safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2024-12-2-214-229safetyrisk-426Research ArticleРАЦИОНАЛЬНАЯ ФАРМАКОТЕРАПИЯ И ФАРМАКОНАДЗОРRATIONAL PHARMACOTHERAPY AND PHARMACOVIGILANCEКомбинированные оральные контрацептивы при синдроме поликистозных яичников: pro и contra (обзор)Combined Oral Contraceptives for Polycystic Ovary Syndrome: Pro and Contra (Review)https://orcid.org/0000-0002-3733-6822МазеркинаИ. А.MazerkinaI. A.

Мазеркина Ирина Анатольевна - канд. мед. наук, ведущий аналитик.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Irina A. Mazerkina - Cand. Sci. (Med.).

8/2 Petrovsky Blvd, Moscow 127051

mazerkina@expmed.ruhttps://orcid.org/0009-0003-4456-6567ДавыдовИ. Г.DavydovI. G.

Давыдов Игорь Григорьевич.

Можайское шоссе, д. 14, Москва, 121374

Igor G. Davydov.

14 Mozhayskoe Hwy, Moscow 121374

medhelp@mail.ruhttps://orcid.org/0000-0003-0770-8020АляутдинаО. С.AlyautdinaO. S.

Аляутдина Ольга Сергеевна - д-р мед. наук, профессор.

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Olga S. Alyautdina - Dr. Sci. (Med.), Professor.

8/2 Trubetskaya St., Moscow 119991

olasa@list.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationГосударственное бюджетное учреждение здравоохранения города Москвы «Городская клиническая больница имени М.Е. Жадкевича Департамента здравоохранения города Москвы»РоссияCity Clinical Hospital named after M.E. Zhadkevich of the Moscow City Health DepartmentRussian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияI.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202406062024122214229Copyright © Мазеркина И.А., Давыдов И.Г., Аляутдина О.С., 20242024Мазеркина И.А., Давыдов И.Г., Аляутдина О.С.Mazerkina I.A., Davydov I.G., Alyautdina O.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/426ВВЕДЕНИЕ

ВВЕДЕНИЕ. Синдром поликистозных яичников (СПЯ) — основная причина женского бесплодия. Комбинированные оральные контрацептивы (КОК) позиционируются в клинических рекомендациях по СПЯ как препараты первой линии медикаментозного лечения. Учитывая ассоциацию СПЯ с такими клиническими нарушениями, как ожирение, сахарный диабет 2 типа, метаболический синдром, тревожные и депрессивные расстройства, повышенный риск рака эндометрия, сердечно-сосудистые заболевания, важно описать и систематизировать данные о пользе и рисках применения КОК при данном синдроме.

ЦЕЛЬ

ЦЕЛЬ. Обзор современных данных по применению комбинированных оральных контрацептивов при СПЯ с фокусом на рациональность назначения этих препаратов, основные риски при их применении и меры минимизации этих рисков.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Гирсутизм является наиболее заметным клиническим проявлением гиперандрогении, его распространенность при СПЯ составляет 65–75%. По данным литературы, КОК, содержащие прогестагены с антиандрогенными свойствами, эффективны в лечении гирсутизма и имеют преимущество при этом состоянии по сравнению с применением только антиандрогенных препаратов. При СПЯ повышен риск рака эндометрия за счет удлинения эстроген-зависимой пролиферативной фазы. Нормализующее влияние на менструальный цикл и действие прогестагенового компонента КОК может снизить этот риск. Данные литературы о связи применения КОК с возникновением или усугублением психических расстройств при СПЯ, а также с нарушением толерантности к глюкозе, артериальной гипертензией и другими рисками развития сердечно-сосудистых заболеваний неоднозначны. В связи с тем что основной проблемой безопасности применения КОК является тромбогенность, требуется особая осторожность при назначении препаратов этой группы женщинам с СПЯ. Данные о влиянии КОК на фертильность у женщин с СПЯ ограниченны, но в литературе имеются сведения о неблагоприятном влиянии длительного приема КОК на результаты вспомогательных репродуктивных технологий.

ВЫВОДЫ

ВЫВОДЫ. Основная польза неконтрацептивного приема КОК при СПЯ — лечение гиперандрогении, в основном гирсутизма. Для достижения эффекта длительность терапии КОК, содержащими прогестагены с антиандрогенными свойствами, должна быть не менее 6 месяцев. КОК могут также применяться для контрацепции при СПЯ. Назначение КОК при СПЯ должно быть индивидуализированным с учетом цели лечения и всех возможных рисков их применения.

INTRODUCTION

INTRODUCTION. Polycystic ovary syndrome (PCOS) is the main cause of female infertility. Clinical practice guidelines on PCOS recommend combined oral contraceptives (COCs) as first-line therapy. Given the association of PCOS with a number of clinical conditions, including obesity, type 2 diabetes mellitus, metabolic syndrome, anxiety and depressive disorders, an increased risk of endometrial cancer, and cardiovascular diseases, it is important to describe and systematise data on the benefits and risks associated with COCs.

AIM

AIM. This study aimed to review current data on the use of COCs in PCOS, focusing on the rationality of prescribing, the main risks of using COCs, and the measures to minimise these risks.

DISCUSSION

DISCUSSION. Hirsutism is the most prominent clinical manifestation of hyperandrogenism; in PCOS, its prevalence is 65–75%. COCs containing progestins with anti-androgenic properties are effective in treating hirsutism and superior to anti-androgens alone. Women with PCOS are at increased risk of endometrial cancer due to prolongation of the oestrogen-dependent proliferative phase. This risk can be mitigated by the normalising effect of COCs on the menstrual cycle and the effect of the progestin component of COCs. This review highlights the controversial nature of data on the association of COCs with emerging or exacerbating mental disorders, impaired glucose tolerance, and arterial hypertension/other cardiovascular risks in PCOS. Since the main safety issue with COCs is their thrombogenicity, clinicians should take special care when prescribing medicinal products from this group to PCOS patients. Data on the effect of COCs on fertility in women with PCOS are limited, but there is published evidence of an adverse effect of long-term use of COCs on the results of assisted reproductive technologies.

CONCLUSIONS

CONCLUSIONS. The key benefit of the non-contraceptive use of COCs in PCOS is in treating hyperandrogenism, mainly hirsutism. To achieve effect, the patient should take COCs containing progestins with anti-androgenic properties for at least 6 months. PCOS patients can also use COCs for contraception. Clinicians prescribing COCs to women with PCOS should consider the individual patient context, the aim of treatment, and any potential risks associated with COCs.

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The authors declare that there are no conflicts of interest present.