【目的】 基于世界卫生组织国际临床试验注册平台 （WHO International Clinical Trial Registration Platform，WHO ICTRP） 数据，探讨肺结节临床研究的注册现状与研究趋势。【方法】 检索WHO ICTRP中从建库至2023年5月17日期间注册的肺结节 临床试验数据，提取纳入临床试验的注册时间、试验完成情况、注册中心、注册研究发起国家、研究状态等基本信息，以 及试验类型、试验设计、目标样本量、干预措施、结局指标等数据，并进行归类统计与分析。【结果】 最终纳入肺结节相关 临床试验共 199项，中医药相关肺结节临床试验 10项（5.02%）。2020年至 2021年期间注册的肺结节临床试验数量最多，达 38项（占比19.10%）。39.20%的试验处于研究状态，目标样本量少于1 000例的试验有171项（85.93%）。注册于中国临床试验 注册中心的肺结节试验最多，共95项（47.74%）；由我国发起的肺结节相关临床试验占现有肺结节研究总数的68.34%。在肺 结节临床注册试验中，观察性研究101项（50.75%），干预性研究98项（49.25%）。肺结节临床注册试验的结局指标主要可归 为诊断性指标（128项，64.32%）与有效性指标（50项，25.13%）。【结论】 目前肺结节研究已受到国内外关注，研究数量呈上升 趋势。如何判定肺结节的性质及尽早干预以避免结节恶变，是目前肺结节研究的热点与难点。但目前注册研究信息填写不 规范、结果公开度低、研究设计质量参差不齐，导致目前的研究缺乏严谨性且存在一定的重复性。融入中医药元素建立肺 结节诊疗体系将具有广阔研究空间。

Objective To investigate the register status and research trends of clinical studies on pulmonary nodules based on the data from the World Health Organization International Clinical Trial Registration Platform （WHO ICTRP）. Methods The clinical trials of pulmonary nodules registered from the inception of the WHO ICTRP to May 17， 2023 were retrieved. The data extracted from the included trials covered the basic information of the registration date，completion status，registry platform，nation of the sponsor，and study status，as well as study type， study design， target sample size， interventions， and outcome measures. And then these data were categorized for statistical description and analysis. Results A total of 199 clinical trials of pulmonary nodules were included，of which 10（5.02%） were related to traditional Chinese medicine （TCM） for pulmonary nodules. The number of registered pulmonary nodule trials reached the peak between 2020 and 2021，being 38 trials （19.10%）. Of the 199 clinical trials，39.20% were recruiting，and 85.93% （171 trials） had a target sample size of less than 1000 cases. The trials of pulmonary nodule registered in Chinese Clinical Trial Registry accounted for the highest number （95 trials，47.74%），and the trials sponsored by China constituted approximately 68.34% of all existing pulmonary nodule studies. Of the 199 clinical trials ， there were 101 （50.75%） observational studies and 98（49.25%）interventional studies. The outcome measures of the registered clinical trials were mainly categorized into diagnostic indicators （128 trials， 64.32%） and efficacy indicators （50 trials， 25.13%）. Conclusion Pulmonary nodule research has drawn the attention globally，with the number of studies showing an upward trend. How to define the nature of pulmonary nodules and implementing interventions as early as possible to prevent malignant transformation have become the research hotspots and challenges. However， issues such as nonstandardized registration information entry， low rates of result disclosure， and varying quality of study design contribute to a lack of rigor and a degree of redundancy in the current research. Integrating elements of TCM to establish a diagnosis and treatment system for pulmonary nodules presents a promising area for future research.

R259.639

广州市科技局资助项目--广州市中医药防治慢性咳喘病研究重点实验室项目（编号：2023A03J0226）；广东省中医药局林琳省 名中医传承工作室建设项目（粤中医办函〔2023〕108号）；广东省中医院科学研究技术专项（编号：YN2022QN22）；广州中医药大学“双一流” 与高水平大学学科协同创新团队项目（编号：2021xk27）