CAJ | 학술논문

目的：评价SD大鼠连续腹腔注射纤维蛋白封闭剂的安全性。方法 SD大鼠雌雄分别按体质量随机分4组，即空白对照组、纤维蛋白封闭剂低剂量组、中剂量组和高剂量组，每组20只，雌雄各半。3个给药组的给药剂量分别为85.5、171．0和342．0 mg／kg ，每天腹腔注射给药，连续14 d ，恢复期28 d ，进行一般症状、血液学、血液生化和病理组织学等指标检测。结果与空白对照组相比，纤维蛋白封闭剂中、高剂量组大鼠第14天的白细胞计数显著升高，纤维蛋白原显著降低，中、高剂量组大鼠脾脏的脏器重量有增加趋势。组织病理学检查发现部分高剂量动物腹腔出现残留药物引起的纤维肉芽组织包裹。上述变化指标在恢复期结束时基本可恢复。结论大鼠腹腔注射纤维蛋白封闭剂85.5～342．0 mg／kg ，安全剂量为85.5 mg／kg ，毒性剂量为171．0 mg／kg。毒性靶系统或靶部位为血液系统、免疫系统和给药局部，毒性作用可逆。
목적：평개SD대서련속복강주사섬유단백봉폐제적안전성。방법 SD대서자웅분별안체질량수궤분4조，즉공백대조조、섬유단백봉폐제저제량조、중제량조화고제량조，매조20지，자웅각반。3개급약조적급약제량분별위85.5、171．0화342．0 mg／kg ，매천복강주사급약，련속14 d ，회복기28 d ，진행일반증상、혈액학、혈액생화화병리조직학등지표검측。결과여공백대조조상비，섬유단백봉폐제중、고제량조대서제14천적백세포계수현저승고，섬유단백원현저강저，중、고제량조대서비장적장기중량유증가추세。조직병이학검사발현부분고제량동물복강출현잔류약물인기적섬유육아조직포과。상술변화지표재회복기결속시기본가회복。결론대서복강주사섬유단백봉폐제85.5～342．0 mg／kg ，안전제량위85.5 mg／kg ，독성제량위171．0 mg／kg。독성파계통혹파부위위혈액계통、면역계통화급약국부，독성작용가역。
Objective To evaluate the safety of fibrin sealant (FS) intraperitoneal injection in SD rats .Methods 80 male and female SD rats were randomly divided into four groups (0 ,85.5 ,171 .0 ,342 .0 mg/kg) by body weight .All rats were in-traperitoneally injected with vehicle or FS daily for 14 days followed by a 28-day recovery period .The clinical signs ,hematolog-ical and biochemical indices were measured .The pathology were observed .Results Increase of white blood cell count (WBC) and decrease of fibrinogen (FIB) in d 14 were found in 171 .0 mg/kg and 342 .0 mg/kg dosage groups .Furthermore ,the tend-ency of weight increase of spleen were found in 171 .0 mg/kg and 342 .0 mg/kg dosage groups .Pathological exams of peritoneal cavity found that there were granulation tissues containing FS in some of the rats in 342 .0 mg/kg group .All of these changes got reversed after the recovery period .Conclusion The safety dose in this study is considered to be 85.5 mg/kg ,and the toxic-ity dose is 171 .0 mg/kg .The target toxicity systems or site of FS in SD rats are hematological system ,immune system and in-jection site .The toxic effects of FS are reversible .