肝毒性生物标志物的研究进展.pdfVIP

肝毒性生物标志物研究进展 耿兴超1 1 1 2 ，沈连忠 ，李波 ，王军志 作者简介：耿兴超，男，助理研究员， Tel ：（010 E-mail ： gengxch@nicpbp.org.cn 作者单位：1. 中国药品生物制品检定所，国家药物安全评价监测中心，北京， 100176 2. 中国药品生物制品检定所，北京，100050 通讯作者：王军志，男，研究员，博士生导师 基金项目：国家科技部“十一五”重大新药创制课题《药物安全评价技术平台》 （ ） 2008ZX09305-002 摘要：目的综述近年来肝毒性生物标志物的研究现状和最新进展。方法通过查阅 与肝毒性生物标志物相关的国内外文献报道和美国FDA 相关指导原则，对传统的 和新发现的肝毒性标志物的研究现状和最新进展进行总结和分析。结果与结论： 近年来，肝毒性生物标志物的研究已取得了很大的进步，许多新的肝毒性生物标志 物在灵敏度和特异性方面都超过了传统肝毒性生物标志物ALT 和AST 等，但是目 前肝毒性生物标志物的研究中仍存在许多问题，还需要开展更多的研究和验证工 作。 关键词：肝毒性；生物标志物；临床研究；临床前研究；临床检验；基因组学 The Development and Current State of Biomarkers of Hepatotoxicity 1 1 1 2 GENG Xing-chao , SHEN Lian-zhong , LI Bo , WANG Jun-zhi (1. National Center for Safety Evaluation of Drugs, National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100176; 2. National Institute for Control of Pharmaceutical and Biological Products, Beijing, 10050) Abstract: Purpose: To review the development and current states of the biomarkers for hepatotoxicity studies in recent years. Method: According to the recently reporting or references on hepatotoxicity biomarkers and some guidelines from USA FDA, this review summarizes the current practice and future perspectives for hepatotoxicity biomarkers. Result and Conclusion: Novel approaches for hepatotoxicity biomarkers have been actively investigated recently, and numerous novel animal-based biomarkers for hepatotoxicity have been explored, which are individual or a panel of proteins, nucleic acids or metabolites with better specificity and sensitivity. However, there are still some issues in biomarkers developments, including biomarker qualification, validation and translation from preclinical studies to clinical test, which need further research i