目的 评价中医药治疗儿童腺样体肥大（adenoid hypertrophy，AH）的随机对照试验（randomized controlled trial，RCTs）的方法学质量和报告质量，分析临床试验设计现状，以期为今后开展儿童AH的RCTs提供参考。方法 系统检索中国知网（CNKI）、万方（Wanfang）、维普（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、Cochrane Library、Embase、Web of Science数据库，及ClinicalTrials.gov、中国临床试验注册中心、国际传统医学临床试验注册平台，检索时限为建库至2024年5月15日，纳入符合标准的中医药治疗儿童AH的RCTs。采用ROB 2.0和CONSORT-结局指标2022扩展版分别评价文献方法学和报告质量，总结临床试验设计的基本特征，并重点分析结局指标。结果 共纳入182项RCTs，包括178篇文献和4项注册信息；样本量14 798例，集中在60～100例（84.07%）；干预措施主要为中药（86.29%），对照措施主要为化学药（74.73%）；疗程集中在4～12周（86.26%）。ROB 2.0评价结果显示，文献整体偏倚风险为166篇“有一定风险”（93.3%）、12篇“高风险”（6.74%）。CONSORT-结局指标2022扩展版评价结果显示，41个条目报告率＜50%（75.93%）。共报告90种结局指标，出现频次996次；在8个指标域中，中医病证9种（264次，26.51%）、理化检查50种（256次，25.70%）、症状/体征13种（244次，24.50%）、安全性事件8种（101次，10.14%）、生活质量6种（97次，9.74%）、远期预后2种（32次，3.21%）、其他指标2种（2次，0.20%）、经济学评估0种。结论 中医药治疗儿童AH的RCTs整体质量较差，临床试验设计存在诸多问题，期望今后开展设计严谨、体现中医药临床优势的高质量RCTs，促进临床研究向临床应用转化。

Objective To evaluate the methodological and reporting quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for the treatment of adenoid hypertrophy (AH) in children and analyze the current status of clinical trial design, in order to provide a reference for future RCTs of AH in children. Methods CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Embase, Web of Science, ClinicalTrials.gov, Chinese Clinical Trial Registry, and International Traditional Medicine Clinical Trial Registry were systematically searched for RCTs on TCM in the treatment of AH in children, with the time interval from database inception to May 15, 2024, RCTs were included according to the inclusion and exclusion criteria. The ROB 2.0 tool and the CONSORT-Outcomes 2022 extension were used to evaluate the methodological and reporting quality of the literature, respectively. The basic characteristics of clinical trial designs were summarized, with a focus on the analysis of outcome measures Results A total of 182 RCTs were included, including 178 articles and four registration information; the sample size was 14798 cases, concentrated in 60—100 cases (84.07%); the intervention measures were mainly Chinese herbal medicine (86.29%), and the control measures were mainly chemical drugs (74.73%); the treatment course was concentrated in 4—12 weeks (86.26%). The results of ROB 2.0 showed that the overall risk of bias of the literature was “some concerns” in 166 articles (93.3%) and “high risk of bias” in 12 articles (6.74%). The results of CONSORT-Outcomes 2022 Extension showed that the reporting rate of 41 items (75.93%) was less than 50%. A total of 90 outcome indicators were reported, with a frequency of 996 times, which were divided into eight indicator domains: nine TCM disease and syndrome indicators with a frequency of 264 times (26.51%), 50 physical and chemical examination indicators with a frequency of 256 times (25.70%), 13 symptom/sign indicators with a frequency of 244 times (24.50%), 8 safety event indicators with a frequency of 101 times (10.14%), six quality of life indicators with a frequency of 97 times (9.74%), two long-term prognosis indicators with a frequency of 32 times (3.21%), two other indicators with a frequency of 2 times (0.20%), and 0 economic evaluation indicators. Conclusion The overall quality of RCTs for TCM treatment of AH in children is poor, and there are many problems in the design of clinical trials. Future studies should prioritize rigorously designed trials that reflect TCM's clinical advantages to promote the transformation of clinical research into clinical application.

R285.64

中华中医药学会团体标准立项项目“儿科系列常见病中药临床试验设计与评价技术指南：腺样体肥大”（20221201-BZ-CACM）；中国中药协会儿童健康与药物研究专业委员会青年医师创新基金项目（EKQNJJ-2023-13）