目的 評(píng)價(jià)中醫(yī)藥治療兒童腺樣體肥大（adenoid hypertrophy，AH）的隨機(jī)對(duì)照試驗(yàn)（randomized controlled trial，RCTs）的方法學(xué)質(zhì)量和報(bào)告質(zhì)量，分析臨床試驗(yàn)設(shè)計(jì)現(xiàn)狀，以期為今后開(kāi)展兒童AH的RCTs提供參考。方法 系統(tǒng)檢索中國(guó)知網(wǎng)（CNKI）、萬(wàn)方（Wanfang）、維普（VIP）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)服務(wù)系統(tǒng)（SinoMed）、PubMed、Cochrane Library、Embase、Web of Science數(shù)據(jù)庫(kù)，及ClinicalTrials.gov、中國(guó)臨床試驗(yàn)注冊(cè)中心、國(guó)際傳統(tǒng)醫(yī)學(xué)臨床試驗(yàn)注冊(cè)平臺(tái)，檢索時(shí)限為建庫(kù)至2024年5月15日，納入符合標(biāo)準(zhǔn)的中醫(yī)藥治療兒童AH的RCTs。采用ROB 2.0和CONSORT-結(jié)局指標(biāo)2022擴(kuò)展版分別評(píng)價(jià)文獻(xiàn)方法學(xué)和報(bào)告質(zhì)量，總結(jié)臨床試驗(yàn)設(shè)計(jì)的基本特征，并重點(diǎn)分析結(jié)局指標(biāo)。結(jié)果 共納入182項(xiàng)RCTs，包括178篇文獻(xiàn)和4項(xiàng)注冊(cè)信息；樣本量14 798例，集中在60～100例（84.07%）；干預(yù)措施主要為中藥（86.29%），對(duì)照措施主要為化學(xué)藥（74.73%）；療程集中在4～12周（86.26%）。ROB 2.0評(píng)價(jià)結(jié)果顯示，文獻(xiàn)整體偏倚風(fēng)險(xiǎn)為166篇“有一定風(fēng)險(xiǎn)”（93.3%）、12篇“高風(fēng)險(xiǎn)”（6.74%）。CONSORT-結(jié)局指標(biāo)2022擴(kuò)展版評(píng)價(jià)結(jié)果顯示，41個(gè)條目報(bào)告率＜50%（75.93%）。共報(bào)告90種結(jié)局指標(biāo)，出現(xiàn)頻次996次；在8個(gè)指標(biāo)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(yuǎn)期預(yù)后2種（32次，3.21%）、其他指標(biāo)2種（2次，0.20%）、經(jīng)濟(jì)學(xué)評(píng)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(yàn)設(shè)計(jì)存在諸多問(wèn)題，期望今后開(kāi)展設(shè)計(jì)嚴(yán)謹(jǐn)、體現(xiàn)中醫(yī)藥臨床優(yōu)勢(shì)的高質(zhì)量RCTs，促進(jìn)臨床研究向臨床應(yīng)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(xué)會(huì)團(tuán)體標(biāo)準(zhǔn)立項(xiàng)項(xiàng)目“兒科系列常見(jiàn)病中藥臨床試驗(yàn)設(shè)計(jì)與評(píng)價(jià)技術(shù)指南：腺樣體肥大”（20221201-BZ-CACM）；中國(guó)中藥協(xié)會(huì)兒童健康與藥物研究專(zhuān)業(yè)委員會(huì)青年醫(yī)師創(chuàng)新基金項(xiàng)目（EKQNJJ-2023-13）