Potential approaches to prevent uncommon hemolytic side effects of AB0 antibodies in plasma derivatives

被引：8

作者：

Buchta, C ^{[1
]}

Macher, M ^{[1
]}

Höcker, P ^{[1
]}

机构：

[1] Med Univ Vienna, Dept Transfus Med, Clin Blood Grp Serol & Transfus Med, A-1090 Vienna, Austria

来源：

BIOLOGICALS | 2005年 / 33卷 / 01期

关键词：

D O I：

10.1016/j.biologicals.2004.10.004

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Since hemolytic reactions in patients after administration of plasma derivatives like immunoglobulins or coagulation factor preparations have been described, titers of anti-A and anti-B-antibodies have to be below defined levels for batch release of these plasma-derived therapeutic products according to the European Pharmacopoeia. We have summarized clinical relevance of ABO antibodies in plasma derivatives and related legal issues in the European Union, United States of America, and Japan. We have also discussed potential approaches for the prevention of hemolytic side effects with feasible steps in preparation of plasma derivatives, viz., (1) selection of donors, (2) exclusion of "dangerous donors", (3) optimizing ratio of the types of plasma, (4) removal of antibodies, (5) production of blood-group-specific plasma derivatives, (6) rejection of batches of plasma derivatives with high titers of antibodies, and (7) crossmatching before administration. For harmonization of standards for anti-A and anti-B in plasma-derived therapeutics the regulators and manufacturers will have to realistically deal with complex clinical, practical, and economic issues. (C) 2004 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

引用

页码：41 / 48

页数：8

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