Лечение диффузной дисгормональной дисплазии молочных желез у пациенток в периоде менопаузального перехода

Н. В. Кулагина

Authors

Н. В. Кулагина I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, St. Petersburg, Russian Federation

Keywords:

hyperprolactinemia, cyclical mastalgia, premenstrual syndrome, mastopathy, menopausal transition, clinical trial, Mastodynon

Abstract

Objective. To evaluate the efficacy and tolerability of Mastodynon® in the treatment of diffuse mastopathy and symptoms of premenstrual syndrome (PMS) in women in the menopausal

transition period.

Subjects and methods. A clinical prospective, parallel-group, randomized, monocenter, open-label trial with active control was conducted. The trial included 60 patients (mean age, 49.0 ± 3.1 years) who used Mastodynon® or bromocriptine for 24 weeks.

Results. Hyperprolactinemia was detected in 63.3% of the women suffering from different forms of diffuse mastopathy in the menopausal transition period. There was a statistically significant decrease in prolactin levels at 24 weeks of treatment with Mastodynon® (Δ -244 ± 95.8 mU/ml) (p < 0.001) and bromocryptine (Δ -226.4 ± 101.5 mU/ml) (p < 0.001). The results of therapy with Mastodynon® were comparable to the efficiency of that with bromocryptine (p > 0.05). Ultrasound mammography revealed positive changes in the breast structure in 67% of the patients with different forms of diffuse mastopathy treated with Mastodynon® and in 43% of those treated with bromocriptine. There was a decrease in the incidence (92% vs 37%; p < 0.001) and severity of mastalgia at month 6 of Mastodynon® treatment, the results of therapy did not differ in the two groups (p > 0.05). Treatment with Mastodynon® in patients with different forms of mastopathy concurrent with the symptoms of PMS was more effective than that with bromocryptine in relieving autonomic disorders (p < 0.05). Adverse events (AEs) occurred more commonly in the patients receiving bromocriptine (60%); AEs were noted in 7% in the Mastodynon® group (p < 0.05).

Conclusion. Mastodynon® that contains Vitex agnus-castus extract is an effective agent with a high safety profile to treat mastalgia and symptoms of PMS in patients with different forms of diffuse mastopathy during the menopausal transition period.

Author Biography

Н. В. Кулагина, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, St. Petersburg

MD, professor of Obstetrics and Gynecology Department

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