Local therapy with a complex of exogenous cytokines in patients with recurrent viral-bacterial infections of the lower genital tract

DOI: https://dx.doi.org/10.18565/pharmateca.2021.6.44-50

G.B. Dikke (1), A.A. Sukhanov (2), I.I. Kukarskaya (2, 3), V.V. Ostromensky (1)

1) Academy of Medical Education n.a. F.I. Inozemtsev, St. Petersburg, Russia; 2) Perinatal Center, Tyumen, Russia; 3) Department of Obstetrics, Gynecology and Emergency Medicine with a Course of Clinical Laboratory Diagnostics of the Institute of Continuing Professional Development, Tyumen State Medical University, Tyumen, Russia
Background. Researchers note an increase in the frequency of relapses of vaginal dysbiosis to 69–80% of observations within 12 months. Currently, information on the participation of cytokines in the implementation of the innate immune response of the mucous membranes of the female reproductive tract has been obtained. The use of immunodiagnostics and immunomodulatory therapy with exogenous cytokines can significantly improve treatment outcomes and relapse prevention.
Objective. Evaluation of the effectiveness of therapy and the frequency of relapses in patients with recurrent infectious and inflammatory diseases of the lower genital tract of combined viral and bacterial etiology using various regimens of local immunomodulatory therapy.
Methods. A prospective, randomized, comparative, parallel-group clinical study was conducted. 58 women with recurrent vaginal dysbiosis were examined. In group I (n=30), the drug Superlimph 25 U was used vaginally daily for 10 days, in group II (n=28) – 10 U for 20 days; both groups reseived etiotropic therapy with a combined broad-spectrum drug with antibacterial, antifungal and anti-inflammatory effects (1 vaginal tablet daily for 10 days). Microscopy of vaginal smears, real-time PCR, determination of blood serum cytokine levels (IL-1β, -2, -4, -6, -8, -10, tumor necrosis factor α, interferon γ – IFN-γ) were used.
Results. Clinical recovery occurred in 90% (27/30; p<0.001) and 89% (25/28; p<0.001), respectively. Microbiological recovery according to microscopic examination was observed in 100% of patients in both groups (30/30 and 28/28; p<0.001). The frequency of HSV-2 virus shedding in group I decreased from 83% before treatment to 37% after it (p<0.001), as in group II – from 82 to 43%, respectively (p=0.002), p=0.63 – between groups after treatment. Before treatment, the level of all cytokines, except IFN-γ, was higher than the reference values; after treatment, their values decreased in both groups (p<0.001). During 12 months after treatment, in group I, high cytokine levels persisted in 13.3% and a relapse of vaginal dysbiosis was detected in 6.7% (2/30) of patients, in group II it was not observed (p=0.44). No side effects were observed during treatment. Adherence and acceptability were 100% in both groups.
Conclusion. Recurrent combined viral-bacterial vaginal infections are accompanied by an imbalance of pro- and anti-inflammatory cytokines. Treatment using the drug Superlimph (25 IU for 10 and 10 IU 20 days) in combination with etiotropic therapy has comparable clinical and microbiological efficacy, prevents recurrence of infections, with a preferable course of 20 days with a dose of 10 IU.

About the Autors

Corresponding author: Galina B. Dikke, Dr. Sci. (Med.), Associate Professor, Professor at the Department of Obstetrics and Gynecology with a Course in Reproductive Medicine, Academy of Medical Education n.a. F.I. Inozemtsev, St. Petersburg, Russia; e-mail: galadikke@yandex.ru
Address: lit. M, 22 Moscow Ave., St. Petersburg 190013, Russian Federation

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