医用纤维蛋白胶亚急性毒性实验研究

The Subacute Systemic Toxicity Investighation of Medical Fibrin Glue

按照GB/T16886.11医疗器械生物学评价第11部分全身毒性试验的方法,观察了医用纤维蛋白胶对大鼠的全身亚急性毒性反应,其目的是找出纤维蛋白胶毒副反应的靶器官,确定是否有潜在的毒性反应,研究发现纤维蛋白胶浸提液高低剂量连续大鼠腹腔注射给样14天,大鼠一般状况良好,体重增加。给供试品后高剂量雄性和低剂量雄、雌性大鼠的凝血时间与对照组比较明显延长。高、低剂量雌雄性大鼠脾脏系数与对照组比较有显著性差异。病理组织学检查不同剂量浸提液组大鼠脾肿大、充血及生发中心淋巴细胞增生。因此纤维蛋白胶毒性可能的靶器官主要是凝血系统和免疫系统的脾脏,提示可能有潜在的免疫毒性。

The subacute systemic toxicity of medical fibrin glue was investigated based on the method described in the GB/T16886.11 Biological Evaluation of Medical Devices Part 11. Systemic Toxicity for finding possible target organ of fibrin glue which potentially cause toxic and side effect. The determination of toxicity was based upon clinical observation, animal/organ weights, haematological parameters and serum biochemical analysis, necropsy observation and histopathological assessment of selected tissues from animals in test and control group did not exhibit any signs of clinical observation with body weight gain over the course of the study. The blood clotting timw was prolonged in the female high dose group and lower dose group. Necropsy found that the spleen enlargement in the test groups and spleen organ index in the test groups was significantly difference from the control groups. The histopathological observation also found the congestion and lymphocytes proliferation in the enlarged spleen tissue. The study concluded that the potentical toxic target organ of the fibrin glue was the immunological spleen and blood coagulation system.