中国组织工程研究

中国组织工程研究 ›› 2012, Vol. 16 ›› Issue (38): 7096-7100.doi: 10.3969/j.issn.2095-4344.2012.38.014

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

胆红素吸附柱的血液相容性

许建霞1，邵安良1，殷淑娟2，王淑琴2，张秀敏3，奚廷斐4   

  1. 1中国食品药品检定研究院，医疗器械检验中心，北京市 100050
    2温州医学院，信息与工程学院，浙江省温州市 325035
    3廊坊市爱尔血液净化器材厂，河北省廊坊市 065000
    4北京大学，前沿交叉学科研究院，生物医用材料与组织工程研究中心，北京市100871
  • 收稿日期:2012-05-03 修回日期:2012-07-31 出版日期:2012-09-16 发布日期:2012-09-16
  • 作者简介:许建霞★，女，1976年生，山西省稷山县人，汉族，2003年中国食品药品检定研究院毕业，硕士，助理研究员，主要从事生物材料及医疗器械的生物学评价研究。 xujianxia@nicpbp.org.cn

Blood compatibility of a bilirubin adsorbent column

Xu Jian-xia1, Shao An-liang1, Yin Shu-juan2, Wang Shu-qin2, Zhang Xiu-min3, Xi Ting-fei4   

  1. 1Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China
    2School of Information and Engineering, Wenzhou Medical College, Wenzhou 325035, Zhejiang Province, China
    3Langfang Aier Blood Purification Equipment Factory, Langfang 065000, Hebei Province, China
    4Academy for Advanced Interdisciplinary Studies, Peking University, Beijing 100871,China
  • Received:2012-05-03 Revised:2012-07-31 Online:2012-09-16 Published:2012-09-16
  • About author:Xu Jian-xia★, Master, Assistant researcher, Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China xujianxia@nicpbp.org.cn

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641

被引次数

1

摘要：

背景：胆红素吸附柱在临床上用于清除患者体内高浓度的胆红素，在使用过程中与血液有大面积长时间的接触，对其血液相容性的评价具有重要意义。
目的：评价一个树脂类胆红素吸附柱的血液相容性。
方法：将待测胆红素吸附柱及对照已经上市胆红素吸附柱中的树脂微粒置于硅化玻璃管中，以空硅化玻璃管作为空白对照。向3组硅化玻璃管中加入人新鲜血浆，于37 ℃隔水培养箱的旋转培养器上以30 r/min的速率旋转，3 min后吸取出血浆，用于凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原含量及总补体活性CH50的检测，实验重复3次。
结果与结论：与空白对照组比较，对照组与实验组凝血酶原时间、活化部分凝血活酶时间延长，纤维蛋白原含量减少，CH50减小，但随着树脂微粒与新鲜血浆接触次数的增多，这种变化越来越小。与对照组比较，实验组凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原含量的3次检测数值更接近于空白对照组；实验组CH50在3次检测中先大于对照组，再与对照组相当，最后小于对照组。表明：①随着与新鲜血浆接触次数的增多，树脂微粒的血液相容性得到改善。②待测胆红素吸附柱中树脂微粒对凝血系统的影响小于对照，对补体系统的影响在预吸附过程中小于对照，但其相容性的改善慢于对照。

关键词: 树脂微粒, 胆红素吸附柱, 血液相容性, 体外评价, 凝血酶原时间, 活化部分凝血活酶时间, 纤维蛋白原, 补体

Abstract:

BACKGROUND: The bilirubin adsorbent column is used to reduce the high concentration of bilirubin in the blood of patients. During the healing process, the resin particle in the column has a large-scale and long-time contact with the blood of patients. Therefore, the evaluation of blood compatibility of bilirubin adsorbent column is very important.
OBJECTIVE: To assess the blood compatibility of a bilirubin adsorbent column.
METHODS: Commercially available bilirubin adsorbent column was used as product control. The resin particles in test and control bilirubin adsorbent column were put into silicified glass tubes, respectively. The empty silicified glass tubes were used as blank control. The fresh human plasma was put into silicified glass tubes in three groups and cultured on the rotary incubator in impermeable incubator at the rate of 30 r/min under 37 ℃. After 3 minutes, the plasma was taken out to detect the prothrombin time, activated partial thromboplastin time, fibrinogen and complement hemolysis CH50. The whole process was repeated three times.
RESULTS AND CONCLUSION: Compared with the blank control group, prothrombin time and activated partial thromboplastin time in the control group and experimental group were prolonged; concentration of fibrinogen and complement hemolysis CH50 in the control group and experimental group were decreased, but the difference was reducing with the increasing plasma-resin particle contact processes. Compared with control group, values of prothrombin time, activated partial thromboplastin time, fibrinogen in the experimental group were closer to those in the blank control group in three determinations. In three determinations, complement hemolysis CH50 concentration in the experimental group was larger than that in the control group at first, then insignificantly different from the control group and at last smaller than that in the control group. Results indicated that: ①The blood compatibility of the resin particles was improved with increasing plasma-resin particle contact processes. ②The resin particle in the test bilirubin adsorbent column has fewer effect on the coagulation system than the control product. In first adsorption, the influence of the test resin particle on the complement system was smaller than the control product, but the control product had a faster increase in comparison with complement in later two adsorption processes.

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