Sandler S Gerald
Georgetown University Medical Center, Washington, DC, USA.
Transfus Apher Sci. 2010 Dec;43(3):393-399. doi: 10.1016/j.transci.2010.09.006. Epub 2010 Oct 6.
Efforts to reduce the risk of transfusion-transmitted infectious diseases began more than 4 decades ago with testing donated blood for syphilis. During the subsequent 4 decades, the number of recognized blood-borne transmissible agents and new laboratory tests has proliferated to a logistical breaking point. Further, the number of "emerging agents" which might enter the donor population is increasing continuously. In the search for an alternative to the laboratory testing strategy, pathogen-reduction technologies have emerged as the most promising. The model for this paradigm is pasteurization of a bottle of cow's milk. No matter what infective agent may be present in freshly collected cow's milk, pasteurization, i.e., a generic purification process can eliminate all potential infectivity, while preserving its essential biological properties--and an affordable cost. Several manufacturers have undertaken the challenge of developing a pathogen-reduction technology for blood components. Some novel technologies have proven successful for pooled plasma derivatives such as immune globulins, coagulation factor concentrate concentrates and albumin. The greatest challenge is finding a technology that is suitable for red blood cell and platelet components, whereas significant progress has been made already for pathogen-reduced plasma products. The present review addresses the status of implementation of pathogen-reduced plasma products in the global market. Some blood centers and hospital blood banks in Europe and the Middle East have begun to distribute pathogen-reduced plasma, but no pathogen-reduced plasma product is presently approved by the US Food and Drug Administration. While many observers in the United States focus on the regulatory process as the impediment to widespread implementation, the real challenge will be paying the surcharge for the pathogen-reduction process - an as yet unspecified figure - but likely to add a very substantial amount to the annual healthcare budget.
40多年前，人们就开始努力降低输血传播感染性疾病的风险，当时通过检测献血者血液中的梅毒来进行防控。在随后的40年里，已知的血源传播病原体数量以及新的实验室检测方法激增，已达到后勤保障的极限。此外，可能进入献血人群的“新兴病原体”数量也在不断增加。在寻求实验室检测策略的替代方法时，病原体灭活技术已成为最有前景的方法。这种模式的典范就是一瓶牛奶的巴氏杀菌法。无论新鲜采集的牛奶中存在何种感染因子，巴氏杀菌法，即一种通用的净化过程，都能消除所有潜在的传染性，同时保留其基本生物学特性，而且成本可控。几家制造商已着手开发用于血液成分的病原体灭活技术。一些新技术已被证明对免疫球蛋白、凝血因子浓缩物和白蛋白等混合血浆衍生物有效。最大的挑战是找到一种适用于红细胞和血小板成分的技术，而在病原体灭活血浆产品方面已经取得了重大进展。本综述阐述了病原体灭活血浆产品在全球市场的应用现状。欧洲和中东的一些血液中心和医院血库已开始分发病原体灭活血浆，但目前美国食品药品监督管理局尚未批准任何病原体灭活血浆产品。虽然美国的许多观察家将监管程序视为广泛应用的障碍，但真正的挑战将是为病原体灭活过程支付附加费——这一数字尚未明确——但可能会使年度医疗保健预算大幅增加。
