药物非临床安全性评价毒性病理学评价及病理学数据分析要点  

Considerations of toxicologic pathology assessment and pathological data analysis during nonclinical safety evaluation of drugs

作　　者：陈晓俊 郑少秋 闫振龙 钱庄 胡文元 钟小群 胡静 李一昊 彭瑞楠 王娅 李慧 葛建雅 缪成贤 邵薇 张亚群 吕建军 CHEN Xiaojun;ZHENG Shaoqiu;YAN Zhenlong;QIAN Zhuang;HU Wenyuan;ZHONG Xiaoqun;HU Jing;LI Yihao;PENG Ruinan;WANG Ya;LI Hui;GE Jianya;MIAO Chengxian;SHAO Wei;ZHANG Yaqun;LYU Jianjun(Innostar Biotechnology Nantong Co.,Ltd.,Nantong 226133,China;Jiangxi University of Traditional Chinese Medicine,Nanchang 330103,China;Yangtze Delta Advanced Research Institute,Yangtze Delta Pharmaceutical College,Nantong 226133,China)

机构地区：[1]益诺思生物技术南通有限公司,江苏南通226133 [2]江西中医药大学,江西南昌330103 [3]长三角药物高等研究院,长三角药学高等工程学院,江苏南通226133

出　　处：《药物评价研究》2022年第8期1472-1479,共8页Drug Evaluation Research

基　　金：江苏省新药一站式高效非临床评价公共服务平台建设项目(BM2021002)。

摘　　要：毒性病理学是一门综合了病理学和毒理学两门学科的交叉学科,主要研究有毒物质的潜在作用。准确诊断病变和报告组织病理学检查结果将继续在药物非临床安全性评价中发挥关键作用。此外,毒性病理学评价必须结合其他相关数据进行,例如临床观察、体质量变化、临床病理学结果、以及代谢和药动学数据。简要介绍了组织病理学检查的基本要素、组织病理学的特点、组织病理学诊断注意事项、病理学数据分析和报告病理学结果的要点,以期为中国药物非临床安全性评价毒性病理学组织病理学检查及病理学数据分析提供一定参考。Toxicologic pathology is the science that integrates the disciplines of pathology and toxicology and is concerned with the effects of potentially noxious substances.Accurate diagnosis and reporting of findings derived from histopathological examination have been and will continue to play a critical role in the nonclinical safety evaluation of drugs.In addition,the toxicologic pathology assessment must integrate other relevant data,such as clinical signs,body weight changes,clinical pathology findings,as well as metabolism and pharmacokinetic data.The paper gave a brief introduction of the fundamental elements of histopathological examination,features of the histopathology,considerations of diagnosis of histopathology,analysis of pathology data and reporting pathology findings,in order to provide some references for toxicologic pathology assessment and pathological data analysis during preclinical safety evaluation of drugs in China.

关 键 词：药物非临床安全性评价 组织病理学 有毒物质 数据分析 病理学数据 

分 类 号：R965.3[医药卫生—药理学]