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The efficacy and safety of gamma-interferon in the treatment of community-acquired pneumonia: results of the open randomized trial IN/100000-317

Journal «MEDICINA» ¹ 4, 2019, pp.110-125 (Research)

Authors

Belevsky A. S.
Doctor of Medicine, Professor, Head, Chair for Pulmonology, Faculty of Additional Professional Education1

Berns S. A.
Doctor of Medicine, Professor, Chair for Internal Medicine2

Lartseva O. A.
Head, Therapy Department ¹13

Myasnikov A. L.
MD, PhD, Head Physician3

Nadaraya V. M.
MD, PhD, Deputy Chief Physician for Surgery3

Talyzin P. A.
Head, Intensive Care Unit for CVA Patients3

1 - Pirogov Medical University, Moscow, Russian Federation
2 - A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russian Federation
3 - M.E. Zhadkevich City Clinical Hospital, Moscow, Russian Federation

Corresponding author

Svetlana Berns; e-mail: svberns@yandex.ru

Conflict of interest

The authors declare no conflict of interest.

Funding

The study was sponsored by Pharmaclon LLC.

Abstract

Introduction. Gamma-interferon plays an important role in the pathogenesis of bacterial infections. It was shown that some microorganisms, as well as the use of antibiotics, can specifically repress the synthesis of endogenous gamma-interferon. Therefore, the additional effect of exogenous gamma-interferon can play the role of the immune system inducer in a reduced response to antibiotic therapy conditions. Objective. To evaluate the efficacy and safety of gamma-interferon as part of antibiotic therapy in patients with community-acquired pneumonia. Materials and methods of research. Open randomized controlled trial in parallel groups. The studied group of patients received, in addition to the basic antibacterial therapy, gamma-interferon; the control group of patients received the combined antibacterial therapy: ceftriaxone and azithromycin. Study Results and Discussion. Of the 114 randomized patients, 110 completed the study. The actual distribution of patients was as follows: 54 patients in the study group and 60 patients in the control group. The average duration of hospital stay in the control group was significantly longer – by almost two days compared with the study group. The similar trend was observed in the subpopulation of bacteria resistant patients, although due to the small sample of patients no statistically significant differences between the groups were demonstrated. Changes in the Borg scale compared to the screening visit showed statistically significant differences between the groups in favor of the study group. By the 8-10th days of therapy, a decrease in the total score on the BCSS scale also reached statistically significant differences between the groups in favor of the study group. In the study group a significantly greater dynamics of a decrease in the level of leukocytes was also observed. The remaining criteria of effectiveness did not show statistically significant differences between groups. In terms of adverse reactions, both groups were similar and did not differ statistically. Conclusions: The results of the study positively demonstrated clinical efficacy and safety of gamma-interferon as part of antibiotic therapy in patients with community-acquired pneumonia, including patients with bacteriologically confirmed pathogen resistance. The use of gamma-interferon was accompanied by a significant reduction in the length of sickness and the duration of hospital stay.

Key words

gamma-interferon, antibiotic therapy, community-acquired pneumonia, bacterial resistance, ceftriaxone, azithromycin, white blood cell count

DOI

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