目的 系統(tǒng)評(píng)價(jià)活血類(lèi)口服中成藥聯(lián)合阿替普酶靜脈溶栓術(shù)對(duì)急性腦梗死神經(jīng)功能、凝血功能及出血風(fēng)險(xiǎn)的影響。方法 計(jì)算機(jī)檢索中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)（CNKI）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（CBM）、維普中文期刊全文數(shù)據(jù)庫(kù)（VIP）、萬(wàn)方數(shù)據(jù)庫(kù)、中國(guó)臨床試驗(yàn)注冊(cè)中心、PubMed、the Cochrane Library、Web of Science、和Embase數(shù)據(jù)庫(kù)中活血類(lèi)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(jī)對(duì)照試驗(yàn)（RCTs），檢索時(shí)間均為建庫(kù)至2021年7月1日，依據(jù)RoB量表評(píng)價(jià)偏倚風(fēng)險(xiǎn)，用RevMan 5.4軟件進(jìn)行Meta分析。結(jié)果 共納入13個(gè)RCTs，Meta分析結(jié)果顯示：相較于對(duì)照組，阿替普酶靜脈溶栓術(shù)聯(lián)用活血類(lèi)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(guó)國(guó)立衛(wèi)生研究院卒中量表評(píng)分[MD=-3.21，95% CI（-4.02，-2.40），P<0.000 01]、延長(zhǎng)活化部分凝血活酶時(shí)間[MD=3.47，95% CI （1.84，5.09），P<0.000 1]及凝血酶原時(shí)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(wú)統(tǒng)計(jì)學(xué)意義[RR=0.17，95% CI（0.02，1.34），P=0.09]。結(jié)論 活血類(lèi)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(píng)分及凝血功能，進(jìn)一步促進(jìn)神經(jīng)功能恢復(fù)、血栓溶解，且安全性較好。但受限于文獻(xiàn)質(zhì)量，尚需更多嚴(yán)格設(shè)計(jì)的RCTs以進(jìn)一步驗(yàn)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(guó)家中醫(yī)藥管理局中醫(yī)藥腦病循證能力提升及平臺(tái)建設(shè)（2019XZZX-NB003）