目的 系统评价中药注射液（注射用丹参多酚酸、丹红注射液、疏血通注射液、银杏二萜内酯葡胺注射液、银杏内酯注射液）联合化学药治疗急性缺血性脑卒中的有效性和安全性。方法 计算机检索中国学术期刊全文数据库（CNKI）、万方数据知识服务平台（Wanfang Data）、维普中文期刊全文数据库（VIP）、中国生物医学文献数据库（CBM）、美国生物医学期刊文献数据库（PubMed）、荷兰医学文摘数据库（Embase）、循证医学图书馆（Cochrane Library）、美国引文数据库（Web of Science），检索时间从建库至2023年5月31日，全面收集相关临床随机对照试验（RCT），使用Cochrane系统评价手册进行纳入研究的质量评价，采用R 4.0.5和Stata 16软件进行网状Meta分析。结果 共纳入72项研究，共纳入7 343例患者，涉及5种中药注射剂。网状Meta分析结果显示：在临床有效率方面，注射用丹参多酚酸、丹红注射液、疏血通注射液、银杏二萜内酯葡胺注射液、银杏内酯注射液联合化学药的临床有效率均高于化学药对照组，累积概率排序为疏血通注射液＋化学药（89.36%）＞注射用丹参多酚酸＋化学药（87.25%）＞丹红注射液＋化学药（54.14%）＞银杏内酯注射液＋化学药（44.48%）＞银杏二萜内酯葡胺注射液＋化学药（24.77%）＞化学药（0.0%）；在降低美国国立卫生研究院卒中量表（NIHSS）评分方面，注射用丹参多酚酸、丹红注射液、疏血通注射液、银杏二萜内酯葡胺注射液、银杏内酯注射液联合化学药的NIHSS评分均低于化学药对照组，累积概率排序为丹红注射液＋化学药（89.63%）＞疏血通注射液＋化学药（71.44%）＞注射用丹参多酚酸＋化学药（65.19%）＞银杏内酯注射液＋化学药（50.41%）＞银杏二萜内酯葡胺注射液＋化学药（23.21%）＞化学药（0.00%）；在提高日常生活能力量表（BI）评分方面，注射用丹参多酚酸、丹红注射液、疏血通注射液、银杏二萜内酯葡胺注射液、银杏内酯注射液联合化学药的BI评分均高于化学药对照组，累积概率排序为银杏二萜内酯葡胺注射液＋化学药（81.33%）＞疏血通注射液＋化学药（71.54%）＞丹红注射液＋化学药（64.85%）＞注射用丹参多酚酸＋化学药（51.81%）＞银杏内酯注射液＋化学药（30.44%）＞化学药（0.00%）。共有40项研究报告了不良反应，其中19项研究报告未出现不良反应，其余均无严重不良反应，已报告的不良反应类型均为常见不良反应类型，直接Meta分析结果表明这5种中药注射液联合化学药的不良反应率与化学药不良反应率比较，无统计学差异。结论 5种中药注射液联合化学药治疗急性缺血性脑卒中均可提高临床有效率、降低NIHSS评分和提高BI评分，提高临床有效率以疏血通注射液和注射用丹参多酚酸有优势，丹红注射液和银杏二萜内酯葡胺注射液在降低NIHSS评分和提高BI评分上有优势。受纳入研究的质量等局限性，该研究结论仍需更多高质量RCT试验进一步证实。

Objective To evaluate the efficacy and safety of traditional Chinese medicine injections [Salvianolic Acids for Injection (SAFI), Danhong Injection (DH), Shuxuetong Injection (SXT), Ginkgo Diterpene Lactone Meglumine Injection (YXETNZ), Ginkgolide Injection (YXNZ) ] combined with western medicine in the treatment of acute ischemic stroke. Methods Databases including CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, the Cochrane library, and Web of Science were searched to collect randomized controlled trials from the date of establishment to May 31, 2023. ReviewManager 5.3 software was used to make studies quality bias. Network Meta-analysis was performed by R 4.0.5 and Stata 16 software. Results A total of 72 RCTs were included, with a total sample size of 7343 cases. Salvianolic Acids for Injection combined with chemical drugs (SAFI+CM), Danhong Injection combined with chemical drugs (DH+CM), Shuxuetong Injection combined with chemical drugs (SXT+CM), Ginkgo Diterpene Lactone Meglumine Injection combined with chemical drugs (YXETNZ+CM), Ginkgolide Injection combined with chemical drugs (YXNZ+CM) are five interventions. Network Meta-analysis showed that SAFI+CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could improve clinical efficiency, and the rank of cumulative probability was SXT+CM(89.36%)＞SAFI+CM (87.25%)＞DH+CM (54.14%)＞YXNZ+CM (44.48%)＞YXETNZ+CM (24.77%)＞CM (0.00%). SAFI+CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could reduce NIHSS scores, and the rank of cumulative probability was DH+CM (89.63%)＞SXT+CM (71.44%)＞SAFI+CM (65.19%)＞YXNZ+CM (50.41%)＞YXETNZ+CM (23.21%)＞CM (0.00%). SAFI+ CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could improve BI index, and the rank of cumulative probability was YXETNZ+CM (81.33%)＞SXT+CM (71.54%)＞DH+CM (64.85%)＞SAFI+CM (51.81%)＞YXNZ+CM (30.44%)＞CM (0.00%). A total of 40 studies reported adverse reactions, of which 19 studies reported no reactions. Others were no serious adverse reactions. The reported types of adverse reactions are all common types of adverse reactions. Meta-analysis results show that there is no statistically significant difference in the incidence of adverse reactions between the combination of these five traditional Chinese medicine injections and chemical drugs. Conclusion Five traditional Chinese medicine injections combined with chemical drugs in the treatment of acute ischemic stroke can improve the clinical efficiency, without serious adverse reactions. SXT+CM and SAFI+ CM have an improved effect on the total effective rate, while DH+CM and YXETNZ+CM show advantages in NIHSS score and Barthel index. The above research results still need to be verified by more multicenter, large sample and double-blind randomized controlled trials.

R286.1

河北省医学研究重点课题计划项目（20181487）