Department of Obstetrics and Gynecology, University of Yamanashi, 1110 Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan.
Department of Physical Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.
Adv Ther. 2022 Nov;39(11):5087-5104. doi: 10.1007/s12325-022-02301-3. Epub 2022 Sep 2.
Dysmenorrhea and endometriosis are common gynecologic disorders among women of reproductive age that significantly impact health-related quality of life (HRQL) as well as productivity. Although there are treatment options listed in Japanese guidelines, a gap remains in unmet medical needs for maximizing treatment outcome. The extended regimen of ethinylestradiol and drospirenone (EE/DRSP) (taken daily for up to 120 consecutive days) has been available in Japan for treating dysmenorrhea and/or endometriosis-associated pain since 2016. Yet, the effectiveness of its usage on HRQL has not been investigated elsewhere to date. Therefore, in this study, we aim to observe changes in HRQL of Japanese women treated with an extended regimen of EE/DRSP for dysmenorrhea and/or endometriosis-associated pain.
As part of a 2-year post-marketing surveillance study, women with dysmenorrhea or endometriosis-associated pelvic pain were prescribed extended EE/DRSP during routine clinical practice. Data were collected 1 month before and 3 and 6 months after initiating treatment. Primary outcomes were the Menstrual Distress Questionnaire (MDQ) (before, during, and after menstruation) in patients with dysmenorrhea, and the Endometriosis Impact Scale (EIS) and European Quality of Life 5-dimensions 5-level instrument (EQ-5D-5L) in patients with endometriosis.
The study cohort included 315 patients (mean age 28.9 years) with dysmenorrhea and 262 patients (mean age 31.3 years) with endometriosis. Mean MDQ total scores before and during menstruation decreased significantly after 6 months with extended EE/DRSP; there was no improvement in after-menstruation MDQ score. Mean EIS domain scores improved significantly by 6 months, with improvement in most EIS individual item scores. Mean EQ-5D-5L scores increased slightly during 6 months of treatment.
Extended EE/DRSP treatment improved HRQL outcomes in Japanese women with dysmenorrhea or endometriosis-associated pelvic pain.
Registered at ClinicalTrials.gov (NCT03126747) on June 2017.
痛经和子宫内膜异位症是育龄妇女常见的妇科疾病，严重影响健康相关生活质量（HRQL）和生产力。尽管日本指南中列出了治疗方案，但在最大限度地提高治疗效果方面仍存在未满足的医疗需求。屈螺酮炔雌醇（EE/DRSP）的延长疗程（连续服用长达 120 天）自 2016 年以来在日本可用于治疗痛经和/或子宫内膜异位症相关疼痛。然而，迄今为止，其对 HRQL 的有效性尚未在其他地方进行研究。因此，在这项研究中，我们旨在观察接受 EE/DRSP 延长疗程治疗的日本女性痛经和/或子宫内膜异位症相关疼痛的 HRQL 变化。
作为为期 2 年的上市后监测研究的一部分，在常规临床实践中，患有痛经或子宫内膜异位症相关盆腔疼痛的女性被处方 EE/DRSP 延长疗程。在开始治疗前 1 个月以及治疗后 3 个月和 6 个月收集数据。主要结局是痛经患者的月经困扰问卷（MDQ）（经期前、经期中和经期后），以及子宫内膜异位症患者的子宫内膜异位症影响量表（EIS）和欧洲五维健康量表 5 级简表（EQ-5D-5L）。
研究队列包括 315 例痛经患者（平均年龄 28.9 岁）和 262 例子宫内膜异位症患者（平均年龄 31.3 岁）。EE/DRSP 延长疗程治疗 6 个月后，经期前和经期中的 MDQ 总分明显下降；经期后 MDQ 评分无改善。EIS 各域评分在 6 个月时显著改善，大多数 EIS 单项评分也有所改善。EQ-5D-5L 评分在治疗 6 个月期间略有升高。
EE/DRSP 延长疗程治疗改善了日本痛经或子宫内膜异位症相关盆腔疼痛女性的 HRQL 结局。
于 2017 年 6 月在 ClinicalTrials.gov（NCT03126747）注册。
