Cullberg G, Samsioe G, Andersen R F, Bredesgaard P, Andersen N B, Ernerot H, Fanøe E, Fylling P, Haack-Sørensen P E, Klottrup P, Pedersen J H, Sandager T
Contraception. 1982 Sep;26(3):229-43. doi: 10.1016/0010-7824(82)90072-5.
A triphasic, combined oral contraceptive containing 30 - 40 - 30 micrograms ethinyloestradiol (EE), and 50 - 75 - 125 micrograms levonorgestrel was compared with a fixed dose combination containing 30 micrograms EE and 150 micrograms desogestrel in a randomized multicentre trial in 193/199 women and 1 063/1 073 cycles, respectively. The duration of the trial was six months. Eleven centres in Denmark, Sweden, and Norway participated. Contraceptive reliability, bleeding control and side effects were evaluated. Influence on serum sex hormone binding globulin (SHBG) and transcortin was assayed as well as lipid metabolism. Three pregnancies occurred in the group using the triphasic regimen but none in the fixed dose regimen. Two of the three pregnancies were considered drug failures and the third a possible interaction. Possible reasons for the triphasic contraceptive failure are discussed with special reference to a British report on eight pregnancies. Bleeding control appeared to be equally good for the two preparations. However, the number of cycles with spotting, breakthrough bleeding and missed withdrawal bleeding were above the levels reported earlier on the triphasic regimen. About 80 per cent of the women completed the planned six months on either combination. Side effects were generally mild and in accordance with earlier reports on low dose oral contraceptives. Metabolically the triphasic levonorgestrel combination increased SHBG 100 per cent versus 200 per cent for the fixed desogestrel combination. Transcortin rose about 98 and 110 per cent, respectively. Both preparations induced similar changes in the levels of lipids and lipoproteins with the exception of a significant increase in the arachidonic content of cholesterol during treatment with the desogestrel-containing preparation.
在一项随机多中心试验中，将一种含30 - 40 - 30微克炔雌醇（EE）和50 - 75 - 125微克左炔诺孕酮的三相复方口服避孕药，分别与一种含30微克EE和150微克去氧孕烯的固定剂量复方避孕药进行了比较，受试女性分别为193/199名和1063/1073个周期。试验持续时间为6个月。丹麦、瑞典和挪威的11个中心参与了试验。评估了避孕可靠性、出血控制情况和副作用。还测定了对血清性激素结合球蛋白（SHBG）和皮质素转运蛋白的影响以及脂质代谢情况。使用三相方案的组中有3例妊娠，而固定剂量方案组中无妊娠发生。3例妊娠中有2例被认为是药物失效，第3例可能是相互作用所致。结合一份关于8例妊娠的英国报告，讨论了三相避孕药失败的可能原因。两种制剂的出血控制情况似乎同样良好。然而，有点滴出血、突破性出血和漏服撤退性出血的周期数高于此前报道的三相方案水平。约80%的女性完成了任一复方避孕药的计划6个月疗程。副作用一般较轻，与此前关于低剂量口服避孕药的报告一致。在代谢方面，三相左炔诺孕酮复方使SHBG升高了100%，而去氧孕烯固定复方使SHBG升高了200%。皮质素转运蛋白分别升高了约98%和110%。两种制剂在脂质和脂蛋白水平上引起了相似的变化，但在使用含去氧孕烯制剂治疗期间，胆固醇的花生四烯酸含量显著增加。
