1 Department of Obstetrics and Gynecology, Peking Union Medical College Hospital , Beijing, China .
2 Department of Gynecology and Obstetrics, China Medical University Shengjing Hospital , Shenyang, China .
J Womens Health (Larchmt). 2018 Feb;27(2):148-155. doi: 10.1089/jwh.2017.6399. Epub 2017 Oct 30.
Dienogest is a progestin with demonstrated efficacy in the treatment of endometriosis in European women. The objective of this study was to evaluate the efficacy and safety of dienogest in Chinese women.
This 24-week, randomized, double-blind, placebo-controlled multicenter (n = 23) study evaluated the efficacy and safety of 2 mg dienogest once daily in 255 Chinese women aged 18-45 years with laparoscopically diagnosed endometriosis and an endometriosis-associated pelvic pain (EAPP) score ≥30 mm on a 0-100 mm visual analog scale. The primary efficacy variable was absolute change in EAPP from baseline to week 24. Secondary efficacy variables included proportions of responders and intake of supportive analgesic medication. Safety variables included adverse events (AEs), laboratory parameters, and bleeding patterns. Bone mineral density (BMD) was evaluated in a subset of 140 women.
After 24 weeks of treatment, the difference between treatment arms for mean reduction in EAPP was statistically significant in favor of dienogest (-24.54 mm; 95% CI -29.93 to -19.15; p < 0.0001). Secondary efficacy analyses supported the significant superiority of dienogest over placebo. Dienogest was well tolerated, with few AEs associated with therapy. Dienogest had no effect on BMD levels after 24 weeks of treatment.
Dienogest 2 mg once daily for 24 weeks was superior to placebo in reducing EAPP and was safe and well tolerated in Chinese women with endometriosis. The results are consistent with studies previously conducted in European women.
地诺孕素是一种孕激素，已被证明在治疗欧洲女性子宫内膜异位症方面有效。本研究的目的是评估地诺孕素在中国女性中的疗效和安全性。
这是一项为期 24 周、随机、双盲、安慰剂对照的多中心（n=23）研究，评估了 255 例年龄在 18-45 岁之间的中国女性中，每日一次口服 2 毫克地诺孕素的疗效和安全性，这些女性均经腹腔镜诊断为子宫内膜异位症，且在 0-100mm 视觉模拟量表上的子宫内膜异位症相关盆腔疼痛（EAPP）评分≥30mm。主要疗效变量是从基线到第 24 周 EAPP 的绝对变化。次要疗效变量包括反应者的比例和辅助镇痛药物的摄入。安全性变量包括不良事件（AE）、实验室参数和出血模式。在 140 名女性的亚组中评估了骨密度（BMD）。
治疗 24 周后，地诺孕素组 EAPP 的平均下降幅度明显优于安慰剂组（-24.54mm；95%置信区间-29.93 至-19.15；p<0.0001）。二次疗效分析支持地诺孕素明显优于安慰剂。地诺孕素耐受性良好，与治疗相关的不良事件较少。地诺孕素治疗 24 周后对 BMD 水平无影响。
地诺孕素 2mg 每日一次治疗 24 周，在降低 EAPP 方面优于安慰剂，且在中国子宫内膜异位症女性中安全且耐受良好。这些结果与先前在欧洲女性中进行的研究一致。
