Ebert Andreas D, Dong Liying, Merz Martin, Kirsch Bodo, Francuski Maja, Böttcher Bettina, Roman Horace, Suvitie Pia, Hlavackova Olga, Gude Kerstin, Seitz Christian
Praxis for Women's Health, Gynecology & Obstetrics, Berlin, Germany.
Bayer AG, Berlin, Germany.
J Pediatr Adolesc Gynecol. 2017 Oct;30(5):560-567. doi: 10.1016/j.jpag.2017.01.014. Epub 2017 Feb 9.
To study the safety and efficacy of dienogest 2 mg in adolescents with suspected endometriosis.
A 52-week, open-label, single-arm study.
In 21 study centers, in 6 European countries.
Adolescents aged 12 to younger than 18 years with clinically suspected or laparoscopically confirmed endometriosis.
Dienogest 2 mg once daily.
The primary end point was relative change in lumbar spine (L2-L4) bone mineral density (BMD) measured using dual-energy x-ray absorptiometry. A key secondary end point was change in endometriosis-associated pain assessed using a visual analogue scale.
Of 120 patients screened, 111 comprised the full-analysis set (ie, patients who took ≥1 dose of study drug and had ≥1 post-treatment observation) and 97 (87.4%) completed the study. Mean lumbar BMD at baseline was 1.1046 (SD, 0.1550) g/cm. At the end of dienogest treatment (EOT; defined as at 52 weeks or premature study discontinuation), mean relative change in BMD from baseline was -1.2% (SD, 2.3%; n = 103). Follow-up measurement 6 months after EOT in the subgroup with decreased BMD at EOT (n = 60) showed partial recovery in lumbar BMD (mean change from baseline: -2.3% at EOT, -0.6% 6 months after EOT). Mean endometriosis-associated pain score was 64.3 (SD, 19.1) mm at baseline and decreased to 9.0 (SD, 13.9) mm by week 48.
In adolescents with suspected endometriosis, dienogest 2 mg for 52 weeks was associated with a decrease in lumbar BMD, followed by partial recovery after treatment discontinuation. Endometriosis-associated pain was substantially reduced during treatment. Because bone accretion is critical during adolescence, results of the VISanne study to assess safety in ADOlescents (VISADO) study highlights the need for tailored treatment in this population, taking into account the expected efficacy on endometriosis-associated pain and an individual's risk factors for osteoporosis.
研究2mg地诺孕素治疗疑似子宫内膜异位症青少年患者的安全性和有效性。
一项为期52周的开放标签单臂研究。
在欧洲6个国家的21个研究中心。
年龄在12至未满18岁、临床疑似或经腹腔镜确诊为子宫内膜异位症的青少年。
每日一次服用2mg地诺孕素。
主要终点是使用双能X线吸收法测量的腰椎（L2-L4）骨矿物质密度（BMD）的相对变化。一个关键次要终点是使用视觉模拟量表评估的子宫内膜异位症相关疼痛的变化。
在120例筛查患者中，111例纳入全分析集（即服用≥1剂研究药物且有≥1次治疗后观察结果的患者），97例（87.4%）完成研究。基线时腰椎BMD的平均值为1.1046（标准差，0.1550）g/cm²。在地诺孕素治疗结束时（EOT；定义为52周或提前终止研究），BMD相对于基线的平均变化为-1.2%（标准差，2.3%；n = 103）。在EOT时BMD降低的亚组（n = 60）中，EOT后6个月的随访测量显示腰椎BMD部分恢复（相对于基线的平均变化：EOT时为-2.3%，EOT后6个月为-0.6%）。基线时子宫内膜异位症相关疼痛评分的平均值为64.3（标准差，19.1）mm，到第48周时降至9.0（标准差，13.9）mm。
在疑似子宫内膜异位症的青少年中，服用2mg地诺孕素52周会导致腰椎BMD降低，停药后部分恢复。治疗期间子宫内膜异位症相关疼痛显著减轻。由于青春期骨生长至关重要，评估青少年安全性的VISanne研究（VISADO）的结果凸显了在该人群中进行个性化治疗的必要性，要考虑到对子宫内膜异位症相关疼痛的预期疗效以及个体骨质疏松风险因素。
