Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Vossstrasse 9, 69115 Heidelberg, Germany.
Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5.
To investigate the efficacy and safety of oral dienogest 2mg compared with placebo in the treatment of endometriosis-associated pelvic pain (EAPP).
This was a 12-week, randomized, double-blind, placebo-controlled, multicenter (n=33) study in Germany, Italy, and Ukraine of 198 women aged 18-45 years with laparoscopically confirmed endometriosis and EAPP score > or =30 mm on a visual analog scale (VAS). Dienogest 2mg or placebo was administered orally once daily. The primary efficacy variable was absolute change in EAPP from baseline to Week 12, as determined by the target variables of change in VAS score and change in intake of supportive analgesic medication (ibuprofen) for pelvic pain.
Mean reductions in VAS score between baseline and Week 12 in the full analysis set were 27.4 mm and 15.1mm in the dienogest and placebo groups, respectively-a significant score difference of 12.3 mm in favor of dienogest (P<0.0001). Changes in intake of supportive analgesic medication were modest in both groups. The primary efficacy measure of absolute change in EAPP demonstrated the superiority of dienogest over placebo. Dienogest was generally well tolerated and few adverse events were associated with therapy.
Dienogest at a dose of 2mg daily for 12 weeks was significantly more effective than placebo for reducing EAPP.
研究地诺孕素 2mg 口服与安慰剂在治疗子宫内膜异位症相关盆腔痛（EAPP）中的疗效和安全性。
这是在德国、意大利和乌克兰开展的一项为期 12 周、随机、双盲、安慰剂对照、多中心（n=33）研究，共纳入 198 例年龄 18-45 岁、经腹腔镜确诊的子宫内膜异位症且视觉模拟评分（VAS）EAPP 评分≥30mm 的患者。患者接受地诺孕素 2mg 或安慰剂每日口服 1 次。主要疗效变量为 EAPP 自基线至第 12 周的绝对变化，采用 VAS 评分变化和盆腔痛辅助镇痛药物（布洛芬）摄入量变化的目标变量来评估。
在全分析集患者中，与基线相比，第 12 周 VAS 评分的平均降幅分别为地诺孕素组 27.4mm 和安慰剂组 15.1mm，地诺孕素组显著优于安慰剂组，差值为 12.3mm（P<0.0001）。两组患者辅助镇痛药物摄入量的变化均较小。EAPP 绝对变化的主要疗效指标显示地诺孕素优于安慰剂。地诺孕素总体耐受性良好，治疗相关不良事件较少。
地诺孕素 2mg 每日 1 次治疗 12 周可显著改善 EAPP，疗效优于安慰剂。
