Division of Pulmonary Inflammation, Charité⁻Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10117 Berlin, Germany.
Department of Infectious Diseases and Respiratory Medicine, Charité⁻Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10117 Berlin, Germany.
Viruses. 2019 Mar 23;11(3):295. doi: 10.3390/v11030295.
The emergence of multidrug-resistant bacteria constitutes a great challenge for modern medicine, recognized by leading medical experts and politicians worldwide. Rediscovery and implementation of bacteriophage therapy by Western medicine might be one solution to the problem of increasing antibiotic failure. In some Eastern European countries phage therapy is used for treating infectious diseases. However, while the European Medicines Agency (EMA) advised that the development of bacteriophage-based therapies should be expedited due to its significant potential, EMA emphasized that phages cannot be recommended for approval before efficacy and safety have been proven by appropriately designed preclinical and clinical trials. More evidence-based data is required, particularly in the areas of pharmacokinetics, repeat applications, immunological reactions to the application of phages as well as the interactions and effects on bacterial biofilms and organ-specific environments. In this brief review we summarize advantages and disadvantages of phage therapy and discuss challenges to the establishment of phage therapy as approved treatment for multidrug-resistant bacteria.
多药耐药菌的出现对现代医学构成了巨大挑战，这一问题得到了全球领先医学专家和政界人士的认可。重新发现和采用西方医学的噬菌体疗法可能是解决抗生素耐药性日益严重问题的一种方法。在一些东欧国家，噬菌体疗法被用于治疗传染病。然而，尽管欧洲药品管理局（EMA）建议应加快基于噬菌体的疗法的开发，因为其具有重大潜力，但 EMA 强调，在通过适当设计的临床前和临床试验证明疗效和安全性之前，不能推荐噬菌体批准用于治疗。需要更多基于证据的数据，特别是在药代动力学、重复应用、对噬菌体应用的免疫反应以及对细菌生物膜和器官特异性环境的相互作用和影响等领域。在这篇简要综述中，我们总结了噬菌体疗法的优缺点，并讨论了将噬菌体疗法确立为多药耐药菌批准治疗方法所面临的挑战。
