医疗器械的非遗传性致癌物检测：体外细胞形态转化试验(英文)  

Mini-review on non-genotoxic carcinogens detection of medical devices:in vitro cell transformation assay

作　　者：徐丽明[1] 陈亮[1] 王春仁[1] 

机构地区：[1]中国药品生物制品检定所,医疗器械检验中心,北京100050

出　　处：《药物分析杂志》2010年第12期2454-2461,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：supporting by Human Resources and Social Security Office,People who study abroad technological activity project according to qualification financing projects(HRSSO Letter[2009],No.416)

摘　　要：为保证体内植入性生物材料和医疗器械的安全使用,减少其对人体潜在的危害性,有效的致癌性检测试验体系是非常重要的。本文结合致癌性机理的分析,针对目前已有的遗传毒性检测方法,特别是对生物材料及医疗器械生物安全检测中遗传毒性及致癌性检测实施现状做了具体分析,指出了目前的检测体系对高风险医疗产品致癌性检测的不足。为弥补这一不足,确保医疗产品的安全使用,本文详细介绍了目前欧美已进行了广泛研究的细胞形态转化致癌性检测系统。在目前参与替代法验证的三种动物细胞形态转化试验系统中,金黄地鼠胚胎(syrian hamster embryo)细胞形态转化试验被证实是比较成熟的方法。此方法很好地模仿了机体内癌症发生过程,既能检测遗传毒性致癌物又能检测非遗传毒性致癌物的潜在致癌性。据欧洲替代法验证协会的资料分析,金黄地鼠胚胎细胞形态转化试验的敏感性高达87%,特异性达83%,和动物致癌性试验的一致率达85%。ISO推荐这种短期的致癌性检测方法可以用做遗传毒性试验阴性(非遗传毒性)的高风险医疗产品的检测,以弥补缺乏动物致癌性检测的不足或作为动物致癌性检测的前筛选。目前,我们正在优化金黄地鼠胚胎细胞形态转化试验的操作规程,准备将其作为生物材料和医疗器械非遗传性致癌物检测的常规检测方法。To ensure safe employing of biomaterials and medical devices,and decrease potential human health risk,powerful test systems for detecting carcinogenic potential are necessary.In this paper,the current available test systems for detecting carcinogenic potential of chemicals,in particularly biomaterials and medical devices are overviewed,and the demerits of these test systems are pointed out.For alternative methods of the non-genotoxic carcinogen detection the in vitro cell transformation assay models are introduced.The Syrian hamster embryo（SHE）cell transformation assay is considered that it has ability to detect both genotoxic and non-genotoxic carcinogens.The data provided from ECVAM（European Centre for the Validation of Alternative Methods）suggested that the SHE cell transformation assay has a sensitivity of 87%,specificity of 83% and concordance to the bioassay is 85%.The SHE cell transformation assay has been recommended by ISO as a short term in vitro assay for pre-screening the carcinogenic potential of test articles,before performing bioassay or at the case of less bioassay data.We are continuing a directed effort in refining SHE assay protocol,and try to use SHE assay as a general test for non-genotoxic carcinogens detection of medical devices.

关 键 词：非遗传性致癌物 体外细胞形态转化试验 生物材料和医疗器械 金黄地鼠胚胎细胞 

分 类 号：R917[医药卫生—药物分析学]