苦碟子注射液联合常规西药治疗缺血性脑卒中的系统评价和Meta分析  

Kudiezi Injection Combined with Conventional Western Medicine in the Treatment of Ischemic Stroke:a Meta-analysis

作　　者：周莹[1] 孟繁兴[2] 周彦吉 刘雪梅[2] 傅晨[2] 张允岭 王凤丽[2] ZHOU Ying;MENG Fanxing;ZHOU Yanji;LIU Xuemei;FU Chen;ZHANG Yunling;WANG Fengli(Beijing University of Chinese Medicine,Beijing 100029,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 [3]中国中医科学院西苑医院

出　　处：《中西医结合心脑血管病杂志》2020年第23期3935-3944,共10页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：国家自然科学基金青年科学项目(No.81804023);国家国际科技合作专项项目(No.2015DFA31130);国家重点基础研究发展计划(973计划)(No.2012CB518406)。

摘　　要：目的系统评价苦碟子注射液联合常规西药治疗缺血性脑卒中的有效性和安全性。方法全面检索中文科技期刊全文数据库(VIP)、万方数据库、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(SinoMed)、the Cochrane Library、PubMed、EMbase、Clinical Trail gov数据库,收集苦碟子注射液联合常规西药治疗缺血性脑卒中的随机对照试验(RCTs),检索时间为各数据库建库至2020年1月1日,根据预先制定的纳入与排除标准筛选文献,并进行提取资料和质量评估,最后采用RevMan 5.3软件进行Meta分析。结果检索出文献共892篇,最终纳入29项RCT研究,累计受试者3682例。Meta分析结果显示:与对照组相比,苦碟子注射液联合常规西药组(治疗组)可明显提高缺血性脑卒中病人临床疗效[RR=1.21,95%CI(1.17,1.25),P<0.00001],降低神经功能缺损评分[MDNIHSS=-2.87,95%CI(-5.16,-0.58),P=0.01;MDNDS=-7.22,95%CI(-11.43,-3.00),P=0.0008],降低血浆黏度[MD=-0.15,95%CI(-0.18,-0.12),P<0.00001]。通过描述性分析有两项研究结果表明苦碟子联合常规西药组的Bathel指数优于对照组。有14项研究明确无不良反应,1项研究报道了10例不良反应事件,无严重不良反应,其他研究均未对安全性做出说明。结论现有证据表明,苦碟子注射液联合常规西药能明显提高临床总有效率和Bathel指数,降低神经功能缺损评分和血浆黏度。Objective To evaluate the efficacy and safety of Kudiezi injection combined with conventional western medicine in the treatment of ischemic stroke.Methods Chinese Journal Full-text Database(VIP),Wanfang Database,China Journal Full-Text Database(CNKI),Chinese Biomedical Database(SinoMed),the Cochrane Library,PubMed,EMbase and Clinical Trail Gov were searched from the establishment to January 1,2020.Randomized controlled trials(RCTs)in the treatment of cerebral ischemic stroke by Kudiezi injection combined with conventional western medicine were screened according to pre-established inclusion criteria and exclusion criteria.The quality of the included literature was assessed by the Cochrane Risk Assessment Tool,and the included literature were put into descriptive analysis or Meta-analysis by the Rev Man 5.3 software.Results A total of 892 literatures in Both Chinese and English were retrieved,and 29 RCTs were included eventually,involving 3682 patients.The results of Meta-analysis showed that Kudiezi injection for cerebral ischemic stroke was superior to conventional therapy with total clinical efficacy[RR=1.21,95%CI(1.17,1.25),P<0.00001],it reduced the neurological deficit scores[MDNIHSS=-2.87,95%CI(-5.16,-0.58),P=0.01;MDNDS=-7.22,95%CI(-11.43,-3.00),P=0.0008]and the plasma viscosity[MD=-0.15,95%CI(-0.18,-0.12),P<0.00001].Descriptive analysis of 2 literatures showed that the Bathel index of Kudiezi injection combined with conventional western medicine group was better than that of control group.There were 14 literatures with no adverse reactions,and 1 literature reported 10 adverse events with mild adverse reactions.Other studies did not provide any safety data.Conclusion Current evidences showed that,Kudiezi injection combined with conventional western medicine could significantly improve the total clinical efficacy and Bathel index,and reduce neurological deficit score and plasma viscosity.

关 键 词：缺血性脑卒中 苦碟子注射液 随机对照试验 系统评价 META分析 临床总有效率 神经功能缺损评分 血浆黏度 BARTHEL指数 

分 类 号：R743.3[医药卫生—神经病学与精神病学] R255.2[医药卫生—临床医学]