目的:系统评价银杏叶提取物注射液辅助治疗脑出血的疗效和安全性.方法:检索知网、万方、维普、SinoMed及PubMed、Embace、Cochrane Library等数据库从建库到2021年9月收录有关银杏叶提取物治疗脑出血的随机对照试验.Rev Man 5.4数据分析,结局指标的证据质量分级采用GRADE系统.结果:共检索文献192篇,最终纳入16篇文献,共1435例脑出血患者,其中试验组718例,对照组717例.Meta分析结果显示,同内科保守治疗相比,联用银杏叶提取物注射液,有以下几个方面的功效:①能提高临床有效率(RR=1.21,95％CI[1.14,1.29],P<0.01);②能降低神经功能缺损评分(MD=-5.36,95％CI[-6.90,-3.81],P<0.01;MD=-4.41,95％CI[-5.23,-3.60],P<0.01);③能减小脑血肿体积(MD=-4.13,95％CI[-5.75,-2.51],P<0.01);④能减小脑水肿体积(MD=-4.34,95％CI[-5.78,-2.90],P<0.01);⑤能提高日常生活活动能力(ADL)(MD=11.99,95％CI[9.85,14.13],P<0.01);⑥能改善蒙特利尔认知功能评分(MD=5.33,95％CI[2.53,8.13],P<0.01);⑦能降低hs-CRP(MD=-6.03,95％CI[-10.26,-1.81],P<0.01;IL-6的MD=-8.56,95％CI[-15.92,-1.20],P<0.05;IL-8[MD=-10.99,95％CI[-13.14,-8.85],P<0.01];TNF-α[MD=-18.26,95％CI[-34.31,-2.22],P<0.05)];⑧在安全性方面,未发现联用银杏叶提取物注射液有增加不良反应的风险.同手术治疗相比,联用银杏叶提取物注射液,具有以下几个方面的优势:①能提高临床有效率(RR=1.30,95％CI[1.21,1.51],P<0.01);②能提高卒中专用生活质量(SS-QOL)(MD=23.14,95％CI[14.06,32.21],P<0.01);③能提高日常生活活动能力(MBI)(MD=11.39,95％CI[5.34,17.43],P<0.01);④能降低炎症指标hs-CRP(MD=-0.66,95％CI[-0.95,-0.37],P<0.01;IL-6[MD=-14.97,95％CI[-19.97,-9.98],P<0.01)];TNF-α[MD=-16.12,95％CI[-20.68,-11.56],P<0.01)].结论:银杏叶提取物注射液联合西医常规治疗或手术治疗,对脑出血均有较好的疗效和安全性,可提高临床有效率、提高日常生活活动能力、提高卒中生活质量、改善蒙特利尔认知功能评分,降低脑水肿、脑血肿体积,降低神经功能缺损评分,降低炎症指标,且安全性较好.
Mate-Analysis of the Efficacy and Safety of Ginkgo biloba Extract Injection in Adjuvant Treatment of Cerebral Hemorrhage
Objective:To systematically evaluate the efficacy and safety of Ginkgo biloba extract (GBE) injection in the adjuvant treatment of cere-bral hemorrhage.Methods:Randomized controlled trials (RCTs) on the treatment of cerebral hemorrhage with GBE were retrieved from data-bases such as CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,and Cochrane Library from their inception to September 2021.Data a-nalysis was conducted using RevMan 5.4,and the quality of evidence for outcome indicators was graded using the GRADE system.Results:A total of 192 articles were retrieved,and 16 articles were finally included,covering 1435 patients with cerebral hemorrhage,including 718 in the experimental group and 717 in the control group.Meta-analysis results showed that compared with internal medical conservative treat-ment,the combined use of GBE injection could increase clinical efficacy (RR=1.21,95％ CI[1.14,1.29],P<0.01),decrease neurological deficit scores (MD=-5.36,95％ CI[-6.90,-3.81],P<0.01;MD=-4.41,95％ CI[-5.23,-3.60],P<0.01),reduce cerebral hematoma volume (MD=-4.13,95％ CI[-5.75,-2.51],P<0.01),decrease brain edema volume (MD=-4.34,95％ CI[-5.78,-2.90],P<0.01),improve activities of daily living (ADL) (MD=11.99,95％ CI[9.85,14.13],P<0.01),enhance Montreal Cognitive Assessment (MoCA) scores (MD=5.33,95％ CI[2.53,8.13],P<0.01),and reduce inflammatory indicators (MD=-6.03,95％ CI[-10.26,-1.81],P<0.01;MD=-8.56,95％ CI[-15.92,-1.20],P<0.05;MD=-10.99,95％ CI[-13.14,-8.85],P<0.01;MD=-18.26,95％ CI[-34.31,-2.22],P<0.05).In terms of safety,there was no increased risk of adverse reactions associated with the use of GBE injection.Compared with surgical treatment,the combined use of GBE injection could increase clinical efficacy (RR=1.30,95％ CI[1.21,1.51],P<0.01),improve Stroke-Specific Quality of Life (SS-QOL) scores (MD=23.14,95％ CI[14.06,32.21],P<0.01),enhance Modified Barthel Index (MBI) of ADL (MD=11.39,95％ CI[5.34,17.43],P<0.01),and reduce inflammatory indicators (MD=-0.66,95％ CI[-0.95,-0.37],P<0.01;MD=-14.97,95％ CI[-19.97,-9.98],P<0.01);MD=-16.12,95％ CI[-20.68,-11.56],P<0.01).Conclusion:GBE injection,when com-bined with conventional western medicine treatment or surgical treatment,exhibits favorable efficacy and safety in treating cerebral hemor-rhage.It can enhance clinical efficacy,ADL,stroke-specific quality of life,MoCA scores,reduce brain edema and hematoma volume,decrease neurological deficit scores,reduce inflammatory indicators,and maintain a good safety profile.
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