Traditional Chinese acupuncture has been widely applied for the treatment of knee osteoarthritis (KOA) with outstanding efficacy. However, recognized and unified outcome indicators remain to be absent, which impedes the translation of research into high-quality clinical evidence. Therefore, the establishment of core outcome indicators for acupuncture in KOA is conducive to enhance the scientific rigor, rationality, and feasibility of clinical research programs in traditional Chinese medicine (TCM) , provide higher quality evidence-based basis for clinical research.

To analyze the current status of the application of outcome indicators in randomized controlled trials (RCTs) of acupuncture for KOA, so as to provide a basis for the assessment method of clinical efficacy.

PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfang, VIP and SinoMed were searched for clinical RCTs of acupuncture in the treatment of KOA from 2003 to 2022. Two researchers screened and extracted the characteristics of literature. The indicator domain, measurement tools and the time point of measurement of RCTs of acupuncture for KOA were analyzed.

A total of 131 papers were included, with a sample size of 22 726 cases and 89 outcome indicators, which were classified into 40 (44.9%) items for symptoms and signs, 22 (24.7%) items for physical and chemical examinations, 5 (5.6%) items for quality of life, 5 (5.6%) items for psychological state, 3 (3.4%) items for satisfaction evaluation, 2 (2.2%) items for safety indicators, and 12 (13.5%) items for other indicators. Among the 131 articles, 23 measurement time points were included in the 131 articles, ranging from 1 hour to 3 years after treatment, 106 (80.9%) articles used "clinical efficacy" as the outcome indicator, 23 (17.6%) articles used safety evaluation and adverse event reports.

There are some problems in the use of outcome indicators in the RCTs of acupuncture for KOA, such as large variation in the use of outcome indicators, confounding of primary and secondary indicators, abuse of index combination, irregular use of composite indexes, inadequate safety evaluation, irregular measurement time points, insufficient evaluation of long-term prognosis, and failing to reflect the characteristics of TCM intervention of acupuncture. Future research should combine treatment based on syndrome differentiation characteristics of TCM, to evaluate the efficacy of acupuncture in the treatment of KOA by using scientific and reasonable outcome indicators. It is urgent to establish the core indicators set of TCM in the treatment of KOA, and to construct a standardized and recognized COS-TCM.

中医针刺已被广泛用于膝骨关节炎（KOA）治疗且疗效突出，但缺乏公认、统一的结局指标，无法使研究结果转化为高质量的临床证据，构建针刺治疗KOA的核心结局指标集有利于提高中医临床研究方案的科学性、合理性和可行性，为临床研究提供更高质量循证依据。

通过分析目前针刺治疗KOA随机对照试验（RCT）结局指标的使用现状，为针刺治疗KOA的临床疗效评价方法提供依据。

检索PubMed、Cochrane Library、Embase、Web of Science、中国知网（CNKI）、万方数据知识服务平台、维普中文期刊全文数据库（VIP）、中国生物医学文献数据库（SinoMed）中有关针刺方法治疗KOA的临床RCT，检索时间为2003—2022年。由2名研究者筛查文献，提取文献特征，并分析针灸治疗KOA的RCT指标域、测量工具、测量时点。

共纳入131篇文献，样本量22 726例，共使用89个结局指标，将结局指标进行分类：症状体征类40项（44.9%）、理化检查类22项（24.7%）、生活质量类5项（5.6%）、心理状态指标5项（5.6%）、满意度评价3项（3.4%）、安全性指标2项（2.2%）、其他指标12项（13.5%）。131篇文献中，共包含23个测量时间点，研究时间跨度为治疗后1 h~3年；106篇（80.9%）文献使用了"临床疗效"作为结局指标；23篇（17.6%）文献进行了安全性评价及不良事件报告。

针刺治疗KOARCT结局指标存在使用差异大、不分主次结局、指标组合随意性高、复合指标使用欠规范、安全性指标使用欠缺、结局指标测量时间点欠规范、远期预后评价不足、没有体现针刺的中医药干预治疗特色等问题。之后相关研究应结合中医药辨证论治特色，选用科学合理的结局指标来评价针刺治疗KOA的疗效，并且亟须建立中医药治疗KOA的核心指标集，构建规范公认的中医药核心指标集。