儿童超说明书用药的伦理问题及对策  

Ethical issues and countermeasures of off-label drug use in children

作　　者：李立敏[1] 胡海鹏[1] 曹晓琴[1] 刘小红[1] LI Limin;HU Haipeng;CAO Xiaoqin;LIU Xiaohong(Department of Pediatrics,the First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China)

机构地区：[1]西安交通大学第一附属医院儿科,陕西西安710061

出　　处：《中国医学伦理学》2025年第2期227-231,共5页Chinese Medical Ethics

摘　　要：儿童作为一类特殊群体,超说明书用药现象在世界范围内普遍存在。造成儿童超说明书用药的常见原因包括药物研发临床试验阶段缺乏儿童患者数据、药品说明书更新滞后、部分医生执业行为不规范等。儿童超说明书用药是把双刃剑,它可以挽救生命、为探索药品的更多功能提供途径,同时也可能引发药物超适应症滥用的现象,增加发生医疗不良事件的风险。规范儿童超说明书用药,可以保障患儿最佳治疗权益。建议鼓励药企开展儿科新药研发,简化药品说明书修正审批流程,积累儿童超说明书用药循证医学证据,医疗机构规范儿童超说明书用药流程,儿科医师不断提升规范诊疗能力,患儿家属积极配合诊疗,以全方位保障医患双方权益。Children,as a special group,frequently experience of off-label drug use worldwide.Common reasons for off-label drug use in children include the lack of data on pediatric patients during the clinical trial stage of drug development,delayed updates to drug instructions,and the non-standard professional behavior of some doctors.Off-label drug use in children is a double-edged sword.It could save lives and provide a way to explore additional functions of drugs,while it may also lead to the phenomenon of hyper-indication abuse,increasing the risk of adverse drug events.Regulating off-label drug use in children can safeguard the best treatment rights and interests of children.It is recommended to encourage pharmaceutical enterprises to conduct research and development of pediatric new drugs,simplify the approval process for drug instructions amendments,accumulate evidence-based medical evidence for off-label drug use in children,standardize the process of off-label drug use in children in medical institutions,continuously improve the standardized diagnosis and treatment capabilities of pediatricians,and actively cooperate with the families of pediatric patients in diagnosis and treatment,so as to comprehensively safeguard the rights and interests of both doctors and patients.

关 键 词：儿童 超说明书用药 医学伦理 医患沟通 医疗管理 规范诊疗 

分 类 号：R-052[医药卫生]