目的 系統(tǒng)評價活血類口服中成藥聯(lián)合阿替普酶靜脈溶栓術(shù)對急性腦梗死神經(jīng)功能、凝血功能及出血風(fēng)險的影響。方法 計算機檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM）、維普中文期刊全文數(shù)據(jù)庫（VIP）、萬方數(shù)據(jù)庫、中國臨床試驗注冊中心、PubMed、the Cochrane Library、Web of Science、和Embase數(shù)據(jù)庫中活血類口服中成藥聯(lián)合阿替普酶靜脈溶栓術(shù)治療急性腦梗死的臨床隨機對照試驗（RCTs），檢索時間均為建庫至2021年7月1日，依據(jù)RoB量表評價偏倚風(fēng)險，用RevMan 5.4軟件進行Meta分析。結(jié)果 共納入13個RCTs，Meta分析結(jié)果顯示：相較于對照組，阿替普酶靜脈溶栓術(shù)聯(lián)用活血類口服中成藥更能提高臨床總有效率[OR=3.42，95% CI（2.25，5.18），P<0.000 01]；改善美國國立衛(wèi)生研究院卒中量表評分[MD=-3.21，95% CI（-4.02，-2.40），P<0.000 01]、延長活化部分凝血活酶時間[MD=3.47，95% CI （1.84，5.09），P<0.000 1]及凝血酶原時間[MD=1.15，95% CI （0.36，1.94），P=0.004]；降低纖維蛋白原水平[MD=-0.69，95% CI（-1.10，-0.29），P=0.000 7]；兩組出血不良反應(yīng)發(fā)生率比較，差異無統(tǒng)計學(xué)意義[RR=0.17，95% CI（0.02，1.34），P=0.09]。結(jié)論 活血類口服中成藥聯(lián)合阿替普酶靜脈溶栓術(shù)可提高急性腦梗死患者的臨床總有效率，改善神經(jīng)功能缺損評分及凝血功能，進一步促進神經(jīng)功能恢復(fù)、血栓溶解，且安全性較好。但受限于文獻質(zhì)量，尚需更多嚴格設(shè)計的RCTs以進一步驗證。

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

國家中醫(yī)藥管理局中醫(yī)藥腦病循證能力提升及平臺建設(shè)（2019XZZX-NB003）