儿童超说明书用药的伦理实践  

Ethical Practice of Off-Label Drug Use in Children

作　　者：吴柳娟 柳龚堡[1,2,3] 史雨 陆毅群[1,3] WU Liujuan;LIU Gongbao;SHI Yu;LU Yiqun(National Center for Children’s Health,China(Shanghai),Shanghai 201102,China;Dept.of Medical Affairs,Children’s Hospital of Fudan University,Shanghai 201102,China;Ethics Committee,Children’s Hospital of Fudan University,Shanghai 201102,China)

机构地区：[1]国家儿童医学中心(上海),上海201102 [2]复旦大学附属儿科医院医务部,上海201102 [3]复旦大学附属儿科医院伦理委员会,上海201102

出　　处：《中国医院用药评价与分析》2020年第6期734-737,741,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:探讨儿童超说明书用药的伦理问题,总结伦理审查要点。方法:对2012年6月至2019年6月复旦大学附属儿科医院伦理委员会审查的83份超说明书用药申请进行回顾性分析。结果:83份超说明书用药申请中,超给药途径占6.02%(5份),超适应证占55.42%(46份),超年龄占68.67%(57份),其中同时超适应证和超年龄占30.12%(25份);>80%的临床科室申请过超说明书用药;超说明书用药申请数排序居前5位的疾病依次为风湿类疾病、神经系统疾病、恶性实体肿瘤、新生儿疾病和感染性疾病;超说明书用药申请数排序居前5位的药品分布为生物制剂(15份)、抗菌药物(14份)、免疫抑制剂(13份)、抗癫痫药(7份)、抗肿瘤药(3份)和抗精神类药(3份);伦理审查结果方面,初始审查同意59例(占71.08%),修改后同意21例(占25.30%),不同意3例(占3.61%)。结论:儿童超说明书用药的伦理审查要点在于严格审核超说明书用药指征、科学性和知情同意情况,经伦理委员会及药事管理委员会审查通过后方可被批准应用于临床。OBJECTIVE:To probe into the ethical problems of off-label drug use in children,and to summarize the key points of ethical practice.METHODS:Retrospective analysis was conducted on 83 applications of off-label drug use submitted to the Ethics Committee of Children’s Hospital of Fudan University from Jun.2012 to Jun.2019.RESULTS:Among the 83 applications for off-label drug use,6.02%(5 pieces)was over administration routes,55.42%(46 pieces)was over indications,and 68.67%(57 pieces)was over ages,of which over indications and over ages accounted for 30.12%(25 pieces).>80%of clinical departments of our hospital applied for off-label drug use.The top five categories of disease were rheumatic diseases,neurological diseases,malignant solid tumors,neonatal diseases and infectious diseases,respectively.The top five categories of drugs ranked by application of off-label drug use were biological preparations(15 pieces),antibiotics(14 pieces),immunosuppressive drugs(13 pieces),antiepileptic drugs(7 pieces),antitumor drugs(3 pieces)and antipsychotics(3 pieces),respectively.With regard to the results of the ethical review,59 cases were approved in the initial review(71.08%),and 21 cases were approved after revision(25.30%)and 3 cases(3.61%)were disagreed.CONCLUSIONS:The key point of the ethical review of off-label drug use in children lies in the strict review of the indications,scientific validity and informed consent of off-label drug use,which can only be approved for clinical use after being reviewed and approved by the Ethics Committee and the Pharmaceutical Administration Committee.

关 键 词：超说明书用药 伦理 儿童 

分 类 号：R97[医药卫生—药品]