Akerlund M, Røde A, Westergaard J
Student Gynaecology Clinic, Lund, Sweden.
Br J Obstet Gynaecol. 1993 Sep;100(9):832-8. doi: 10.1111/j.1471-0528.1993.tb14309.x.
To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile.
A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards.
University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark.
One thousand women aged 18 to 40 years requesting oral contraceptive pills.
Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin.
In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial.
Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.
比较两种口服避孕药，二者均含150微克去氧孕烯，但炔雌醇（EE）含量分别为20微克（美欣乐）或30微克（妈富隆/德索莱特），比较其可靠性、周期控制情况及副作用。
一项为期一年的双盲、随机、多中心研究，在3个月、6个月和12个月后进行随访。女性在专门设计的日记卡上记录服药情况和所有出血情况。
挪威、瑞典和丹麦的大学诊所、中心医院及私立妇科诊所。
1000名年龄在18至40岁之间、要求服用口服避孕药的女性。
可靠性、周期控制、副作用、血压、体重和血红蛋白。
在服用20微克EE剂量避孕药的4543个周期和服用30微克EE剂量避孕药的4688个周期中，因方法失败导致的妊娠数分别为0例和2例。在研究的一年中随机分布的约三分之二周期里，150/20组合的不规则出血（突破性出血或点滴出血）明显更频繁。平均血压略有下降，尤其是150/20组合组（约1 mmHg），而150/30组合组在12个月后平均体重增加约0.5 kg。血红蛋白未发生变化。除出血问题外的副作用很少见，但150/20组合组的头晕和情绪变化更频繁。由于副作用，150/20组合组更多女性在1至3个月和4至6个月期间退出研究，且该组女性在试验结束时对继续服用研究药物的积极性也较低。
两种避孕药都具有较高的避孕可靠性且耐受性良好，但150/20组合的周期控制效果较差。然而，鉴于150/20组合可能具有更高的安全性，预计许多女性会接受因不规则出血带来的一些额外不适。
