中药治疗儿童流行性感冒临床试验设计与评价概要

Summary of clinical trial design and evaluation of Chinese materia medica for treatment of children with influenza

流行性感冒(流感)是儿童常见的呼吸道传染性疾病。参考国内外儿童流感诊疗指南、流感药物临床试验指导原则及相关注册或已发表的临床试验等,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,系统阐述中药治疗儿童流感临床试验设计和评价等方面的技术要点和特点,以期丰富儿科疾病中药临床评价的方法学内容。

Influenza is a common infective respiratory system disease in pediatric clinical. Based on the guidelines for diagnosis and treatment of influenza in children at home and abroad, guidelines for clinical trials of influenza drugs, and related registrations or published clinical trials combined with clinical experiences, the key technical points and characteristics of clinical trial design and evaluation of Chinese medicine for this disease was mainly elaborated, in order to enrich the methodological content of traditional Chinese medicine clinical evaluation of pediatric diseases.