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遗传毒性研究是新药非临床安全性评价的重要内容之一。由于遗传毒性体外细胞试验不能完全反映整体动物系统对受试物的吸收、分布、代谢和排泄等情况,而且试验结果的假阳性率过高,因此采用体外细胞试验进行药物安全性评价尚存在一定局限性。为了进一步完善对致突变风险的控制,尚需建立更加灵敏的体内基因突变试验方法。本文主要就体内基因突变试验的基本原理、优缺点及基本应用等研究进展进行综述,并对这些体内试验的发展和完善提出一些展望。
Genotoxicity research is one of the important contents of non-clinical safety evaluation of new drugs. Since genotoxic in vitro cell tests do not fully reflect the absorption, distribution, metabolism, and excretion of test articles by whole animal systems, and the false positive rate of test results is too high, there is a certainty that drug safety evaluation using in vitro cell tests limitation. In order to further improve the control of the risk of mutagenesis, we still need to establish a more sensitive in vivo gene mutation test method. This article mainly reviews the research progress of the basic principles, advantages, disadvantages and basic applications of in vivo gene mutation tests, and puts forward some prospects for the development and improvement of these in vivo tests.