醋酸乌利司他用于子宫腺肌病的随机对照试验。

Ulipristal acetate use in adenomyosis: A randomized controlled trial.

机构信息

Gynecology Obstetric Department, Bicetre Hospital, GHU Sud, AP-HP, F-94276, Le Kremlin Bicetre, France; Inserm, Centre of Research in EPIDEMIOLOGY and Population Health (CESP), U1018, F-94276, Le Kremlin Bicetre, France; Medical School, University Paris Sud, F-94276, Le Kremlin Bicêtre, France.

Gynecology Obstetric Department, Centre Aliénor D'aquitaine CHU Bordeaux, F-33076, Bordeaux, France.

出版信息

J Gynecol Obstet Hum Reprod. 2021 Jan;50(1):101978. doi: 10.1016/j.jogoh.2020.101978. Epub 2020 Nov 10.

DOI:10.1016/j.jogoh.2020.101978

PMID:33186772

Abstract

OBJECTIVE

To evaluate the effect of a 10 mg per day 12 week treatment of ulipristal acetate (UPA) on abnormal uterine bleeding due to adenomyosis.

DESIGN

A double-blind phase 2 randomized controlled pilot study.

SETTING

From May 2015 to February 2018 in five teaching hospitals.

POPULATION

Premenopausal women with abnormal uterine bleeding (with a pictorial blood loss assessment score (PBAC) higher than 100 at inclusion) and a sonographic or MRI diagnosis of adenomyosis.

METHODS

After random allocation, either UPA 10 mg or placebo were orally administered during 12 weeks. A 3:1 ratio was used.

MAIN OUTCOME MEASURES

The primary outcome was the rate of women with a PBAC score of less than 75 as evaluated over the 28 days following the 12-week treatment. Secondary outcomes included rate of amenorrhea, evolution of pain, quality of life and tolerance.

RESULTS

Thirty women were included in the UPA group and 10 in the placebo group. No woman in the placebo group versus 95.24 % of women in the UPA group had a PBAC score under 75 during the 28 day period following the 12-week treatment (p < 0.01). A significant decrease in pain was noticed between inclusion and 13 weeks in the UPA group (p < 0.01). At 6 months, there was no significant difference in PBAC score or pain between groups. No serious adverse event was recorded.

CONCLUSION

UPA could be an interesting option for treatment of abnormal uterine bleeding related to adenomyosis in women wishing to preserve their fertility.

摘要

目的

评估醋酸乌利司他（UPA）10mg/天，治疗 12 周对因子宫腺肌病导致的异常子宫出血的疗效。

设计

双盲、2 期、随机对照试验。

地点

五所教学医院，于 2015 年 5 月至 2018 年 2 月进行。

人群

有异常子宫出血的绝经前妇女（纳入时 PBAC 评分高于 100）和经超声或 MRI 诊断为子宫腺肌病的妇女。

方法

随机分组后，口服 UPA 10mg 或安慰剂，为期 12 周。采用 3:1 的比例。

主要观察指标

主要疗效指标为治疗 12 周后 28 天内 PBAC 评分＜75 的患者比例。次要疗效指标包括闭经率、疼痛变化、生活质量和耐受性。

结果

UPA 组纳入 30 例，安慰剂组纳入 10 例。安慰剂组无一例患者 PBAC 评分在 12 周治疗后 28 天内＜75，而 UPA 组有 95.24%（28/30）的患者 PBAC 评分＜75（p＜0.01）。UPA 组在纳入和第 13 周时疼痛显著减轻（p＜0.01）。6 个月时，两组 PBAC 评分和疼痛无显著差异。未记录到严重不良事件。