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噬菌体疗法:迈向成功的临床试验。

Phage Therapy: Towards a Successful Clinical Trial.

作者信息

Górski Andrzej, Borysowski Jan, Międzybrodzki Ryszard

机构信息

Bacteriophage Laboratory, Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences (HIIET PAS), 53-114 Wroclaw, Poland.

Phage Therapy Unit, Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences (HIIET PAS), 53-114 Wroclaw, Poland.

出版信息

Antibiotics (Basel). 2020 Nov 19;9(11):827. doi: 10.3390/antibiotics9110827.

Abstract

While phage therapy carried out as compassionate use (experimental therapy) has recently flourished, providing numerous case reports of supposedly healed patients, clinical trials aiming to formally prove their value in accord with current regulatory requirements have failed. In light of the current issue of increasing antibiotic resistance, the need for a final say regarding the place of phage therapy in modern medicine is evident. We analyze the possible factors that may favor success or lead to the failure of phage therapy: quality of phage preparations, their titer and dosage, as well as external factors that could also contribute to the outcome of phage therapy. Hopefully, better control of these factors may eventually bring about long-awaited positive results.

摘要

尽管作为同情用药(实验性疗法)开展的噬菌体疗法近来蓬勃发展,涌现出大量关于疑似治愈患者的病例报告,但旨在依据现行监管要求正式证明其价值的临床试验却失败了。鉴于当前抗生素耐药性不断增加的问题,对于噬菌体疗法在现代医学中的地位给出最终定论的必要性显而易见。我们分析了可能有利于噬菌体疗法取得成功或导致其失败的因素:噬菌体制剂的质量、效价和剂量,以及也可能影响噬菌体疗法结果的外部因素。有望对这些因素进行更好的控制最终能带来期待已久的积极成果。

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