论文部分内容阅读
动物致癌性试验是药物非临床安全性评价的重要内容之一,在我国起步相对较晚。随着我国新药创制及相关领域的不断发展,初步具备了进行致癌性评价的条件。机制研究是致癌性评价的重要内容,结合暴露量分析、适应症与患者人群特征、同类化合物致癌性特征等进行利弊权衡,综合评估对人体的潜在风险,并最终通过说明书等方式进行风险控制。目前国际上正在着力于致癌机制的探索,有些已经被药品评价机构接受。文中对一些常见的机制研究进行总结分析,包括遗传毒性机制、药理学作用相关机制、苯巴比妥样CYP450诱导作用、致癌组织的种属差异等,以期为我国药物致癌性评价提供一定参考。
Animal carcinogenicity test is one of the important contents of non-clinical safety evaluation of drugs, which started relatively late in our country. With the continuous development of the creation of new drugs and related fields in our country, preliminary conditions for carcinogenicity assessment are provided. Mechanism study is an important part of carcinogenicity assessment. Combining the analysis of exposure, the characteristics of patients and the characteristics of patients, the carcinogenicity characteristics of similar compounds, the potential risks and risks of human beings are evaluated comprehensively. Finally, the risk control is carried out through manuals and other methods. At present, international efforts are being made to explore carcinogenic mechanisms, some of which have been accepted by drug evaluation agencies. In this paper, some common mechanism studies are summarized, including mechanisms of genotoxicity, mechanism of pharmacological effects, induction of phenobarbital-like CYP450, species differences of carcinogenic tissues, etc., in order to provide some reference for the evaluation of carcinogenicity of drugs in our country.