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输血医学中病原体灭活的临床试验:综述

Clinical trials for pathogen reduction in transfusion medicine: a review.

作者信息

McClaskey John, Xu Mina, Snyder Edward L, Tormey Christopher A

机构信息

Department of Laboratory Medicine, Yale University School of Medicine, New Haven, CT, United States.

出版信息

Transfus Apher Sci. 2009 Dec;41(3):217-25. doi: 10.1016/j.transci.2009.09.008. Epub 2009 Sep 29.

DOI:10.1016/j.transci.2009.09.008
PMID:19793679
Abstract

Despite the implementation of highly sensitive methods for the detection of pathogens in donor blood products, the risk of transmission of infectious disease to transfusion recipients remains. Of greatest concern, and accounting for most of the risk, are newly-emerging pathogens for which screening assays do not yet exist or well-known pathogens for which testing regimens are not routinely employed. Furthermore, passive donor screening programs are unlikely to capture all potentially infective donors. A promising strategy to overcome these limitations is the proactive incapacitation of pathogens residing in donor units. Several unique pathogen reduction/inactivation (PR/PI) platforms have been developed and implemented in clinical settings. The aims of this article are to review: (1) the basic methodology underlying PR/PI platforms, (2) the potential toxicities associated with PR/PI treatment of blood products, and (3) the data and outcomes from clinical trials involving currently available PR/PI platforms.

摘要

尽管实施了高灵敏度的方法来检测供血产品中的病原体,但传染病传播给输血接受者的风险依然存在。最令人担忧且占大部分风险的是那些尚无筛查检测方法的新出现病原体,或未常规采用检测方案的知名病原体。此外,被动的供血者筛查计划不太可能找出所有潜在的感染性供血者。克服这些限制的一个有前景的策略是主动灭活供血单位中的病原体。已开发出几种独特的病原体去除/灭活(PR/PI)平台并在临床环境中实施。本文的目的是综述:(1)PR/PI平台的基本方法,(2)与血液制品PR/PI处理相关的潜在毒性,以及(3)涉及当前可用PR/PI平台的临床试验的数据和结果。

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Clinical trials for pathogen reduction in transfusion medicine: a review.输血医学中病原体灭活的临床试验:综述
Transfus Apher Sci. 2009 Dec;41(3):217-25. doi: 10.1016/j.transci.2009.09.008. Epub 2009 Sep 29.
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Pathogen inactivation technology: cleansing the blood supply.病原体灭活技术:净化血液供应。
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Pathogen reduction technology: methods, status of clinical trials, and future prospects.病原体灭活技术:方法、临床试验现状及未来前景。
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Protecting the blood supply from emerging pathogens: the role of pathogen inactivation.保护血液供应免受新出现病原体的影响:病原体灭活的作用。
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