我国儿童特应性皮炎药物临床试验分析

Analysis on Clinical Trials of Atopic Dermatitis Drugs in Children in China

目的:基于我国儿童特应性皮炎药物临床试验的登记情况及特应性皮炎治疗药品在我国的上市情况进行分析,为药品研究提供参考。方法:检索国家药品监督管理局“药物临床试验登记与信息公示平台”和“药品查询”数据库(检索时间均为2017年1月1日至2023年4月17日),获得儿童特应性皮炎临床试验注册信息及特应性皮炎治疗药品的上市信息,进行分类统计。结果:平台共登记了40项包含儿童受试者的湿疹/特应性皮炎药物临床试验,目前数据库有36家国内外生产企业的10个品种的特应性皮炎治疗药品在我国获准上市。结论:国内制药企业在儿童特应性皮炎药物研发上多集中于仿制药,目前已有2种治疗用生物制品1类药物,需要继续深耕,进一步开展药物临床试验,同时发挥我国中医药优势,发掘中药品种开展临床试验,为儿童用药添砖加瓦。

OBJECTIVE:To provide reference for drug research based on registration of clinical trials of atopic dermatitis drugs in children and marketing of atopic dermatitis drugs in China.METHODS:The registration information of clinical trials in children with atopic dermatitis and marketing information of atopic dermatitis drugs were obtained by searching the databases of“platform for registry and publicity of drug clinical trials”and“drug inquiry”of the National Medical Products Administration(both searched from Jan.1st,2017 to Apr.17th,2023),and classified statistics were conducted.RESULTS:A total of 40 clinical trials of eczema/atopic dermatitis drugs for children were registered on the platform,and 10 varieties of atopic dermatitis drugs from 36 domestic and foreign manufacturers had been approved to be listed in China.CONCLUSIONS:Domestic pharmaceutical manufacturers mainly focus on generic drugs in the research and development of atopic dermatitis drugs for children.At present,there are two kinds of biological products for the treatment of class 1 drugs,and it is necessary to further carry out clinical trials of drugs,while giving full play to the advantages of traditional Chinese medicine to explore traditional Chinese medicine varieties to carry out clinical trials for children’s drugs.