a Department of Surgical Sciences, University of Cagliari , Cagliari , Italy.
b Department of Obstetrics and Gynecology, University Hospital of Cagliari , Cagliari , Italy.
Gynecol Endocrinol. 2019 Sep;35(9):756-761. doi: 10.1080/09513590.2019.1576618. Epub 2019 Mar 1.
This observational study was conducted in premenopausal women who presented themselves at the Obstetrics and Gynecology Department of the University Hospital of Cagliari (Italy), for heavy menstrual bleeding (HMB) dependent on uterine myomas. After a screening visit, 19 women without contraindications to ulipristal acetate (UPA) treatment, were included in the study that envisaged 12 months of observation in which each subject was asked to assume UPA (tablet of 5 mg, ESMYA, one tablet a day for 3 months: first cycle) two menstrual cycles of interruption and a second ESMYA cycle, followed by 3 months of observation (third follow-up month, visit 4). The significant decrease of myoma volume, diagnosed after the first ESMYA cycle, persisted until the visit 4. The HMB significantly decreased during the ESMYA treatment and persisted until visit 4. The quality of life (QoL), evaluated with the questionnaire SF-36, significantly improved during the study. The values of estradiol (E2), biochemical parameters of bone metabolism, as well as those of lumbar and hip bone mineral density, did not change during the study in comparison with basal levels. The efficacy of two repeated ESMYA cycles to treat uterine myomas and their related symptoms improves the QoL without interfering with bone health.
这项观察性研究纳入了因子宫肌瘤导致月经过多(HMB)而就诊于意大利卡利亚里大学医院妇产科的绝经前女性。在筛选就诊后,19 名无醋酸乌利司他(UPA)治疗禁忌证的女性被纳入研究,该研究对她们进行了 12 个月的观察,要求每位受试者服用 UPA(5mg 片剂,ESMIA,每日 1 片,持续 3 个月:第 1 个周期),停药 2 个月经周期后,再服用第二个 ESMYA 周期,然后进行 3 个月的观察(第 3 次随访月,就诊 4)。第 1 个 ESMYA 周期后诊断出的肌瘤体积显著减小,直至就诊 4 时仍持续存在。ESMYA 治疗期间,HMB 显著减少,并持续至就诊 4。使用 SF-36 问卷评估的生活质量(QoL)在研究期间显著改善。与基础水平相比,研究期间雌二醇(E2)、骨代谢生化参数以及腰椎和髋部骨密度值没有变化。两次重复 ESMYA 周期治疗子宫肌瘤及其相关症状的疗效可提高 QoL,而不会对骨骼健康造成影响。