Azoximer bromide-modulated immune response in aerobic vaginitis

Abstract

Aim: to evaluate the efficacy of azoximer bromide along with a combined antimicrobial drug in treatment of patients with aerobic vaginitis (AV).Materials and Methods. There was conducted a prospective, randomized, parallel group study with enrolled 60 patients diagnosed with AV and 10 apparently healthy women (control group III). Group I (n = 30) received azoximer bromide (10 vaginal insertion according to the scheme, course of 10 days) and a combined antimicrobial drug, while Group II (n = 30) received only antimicrobial drug (course of 10 days). Microscopy of vaginal discharge smears, polymerase chain reaction method was used, detection of cytokines – interleukins (IL) and tumor necrosis factor-alpha (TNF-α) in vaginal washings was performed by ELISA. The study of neutrophil extracellular traps (NETs) was performed by ELISA, and DNA-containing strands ejected by neutrophils were determined by fluorescence method.Results. Recovery from disease was found in 100 % (30/30) and 86.7 % (26/30) in group I and group II, respectively. After treatment, serum level of IL-8 was revealed to decline in group I from 35.2 to 5.5 pg/ml (p = 0.05), in group II – from 33.4 to 5.3 pg/ml (p = 0.04), also not differ (p > 0.05) from the control values (5.2 pg/ml). The level of IL-1β also decreased after treatment in group I from 51.5 to 15.1 pg/ml (p = 0.002), in group II – from 57.9 to 20.1 pg/ml (p = 0.03), which also did not differ (p > 0.05) from the control values (16.7 pg/ml). The IL-10 level in both main groups decreased slightly (from 0.26 and 0.24 to 0.16 pg/ml in both groups), which was higher by 1.8-fold than in the control group (0.09 pg/ml; p < 0.001). The number of ejected NETs in both main groups decreased significantly after treatment, reaching control level. No side effects were observed, compliance and acceptability were 100 % in both groups. The frequency of AV relapses within 3 months was observed in 3.3 % (1/30) and 14.3 % (4/28) patients, after 6 months – in 14.3 % (4/28) and in 20.0 % (5/25) patients in groups I and II, respectively. Using the logit regression model, demonstrated that AV relapse might occur with a 50 %-probability at TNF-α level < 0.1 pg/ml after treatment (sensitivity – 67 %, specificity – 79 %). The risk of relapses in group I, in contrast to group II, showed a downward trend.Conclusions. The use of azoximer bromide and a combined broad-spectrum antimicrobial drug is effective in AV treatment, exerts a modulating effect on immune response parameters contributes to lowering relapse rate.