目的 分析2012—2025年中医药干预治疗脑卒中后继发癫痫随机对照试验（RCT）中结局指标的使用情况、分布特征及存在问题，为该领域构建规范化结局指标体系提供参考。方法 检索中、英文共7个数据库，按照纳排标准遴选文献，并对所有结局指标进行提取、名称规范化处理、分类归纳及频次统计，并采用描述性分析方法总结其使用现状。结果 初筛获得文献1 182篇，最终纳入70篇。纳入研究的结局指标经规范化处理后共计298次，可归纳为9类，其中发作控制/疾病活动性结局62次（20.81%）、生物标志物及生理参数结局61次（20.47%）、脑电图结局41次（13.76%）、安全性结局36次（12.08%）、神经功能结局23次（7.72%）、其他结局23次（7.72%）、中医证候结局19次（6.38%）、认知功能结局17次（5.70%）及生活质量/生活影响结局16次（5.37%）。现有研究在结局指标设置与报告方面存在较大异质性，主要表现为病情评估维度不够全面、方法学质量有限、中医药特色结局纳入不足、主要与次要结局界定不清、患者报告结局较少，以及经济学与安全性评估报告不充分。结论 目前中医药干预治疗脑卒中后继发癫痫RCT中结局指标的使用尚需完善，未来应提高临床研究的方法学质量，规范结局指标的选择、定义与报告，并探索构建具有中医治疗特色的证候核心指标集，以促进中医药干预的推广。

Objective To analyze the use, distribution characteristics, and existing problems of outcome indicators in randomized controlled trials of traditional Chinese medicine interventions for post-stroke secondary epilepsy from 2012 to 2025, and to provide a reference for constructing a standardized outcome indicator system in this field. Methods Seven Chinese and English databases were searched. The literature was screened according to the inclusion and exclusion criteria, and all outcome indicators were extracted, standardized in nomenclature, categorized, and analyzed by frequency statistics. Descriptive analysis was used to summarize their current application status. Results A total of 1 182 records were identified in the initial screening, and 70 studies were finally included. After standardization, the outcome indicators reported in the included studies totaled 298 occurrences and were classified into nine categories, including seizure control/disease activity outcomes [62 (20.81%)], biomarker and physiological parameter outcomes [61 (20.47%)], electroencephalogram outcomes [41 (13.76%)], safety outcomes [36 (12.08%)], neurological function outcomes [23 (7.72%)], other outcomes [23 (7.72%)], traditional Chinese medicine syndrome outcomes [19 (6.38%)], cognitive function outcomes [17 (5.70%)], and quality of life/life impact outcomes [16 (5.37%)]. Considerable heterogeneity existed in the selection and reporting of outcome indicators in the existing studies, mainly manifested as insufficient comprehensiveness of disease assessment dimensions, limited methodological quality, inadequate inclusion of outcome indicators with traditional Chinese medicine characteristics, unclear distinction between primary and secondary outcomes, insufficient patient-reported outcomes, and inadequate reporting of economic and safety evaluations. Conclusion The use of outcome indicators in randomized controlled trials of traditional Chinese medicine interventions for post-stroke secondary epilepsy still needs to be improved. In the future, the methodological quality of clinical research should be enhanced, the selection, definition, and reporting of outcome indicators should be standardized, and a core outcome set of syndrome indicators with characteristics of traditional Chinese medicine should be explored, so as to promote the application of traditional Chinese medicine interventions.

R971

国家“重大新药创制”科技重大专项（2017ZX09301059）；中国中医科学院研究生科技创新项目（KC2025030）