Abstract: Background　Alzheimer's disease（AD）is a complex neurodegenerative disease. The therapies of AD bring some heavy burdens to patients and their families at present. The clinical studies on Chinese patent medicines for AD has been increasing in recent years，but the study evidence is still unclear. Objective　To analyze the clinical researches evidence of Chinese patent medicines for Alzheimer's disease in recent 5 years. Methods　The relevant literatures published between January 2019 and December 2024 was systematically searched in 8 electronic databases. The data were presented by combining text descriptions and graphs to clearly reveal the distribution of evidence. Results　A total of 82 clinical trials，30 systematic reviews/Meta-analyses，9 network Meta-analyses，7 guidelines/consensus/clinical pathways，1 overview of systematic review，and 1 health technology assessment were included. The attention of Chinese patent medicines for AD has fluctuated and declined. The clinical study and assessment focused on 21 kinds of Chinese patent medicines，mainly focus including Compound Congrong Yizhi Capsule and Compound Haishe Capsule，and the injection was mainly Ginkgo biloba extract. Clinical studies were mainly single-center and small-sample RCTs，and the quality of literature was generally not high. On the selection of outcome indicators，it mainly focuses on cognitive function，alternative outcomes and quality of life indicators，which lack the characteristics of TCM syndrome differentiation and treatment，and the selection and measurement of outcomes were lack of standardization. The overall quality of systematic review/Meta-analysis were relatively lower，and the quality of methodology，the formulation and reporting standardization of clinical practice guidelines and consensus need to be further improved. Conclusion　Some single-center，small-sample clinical studies have been carried out on the Chinese patent medicines for AD. The multi-center，large-sample and high-quality clinical studies should be further carried out based on the characteristics of AD clinical diagnosis and treatment with Chinese patent medicines in the future，so as to produce high-quality clinical evidence and provide relevant reference for the treatment of AD with Chinese patent medicines.

Key words: Alzheimer's disease, Chinese patent medicines, Clinical studies, Methodology, Evidence mapping

摘要： 背景　阿尔茨海默病（AD）是一种复杂的神经系统退行性疾病，其治疗给患者及家庭带来沉重的负担。近年来中成药治疗AD的临床研究不断增加，但研究的证据支撑情况尚不清楚。目的　分析近5年中成药治疗阿尔茨海默病的临床研究相关证据情况。方法　检索2019年1月—2024年12月的8个中英文数据库（中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统、PubMed、Web of Science、Cochrane Library、Embase数据库）中收录的中成药治疗AD的文献，采用文字结合图表的形式展示证据分布特征。结果　最终纳入临床试验82篇，系统综述/Meta分析30篇，网状Meta分析9篇，指南/专家共识/路径等7篇，系统评价再评价1篇，卫生技术评估1篇。近年来中成药治疗AD的关注度呈波动下降的趋势，临床研究与评价集中于21种中成药，其中对口服中成药复方苁蓉益智胶囊和复方海蛇胶囊关注度最多，注射剂主要为银杏叶提取物。临床研究主要为单中心、小规模的随机对照试验，且文献质量普遍不高。在结局指标选择方面，主要侧重于认知功能指标、替代结局指标和生活质量等指标，指标缺乏中医辨证论治的特色，指标的选择、测量等缺乏规范性。系统综述/Meta分析的整体质量较低，方法学质量以及临床实践指南和专家共识的制定和报告规范性均有待进一步提高。结论　中成药治疗AD已开展了一些单中心、小样本的临床研究，今后需结合中药治疗AD的临床诊疗实践特点进一步开展多中心、大样本、高质量的临床研究，以利于形成高质量的临床证据，为中成药治疗AD提供相关参考。

关键词: 阿尔茨海默病, 中成药, 临床研究, 方法学, 证据图