Momoeda Mikio, Harada Tasuku, Terakawa Naoki, Aso Takeshi, Fukunaga Masao, Hagino Hiroshi, Taketani Yuji
Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
J Obstet Gynaecol Res. 2009 Dec;35(6):1069-76. doi: 10.1111/j.1447-0756.2009.01076.x.
To investigate the safety and efficacy of 52 weeks of dienogest treatment in patients with endometriosis.
One hundred and thirty-five patients with endometriosis received 2 mg of dienogest orally each day for 52 weeks. Adverse drug reactions and bone density were evaluated. Global improvement was assessed based on the changes in severity categories of five subjective symptoms during non-menstruation (lower abdominal pain, lumbago, dyschezia, dyspareunia, and pain on vaginal examination) and two objective findings (induration involving the pouch of Douglas and limited uterine mobility).
The most common adverse drug reactions included metrorrhagia (71.9%), headaches (18.5%), and constipation (10.4%). No clinically significant changes were noted in the incidence or severity of reactions associated with the course of the treatment period (52 weeks). Changes from the baseline bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry were -1.6 +/- 2.4% and -1.7 +/- 2.2% (mean +/- standard deviation) at 24 and 52 weeks, respectively, which were statistically significant decreases; however, there was no cumulative decrease. The proportions of patients assessed as marked or moderate improvement in terms of global improvement were 72.5% (95/131 cases) at 24 weeks and 90.6% (106/117 cases) at 52 weeks.
The long-term effect of dienogest on bone mineral density was slight, whereas the efficacy increased cumulatively.
探讨地诺孕素治疗子宫内膜异位症患者52周的安全性和有效性。
135例子宫内膜异位症患者每天口服2mg地诺孕素，持续52周。评估药物不良反应和骨密度。根据非月经期5种主观症状（下腹痛、腰痛、排便困难、性交困难和阴道检查时疼痛）严重程度类别变化以及2种客观体征（Douglas窝硬结和子宫活动受限）评估整体改善情况。
最常见的药物不良反应包括子宫出血（71.9%）、头痛（18.5%）和便秘（10.4%）。在治疗期（52周）内，与反应相关的发生率或严重程度未观察到具有临床意义的变化。双能X线吸收法测量的腰椎骨矿物质密度与基线相比，在24周和52周时分别变化了-1.6±2.4%和-1.7±2.2%（平均值±标准差），为统计学显著下降；然而，无累积下降。在整体改善方面，评估为显著或中度改善患者的比例在24周时为72.5%（95/131例），在52周时为90.6%（106/117例）。
地诺孕素对骨矿物质密度的长期影响轻微，而疗效呈累积增加。
