Ecofucin® for the prevention of vaginal microbiota dysbiosis — bacterial vaginosis and candidiasis amid the use of systemic antimicrobial therapy

Abstract

V.N. Kuzmin A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russian Federation Aim: to assess the efficacy and safety of Ecofucin® in patients after performing planned gynecologic surgery procedures based on the changes in vaginal microbiota over time amid the use of systemic antimicrobial therapy (AMT). Patients and Methods: this prospective open randomized comparative parallel-group clinical study involved patients without signs of vaginal microbiota dysbiosis — bacterial vaginosis or candidiasis, who were hospitalized for planned surgery procedures. The group 1 patients (n=39) received systemic AMT and Ecofucin® for intravaginal application once a day at the bedtime for 12 days, starting 6 days before the planned surgery and AMT initiation, while the group 2 patients (n=40) received only systemic AMT. The efficacy was assessed a day after the completion of AMT and the use of the tested medication (i.e. on day 13 after the initiation of Ecofucin application) and 30±2 days after the initiation of using the tested drug. Clinical, microbiological and molecular genetic methods were used for the assessment. Results: symptoms common for vaginal microbiota dysbiosis — bacterial vaginosis and candidiasis were reported by 18% and 21% of the group 2 patients at days 13 and 30±2 after the initiation of AMT, while such symptoms were not recorded in any of the group 1 patients (F=0,107, р=0,007). In 100% of the group 1 patients both lactobacilli and bifidobacteria were detected at all endpoints. In group 2, lactobacilli were found at days 13 and 30±2 in 93.8% and 97% of patients, respectively (F=0.035, p=0.2; F=0.017, p=0.458), bifidobacteria — in 84.4% and 81.1% of patients, respectively (F=0.092, р=0.016; F=0.107, р=0,007, respectively). At the baseline, the groups had similar results of the vaginal discharge culture tests. In the group 1 patients, Candida spp. were not identified at any of the endpoints, in group 2 — Candida spp. were found in 22.5% of patients, starting from day 13 (F=0,125, р=0,002). No adverse events were reported. Conclusion: the administration of Ecofucin® vaginal suppositories containing natamycin 100 mg and excipient lactulose is effective for preventing microbiota dysbiosis — bacterial vaginosis and candidiasis in patients receiving antimicrobial therapy. Keywords: vagina, microbiocenosis, antimicrobial therapy, lactobacilli, bifidobacteria, candidiasis, natamycin, lactulose. For citation: Kuzmin V.N. Ecofucin® for the prevention of vaginal microbiota dysbiosis — bacterial vaginosis and candidiasis amid the use of systemic antimicrobial therapy. Russian Journal of Woman and Child Health. 2022;5(4):292–296 (in Russ.). DOI: 10.32364/2618-8430-2022-5-4-292-296.