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首页> 外文期刊>Contraception >An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables.
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An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables.

机译：一项开放性的比较研究，研究了一种口服避孕药，该口服避孕药含有0.02 mg炔雌醇/ 2 mg醋酸氯麦定，对止血参数以及脂质和碳水化合物代谢变量的影响。

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OBJECTIVE: The study was conducted to compare the effects of 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), given for 24 days each cycle, with those of 0.02 mg EE/0.15 mg desogestrel (DSG) and 0.03 mg EE/0.15 mg levonorgestrel (LNG), given for 21 days each cycle, on hemostatic, lipid, and carbohydrate metabolism parameters in healthy subjects, over six medication cycles. STUDY DESIGN: A randomized, multicentre, open-label, Phase II trial measured markers of hemostasis, and of lipid and carbohydrate metabolism in 165 subjects randomly assigned to treatment with one of three combined oral contraceptives (COCs). RESULTS: EE/CMA and EE/DSG had a similar effect on hemostatic parameters, the EE/LNG group showed comparatively smaller increases in the activity of factor VII [8.1% vs. 36.6% (EE/CMA) and 28.2% (EE/DSG)], protein C [5.9% vs. 32.9% (EE/CMA) and 21% (EE/DSG)] and endogenous thrombin potential-based activated protein C resistance [44.1% vs. 93.5% (EE/CMA) and 108.1% (EE/DSG)], and in contrast, free protein S levels decreased in the EE/CMA and EE/DSG groups (-12.7% and -4.3%, respectively) but rose in the EE/LNG group (20.4%). In all treatments, total cholesterol, total triglyceride and apolipoproteins increased. Levels of very low-density lipoprotein cholesterol particularly rose across all groups. Slight increases in high-density lipoprotein (HDL) cholesterol were observed for EE/CMA (14.6%) and EE/DSG (8.5%), with a rise above the upper limit of normal in 30% of the subjects taking EE/CMA. Conversely, for EE/LNG slight decreases in HDL cholesterol were observed (-12.4%) lipoprotein (a) levels decreased in the EE/CMA (-6.6%) and EE/LNG (-16.9%) groups and were unchanged in the EE/DSG group. CONCLUSIONS: The changes observed were typical of those seen across low-dose COCs that differ according to commonly-used progestogens.
机译：目的：本研究旨在比较0.02 mg乙炔雌二醇（EE）/ 2 mg醋酸氯马酮（CMA）（每个周期24天）与0.02 mg EE / 0.15 mg去氧孕烯（DSG）和0.03 mg EE的影响/ 0.15 mg左炔诺孕酮（LNG），在六个疗程中，在健康受试者中每个周期给予21天，用于研究健康受试者的止血，脂质和碳水化合物代谢参数。研究设计：一项随机，多中心，开放标签的II期临床试验在165名随机分配接受三种联合口服避孕药（COC）之一治疗的受试者中测量了止血，脂质和碳水化合物代谢的指标。结果：EE / CMA和EE / DSG对止血参数的作用相似，EE / LNG组的VII因子活性增加相对较小[8.1％比36.6％（EE / CMA）和28.2％（EE / DSG），蛋白C [5.9％vs. 32.9％（EE / CMA）和21％（EE / DSG）]和内源性凝血酶电位激活蛋白C抗性[44.1％vs. 93.5％（EE / CMA）和108.1％（EE / DSG）]，相比之下，EE / CMA和EE / DSG组的游离蛋白S水平下降（分别为-12.7％和-4.3％），但在EE / LNG组中上升（20.4％） ）。在所有治疗中，总胆固醇，总甘油三酸酯和载脂蛋白增加。在所有组中，极低密度脂蛋白胆固醇的水平特别上升。 EE / CMA（14.6％）和EE / DSG（8.5％）的高密度脂蛋白（HDL）胆固醇略有增加，服用EE / CMA的受试者中有30％的升高高于正常上限。相反，对于EE / LNG，HDL胆固醇略有下降（-12.4％），EE / CMA（-6.6％）和EE / LNG（-16.9％）组的脂蛋白（a）水平下降，而在EE中未发生变化/ DSG组。结论：观察到的变化是典型的低剂量COC的变化，这些变化根据常用的孕激素而有所不同。

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