Bonassi Machado Rogerio, Pompei Luciano de Melo, Andrade Rosires, Nahas Eliana, Guazzelli Cristina, Wender Maria Celeste, Cruz Achilles Machado
Department of Gynecology and Obstetrics, Jundiaí School of Medicine, Jundiaí, São Paulo 13202-550, Brazil.
Department of Gynecology and Obstetrics, ABC School of Medicine, Santo André, São Paulo 09060-650, Brazil.
Int J Womens Health. 2020 Mar 30;12:235-242. doi: 10.2147/IJWH.S238294. eCollection 2020.
To compare the bleeding pattern in women using ethinylestradiol 20 mcg/drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI).
This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSP group) or a 24/4-day cyclic regimen (EE/DRSP group) and followed for 168 days. In the EE/DRSP group, a 4-day HFI was allowed whenever unexpected bleeding/spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as "no bleeding," "spotting," or "light," "moderate," or "heavy" bleeding according to a predefined scale.
EE/DRSP group experienced fewer days of bleeding than those using a 24/4 cyclic regimen ( < 0.001). After 168 days, 57.5% of women in the EE/DRSP group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved "no bleeding" (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting.
The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and "no bleeding". Unexpected bleeding/spotting in the EE/DRSP group could be managed effectively with a 4-day HFI.
International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.
比较采用24/4天周期方案使用炔雌醇20微克/屈螺酮3毫克（EE 20微克/DRSP 3毫克）的女性与采用延长方案的女性的出血模式。延长方案组中意外出血/点滴出血的情况通过给予4天无激素间隔期（HFI）来处理。
这是一项随机、前瞻性、开放标签、多中心研究。参与者（N = 348）被随机分配接受EE 20微克/DRSP 3毫克，采用延长方案（EE/DRSP组）或24/4天周期方案（EE/DRSP组），并随访168天。在EE/DRSP组中，每当意外出血/点滴出血持续≥7天时，给予4天HFI。参与者根据预定义的量表每天将其出血情况评估为“无出血”“点滴出血”或“少量”“中度”或“大量”出血。
EE/DRSP组的出血天数少于采用24/4天周期方案的组（<0.001）。168天后，EE/DRSP组中57.5%的女性在研究期的最后28天间隔内实现了完全闭经（即既无出血也无点滴出血），73.9%的女性实现了“无出血”（即无论有无点滴出血均无出血）。采用4天HFI的延长组女性中，意外出血/点滴出血的成功处理率为94.1%。
采用延长方案使用EE 20微克/DRSP 3毫克导致闭经和“无出血”的发生率较高。EE/DRSP组中的意外出血/点滴出血可通过4天HFI有效处理。
国际标准随机对照试验编号（ISRCTN57661673）：http://www.controlled-trials.com/isrctn/pf/57661673 。
