药物临床前安全性评价毒性病理学诊断术语和诊断标准项目及数据库简介

毒性病理学是药物临床前安全性评价的重要组成部分,目前诊断术语和诊断标准尚未完全统一,严重影响了不同国家和地区实验室间病理诊断人员对病变的描述或记录、报告的解读以及同行间交流和诊断水平的提高。术语和诊断标准的统一,尤其是大鼠和小鼠,已成为病理学家多年来努力的目标。本文对美国毒性病理学会的术语和诊断标准规范化系统,世界卫生组织肿瘤研究国际机构的啮齿类肿瘤国际分类、北美对照动物数据库、欧洲工业毒理学动物注册数据库以及最新的大鼠和小鼠病变术语和诊断标准的国际统一项目的现状及基本原则进行综述。

Toxicologic pathology is an important part of the preclinical safety evaluation of drugs.So far,the nomenclature and diagnostic criteria have not been standardized,thus greatly influencing the understanding of the description and reports of the lesions,communication among colleagues of different labs or countries,as well as the improvement of the diagnostic level.For many years,standardization of toxicologic pathology nomenclature in the field of preclinical safety evaluation of drugs,especially for rats and mice,has been a goal of toxicologic pathologists.In this paper,we comprehensively reviewed the status and the basic principles of several nomenclature and diagnostic criteria projects and/or databases,such as SSNDC of the STP of US,International Classification of Rodent Tumors by WHO/IARC,RITA,NACAD,International Harmonization of Rat Nomenclature and the INHAND.