目的 系統(tǒng)評(píng)價(jià)消栓腸溶膠囊治療急性腦梗死的臨床療效和安全性。方法 系統(tǒng)檢索中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）和維普中文期刊全文數(shù)據(jù)庫（VIP）、萬方數(shù)據(jù)庫、Pub Med、CochraneLibrary和Web of science數(shù)據(jù)庫，收集從建庫至2020年5月消栓腸溶膠囊治療急性腦梗死的臨床隨機(jī)對(duì)照試驗(yàn)（RCTs），應(yīng)用RevMan 5.3軟件進(jìn)行Meta-分析，最后采用GRADE系統(tǒng)對(duì)重要結(jié)局指標(biāo)進(jìn)行證據(jù)質(zhì)量的評(píng)價(jià)并形成推薦意見。結(jié)果 納入14項(xiàng)RCTs，共1 093例患者。Meta-分析結(jié)果顯示：在改善臨床總有效率方面，消栓腸溶膠囊+常規(guī)治療組優(yōu)于常規(guī)治療組[RR=1.23，95% CI=（1.15，1.32），P<0.000 01]和安慰劑+常規(guī)治療組[RR=1.52，95% CI=（1.14，2.02），P=0.004]；在改善神經(jīng)功能缺損評(píng)分方面，消栓腸溶膠囊+常規(guī)治療組優(yōu)于常規(guī)治療組[MD_NIHSS=-2.70，95% CI=（-3.80，-1.59），P<0.000 01；MD_NDS=-3.87，95% CI=（-4.64，-3.09），P<0.000 01]和安慰劑+常規(guī)治療組[MD_NIHSS=-1.87，95% CI=（-3.27，-0.47），P=0.009]；在改善日常生活能力評(píng)分方面，消栓腸溶膠囊+常規(guī)治療組優(yōu)于常規(guī)治療組[MD=14.60，95% CI=（6.17，23.02），P=0.000 7]和安慰劑+常規(guī)治療組[MD=36.11，95% CI=（27.04，45.18），P<0.000 01]；在不良事件發(fā)生率方面，消栓腸溶膠囊+常規(guī)治療組與常規(guī)治療組比較差異無統(tǒng)計(jì)學(xué)意義[RR=0.86，95% CI=（0.29，2.58），P=0.79]。GRADE系統(tǒng)評(píng)價(jià)臨床總有效率、神經(jīng)功能缺損評(píng)分、日常生活能力評(píng)分，顯示證據(jù)等級(jí)為低或極低，推薦強(qiáng)度均為弱推薦。結(jié)論 消栓腸溶膠囊在改善急性腦梗死患者臨床總有效率、神經(jīng)功能缺損程度及日常生活質(zhì)量方面具有一定的療效，且安全性較好。但因納入研究的文獻(xiàn)質(zhì)量不高，證據(jù)等級(jí)較低，故需要樣本量更大、質(zhì)量更高、設(shè)計(jì)更嚴(yán)格的隨機(jī)對(duì)照試驗(yàn)作進(jìn)一步論證。

Objective To systematically access the efficacy and safety of Xiaoshuan Enteric-coated Capsules for acute cerebral infarction. Methods Databases including CNKI, CBM, VIP, Wanfang Data, Pub Med, Cochrane Library and Web of science were searched to collect randomized controlled trials (RCTs) about Xiaoshuan Enteric-coated Capsules in treatment of patients with acute cerebral infarction from inception to May 2020. The included studies were put into Meta-analysis by RevMan 5.3 software. Finally, Evaluated the evidence quality of major outcome indicators and formed recommendations by the GRADE system. Results A total of 14 RCTs were included 1 093 patients. The results of Meta-analysis showed that the effective rate of Xiaoshuan Enteric-coated Capsules group was superior to routine medicine group[RR=1.23, 95% CI=(1.15, 1.32), P<0.000 01] and placebo group[RR=1.52, 95% CI=(1.14, 2.02), P=0.004]. On the improving of neurological deficit score, Xiaoshuan Enteric-coated Capsules group was better than routine medicine group[MD_NIHSS=-2.70, 95% CI=(-3.80, -1.59), P<0.000 01; MD_NDS=-3.87, 95% CI(-4.64, -3.09), P<0.000 01] and placebo group[MD_NIHSS=-1.87, 95% CI=(-3.27, -0.47), P=0.009]. On the improving activity of daily living score, also showed a better effectiveness of Xiaoshuan Enteric-coated Capsules group than routine medicine group[MD=14.60, 95% CI=(6.17, 23.02), P=0.000 7] and placebo group[MD=36.11, 95% CI=(27.04, 45.18), P<0.000 01]. And the result showed no statistical significance in safety evaluation between Xiaoshuan Enteric-coated Capsules group and routine medicine group[RR=0.86, 95% CI=(0.29, 2.58), P=0.79]. However, the results of the GRADE Evaluation showed that the evidence level of the effective rate, neurological deficit score and activity of daily living score were low or very low. The recommendations strength were weak. Conclusion Although the results support the conclusion that Xiaoshuan Enteric-coated Capsules is safe and superior to routine medicine group or placebo group on the improving the effective rate, neurological deficit score and activity of daily living score, due to the low study quality and low level of evidence, further large sample and high quality RCTs should be carried out.

R969.3;R971

國(guó)家重點(diǎn)研發(fā)計(jì)劃項(xiàng)目（2018YFC1705000；2018YFC1705001）