Эффективность и безопасность препарата Экорутель форте, содержащего 750 мг метронидазола, 200 мг миконазола и 500 мг лактулозы, у пациенток с бактериальным вагинозом и/или кандидозным вульвовагинитом: международное многоцентровое рандомизированное контролируемое исследование

Abstract

Aim: to compare the efficacy and safety of Ecorutel forte vaginal suppositories (750 mg metronidazole + 200 mg miconazole + 500 mg lactulose) and Neo-Penotran® forte vaginal suppositories (750 mg metronidazole + 200 mg miconazole) in women with bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC). Patients and Methods: this multicenter, open-label, prospective, comparative, randomized controlled trial was conducted in parallel groups. A total of 220 women diagnosed with BV and/or VVC were included (PP population included 202 women who completed the treatment and safety population included 220 women). Women were randomized into two groups, depending on the drug. The study group (n=108) received vaginal suppositories containing 750 mg metronidazole, 200 mg miconazole, and 500 mg lactulose (Ecorutel forte). The comparison group (n=112) received vaginal suppositories containing 750 mg metronidazole and 200 mg miconazole. The efficacy of the treatment was assessed by microbiological, clinical, and overall (clinical and microbiological) recovery. In addition, treatment satisfaction and changes in lactobacilli count on day 30–35 compared to baseline were evaluated. The evidence of superior efficacy of Ecorutel forte was based on the difference between two groups with a type 1 error. Results: the analysis of the PP population on day 14–18 after the start of treatment showed that microbiological recovery occurred in 69.7% (69/99) of the women in the study group and in 53.4% (55/103) of the women in the comparison group. The difference between the two groups was 16.3% (95% CI 2.87-28.9). This difference indicates that the study drug is more effective than the comparison drug in terms of microbiological recovery at this time point (p=0.02). On day 30-35, clinical recovery was reported in 76.8% (76/99) and 66% (68/103), respectively (difference 10.8%, 95% CI 1.74-22.7, p=0.09). At this time point, the study drug demonstrated superior efficacy in terms of microbiological recovery (difference 19.5%, 95% CI 6.51-31.5, p=0.003) and overall recovery rate (difference 18.2%, 95% CI 4.66-30.8, p=0.009). A notable increase in the number of women with a lactobacillus count of 105 CFU/ml or more was observed in both groups following treatment. In the subgroup of women who received Ecorutel forte, an increase of 47.8% (95% CI 28.8-66.8, p<0.05) was observed in the BV group, while in the VVC subgroup, the increase was 23.9% (95% CI 4.49-43.3, p<0.05). Significant differences were observed between the groups on days 30–35 in favor of the study drug (p=0.05) at the same baseline (p=0.65). In the safety population, a significant difference between the groups was found for irritation after insertion, with 8.3% (9/108) of women experiencing this adverse event compared to 17.9% (20/112). The difference was 9.5% (95% CI 0.5-18.5, p=0.04), indicating that Ecorutel forte is more comfortable. Conclusion: Ecorutel forte demonstrated superior microbiologic efficacy compared to Neo-Penotran® forte on days 14–18 following the initiation of treatment. Furthermore, Ecorutel forte exhibited superior microbiologic efficacy and overall recovery on days 30–35 in the treatment of BV and/or VVC. KEYWORDS: bacterial vaginosis, vulvovaginal candidiasis, mixed vaginitis, lactobacilli, prebiotics, metronidazole, miconazole, lactulose. FOR CITATION: Dikke G.B., Kuz'min V.N., Yarosh E.E., Degileva I.N., Luchko S.V., Mavricheva L.A., Mos'ko T.V. Efficacy and safety of Ecorutel forte (750 mg metronidazole + 200 mg miconazole + 500 mg lactulose) in bacterial vaginosis and/or vulvovaginal candidiasis: international, multicenter, randomized, controlled trial. Russian Journal of Woman and Child Health. 2024;7(3):214–221 (in Russ.). DOI: 10.32364/2618- 8430-2024-7-3-3.