以树鼩为微核试验新型动物模型的初步研究

Potential use of tree shrew as an animal model for the micronucleus test

目的:初步探讨建立树鼩体内微核试验体系,将树鼩作为试验动物模型应用于医疗器械生物学评价。方法:将30只树鼩随机分为3组,分别是阴性对照组、样品组(胶原蛋白植入剂)和阳性对照组,样品组按照10 mL/kg两次腹腔注射受试物进行诱导。各组树鼩取股骨骨髓细胞检测微核率,并进行血常规、血生化和电解质检测,计算脾、肝、肾的脏器系数并进行组织病理学检测。同时,用小鼠进行试验,作为体系参考。结果:树鼩和小鼠的微核试验中,阴性对照组、供试样品组的微核率均<5%,供试样品组与阴性对照组间的差异无统计学意义(P>0.05),阳性对照组与阴性对照组间的差异显著(P<0.01),树鼩微核试验结果与小鼠微核试验结果一致。与阴性对照组比较,样品组树鼩血常规、血生化、电解质和组织病理学检测结果均未发现明显异常。与小鼠比较,树鼩的脏器系数更接近于人类。结论:树鼩可以作为模式动物进行微核试验,有可能将其应用于医疗器械的生物安全性评价。

OBJECTIVE:To explore the use of tree shrews in the micronucleus test as an assay to evaluate medical devices.METHODS:30 tree shrews were randomly divided into three groups:negative control,test sample(collagen implant)and positive control.Treated animals were each induced by two intraperitoneal injections of 10 mL/kg.Femoral bone marrow cells were removed from each animal to detect micronucleus rates,and to conduct other tests:blood biochemistry and electrolyte tests,spleen,liver and kidney organ coefficients and histopathological tests.At the same time,experiments were performed using mice as a reference for the system.RESULTS:The micronucleus rates from the negative control and the test sample groups of the tree shrews and that from mice were<5%.The difference in micronucleus rates between the test sample and the negative control groups were not significant(P>0.05),but the difference between the positive control and the negative control groups were statistically significant(P<0.01).The results of the tree shrew micronucleus test were consistent with those from the mice.Compared with the negative control group,the tree shrew blood routine,blood biochemistry,electrolyte and histopathological test results in the test sample group were not found to be abnormal.Compared with mice,the organ coefficient of tree shrews is closer to that of humans.CONCLUSION:Tree shrew can be used as an animal modal for micronucleus test evaluation,and tree shrew has the potential to be used as a biological evaluation of medical devices.