中医药治疗儿童哮喘随机对照试验结局指标现状

doi:10.20223/j.cnki.1000-8535.2025.11.009

摘要/Abstract

摘要： 目的剖析中医药治疗儿童哮喘的随机对照试验（RCT）结局指标,为中医药治疗该病临床试验的核心指标集构建提供初步依据。方法检索中国知网（CNKI）、万方（WanFang）、维普网（VIP）、中国生物医学文献数据库（SinoMed）、PubMed、Cochrane Library、EmBase、Web of Science。时间跨度为建库至2024年7月1日。此次检索全面覆盖了中医药疗法治疗儿童哮喘的临床随机对照研究,由两名研究者根据纳排标准独立完成文献筛选和资料提取,提取文献基本特征和结局指标。结果初步检索出2 449篇文献,最终纳入165个RCT,包括205个结局指标,分为症状/体征、中医症状/证候、理化检查、生活质量评价、远期预后、安全性指标六域。结论中医药治疗儿童哮喘尚存在中医证候诊断和疗效标准不完善、主要和次要结局指标界限不清等问题,应当构建统一规范且广为认可的核心指标集,以促进儿童哮喘核心指标集的完善。

关键词: 儿童, 哮喘, 中医药, 随机对照试验, 结局指标, 核心指标集

Abstract: Objective To analyze the outcome indicators of randomised controlled trials（RCTs）of traditional Chinese medicine（TCM）for the treatment of childhood asthma,and to provide a preliminary basis for the construction of a core set of indicators for clinical trials of TCM for the treatment of this disease．Methods A database search was conducted on China Knowledge Network（CNKI）,WanFang,VIP,SinoMed,PubMed,Cochrane Library,EmBase,and Web of Science,covering the period from the establishment of the database to 1 July 2024．The search comprehensively covered clinical randomised controlled studies of TCM therapies in the treatment of childhood asthma,and was completed independently by two investigators who screened the literature and extracted information according to the criteria,and extracted the basic characteristics of the literature and outcome indicators．Results Initially,2 449 literatures were retrieved,and 165 RCTs were finally included,including 205 outcome indicators,which were classified into six domains：symptoms/signs,TCM symptoms/evidence,physical and chemical examination,quality of life evaluation,long-term prognosis,and safety indicators．Conclusions Currently,there are problems such as imperfect diagnostic and efficacy criteria for TCM evidence,and unclear boundaries between primary and secondary outcome indicators in the treatment of childhood asthma with TCM．A unified,standardised and widely recognised core indicator set should be constructed to promote the improvement of the core indicator set for childhood asthma．

Key words: childhood, asthma, traditional Chinese medicine, randomized controlled trials, outcome indicators, core indicator set

纪丰烨, 朱中一, 王玲, 陈洁, 杨燕. 中医药治疗儿童哮喘随机对照试验结局指标现状[J]. 广州医药, 2025, 56(11): 1531-1541.

JI Fengye, ZHU Zhongyi, WANG Ling, CHEN Jie, YANG Yan. Current status of outcome indicators of randomized controlled trials of traditional Chinese medicine for the treatment of childhood asthma[J]. Guangzhou Medical Journal, 2025, 56(11): 1531-1541.

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