可吸收止血材料的体外抑菌和止血效果评价  

Evaluation of in Vitro Antibacterial and Hemostatic Effect of Absorbable Hemostatic Materials

作　　者：张爽 叶红[1] 童琳 曹琛 徐庆华 ZHANG Shuang;YE Hong;TONG Lin;CAO Chen;XU Qinghua(Institute of Preventive Medicine,Anhui Academy of Medical Sciences,Hefei Anhui 230061,China)

机构地区：[1]安徽省医学科学研究院预防医学研究所,安徽合肥230061

出　　处：《中国医疗设备》2022年第5期141-145,156,共6页China Medical Devices

基　　金：安徽省卫生计生委科研计划项目(2018YK002)。

摘　　要：目的比较不同材质、不同形态可吸收止血材料的体外抑菌和止血效果差异。方法选取9款市售的可吸收止血材料,根据国家医保医用耗材分类与代码目录,先按形态分为纱布类、非织布类及纤丝类;同形态下再按材质分为再生氧化纤维素(Oxidized Regenerated Cellulose,ORC)类、羧甲基纤维素(Carboxymethyl Cellulose,CMC)类、羟乙基纤维素(Hydroxyethyl Cellulose,HEC)类和壳聚糖(Chitosan,CTS)类。采用抑菌环实验评价止血材料的抑菌性,体外倒置凝血和体外动态凝血实验评价止血材料的凝血功能。计算体外凝血指数(Blood Clotting Index,BCI),BCI越低,表明凝血效果越好。结果仅ORC类材料形成了抑菌环,直径均>7 mm。与纱布类材料相比,纤丝类和非织布类材料产生了更明显的凝血现象;ORC材质的纱布产生的凝血现象较CMC和HEC材质更显著。纤丝类材料的BCI显著低于纱布类和非织布类(P<0.05);纱布类和非织布类材料中,ORC材质的BCI显著低于CMC、HEC和CTS材质(P<0.05)。结论不同材质的止血材料中,ORC类具有抑菌效果。不同形态材料的止血效果不同,纤丝类的止血效果优于非织布类和纱布类;非织布类和纱布类材料中,不同材质的止血效果也有显著差异,相同形态下ORC材质的止血效果优于CMC、HEC和CTS材质。本研究使用的实验方法为建立可吸收止血材料评价体系以及行业标准提供了一定的基础。Objective To compare the antibacterial and hemostatic effects of absorbable hemostatic materials with different materials and forms in vitro.Methods Totally nine commercially available absorbable hemostatic materials were selected.According to the coding classification catalog of medical consumables,they were classified as gauze,non-woven fabrics and fibril based on morphology,and oxidized regenerated cellulose(ORC),carboxymethyl celluloses(CMC),hydroxyethyl cellulose(HEC)and chitosan(CTS)based on textures.The antibacterial ring test was used to evaluate the antibacterial effect of hemostatic materials,and inverted and dynamic coagulation tests in vitro were used to evaluate the coagulation effect of the materials.In vitro blood clotting index(BCI)was calculated,and the lower the BCI,the better the coagulation effect was.Results Only ORC materials formed antibacterial rings with diameters of>7 mm.Compared with gauze material,fibril and non-woven material produced more obvious coagulation phenomenon.The coagulation phenomenon of ORC gauze was more significant than CMC and HEC gauze.The BCI value of the fibril was significantly lower than those of gauze and non-woven fabrics(P<0.05).In addition,among gauze and non-woven fabrics,the BCI values of ORC were significantly lower than those of CMC,HEC and CTS(P<0.05).Conclusion Among hemostatic materials with different textures,ORC has antibacterial effects.Materials with different morphology have different hemostatic effect,and the fibril has better hemostatic effect than non-woven fabrics and gauze.Among non-woven and gauze materials,the hemostatic effect of different materials is also significantly different,and the hemostatic effect of ORC material is superior to CMC,HEC and CTS material in the same form.The experimental methods used in this study also provide a basis for establishing an evaluation system of absorbable hemostatic materials and industry standards.

关 键 词：可吸收止血材料 抑菌效果 止血效果 纤丝类可吸收止血材料 再生氧化纤维素 

分 类 号：R318[医药卫生—生物医学工程]