Реальная клиническая практика и контрацепция для молодых женщин с детьми

Аганезова Н.В., Аганезов С.С. Реальная клиническая практика и контрацепция для молодых женщин с детьми. Гинекология. 2021; 23 (1): 25–32. DOI: 10.26442/20795696.2021.1.200629

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Aganezova N.V., Aganezov S.S. Real clinical practice and contraception for young women with children. Gynecology. 2021; 23 (1): 25–32. DOI: 10.26442/20795696.2021.1.200629

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Аннотация

В обзоре представлены психосоциальные характеристики молодых женщин современного поколения миллениалов и данные опросов в отношении их требований к гормональным контрацептивным средствам. Проанализированы результаты рандомизированных клинических исследований и исследований реальной практики использования комбинированного орального контрацептива (КОК) Клайра®, содержащего эстрадиола валерат и диеногест (Э2В/ДНГ) в динамическом режиме дозирования, в которых выявлены и подтверждены надежность контрацептивного эффекта препарата, восстановление фертильности на популяционном уровне после отмены средства, его минимальное влияние на метаболизм и сниженный риск сердечно-сосудистых осложнений (венозных и артериальных тромбозов) при использовании КОК Клайра® по сравнению с другими КОК. Доказано отсутствие отрицательного влияния КОК Э2В/ДНГ на массу тела, сексуальную функцию и микробиоценоз влагалища у большинства женщин. Приведены данные об удовлетворительных характеристиках менструальноподобных кровотечений (более легких и коротких) у пользователей КОК Клайра® и уменьшении симптомов, связанных с безгормональным интервалом, которые нередко возникают при приеме других КОК в режиме 21/7. Благоприятный профиль эффективности и безопасности КОК Э2В/ДНГ в реальных условиях, преимущества эстрогена, биоидентичного эндогенному, в составе препарата, режим дозирования 26/2, позитивное влияние на образ жизни определяют значительную удовлетворенность молодых женщин, в том числе молодых женщин с детьми, и возможность использовать препарат длительно вплоть до менопаузы.

Ключевые слова: молодые женщины с детьми, поколение миллениалов, комбинированные оральные контрацептивы, эстрадиола валерат, диеногест, Клайра

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The review presents the psychosocial characteristics of young women in today's millennial generation and survey data regarding their hormonal contraceptive requirements. The results of randomized clinical trials and real-life studies of the use of the combined oral contraceptive (COC) Qlaira® containing estradiol valerate and dienogest (E2V/DNG) in a dynamic dosing regimen were analyzed, in which the reliability of the contraceptive effect of the drug was identified and confirmed, the restoration of fertility was population level after drug withdrawal, its minimal effect on metabolism and a reduced risk of cardiovascular complications (venous and arterial thrombosis) when using Qlaira® COC in comparison with other COCs. The absence of a negative effect of COC E2V/DNG on body weight, sexual function and vaginal microbiocenosis in most women has been proven. The data on satisfactory characteristics of menstrual bleeding (lighter and shorter) in users of Qlaira® COC and a decrease in symptoms associated with a hormone-free interval, which often occur when taking other COCs in the 21/7 regimen, are presented. The favorable efficacy and safety profile of COC E2V/DNG in real conditions, the advantages of estrogen bioidentical to the endogenous, in the composition of the drug, the dosage regimen 26/2, the positive effect on the lifestyle, determine the significant satisfaction of young women, including young women with children, and the ability to use the drug for a long time until menopause.

Keywords: young women with children, millennials generation, combined oral contraceptives, estradiol valerate, dienogest, Qlaira

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37. De Seta F, Restaino S, Banco R et al. Effects of estroprostins containing natural estrogen on vaginal flora. Gynecol Endocrinol 2014; 30 (11): 830–5.
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39. Macìas G et al. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol 2013; 33: 591–6. DOI: 10.3109/01443615.2013.800851
40. Fruzzetti F et al. An overview of the development of combined oral contraceptives containing estradiol: focus on estradiol valerate/dienogest. Gynecol Endocrinol 2012; 28 (5): 400–8. DOI: 10.3109/09513590.2012.662547
41. Nappi RE et al. Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM). Contraception 2013; 8: 369–75. DOI: 10.1016/j.contraception.2013.02.001
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________________________________________________

1. Howe N, Strauss W. The next 20 years: how customer and workforce attitudes will evolve. Harv Bus Rev 2007; 85 (7–8): 41–52, 191.
2. Rudolph CW, Rauvola RS, Costanza DP, Zacher H. Generations and Generational Differences: Debunking Myths in Organizational Science and Practice and Paving New Paths Forward. J Bus Psychol 2020; 1–23. DOI: 10.1007/s10869-020-09715-2
3. Piper LE. Generation Y in healthcare: leading millennials in an era of reform. Front Health Serv Manage. 2012; 29 (1): 16–28.
4. Sokolova N. Generation Ygrek. Profile. 2010; 34. Available at: http://web.archive.org/web/20101127131552/http://profile.ru/items/?item=30843 (in Russian)
5. Samarin A.V., Mekhrishvili L.L. Health in the system of life values of student youth: on the results of sociological research. International Scientific Research Journal. 2017; 1 (Part 3): 151–4 (in Russian)
6. Ageeva L.I., Alexandrova G.A., Zaichenko N.M. et al. Health care in Russia. 2019. Statistical collection. Moscow, 2019 (in Russian)
7. Aganezova N.V., Aganezov S.S., Gugalo N.V. Contraception: awareness and choice of young users. Gynecology. 2020; 22 (6): 50–5 (in Russian) DOI: 10.26442/20795696.2020.6.200506
8. WHO. Contraception. World Health Organization Evidence Brief, 2017. Available at: https://apps.who.int/iris/bitstream/handle/10665/329884/
WHO-RHR-19.18-eng.pdf?ua=1
9. Dikke G.B. Needs, expectations and doubt users of hormonal contraceptives. Gynecology. 2020; 22 (1): 33–7 (in Russian) DOI: 10.26442/20795696.2020.1.200044
10. WHO. Medical eligibility criteria for contraceptive use. Fifth edition, 2015. Available at: https://apps.who.int/iris/bitstream/handle/10665/181468/9789241549158_eng.pdf?sequence=9
11. Fait T et al. Needs and preferences of women users of oral contraceptives in selected countries in Central and Eastern Europe. Drugs Context 2018; 7. DOI: 10.7573/dic.212510
12. Ahrendt HJ, Makalová D, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception 2009; 80: 436–44.
13. Dinger J, Möhner S, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Comparative Study. Contraception 2016; 94 (4): 328–39.
14. Dinger J, Möhner S, Heinemann K. Combined oral contraceptives containing dienogest and estradiol valerate may carry a lower risk of venous and arterial thromboembolism compared to conventional preparations: Results from the extended INAS-SCORE study. Front Womens Health 2020; 5. DOI: 10.15761/FWH.1000178
15. Barnett C et al. Unintended pregnancy rates differ according to combined oral contraceptive – results from the INAS-SCORE study. Eur J Contracept Reprod Health Care 2019; 24 (4): 247–50. DOI: 10.1080/13625187.2019.1629412
16. Barnett C et al. Fertility and combined oral contraceptives – unintended pregnancies and planned pregnancies following oral contraceptive use – results from the INAS-SCORE study. Eur J Contracept Reprod Health Care 2017; 22 (1): 17–23. DOI: 10.1080/13625187.2016.1241991
17. Aktual'naia instruktsiia po meditsinskomu primeneniiu lekarstvennogo preparata Klaira® №LP-000010 ot 29.11.2019 (in Russian)
18. Sitruk-Ware R, Narh A. Characteristics and metabolic effects of estrogen and progestins contained in oral contraceptive pills. Best Pract Res Clin Endocrinol Metab 2013; 27: 13–24. DOI: 10.1016/j.beem.2012.09.004
19. Junge W et al. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Randomized Controlled Trial. Clin Drug Investig 2011; 31 (8): 573–84. DOI: 10.2165/11590220-000000000-00000
20. Klipping C et al. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Randomized Controlled Trial. Drugs R D 2011; 11: 159–70. DOI: 10.2165/11591200-000000000-00000
21. Grandi G et al. Modification of body composition and metabolism during oral contraceptives containing non-androgenic progestins in association with estradiol or ethinyl estradiol. Observational Study. Gynecol Endocrinol 2014; 30 (9): 676–80. DOI: 10.3109/09513590.2014.922947
22. Mezhevitinova E.A., Burlev V.A., Nabieva K.R. et al. Comprehensive assessment of the efficacy, tolerance and safety of the third generation combined hormonal contraceptive. Medical Advice. 2015; 9 (in Russian)
23. Dovletkhanova E.R., Prilepskaya V.N. Estradiol valerate and dienogest in hormonal contraception. Acceptability and effectiveness in real clinical practice. Medical Advice. 2018; 1 (in Russian)
24. Grandi G et al. Prospective measurement of blood pressure and heart rate over 24 h in women using combined oral contraceptives with estradiol. Contraception 2014; 90 (5): 529–34. DOI: 10.1016/j.contraception.2014.05.011
25. Girum T, Wasie A. Return of fertility after discontinuation of contraception: a systematic review and meta-analysis. Contracept Reprod Med 2018; 3: 9.
DOI: 10.1186/s40834-018-0064-y
26. Briggs P et al. Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study. Int J Womens Health 2016; 8: 477–87. DOI: 10.2147/IJWH.S107586
27. Mansour D. International survey to assess women's attitudes regarding choice of daily versus nondaily female hormonal contraception. Int J Womens Health 2014; 6: 367–75. DOI: 10.2147/IJWH.S59059
28. Nelson A et al. Efficacy and bleeding profile of a combined oral contraceptive containing oestradiol valerate/dienogest: a pooled analysis of three studies conducted in North America and Europe. Eur J Contracept Reprod Health Care 2013; 18 (4): 264–73. DOI: 10.3109/13625187.2013.780202
29. Pastor Z et al. The influence of combined oral contraceptives on female sexual desire: a systematic review. Eur J Contracept Reprod Health Care 2013; 18 (1): 27–43. DOI: 10.3109/13625187.2012.728643
30. Malmborg A, Persson E, Brynhildsen J, Hammar M. Hormonal contraception and sexual desire: A questionnaire-based study of young Swedish women. Eur J Contracept Reprod Health Care 2016; 21 (2): 158–67. DOI: 10.3109/13625187.2015.1079609
31. Higgins JA, Wright KQ, Turok DK, Sanders JN. Beyond safety and efficacy: sexuality-related priorities and their associations with contraceptive method selection. Contraception: X 2020; 2: 100038. DOI: 10.1016/j.conx.2020.100038
32. Burrows LJ, Basha M, Goldstein AT. The effects of hormonal contraceptives on female sexuality: a review. J Sex Med 2012; 9 (9): 2213–23.
33. Caruso S et al. Preliminary Study on the Effect of Four-phasic Estradiol Valerate and Dienogest (E2V/DNG) Oral Contraceptive on the Quality of Sexual Life. Sex Med 2011; 8: 2841–50.
34. Davis SR et al. J Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. Sex Med 2013; 10: 3069–79. DOI: 10.1111/jsm.12310
35. Spear GT, French AL, Gilbert D et al. Human alpha-amylase present in lower-genital-tract mucosal fluid processes glycogen to support vaginal colonization by Lactobacillus. J Infect Dis 2014; 210 (7): 1019–28.
36. Vodstrcil LA, Hocking JS, Law M et al. Hormonal Contraception Is Associated with a Reduced Risk of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. PLoS ONE 2013; 8 (9): e73055.
37. De Seta F, Restaino S, Banco R et al. Effects of estroprostins containing natural estrogen on vaginal flora. Gynecol Endocrinol 2014; 30 (11): 830–5.
38. Jensen JT et al. Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. Eur J Contracept Reprod Health Care 2013; 18: 274–83. DOI: 10.3109/13625187.2013.785516
39. Macìas G et al. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol 2013; 33: 591–6. DOI: 10.3109/01443615.2013.800851
40. Fruzzetti F et al. An overview of the development of combined oral contraceptives containing estradiol: focus on estradiol valerate/dienogest. Gynecol Endocrinol 2012; 28 (5): 400–8. DOI: 10.3109/09513590.2012.662547
41. Nappi RE et al. Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM). Contraception 2013; 8: 369–75. DOI: 10.1016/j.contraception.2013.02.001
42. Graziottin A. The shorter, the better: A review of the evidence for a shorter contraceptive hormone-free interval. Eur J Contracept Reprod Health Care 2016; 21 (2): 93–105. DOI: 10.3109/13625187.2015.1077380

Авторы

Н.В. Аганезова*, С.С. Аганезов

ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия
*aganezova@mail.ru

________________________________________________

Natalia V. Aganezova*, Sergey S. Aganezov

Mechnikov North-Western State Medical University, Saint Petersburg, Russia
*aganezova@mail.ru

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