目的 运用网状Meta分析评价中成药用于辅助治疗阿尔茨海默病的疗效及安全性。方法 计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方、中国生物医学文献数据库(CBM)收录的口服中成药治疗阿尔茨海默病的随机对照试验,检索时限为各数据库建库至2022年4月。2名研究员独立进行文献筛选、数据提取并对纳入的研究进行质量评价,应用Stata 16对数据进行传统Meta分析以及网状Meta分析。结果 最终纳入35项研究,包括复方海蛇胶囊、天智颗粒、银杏叶、六味地黄丸等8种中成药。网状Meta分析结果显示,(1)认知评估:在改善简易智力状态评分方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>红景天胶囊联合处方药>六味地黄丸联合处方药;在改善阿尔茨海默病评估量表-认知方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>复方丹参片联合处方药。(2)在治疗总有效率方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(3)在提高日常生活活动能力方面,最优的前3种干预措施为银杏叶联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(4)在不良反应方面,不良反应发生较少的前3种方案为天智颗粒联合处方药>复方海蛇胶囊联合处方药>银杏叶联合处方药。结论 中成药联合胆碱酯酶抑制剂或谷氨酸受体拮抗剂可有效改善阿尔茨海默病患者的认知功能、提高日常生活活动能力,治疗效果均优于单用处方药,且安全性较好,未观察到有明显增加不良反应发生的风险。但纳入的研究方法学质量普遍偏低,故结论仍待更多大样本、高质量的研究进一步验证。

Objiective To evaluate the efficacy and safety of Chinese patent medicines in adjuvant treatment of Alzheimer's disease by network Meta-analysis.Methods PubMed,Web of Science,Embase,Cochrane Library,China National Knowledge Infrastructure (CNKI),Wanfang,China Biomedical Literature Database (CBM) were searched for randomized controlled trials of oral Chinese patent medicines in the treatment of Alzheimer's disease,the search time limit was from the establishment of each database to April 2022.Two researchers independently screened literature,extracted data,and evaluated the quality of the included studies.Stata 16 was used to perform Meta-analysis and network Meta-analysis.Results A total of 35 studies were finally included,including eight kinds of Chinese patent medicines including Compound Haishe Capsules (复方海蛇胶囊),Tianzhi Granules (天智颗粒),Ginkgo biloba leaf,Liuwei Dihuang Pills (六味地黄丸),etc.The results of the network Meta-analysis showed that:(1) Cognitive assessment:In terms of improving the mini-mental state exam,the top three optimal interventions were Compound Congrong Yizhi Capsules (复方苁蓉益智胶囊) combined with prescription drugs>Hongjingtian Capsules (红景天胶囊) combined with prescription drugs>Liuwei Dihuang Pills combined with prescription drugs;In terms of improvement of Alzheimer's disease assessment scale-cognition:The top three optimal interventions were Compound Congrong Yizhi Capsules combined with prescription drugs>Compound Haishe Capsules combined with prescription drugs>Compound Danshen Tablets combined with prescription drugs.(2) In terms of treatment total effective rate,the top three optimal intervention were Compound Congrong Yizhi Capsules combined with prescription drugs>Compound Haishe Capsules combined with prescription drugs>Tianzhi Granules combined with prescription drugs.(3) In terms of improving activities of daily living,the top three optimal interventions wereGinkgo biloba leaf combined with prescription drugs>Compound Haishe Capsules combined with prescription drugs>Tianzhi Granules combined with prescription drugs.(4) In terms of adverse reactions,the top three regimens with less adverse reactions were Tianzhi Granules combined with prescription drugs>Compound Haishe Capsules combined with prescription drugs>Ginkgo biloba leaf combined with prescription drugs.Conclusion The results show that Chinese patent medicine combined with cholinesterase inhibitors or glutamate receptor antagonists could effectively improve the cognitive function and activities of daily living in Alzheimer's disease patients.The therapeutic effect was better than that of single prescription drugs,and the safety is better.No significant increase in the risk of adverse reactions had been observed.However,due to the low methodological quality of the included studies,the conclusions still need to be further verified by more high-quality studies.

R285.64

国家自然科学基金青年基金项目(81303028);山东省科技发展计划(2014GSF119038);济南市科技创新发展计划(202019027,201805083);山东省中医药科技发展计划(2017-040,2019-0107,2019-0094,2017-037);山东中医药大学附属医院首批青年科研创新团队项目