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引用次数: 0
摘要
抗菌剂耐药性(AMR)细菌病原体的威胁与日俱增,而有前景的新型抗生素却相对匮乏,这就需要发现和开发更多的医疗干预措施。在过去的十年中,噬菌体已成为对抗 AMR 病原体的最有前途的新工具之一。所谓 "同情使用 "监管途径下的轶事临床经验以及数量有限的临床试验提供了充分的安全性证据和早期疗效证据。要充分发挥噬菌体的潜力,关键是要进行严格的临床试验,以确定其最佳用途,并使监管机构能够支持所需的商业化,让全球都能使用噬菌体。噬菌体疗法的临床开发需要设计和实施临床试验,充分利用从一个世纪的抗生素开发中吸取的经验教训,并将临床研究作为一个平台,在这个平台上,噬菌体生物学中对疗法至关重要的方面得到了更清晰的阐释。在临床试验中阐明噬菌体生物学的转化研究将促进基础科学实验室中高度相关的假设驱动工作,并将大大加快噬菌体疗法领域的发展。
Translational research priorities for bacteriophage therapeutics.
The growing threat of antimicrobial resistant (AMR) bacterial pathogens coupled with the relative dearth of promising novel antibiotics requires the discovery and development additional medical interventions. Over the past decade bacteriophages have emerged one of the most promising new tools to combat AMR pathogens. Anecdotal clinical experiences under so-called 'compassionate use' regulatory pathways as well as a limited number of clinical trials have provided ample evidence of safety and early evidence of efficacy. For phages to reach their full potential it is critical that rigorous clinical trials be conducted that define their optimal use and that enable regulatory authorities to support the commercialization required to afford global access. The clinical development of phage therapeutics requires the design and execution of clinical trials that take full advantage of lessons learned from a century of antibiotic development and that use clinical investigation as a platform in which aspects of phage biology that are critical to therapeutics are more clearly elucidated. Translational research that elucidates phage biology in the context of clinical trials will promote highly relevant hypothesis-driven work in basic science laboratories and will greatly accelerate the development of the field of phage therapeutics.
期刊介绍:
Essays in Biochemistry publishes short, digestible reviews from experts highlighting recent key topics in biochemistry and the molecular biosciences. Written to be accessible for those not yet immersed in the subject, each article is an up-to-date, self-contained summary of the topic.
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