Seghatchian Jerard, Struff Wilhelm G, Reichenberg Stefan
Blood Components Technology & Haemostasis/Thrombosis Consultancy, London, UK.
Transfus Med Hemother. 2011;38(1):55-64. doi: 10.1159/000323786. Epub 2011 Jan 27.
Methylene blue (MB) treated plasma has been in clinical use for 18 years. The current THERAFLEX MB-Plasma has a number of improved features compared with the original Springe methodology. This overview embodies: the biochemical characteristics of MB, the mechanism of the technology, toxicology, pathogen reduction capacity, current position in clinical setting and status within Europe. The THERAFLEX MB (TMB) procedure is a robust, well standardised system lending itself to transfusion setting and meets the current guidelines. The pathogen kill power of the TMB system, like the other available technologies, is not limitless, probably in order of 6 log for most enveloped viruses and considerably less for non-enveloped ones. It does not induce either new antigen or grossly reducing the function and life span of active principle in fresh frozen plasma (FFP). The removal of the residual MB at the end of the process has the beneficial effect of reducing potential toxic impacts. Clinical haemovigilance data, so far, indicate that cell-free MB plasma is effective in all therapeutic setting requiring FFP, besides inconsistent thrombotic thrombocytopenia purpura data, without serious side-effects or toxicity. The current system is in continuous improvement e.g. regarding virus reduction range, illumination device, software used, and process integration in the blood bank setting.
亚甲蓝（MB）处理的血浆已临床应用18年。与最初的Springe方法相比，当前的THERAFLEX MB-血浆具有许多改进的特性。本概述涵盖：MB的生化特性、该技术的机制、毒理学、病原体灭活能力、在临床环境中的当前地位以及在欧洲的状况。THERAFLEX MB（TMB）程序是一个强大、标准化良好的系统，适用于输血环境并符合当前指南。与其他可用技术一样，TMB系统的病原体杀灭能力并非无限，对于大多数包膜病毒可能为6个对数级，对于非包膜病毒则要低得多。它既不会诱导新抗原，也不会大幅降低新鲜冰冻血浆（FFP）中活性成分的功能和寿命。在过程结束时去除残留的MB具有减少潜在毒性影响的有益效果。到目前为止，临床血液监测数据表明，除了血栓性血小板减少性紫癜数据不一致外，无细胞MB血浆在所有需要FFP的治疗环境中均有效，且无严重副作用或毒性。当前系统正在持续改进，例如在病毒减少范围、照明设备、使用的软件以及血库环境中的过程整合方面。
