用Cochrane偏倚风险评价工具进行质量评价,应用RevMan 5.3软件进行Meta分析。结果:纳入25项临床随机对照试验,总样本量2440例,其中,试验组1251例,对照组1189例。Meta分析结果显示,与常规西医治疗相比,联合通心络胶囊治疗脑梗死恢复期,能够提高临床总有效率[RR=1.19,95%CI(1.15,1.23),P<0.00001],改善脑卒中病人临床神经功能缺损程度量表(NDS)评分[MD=-6.20,95%CI(-8.46,-3.95),P<0.00001],改善日常生活能力Barthel指数(BI)评分[MD=14.29,95%CI(6.93,21.65),P=0.0001],改善运动功能量表(FMS)评分[MD=5.35,95%CI(3.37,7.33),P<0.00001],不良反应发生率差异无统计学意义[RR=1.18,95%CI(0.19,7.40),P=0.86]。结论:现有证据表明,通心络胶囊治疗脑梗死恢复期有一定疗效,安全性较好。由于本研究纳入的文献整体质量不高,结论需要多中心、大样本、设计严格的随机对照试验进一步验证。
Objective:To evaluate the clinical efficacy and safety of Tongxinluo Capsule in the treatment of convalescent cerebral infarction.Methods:The search was performed on CNKI,WanFang,VIP,SinoMed,PubMed,EMbase,and the Cochrane Library from the establishment of the database to March 1,2022 to collect the clinical randomized controlled trials of Tongxinluo Capsule in the treatment of convalescent cerebral infarction.Cochrane bias risk assessment tool was used for quality evaluation.and RevMan 5.3 software was used for Meta-analysis.Results:Twenty-five randomized controlled trials were included with 2440 patients,including 1251 in experimental group and 1189 in control group.Meta-analysis results showed that compared with conventional western medicine treatment,the combined treatment of Tongxinluo Capsule in the treatment of convalescent cerebral infarction could improve the total clinical response rate(RR=1.19,95%CI 1.15-1.23,P<0.00001),neurological deficit score(NDS)(MD=-6.20,95%CI-8.46--3.95,P<0.00001),Barthel index(BI)Score(MD=14.29,95%CI 6.93-21.65,P=0.0001),motor function Fugl-Meyer Score(FMS)(MD=5.35,95%CI 3.37-7.33,P<0.00001).There was no significant difference in the incidence of adverse reactions(RR=1.18,95%CI 0.19-7.40,P=0.86).Conclusion:The existing evidence shows that Tongxinluo Capsule is effective and safe in the treatment of cerebral infarction in the convalescent period.As the overall quality of the included research literature is not perfect,the conclusions need to be further verified by multi-center,large sample,and rigorously designed randomized controlled trials.
作者
苏扬
崔书克
陈爽
张晨
牛元
SU Yang;CUI Shuke;CHEN Shuang;ZHANG Chen;NIU Yuan(Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan,China)
出处
《中西医结合心脑血管病杂志》
2023年第18期3329-3335,共7页
Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease
基金
河南省中医药科学研究专项课题(No.2018ZY1014)。
关键词
脑梗死
恢复期
通心络胶囊
系统评价
META分析
cerebral infarction
convalescence
Tongxinluo Capsule
systematic review
Meta-analysis
