Hayashi M, Hashimoto S, Sakamoto Y, Hamada C, Sofuni T, Yoshimura I
Division of Genetics and Mutagenesis, National Institute of Hygienic Science, Tokyo, Japan.
Environ Health Perspect. 1994 Jan;102 Suppl 1(Suppl 1):49-52. doi: 10.1289/ehp.94102s149.
To evaluate chemical safety, many kinds of short-term mutagenicity assays are performed together with long-term assays in animals. Rationales and methodology for these assays have been well discussed and documented. No statistical method, however, has been singled out as the method of choice for the evaluation of mutagenicity assay data, although a number of reports on statistical methods to evaluate such data have been published. Among the mutagenicity assays, the micronucleus assay using mouse bone marrow erythropoietic cells have been widely used to assess cytogenetic activities of test chemicals. A statistical evaluation procedure for this assay is proposed herein, combining the use of historical control data and dose-response relationships. The probability of type I errors and the power of this method are compared with those of some other conventional methods by Monte Carlo simulation.
为评估化学安全性，人们在动物体内同时进行了多种短期致突变性试验以及长期试验。这些试验的基本原理和方法已得到充分讨论和记录。然而，尽管已经发表了许多关于评估此类数据的统计方法的报告，但尚未有单一的统计方法被选为评估致突变性试验数据的首选方法。在致突变性试验中，利用小鼠骨髓红细胞生成细胞的微核试验已被广泛用于评估受试化学品的细胞遗传活性。本文提出了一种针对该试验的统计评估程序，结合了历史对照数据和剂量反应关系的使用。通过蒙特卡罗模拟，将该方法的I型错误概率和检验效能与其他一些传统方法进行了比较。
