摘要
目的系统评价银杏叶相关制剂对阿尔茨海默病的疗效及安全性。方法检索PubMed、Web of Science、Embase、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)和万方数据库关于银杏叶制剂治疗阿尔茨海默病的临床随机对照试验(RCT)。检索时限为建库-2019年10月29日,两名评估人员独立筛选文献,进行质量评价,统计学分析采用RevMan 5.3.5软件。结果共纳入21篇RCTs,涉及1 643例患者。Meta-分析结果显示:(1)银杏叶制剂较胞二磷胆碱可更有效改善简易精神状态量表(MMSE)[MD=3.80,95%CI(2.05,5.55),P<0.000 1]、日常生活功能量表(ADL)评分[MD=-3.30,95%CI(-4.75,-1.85),P<0.000 01]及总有效率[OR=3.69,95%CI(1.87,7.27),P=0.000 2];(2)基础治疗或其他药物联用银杏叶制剂较仅基础治疗或单用其他药物可更有效改善MMSE [MD=2.68,95%CI(2.35,3.02),P<0.000 01]、ADL评分[MD=-3.48,95%CI(-4.36,-2.60),P<0.000 01]及总有效率[OR=3.50,95%CI(1.09,11.22),P=0.03];(3)与安慰剂或无干预措施相比,银杏叶制剂可有效改善MMSE[MD=1.82,95%CI(0.33,3.32),P=0.02]、ADL评分[MD=-7.00,95%CI(-10.93,-3.07),P=0.000 5];(4)多奈哌齐联用银杏叶制剂较其单药治疗可显著改善MMSE[MD=1.82,95%CI(0.33,3.32),P=0.02]、ADL评分[MD=-4.29,95%CI(-5.58,-2.99),P<0.000 01]及总有效率[OR=2.95,95%CI(1.42,6.13),P=0.004];(5)单用银杏叶制剂改善MMSE[MD=-1.79,95%CI(-2.39,-1.20),P<0.000 01]及总有效率[OR=0.15,95%CI(0.08,0.30),P<0.000 01]作用显著低于单用多奈哌齐。结论银杏叶制剂辅助治疗阿尔茨海默病疗效确切,且不良反应发生无明显差异。
Objective To systematically evaluate the efficacy and safety of extract of Ginkgo biloba preparations(EGb) for Alzheimer’s disease. Methods A randomized controlled trial(RCT) of EGb for Alzheimer’s disease was conducted on PubMed, Web of Science, Embase, CBM, CNKI, VIP and Wanfang databases from inception to October 29, 2019. Two evaluators independently screened the literature for quality evaluation, and RevMan 5.3.5 software was used for statistical analysis. Results A total of 21 RCTs were included, including 1 643 patients. Meta-analysis results showed:(1) Compared with citicoline, EGb can improve MMSE [MD = 3.80, 95%CI(2.05, 5.55), P < 0.000 1], ADL scores [MD =-3.30, 95%CI(-4.75,-1.85), P < 0.000 01] and total effective rate [OR = 3.69, 95%CI(1.87, 7.27), P = 0.000 2] more effectively;(2) Compared with the use of only basic treatment or other drugs alone, the combination of EGb can improve MMSE [MD = 2.68, 95%CI( 2.35, 3.02), P < 0.000 01], ADL score [MD =-3.48, 95%CI(-4.36,-2.60), P < 0.000 01] and total effective rate [OR = 3.50, 95%CI(1.09, 11.22), P = 0.03] more effectively;(3)Compared with placebo or no intervention, EGb can effectively improve MMSE [MD = 1.82, 95%CI(0.33, 3.32), P = 0.02] and ADL scores [MD =-7.00, 95%CI(-10.93,-3.07), P = 0.0005];(4) Compared with donepezil monotherapy, the combination of donepezil and EGb can improve MMSE[MD = 1.82, 95%CI(0.33, 3.32), P = 0.02], ADL scores [MD =-4.29, 95%CI(-5.58,-2.99),P < 0.000 01] and total effective rate[OR = 2.95, 95%CI(1.42, 6.13), P = 0.004] more effectively;(5) EGb has a significantly lower effect on the MMSE score[MD =-1.79, 95%CI(-2.39,-1.20), P < 0.000 01] and total effective rate [OR =0.15, 95%CI(0.08, 0.30),P < 0.000 01] than donepezil. Conclusions EGb are effective in the treatment of Alzheimer’s disease, and there is no significant difference in adverse reactions.
作者
杜荣蓉
秦祉祎
曲连悦
林建阳
DU Rongrong;QIN Zhiyi;QU Lianyue;LIN Jianyang(Department of Pharmacy,The First Affiliated Hospital of China Medical University,Shenyang 110001,China;College of Pharmaceutical Science,China Medical University,Shenyang 110122,China;Department of Pharmacy,Northern Theater General Hospital,Shenyang 110000,China)
出处
《药物评价研究》
CAS
2020年第4期765-772,共8页
Drug Evaluation Research
基金
国家自然科学基金青年科学基金项目(81302841)
辽宁省高等学校优秀人才支持计划(LJQ2014086)。
关键词
银杏叶制剂
阿尔茨海默病
META-分析
系统评价
Extract of Ginkgo biloba(EGb)
Alzheimer’s disease
Meta-analysis
systematic review
