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血浆输入和使用单采血小板作为变异型克雅氏病的降低风险措施:SaBTO 综述。

Importation of plasma and use of apheresis platelets as risk reduction measures for variant Creutzfeldt-Jakob disease: The SaBTO review.

机构信息

NHS Blood and Transplant, London, UK.

Department of Health and Social Care, London, UK.

出版信息

Transfus Med. 2022 Feb;32(1):24-31. doi: 10.1111/tme.12840. Epub 2021 Dec 7.

DOI:10.1111/tme.12840
PMID:34873757
Abstract

Following recognition that blood, blood components, tissues and organs donated by infected donors could transmit infectious prions causing variant Creutzfeldt-Jakob Disease (vCJD), several risk reduction measures were introduced in the UK. The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) established a working group to review the measures in place. Factors considered included: ethical issues around the current provisions and potential changes; operational issues for blood establishments and hospitals; a review from the Advisory Committee on Dangerous Pathogens (ACDP) showing the downward trend in the estimated number of future cases of vCJD; and cost-effectiveness. The working group recommended that the current vCJD risk reduction measures for individuals born after 1995 or with thrombotic thrombocytopenic purpura (TTP) could be withdrawn. After consultation with stakeholders, SaBTO accepted these proposals which allow more equal provision of components, less operational complexity and risk, and more resources to be deployed elsewhere in the NHS. The potential saving on plasma will be £500 m and moving to using pooled platelets in additive solution for all recipients will bring potential savings of £280 m over the next 50 to 60 years. There could be small number of additional clinical cases of vCJD: 1-2 (<1-14; 95% CI) from plasma and 3-4 (<1 to 45; 95% CI) from platelets. Local and national guidelines will still be applied for managing individual conditions. UK Ministers for Health accepted SaBTO's recommendations on 9 Sept 2019 and implementation began immediately. This paper describes the review and rationale leading to these recommendations.

摘要

鉴于受感染供体捐献的血液、血液成分、组织和器官可能传播传染性朊病毒,从而导致变异型克雅氏病(vCJD),英国采取了若干降低风险的措施。血液、组织和器官安全咨询委员会(SaBTO)成立了一个工作组,对现有措施进行审查。所考虑的因素包括:现行规定的伦理问题及可能的变更;血液机构和医院的运营问题;危险病原体咨询委员会(ACDP)的审查表明 vCJD 未来病例数呈下降趋势;以及成本效益。工作组建议取消针对 1995 年后出生或患有血栓性血小板减少性紫癜(TTP)人群的现行 vCJD 降低风险措施。SaBTO 在与利益相关者协商后,接受了这些提案,这使得成分供应更加平等,运营复杂性和风险降低,同时可以将更多资源部署到国民保健制度的其他领域。血浆潜在节省额为 5 亿英镑,未来 50 至 60 年,在所有受血者中使用添加溶液中的混合血小板,潜在节省额为 2.8 亿英镑。可能会有少量额外的 vCJD 临床病例:来自血浆的 1-2 例(<1-14;95%CI),来自血小板的 3-4 例(<1 至 45;95%CI)。局部和国家指南仍将适用于管理个别情况。英国卫生部长们于 2019 年 9 月 9 日接受了 SaBTO 的建议,并立即开始实施。本文描述了进行此项审查的理由和依据。

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