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如何:评估英国患者对未经许可的噬菌体疗法的适用性。

How to: assess patient suitability for unlicensed phage therapy in the United Kingdom.

作者信息

Jones Joshua D, Stacey Helen J, Kennedy Ian W, Merabishvilli Maya, Haines Melissa E K, Blocker Oliver, Dharmasena Kumara, Gordon Andrew, Hamilton Stuart A, Aggarwal Ila, Nagy John, Urquhart Don S, Hall Lesley M L, Young Matthew J, MacGregor Gordon, Langley Ross J, Peters Christine, Munteanu Daniela I

机构信息

Infection Medicine, Edinburgh Medical School: Biomedical Sciences, University of Edinburgh, United Kingdom.

Public Health, Kings Cross Hospital, United Kingdom.

出版信息

Clin Microbiol Infect. 2025 Jan;31(1):57-61. doi: 10.1016/j.cmi.2024.07.022. Epub 2024 Aug 5.

DOI:
10.1016/j.cmi.2024.07.022
PMID:39111698
Abstract

BACKGROUND

Bacteriophage (phage) therapy is a promising alternative antimicrobial approach that has the potential to transform the way we treat bacterial infections. The antibiotic resistance crisis is driving renewed interest in phage therapy. There are currently no licensed phage therapy medicinal products and phage therapy is used in small but growing patient numbers on an unlicensed basis.

OBJECTIVES

This article provides guidelines on the assessment of patient suitability for unlicensed phage therapy for clinicians in the United Kingdom.

SOURCES

This article builds on Health Improvement Scotland's recommendation for the consideration of phage therapy in difficult-to-treat infections and the experience of the author group, who have collectively assessed the suitability of 30 patients for phage therapy.

CONTENT

In the United Kingdom, unlicenced medicines, including phages, may be considered to meet special clinical needs. The use of unlicenced medicines is governed by national legislation and local National Health Service trust policies. Phages can be used in any National Health Service trust and decisions about suitability should be made through existing local clinical management pathways. This article sets out guidelines to support local clinical teams in the assessment of patient suitability for phage therapy. Clinical and microbiological considerations are presented, including allergy and pregnancy.

IMPLICATIONS

The assessment of patient suitability for phage therapy is within the scope of local clinical teams. Local assessment through existing clinical management pathways will develop confidence and competence in phage therapy among clinical teams nationally and ensure timely patient care.

摘要

背景

噬菌体疗法是一种很有前景的抗菌替代方法,有可能改变我们治疗细菌感染的方式。抗生素耐药性危机正促使人们对噬菌体疗法重新产生兴趣。目前尚无获得许可的噬菌体疗法药品,噬菌体疗法在未经许可的情况下应用于数量虽少但不断增加的患者。

目的

本文为英国临床医生提供关于评估患者是否适合接受未经许可的噬菌体疗法的指南。

资料来源

本文基于苏格兰改善健康组织关于在难治性感染中考虑噬菌体疗法的建议以及作者团队的经验,该团队已共同评估了30名患者接受噬菌体疗法的适用性。

内容

在英国,包括噬菌体在内的未经许可的药品可被视为满足特殊临床需求。未经许可药品的使用受国家立法和当地国民健康服务信托政策的管辖。噬菌体可在任何国民健康服务信托机构中使用,关于适用性的决定应通过现有的当地临床管理途径做出。本文制定了指南,以支持当地临床团队评估患者接受噬菌体疗法的适用性。文中介绍了临床和微生物学方面的考虑因素,包括过敏和妊娠。

影响

对患者接受噬菌体疗法适用性的评估属于当地临床团队的职责范围。通过现有的临床管理途径进行当地评估将在全国临床团队中培养对噬菌体疗法的信心和能力,并确保及时为患者提供治疗。

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