中医药治疗儿童支气管哮喘缓解期临床随机对照试验结局指标分析  

Analysis of Outcome Measures in Randomized Controlled Trials of Traditional Chinese Medicine for the Management of the Remission Phase in Pediatric Bronchial Asthma

作　　者：王茁 刘芳[2] 李弋 隋宁 熊馨 WANG Zhuo;LIU Fang;LI Yi;SUI Ning;XIONG Xin(Liaoning University of Traditional Chinese Medicine,Shenyang,Liaoning 110847;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang,Liaoning 110847)

机构地区：[1]辽宁中医药大学,辽宁沈阳110847 [2]辽宁中医药大学附属医院,辽宁沈阳110847

出　　处：《智慧健康》2025年第3期94-99,共6页Smart Healthcare

摘　　要：目的分析中医药治疗儿童支气管哮喘缓解期随机对照试验(RCT)结局指标,为中医药治疗儿童支气管哮喘缓解期的临床试验提供关键指标的评估参考。方法通过检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(Sinomed)以及PubMed等数据库。检索时间段为建库至2024年6月6日,收集数据库收录的中医药疗法治疗儿童哮喘缓解期的临床随机对照试验,从中提取结局指标及相关资料(包括诊断标准、中医辨证分型、干预周期时长、疗效评价指标、随访情况等),将结局指标按照功能属性分类后进行频次的描述性分析。结果纳入文献167篇,指标域分5类:症状体征(19种)、检验检查(28种)、中医证候(24种)、临床疗效评价(23种)、安全性评价(9种)及各评价参考标准。随访报告率为43.7%,随访时间超6个月的研究共28篇。结论中医药在治疗哮喘缓解期的随机对照试验(RCT)中,在结局指标的选择上存在较多问题,包括主要结局指标与次要结局指标界定不清、终点指标选取缺乏标准化、中医证候疗效评价标准不统一以及较少采用生活质量量表进行评估等。Objective To analyze the outcome measures of randomized controlled trials(RCTs)using Traditional Chinese Medicine(TCM)for the remission phase of childhood bronchial asthma,providing key indicators for evaluating clinical trials of TCM treatment in this context.Methods Databases including China National Knowledge Infrastructure(CN KI),WanFang,VIP,China Biological Medical Literature Service System(Sinomed),and PubMed were searched from their inception to June 6,2024.Clinical RCTs on TCM treatments for the remission phase of childhood asthma were collected,and outcome measures along with related information(including diagnostic criteria,TCM syndrome differentiation,intervention duration,efficacy evaluation criteria,follow-up status,etc.)were extracted.Outcome measures were categorized according to functional attributes and descriptive frequency analysis was performed.Results A total of 167 studies were included,with outcome domains divided into five categories:symptoms and signs(19 types),examinations and tests(28 types),TCM syndromes(24 types),clinical efficacy evaluations(23 types),safety evaluations(9 types),and respective reference standards.The follow-up reporting rate was 43.7%,with 28 studies having follow-up periods exceeding six months.Conclusion In RCTs utilizing TCM for the remission phase of asthma,there are several issues regarding the selection of outcome measures,including unclear distinction between primary and secondary outcomes,lack of standardization in endpoint selection,non-uniformity in TCM syndrome efficacy evaluation criteria,and infrequent use of quality-of-life scales for assessment.

关 键 词：支气管哮喘 儿童 缓解期 中医药 随机对照试验 结局指标 

分 类 号：R256.12[医药卫生—中医内科学]