Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
J Obstet Gynaecol Res. 2020 Apr;46(4):606-617. doi: 10.1111/jog.14209. Epub 2020 Feb 12.
To investigate the safety and efficacy of dienogest (DNG), a progestational 19-norsteroid, administered for 52 weeks in patients with primary and secondary dysmenorrhea.
A total of 147 patients with dysmenorrhea received 1 mg of DNG orally each day for 52 weeks. The dose could be increased to 2 mg/day at or after Week 12 according to the investigator's determination. The primary safety endpoint was evaluation of adverse events, and the secondary safety endpoint was evaluation of adverse drug reactions. The number of days and severity of genital bleeding were assessed according to records in the patients' diary. Lower abdominal pain and/or low back pain because of dysmenorrhea were assessed according to the dysmenorrhea score.
The most frequent adverse drug reaction was irregular uterine bleeding (94.6%). Most subjects completed the 52-week administration. Genital bleeding was more likely to occur in subjects with secondary dysmenorrhea than in those with primary dysmenorrhea, and in subjects with "uterine myoma or adenomyosis" than in those with "endometriosis alone." In any of the categorizations, there tended to be fewer days with genital bleeding as the treatment period increased in length, and most of the genital bleeding cases were mild. The change from baseline in the dysmenorrhea score (mean ± standard deviation [SD]) was -3.7 ± 1.6 at Week 24 of treatment and -4.0 ± 1.3 at Week 52.
This study showed favorable tolerability of the long-term use of DNG to patients with dysmenorrhea and a sustainable pain relief effect.
研究屈螺酮（DNG）作为一种孕激素 19-去甲甾体，在原发性和继发性痛经患者中应用 52 周的安全性和疗效。
共有 147 例痛经患者每天口服 1 毫克 DNG，持续 52 周。根据研究者的决定，在第 12 周或之后可将剂量增加至 2 毫克/天。主要安全性终点为不良事件评估，次要安全性终点为药物不良反应评估。根据患者日记中的记录评估生殖器出血的天数和严重程度。下腹痛和/或痛经引起的腰痛根据痛经评分进行评估。
最常见的药物不良反应是不规则子宫出血（94.6%）。大多数患者完成了 52 周的治疗。继发性痛经患者比原发性痛经患者、有“子宫肌瘤或腺肌病”的患者比只有“子宫内膜异位症”的患者更易发生生殖器出血。在任何分类中，随着治疗时间的延长，生殖器出血天数往往更少，且大多数生殖器出血病例为轻度。治疗 24 周和 52 周时痛经评分的变化（平均值±标准差 [SD]）分别为-3.7±1.6 和-4.0±1.3。
本研究表明，DNG 长期用于痛经患者具有良好的耐受性，且疼痛缓解效果可持续。
