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使用噬菌体进行临床研究的优先排序考量

Considerations for prioritising clinical research using bacteriophage.

作者信息

Edwards Sarah J L, Tao Yiran, Elias Rodas, Schooley Robert

机构信息

STEaPP, University College London, 255309, Gower Street, London, U.K.

STS, University College London, 265201, London, U.K.

出版信息

Essays Biochem. 2024 Dec 17;68(5):679-686. doi: 10.1042/EBC20240013.

Abstract

Antimicrobial resistance (AMR) poses a significant global health threat, as it contributes to prolonged illness, higher mortality rates and increased healthcare costs. As traditional antibiotics become less effective, treatments such as bacteriophage therapy offer potential solutions. The question remains, however, on how to set research priorities in the face of a growing number of antibiotic-resistant pathogens, some common and/or dangerous. One standard way of making decisions about which research to prioritise is by using the disability-adjusted life year metric to estimate the current global impact of a disease or condition, combined with considerations of social justice although decisions made at a national level by governments, especially in low income countries with forecasting potential over future needs may look very different. Another approach is based on the needs of researchers and regulators given what we know about the technology itself. The biological characteristics of bacteriophage therapies set challenges to a universal and standardised prioritisation method. A proof of principle is still arguably needed. With a preliminary discussion of the scope and complexity of AMR and AMR therapeutics, we propose some implications of regulatory frameworks aiming to integrate bacteriophage therapy into mainstream medical practice while gathering scientific data on safety and efficacy, enhancing the collective action needed to combat AMR.

摘要

抗菌药物耐药性(AMR)对全球健康构成重大威胁,因为它会导致病程延长、死亡率升高以及医疗成本增加。随着传统抗生素的疗效降低,诸如噬菌体疗法等治疗方法提供了潜在的解决方案。然而,面对越来越多的耐药病原体,其中一些既常见又危险,如何确定研究重点仍是个问题。确定优先研究方向的一种标准方法是使用伤残调整生命年指标来估计一种疾病或病症当前对全球的影响,并结合社会正义因素进行考量,不过各国政府在国家层面做出的决策,尤其是在具有对未来需求预测潜力的低收入国家,可能会大不相同。另一种方法是根据我们对技术本身的了解,考虑研究人员和监管机构的需求。噬菌体疗法的生物学特性给通用和标准化的优先排序方法带来了挑战。原则性证明可能仍然是必要的。在初步讨论了AMR及AMR治疗方法的范围和复杂性之后,我们提出了一些监管框架的启示,旨在将噬菌体疗法纳入主流医疗实践,同时收集关于安全性和有效性的科学数据,加强对抗击AMR所需的集体行动。

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