幼龄动物研究在儿科药物安全性评价中的新进展

New progress in application of juvenile animal studies for pediatric drug safety evaluation

儿童用药缺乏是世界难题,儿童用药和其安全性受到普遍重视。儿童正处于生长发育的特殊时期,器官的生理功能尚未发育成熟。与成年人存在差异,在机体成分,生理功能,药物的吸收、分布、代谢、排泄等药物处置动力学以及对药物的毒性敏感性等方面有其独特的特点。幼龄动物实验是儿科药物安全性评价的基本方法,然而当前尚存在一些合理的质疑。随着国际上及我国儿科临床试验法律和法规的出台,药政管理部门也要求申报幼龄动物毒理学研究的资料。本文将从临床前评价中关于幼龄动物的法规要求、特点、应用价值和必要性等方面的进展进行综述,以期全面科学地认识幼龄动物实验的意义,并为国内政策制定和开展幼龄动物实验提供支持。

Lack of pediatric medication is a world problem,and pediatric medication and its safety have received widespread attention.Children are in a special period of growth and development,and the physiological functions of organs are not yet mature.They have unique characteristics in terms of body composition,physiological function,drug absorption,distribution,metabolism and excretion and other drug disposition kinetics as well as toxicity sensitivity to drugs.Juvenile animal experiment is the basic method for drug safety evaluation in children.However,there are still some doubts about the rationality.With the introduction of international and national pediatric clinical trial laws and regulations,drug regulatory authorities also require the submission of toxicological study data of juvenile animals.This article will review the progress in the regulatory requirements for juvenile animals,characteristics,application value and necessity of juvenile animals in preclinical evaluation in order to comprehensively and scientifically understand the significance of juvenile animal experiments and provide support for domestic policy formulation and carrying out juvenile animal experiments.