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目的评价临床使用奥沙利铂脂质微球注射液的安全性。方法肌肉刺激性实验:主要观察家兔注射奥沙利铂脂质微球后48 h和2周的组织病理变化;溶血性实验:观察本品在3 h内有无溶血和聚集现象;全身过敏性实验:豚鼠隔日3次腹腔注射奥沙利铂脂质微球或牛血清白蛋白V,于末次给药后第10天静脉注射本品,观察3 h内动物的变化。结果奥沙利铂脂质微球注射液对家兔股四头肌无刺激作用,家兔红细胞无溶血现象,豚鼠未见过敏反应。结论实验结果表明奥沙利铂脂质微球注射液安全可靠。
Objective To evaluate the safety of clinical use of oxaliplatin lipid microsphere injection. Methods Muscle irritation test: observe the histopathological changes at 48 h and 2 weeks after injection of oxaliplatin lipid microspheres in rabbits. Hemolytic experiment: observe the presence or absence of hemolysis and aggregation within 3 h; systemic allergy Sexual experiments: Guinea pigs were injected intraperitoneally with oxaliplatin lipid microspheres or bovine serum albumin V three times every other day. The animals were injected intravenously at the 10th day after the last administration, and the changes of the animals within 3 hours were observed. Results Oxaliplatin injection of lipid microspheres had no stimulation on quadriceps femoris, no hemolysis in rabbit erythrocytes and no allergic reaction in guinea pigs. Conclusion The experimental results show that Oxaliplatin lipid microsphere injection is safe and reliable.