目的 系统评价丹参川芎嗪注射液辅助治疗72 h内急性缺血性卒中（acute ischemic stroke，AIS）的疗效与安全性。方法 通过系统检索知网、万方、维普、中国生物医学文献数据库、中国临床试验注册中心、PubMed、Web of Science、Cochrane Library、Embase、Clinical Trails，收集丹参川芎嗪注射液辅助治疗72 h内AIS的临床随机对照试验，检索时限均为建库至2019年12月31日。采用《Cochrane干预措施系统评价手册》推荐的质量评价方法评价纳入研究的质量，提取资料后通过RevMan5.4和Stata14软件进行Meta分析。结果 共纳入52篇文献，5182例患者。Meta分析结果显示，丹参川芎嗪注射液辅助西医常规治疗（试验组）与单纯西医常规治疗（对照组）相比，可显著提高临床总有效率[RR=1.24，95% CI（1.21，1.28），P<0.000 01]，2种神经功能缺损评分改善程度[SMD_NIHSS=-3.62，95% CI（-4.37，-2.87），P<0.000 01；MD_CSS=-5.65，95% CI（-6.46，-4.85），P<0.000 01]和日常生活活动能力评分的改善程度[SMD_ADL=12.41，95% CI（8.60，16.22），P<0.000 01]；显著降低多种血液流变学指标。2组不良反应发生率无统计学差异[RR=1.34，95% CI（0.87，2.06），P=0.18>0.01]。结论 丹参川芎嗪注射液辅助治疗72 h内AIS可以显著提高其临床疗效，且安全性较好，但纳入文献质量较低，缺乏更多高质量证据支持。Prospero注册号CRD42021225911。

Objective To evaluate the efficacy and safety of Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection (SLI, 丹参川芎嗪注射液) as an adjunctive treatment for acute ischemic stroke (AIS) within 72 h. Methods By systematically searching CNKI, Wanfang, VIP, Sinomed, Chinese Clinical Trial Registry, PubMed, Web of Science, Cochrane Library, Embase, Clinical Trails, the randomized controlled trials of AIS within 72 h treatment accessorially with SLI were collected, the retrieval time was up to December 31, 2019. The evaluation method recommended by Cochrane Handbook for Systematic Reviews of Interventions was used to evaluate the quality of studies, and the data was analyzed by Revman5.4 and STATA14. Results A total of 5182 patients from 52 literatures were included in this study. The results of Meta-analysis showed that SLI combined with routine treatment of western medicine can improve the total effective rate[RR=1.24, 95% CI (1.21, 1.28), P<0.000 01], two kinds of neural function defect scores and activity of daily living score significantly[SMD_NIHSS=-3.62, 95% CI (-4.37, -2.87), P<0.000 01; MD_CSS=-5.65, 95% CI (-6.46, -4.85), P<0.000 01; SMD_ADL=12.41, 95% CI (8.60, 16.22), P<0.000 01], and reduced various hemorheology indicators significantly. There was no significant difference in the incidence of adverse reactions between the two groups[RR=1.34, 95% CI (0.87, 2.06), P=0.18 > 0.01]. Conclusion The adjuvant treatment of AIS within 72 h with SLI can significantly improve its clinical efficacy and had good safety, but the quality of the literatures included in this study is low and lack of high-quality evidence to support the conclusion. Prospero registration number CRD42021225911.

R285.64

国家第四批优秀中医临床人才项目（J20184832009）；山东省科技创新基地专项[鲁科字（2018）103号]