| 摘要: |
| [目的] 分析针灸治疗阿尔兹海默病（AD）的随机对照试验（RCT）结局指标应用情况，为构建核心指标集、优化中医临床研究方案及提高中医临床研究质量提供参考。[方法] 检索中国知网（CNKI）、万方（Wanfang）、维普（VIP）、中国生物医学文献数据库（SinoMed）、Embase、PubMed、Web of Science、Cochrane Library 国内外8个数据库中针灸治疗AD的RCT文献，检索时间限定为2014年1月1日至2024年10月31日，对纳入研究的基本信息及结局指标进行整理和统计。[结果] 共纳入127项研究，11 122例样本，涉及38项诊断标准，共报告124个结局指标，使用频次共625次。针灸治疗AD的RCT研究目前存在诊断标准不统一、理化检测指标的应用缺乏合理性、受试者受教育水平报告不足、结局指标缺乏中医药特色、安全性评价报告不规范的问题。[结论] 建议未来研究者共同推进构建针灸治疗AD的临床试验核心指标集，有助于降低临床研究方案设计之间的异质性，完善结局指标的应用体系，提高研究结果的严谨性与可靠性。 |
| 关键词: 阿尔兹海默病 针灸 随机对照试验 结局指标 核心指标集 |
| DOI：10.11656/j.issn.1673-9043.2026.09.10 |
| 分类号:R749.1 |
| 基金项目:2023年国家药品监督管理局中医药循证评价重点实验室开放课题项目（KLET2023006）；2024年浙江省“尖兵领雁+X”科技计划项目（2025C02200）。 |
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| Analysis of current status of outcome indicators in a randomized controlled trial of acupuncture for Alzheimer’s disease |
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SUN Shiyun1, CHEN Lingqian1, LI Zhuoyi1, FU Luyao1, HE Kelin2, MA Ruijie1,2
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1.The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China;2.Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China
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| Abstract: |
| [Objective] This study aims to analyze the current situation of outcome indicators in randomized controlled trials（RCTs） of acupuncture treatment for Alzheimer’s disease（AD），so as to provide a reference for constructing core outcome sets（COS），optimizing traditional Chinese medicine（TCM） clinical research protocols，and improving the quality of TCM clinical research. [Methods] The RCTs of acupuncture for the treatment of AD in 8 databases，including CNKI，Wanfang，VIP，SinoMed，Embase，PubMed，Web of Science，and Cochrane Library，which were searched from January 1，2014 to October 31，2024. The basic information and outcome indicators of the included studies were statistically collected. [Results] A total of 127 studies with a sample of 11 122 patients involving 38 diagnostic criteria were included，and a total of 124 outcome indicators were reported，with a total frequency of 625 uses. At present，the RCT studies of acupuncture in the treatment of AD have some problems，such as inconsistent diagnostic criteria，lack of rationality in the application of physical and chemical examination indicators，insufficient reporting of participants’ education level，lack of TCM characteristics in outcome indicators，and non-standard safety evaluation reports. [Conclusion] It is suggested that future investigators should jointly promote the construction of the COS of clinical trials for the treatment of AD with acupuncture，which is helpful to reduce the heterogeneity between clinical research protocol design，improve the application system of outcome indicators，and improve the rigor and reliability of research results. |
| Key words: Alzheimer's disease acupuncture randomized controlled trial outcome indicator core outcome set |
