摘要
背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药治疗AECOPD临床试验设计和结局指标选择提供参考。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science、Cochrane Library、ClinicalTrials.gov、中国临床试验注册中心,获取口服中药治疗AECOPD的RCT和临床试验注册方案,检索时限为2018年1月—2022年10月。由2位评价员独立筛选文献、提取资料后,采用定性分析的方法,对纳入研究的结局指标选择情况进行描述。结果纳入578篇文献,包含574篇已报告试验结果的RCT及4个临床试验注册方案。574篇RCT共纳入51508例患者。88篇文献在纳入标准中限定了患者的疾病分级,361篇文献在纳入标准中限定了中医证型,6篇文献报告了盲法,6篇文献提及了随访。纳入文献共涉及4030个结局指标,单篇文献结局指标数量范围为1~24个。按照结局指标的功能属性,将其归为8个指标域:中医症状/证候、症状/体征、理化检测、生活质量、远期预后、经济学评估、安全性评价、其他,报告率最高的指标域是理化检测,报告频次排名前5位的结局指标项目是:有效率(11.5%)、第1秒用力呼气容积(7.5%)、中医症状/证候评分(7.0%)、第1秒用力呼气容积/用力肺活量(6.8%)、用力肺活量(4.6%)。445篇文献报告了有效率的组成,报告率排名前5位的研究指标依次为症状(423篇)、体征(281篇)、中医证候评分(203篇)、实验室检查(89篇)、肺功能(71篇)。结论口服中药治疗AECOPD的RCT涉及的结局指标数量多、范围广,纳入的文献在不同程度上关注了口服中药对AECOPD患者的症状体征、理化检测指标、生活质量、远期预后、经济学评价和安全性结局等方面的影响。但结局指标的选择仍存在多方面的问题:结局指标主次不清;主要关注替代终点,对临床终点的关注不足;对卫生经济学指标关注不足;有效性参考来源不一、判断标准不一。研究者可参考已发表的核心指标集,合理设计结局指标,以提高中医药临床研究的质量。
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,ClinicalTrials.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 51508 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 4030 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 fortyfive 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,longterm 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.
作者
王婧
王慧
宋仕群
吉广荷
郭亚坤
要丹柠
赵书晗
李多多
夏如玉
张立山
WANG Jing;WANG Hui;SONG Shiqun;JI Guanghe;GUO Yakun;YAO Danning;ZHAO Shuhan;LI Duoduo;XIA Ruyu;ZHANG Lishan(Department of Respiratory,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;School of Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Department of Tuina and Pain Management,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Center for Evidence-based Medicine,Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中国全科医学》
北大核心
2024年第2期226-232,共7页
Chinese General Practice
基金
国家重点研发计划项目(2018YFE0102300)。
关键词
中药
肺疾病
慢性阻塞性
疾病加重期
随机对照试验
患者报告结局评价
Traditional Chinese drugs
Pulmonary disease,chronic obstructive
Acute exacerbation period
Randomized controlled trial
Patient reported outcome measures
