动物法则在骨髓型急性放射病药物研发中的应用  

The application of animal rule to drug development for hematopoietic acute radiation syndrome

作　　者：邹丽敏 杨晓春[2] 陆佳斌 唐凌 杜瑜 齐玥丽 杨志敏 ZOU Li-min;YANG Xiao-chun;LU Jia-bin;TANG Ling;DU Yu;QI Yue-li;YANG Zhi-min(Center for Drug Evaluation,National Medicine Products Administration,Beijing 100022,China;Center for Drug Safety Evaluation and Research,College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,Zhejiang Province,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]浙江大学药物安全评价研究中心,浙江杭州310000

出　　处：《中国临床药理学杂志》2021年第12期1607-1611,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：随着核工业和核应用的发展,核暴露的风险越来越大,随之引起的不良事件严重威胁着人类的健康和生命。因此,针对核暴露引起的骨髓型急性放射病(ARS)的药物研发具有迫切的临床需求。但是,由于骨髓型ARS的病因特殊,开展药物人体临床有效性研究的可行性较差,在这种情况下国际上通常采用动物法则进行药效评价。本文总结了动物法则在骨髓型ARS中的应用现状,提出了动物法则的适用要点,重点阐述了骨髓型ARS动物模型的建立、药物有效性评价和药物临床安全性研究的相关要求。本文对于骨髓型ARS相关适应症治疗药物的开发具有一定的指导意义。With the development of nuclear industry and nuclear technology applications,the risk of nuclear exposure is increasing,and the consequent adverse events seriously threaten human health and life.Therefore,there is an urgent clinical need for drug development for hematopoietic acute radiation syndrome(ARS)caused by radiation exposure.However,due to the special etiology of hematopoietic ARS,the feasibility of conducting drugs clinical efficacy studies in humans is poor,in which case animal rule is generally adopted internationally to evaluate drug efficacy.In this paper,we summarize the current applications of animal rule in hematopoietic ARS,put forward the applicable points of animal rule,and focus on requirements to establish animal models of hematopoietic ARS,evaluate drug efficacy and drug clinical safety.This article has certain guiding significance for the development of therapeutic drugs for hematopoietic ARS related indications.

关 键 词：核暴露 骨髓型急性放射病 动物法则 药物有效性 药物临床安全性 

分 类 号：R95[医药卫生—药学]