Laboratory for Molecular and Cellular Technology, Queen Astrid Military Hospital, Brussels, 1120, Belgium.
Department of Infectious Diseases, Hospices Civils de Lyon, Lyon, 69002, France.
FEMS Microbiol Rev. 2022 Jan 18;46(1). doi: 10.1093/femsre/fuab040.
Like the sword of Damocles, the threat of a post-antibiotic era is hanging over humanity's head. The scientific and medical community is thus reconsidering bacteriophage therapy (BT) as a partial but realistic solution for treatment of difficult-to-eradicate bacterial infections. Here, we summarize the latest developments in clinical BT applications, with a focus on developments in the following areas: (i) pharmacology of bacteriophages of major clinical importance and their synergy with antibiotics; (ii) production of therapeutic phages; and (iii) clinical trials, case studies and case reports in the field. We address regulatory concerns, which are of paramount importance insofar as they dictate the conduct of clinical trials, which are needed for broader BT application. The increasing amount of new available data confirms the particularities of BT as being innovative and highly personalized. The current circumstances suggest that the immediate future of BT may be advanced within the framework of national BT centers in collaboration with competent authorities, which are urged to adopt incisive initiatives originally launched by some national regulatory authorities.
如同达摩克利斯之剑悬在头顶，后抗生素时代的威胁正笼罩着人类。科学界和医学界正在重新考虑噬菌体疗法（BT），将其作为治疗难以根除的细菌感染的一种部分但现实的解决方案。在这里，我们总结了临床 BT 应用的最新进展，重点关注以下领域的发展：（i）主要临床重要噬菌体的药理学及其与抗生素的协同作用；（ii）治疗性噬菌体的生产；以及（iii）该领域的临床试验、案例研究和案例报告。我们解决了监管方面的担忧，这些担忧至关重要，因为它们决定了临床试验的进行，而临床试验是更广泛地应用 BT 所必需的。越来越多的新数据证实了 BT 的独特创新性和高度个性化。目前的情况表明，BT 的近期未来可能会在国家 BT 中心与主管部门合作的框架内得到推进，主管部门被敦促采取一些国家监管部门最初提出的果断举措。
