Abstract
Successful implementation of lytic virulent bacteriophages in clinical practice requires convincing evidence of its safety and efficacy. Design : We searched in CENTRAL, MEDLINE, Embase, and Russian-language literature databases in May 2018. Original articles must fulfill the following eligibility criteria: randomized, controlled trials investigating the effects of phage therapy in people with bacterial infections; at least one patient outcome was reported. Three review authors independently selected, studies, extracted, data, and. assessed, risk of bias. We used, random-effects models for meta-analysis. Participants: adults and. children of both, sexes with bacterial infection, including multi-drug resistant variants, or individuals at risk of infection. Outcomes: recovery or resolution of infection; clinical improvement; change in number of exacerbations; recurrence of infection; quality of life; elimination or load, reduction of a pathogen in an anatomical compartment. Results : We included 13 trials (issued in 1965-2018) including 9 treatment studies and. 4 prevention studies. Overall, eight randomized, trials involved, adults. Five studies addressed skin and soft tissues infections, six studies concerned intestinal infections, one study addressed respiratory tract infection and. one study — ear infection. Across bias domains, 35-90% of trials scored, low risk of bias. Meta-analysis for adverse events attributable to phages and. for wound, healing provided us with pooled relative risks of 0.74 (95% CI 0.68;1.2) and 0.91 (95% CI0.68;1.2) respectively. Conclusions: Beneficial effect of bacteriophages can be demonstrated, and. not refuted. However, our study led. to tentative conclusions. The conduct of well-designed and sufficiently powered, trials would, facilitate registration and. wide accepting of bacteriophage treatment.
Highlights
Successful implementation of lytic virulent bacteriophages in clinical practice requires convincing evidence of its safety and efficacy
We searched in CENTRAL
randomized controlled trials investigating the effects of phage therapy in people
Summary
Cистематический обзор направлен на оценку эффективности бактериофагов для профилактики или лечения бактериальных инфекций у людей. Для отбора публикаций оригинальных исследований, а также анализа содержащейся в них информации были использованы строгие научные методы. Такой подход к синтезу результатов научных исследований обеспечивает применение предварительно заданных критериев включения и сводит к минимуму риск смещения (систематической ошибки) при формулировании выводов. Необходимо отметить, что такой подход к проведению исследования заранее документируется посредством протокола систематического обзора. В нашем случае протокол был зарегистрирован в международном реестре PROSPERO под номером CRD42018100813
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