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Сравнительное открытое проспективное клиническое исследование по оценке эффективности и безопасности применения препарата Берголак (каберголин) в лечении пациентов с пролактин-секретирующими опухолями

Сравнительное открытое проспективное клиническое исследование по оценке эффективности и безопасности применения препарата Берголак (каберголин) в лечении пациентов с пролактин-секретирующими опухолями

Abstract

Цель. Оценить эффективность и безопасность применения препарата каберголина Берголак (ПАО «Верофарм», РФ) в лечении пациентов с пролактин-секретирующими опухолями. Материалы и методы. В исследование были включены 14 пациентов (14 женщин, средний возраст 46±12 лет) с диагнозом «пролактинома». В течение 1 месяца пациенты получали терапию оригинальным каберголином, после чего назначался Берголак. Доза каберголина варьировала от 0,125 мг до 3,25 мг, в среднем 0,875±1,193 мг в неделю. Оценка уровня пролактина, компенсации симптомов гиперпролактинемического гипогонадизма и выраженности побочных эффектов регистрировались в момент включения в исследование, через 1 месяц терапии оригинальным каберголином, через 1 и 2 месяца применения Берголака. Результаты. Достоверных отличий в уровне пролактина (р>0,05), а также частоте побочных эффектов (р>0,43) на фоне терапии Берголаком в сравнении с оригинальным препаратом не отмечено. Выводы. Дженерический препарат каберголина Берголак является эффективным лекарственным средством для лечения пациентов с пролактин-секретирующими опухолями. Частота побочных эффектов при терапии Берголаком не превышает таковую при применении оригинального каберголина.

Aim. Evaluate the efficacy and safety of cabergoline Bergolak ("Veropharm", Russia) in the treatment of patients with prolactin-secreting tumors. Materials and methods. The study included 14 patients (14 women, mean age 46±12) with diagnosis prolactinoma. The patients at inclusion were normoprolactinemic on the stable dose of brand cabergoline for more than 6 months (from 0,125 mg to 3,25 mg per week) and after 1 month were switched to generic cabergoline (Bergolak) in equivalent dose. Prolactin level, symptoms of hyperprolactinemic hypogonadism, side-effects were evaluated at the baseline, after 1 month of original cabergoline treatment and 1 and 2 months of Bergolak therapy. Results. Statistical differences in the level of prolactin (p>0.05), and the incidence of side-effects (p>0.43) during Bergolak therapy in comparison with the original drug were not registered. Conclusions. Generic cabergoline (Bergolak) showed to be equally effective drug for treatment of patients with prolactin-secreting tumors. The incidence of side-effects during Bergolak therapy is equal to the original cabergoline treatment.

Keywords

ГИПЕРПРОЛАКТИНЕМИЯ, ПРОЛАКТИНОМА, АГОНИСТЫ ДОФАМИНА, КАБЕРГОЛИН

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
gold