Department of Obstetrics and Gynecology, Gynecologic Endocrinology Unit, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Department of Obstetrics and Gynecology, Faculty of Medicine, Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia.
BMC Womens Health. 2019 May 16;19(1):68. doi: 10.1186/s12905-019-0758-6.
Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL.
Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.
Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.
The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.
Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.
地诺孕素已被证明可显著改善子宫内膜异位症相关症状，如使人虚弱的慢性盆腔痛，并进而改善健康相关生活质量（HRQoL）。迄今为止，尚无反映亚洲实际情况的患者报告结局数据，在亚洲，子宫内膜异位症是一个相关的健康、社会和经济负担。这项非干预性、多中心、前瞻性研究旨在研究地诺孕素对 HRQoL 的影响。
亚洲女性接受地诺孕素（2mg/天）治疗，并随访 24 个月。患者报告的结局用于评估地诺孕素改善 HRQoL 和子宫内膜异位症相关盆腔痛（EAPP）的效果。HRQoL，特别是作为主要终点的“疼痛”域，使用子宫内膜异位症健康状况问卷-30（EHP-30）进行评估。数字评分量表用于确定 EAPP 严重程度的变化。在本次中期分析（数据截止日期：2017-11-27）中，评估了从基线到数据可用时的 6 个月时 EHP-30 和 EAPP 评分的平均变化。记录了治疗中出现的不良事件（TEAEs）和出血情况。
地诺孕素治疗降低了所有评估域的 EHP-30 评分（评分 0-100，较低的评分表示 HRQoL 较好）。主要是“疼痛”域在 78.4%的患者中得到改善。EAPP 减少（评分 0-10，较低的评分表示疼痛减轻），疼痛评分平均降低了-4.5 分。基线 EAPP 严重程度较高的患者对地诺孕素的反应增加（平均变化-6.2 分），而基线 EAPP 严重程度较低的患者（平均变化-1.4 分）。手术和临床诊断的患者均描述了类似的疼痛减轻，以及有或没有既往治疗的患者。有 31.5%的患者发生了与药物相关的 TEAEs，最常见的事件是闭经（5.9%）和经间出血（5.1%）。地诺孕素治疗后出血模式发生改变，表现为正常出血减少（84.2%降至 28.8%）和闭经增加（3.2%升至 42.9%），6 个月时。
数据表明，地诺孕素治疗可改善 HRQoL 和 EAPP。未观察到新的安全信号。因此，作为治疗使人虚弱的慢性子宫内膜异位症相关疼痛的一线治疗方法，它是一种有趣的选择，有待进一步研究。
名称：临床试验Clinicaltrials.gov 注册号：NCT02425462注册日期：2015-04-24。注册时间：前瞻性。
