2020年版《中国药典》儿童禁忌相关药品研究

A study of drugs related to contraindications in children in the 2020 edition of the Chinese Pharmacopoeia

目的分析2020年版《中国药典》收载化学药品中儿童禁忌相关品种,为根据中国儿童发展纲要(2021年至2030年)要求制定儿童禁用药品目录提供技术基础。方法通过“药智网”等网站收集药品说明书,从中提取儿童禁用相关信息,对不同生产企业说明书标注儿童禁用相关信息一致的药品进行分析。结果1741种化学药品中不同生产企业说明书标注儿童禁用相关信息一致的药品共计240种,其中标注“禁用”于不同年龄段儿童113种,“不宜”用于不同年龄段儿童53种,“不推荐”用于不同年龄段儿童38种,标注其他儿童禁用相关信息的36种。依据中国药典《临床用药须知》(2020年版)分类,涉及21个药物类别,包含抗感染药物(77个),解热、镇痛、抗炎与抗风湿药以及抗痛风药(28个),神经系统用药(20个),精神药物(16个),消化系统用药(16个),内分泌系统用药(16个)等。结论儿童生长发育处在特殊阶段,药物在儿童体内的药理毒理特征与成人存在差异,药品用于儿童的风险获益比需要不断研究以提供更详实的用药依据,保障儿童用药安全。

Objective The varieties of chemical drugs prohibited for children in the 2020 edition of Chinese Pharmacopoeia were analyzed.Provide a technical basis for the development of a list of drugs prohibited by children.This is requirement of China's Children's Development Program(2021—2030).Methods Drug inserts are collected through websites such as“PharmaIntelligence”,from which information on children's prohibitions is extracted,and drugs with consistent information on children's prohibitions are analyzed in the instructions of different manufacturers.Results Among the 1741 kinds of chemicals,there are a total of 240 drugs with consistent information on the prohibition of children in the instructions of different manufacturers,of which 113 are labeled“prohibited”for children of different ages,53 are“not suitable”for children of different ages,38 are“not recommended””for children of different ages,and 36 are labeled with other children's prohibition related information.According to the classification of the clinical drug instructions involving 21 categories.Including anti-infective drugs(77),nonsteroidal anti-inflammatory drugs and anti-gout drugs(28),nervous system drugs(20),psychotropic drugs(16),digestive system drugs(16)endocrine system drugs(16),etc.Conclusion Children are at a special stage of growth and development,and the pharmacological and toxicological characteristics of drugs in children are different from those in adults.The risk-benefit ratio of drugs used in children needs continuous research to provide more detailed evidence for drug use and ensure the safety of drug use in children.