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一种用于治疗性血浆置换的新型微孔过滤膜系统的评估。

Evaluation of a new microporous filtration membrane system for therapeutic plasma exchange.

作者信息

Kurtz S R, Carey P M, McGill M, Pineda A A, Zaroulis C G, Case M T

机构信息

Department of Laboratory Medicine, Lahey Clinic Medical Center, Burlington, Mass.

出版信息

Vox Sang. 1987;53(2):89-95. doi: 10.1111/j.1423-0410.1987.tb04925.x.

DOI:10.1111/j.1423-0410.1987.tb04925.x
PMID:3686940
Abstract

A new therapeutic plasma exchange device developed by Sarns Inc./3M was evaluated in plasmapheresis of 20 healthy volunteers and in a multicenter clinical study of therapeutic plasma exchange that included 49 patients. Safety and efficacy of plasma separation from whole blood were assessed for a module that contains Durapore microporous surfactant-free polyvinylidene fluoride membrane (Millipore Corp., Bedford, Mass., USA). The extra-corporeal volume was 80 ml. Citrate and heparin anticoagulants were utilized. Mean plasma separation efficiency was 62% with unhindered passage of plasma proteins through the membrane pores and no hemolysis or activation of complement as measured by total hemolytic complement (CH50) and C3 conversion. Mean decrease in platelet count after procedures was 10%. No severe reactions occurred, and citrate effects (13%) were comparable to values reported with centrifugal instruments. The Sarns Inc./3M Therapore device is a rapid, safe and efficient system for plasma exchange and potentially for source plasma collection. The principal benefits are small extracorporeal volume and cell-free filtrate.

摘要

由Sarns公司/3M公司研发的一种新型治疗性血浆置换设备,在20名健康志愿者的血浆置换以及一项纳入49名患者的治疗性血浆置换多中心临床研究中进行了评估。对于一个包含Durapore无表面活性剂微孔聚偏二氟乙烯膜(美国马萨诸塞州贝德福德市密理博公司)的组件,评估了从全血中分离血浆的安全性和有效性。体外循环血量为80毫升。使用了柠檬酸盐和肝素抗凝剂。血浆平均分离效率为62%,血浆蛋白可不受阻碍地通过膜孔,且通过总溶血补体(CH50)和C3转化率测定,未出现溶血或补体激活现象。操作后血小板计数平均下降10%。未发生严重反应,柠檬酸盐效应(13%)与离心式仪器报告的值相当。Sarns公司/3M公司的Therapore设备是一种用于血浆置换以及潜在用于采集原料血浆的快速、安全且高效的系统。其主要优点是体外循环血量小且滤液无细胞。

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