目的 系统梳理口服中成药治疗稳定性心绞痛（SAP）随机对照试验（RCT）中结局指标的应用现状，识别存在的问题，旨在规范相关临床研究的结局测量，为未来构建该领域的核心指标集提供循证依据。方法 系统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）和PubMed、Embase、Cochrane Library数据库，纳入近5年（至2026年6月）发表的口服中成药治疗SAP的双臂RCT。由2名研究者独立进行文献筛选及资料提取，采用Cochrane偏倚风险评估工具ROB 2.0评价纳入研究的方法学质量。对提取的结局指标进行同义词合并与标准化处理，并依据《中医药临床试验核心指标集研制技术规范》进行指标域划分及频次统计。结果 共纳入110项RCT，提取出51个结局指标，总报告频次达574次。其中，仅15项RCT（13.64%）明确区分了主要和次要结局，其余95项（86.36%）未作区分。全部指标被归入以下指标域：症状体征指标10种（215次，37.46%）、理化检查指标30种（194次，33.80%）、安全性指标1种（73次，12.72%）、中医病证指标3种（49次，8.54%）、生活质量指标5种（41次，7.14%）、远期预后指标2种（2次，0.35%），未见经济学评估相关指标。在测量时点方面，108项（98.18%）进行了明确报告：其中22项（20.37%）在治疗前、中、后均进行了测量，其余86项（79.63%）仅在治疗前、后进行测量。结论 近5年口服中成药治疗SAP的RCT在整体方法学上存在较高的偏倚风险。现有研究在结局指标选择上存在显著异质性，主、次要终点界定模糊，且缺乏相对统一的测量时点；同时，对安全性、远期预后和卫生经济学评价的关注明显不足。未来亟须加强临床研究顶层设计，并构建适用于口服中成药治疗SAP的核心结局指标集，以减少选择性报告偏倚，提升临床证据的质量与其转化应用价值。

Objective To systematically review the current application of outcomes in randomised controlled trials (RCT) of oral Chinese patent medicines for stable angina pectoris (SAP), identify existing issues, and provide an evidence-based foundation for developing a core outcome set (COS) to standardise outcome assessment in future clinical research. Methods CNKI, Wanfang, VIP, PubMed, Embase, and the Cochrane Library were systematically searched for two-arm RCT of oral Chinese patent medicines for SAP published in the past five years (up to June 2026). Two reviewers independently screened studies and extracted data. Methodological quality was assessed using the Cochrane Risk of Bias tool (ROB 2.0). Extracted outcomes were merged for synonyms, standardised, and classified into domains according to the Technical Specification for the Development of Core Outcome Sets for Traditional Chinese Medicine Clinical Trials, with frequencies calculated accordingly. Results A total of 110 RCT were included, yielding 51 distinct outcomes reported 574 times. Only 15 RCT (13.64%) clearly specified primary and secondary outcomes; the remaining 95 (86.36%) did not. Outcomes were categorised into six domains: Symptom and sign measures (10 types, 215 reports, 37.46%), laboratory/physiological measures (30 types, 194 reports, 33.80%), safety measures (one type, 73 reports, 12.72%), TCM syndromedisease measures (three types, 49 reports, 8.54%), quality of life measures (five types, 41 reports, 7.14%), and long-term prognosis measures (two types, two reports, 0.35%). No studies reported economic evaluation outcomes. Measurement time points were explicitly stated in 108 RCTs (98.18%): 22 (20.37%) measured outcomes before, during, and after treatment, while 86 (79.63%) assessed only pre- and post-treatment. Conclusion RCT of oral Chinese patent medicines for SAP published in the past five years generally exhibit high methodological bias risk. Outcome selection is highly heterogeneous, with unclear distinction between primary and secondary endpoints, inconsistent measurement time points, and insufficient attention to safety, long-term prognosis, and health economics. Future research urgently requires improved top-level study design and the establishment of a COS for oral Chinese patent medicines in SAP to minimise selective reporting bias and enhance the quality and translational value of clinical evidence.

R972

济南市市校融合发展战略工程项目（JNSX2024018）；2025年度山东省青年科技人才托举工程项目（SDAST2025QTB062）；山东省医药卫生科技项目（202303010788）；山东中医药大学临床科研专项（LCKY202415）