跨境对话:关于菌体治疗的监管机构的国际调查
Riley D Alvarez1, Christine Årdal2, Annika Y Classen3
1Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
International journal of antimicrobial agents
|September 8, 2025
概括
对细菌体 (体) 治疗 (PT) 的监管观点对于其临床准入至关重要. 这项全球调查显示,监管机构需要更多的意识和合作,以建立PT的清晰途径,这是抗生素的有希望的替代品.
科学领域:
- 微生物学 微生物学
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 抗菌素耐药性是全球卫生危机.
- 菌体治疗 (PT) 提供了抗生素的替代方案.
- 对于PT的监管框架在全球范围内有很大差异.
研究的目的:
- 探索全球监管机构对细菌治疗的看法.
- 了解PT的当前和未来的监管环境.
- 确定PT临床接入的挑战和机会.
主要方法:
- 一项国际调查被分发给监管机构.
- 受访者是欧盟关于抗菌素耐药性和医疗保健相关感染的联合行动的成员,并单独联系监管机构.
- 从21个国家的23名受访者收集了数据.
主要成果:
- 只有13%的国家行动计划提到菌体或PT.
- 近一半的监管机构之前没有参与与菌体相关的监管过程.
- 许多监管机构对其国家以前的治疗菌体使用不确定,单次使用案例造成了资源负担.
结论:
- 在监管机构对PT的认识和参与方面存在重大差距.
- 需要在PT监管的最佳实践方面加强合作.
- 澄清调控途径对于改善临床对菌体治疗的准入至关重要.
相关概念视频
DNA Bacteriophages
827
Bacteriophages, or phages, are viruses that specifically infect bacteria, utilizing their genetic material to hijack host cellular machinery for replication. DNA bacteriophages employ single-stranded DNA (ssDNA) or double-stranded DNA (dsDNA) genomes. These phages exhibit diverse replication strategies and host interactions, influencing their ecological roles and applications in biotechnology and medicine.ssDNA BacteriophagesssDNA phages, with their small genomes, utilize unique strategies to...
827
Lytic Cycle of Bacteriophages
77.5K
Bacteriophages, also known as phages, are specialized viruses that infect bacteria. A key characteristic of phages is their distinctive “head-tail” morphology. A phage begins the infection process (i.e., lytic cycle) by attaching to the outside of a bacterial cell. Attachment is accomplished via proteins in the phage tail that bind to specific receptor proteins on the outer surface of the bacterium. The tail injects the phage’s DNA genome into the bacterial cytoplasm. In the...
77.5K
Microorganisms in Medicine and Therapeutics
989
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
989
Drug Control Governance: Regulatory Bodies and Their Impact
497
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
497
Drug Regulation
2.7K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.7K
Transduction
1.3K
Among the three main modes of HGT—transformation, conjugation, and transduction—transduction is unique in that it is mediated by bacteriophages, or bacterial viruses.Transduction occurs in two ways. Generalized transduction occurs during the lytic cycle of a bacteriophage infection. In this process, bacteriophages infect bacterial cells, replicate within them, and ultimately cause cell lysis, releasing newly assembled virions. Occasionally, random fragments of the bacterial genome...
1.3K


