Weinges K F, Wenzel E, Hellstern P, Geurts T B, Dieben T O
Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany.
Adv Contracept. 1995 Sep;11(3):227-37. doi: 10.1007/BF01978423.
To compare the effects on hemostatic parameters of a combiphasic oral contraceptive containing desogestrel and ethinyl estradiol (DSG/EE) and a triphasic oral contraceptive containing levonorgestrel and ethinyl estradiol (LNG/EE).
In an open-label, randomized, group-comparative study in 10 healthy volunteers per treatment group, the effects on parameters of coagulation, anticoagulation, fibrinolysis, antifibrinolysis and platelet function were determined at baseline, after three treatment cycles, and after a post-treatment cycle. Changes from baseline were analyzed using a paired t-test, whereas between-group differences were analyzed by means of an analysis of co-variance.
Both OC preparations induced modest changes of some coagulation, anticoagulation, fibrinolysis and antifibrinolysis parameters, although all mean values remained within the normal range. No significant effects were observed with either OC with respect to platelet function. Statistically significant differences between the two preparations could occasionally e observed: the concentrations of antithrombin II (AT-III) and Factor VII were higher with the DSG/EE preparation than with LNG/EE preparation at the end of treatment and AT-III activity, AT-III concentration, Factor X concentration, and plasminogen activity were higher with DSG/EE than with LNG/EE in the post-treatment cycle.
Combiphasic DSG/EE and triphasic LNG/EE, both OCs with a comparable amount of EE per cycle, had no clinically significant effect on the overall hemostatic balance.
比较含去氧孕烯和炔雌醇的双相口服避孕药(DSG/EE)与含左炔诺孕酮和炔雌醇的三相口服避孕药(LNG/EE)对止血参数的影响。
在一项开放标签、随机分组对照研究中,每个治疗组有10名健康志愿者,分别在基线期、三个治疗周期后以及治疗后周期测定凝血、抗凝、纤维蛋白溶解、抗纤维蛋白溶解和血小板功能参数的影响。使用配对t检验分析与基线的变化,而组间差异通过协方差分析。
两种口服避孕药制剂均引起了一些凝血、抗凝、纤维蛋白溶解和抗纤维蛋白溶解参数的适度变化,尽管所有平均值仍在正常范围内。两种口服避孕药对血小板功能均未观察到显著影响。两种制剂之间偶尔可观察到统计学上的显著差异:治疗结束时,DSG/EE制剂的抗凝血酶II(AT-III)和因子VII浓度高于LNG/EE制剂,且在治疗后周期中,DSG/EE的AT-III活性、AT-III浓度、因子X浓度和纤溶酶原活性均高于LNG/EE。
双相DSG/EE和三相LNG/EE这两种每个周期炔雌醇含量相当的口服避孕药,对整体止血平衡均无临床显著影响。