医疗产品细胞毒性3种评价方法的比较

Comparison of Three Methods for Evaluation on Cytotoxicity of Medical Products

目的比较评价医疗产品细胞毒性的3种方法,即MTT法、活细胞计数法及形态观察法。方法用MTT法、活细胞计数法及形态观察法对19种医疗产品进行细胞毒性测试,并对样品毒性分级及作出合格与否的判断,比较这些方法之间的符合程度及在检测细胞毒性方面各自的优缺点。结果MTT法与活细胞计数法的毒性级别判断符合率为73.7%(14/19),判断样品合格与否,两者符合率为94.7%(18/19),15号样品MTT法毒性级别判为4级,但细胞形态观察法发现细胞形态正常,贴壁生长良好,结果与活细胞计数法一致。重复3次检测,仍出现这种现象。结论MTT法操作简便,人为误差小,更适于多种医疗产品的同时检测,但对于MTT检测不合格产品要结合活细胞计数法及形态观察法,作出综合判断。

Objective To compare three methods （MTT assay, living cells count and morphologic observation） for evaluation on cytotoxicity of medical products. Methods MTT assay, living cells count and morphologic observation were used to evaluate the cytotoxicity of nineteen pieces of medical products by cytotoxicity graduation and judgement of qualification, the results of these methods were analysed for degree of coincidence and comparison of advantages and disadvantages among these methods. Results The rate of coincidence of cytotoxicity graduation between MTT assay and living cells count was 73.7% （14/19） and that of qualification was 94.7% （18/19）, the sample No. 15 was tested four times with three methods, and the results show the difference between MTT assay and living cells-count were great, while the results of morphologic observation method were concordant with that of living cells count. Conclusion MTT assay is more suitable for evaluation of cytotoxicity of medical products for it is easy to operate and its errors are small, but living cells-count method and morphologic observation are needed to make a comprehensive judgement to unqualified medical products.