Терапевтический эффект и безопасность использования препарата Блиссель. Результаты многоцентрового открытого российского наблюдательного исследования (БРОНЬ)

Цель исследования - оценка эффективности и безопасности применения вагинального геля, содержащего 50 мкг эстриола, для лечения атрофии слизистой оболочки влагалища в период постменопаузы, а также улучшения качества жизни пациенток в динамике терапии. Материал и методы. В исследование вошли 165 женщин в возрасте 50-72 лет с подтвержденным диагнозом постменопаузального атрофического вагинита [код по Международному классификатору болезней 10-го пересмотра (МКБ-10) N95.2]. Всем пациенткам было проведено курсовое лечение вагинальным гелем Блиссель с 0,005% содержанием эстриола (1 аппликатор - доза вагинального геля в сутки в течение 3 нед), с последующим контрольным осмотром через 3 мес от начала терапии. Для реализации поставленной цели в ходе лечения на 4 визитах в динамике [до начала терапии, на 10±2 дня от начала лечения, на 20±2 дня лечения (завершение курса) и через 3 мес от начала лечения -90±3 дня] оценивали клинические параметры (объем вагинальных выделений, увлажненность влагалища, эластичность тканей влагалища), лабораторные показатели (значение зрелости вагинального эпителия, уровень pH влагалищного отделяемого), рассчитывали индекс вагинального здоровья по Бохману, индекс женской сексуальности (опросник FSFI), сумму баллов по данным опросника «Оценка качества жизни при менопаузе», а также анкетировали участниц и исследователей на предмет удовлетворенности лечением.

The aim of study was to evaluate the effectiveness and safety of vaginal gel containing 50 mcg of estriol for the treatment of postmenopausal vaginal mucosa atrophy, as well as to improve the quality of life of patients over the period of therapy. Materials and methods. The study included 165 women aged 50-72 years with a confirmed diagnosis of postmenopausal atrophic vaginitis [International Classification of Diseases 10th Revision (ICD-10) Code N95.2]. All patients received course treatment with Blissel vaginal gel with 0.005% estriol (1 applicator - vaginal gel dose per day for 3 weeks), with follow-up examination in 3 months after the start of therapy. For this purpose, clinical parameters (volume of vaginal discharge, vaginal moisturization, elasticity of vaginal tissues) were assessed at 4 visits during treatment [before the start of therapy, on 10±2 days after the start of treatment, on 20±2 days of treatment (completion of treatment course) and after 3 months from the start of treatment - 90±3 days], laboratory parameters (vaginal epithelium maturation value, vaginal pH), the Bachmann Vaginal Health Index, the Female Sexual Function Index (FSFI questionnaire), the sum of scores per the MenopauseSpecific Quality of Life Questionnaire were calculated, and participants and researchers were questioned about their satisfaction with the treatment. IBM SPSS Statistics v.26 software (IBM Corporation, USA) was used for statistical analysis of the data. Quantitative parameters other than normal distribution were described using median (Me) and interquartile range (IQR%). The Friedman test was used to assess differences between four series of measurements performed for the same population but at different times (before-after analysis). The Wilcoxon test was used to assess differences between two series of measurements performed for the same population but at different times (before-after analysis). Differences were considered statistically significant at p<0.05. Results. The median age of the patients was 58 years (IQR%: 54-62). By the end of course of therapy a significant (p<0.001) clinical response in vulvovaginal atrophy (VVA) was recorded, i.e. increase in the volume of vaginal discharge, improvement of elasticity and moisturization of the vaginal mucosa. The clinical effect was found to persist after completion of course of therapy (after 3 months from the start of therapy, moderate/ abundant vaginal discharge - 93.5%; moderate/normal moisturization - 91.3%; good/excellent tissue elasticity -71.7%; no single pass petechiae - 100%). It was found that in only 10 days after the start of treatment there was a significant positive response in pH of vaginal discharge, which persisted until the end of treatment course [Me = 4.8 (4.5-5.0), p<0.001] and even after the end of therapy (after 90 days - 94.5%, p<0.001). Due to the integral effect of both components of Blissel gel on vaginal epithelium, the increase of vaginal health index by the end of treatment was recorded in 93.3% of patients [Me = 4 (4-5), p<0,001], vaginal epithelium maturation value (VEMV) improved in 3 months in 92.8% of women [Me = 65 (50-70), p<0.001]. Significant (p=0.004) improvement in sexual function (increase in FSFI questionnaire score) was observed after 10 days of drug administration. By the end of treatment, improvement in FSFI questionnaire score was recorded in 76.4% of patients [Me = 57 (27-72), p<0.001]. Importantly, an increase in FSFI questionnaire score was maintained during the passive observation period [at 3 months from the start of treatment, 83.6%, Me = 65 (38-78), p<0.001]. When assessing the quality of life of the patients, it was found that the sum of scores per the MenopauseSpecific Quality of Life Questionnaire by the end of course of therapy increased 1.3 times [64.8%, Me = 101 (95-104), p<0.001], and its significant increase was recorded during the whole period of passive observation [70.3%, Me = 103 (98-107), p=0.001]. No adverse events were reported during the study period. The research physicians and the patients were completely satisfied with the results of therapy. Conclusion. Blissel vaginal gel containing 50 μg of estriol (S.A. Italfarmaco, Spain) is clinically effective (p<0.001) for the topical treatment of vaginal mucosal dryness in postmenopausal women with atrophic vaginitis, which is mediated by the integral effect on the vaginal epithelium of both components of the drug (polycarbophilic gel and microdose of estriol - 50 μg). The course therapy of vaginal dryness in postmenopausal patients with atrophic vaginitis using Blissel vaginal gel is accompanied by a significant improvement in sexual function and contributes to the improvement of the quality of life of patients even during the period of drug administration.