临床前药物安全性评价中关于脏器质量的探讨

Discussion on organ weights in preclinical drug safety evaluation

毒性研究中脏器质量的评价是药物、化合物以及医疗器械评估的重要组成部分。美国毒理病理学会(STP)对一般毒性研究的脏器称量作了相应的指导推荐,并针对特殊系统如内分泌系统、免疫系统、生殖系统等的主要脏器称量数据的价值进行了详细解释。根据供试品的不同采用恰当的解剖实验方案,对脏器质量的称量有选择地增加或剔除非常重要。无论哪种类型的研究或哪种脏器进行评价,病理学家进行脏器质量的评价时最好综合考虑该研究的化合物的类别、作用机制以及整体数据设置等内容。从脏器质量采集规范性、不同系统中需收集的脏器质量以及脏器质量数据解释等方面进行阐述,这将为我国药物非临床安全性研究中脏器质量数据的科学性评估提供支持和帮助。

The evaluation of organ weights in toxicology studies is an integral component in the assessment of pharmaceuticals,chemicals,and medical devices.The Society of Toxicologic Pathology(STP)has created recommendations for weighing organs in GLP general toxicology studies,and has explained in detail the main organ weighing data of special systems such as endocrine system,immunes system and reproductive system.It is important to note that organs weighed should be added or removed from the necropsy protocol as appropriate for the test article.Regardless of the study type or organ evaluated,organ weight changes must be evaluated by the pathologist within the context of the compound class,mechanism of action,and the entire data set for that study.This paper elaborates on the standardization of organ weight collection,organ weight to be collected in different systems and the interpretation of organ weight data,which willprovide support and help for the scientific evaluation of organ weight data in nonclinical drug safety studies in China.