Background Oral traditional Chinese medicine(TCM)has been widely used in the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD),but the outcome measures of relevant clinical trials have not been standardized and regulated.Objective To screen the published randomized controlled trials(RCTs)of oral TCM in the treatment of AECOPD,summarize the literature characteristics and outcome measures,so as to provide reference for the design of clinical trials and the selection of outcome measures for the treatment of AECOPD with TCM.Methods CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Web of Science,Cochrane Library,Clinical Trials.gov and Chinese Clinical Trial Registry were systematically searched by computer to obtain RCTs and clinical trial registration protocols for the treatment of AECOPD with oral TCM from January 2018 to October 2022.After independent screening of the literature and extraction of data by 2 researchers,qualitative analysis was used to describe the selection of outcome measures in the enrolled studies.Results A total of 578 studies were enrolled,including 574 RCTs with reported trial results and 4 clinical trial registration protocols.A total of 51 508 patients were involved in 574 RCTs.In the inclusion criteria,88 studies limited the classification of disease,and 361 studies limited the TCM syndrome type,6 studies reported the blinding method,and 6 studies mentioned the follow-up.A total of 4 030 outcome measures were covered and the number of outcome measures in a single article ranged from 1 to 24.According to the functional attributes,the outcome measures were classified into 8 measure domains:TCM symptoms/syndromes,symptoms/signs,physical and chemical tests,quality of life,long-term prognosis,economic evaluation,safety evaluation and others.The measure domain with the highest reporting rate was physical and chemical tests,and the top 5 outcome measure items reported in terms of frequency were:response rate(11.5%),forced expiratory volume in 1 s(FEV1)(7.5%),TCM symptom/syndrome score(7.0%),FEV1/Forced Vital Capacity(FVC)(6.8%),FVC(4.6%).Four hundred and forty-five studies reported the composition of response rate,and the top 5 measures with reporting rate were symptoms(423),signs(281),TCM syndrome score(203),laboratory tests(89),and pulmonary function(71).Conclusion The RCTs of oral TCM in the treatment of AECOPD involved a large number and a wide range of outcome measures.The included literature focused on the effects of oral TCM on the symptoms and signs,physical and chemical test indicators,quality of life,long-term prognosis,economic evaluation and safety outcomes of patients with AECOPD in varying degrees.However,the selection of outcome measures remains problematic in multiple ways:unclear prioritization of outcome measures;focusing on clinical endpoints with insufficient attention to clinical endpoints;insufficient attention to health economics indicators;different sources and judgment criterias of reference of response.In the future studies,researchers can design the rational outcome measures by refering to the published core outcome set(COS)to improve the quality of TCM clinical research.

[目的]探析"虚气留滞"理论辨治肺部结节的核心病机观内涵,为肺部结节的预防和治疗拓展思路.[方法]基于王永炎院士根据其多年脑病学临床实践经验提出的"虚气留滞"理论,通过查阅中医古籍和现代文献资料,搜集部分医家对于"虚气留滞"理论的学术观点,并结合临床实践经验总结,探讨肺部结节的核心病机.[结果]"虚气留滞"理论符合肺部结节起病隐匿、病程日久等临床发病特征及病机要点,虚实夹杂、本虚标实是肺部结节的病机特点,正气亏虚(虚气)是肺部结节发病的内在病机基础,是发病之本;气机阻滞、痰瘀凝聚、毒邪损肺(留滞)是该病发生与发展的重要环节,是发病之标;"虚气"与"留滞"互为因果,相互影响,共同致病.[结论]基于"虚气留滞"理论,探讨肺部结节核心病机合理可靠.建立肺部结节辨证体系,有助于弥补现代医学对肺部结节诊治体系的不足,可为今后中医药早期干预与治疗肺部结节提供更为广阔的思路和方法,提高临床疗效.