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Elagolix sodium for the treatment of women with moderate to severe endometriosis-associated pain

机译:Elagolix钠用于治疗患有中度至重度子宫内膜异位症相关的疼痛的妇女

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摘要

First-line medical therapies for treating pain associated with endometriosis mainly consist in combined oral contraceptives and progestins. However, some women, having persistence of symptoms, may require further therapeutic options. Among these, gonadotropinr-eleasing hormone (GnRH) agonists (GnRH-as) have been widely employed in the last 30 years, despite being characterized by an unfavorable safety profile. Currently, new alternative investigational options are being investigated to treat this benign chronic disease. GnRH antagonists (GnRH-ants) are innovative hormonal drugs that do not induce flare-up effects and present also a limited onset of hypoestrogenic symptoms; in fact, their pharmacological mechanism of action, which consists in pure antagonistic activity, differs from that of traditional GnRH-as. In July 2018, the U.S. Food and Drug Administration (FDA) approved elagolix sodium for the management of moderate to severe pain associated with endometriosis, after the drug showed promising efficacy and safety results in previous phase III trials. This monograph aims to provide a complete overview of the pharmacokinetics, clinical efficacy and safety of this GnRH-ant for treating patients with endometriosis.
机译:用于治疗与子宫内膜异位症相关的疼痛的一线医疗疗法主要由组合口服避孕药和孕激素组成。然而,一些患有症状持续存在的妇女可能需要进一步的治疗选择。其中,尽管受到不利安全性的特点,但在过去30年中,促性腺激素的激素(GNRH)激动剂(GNRH-AS)已被广泛使用。目前,正在调查新的替代调查选择来治疗这种良性慢性病。 GNRH拮抗剂(GNRH-Ants)是创新的激素药物,不会诱导爆发效果,也存在有限的低雌激素症状;事实上,它们由纯拮抗活性组成的作用的药理学机制不同于传统的GNRH-AS。 2018年7月,美国食品和药物管理局(FDA)批准了Elagolix钠,用于治疗中度至严重疼痛与子宫内膜异位症,在此药物表现出前期III期试验中的有希望的疗效和安全结果后。本专着旨在完全概述该GNRH-ANT的药代动力学,临床疗效和安全性,用于治疗子宫内膜异位症患者。

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