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| 中医药治疗糖尿病视网膜病变随机对照试验结局指标的现状分析 |
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尹子豪1,2, 王晓磊2, 周晖2, 杨泽佩2, 谢文莹1,2, 李文慧1,2, 吴长江1,2, 郝利伟1,2, 张可京3, 张莘婕4, 张涛静2
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1.北京中医药大学, 北京 100029;2.北京中医药大学东方医院, 北京 100078;3.北京中医药大学东直门医院, 北京 100700;4.山西中医药大学, 晋中 030619
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| 摘要: |
| [目的] 系统梳理中医药治疗糖尿病视网膜病变（DR）随机对照试验（RCT）的结局指标应用现状，为构建中医药治疗DR的核心指标集（COS）提供参考。[方法] 计算机检索中国知网（CNKI）、万方知识服务平台（Wanfang Database）、维普数据库（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、Cochrane Library、Web of Science共7大数据库由建库至2025年2月27日发表的文献，并用Cochrane偏倚风险评估工具评价文献偏倚风险，提取文献信息至Excel表格中并进行描述性分析。[结果] 最终纳入423篇RCTs，汇总得到385种结局指标，共计使用2 830次。结局指标在7大指标域中的分布依次为：中医病证（4种，129次）、临床症状/体征（158种，1 205次）、理化检测（197种，1 326次）、生活质量（13种，22次）、远期预后（8种，31次）、安全性事件（5种，117次）、经济学评估（0种，0次）。纳入文献存在以下问题：偏倚风险欠控制，多数文献随机序列产生方法、分配隐藏、盲法未明确；中医辨证分型术语繁杂，证型名称不统一；指标名称指代不明确，使用不规范；经济学指标缺失，经济负担不明；复合结局指标误用，判断标准欠客观；主次结局指标不明，总体可信度待提升。[结论] 当前中医药研究DR的RCT仍存在不足，建议构建中医药治疗DR的COS，提升未来研究质量，推动中医药国际化发展。 |
| 关键词: 中医药 糖尿病视网膜病变 随机对照试验 结局指标 核心指标集 |
| DOI：10.11656/j.issn.1672-1519.2026.07.08 |
| 分类号:R587.1 |
| 基金项目:国家自然科学基金面上项目（82374268）；中国中医药科技发展中心中西医协同慢病管理研究项目（CXZH2024117）。 |
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| Current status analysis of outcomes in randomized controlled trials of traditional Chinese medicine in treatment of diabetic retinopathy |
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YIN Zihao1,2, WANG Xiaolei2, ZHOU Hui2, YANG Zepei2, XIE Wenying1,2, LI Wenhui1,2, WU Changjiang1,2, HAO Liwei1,2, ZHANG Kejing3, ZHANG Xinjie4, ZHANG Taojing2
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1.Beijing University of Chinese Medicine, Beijing 100029, China;2.Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China;3.Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China;4.Shanxi University of Traditional Chinese Medicine, Jinzhong 030619, China
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| Abstract: |
| [Objective] To systematically sort out the current application status of outcome indicators in randomized controlled trials （RCTs）of traditional Chinese medicine in the treatment of diabetic retinopathy（DR），and to provide reference for the construction of a core outcome set（COS）for traditional Chinese medicine treatment of DR. [Methods] A computer-based search was conducted in 7 major databases，including CNKI，Wanfang Database，VIP，SinoMed，PubMed，Cochrane Library，and Web of Science，for literatures published from the establishment of the databases to February 27，2025. The Cochrane Risk of Bias Assessment Tool was used to evaluate the risk of bias in the literatures，and the literature information was extracted into Excel spreadsheets for description. [Results] A total of 423 RCTs were finally included，with 385 types of outcome indicators summarized，used a total of 2 830 times. The distribution of outcome indicators in the 7 major indicator domains was as follows：traditional Chinese medicine syndromes（4 types， 129 times），clinical symptoms/signs（158 types，1 205 times），physical and chemical tests（197 types，1 326 times），quality of life （13 types，22 times），long-term prognosis（8 types，31 times），safety events（5 types，117 times），and economic evaluation（0 type， 0 time）. The included literatures had the following problems：insufficient control of bias risk，with the methods of random sequence generation，allocation concealment，and blinding not clearly stated in most literatures；complicated terminology for traditional Chinese medicine syndrome differentiation and classification，with inconsistent names of syndromes；unclear reference and non-standard use of indicator names；lack of economic indicators，leading to unclear economic burden；misuse of composite outcome indicators and lack of objectivity in judgment criteria；unclear primary and secondary outcome indicators，resulting in the need to improve the overall credibility. [Conclusion] At present，there are still deficiencies in RCTs of traditional Chinese medicine research on DR. It is suggested to construct a COS for traditional Chinese medicine treatment of DR to improve the quality of future research and promote the international development of traditional Chinese medicine. |
| Key words: traditional Chinese medicine diabetic retinopathy randomized controlled trial outcomes indicator core outcome set |
