可溶性止血纱布止血效果以及安全性评价试验  被引量:8

The Hemostatic Effect and Safety Evaluation Tests of Soluble Hemostatic Gauze

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作  者:徐玉茵 周小婷 柳小军 田林奇 田源 

机构地区:[1]河南省医疗器械检验所,郑州市450000 [2]南阳市久康医疗器械有限公司,南阳市473000

出  处:《中国医疗器械杂志》2016年第6期441-444,共4页Chinese Journal of Medical Instrumentation

摘  要:目的研究可溶性止血纱布对兔肝脏创面的止血效果以及安全性。方法制作兔肝脏出血模型,空白对照组用无菌纱布止血,阳性对照组用泰绫止血,受试组用可溶性止血纱布止血。记录止血时间,计算出血量,术后动物进行临床症状观察,测定肝和肾功能指标,组织病理学以及透射电镜检查。结果受试组的出血量减少,止血时间缩短;其他检查与空白对照组无差异。结论未见受试组样品对兔机体有毒性作用,止血效果较阳性对照组无差异。Objective The aim of this paper is to study the hemostasis and security of soluble hemostatic gauze in the rabbit liver hemorrhage model.Methods After making the rabbit liver hemorrhage model, the control group used sterile gauze to stop bleeding, the positive control group used TISTAT to stop bleeding, the test group used soluble hemostatic gauze to stop bleeding. Hemostasis, blood loss and animal clinical symptoms were measured. Liver and kidney parameters, along with histopathology were recorded and analyzed. Transmission electron microscopy examination was also done. Results The blood loss is cut back and hemostasis is shortened in the test group. Other tests have no difference with the control group.Conclusion No toxic effects on rabbit are found in the test group. The hemostatic effects have no difference with positive control group.

关 键 词:可溶性止血纱布 泰绫 止血 安全性 

分 类 号:R605[医药卫生—外科学]

 

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