Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, Stockholm, Sweden.
Ups J Med Sci. 2019 Nov;124(4):218-227. doi: 10.1080/03009734.2019.1688433. Epub 2019 Nov 14.
Clinical trial results of phage treatment of bacterial infections show a low to moderate efficacy, and the variation in infection clearance between subjects within studies is often large. Phage therapy is complicated and introduces many additional components of variance as compared to antibiotic treatment. A large part of the variation is due to pharmacokinetics and pharmacodynamics being virtually unknown, but also to a lack of standardisation. This is a consequence of the great variation of phages, bacteria, and infections, which results in different experiments or trials being impossible to compare, and difficulties in estimating important parameter values in a quantitative and reproducible way. The limitations of phage therapy will have to be recognised and future research focussed on optimising infection clearance rates by e.g. selecting phages, bacteria, and target bacterial infections where the prospects of high efficacy can be anticipated, and by combining information from new mathematical modelling of pharmacokinetic and pharmacodynamic processes and quantitatively assessed experiments.
噬菌体治疗细菌感染的临床试验结果显示其疗效较低或中等，并且研究中受试者之间的感染清除率差异通常较大。与抗生素治疗相比，噬菌体治疗更为复杂，引入了许多额外的变异因素。这种变异很大程度上是由于噬菌体、细菌和感染的药代动力学和药效动力学几乎未知，但也缺乏标准化。这是由于噬菌体、细菌和感染的巨大差异，导致不同的实验或试验无法进行比较，并且难以以定量和可重复的方式估计重要参数值。噬菌体治疗的局限性必须得到承认，未来的研究应侧重于通过选择噬菌体、细菌和目标细菌感染来优化感染清除率，这些感染可以预期有很高的疗效，并结合新的药代动力学和药效动力学过程的数学建模信息以及经过定量评估的实验。
