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目的研究两年慢性毒性联合致癌性试验中SD大鼠的体质量、死亡率、血常规值和血生化值的变化。方法SPF级雄性SD大鼠135只,雌性138只,4～17周龄间每周测量体质量1次,18～108周龄间每4周测定动物体质量1次并计算动物的死亡率;分别于8周龄、30周龄、56周龄、82周龄和108周采血,检测血常规和血生化指标。结果雌性大鼠在6～108周的体质量与雄性大鼠比较具有显著性差异(P<0.05);82～108周龄是大鼠死亡率增长的快速期。随着周龄的增加,雌鼠和雄鼠血液指标的变异系数增大。性别对大鼠的血常规和血生化指标具有明显的影响,但雌鼠与雄鼠比较具有显著性差异的血液指标,随着周龄的增加而减少。结论在进行安全性评价试验中,性别、周龄对SD大鼠体质量、血常规值、血生化指标均有较大的影响,因此,雌雄宜分开统计,并需使用相同周龄的动物背景数据作为参考值范围。
Objective To study the changes of body mass, mortality, blood routine and blood biochemical values in two-year chronic toxicity carcinogenicity test in SD rats. Methods 135 SPF male Sprague Dawley rats were selected and 138 females were selected. The body weight was measured once every week from 4 to 17 weeks. The body weight was measured every 4 weeks from 18 to 108 weeks and the mortality was calculated. Blood samples were collected at 8 weeks, 30 weeks, 56 weeks, 82 weeks and 108 weeks respectively. Blood and blood biochemical parameters were measured. Results The body weight of female rats at 6 ~ 108 weeks was significantly different from that of male rats (P <0.05). The mortality rate of 82 ~ 108 weeks old was a rapid phase. With the increase of age, the coefficient of variation of blood indexes of female and male mice increased. Sex has a significant effect on blood and blood biochemical markers in rats, but blood markers with significant differences between female and male rats decrease with increasing age. Conclusions In the safety evaluation test, gender and age of week have significant effects on the body weight, blood routine and blood biochemical indexes of SD rats. Therefore, the male and female should be statistically separated and the animals of the same age should be used Data as a reference range.