儿童临床试验药物警戒浅析与思考

Brief analysis and Pondering on Pharmacovigilance in Pediatric Clinical Trials

参考欧盟儿童用药药物警戒指南,文章分析了儿童临床试验与儿童人群不良反应特征、儿童人群药物警戒要点。结果显示,儿童人群处于生长发育阶段,其不良反应的发生率和性质与成人有所不同,应根据儿童人群生理病理特点,在不良反应的报告与处理、风险控制、信号管理、定期安全性报告与上市后研究等方面加以区分。建议结合我国临床试验期间药物警戒建设现状,加快建立儿童临床试验药物警戒体系,加强儿童受试者保护,以期为我国儿童临床试验药物警戒工作提供参考。

Refer to the EU Guidelines for pharmacovigilance of pediatric medicines,this paper analyzed the characteristics of adverse reactions in pediatric clinical trials and pediatric populations,and the main points of pharmacovigilance in pediatric populations.The pediatric population is in the stage of growth and development.The frequency and nature of adverse reactions are different from that of adults.According to the physiological and pathological characteristics of the pediatric population,they should be distinguished in terms of adverse reaction reporting and treatment,risk control,signal management,regular safety reports,and post-marketing research.Taking into account the current situation of pharmacovigilance construction during clinical trials in China,accelerate the establishment of a pharmacovigilance system for pediatric clinical trials and strengthen the protection of subjects in pediatric populations.