Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months.
Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months.
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DOI：
10.5653/cerm.2016.43.4.215
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发表时间：
2016-12
期刊：
影响因子：
--
通讯作者：
Kang BM
中科院分区：
文献类型：
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作者：
Park SY;Kim SH;Chae HD;Kim CH;Kang BM
目的：评价地诺孕素治疗子宫内膜异位症12个月及以上患者的疗效和安全性。我们分析了188名患有子宫内膜异位症的妇女的临床资料，这些妇女在一个研究所接受了每天一次2毫克的地诺孕素治疗，持续12个月或更长时间。我们评估了子宫内膜异位症相关疼痛、子宫内膜异位症大小、复发率和服用双炔诺孕酮后不良事件的变化。研究人员测量了服用孕激素超过18个月的患者的骨密度（BMD）。用药后12个月疼痛明显减轻。在那些因复发性子宫内膜异位瘤而接受dienogest治疗的患者中，在12个月和18个月的随访中，子宫内膜异位瘤的大小明显减小。我们发现在术后治疗预防复发的患者中，仅有1例超声检查复发（114例中的1例，0.9%）。最常见的药物不良反应是子宫出血（3.2%），其他不良事件一般可耐受，停药率较低（5.2%）。在测量BMD的50例患者中，10例患者（20%）的Z-score低于年龄的预期范围。dienogest治疗一年或一年以上似乎在预防手术后复发，减少子宫内膜异位症相关疼痛，减小复发子宫内膜异位症的大小方面非常有效，具有良好的安全性和耐受性。然而，由于一些女性可能出现骨质流失，应该对长期服用药物的患者进行骨密度检查。
To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women.