Efficacy and safety of enzymatic hydrolysis in the complex treatment of bacterial vaginosis: preliminary results of a clinical trial

Bacterial vaginosis is a biofilm-related disease. Biofilms increase the resistance of microorganisms to antibiotics, which reduces the efficacy of treatment and contributes to recurrences. Clinical guidelines do not provide options to combat biofilms in the treatment of patients with bacterial vaginosis. Objective. To study the efficacy and safety of enzymatic hydrolysis of the biofilm matrix by bovhyaluronidase azoximer (BA) in bacterial vaginosis. Patients and methods. A comparative analysis of clinical and laboratory characteristics of female patients aged 18 to 45 years with bacterial vaginosis treated with metronidazole monotherapy (control group, n = 35) and a combination of metronidazole and bovhyaluronidase azoximer (BA) (study group, n = 37) was performed. To visualize and evaluate the structure of biofilms, all patients underwent electron microscopic examination of a sample from the posterior vaginal vault epithelium. Results. After treatment, the score according to Amsel’s criteria normalized in 97.3% of patients in the study group and in 54.3% of patients in the control group. Complaints of discharge (2.7% and 20%) and vaginal odor (2.7% and 25.7%), Gardnerella vaginalis growth (5.4% and 22.9%), detection of key cells (2.7% and 5.9%) and coccobacillary flora (2.7% and 23.5%) were significantly less frequent in the study group. According to the results of the Femoflor-16 test, patients in the study group had significantly more lactobacilli and fewer anaerobes. According to electron microscopy, biofilms were initially detected in 95.5% of patients in the study group and in 84.2% of patients in the control group. During treatment, their number did not change in 15 of 19 women in the control group (78.9%). In all patients in the study group (100%, n = 22), they were absent or there was a change in their structure. Conclusion. Electron microscopy in the study of a sample from the posterior vaginal vault epithelium in women with bacterial vaginosis allows us to determine the presence of biofilms and assess their structure. Combination therapy with bovhyaluronidase azoximer destroys the biofilm matrix and promotes the transition of bacteria to the planktonic form, which is accompanied by vaginal microbiome normalization, reduction in the severity of complaints and improvement in laboratory test results.