目的 系统评价活血类口服中成药联合阿替普酶静脉溶栓术对急性脑梗死神经功能、凝血功能及出血风险的影响。方法 计算机检索中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普中文期刊全文数据库（VIP）、万方数据库、中国临床试验注册中心、PubMed、the Cochrane Library、Web of Science、和Embase数据库中活血类口服中成药联合阿替普酶静脉溶栓术治疗急性脑梗死的临床随机对照试验（RCTs），检索时间均为建库至2021年7月1日，依据RoB量表评价偏倚风险，用RevMan 5.4软件进行Meta分析。结果 共纳入13个RCTs，Meta分析结果显示：相较于对照组，阿替普酶静脉溶栓术联用活血类口服中成药更能提高临床总有效率[OR=3.42，95% CI（2.25，5.18），P<0.000 01]；改善美国国立卫生研究院卒中量表评分[MD=-3.21，95% CI（-4.02，-2.40），P<0.000 01]、延长活化部分凝血活酶时间[MD=3.47，95% CI （1.84，5.09），P<0.000 1]及凝血酶原时间[MD=1.15，95% CI （0.36，1.94），P=0.004]；降低纤维蛋白原水平[MD=-0.69，95% CI（-1.10，-0.29），P=0.000 7]；两组出血不良反应发生率比较，差异无统计学意义[RR=0.17，95% CI（0.02，1.34），P=0.09]。结论 活血类口服中成药联合阿替普酶静脉溶栓术可提高急性脑梗死患者的临床总有效率，改善神经功能缺损评分及凝血功能，进一步促进神经功能恢复、血栓溶解，且安全性较好。但受限于文献质量，尚需更多严格设计的RCTs以进一步验证。

Objective To systematically evaluate the effects of activating blood oral Chinese patent medicine combined intravenous thrombolysis with alteplase on the neurological function, coagulation function and bleeding risk in treatment of acute cerebral infarction (ACI). Methods Computers search the randomized controlled trial (randomized controlled trial, RCT) of activating blood oral Chinese patent medicine combined with intravenous thrombolysis with alteplase for ACI in CNKI, WanFang Data, VIP, CBM, ChiCTR, PubMed, the Cochrane Library, Web of Science, and Embase database. The search time span is from the establishment of the database to July 1, 2021, evaluated the risk of bias based on the RoB scale, and Meta-analyzed with RevMan 5.4 software. Results A total of 13 RCTs were included. The results of the Meta-analysis showed that compared with the control group, the combination of intravenous alteplase thrombolysis and blood-promoting oral Chinese patent medicines significantly improved the total clinical effective rate[OR=3.42, 95%CI (2.25, 5.18), P < 0.000 01], improved the National Institutes of Health Stroke Scale[MD=-3.21, 95%CI (-4.02, -2.40), P < 0.000 01], prolonged the activation time of partial thromboplastin[MD=3.47, 95%CI (1.84, 5.09), P < 0.000 1], the prothrombin time[MD=1.15, 95%CI (0.36, 1.94), P=0.004], and reduced the level of fibrinogen[MD=-0.69, 95%CI (-1.10, -0.29), P=0.000 7]; there was no difference in the incidence of bleeding adverse reactions between the two Statistically significant[RR=0.17, 95%CI (0.02, 1.34), P=0.09]. Conclusion Activating blood oral Chinese patent medicine combined with alteplase intravenous thrombolysis can improve the total clinical effective rate of ACI, improve neurological deficit score, and improve coagulation function, can further promote the recovery of nerve function and thrombolysis, and the safety is good. However, due to the quality of the literature, more rigorously designed RCTs are needed for further demonstration.

R286.1

国家中医药管理局中医药脑病循证能力提升及平台建设（2019XZZX-NB003）