Center of Obstetrics and Gynecology, University Hospital of Frankfurt, Germany.
Contraception. 2011 Aug;84(2):133-43. doi: 10.1016/j.contraception.2011.01.002. Epub 2011 Feb 21.
The present study compared the efficacy and safety of a combined oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest (EE/DNG) in conventional and extended-cycle regimen over 1 year of treatment.
In a phase III, randomized, prospective, open, two-arm, multicenter study, 1315 sexually active women (range, 18-40 years) were treated with EE/DNG either conventionally (21/7 days) or according to an extended-cycle regimen (84/7 days). Data were documented on volunteer diaries, and adverse events (AEs) were reported during five visits.
In the extended-regimen group, the total number of days with bleeding progressively decreased over time, and overall, the volunteers had fewer numbers of days with bleeding/spotting compared to those treated conventionally. Intracyclic bleeding, on the other hand, was more frequent in the extended-cycle group, although its frequency considerably decreased over time. Both regimens offered reliable contraception, with an unadjusted Pearl Index of 0.489 for the conventional regimen and 0.495 for the extended regimen. The number of AEs was higher in the extended-cycle group, although the group differences tended to decrease over time.
Extended-cycle use of EE/DNG was effective and mostly well tolerated, appearing to be a favorable option for women who need or wish to omit the pill-free interval.
本研究比较了含 30μg 炔雌醇和 2mg 地诺孕素的复方口服避孕药在常规和延长周期方案下治疗 1 年的疗效和安全性。
在一项为期 3 期、随机、前瞻性、开放、双臂、多中心研究中，1315 名有性生活的女性（年龄 18-40 岁）接受了炔雌醇/地诺孕素的治疗，方案分别为常规（21/7 天）或延长周期（84/7 天）。数据记录在志愿者日记中，在 5 次就诊期间报告不良事件（AE）。
在延长周期组中，总的出血天数随着时间的推移逐渐减少，与常规治疗组相比，志愿者的出血/点滴天数总体上更少。另一方面，尽管其频率随着时间的推移而显著降低，但延长周期组的周期内出血更为频繁。两种方案均提供了可靠的避孕效果，常规方案的未调整 Pearl 指数为 0.489，延长周期方案为 0.495。延长周期组的不良事件数量较高，但组间差异随着时间的推移趋于减少。
炔雌醇/地诺孕素的延长周期使用是有效且大多耐受良好的，似乎是需要或希望省略无药物间隔期的女性的一个有利选择。
