目的 評價中醫(yī)藥治療兒童腺樣體肥大（adenoid hypertrophy，AH）的隨機對照試驗（randomized controlled trial，RCTs）的方法學質(zhì)量和報告質(zhì)量，分析臨床試驗設計現(xiàn)狀，以期為今后開展兒童AH的RCTs提供參考。方法 系統(tǒng)檢索中國知網(wǎng)（CNKI）、萬方（Wanfang）、維普（VIP）、中國生物醫(yī)學文獻服務系統(tǒng)（SinoMed）、PubMed、Cochrane Library、Embase、Web of Science數(shù)據(jù)庫，及ClinicalTrials.gov、中國臨床試驗注冊中心、國際傳統(tǒng)醫(yī)學臨床試驗注冊平臺，檢索時限為建庫至2024年5月15日，納入符合標準的中醫(yī)藥治療兒童AH的RCTs。采用ROB 2.0和CONSORT-結(jié)局指標2022擴展版分別評價文獻方法學和報告質(zhì)量，總結(jié)臨床試驗設計的基本特征，并重點分析結(jié)局指標。結(jié)果 共納入182項RCTs，包括178篇文獻和4項注冊信息；樣本量14 798例，集中在60～100例（84.07%）；干預措施主要為中藥（86.29%），對照措施主要為化學藥（74.73%）；療程集中在4～12周（86.26%）。ROB 2.0評價結(jié)果顯示，文獻整體偏倚風險為166篇“有一定風險”（93.3%）、12篇“高風險”（6.74%）。CONSORT-結(jié)局指標2022擴展版評價結(jié)果顯示，41個條目報告率＜50%（75.93%）。共報告90種結(jié)局指標，出現(xiàn)頻次996次；在8個指標域中，中醫(yī)病證9種（264次，26.51%）、理化檢查50種（256次，25.70%）、癥狀/體征13種（244次，24.50%）、安全性事件8種（101次，10.14%）、生活質(zhì)量6種（97次，9.74%）、遠期預后2種（32次，3.21%）、其他指標2種（2次，0.20%）、經(jīng)濟學評估0種。結(jié)論 中醫(yī)藥治療兒童AH的RCTs整體質(zhì)量較差，臨床試驗設計存在諸多問題，期望今后開展設計嚴謹、體現(xiàn)中醫(yī)藥臨床優(yōu)勢的高質(zhì)量RCTs，促進臨床研究向臨床應用轉(zhuǎn)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

中華中醫(yī)藥學會團體標準立項項目“兒科系列常見病中藥臨床試驗設計與評價技術(shù)指南：腺樣體肥大”（20221201-BZ-CACM）；中國中藥協(xié)會兒童健康與藥物研究專業(yè)委員會青年醫(yī)師創(chuàng)新基金項目（EKQNJJ-2023-13）