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在子宫肌瘤妇女中使用乌利司他醋酸酯治疗期间的肝功能、耐受性和满意度:单中心经验。

Liver function, tolerability and satisfaction during treatment with ulipristal acetate in women with fibroids: a single center experience.

机构信息

Gynecology and Human Reproduction Physiopathology, DIMEC, S. Orsola Hospital University of Bologna, Bologna, Italy.

出版信息

Gynecol Endocrinol. 2020 May;36(5):445-447. doi: 10.1080/09513590.2019.1680626. Epub 2019 Oct 24.

Abstract

The aim of the study was to evaluate liver function in women treated with ulipristal acetate (UPA) and to assess the tolerability and satisfaction during treatment. This Cross-sectional study included women with symptomatic uterine fibroids subjected to one or more 3-month treatment courses of 5 mg UPA daily. Following European Medical Agency's prescriptions, women were asked about symptoms potentially related to liver damage and had blood tests done, to assess serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Data on side effects, tolerability and satisfaction with the therapy were obtained during a phone interview. A total of 162 women completed the study with a mean treatment duration of 1.8 ± 0.9 cycles. No increased AST and ALT serum levels were detected and no woman reported symptoms suggestive of liver injury. The majority of women reported improvement of fibroids-related symptoms and a high degree of satisfaction with treatment. More than half of women had side effects, in most cases not as severe as to discontinue therapy. Ulipristal acetate did not worsen liver function or cause severe organ injury and showed high tolerability and satisfaction profiles. Therefore, we believe that it can still be considered a valuable option in the treatment of uterine fibroids.

摘要

本研究旨在评估接受醋酸乌利司他(UPA)治疗的女性的肝功能,并评估治疗期间的耐受性和满意度。这是一项横断面研究,纳入了因症状性子宫肌瘤接受过一次或多次为期 3 个月、每日 5mg UPA 治疗的女性。按照欧洲药品管理局的规定,我们询问了女性是否有与肝损伤相关的症状,并进行了血液检查,以评估血清天门冬氨酸氨基转移酶(AST)和丙氨酸氨基转移酶(ALT)水平。在电话访谈中,我们获取了关于副作用、耐受性和对治疗的满意度的数据。共有 162 名女性完成了研究,平均治疗持续时间为 1.8±0.9 个周期。未检测到血清 AST 和 ALT 水平升高,也没有女性报告提示肝损伤的症状。大多数女性报告称子宫肌瘤相关症状得到改善,对治疗的满意度很高。超过一半的女性出现了副作用,但大多数情况下并不严重,无需停止治疗。醋酸乌利司他不会加重肝功能或导致严重的器官损伤,具有较高的耐受性和满意度。因此,我们认为它仍然是治疗子宫肌瘤的一种有价值的选择。

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