一次性使用血液灌流器的体外血液相容性

Blood compatibility of disposable blood perfusion device in vitro

背景:作为与循环血液大面积、长时间接触的医疗器械,血液灌流器的血液相容性检测非常重要。目的:检测供试血液灌流器的血液相容性。方法:取供试血液灌流器与已经上市血液灌流器(对照)中的树脂微粒,分别与人抗凝血混合,置于37℃的旋转培养器上,进行体外血液学、血小板、凝血、补体检测。将两种树脂微粒分别与半抗凝兔血接触,通过检测血浆中剩余纤维蛋白原的含量来比较两者血栓形成的程度。将两种树脂微粒置入生理盐水中,再加入稀释抗凝兔血,进行溶血实验。动物实验经中国食品药品检定研究院伦理委员会批准。结果与结论:①供试血液灌流器树脂微粒组的活化部分凝血活酶时间、血小板数量大于对照灌流器树脂微粒组(P<0.01),总补体活性小于对照灌流器树脂微粒组(P<0.01);两组的凝血酶原时间、纤维蛋白原、白细胞及红细胞数量比较差异无显著性意义(P>0.05);②血栓形成实验中,两组的纤维蛋白原浓度比较差异无显著性意义(P>0.05);③供试血液灌流器树脂微粒的溶血率为0.2%;④结果表明与对照灌流器中的树脂微粒相比,供试血液灌流器中的树脂微粒对补体和凝血系统的激活相对较为严重(与对照的相对百分比在85%-115%之间),但对血小板数量的影响相对较小,供试血液灌流器中树脂微粒的溶血率较小,其血液相容性可被接受。

BACKGROUND:As a medical device that is in contact with circulating blood in a large area for a long time,blood compatibility testing of the blood perfusion device is very important.OBJECTIVE:To test the blood compatibility of the test blood perfusion device.METHODS:The resin microparticles in the test blood perfusion device and the marketed blood perfusion device(as a control)were mixed with human anticoagulated blood respectively,and placed on a 37°C rotating incubator for hematology,platelet,coagulation and complement detection in vitro.The two kinds of resin microparticles were respectively contacted with rabbit semi-anticoagulated blood,and the degree of thrombosis was compared by detecting the remaining fibrinogen content in the plasma.The two resin microparticles were placed in physiological saline,and then diluted anticoagulated rabbit blood was added for hemolysis experiment.The animal experiment was approved by the Ethics Committee of National Institutes for Food and Drug Control.RESULTS AND CONCLUSION:(1)The activated partial thromboplastin time and platelet concentration of the test blood perfusion device resin particle group were greater than those of the control perfusion device resin particle group(P<0.01),and the total complement activity was lower than that of the control perfusion device resin particle group(P<0.01).There was no statistically significant difference in prothrombin time,fibrinogen,the number of leukocytes and erythrocytes between the two groups(P>0.05).(2)In the thrombosis test,there was no statistical difference in the concentration of fibrinogen between the two groups(P>0.05).(3)The hemolysis rate of the resin microparticles in the test blood perfusion device was 0.2%.(4)The results showed that compared with the resin microparticles in the control perfusion device,the resin microparticles in the test blood perfusion device activated the complement and the coagulation system more severely(relative percentage to the control between 85%-115%),but the effect on the number of platelets is relatively small;the hemolysis rate of the resin particles in the test blood perfusion device is low;and its blood compatibility is acceptable.