Foidart J M, Wuttke W, Bouw G M, Gerlinger C, Heithecker R
Department of Gynecology and Obstetrics, University of Liège, Belgium.
Eur J Contracept Reprod Health Care. 2000 Jun;5(2):124-34. doi: 10.1080/13625180008500387.
To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral contraceptive (Yasmin) containing 30 microg ethinylestradiol and 3 mg drospirenone and compare it with a preparation containing an equal dose of ethinylestradiol combined with 150 microg desogestrel (Marvelon).
A multicenter, open-label, randomized study was carried out in 26 European centers. Contraceptive efficacy, cycle control and tolerance (including body weight, blood pressure and heart rate) were assessed over 26 cycles, plus a 3-month follow-up period.
Of 900 women who were randomized, 887 started treatment and 627 completed the 26 cycles plus follow-up (310 in the ethinylestradiol/drospirenone group and 317 in the ethinylestradiol/desogestrel group). Both study preparations were found to be effective with regard to contraceptive reliability and cycle control was good. There were six pregnancies (three in each group), but none were considered to have been the result of method failures. The subjective and objective tolerances were good in both groups. A statistically significant difference was found in body weight changes between the two groups. While there was an increase in mean body weight in the ethinylestradiol/desogestrel group from cycle 5 onward, the mean body weight per cycle in the ethinylestradiol/drospirenone group was slightly below the baseline value throughout the study. The incidence ofpremenstrual symptoms was higher in the ethinylestradiol/drospirenone group than in the ethinylestradiol/desogestrel group during the 6 months prior to the study, but lower during treatment. The rates ofdysmenorrhea were identical under both treatments but the symptoms were more often mild and less often severe in the ethinylestradiol/drospirenone group.
The combination of 30 microg ethinylestradiol combined with 3 mg drospirenone provides effective oral contraception and good cycle control, and is well tolerated. Ethinylestradiol/drospirenone had a more favorable effect on body weight than ethinylestradiol/desogestrel, with the mean body weight remaining lower than baseline for the majority of the women.
评估一种含有30微克炔雌醇和3毫克屈螺酮的新型单相口服避孕药（优思明）的避孕可靠性、周期控制情况及耐受性，并与一种含有等量炔雌醇及150微克去氧孕烯的制剂（妈富隆）进行比较。
在欧洲26个中心开展了一项多中心、开放标签、随机研究。在26个周期外加3个月的随访期内评估避孕效果、周期控制情况及耐受性（包括体重、血压和心率）。
在900名随机分组的女性中，887名开始治疗，627名完成了26个周期加随访（炔雌醇/屈螺酮组310名，炔雌醇/去氧孕烯组317名）。两种研究制剂在避孕可靠性方面均有效，周期控制良好。共有6例妊娠（每组3例），但均不认为是方法失败所致。两组的主观和客观耐受性均良好。两组间体重变化存在统计学显著差异。炔雌醇/去氧孕烯组从第5周期起平均体重增加，而炔雌醇/屈螺酮组在整个研究期间每个周期的平均体重略低于基线值。在研究前6个月，炔雌醇/屈螺酮组经前症状的发生率高于炔雌醇/去氧孕烯组，但在治疗期间较低。两种治疗下痛经发生率相同，但炔雌醇/屈螺酮组症状多为轻度，重度较少。
30微克炔雌醇与3毫克屈螺酮的组合提供了有效的口服避孕效果及良好的周期控制，且耐受性良好。与炔雌醇/去氧孕烯相比，炔雌醇/屈螺酮对体重的影响更有利，大多数女性的平均体重保持低于基线水平。
