Tong Kang, Lian QiaoYing, Tang Wen, Chen Xingyu, Chen Fang, Wang Zhibin, Qiao Shijie, Han Hairui, Yang Chaoyang
College of Traditional Chinese Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
Department of Traditional Chinese Medicine, Xiamen Third Hospital, Xiamen, China.
Medicine (Baltimore). 2025 Aug 29;104(35):e43988. doi: 10.1097/MD.0000000000043988.
This narrative review systematically analyzes outcome indicators in clinical research on traditional Chinese medicine (TCM) interventions for dry eye, aiming to analyze current methodological patterns and establish foundations for core outcome set development. Through comprehensive searches across Chinese (China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang) and English databases (PubMed, Cochrane Library, Embase), 863 clinical studies were identified and analyzed for outcome indicator usage. Forty-six distinct outcome indicators were documented, cumulatively appearing 3885 times across 6 categories. The most frequently employed metrics were tear film break-up time (772 times), Schirmer test (753 times), and corneal fluorescein staining (559 times). Significant methodological concerns emerged, including marginalization of TCM-specific indicators, nonstandardized outcome reporting, substantial heterogeneity in indicator combinations lacking theoretical justification, poor clinical applicability, and absence of economic evaluations. The findings underscore the urgent need to develop a standardized core outcome set for TCM dry eye research to enhance methodological rigor, strengthen evidence synthesis, and optimize the integration of TCM's therapeutic advantages in dry eye management.
本叙述性综述系统分析了中医干预干眼症临床研究中的结局指标，旨在剖析当前的方法学模式，并为核心结局集的制定奠定基础。通过全面检索中文数据库（中国知网、维普中文科技期刊数据库、万方）和英文数据库（PubMed、Cochrane图书馆、Embase），共识别并分析了863项关于结局指标使用情况的临床研究。记录了46种不同的结局指标，累计在6个类别中出现3885次。使用最频繁的指标是泪膜破裂时间（772次）、泪液分泌试验（753次）和角膜荧光素染色（559次）。出现了一些重大的方法学问题，包括中医特有指标被边缘化、结局报告不规范、指标组合存在大量缺乏理论依据的异质性、临床适用性差以及缺乏经济学评价。研究结果强调，迫切需要为中医干眼症研究制定标准化的核心结局集，以提高方法学的严谨性、加强证据综合，并优化中医在干眼症管理中的治疗优势整合。
