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中医药治疗儿童哮喘随机对照试验结局指标现状

JI Fengye ZHU Zhongyi WANG Ling CHEN Jie YANG Yan

广州医药2025,Vol.56Issue(11):1531-1541,1554,12.
广州医药2025,Vol.56Issue(11):1531-1541,1554,12.DOI:10.20223/j.cnki.1000-8535.2025.11.009

中医药治疗儿童哮喘随机对照试验结局指标现状

Current status of outcome indicators of randomized controlled trials of traditional Chinese medicine for the treatment of childhood asthma

JI Fengye 1ZHU Zhongyi 2WANG Ling 1CHEN Jie 3YANG Yan2

作者信息

  • 1. Department of Pediatrics,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China
  • 2. Department of Traditional Chinese Medicine,National Center for Children's Health,China Beijing Children's Hospital,Capital Medical University,Beijing 100045,China
  • 3. Department of Pediatrics,Suzhou Hospital of Traditional Chinese Medicine,Suzhou 213000,China
  • 折叠

摘要

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.

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

Key words

childhood/asthma/traditional Chinese medicine/randomized controlled trials/outcome indicators/core indicator set

引用本文复制引用

JI Fengye,ZHU Zhongyi,WANG Ling,CHEN Jie,YANG Yan..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):1531-1541,1554,12.

广州医药

1000-8535

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