Wiegratz I, Lee J H, Kutschera E, Bauer H H, von Hayn C, Moore C, Mellinger U, Winkler U H, Gross W, Kuhl H
Center of Obstetrics and Gynecology, University Hospital of Frankfurt, Frankfurt, Germany.
Contraception. 2002 Mar;65(3):223-9. doi: 10.1016/s0010-7824(01)00310-9.
In a double-blind, controlled, randomized, four-arm, bicentric clinical study, the effect of four oral contraceptives (OCs) on lipid metabolism was investigated. Four groups composed of 25 volunteers each (mean age 26.1 +/- 4.5 years; body mass index 21.9 +/- 2.8 kg/m(2)) were treated for six cycles with monophasic combinations containing 21 tablets with either 30 microg ethinyl estradiol (EE) + 2 mg dienogest (DNG) (30 EE/DNG), 20 microg EE + 2 mg DNG (20 EE/DNG), 10 microg EE + 2 mg estradiol valerate (EV) + 2 mg DNG (EE/EV/DNG), or 20 microg EE + 100 microg levonorgestrel (LNG; EE/LNG). The study was completed by 91 women. Blood samples were taken by venipuncture after at least 12 h fasting on Days 21-26 of the control cycle and Days 18-21 of the first, third, and sixth treatment cycle. There were clear differences between the effects of EE/LNG and the formulations containing estrogens and DNG. Although EE/LNG did not change the triglycerides levels, a significant increase was observed during treatment with the DNG-containing preparations. Although EE/LNG significantly reduced HDL-CH and HDL(2)-CH, there was a nonsignificant increase with the DNG-containing OCs. No change was observed in the levels of HDL(3)-CH. A significant rise in apolipoprotein A1 occurred during intake with the three DNG-containing formulations, but not with EE/LNG. In contrast to the women treated with combinations of estrogens and DNG, apolipoprotein B rose significantly in the women in the EE/LNG group. Lipoprotein (a) was significantly reduced by 30 EE/DNG and EE/LNG and remained unaltered with 20 EE/DNG and EE/EV/DNG. Altogether, the changes in lipid metabolism caused by the DNG-containing formulations appeared to be more favorable than those observed with EE/LNG. In OCs with DNG, the EE dose does not seem to play a major role with respect to the effect on lipids.
在一项双盲、对照、随机、四臂、双中心临床研究中，研究了四种口服避孕药（OCs）对脂质代谢的影响。四组，每组由25名志愿者组成（平均年龄26.1±4.5岁；体重指数21.9±2.8kg/m²），接受含21片的单相复方制剂治疗六个周期，其中分别含有30μg炔雌醇（EE）+2mg地诺孕素（DNG）（30EE/DNG）、20μg EE+2mg DNG（20EE/DNG）、10μg EE+2mg戊酸雌二醇（EV）+2mg DNG（EE/EV/DNG）或20μg EE+100μg左炔诺孕酮（LNG；EE/LNG）。91名女性完成了该研究。在对照周期的第21 - 26天以及第一个、第三个和第六个治疗周期的第18 - 21天，至少禁食12小时后通过静脉穿刺采集血样。EE/LNG与含雌激素和DNG的制剂的效果存在明显差异。虽然EE/LNG未改变甘油三酯水平，但含DNG制剂治疗期间甘油三酯水平显著升高。虽然EE/LNG显著降低了高密度脂蛋白胆固醇（HDL-CH）和高密度脂蛋白2胆固醇（HDL₂-CH），但含DNG的口服避孕药使其有不显著的升高。高密度脂蛋白3胆固醇（HDL₃-CH）水平未观察到变化。服用三种含DNG制剂期间载脂蛋白A1显著升高，但EE/LNG组未升高。与接受雌激素和DNG复方制剂治疗的女性相反，EE/LNG组女性的载脂蛋白B显著升高。脂蛋白（a）在30EE/DNG和EE/LNG组显著降低，而在20EE/DNG和EE/EV/DNG组保持不变。总体而言，含DNG制剂引起的脂质代谢变化似乎比EE/LNG观察到的更有利。在含DNG的口服避孕药中，EE剂量似乎对脂质的影响不起主要作用。
