一种含3毫克屈螺酮和20微克炔雌醇的低剂量复方口服避孕药在24/4天方案中的疗效和安全性。
Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen.
作者信息
Hernádi László, Marr Joachim, Trummer Dietmar, De Leo Vincenzo, Petraglia Felice
机构信息
Department of Obstetrics and Gynaecology, Markhot F. Heves County Hospital, Eger, Hungary.
出版信息
Contraception. 2009 Jul;80(1):18-24. doi: 10.1016/j.contraception.2009.01.016. Epub 2009 Mar 18.
OBJECTIVE
The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen).
STUDY DESIGN
In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m(2) received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies.
RESULTS
Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for 'perfect use' of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles.
CONCLUSION
Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.
目的
本研究旨在评估一种低剂量复方口服避孕药（COC）的疗效，该避孕药含3毫克屈螺酮（drsp）/20微克炔雌醇（EE），进行24天的积极治疗，随后是4天的无激素间隔期（24/4方案）。
研究设计
在欧洲50个中心进行的这项开放标签非对照研究中，18至35岁、体重指数小于30kg/m²的健康女性接受了13个周期的3毫克drsp/20微克EE 24/4方案治疗。主要疗效变量是意外怀孕的数量。
结果
在13248个治疗周期中的1101名女性中发生了5次怀孕，Pearl指数（PI）为0.49，双侧95%CI上限为1.14。在这些怀孕中，3次归因于未按规定服药，基于11755个周期，“完美使用”的调整后PI为0.22（双侧95%CI上限：0.80）。
结论
3毫克屈螺酮/20微克EE 24/4方案对于非肥胖女性是一种高效的复方口服避孕药。
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