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Эстетрол: новое слово в современной гормональной контрацепции
Эстетрол: новое слово в современной гормональной контрацепции
Прилепская В.Н., Юрова М.В. Эстетрол: новое слово в современной гормональной контрацепции. Гинекология. 2024;26(2):108–118. DOI: 10.26442/20795696.2024.2.202621
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
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Аннотация
Концепция демографической политики Российской Федерации заключается в повышении рождаемости, сохранении здоровья граждан и увеличении продолжительности жизни. Безусловно, одним из приоритетных направлений является репродуктивное здоровье женщин. Плейотропное действие компонентов комбинированных гормональных препаратов успешно используют в клинической практике врачи – акушеры-гинекологи не только для контрацепции, но и при состояниях, требующих профилактики и медикаментозной коррекции. Эстрогены обладают протективным эффектом в отношении репродуктивных и экстрагенитальных органов, однако дискутабельными остаются сведения о влиянии эстрогенсодержащих препаратов на ткань молочной железы (МЖ) и гемостаз. Провели анализ данных, опубликованных в международных базах PubMed, Google Scholar, Medline (глубина поиска – 5 лет). Эстетрол (Э4) – нативный фетальный эстроген, вырабатываемый печенью плода во время беременности. Ключевым отличием от прочих эстрогенов является его высоко селективное и дифференцированное действие на различные ткани, а также уникальные антипролиферативные свойства. В обзоре представлены результаты исследований, в которых изучены эстрогенные и антиэстрогенные эффекты Э4 и комбинации Э4 с прогестагеном (в России зарегистрирован препарат «Эстеретта»), особое внимание уделено онкопротективному действию Э4. Данные исследований показывают, что Э4 по сравнению с другими эстрогенами может оказывать различное влияние на эпителиальные клетки МЖ и клетки рака МЖ. Клинические данные свидетельствуют, что Э4 обладает более избирательным фармакологическим профилем по сравнению с другими эстрогенами, что отражается в низком эстрогенном влиянии на печень, в том числе на продукцию глобулина, связывающего половые гормоны, параметры гемостаза и липидный профиль.
Ключевые слова: аборт, дроспиренон, контрацепция, онкопрофилактика, эстетрол
Keywords: abortion, drospirenone, contraception, cancer prophylaxis, estetrol
Ключевые слова: аборт, дроспиренон, контрацепция, онкопрофилактика, эстетрол
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Keywords: abortion, drospirenone, contraception, cancer prophylaxis, estetrol
Полный текст
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6. Pincus G, Garcia CR, Rock J, et al. Effectiveness of an oral contraceptive; effects of a progestin-estrogen combination upon fertility, menstrual phenomena, and health. Science. 1959;130(3367):81-3. DOI:10.1126/science.130.3367.81
7. Iversen L, Sivasubramaniam S, Lee AJ, et al. Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners’ Oral Contraception Study. Am J Obstet Gynecol. 2017;216(6):580.e1-9. DOI:10.1016/j.ajog.2017.02.002
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DOI:10.1016/s0140-6736(03)12949-2
9. Both S, Lew-Starowicz M, Luria M, et al. Hormonal Contraception and Female Sexuality: Position Statements from the European Society of Sexual Medicine (ESSM). J Sex Med. 2019;16(11):1681-95. DOI:10.1016/j.jsxm.2019.08.005
10. Charlton BM, Rich-Edwards JW, Colditz GA, et al. Oral contraceptive use and mortality after 36 years of follow-up in the Nurses' Health Study: prospective cohort study. BMJ. 2014;349:g6356. DOI:10.1136/bmj.g6356
11. Zafrakas M, Grimbizis G, Timologou A, Tarlatzis BC. Endometriosis and ovarian cancer risk: a systematic review of epidemiological studies. Front Surg. 2014;1:14. DOI:10.3389/fsurg.2014.00014
12. Li J, Panucci G, Moeny D, et al. Association of risk for venous thromboembolism with use of low-dose extended- and continuous-cycle combined oral contraceptives: A safety study using the sentinel distributed database. JAMA Intern Med. 2018;178(11):1482-8. DOI:10.1001/jamainternmed.2018.4251
13. Douxfils J, Klipping C, Duijkers I, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6):396-402. DOI:10.1016/j.contraception.2020.08.015
14. Stegeman BH, de Bastos M, Rosendaal FR, et al. Different combined oral contraceptives and the risk of venous thrombosis: Systematic review and network meta-analysis. BMJ. 2013;347:f5298. DOI:10.1136/bmj.f5298
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27. Douxfils J, Gaspard U, Taziaux M, et al. Impact of estetrol (E4) on hemostasis, metabolism and bone turnover in postmenopausal women. Climacteric. 2023;26(1):55-63. DOI:10.1080/13697137.2022.2139599
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29. Singer CF, Bennink HJ, Natter C, et al. Antiestrogenic effects of the fetal estrogen estetrol in women with estrogen-receptor positive early breast cancer. Carcinogenesis. 2014;35(11):2447-51. DOI:10.1093/carcin/bgu144
30. Schmidt M, Lenhard H, Hoenig A, et al. Tumor suppression, dose-limiting toxicity and wellbeing with the fetal estrogen estetrol in patients with advanced breast cancer. J Cancer Res Clin Oncol. 2021;147(6):1833-42. DOI:10.1007/s00432-020-03472-8
31. Gallez A, Dias Da Silva I, Wuidar V, et al. Estetrol and Mammary Gland: Friends or Foes? J Mammary Gland Biol Neoplasia. 2021;26(3):297-308. DOI:10.1007/s10911-021-09497-0
32. Gerard C, Mestdagt M, Tskitishvili E, et al. Combined estrogenic and anti-estrogenic properties of estetrol on breast cancer may provide a safe therapeutic window for the treatment of menopausal symptoms. Oncotarget. 2015;6(19):17621-36. DOI:10.18632/oncotarget.4184
33. Gallez A, Blacher S, Maquoi E, et al. Estetrol Combined to Progestogen for Menopause or Contraception Indication Is Neutral on Breast Cancer. Cancers (Basel). 2021;13(10):2486. DOI:10.3390/cancers13102486
34. Gerard, C., Foidart, JM. Estetrol: From Preclinical to Clinical Pharmacology and Advances in the Understanding of the Molecular Mechanism of Action. Drugs R D.
2023;23(2):77-92. DOI:10.1007/s40268-023-00419-5
35. Mayne Pharma. NEXTSTELLIS (estetrol/drospirenone) tablets: US prescribing information. 2021. Available at: https://dailymed.nlm.nih.gov/ Accessed: 09.06.2022.
36. Foidart JM, Gaspard U, Pequeux C, et al. Unique vascular benefits of estetrol, a native fetal estrogen with specific actions in tissues (NEST). In: Sex steroids' Effects on Brain, Heart and Vessels. Brinton R, Genazzani A, Simoncini T, Stevenson J (eds). ISGE series. Volume 6. P. 169-95. Cham: Springer, 2019. DOI:10.1007/978-3-030-11355-1_12
37. Visser M, Foidart JM, Coelingh Bennink HJ. In vitro effects of estetrol on receptor binding, drug targets and human liver cell metabolism. Climacteric. 2008;11(Suppl. 1):64-8. DOI:10.1080/13697130802050340
38. Gérard C, Apter D, Chatel G, et al. RF34 | PMON202 The Human Metabolic Profile of Estetrol. J Endocrine Society. 2022;6(Suppl. 1):A714-5. DOI:10.1210/jendso/bvac150.1472
39. Chen MJ, Jensen JT, Kaunitz AM, et al. Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials. Contraception. 2022;116:44-50. DOI:10.1016/j.contraception.2022
40. Kluft C, Zimmerman Y, Mawet M, et al. Reduced hemostatic effects with drospirenone-based oral contraceptives containing estetrol vs. ethinyl estradiol. Contraception. 2017;95(2):140-7. DOI:10.1016/j.contraception.2016.08.018
41. Hammond GL, Hogeveen KN, Visser M, Coelingh Bennink HJ. Estetrol does not bind sex hormone binding globulin or increase its production by human HepG2 cells. Climacteric. 2008;11(Suppl. 1):41-6. DOI:10.1080/13697130701851814
42. Raps M, Helmerhorst F, Fleischer K, et al. Sex hormone-binding globulin as a marker for the thrombotic risk of hormonal contraceptives. J Thromb Haemost.
2012;10(6):992-7. DOI:10.1111/j.1538-7836.2012.04720.x
43. Grandi G, Del Savio MC, Lopes da Silva-Filho A, Facchinetti F. Estetrol (E4): The new estrogenic component of combined oral contraceptives. Expert Rev Clin Pharmacol. 2020;13(4):327-30. DOI:10.1080/17512433.2020.1750365
44. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y, et al. Pharmacodynamic effects of the fetal estrogen estetrol in postmenopausal women: results from a multiple-rising-dose study. Menopause. 2017;24(6):677-85. DOI:10.1097/GME.0000000000000823
45. Hemker HC, Giesen P, Al Dieri R, et al. Calibrated automated thrombin generation measurement in clotting plasma. Pathophysiol Haemost Thromb. 2003;33(1):4-15. DOI:10.1159/000071636
46. Morimont L, Haguet H, Dogné JM, et al. Combined Oral Contraceptives and Venous Thromboembolism: Review and Perspective to Mitigate the Risk. Front Endocrinol (Lausanne). 2021;12:769187. DOI:10.3389/fendo.2021.769187
47. Morimont L, Jost M, Gaspard U, et al. Low Thrombin Generation in Users of a Contraceptive Containing Estetrol and Drospirenone. J Clin Endocrinol Metab. 2022;108(1):135-43. DOI:10.1210/clinem/dgac511
48. https://clinicaltrials.gov/study/NCT06186271?rank=2
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66. Montt-Guevara MM, Palla G, Spina S, et al. Regulatory effects of estetrol on the endothelial plasminogen pathway and endothelial cell migration. Maturitas. 2017;99:1-9. DOI:10.1016/j.maturitas.2017.02.005
67. Guivarc'h E, Buscato M, Guihot AL, et al. Predominant Role of Nuclear Versus Membrane Estrogen Receptor α in Arterial Protection: Implications for Estrogen Receptor α Modulation in Cardiovascular Prevention/Safety. J Am Heart Assoc. 2018;7(13):e008950. DOI:10.1161/JAHA.118.008950
68. Davezac M, Zahreddine R, Buscato M, et al. The different natural estrogens promote endothelial healing through distinct cell targets. JCI Insight. 2023;8(5):e161284. DOI:10.1172/jci.insight.161284
69. Dama A, Baggio C, Trevisi L, et al. Regulation of human endothelial cell migration by oral contraceptive estrogen receptor ligands. Eur J Pharmacol. 2023;945:175591. DOI:10.1016/j.ejphar.2023.175591
70. Tskitishvili E, Pequeux C, Munaut C, et al. Use of estetrol with other steroids for attenuation of neonatal hypoxic-ischemic brain injury: to combine or not to combine? Oncotarget. 2016;7(23):33722-43. DOI:10.18632/oncotarget.9591
71. Holinka CF, Brincat M, Coelingh Bennink HJ. Preventive effect of oral estetrol in a menopausal hot flush model. Climacteric. 2008;11(Suppl. 1):15-21. DOI:10.1080/13697130701822807
72. Pluchino N, Drakopoulos P, Casarosa E, et al. Effect of estetrol on Beta-Endorphin level in female rats. Steroids. 2015;95:104-10. DOI:10.1016/j.steroids.2015.01.003
73. Gerard C, La Riche A, Altendorf S, et al. FRI378 Estetrol Prolongs Anagen In Healthy Female Scalp Hair Follicles By Positively Modulating Dermal Papilla Functions And Generation Of Progenitor Stem Cells Ex Vivo. J Endocrine Society. 2023;7(Suppl. 1):bvad114.1574. DOI:10.1210/jendso/bvad114.1574
Авторы
В.Н. Прилепская1, М.В. Юрова*1,2
1ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В.И. Кулакова» Минздрава России, Москва, Россия;
2ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*m_yurova@oparina4.ru
1Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia;
2Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*m_yurova@oparina4.ru
1ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В.И. Кулакова» Минздрава России, Москва, Россия;
2ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*m_yurova@oparina4.ru
________________________________________________
1Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia;
2Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*m_yurova@oparina4.ru
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