新型推注式压缩纤维素止血装置在小型猪深部组织大出血急救中的止血效果及安全性研究  

Efficacy and safety evaluation of a new type of pushable compressed cellulose hemostatic device for controlling miniature swine lethal junctional hemorrhage

作　　者：杨磊 赵丹阳 杨志远[1] 叶彤 董佳慧 薛婷 韩鹏 吴卓娜 孙文种 甘慧 窦桂芳 顾若兰 孟志云 Yang Lei;Zhao Dan-Yang;Yang Zhi-Yuan;Ye Tong;Dong Jia-Hui;Xue Ting;Han Peng;Wu Zhuo-Na;Sun Wen-Zhong;Gan Hui;Dou Gui-Fang;Gu Ruo-Lan;Meng Zhi-Yun(Institute of Radiation Medicine,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China)

机构地区：[1]军事科学院军事医学研究院辐射医学研究所,北京100850

出　　处：《解放军医学杂志》2023年第8期913-920,共8页Medical Journal of Chinese People's Liberation Army

摘　　要：目的评估新型推注式压缩纤维素止血装置在小型猪深部组织大出血急救中的止血效果及安全性。方法将压缩纤维素止血颗粒置于过量生理盐水中,测试其吸液性能及体积膨胀性能。取3只大耳白兔的股动脉血,测定压缩纤维素止血颗粒的体外凝血时间,设置等质量CELOX-A®止血粉为阳性对照组,空白离心管为阴性对照组。取10只大鼠血浆,设置阴性对照组、压缩纤维素止血颗粒敷料组与CELOX-A®止血粉组,使用血栓弹性分析仪测试凝血活性。建立小型猪股动静脉完全切断大出血模型,设置模型组、推注式压缩纤维素止血装置组与CELOX-A®止血粉组,采用平行操作的方法对三组模型猪进行止血,记录止血过程中装置所用数量、按压次数、止血时间、止血过程总出血量,并检测止血前后血常规、凝血酶原时间(PT)及活化部分凝血活酶时间(APTT);采用HE染色观察血管组织病理变化。推注式压缩纤维素止血装置用DMEM培养基浸提后,将浸提液加入生长旺盛的L929细胞中,测试其细胞毒性,同时设置加入苯酚的完全DMEM培养基为阳性对照组,加入完全DMEM培养基为阴性对照组。推注式压缩纤维素止血装置用生理盐水浸提后,将生理盐水浸提液注射到小鼠体内,测试其急性毒性,阴性对照组注射等量生理盐水。以生理盐水为阴性对照组,去离子水为阳性对照组,采用溶血试验测定推注式压缩纤维素止血装置的溶血率。结果装置内部的压缩纤维素止血颗粒在生理盐水中可迅速吸液并膨胀,最大吸水倍率≥7.3倍,体积膨胀倍率3 s即可达到(9.0±0.3)倍。压缩纤维素止血颗粒敷料体外凝血时间[(451.7±26.6)s]较阴性对照组[(703.7±32.1)s]明显缩短(P<0.01),并优于CELOX-A®止血粉[(521.7±18.1)s](P<0.05)。血栓弹力图分析结果显示,与阴性对照组比较,压缩纤维素止血颗粒敷料与CELOX-A®止血粉均能明显缩短血凝块形成时�Objective To evaluate the hemostatic efficacy and safety of a new type of pushable compressed cellulose hemostatic device in emergency treatment of deep tissue massive hemorrhage.Methods The internal compressed cellulose hemostatic granules were placed in excess normal saline to test their saline absorption and volume expansion properties.Femoral artery blood was taken from 3 bigeared white rabbits for measuring the in vitro clotting time of the compressed cellulose hemostatic granules,and equal quality CELOX-A®hemostatic powder was set as the positive control group,and the blank plasma as negative control group.Ten rats were divided into the compressed cellulose hemostatic granule dressing group,CELOX-A®hemostatic powder group and negative control group,and plasma was taken to test the coagulation activity by using a thromboelastometer.The swine models of massive hemorrhage were established by complete transection of the femoral artery and vein,and divided into the model group of medical defatted gauze block,the pushable compressed cellulose hemostatic device group,and the positive control group of CELOX-A®.The three groups used parallel operation for hemostasis.The number of pushable compressed cellulose hemostatic device used in the hemostasis process,the number of presses,the hemostasis time,the total blood loss during the hemostasis process were recorded,the routine blood tests before and after hemostasis,the prothrombin time(PT)and activated partial thromboplastin time(APTT)were measured and HE staining was used to observe the pathological changes of the tissue vessels.After DMEM medium was used to extract the pushable compressed cellulose hemostatic device,and the extract was added to L929 cells with vigorous growth to test the cytotoxicity.At the same time,the complete DMEM medium with phenol was set as the positive control group and the complete DMEM medium as the negative control group.After pushable compressed cellulose hemostatic device was extracted with normal saline,the normal saline extract was

关 键 词：推注式止血装置 压缩纤维素止血颗粒 止血敷料 肢体结合部位出血 

分 类 号：R641[医药卫生—外科学]