Marschner Susanne, Goodrich Raymond
CaridianBCT Biotechnologies, Lakewood, CO, USA.
Transfus Med Hemother. 2011;38(1):8-18. doi: 10.1159/000324160. Epub 2011 Jan 31.
Bacterial contamination and emerging infections combined with increased international travel pose a great risk to the safety of the blood supply. Tests to detect the presence of infection in a donor have a 'window period' during which infections cannot be detected but the donor may be infectious. Agents and their transmission routes need to be recognized before specific tests can be developed. Pathogen reduction of blood components represents a means to address these concerns and is a proactive approach for the prevention of transfusion-transmitted diseases. The expectation of a pathogen reduction system is that it achieves high enough levels of pathogen reduction to reduce or prevent the likelihood of disease transmission while preserving adequate cell and protein quality. In addition the system needs to be non-toxic, non-mutagenic and should be simple to use. The Mirasol® Pathogen Reduction Technology (PRT) System for Platelets and Plasma uses riboflavin (vitamin B2) plus UV light to induce damage in nucleic acid-containing agents. The system has been shown to be effective against clinically relevant pathogens and inactivates leukocytes without significantly compromising the efficacy of the product or resulting in product loss. Riboflavin is a naturally occurring vitamin with a well-known and well-characterized safety profile. The same methodology is currently under development for the treatment of whole blood, making pathogen reduction of all blood products using one system achievable. This review gives an overview of the Mirasol PRT System, summarizing the mechanism of action, toxicology profile, pathogen reduction performance and clinical efficacy of the process.
细菌污染和新出现的感染，再加上国际旅行的增加，对血液供应的安全构成了巨大风险。检测献血者是否感染的测试存在一个“窗口期”，在此期间无法检测到感染，但献血者可能具有传染性。在开发特定测试之前，需要识别病原体及其传播途径。血液成分的病原体灭活是解决这些问题的一种手段，是预防输血传播疾病的一种积极方法。对病原体灭活系统的期望是，它能实现足够高的病原体灭活水平，以降低或防止疾病传播的可能性，同时保持足够的细胞和蛋白质质量。此外，该系统需要无毒、无致突变性，并且使用简单。用于血小板和血浆的Mirasol®病原体灭活技术（PRT）系统使用核黄素（维生素B2）加紫外线来诱导含核酸病原体的损伤。该系统已被证明对临床相关病原体有效，并且能使白细胞失活，而不会显著损害产品的功效或导致产品损失。核黄素是一种天然存在的维生素，具有众所周知且特征明确的安全特性。目前正在开发用于全血治疗的相同方法，这使得使用一个系统对所有血液制品进行病原体灭活成为可能。本综述概述了Mirasol PRT系统，总结了其作用机制、毒理学特性、病原体灭活性能和临床疗效。
