毒性研究中臟器質(zhì)量的評價是藥物、化合物以及醫(yī)療器械評估的重要組成部分。美國毒理病理學會（STP）對一般毒性研究的臟器稱量作了相應的指導推薦，并針對特殊系統(tǒng)如內(nèi)分泌系統(tǒng)、免疫系統(tǒng)、生殖系統(tǒng)等的主要臟器稱量數(shù)據(jù)的價值進行了詳細解釋。根據(jù)供試品的不同采用恰當?shù)慕馄蕦嶒灧桨?，對臟器質(zhì)量的稱量有選擇地增加或剔除非常重要。無論哪種類型的研究或哪種臟器進行評價，病理學家進行臟器質(zhì)量的評價時最好綜合考慮該研究的化合物的類別、作用機制以及整體數(shù)據(jù)設(shè)置等內(nèi)容。從臟器質(zhì)量采集規(guī)范性、不同系統(tǒng)中需收集的臟器質(zhì)量以及臟器質(zhì)量數(shù)據(jù)解釋等方面進行闡述，這將為我國藥物非臨床安全性研究中臟器質(zhì)量數(shù)據(jù)的科學性評估提供支持和幫助。

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.

國家科技重大專項（2018ZX09201017-001）