Dynamics of clinical symptoms of fibrocystic breast disease in the course of the transdermal gel of micronized progesterone monotherapy: results of the Russian multicenter observational study BREAST
Objective. To assess the dynamics of fibrocystic mastopathy symptoms regression when applying monotherapy with transdermal gel of micronized progesterone continuously for 3 and 6 months under conditions of routine clinical practice.Protasova A.E., Andreyeva E.N., Rozhkova N.I., Vandeyeva E.N.
Materials and methods. The study included 1044 female patients of 34.8 ± 0.2 years of age diagnosed with diffuse mastopathy with predominant glandular component and diffuse fibrocystic mastopathy with predominant cystic component. All the patients received therapy with transdermal gel of micronized progesterone (Progestogel product) for 3and 6 months. The data related to dynamics of the disease symptoms were evaluated: clinical examination of the lacteal gland was performed, ultrasound and mammography examinations were performed, with assessment according to Bi–RADS categories. Intensity of the pain sense modality was evaluated in dynamics using visual analog scale (VAS) of pain. Statistical analysis of the collected data was carried out using IBM SPSS 23 software.
Results. In 3–6 months of the continuous use of Progestogel product, a significant reduction in the amount of the earlier revealed thickened tissue areas was observed during ultrasound examination, including the areas of 1–2 cm and those exceeding 2 cm (hyperplastic lobules, cysts). According to the analysis of the mammographic conclusions, in the course of the therapy the signs of the fat involution build–up were observed as reducing from 9.1% to 1.3%, the signs of focal fibrosis reduced from 12.9% to 5.3%; the proportion of the patients with diffuse fibrocystic mastopathy with predominant cystic component reduced by 22.4% (from 56.6% to 34.2%). Significant improvement of the disease course is as well demonstrated by the dynamics of the changes as per the assessment according to Bi–RADS categories (p < 0.05). The intensity of the pain in the mammary glands significantly reduced in the therapy dynamics; before treatment it was 62.22 ± 0.84 scores, in 3 months 27.33 ± 0.70 scores (p < 0.001), in 6 months 9.33 ± 0.46 scores (p < 0.001).
Conclusion. The data obtained show the improvement of the life quality and reduction in the pain syndrome intensity in patients with mastalgia/mastodynia.
Keywords
benign mammary gland dysplasia
fibrocystic mastopathy
micronized progesterone
References
1. Кулагина Н.В. Доброкачественные заболевания молочных желез. Учебное пособие. 2-е изд. М.: «Типография «Печатных дел мастер»; 2012. 64с. [Kulagina N.V. Dobrokachestvennye zabolevanija molochnyh zhelez// Uchebnoe posobie. 2-e izdanie, dopolnennoe. – M.: OOO «Tipografija «Pechatnyh del master»; 2012. 68p. (in Russian)]
2. Коган И.Ю., Мясникова М.О., Мусина Е.В. Прогестерон в лечении мастопатии. Айламазян Э.К. ред. М.: «Типография «Печатных дел мастер»; 2012. [Kogan I.Ju. , Mjasnikova M.O., Musina E.V. Progesteron v lechenii mastopatii //Pod redakciej akademika RAMN Z.D.N. RF professora Ajlamazjana Je.K. M.: OOO «Tipografija «Pechatnyh del master»; 2012. 68p. (in Russian)]
3. Сметник В.П., Коновалова В.Н. Молочная железа как своеобразный интракринный орган. Вестник репродуктивного здоровья. 2009; 1: 39-44. [Smetnik V.P., Konovalova V.N. Molochnaia zheleza kak svoeobraznyi intrakrinnyi organ. Vestn. reproduktivnogo zdorov’ia. 2009; 1: 39-44.(in Russian)]
4. Jameson J.L., De Groot L.J., de Kretser D.M., Giudice L.C., Grossman A.B., Melmed S. et al., eds. Endocrinology: adult and pediatric. 7th ed. Philadelphia PA USA: Elsevier; 2016; vol. 2(Pt 12: Hormonal control of breast development).
5. NCCN – Evidence-Based Cancer Guidelines. https://www.nccn.org/
6. Onstad M, Stuckey A, Benign breast disorders. Obstet Gynecol Clin North Am. 2013; 40 (3): 459-473.
7. Dyrstad S.W., Yan Y., Fowler A.M., Colditz G.A. Breast cancer risk associated with benign breast disease: systematic review and meta-analysis. Breast Cancer Res. Treat. 2015; 149(3): 569-75.
8. Mansel RE, Webster DJ, Sweetland HM. Breast pain and nodularity. In: Benign disorders and diseases of the breast. Elsevier 2009; p. 107-39.
9. Андреева Е.Н., Рожкова Н.И., Соколова Д.А., ред. Доброкачественные дисплазии молочных желез: патогенетический вектор лечения. Обзор исследований, клинические рекомендации: Информационный бюллетень. М.: StatusPraesens; 2016. [Dobrokachestvennye displazii molochnykh zhelez: patogeneticheskii vektor lecheniia. Obzor issledovanii, klinicheskie rekomendatsii: nformatsionnyi biulleten’. Pod red. E.N. Andreevoi, N.I. Rozhkovoi, D.A.Sokolovoi. M.: StatusPraesens; 2016.(in Russian)]
10. Высоцкая И.В., Летягин В.П., Черенков В.Г., Лактионов К.П., Бубликов И.Д. Клинические рекомендации РООМ по профилактике РМЖ, дифференциальной диагностике, лечению предопухолевых и доброкачественных заболеваний молочных желез. М.: Российское общество онкомаммологов; 2015. [Vysotskaia I.V., Letiagin V.P., Cherenkov V.G. i dr. Klinicheskie rekomendatsii ROOM po profilaktike RMZh, differentsial’noi diagnostike, lecheniiu predopukholevykh i dobrokachestvennykh zabolevanii molochnykh zhelez. M., 2015.(in Russian)]
11. Меских Е.В., Рожкова Н.И. Применение прожестожеля при диффузных формах мастопатии. Опухоли женской репродуктивной системы. 2012; 1: 57-60. [Meskikh E.V., Rozhkova N.I. Primenenie prozhestozhelia pri diffuznykh formakh mastopatii. Opukholi zhenskoi reproduktivnoi sistemy. 2012; 1: 57-60. (in Russian)]
12. Каприн А.Д., Рожкова Н.И. Маммология. Национальное руководство, М., ГЭОТАР Медиа; 2016: 483. [Kaprin A.D.. Rozhkova N.I. National guide tu mammology. M., GEOTAR Media; 2016: 483. (in Russian)]
13. Fentiman I.S. The pathophysiology and therapy of benign breast disease. In: Fauser B.C. ed. Reproductive medicine: molecular, cellular and genetic fundamentals. Pathenon Publ.; 2003: 87-94.
14. Brkic M., Vujovic S., Ivanisevic M.F., Ivovic M., Gajic M.T., Marina L. et al. The influence of progesterone gel therapy in the treatment of fibrocystic breast disease. Open J. Obstet. Gynecol. 2016; 6(5): 334-41.
15. Pasqualini J.R. Differential effects of progestins on breast tissue enzy- mes. Maturitas 2003; 46 (Suppl. l): S45-54.
16. Winkler U.H., Schindler A.E., Brinkmann U.S., Ebert C., Oberhoff C. Cyclic progestin therapy for the management of mastopathy and mastodynia. Gynecol Endocrinol. 2001 Dec;15 Suppl 6:37-43.
Received 07.09.2018
Accepted 21.09.2018
About the Authors
Protasova, Anna E., Professor of the Department of Obstetrics and Gynecology, Almazov National Medical Scientific Center of the Ministry of Health the Russian Federation. Address: 194354 St–Petersburg, Uchebniy side str. 2. Tel: 8(921)9198424. E-mail: protasova1966@yandex.ruAndreeva, Elena N., Professor, Head of the Institute of Reproductive Medicine National Scientific Endocrinological Center of the Ministry of Health the Russian Federation. Address: 117042 Moscow, Yuzhnobutovskaya str. 38. Tel: 8(916)1270268. E-mail: endogen@mail.ru
Rozhkova, Nadezhda I., Professor, Head of Gertsen National Center of reproductive oncology of the Ministry of Health the Russian Federation.
Address: 117292 Moscow, Krzhizhanvskiy str. 3. Tel: 8(916)255711. E-mail: nrozhkova2013@yandex.ru
Vandeeva, Ekaterina N., Junior assistant of the Department of Obstetrics and Gynecology, Almazov National Medical Scientific Center of the Ministry of Health the Russian Federation. Address: 197760 St–Petersburg, Kronshtadt, Lenin str. 61. Tel: 8(921)6530978. E-mail: katvan1983@mail.ru
For citation: Protasova A. E., Andreeva E. N., Rozhkova N. I., Vandeeva E. N. Dynamics of clinical symptoms of fibrocystic breast disease in the course of monotherapy with transdermal gel of micronized progesterone: results of the russian multicenter observational study BREAST. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (11): 138-44. (in Russian):
https://dx.doi.org/10.18565/aig.2018.11.138-144
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