Department for Blood Group Serology and Transfusion Medicine, Medical University Graz, Graz, Austria.
Transfus Med Hemother. 2014 Jul;41(4):309-25. doi: 10.1159/000365646. Epub 2014 Jul 21.
Nowadays patients receiving blood components are exposed to much less transfusion-transmitted infectious diseases than three decades before when among others HIV was identified as causative agent for the acquired immunodeficiency syndrome and the transmission by blood or coagulation factors became evident. Since that time the implementation of measures for risk prevention and safety precaution was socially and politically accepted. Currently emerging pathogens like arboviruses and the well-known bacterial contamination of platelet concentrates still remain major concerns of blood safety with important clinical consequences, but very rarely with fatal outcome for the blood recipient. In contrast to the well-established pathogen inactivation strategies for fresh frozen plasma using the solvent-detergent procedure or methylene blue and visible light, the bench-to-bedside translation of novel pathogen inactivation technologies for cell-containing blood components such as platelets and red blood cells are still underway. This review summarizes the pharmacological/toxicological assessment and the inactivation efficacy against viruses, bacteria, and protozoa of each of the currently available pathogen inactivation technologies and highlights the impact of the results obtained from several randomized clinical trials and hemovigilance data. Until now in some European countries pathogen inactivation technologies are in in routine use for single-donor plasma and platelets. The invention and adaption of pathogen inactivation technologies for red blood cell units and whole blood donations suggest the universal applicability of these technologies and foster a paradigm shift in the manufacturing of safe blood.
如今，与三十年前相比，接受血液成分输注的患者感染经输血传播的传染病的风险大大降低。当时，人们发现 HIV 是获得性免疫缺陷综合征的病原体，血液或凝血因子的传播途径已得到证实。从那时起，预防风险和安全防范措施的实施在社会和政治上得到了认可。目前，新出现的病原体，如虫媒病毒，以及众所周知的血小板浓缩物的细菌污染，仍然是血液安全的主要关注点，会对临床产生重要影响，但很少导致血液受者死亡。与已建立的针对新鲜冷冻血浆使用溶剂-去污剂程序或亚甲蓝和可见光的病原体灭活策略不同，用于含有细胞的血液成分（如血小板和红细胞）的新型病原体灭活技术从实验室向临床的转化仍在进行中。本文综述了目前可用的病原体灭活技术针对病毒、细菌和原生动物的药理学/毒理学评估和灭活效果，并强调了从几项随机临床试验和血液监测数据中获得的结果的影响。迄今为止，在一些欧洲国家，病原体灭活技术已常规用于单供体血浆和血小板。红细胞单位和全血捐献的病原体灭活技术的发明和应用表明这些技术具有普遍适用性，并推动了安全血液生产的模式转变。
