儿童常用药品说明书药物代谢动力学信息标注情况分析

Analysis on children's pharmacokinetic information of labeling for pediatric drug

目的回顾性调查与分析我国儿童常用药品说明书中儿童药物代谢动力学(简称药动学)标注现状,以期为规范和完善我国儿童药品说明书信息提供参考。方法总结和比较美国食品药品管理局、欧洲药品管理局及国家药品监督管理局发布的药品说明书相关指导原则对药动学标注内容和数据结构的要求,收集我国8家儿童医院常用药品说明书,从疾病种类、药动学数据来源、药动学参数标注情况等维度分析药品说明书儿童药动学标注情况。结果共收集有效药品说明书1719份,说明书信息中标注有成人药动学信息的品种数有914种,标注率53.17%;标注有儿童药动学信息的品种数150种,标注率8.73%,来源于儿童临床试验的数据占70.67%。药动学参数中半衰期标注率88.00%,达峰时间标注率76.00%,达峰浓度标注率47.30%,蛋白结合率、表观分布容积、清除率、生物利用度以及血药浓度曲线下面积标注较少,标注率不超过33.30%。结论药品说明书中儿童药动学信息缺乏现象普遍存在,标注格式不规范、内容不完整、质量不高,建议通过建立药动学数据库及儿童药动学研究方法优化体系等为完善儿童药品说明书儿童药动学信息提供方向。

Objective This study was designed to investigate the status of children's pharmacokinetic information of labeling for pediatric drug in China,so as to provide reference for standardizing and improving drug instructions.Methods The content and format of pharmacokinetic sections in guidelines approved by Food and Drug Administration(FDA),European Medicines Agency(EMA)and National Medical Products Administration(NMPA)were analyzed comparatively.The labeling conditions of pediatric drugs in 8 hospitals were collected,and pharmacokinetic information were analyzed according to the disease types,pharmacokinetic data sources,pharmacokinetic parameters.Results A total of 1719 drug labels were collected,there were 914 varieties marked with adult pharmacokinetic information in the instructions,and the labeling rate was 53.17%;there were 150 varieties labeled with children's pharmacokinetic information,and the labeling rate was 8.73%.The number of data derived from pediatric clinical trials accounted for 70.67%of the total number of drug labels contained pediatric pharmacokinetic information.The main pharmacokinetic parameters were t1/2(88.00%),tmax(76.00%)and Cmax(47.30%)respectively.Conclusion The information on children's pharmacokinetic is insufficient.It is suggested to establish pharmacokinetic database and optimization system of pharmacokinetic research methods in children to meet regulatory requirements and ensure appropriate consistency in the format and content of pharmacokinetic section.