摘要
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 in2009,2014,2018 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.
作者
李凯
张俊华
张明妍
牛柏寒
蔡慧姿
庞博
杨丰文
Li Kai;Zhang Junhua;Zhang Mingyan;Niu Bohan;Chua Huizi;Pang Bo;Yang Fengwen(Evidence-based Medicine Centre,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2021年第8期2593-2600,共8页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金委员会资助项目(81473544):中医药临床试验核心指标集(COS-TCM)构建方法研究,负责人:张俊华
关键词
核心指标集
中医药
肺癌
随机对照试验
Core outcome set
Traditional Chinese medicine
Lung cancer
Randomized controlled trial
作者简介
通讯作者:杨丰文,副研究员,主要研究方向:中医药临床评价和循证中医药研究。
