药物非临床安全性评价中肾毒性指标的分析  

Risk assessment of indicators in non-clinical safety study with drug-induced nephrotoxicity implications

作　　者：宁娜 朱飞鹏[1] 王和枚 贺学林 韩玲[1] NING Na;ZHU Fei-peng;WANG He-mei;HE Xue-lin;HAN Ling(Center for Drug Evaluation,China Food and Drug Administration,Beijing 100038,China;Joinn Laboratories,Inc.,Beijing 100176,China;The First Affiliated Hospital, Zhejiang University,Hangzhou 310003,China)

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]北京昭衍新药研究中心股份有限公司,北京100176 [3]浙江大学附属第一医院,浙江杭州310003

出　　处：《中国药理学与毒理学杂志》2018年第10期754-756,共3页Chinese Journal of Pharmacology and Toxicology

摘　　要：预测新药肾毒性的过程是一个客观、严谨的分析与评价过程,数据链的完整是其必要条件。反映肾毒性的主要检查项目包括尿检、血液生化检查、大体解剖、脏器质量以及组织病理学检查等,如何准确、客观地评价异常指标是药物非临床研究及后续临床试验中需要重点考虑的问题。本文综述了非临床肾毒性指标及其评价思路,为用药风险点的确定和临床试验方案的设计提供参考。Integrity of the data chain is the key to assessment of drug-induced nephrotoxicity. The primary items for inspection related to nephrotoxicity include urinalysis, blood biochemical examination,gross anatomy, relative mass of organs and histopathological examination. How to evaluate these abnormal data is crucial to drug non-clinical research and the subsequent clinical development. This paper presented the non-clinic nephrotoxic items and assessment, in order to provide some reference for the identification of risks and design of clinical trials.

关 键 词：肾毒性 肾病 生物标志物 组织病理学 

分 类 号：R285.5[医药卫生—中药学]