成本-收益视角下呼吸系统疾病患儿药物研发的伦理问题探讨  

Ethical Discussion of Drug Development in Children with Respiratory Diseases from the Perspective of Cost-Benefit

作　　者：李敏[1] 付白娣[1] 石雅丽 杨斌[2] LI Min;FU Baidi;SHI Yali;YANG Bin(Department of Respiration,Children’s Hospital of Nanjing Medical University,Nanjing 210008,China;Department of Pharmacy,Children’s Hospital of Nanjing Medical University,Nanjing 210008,China)

机构地区：[1]南京医科大学附属儿童医院呼吸科,江苏南京210008 [2]南京医科大学附属儿童医院药学部,江苏南京210008

出　　处：《中国医学伦理学》2020年第12期1514-1518,共5页Chinese Medical Ethics

基　　金：南京药学会-常州四药医院药学科研基金(2018YX024)。

摘　　要：目前市场上呼吸系统疾病患儿药物资源分配方式存在不合理现象,由于儿童试验群体的特殊性,多种儿童药物规格是从成人药物“外推”所得,且存在儿童药物临床试验数据缺乏、针对性药物开发市场尚不完善等各种问题。从儿童受试者、“成本-收益”视角下的药物资源分配、市场药品资源分配、临床“数据外推”以及后续药物研发等五方面探讨呼吸系统疾病患儿药物资源合理分配,旨在充分尊重儿童受试者的主体性的基础上以最小成本获取最大疗效的收益,改善目前儿童药物研发现状,使患儿群体能获得有效用药。Currently,the distribution of drug resources for children with respiratory diseases in the market is unreasonable.Due to the particularity of children’s experimental group,a variety of children’s drug dose are derived from the“extrapolation”of adult drugs,and there are several problems such as the lack of clinical trial data of children’s drugs and the imperfection of targeted drug development market.To explore the rational distribution of drug resources in children with respiratory diseases from five aspects:children subjects,drug resource allocation under the perspective of“cost-benefit”,market drug resource allocation,clinical“data extrapolation”,follow-up drug research and development.On the basis of fully respecting the subjectivity of children participants’subjectivity with minimum cost to obtain the biggest effect and improve the present status of the children’s drug development,broaden children groups can obtain effective drugs.

关 键 词：呼吸系统 儿童用药 成本-收益 医学伦理 资源分配 

分 类 号：R-052[医药卫生]