Solheim Bjarte G, Chetty Rangini, Flesland Oystein
Institute of Immunology, Rikshospitalet University Hospital and University of Oslo, Oslo, Norway.
Curr Opin Hematol. 2008 Nov;15(6):612-7. doi: 10.1097/MOH.0b013e32831366d3.
Donor selection and viral screening methods combined with pathogen reduction have increased the safety of pooled plasma to a level which makes reintroduction of ABO-universal plasma an important option.
Solvent detergent-treated pooled plasma has proved to be well suited for the production of pathogen-reduced ABO-universal plasma. One such product, Bioplasma FDP, was licensed in South Africa in 1994 and has since 1996 been in successful clinical use. A clinical study with this product and two studies with the European product, Uniplas, have confirmed the efficacy and safety of pathogen-reduced ABO-universal plasma.
Pooling of plasma enables the production of ABO-universal plasma. Pathogen reduction with solvent detergent eliminates lipid-enveloped viruses, whereas neutralizing antibodies in the plasma pool and nucleic acid amplification testing ensures the safety for recognized nonlipid-enveloped viruses. Pooling also eliminates transfusion-associated acute lung injury (the leading cause of plasma transfusion-related death), reduces immunologic/allergic adverse events by 60-80% and standardizes plasma protein content. Thus, in addition to ABO compatibility, pathogen-reduced ABO-universal plasma has important supplementary benefits that improve the product's cost-effectiveness.
供体选择、病毒筛查方法以及病原体灭活技术相结合，已将混合血浆的安全性提高到了使重新引入ABO通用血浆成为一个重要选择的水平。
经溶剂去污剂处理的混合血浆已被证明非常适合生产经病原体灭活的ABO通用血浆。一种名为Bioplasma FDP的此类产品于1994年在南非获得许可，自1996年以来已成功应用于临床。一项关于该产品的临床研究以及两项关于欧洲产品Uniplas的研究，证实了经病原体灭活的ABO通用血浆的有效性和安全性。
血浆混合可生产ABO通用血浆。用溶剂去污剂进行病原体灭活可消除脂包膜病毒，而血浆池中的中和抗体和核酸扩增检测可确保对已知非脂包膜病毒的安全性。血浆混合还可消除输血相关急性肺损伤（血浆输血相关死亡的主要原因），将免疫/过敏不良事件减少60 - 80%，并使血浆蛋白含量标准化。因此，除了ABO相容性外，经病原体灭活的ABO通用血浆还有重要的附加益处，可提高产品的成本效益。
