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病原体灭活对红细胞和血小板浓缩物储存损伤的影响。

Effect of pathogen inactivation on the storage lesion in red cells and platelet concentrates.

作者信息

Seghatchian Jerard, Hervig Tor, Putter Jeffrey S

机构信息

Blood Components Technology Consultancy, 50 Primrose Hill Road, London, UK.

出版信息

Transfus Apher Sci. 2011 Aug;45(1):75-84. doi: 10.1016/j.transci.2011.06.006. Epub 2011 Jul 22.

Abstract

A primary function of blood transfusion services is to ensure the safety of the community's blood supply. Multilayer strategies of safety need to be incorporated into the processing of blood components in order to minimize untoward transfusion events related to infections or the blood storage lesion. While there have been considerable technical advances over the past few decades to advance blood component safety, there is a need for continued improvement. One significant problem area is transfusion transmitted bacterial infections. In infectious disease, blood borne bacteria are the major cause of morbidity in transfusion medicine. Proactive implementation of pathogen inactivation technologies, PIT can help to eliminate bacterial contamination of blood. This is accomplished by inactivation of various known and emerging bacterial pathogens, which have been identified through their nucleic acid sequences. The current PIT has additional positive impacts on transfusion safety by reducing adverse clinical events associated with viable residual leukocytes in the blood. Given the valuable benefits of pathogen inactivation, there is a practicable need to advance this technology. In order for a particular pathogen inactivation strategy to gain widespread acceptance, it must satisfy a number of important criteria. The technology shall be: (1) Effective to eliminate pathogens. (2) Uncomplicated and cost-effective to implement in the preparation of blood components. (3) Minimally toxic while maintaining the quality of blood storage products for transfusion purposes. (4) Safe. Currently, PIT is not suitable for all blood components. Future advances in PIT for whole blood and red cell components should expand the application of this technology across a broader range of blood products. Based on available laboratory and clinical data, current pathogen inactivation procedures appear to leave the cell components sufficiently viable to achieve an effective transfusion. Novel technologies continue to evolve for the inactivation of pathogens in the blood supply. We need to ensure these procedures do not worsen the storage lesion causing potential harm to patients. Quality research and development supporting multi-centre clinical trials are necessary. One purpose of such trials is to determine whether this new generation of procedures for processing blood yields bioequivalency regarding the quality of the products. Validated haematological assays should be utilized to test the extent of the blood storage lesion. Post-marketing surveillance involving active haemovigilance is necessary regarding possible adverse outcomes of transfusion.

摘要

输血服务的一项主要功能是确保社区血液供应的安全。多层安全策略需要纳入血液成分的处理过程中,以尽量减少与感染或血液储存损伤相关的不良输血事件。虽然在过去几十年里,在提高血液成分安全性方面已经取得了相当大的技术进步,但仍有持续改进的必要。一个重大问题领域是输血传播的细菌感染。在传染病方面,血源细菌是输血医学中发病的主要原因。积极实施病原体灭活技术(PIT)有助于消除血液的细菌污染。这是通过灭活各种已知和新出现的细菌病原体来实现的,这些病原体已通过其核酸序列得以识别。当前的病原体灭活技术通过减少与血液中存活的残余白细胞相关的不良临床事件,对输血安全还有其他积极影响。鉴于病原体灭活的宝贵益处,切实需要推进这项技术。为使特定的病原体灭活策略获得广泛认可,它必须满足一些重要标准。该技术应:(1)有效消除病原体。(2)在血液成分制备过程中实施简单且成本效益高。(3)毒性极小,同时保持用于输血目的的血液储存产品的质量。(4)安全。目前,病原体灭活技术并不适用于所有血液成分。全血和红细胞成分的病原体灭活技术未来的进展应扩大该技术在更广泛血液制品中的应用。根据现有的实验室和临床数据,当前的病原体灭活程序似乎能使细胞成分保持足够的活力以实现有效的输血。用于血液供应中病原体灭活的新技术不断发展。我们需要确保这些程序不会使储存损伤恶化而对患者造成潜在伤害。支持多中心临床试验的高质量研发是必要的。此类试验的一个目的是确定这种新一代血液处理程序在产品质量方面是否产生生物等效性。应使用经过验证的血液学检测方法来测试血液储存损伤的程度。对于输血可能产生的不良后果,有必要开展涉及主动血液监测的上市后监测。

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