统一实验大鼠和小鼠肝细胞空泡变及坏死的毒性病理学诊断术语探讨  

Suggestion on unifying the nomenclature for rat and mouse hepatocellular vacuolation and necrosis in toxicologic pathology

作　　者：金毅[1] 

机构地区：[1]深圳市药品检验所,深圳药品质量标准研究重点实验室,深圳518057

出　　处：《中国新药杂志》2014年第23期2712-2715,2728,共5页Chinese Journal of New Drugs

摘　　要：毒性病理学研究报告是新药研发以及新药申报的安全性评价中不可或缺的重要组成部分,由于病理学诊断受染色方法、检验仪器设备等实验条件制约,而且受诊断人员学识和经验的影响,具有一定的主观性,因此建立统一、规范、科学的诊断术语是保证准确的药物安全性评价必不可少的要素。我国毒性病理学尚处于发展阶段,各诊断人员之间诊断用语有较大差异。组织形态相似的病变,其发病机制可能完全不同,可能出现不同病理学家做出不同诊断的现象。本文以安全性评价中的重要脏器肝脏为例,就肝细胞空泡变和坏死,通过比较各诊断术语的定义、病理生理机制、光学显微镜下所见及确诊的方法,结合我国目前以苏木素-伊红染色切片为主的现状,探讨毒性病理学诊断术语规范化问题。Toxicologic pathology report is an indispensable content in drug safety evaluation of new drug research and application. The value of pathological diagnosis is limited because of problems in dyeing methods, equipments and other experimental conditions, and the diagnosis is affected by pathologist＇s personnel knowledge and experience that unavoidably possess subjectivity. Therefore, peer review based on unified, standardized and scientific terminology is an essential element. Due to the toxicologic pathology in China is still in the developing stage, diagnostic terms among pathologists are quite different, so that sometimes the same pathological change might be given many similar terms but have completely different pathogenesis. In this article, the definition, pathogenesis, light microscopic observation and confirming methods of hepatocellular vaeuolation and necrosis were discussed mainly combined with current situation of the diagnose based on hematoxylin-eosin stained sections, and unifying the nomenclature for rat and mouse hepatoeellular vacuolation and necrosis was suggested.

关 键 词：毒性病理学 诊断术语 病理诊断 苏木素-伊红染色 

分 类 号：R99[医药卫生—毒理学]