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银杏叶提取物注射液辅助治疗脑出血疗效和安全性的Meta分析

Mate-Analysis of the Efficacy and Safety of Ginkgo biloba Extract Injection in Adjuvant Treatment of Cerebral Hemorrhage
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摘要 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� Objective:To systematically evaluate the efficacy and safety of Ginkgo biloba extract(GBE)injection in the adjuvant treatment of cerebral hemorrhage.Methods:Randomized controlled trials(RCTs)on the treatment of cerebral hemorrhage with GBE were retrieved from databases such as CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,and Cochrane Library from their inception to September 2021.Data analysis 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 treatment,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(SSQOL)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
作者 宋文硕 牛岳 关运祥 钱仁义 SONG Wenshuo;NIU Yue;GUAN Yunxiang;QIAN Renyi(Henan University of Chinese Medicine,Zhengzhou 450000;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000)
出处 《中药药理与临床》 CAS CSCD 北大核心 2024年第9期101-108,共8页 Pharmacology and Clinics of Chinese Materia Medica
基金 河南省中医药科学研究专项项目(编号:2019ZY2135) 河南省中医药拔尖人才培养项目资助(豫卫中医函【2021】15)。
关键词 银杏叶提取物 脑出血 META分析 脑水肿 认知 炎症因子 Ginkgo biloba extract Cerebral hemorrhage Meta-analysis Cerebral edema Cognition Inflammatory factors
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