慢性阻塞性肺疾病中医临床试验文献特征分析  

Analysis of literature characteristics of traditional Chinese medicine clinical trials in chronic obstructive pulmonary disease

作　　者：谢洋[1,2] 李宣霖[1] 张东 雷斯媛 王军[1] 郭雯 李建生[1,2] XIE Yang;LI Xuanlin;ZHANG Dong;LEI Siyuan;WANG Jun;GUO Wen;LI Jiansheng(Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan&Education Ministry of China/Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Henan University of Chinese Medicine,Zhengzhou 450046,China;The First Affiliated Hospital of Henan University of CM,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学,呼吸疾病中医药防治省部共建协同创新中心/河南省中医药防治呼吸病重点实验室,郑州450046 [2]河南中医药大学第一附属医院,郑州450000

出　　处：《中华中医药杂志》2023年第8期3867-3871,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金重点项目(No.81830116);国家重点研发计划(No.2018YFC1704800);国家中医药管理局中医药创新团队及人才支持计划项目(No.ZYYCXTD-C-202206);岐黄工程首席科学家项目(No.国中医药人教函[2021]7号);河南省科技攻关计划(No.212102311128);河南省第二批中医药拔尖人才项目(No.豫卫中医函[2021]15号);河南省医学科技攻关计划(No.LHGJ20220586)。

摘　　要：目的:梳理慢性阻塞性肺疾病(COPD)中医临床试验文献特征与结局测量现状,为寻求更优化的中医药诊疗方案、创新发展中医临床疗效评价方法提供助力。方法:计算机检索PubMed、CochraneLibrary、EMbase、万方数据知识服务平台、中国期刊全文数据库、中国生物医学文献数据库、维普中文期刊服务平台收录的中医药治疗COPD的临床随机对照试验(RCT)文献,对文献的年份、期刊、地区、基金资助、临床试验及结局测量特征进行计量分析。结果:中医药治疗COPD的RCT文献逐年上升,干预措施类型多样,发表在高质量期刊比例较低,存在地域和基金资助不均衡特点。结局测量指标种类繁多,具备中医药特色结局指标偏少。统计方法以静态的干预前后比较为主,对结局指标动态变化、关联性分析等统计方法应用较少。结论:未来中医药治疗COPD的临床试验在结局指标测量与评价中需注意:①关注中医临床研究“复杂干预”“整体调节”的作用特点,单一或少数的结局指标难以恰当地反映中医药的整体疗效和远后效应,结局测量时要突出考虑指标的敏感性、发生率和最小临床差异;②各结局指标有不同的数据类型和特征,测量时需分析其数据特点并引入合理的数学模型计算指标权重,客观定量反映临床疗效;③不同指标间既有独立性、变异性,又有关联性,结局测量时需要根据结局指标各层次之间或内部相互作用大小及对整体影响进行综合评价;④纵向采集复杂诊疗信息、生存数据信息,动态比较分析中医疗效变化特征,分析疾病的预后与转归。Objective:To sort out the literature characteristics and outcome measurement status of traditional Chinese medicine(TCM)clinical trials for chronic obstructive pulmonary diseases(COPD),and provide assistance for seeking more optimized TCM diagnosis and treatment plans and innovatively developing TCM clinical efficacy evaluation methods.Methods:Clinical research literatures on TCM treatment of COPD collected in PubMed,Cochrane Library,EMbase,Wanfang Data Knowledge Service platform,Chinese journal full-text database,Chinese biomedical Literature Database,and VIP Chinese Journal Service Platform were searched by computer.The year,journal,region,funding,clinical trials and outcome measurement characteristics of the literature were analyzed.Results:The RCT literature on the treatment of COPD with TCM has been increasing year by year,with various types of interventions,a low proportion of publications in high-quality journals,and uneven geographical and funding characteristics.There are many kinds of outcome measurement indicators,and there are few outcomes with TCM characteristics.Statistical methods are mainly based on static comparison before and after intervention,and statistical methods such as dynamic changes of outcome indicators and correlation analysis are rarely used.Conclusion:In the measurement and evaluation of outcomes in future clinical trials of TCM for the treatment of COPD,attention should be paid to:OPay attention to the characteristics of'complex intervention'and'overall regulation'in clinical research of TCM,and it is difficult for a single or a few outcome indicators to properly reflect the overall efficacy of TCM sensitivity,incidence,and minimal clinical differences of indicators should be prominently considered in outcome measurement;②Each outcome has different data types and characteristics,and its data characteristics should be analyzed and a reasonable mathematical model should be introduced to calculate the indicators.Weight,and objectively and quantitatively reflect the clinical efficacy

关 键 词：慢性阻塞性肺疾病 中医临床试验 结局测量 临床疗效评价 

分 类 号：R259[医药卫生—中西医结合]