Dienogest in long-term treatment of endometriosis.

Dienogest in long-term treatment of endometriosis.
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DOI:
10.2147/ijwh.s5633
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发表时间:
2011
期刊:
International journal of women's health
影响因子:
--
通讯作者:
Schindler AE
Schindler AE
中科院分区:
其他
文献类型:
--
作者:
Schindler AE

文献摘要

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子宫内膜异位症是一种慢性疾病,主要影响育龄妇女,其中子宫内膜异位症病变在子宫外形成,通常导致疼痛症状,疲劳和不孕。子宫内膜异位症的症状可能会导致生活质量的显着损害,并对患者,家庭和社会造成巨大的经济负担。子宫内膜异位症无法治愈;管理包括减轻疼痛和其他症状,减少子宫内膜异位症病变,提高生活质量。手术干预后复发是常见的,而支持目前用于子宫内膜异位症的许多药物的疗效和安全性的临床证据有限。地诺孕素是一种口服维生素E,在欧洲和日本进行的两项临床项目中广泛研究了其治疗子宫内膜异位症的作用,包括剂量范围、安慰剂对照、活性对照和长期(长达65周)研究。这些研究表明,地诺孕素每天2毫克有效地减轻子宫内膜异位症的疼痛症状,减少子宫内膜异位症病变,并改善生活质量指数。地诺孕素在这些研究中显示出良好的安全性和耐受性,具有可预测的不良反应,患者依从性高,停药率低。这篇评论文章描述了地诺孕素治疗子宫内膜异位症的有效性和安全性的临床试验证据,包括两项描述地诺孕素长期使用的研究。这些研究结果的相关性子宫内膜异位症的管理在临床实践中进行了讨论。
Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. The symptoms of endometriosis may cause significant impairment in quality of life and represent a substantial economic burden to patients, families, and society. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life. Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited. Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis in two clinical programs performed in Europe and Japan, including dose-ranging, placebo-controlled, active comparator-controlled, and long-term (up to 65 weeks) studies. These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life. Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates. This review article describes the clinical trial evidence that characterizes the efficacy and safety of dienogest in endometriosis, including two studies characterizing dienogest in long-term use. The relevance of these findings to the management of endometriosis in clinical practice is discussed.