GynecologyGynecologyГинекология2079-56962079-5831Consilium Medicum3007110.26442/20795696.2018.6.000053ArticlesСтатьиUnknownCurrent conservative treatment of uterine fibroids. Ulipristal acetate and liver damage: contrived tragedy?Актуальное консервативное лечение миомы матки. Улипристала ацетат и повреждение печени: надуманная трагедия?TikhomirovA LТихомировАлександр Леонидович

д-р мед. наук, проф., проф. каф. акушерства и гинекологии лечебного фак-та

pacificoff@mail.ruA.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian FederationФГБОУ ВО «МГМСУ им. А.И.Евдокимова»15122018206VOL 20, NO6 (2018)ТОМ 20, №6 (2018)4709042020Copyright ©; 2018, Consilium MedicumCopyright ©; 2018, ООО "Консилиум Медикум"2018Consilium MedicumООО "Консилиум Медикум"https://creativecommons.org/licenses/by-nc-sa/4.0https://gynecology.orscience.ru/2079-5831/article/view/30071

Uterine fibroids are the most common pelvic tumor formation in women and the most common indication for hysterectomy. The effectiveness of long-term intermittent use of ulipristal acetate (UA) in patients with uterine myoma has been proven earlier. In May 2018, the ability of UA to cause a drug-induced liver injury (drug-induced liver injury, DILI) was disproved, and the European Commission approved a positive decision. According to the conclusion Expertise of the Pharmacovigilance Risk Assessment Committee (Pharmacovigilance Risk Assessment Committee - PRAC) the benefit/risk ratio remains favorable. Published recommendations are aimed at reducing the risk of liver damage. UA remains the 1st line of treatment for most myomas.

Миома матки является наиболее часто встречающимся опухолевидным тазовым образованием у женщин и самым распространенным показанием к гистерэктомии. Ранее была доказана эффективность долгосрочного интермиттирующего применения улипристала ацетата (УА) у больных с миомой матки. В мае 2018 г. способность УА вызывать лекарственное поражение печени (drug-induced liver injury - DILI) была опровергнута, Европейская комиссия утвердила положительное решение. По заключению экспертизы Комитета по оценке рисков в сфере фармаконадзора (Pharmacovigilance Risk Assessment Committee - PRAC) соотношение польза/риск остается благоприятным. Выпущены рекомендации, направленные на уменьшение риска развития повреждения печени. УА остается 1-й линией лечения большинства миом.

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