醋酸乌利司他重复用于子宫肌瘤的疗效与安全性

Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids.

作者信息

Donnez Jacques, Hudecek Robert, Donnez Olivier, Matule Dace, Arhendt Hans-Joachim, Zatik Janos, Kasilovskiene Zaneta, Dumitrascu Mihai Cristian, Fernandez Hervé, Barlow David H, Bouchard Philippe, Fauser Bart C J M, Bestel Elke, Terrill Paul, Osterloh Ian, Loumaye Ernest

机构信息

Société de Recherche pour l'infertilité, Brussels, Belgium.

Department of Obstetrics and Gynaecology, Masaryk University and University Hospital Brno, Brno, Czech Republic.

出版信息

Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.

DOI:10.1016/j.fertnstert.2014.10.038

PMID:25542821

Abstract

OBJECTIVE

To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids.

DESIGN

Double-blind, randomized administration of two 12-week courses of ulipristal acetate.

SETTING

Gynecology centers.

PATIENT(S): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding.

INTERVENTION(S): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate.

MAIN OUTCOME MEASURE(S): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain.

RESULT(S): In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events.

CONCLUSION(S): Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01629563 (PEARL IV).

摘要

目的

探讨每日服用5毫克或10毫克醋酸乌利司他，重复进行两个12周疗程用于间歇性治疗有症状子宫肌瘤的疗效和安全性。

设计

醋酸乌利司他两个12周疗程的双盲随机给药。

地点

妇科中心。

患者

共有451例有症状子宫肌瘤且有大量出血的患者。

干预措施

每日5毫克或10毫克醋酸乌利司他重复两个12周治疗疗程。

主要观察指标

闭经、出血得到控制、肌瘤体积、生活质量（QoL）、疼痛。

结果

在5毫克和10毫克治疗组中（分别占患者的62%和73%），两个治疗疗程期间均实现闭经。两个治疗疗程期间出血得到控制的患者比例均>80%。每个治疗疗程后月经恢复，且与基线相比月经量减少。第二个治疗疗程后，接受5毫克和10毫克醋酸乌利司他治疗的患者肌瘤体积较基线的中位数分别减少54%和58%。两组的疼痛和生活质量均有所改善。醋酸乌利司他耐受性良好，因不良事件停药的患者不到5%。