Ecofucin - eradication and growth stimulation of lactobacilli in pregnant women
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St. Petersburg State Budgetary Healthcare Institution "Youth Center" (GC DC "Yuventa"), St. Petersburg, Russia
As a consequence of these pathological processes, fetal hypoxia, low birth weight, wound infections of the birth canal, and the development of postpartum endometritis can occur [3, 4]. During childbirth, yeast fungi from the mother's vagina enter the newborn's body, causing candidal lesions of the oral mucosa and anogenital area in more than 90% of cases [5]. Candida spp. are the cause of infectious and inflammatory diseases in newborns in 15.1–25.8% of cases.
Summary
Objective: To evaluate the efficacy and safety of the drug Ecofucin® (International Nonproprietary Name [INN]: natamycin; excipient: lactulose), intravaginal suppositories, compared to a single-component reference drug with the INN natamycin, based on the time to achieve clinical and microbiological remission of acute candidal vaginitis/vulvovaginitis in pregnant women.
Materials and methods: The study included pregnant women (gestational age 18 to 31 weeks) aged 18 to 45 years with symptoms of acute candidal vaginitis/vulvovaginitis. Patients used either the study drug Ecofucin® or the comparator drug (single-component natamycin). Both drugs were administered at a dose of 1 suppository intravaginally once daily for 6 days. The primary efficacy endpoint was the time to clinical remission; the secondary endpoint was the number of patients who achieved disease remission without relapse. Laboratory tests of vaginal discharge were performed before and after treatment. To assess the safety of the study drug and the comparator drug, adverse events were recorded.
Results: In the main study group, clinical and microbiological remission was achieved in a larger number of patients and, on average, over a shorter period of time compared to the control group. Furthermore, in the main group, some clinical symptoms (itching, burning) resolved faster, and there were fewer disease relapses during the observation period due to an increase in the number of lactobacilli in the vagina (up to 100-fold compared to baseline). After completion of therapy, the lactobacilli content in the cervical canal discharge of patients receiving Ecofucin® increased by an average of 50 times (up to 100 times maximum) compared to baseline, while in the control group patients, this indicator increased only 2.5-fold (p<0.001). No adverse events were identified during the use of either the study drug or the comparator drug.
Conclusions: The results of this comparative study reliably demonstrate more effective eradication of Candida fungi and rapid relief of clinical symptoms of candidal vaginitis/vulvovaginitis in a larger number of patients in the main group who used Ecofucin®. Women treated with Ecofucin® showed an increase in vaginal lactobacilli content of up to 100-fold, which contributed to a reduction in the frequency of disease recurrence.
Keywords: Ecofucin, natamycin, lactulose, vulvovaginal candidiasis, Candida, lactobacilli, candidal vaginitis/vulvovaginitis.
For citation: Kuzmin V.N., Bogdanova M.N. Ecofucin® — the first drug for the eradication of Candida fungi with the effect of stimulating lactobacilli growth in pregnant women. RMZh. 2020;1(*):1–7.
Detailed Description
The full text of the article is available in the file: "Ecofucin® – the first drug for the eradication of Candida fungi with a stimulating effect on lactobacilli growth in pregnant women".
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