中文摘要：本文用转基因玉米MON810对Wistar大鼠分别进行了四组90天喂养试验和一组1年喂养试验。首先，本文将从饲喂非转基因玉米饮食的Wistar大鼠中获取的数据作为一个历史对照数据集；并描述了所有参数的特异性，导出了参考值和范围。接着，本文在五组研究中发现了统计显著差异的一致性。作者对五组研究中大鼠的体重发育、器官重量、血液学和临床生化数据进行了比较研究；并基于历史的控制数据定义了参数的等效范围，并在这些等效范围内对转基因玉米饲喂组的测量值进行了比较。最后，本文对整个饲喂研究的统计数据进行了评估，并给出了各组间检测到的毒性差异。五组饲养试验间的比较在控制数据内显示出明显的效果。它也表现出不一致的统计显着差异的频率、及控制组和测试组间的差异值。
外文摘要：The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (GM) maize MON810 in Wistar Han RCC rats performed in the frame of EU-funded project GRACE were analysed. Firstly, the data obtained from the groups having been fed the non-GM maize diets were combined to establish a historical control data set for Wistar Han RCC rats at the animal housing facility (Slovak Medical University, Bratislava, Slovakia). The variability of all parameters is described, and the reference values and ranges have been derived. Secondly, the consistency of statistically significant differences found in the five studies was analysed. In order to do so, the body weight development, organ weight, haematology and clinical biochemistry data were compared between the studies. Based on the historical control data, equivalence ranges for these parameters were defined, and the values measured in the GM maize-fed groups were compared with these equivalence ranges. Thirdly, the (statistical) power of these feeding studies with whole food/feed was assessed and detectable toxicologically relevant group differences were derived. Linear mixed models (LMM) were applied, and standardized effect sizes (SES) were calculated in order to compare different parameters as well as to provide an overall picture of group and study differences at a glance. The comparison of the five feeding trials showed a clear study effect in the control data. It also showed inconsistency both in the frequency of statistically significant differences and in the difference values between control and test groups.
外文关键词：90-day toxicity study; Genetically modified plants; Maize; Risk assessment; Historical control data; Linear mixed models; Standardized effect sizes; Statistical power; Consistency
作者：Schmidt, Kerstin; Schmidtke, Joerg; Schmidt, Paul; 等
作者单位：BioMath GmbH
期刊名称：ARCHIVES OF TOXICOLOGY
期刊影响因子：6.637
出版年份：2017
出版刊次：4
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