腺樣體肥大主要表現(xiàn)為鼻塞、打鼾、張口呼吸等癥狀，嚴(yán)重影響患兒生活質(zhì)量、生長發(fā)育。近年來中藥治療兒童腺樣體肥大的臨床隨機對照試驗逐漸增多，由于不同隨機對照試驗文章結(jié)局指標(biāo)繁多或同一結(jié)局指標(biāo)判定標(biāo)準(zhǔn)不一致，制約了兒童腺樣體肥大高質(zhì)量的循證醫(yī)學(xué)依據(jù)的產(chǎn)生。目前國內(nèi)外藥物治療兒童腺樣體肥大的臨床試驗主要以改善臨床癥狀、減小腺樣體體積、改善生活質(zhì)量、提高臨床療效、改善中醫(yī)證候和評估藥物的遠期效果為研究目的?；诖?，綜述了兒童腺樣體肥大的療效評價指標(biāo)，以期為臨床和科研工作者開展兒童腺樣體肥大臨床研究時選擇合適的療效評價指標(biāo)提供指導(dǎo)。

The main clinical manifestations of adenoid hypertrophy are nasal congestion, snoring, and open mouth breathing, which seriously affect the quality of life and growth and development of children. In recent years, clinical randomized controlled trials of traditional Chinese medicine in treatment of adenoid hypertrophy in children have gradually increased. Due to the variety of outcome indicators in different randomized controlled trials, or inconsistent criteria for determining the same outcome indicator, the emergence of high-quality evidence-based medical evidence for adenoid hypertrophy in children is restricted. At present, drug clinical trials for adenoid hypertrophy in children at home and abroad mainly focus on improving clinical symptoms, reducing adenoid volume, improving quality of life, improving clinical efficacy, improving traditional Chinese medicine syndromes, and evaluating the long-term effects of drugs. Therefore, this article reviews the efficacy evaluation indicators for adenoid hypertrophy in children, in order to provide guidance for clinical and scientific researchers to choose appropriate efficacy evaluation indicators when conducting clinical research on adenoid hypertrophy in children.

R985

國家科技重大專項（民口）課題（2020ZX09201-008）