中药治疗儿童腺样体肥大临床试验设计与评价概要  

Clinical trial design and evaluation of traditional Chinese medicine in the treatment of adenoid hypertrophy in children

作　　者：柳平 胡思源[1,2] 蔡秋晗 李瑞本 周子楠 LIU Ping;HU Si-yuan;CAI Qiu-han;LI Rui-ben;ZHOU Zi-nan(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)

机构地区：[1]天津中医药大学第一附属医院,天津300381 [2]国家中医针灸临床医学研究中心,天津300381

出　　处：《中国新药杂志》2025年第3期292-296,共5页Chinese Journal of New Drugs

基　　金：中华中医药学会团体标准立项项目(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资助项目(EKQNJJ-2023-13)。

摘　　要：腺样体肥大(adenoid hypertrophy,AH)是儿科常见病,为中医临床优势病种。依据国内外儿童AH临床诊疗指南、药物随机对照试验等,结合天津中医药大学第一附属医院临床试验中心的实践经验,从临床定位、试验总体设计、诊断标准与中医辨证标准、受试者的选择与退出、治疗方案、试验流程、有效性评价、安全性观察、试验的质量控制等方面,系统阐述中药治疗儿童AH临床试验设计与评价的技术要点,以期丰富儿科疾病中药临床试验设计与评价的方法学内容,提高临床试验设计与实施质量,促进儿科中药新药的研发。Adenoid hypertrophy(AH)is a common pediatric disease and a clinically dominant disease in traditional Chinese medicine(TCM).According to the domestic and international clinical diagnosis and treatment guidelines,as well as randomized controlled trials of children with AH,incorperating the practical experience from the clinical trial center of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,this paper systematically outlines the key technical aspects of clinical trial design and evaluation for TCM in treating children with AH,from the aspects of clinical positioning,overall trial design,diagnostic criteria and TCM syndrome differentiation criteria,subject selection and withdrawal,treatment plan,trial procedure,effectiveness evaluation,safety observation,and quality control.This article aims to enrich the methodological content of clinical trial design and evaluation of TCM in pediatric diseases,improve the quality of clinical trial design and implementation,and promote the research and development of new TCM in pediatrics.

关 键 词：中药 儿童 腺样体肥大 临床试验 试验设计 临床评价 

分 类 号：R969.4[医药卫生—药理学]