系统整理近10年发表的中药治疗干燥综合征的随机对照试验（RCT），分析中药临床试验的研究特征和结局指标，为中医药治疗干燥综合征的RCT的设计提供参考，为中医药治疗干燥综合征临床研究的核心指标集的构建奠定基础。方法 检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、维普生物医学数据库（VIP）、中国生物医学文献数据库（Sino Med）、PubMed、EMbase、Cochrane Library及Web of Science、Springer国内外电子数据库自2015年1月1日—2025年3月10日收录的有关中药治疗干燥综合征的RCT，总结研究特征与结局指标，为优化临床试验设计及构建核心指标集提供依据。结果 共纳入96项RCT，涉及7 268例患者，干预疗程为3～24周。50项研究报告随机方法，仅5项采用双盲设计；结局指标分析显示，指标域共5类，其中中医病症结局指标共2种（53次，6.00%）、症状/指征结局指标21种（249次，28.20%）、理化指标57种（396次，44.85%）、生活质量结局指标6种（11次，1.25%）；安全性事件结局指标9种（174次，19.71%）。使用频次前6位的效应指标分别为免疫球蛋白G(IgG,62次，7.02%)、血沉（ESR,55次，6.23%）、临床（总）有效率（51次，5.78%）、C反应蛋白（CPR,47次，5.32%）、中医症状积分（39次，4.42%）及干燥综合征疾病活动指数（ESSDAI,36次，4.08%）。结论 分析结果揭示了当前中药治疗干燥综合征的RCT在研究设计方面存在随机化不严谨、盲法缺失及样本量估算依据不足等问题，影响结果可靠性；在结局指标方面，存在指标数量与频次差异大、主次界定模糊、中医药特色指标缺失、疗效评价标准不统一、测量时点不一致、生物学指标与中医理论脱节，以及安全性报告不充分等问题，需要通过多中心协作制定辨证分型与具有中医药特色的核心结局指标集，明确关键评价指标，以提高中医药研究的质量与循证强度。

To collect the randomized controlled trials（RCT） of traditional Chinese medicine in the treatment of Sjögren’s syndrome（SS） published in the past decade, and analyze the research characteristics and outcome indicators of clinical trials of traditional Chinese medicine, provided a reference for the design of randomized controlled trials of traditional Chinese medicine in the treatment of SS, and laid the foundation for the construction of the core indicator set of traditional Chinese medicine in the treatment of SS. Methods Through China National Knowledge Infrastructure（CNKI）, WanFang Data Knowledge Service Platform, VIP, Sinomed Biomedical Literature Service System, PubMed, EMbase, Cochrane Library and Web of Science Randomized controlled trials on the treatment of SS with traditional Chinese medicine included in Springer’s domestic and international electronic databases from January 1, 2015 to March 10, 2025, and the basic information and outcome index information of the literatures that met the criteria were statistically analyzed. Results Ultimately, 96 RCT were included, with a total sample size of 7 268 cases, reporting eight types of intervention courses ranging from three weeks to 24 weeks. The analysis of outcome measures revealed that there were five categories of outcome domains, including two TCM syndrome outcome measures（53 times, 6.00%）, 21 symptom/indicator outcome measures（249 times, 28.20%）, 57 physical and chemical indicators（396 times, 44.85%）, 6 quality of life outcome measures（11 times, 1.25%）, and 9 safety event outcome measures（174 times, 19.71%）. The top six most frequently used indicators were immunoglobulin G（62 times, 7.02%）, erythrocyte sedimentation rate（55 times, 6.23%）, clinical（total） effective rate（51 times, 5.78%）, C-reactive protein（47 times, 5.32%）, TCM symptom score（39 times, 4.42%）, and the EULAR Sjögren’s Syndrome Disease Activity Index（ESSDAI）（36 times, 4.08%）. Conclusion The current RCT on TCM treatment of Sjogren’s syndrome have problems such as non-rigorous randomization, lack of blinding, and insufficient basis for sample size estimation, which affect the reliability of the results. In terms of outcome measures, there are problems such as large differences in the number and frequency of indicators, unclear primary and secondary indicators, lack of TCM characteristic indicators, inconsistent evaluation standards for efficacy, inconsistent measurement time points, disconnection between biological indicators and TCM theory, and insufficient safety reporting. It is necessary to establish a core outcome set for TCM treatment of SS through multi-center collaboration, including syndrome differentiation and TCM characteristic indicators, to clarify key evaluation indicators and improve the quality and evidence strength of TCM research.

R285.5

国家自然科学基金资助项目(81874465); 河南省中医药科学研究专项课题(2023ZY1010); 河南省科技攻关项目(252102311247); 国家中医药管理局科技专项课题立项(河南省)(GZY-KJS-2025-080); 河南省卫生健康委员会国家中医药传承创新中心联合共建项目(2024ZXZX1188)