目的 分析中药治疗肺癌随机对照试验的结局指标，为构建肺癌临床试验的核心指标集提供基础。方法 计算机检索8个数据库。以2009、2014、2018及2019年发表的临床随机对照试验为样本，由2位作者严格按照纳入与排除标准独立筛选文献、提取资料，如有分歧通过讨论解决。结果 纳入654个RCT研究中共包含55024位患者，共采用116个结局指标。单个研究指标数量最少为１个，最多达10个，平均每个研究结局指标的数量为3.1个。654个RCT研究普遍存在结局指标不规范、临床重要性低、测量工具不一致等问题。结论 中药治疗肺癌临床试验结局指标存在较多问题，需要开展核心指标集研究。

Objective To analyze the outcome measures in randomized controlled trials (RCTs) of lung cancer (LC) using Traditional Chinese Medicine (TCM) as an intervention, so as to provide a basis for the development of a core outcome set (COS) for LC using TCM.Methods Online search of 8 databases. Two authors independently screened the literatures and extracted the data with accordance to the inclusion and exclusion criteria from literature published in 2009, 2014, 2018 and 2019. Any differences were resolved via discussion.Results A total of 654 RCTs were included, involving 55024 patients and retrieving a total of 116 outcome measures. The number of outcomes from a single study ranged from 1 to 10, with an average number of outcomes at 3.1. Among the 654 RCT studies, there were existing problems such as outcome is not standardized, poor clinical correlation of outcome measures, lack of TCM characteristic outcomes and inconsistent measurement methods.Conclusion Existing problems were found in outcomes reported from clinical trials of lung cancer for TCM. Thus, it is necessary to develop a set of core outcomes to improve the quality of relevant clinical studies.

R2-031