论文部分内容阅读
目的:比较注射用奥沙利铂和奥沙利铂脂质体对Beagle犬毒性作用的解剖病理学改变,为抗癌药物脂质体制剂的临床前安全性评价提供重要的形态学参考数据。方法:Beagle犬分为阴性对照组、空载体脂质体组、注射用奥沙利铂组、奥沙利铂脂质体低、高剂量组。静脉滴注每2周给药1次,共4次,恢复期1个月。解剖动物进行组织病理学检查。结果:与脂质体、注射用奥沙利铂和奥沙利铂脂质体相关的组织病理学变化分别为多组织器官的泡沫细胞聚集;睾丸生精细胞数量减少,附睾精子减少症和胸腺、脾脏萎缩;肝脏小肉芽肿,胸腺、脾脏萎缩。结论:通过以上同一抗癌药物不同剂型对Beagle犬的解剖病理学评价比较,为抗癌药物脂质体剂型临床前安全性评价提供了重要的形态学参考数据。
OBJECTIVE: To compare the anatomic and pathological changes of toxic effects of oxaliplatin and oxaliplatin injection on Beagle dogs and provide important morphological reference data for preclinical safety evaluation of anticancer drug liposome preparations. Methods: Beagle dogs were divided into negative control group, empty vector liposome group, oxaliplatin injection group, oxaliplatin liposome low and high dose group. Intravenous infusion once every 2 weeks, a total of 4 times, recovery period of 1 month. Anatomical animals were examined for histopathology. RESULTS: Histopathological changes associated with liposomes, oxaliplatin for injection, and oxaliplatin liposomes were foam cell aggregates in multiple tissues and organs, decreased number of spermatogenic cells in the testes, spermicidal epididymal and thymus , Spleen atrophy; small granuloma of the liver, thymus, spleen atrophy. Conclusion: The comparison of the anatomical pathology of Beagle dogs with different dosage forms of the same anticancer drug provides important morphological reference data for the preclinical safety evaluation of anticancer drug liposome dosage forms.