Эффективность и безопасность топического ультранизкодозного геля с эстриолом у больных гинекологическим раком после противоопухолевой терапии

Efficacy and safety of topical ultra-low dose estriol gel in patients with gynecologic cancer after anti-tumor therapy

Objective. To study the efficacy and safety of topical vaginal gel containing 50 mcg/g estriol (Blissel) for vulvovaginal atrophy (VVA) in women with post-ovariectomy syndrome (POS) and/or chemoradiation-induced ovarian suppression after treatment of gynecologic cancer. Patients and methods. This study involved 82 women aged 33 to 70 years (mean age = 51.5 ± 11.2 years) who had previously undergone treatment of gynecologic cancer (cervical, uterine or ovarian) in the state of POS and chemoradiation-induced ovarian suppression with severe VVA and sexual dysfunction. All patients were divided into two groups: group I – 43 patients, group II – 39 patients. Therapy for VVA in group I included Blissel gel containing 50 mcg/g of estriol – one full applicator once a day for 3 weeks daily, then twice a week for 3 months (maintenance therapy). The total duration of treatment with Blissel gel was 15 weeks. In group II, treatment included emollients based on lactic and hyaluronic acids and plant extracts continuously for 15 weeks.. Results. VVA was diagnosed at 5 years after menopause in 41.9% (n = 18) of patients in group I and in 35.9% (n = 14) of patients in group II. At 3 weeks after continuous treatment and at 3 months after maintenance therapy with Blissel gel, the manifestations of VVA decreased by half in patients in group I: the maximum number of women had no bleeding, and the mucous membrane acquired a pink color. At 3 weeks after continuous treatment with estriol, complaints of vaginal dryness decreased by almost 2.5 times, and at 3 months supportive therapy – by 3.5 times. A similar observation was made in respondents in group I when assessing dyspareunia: the frequency of asexuality decreased to 25.6% (n = 11) and 11.6% (n = 5) at 3 weeks and 3 months after treatment, respectively. At baseline, the overall vaginal pH was 5.3 (4.6–6.0). During follow-up and treatment with 0.005% estriol, a 1.6-fold decrease in pH was recorded in women in group I after 3 weeks. After 3 months supportive therapy, the positive effect of therapy with Blissel gel in patients in group I persisted, and the pH decreased by 1.7 times. Before the initiation of treatment, the vaginal maturation index (VMI) was <49%. During the process of saturating the vaginal mucosa with 0.005% estriol, restoration of the vaginal epithelium and a shift towards normal VMI (≥65%) were observed, which differed significantly from group II, where all signs of VVA persisted (p ≤ 0.0000). The increase in VMI also correlated with a decrease in pH (p < 0.01). A significant decrease in the expression of steroid receptors in the vaginal epithelium was noted: 3.7 times for estrogen receptors (ES1R) (p ≤ 0.0000) and 1.7 times for androgen receptors (AR) (p ≤ 0.0021). At 3 months after maintenance therapy with Blissel gel, ESR1 mRNA expression continued to decrease significantly in patients in group I compared to group II (p ≤ 0.0000). Conclusion. Polycarbophil mucoadhesive vaginal gel with ultra-low dose estriol (50 mcg/g) is clinically effective for the topical treatment of VVA symptoms in women with POS and/or chemoradiation-induced ovarian suppression after treatment of gynecologic cancer. It is also one of the acceptable and relatively safe methods of therapy. © 2025, Dynasty Publishing House. All rights reserved.