Treatment of Endometriosis with the GnRHa Deslorelin and Add-Back Estradiol and Supplementary Testosterone.
Treatment of Endometriosis with the GnRHa Deslorelin and Add-Back Estradiol and Supplementary Testosterone.
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DOI：
10.1155/2015/934164
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发表时间：
2015
影响因子：
--
通讯作者：
Daniels JR
中科院分区：
文献类型：
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作者：
Agarwal SK;Daniels A;Drosman SR;Udoff L;Foster WG;Pike MC;Spicer DV;Daniels JR
背景。这项随机、多中心、开放标签的临床试验旨在生成促性腺激素释放激素激动剂 (GnRHa) 地洛瑞林 (D) 与低剂量雌二醇 ± 睾酮 (E2 ± T) 添加回治疗子宫内膜异位症相关盆腔疼痛的有效性和安全性的初步数据。方法。患有盆腔疼痛并经腹腔镜确诊为子宫内膜异位症的女性接受为期 6 个月的每日鼻内 D 治疗，同时给予透皮 E2、鼻内 E2 或鼻内 E2 + T。疗效数据包括对性交疼痛、痛经、盆腔疼痛、压痛和硬结的评估。还评估了认知和生活质量。安全参数包括子宫内膜增生、骨矿物质密度（BMD）和潮热的评估。结果。所有治疗组的子宫内膜异位症症状和体征评分均从治疗 3 个月后的基线平均值 7.4 降至 2.5，治疗 6 个月后降至 3.4。 BMD 变化和潮热发生率很小，并且未观察到子宫内膜增生。患者报告的结果显示多个领域都有显着改善。结论。每日鼻内 D 加上低剂量 E2 ± T 添加可显着减轻子宫内膜异位症症状和体征的严重程度，并且几乎没有安全信号，并且将单独使用 GnRHa 时预期的低雌激素症状降至最低。
Background. This randomized, multicenter, open-label clinical trial was intended to generate pilot data on the efficacy and safety of the gonadotropin-releasing hormone agonist (GnRHa) deslorelin (D) with low-dose estradiol ± testosterone (E2 ± T) add-back for endometriosis-related pelvic pain. Methods. Women with pelvic pain and laparoscopically confirmed endometriosis were treated with a six-month course of daily intranasal D with concurrent administration of either transdermal E2, intranasal E2, or intranasal E2 + T. Efficacy data included evaluation of dyspareunia, dysmenorrhea, pelvic pain, tenderness, and induration. Cognition and quality of life were also assessed. Safety parameters included assessment of endometrial hyperplasia, bone mineral density (BMD), and hot flashes. Results. Endometriosis symptoms and signs scores decreased in all treatment arms from a baseline average of 7.4 to 2.5 after 3 months of treatment and 3.4 after 6 months. BMD changes and incidence of hot flashes were minimal, and no endometrial hyperplasia was observed. Patient-reported outcomes showed significant improvement across multiple domains. Conclusions. Daily intranasal D with low dose E2 ± T add-back resulted in significant reduction in severity of endometriosis symptoms and signs with few safety signals and minimal hypoestrogenic symptoms that would be expected with the use of a GnRHa alone.