The evaluation of the clinical efficacy of Prodexyn vaginal suppositories in the treatment of recurrent bacterial vaginosis

<p><strong>Background</strong>. Bacterial vaginosis (BV) is the most common vaginal infection among women of reproductive age and is associated with an increased risk of sexually transmitted infections and pregnancy complications. First-line antimicrobial treatments are often accompanied by recurrences due to bacterial resistance, biofilm formation, and other factors.<br><strong>Objective of the study</strong>: to evaluate the clinical efficacy, impact on vaginal microbiota, and safety profile of a combination product containing octenidine dihydrochloride and dexpanthenol<br>(Prodexyn) in the treatment of recurrent BV.<br><strong>Materials and methods</strong>. A prospective study conducted in 2024 and included 192 patients aged 18–36 years with recurrent BV. The participants were divided into two groups: group I – 74 women treated with suppositories based on octenidine dihydrochloride and dexpanthenol, group II – 118 women treated with alternative vaginal antimicrobial drugs (subgroups receiving ternidazole, metronidazole, tinidazole). Efficacy was assessed by symptom resolution, analysis of vaginal microbiota using Hay-Ison criteria, and quality of life using the SF-36 questionnaire.<br><strong>Results</strong>. Group I, treated with octenidine dihydrochloride and dexpanthenol (Prodexyn), demonstrated a higher symptom resolution rate (91.2%) compared to group II (76.3%, p < 0.05). Follow-up PCR analyses confirmed the restoration of normal vaginal biocenosis in 87.5% of patients in group I compared to women in group II: in the ternidazole subgroup, the hazard ratio (HR) was 1.37, 95% confidence interval (CI) was 1.05–1.78 (p = 0.019), in the metronidazole subgroup HR = 1.63, 95% CI = 1.14–2.33 (p = 0.007), in the tinidazole subgroup HR = 1.62, 95% CI = 1.12–2.35 (p = 0.009). The safety profile was favorable, with minimal adverse effects reported.<br><strong>Conclusions</strong>. The combination product containing octenidine dihydrochloride and dexpanthenol (Prodexyn) demonstrates high clinical efficacy, promotes the restoration of normal vaginal microbiota, and has a favorable safety profile. These findings support its use as an effective approach in the treatment of recurrent bacterial vaginosis.</p>

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-12-31
DOI
https://doi.org/10.18370/2309-4117.2024.75.37-43
Primary Topic
Geochemistry and Geologic Mapping
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article
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article

The evaluation of the clinical efficacy of Prodexyn vaginal suppositories in the treatment of recurrent bacterial vaginosis

Zenodo (CERN European Organization for Nuclear Research)
Geochemistry and Geologic Mapping
article

The evaluation of the clinical efficacy of Prodexyn vaginal suppositories in the treatment of recurrent bacterial vaginosis

article en

Abstract

<p><strong>Background</strong>. Bacterial vaginosis (BV) is the most common vaginal infection among women of reproductive age and is associated with an increased risk of sexually transmitted infections and pregnancy complications. First-line antimicrobial treatments are often accompanied by recurrences due to bacterial resistance, biofilm formation, and other factors.<br><strong>Objective of the study</strong>: to evaluate the clinical efficacy, impact on vaginal microbiota, and safety profile of a combination product containing octenidine dihydrochloride and dexpanthenol<br>(Prodexyn) in the treatment of recurrent BV.<br><strong>Materials and methods</strong>. A prospective study conducted in 2024 and included 192 patients aged 18–36 years with recurrent BV. The participants were divided into two groups: group I – 74 women treated with suppositories based on octenidine dihydrochloride and dexpanthenol, group II – 118 women treated with alternative vaginal antimicrobial drugs (subgroups receiving ternidazole, metronidazole, tinidazole). Efficacy was assessed by symptom resolution, analysis of vaginal microbiota using Hay-Ison criteria, and quality of life using the SF-36 questionnaire.<br><strong>Results</strong>. Group I, treated with octenidine dihydrochloride and dexpanthenol (Prodexyn), demonstrated a higher symptom resolution rate (91.2%) compared to group II (76.3%, p < 0.05). Follow-up PCR analyses confirmed the restoration of normal vaginal biocenosis in 87.5% of patients in group I compared to women in group II: in the ternidazole subgroup, the hazard ratio (HR) was 1.37, 95% confidence interval (CI) was 1.05–1.78 (p = 0.019), in the metronidazole subgroup HR = 1.63, 95% CI = 1.14–2.33 (p = 0.007), in the tinidazole subgroup HR = 1.62, 95% CI = 1.12–2.35 (p = 0.009). The safety profile was favorable, with minimal adverse effects reported.<br><strong>Conclusions</strong>. The combination product containing octenidine dihydrochloride and dexpanthenol (Prodexyn) demonstrates high clinical efficacy, promotes the restoration of normal vaginal microbiota, and has a favorable safety profile. These findings support its use as an effective approach in the treatment of recurrent bacterial vaginosis.</p>

Zenodo (CERN European Organization for Nuclear Research)
Good health and well-being
Openalex Percentile: Top 44%
Geochemistry and Geologic Mapping
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The evaluation of the clinical efficacy of Prodexyn vaginal suppositories in the treatment of recurrent bacterial vaginosis · Zenodo (CERN European Organization for Nuclear Research) (2024) | TGRS Research Map | TGRS