Wang Lu, Guan Hai-Yun, Xia He-Xia, Chen Xiu-Ying, Zhang Wei
Department of Reproductive Endocrinology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China.
World J Clin Cases. 2020 Aug 6;8(15):3259-3266. doi: 10.12998/wjcc.v8.i15.3259.
Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding - ovulation dysfunction (AUB-O), but there were few relevant studies. This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O.
To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O.
A prospective, non-interventional, single-arm, post-marketing observational study was conducted. Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled. The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle, consecutively for at least 3 cycles. The main outcome was defined as the percentage of patients whose MCs returned to normal (defined as 21 d < menstrual cycle ≤ 35 d) after three cycles of dydrogesterone treatment.
One hundred and fourteen women with AUB-O were enrolled in the present study. Of 89 patients who completed treatment, 72 (80.9%) achieved a regular MC at the end of the 3 circle. The level of androgen, including testosterone and dehydroepiandrosterone sulfate, declined significantly ( = 0.01 and 0.031, respectively), whereas other hormone levels remained steady. During the treatment, 44/80 (55.0%) subjects in the per-protocol set had reported biphasic basal body temperature.
Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.
地屈孕酮在治疗因异常子宫出血 - 排卵功能障碍（AUB - O）导致的月经周期不规律方面已显示出显著疗效，但相关研究较少。本观察性研究旨在评估地屈孕酮治疗中国AUB - O患者的有效性。
评估地屈孕酮对AUB - O患者月经周期（MC）规律化及代谢的影响。
进行了一项前瞻性、非干预性、单臂、上市后观察性研究。纳入年龄在16岁及以上、因AUB - O而被处方地屈孕酮的中国女性。患者在每个周期的第16天至第25天接受10 mg地屈孕酮治疗，连续至少3个周期。主要结局定义为经过3个周期地屈孕酮治疗后MC恢复正常（定义为21天＜月经周期≤35天）的患者百分比。
本研究共纳入114例AUB - O女性患者。在89例完成治疗的患者中，72例（80.9%）在第3个周期结束时月经周期恢复正常。雄激素水平，包括睾酮和硫酸脱氢表雄酮，显著下降（分别为 = 0.01和0.031），而其他激素水平保持稳定。在治疗期间，符合方案集的80例受试者中有44例（55.0%）报告基础体温呈双相型。
地屈孕酮治疗对中国AUB - O患者实现月经周期规律化有效。
