目的 通过分析近10年中药治疗儿童咳嗽变异性哮喘（CVA）的随机对照试验（RCT），思考现存问题并提出解决策略，为儿童CVA中药临床试验设计提供参考。方法 系统检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（SinoMed）、维普生物医学数据库（VIP）、PubMed、Web of Science、Embase、Cochrane Library及临床试验注册平台中关于中药治疗儿童CVA的RCT文献，对纳入文献进行质量评价，分析基本特征，思考问题与对策。结果 共纳入82项RCT研究，ROB 2.0偏倚风险评估显示72项“有一定风险”、5项“高风险”、5项“低风险”。纳入研究的样本量为8 772例，随机方法中以简单随机法居多（51项），7项实施了盲法，3项进行了分配隐藏，疗程集中在1个月及以内（54项），干预措施以中药联用化学药为主（66项）。共报告127种结局指标，分为7类，包括症状/体征（18种）、中医病证（5种）、理化检测（79种）、生活质量（7种）、远期预后（8种）、安全性事件（8种）、其他指标（2种）。结论 中药治疗儿童CVA的RCT设计需进一步提升疾病认识、规范研究设计、明确临床定位、精准诊断辨证、重视结局指标，提高方法学质量，进而开展设计严谨的RCT，为中药治疗儿童CVA提供循证依据。

Objective By analyzing randomized controlled trials（RCTs） of traditional Chinese medicine（TCM） treatment for childhood cough-variant asthma（CVA） over the past decade, this study aims to identify existing issues and propose solutions, thereby providing reference for designing clinical trials of TCM for pediatric CVAs. Methods A systematic search was conducted in China National Knowledge Infrastructure（CNKI）, Wanfang Data Knowledge Service Platform, VIP Information Network, China Biomedical Literature Database, PubMed, Web of Science, Embase, Cochrane Library, and domestic and international clinical trial registration platforms for RCT literature on TCM treatment for pediatric CVA. The included studies were evaluated for quality using the ROB 2.0 tool, and their basic characteristics were analyzed to identify issues and propose strategies. Results A total of 82 RCTs were included. The ROB 2.0 bias risk assessment showed that 72 studies had “moderate risk,” five had “high risk,” and five had “low risk.” The sample size of the included studies was 8 772 cases. Simple randomization was the most common randomization method（51 studies）, seven studies implemented blinding, and three studies conducted allocation concealment. The treatment duration was concentrated within one month（54 studies）, and the intervention measures primarily involved the combination of TCM and chemical drugs（66 studies）. A total of 127 outcome measures were reported, categorized into seven domains: symptoms/signs（18 measures）, TCM syndromes（five measures）, laboratory tests（79 measures）, quality of life（seven measures）, long-term prognosis（eight measures）, safety measures（eight measures）, and other measures（two measures）. Conclusion Further efforts are needed to enhance disease understanding, standardize study designs, clarify clinical positioning, improve diagnostic and pattern differentiation accuracy, emphasize outcome measures, and elevate methodological quality. This will enable the conduct of rigorously designed RCTs to provide evidence-based support for TCM treatment of pediatric CVA.

R969.4;R974

中华中医药学会团体标准项目“儿科系列常见病中药临床试验设计与评价技术指南”(20240107-BZ-CACM)