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首页> 外文期刊>The European journal of contraception & reproductive health care: the official journal of the European Society of Contraception >Multinational, multicentre, randomised, open-label study evaluating the impact of a 91-day extended regimen combined oral contraceptive, compared with two 28-day traditional combined oral contraceptives, on haemostatic parameters in healthy women
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Multinational, multicentre, randomised, open-label study evaluating the impact of a 91-day extended regimen combined oral contraceptive, compared with two 28-day traditional combined oral contraceptives, on haemostatic parameters in healthy women

机译：一项多国，多中心，随机，开放标签研究，评估了91天延长方案联合两种口服避孕药与两种28天传统联合口服避孕药对健康女性止血参数的影响

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Objectives To evaluate the impact of a 91-day extended regimen combined oral contraceptive (150 μg levonorgestrel [LNG]/30 μg ethinylestradiol [EE] for 84 days, followed by 10 μg EE for seven days [Treatment 1]) compared with two traditional 21/7 regimens (21 days 150 μg LNG/30 μg EE [Treatment 2] or 150 μg desogestrel [DSG]/30 μg EE [Treatment 3], both with seven days' hormone free), on several coagulation factors and thrombin formation markers. Methods Randomised, open-label, parallel-group comparative study involving healthy women (18-40 years). The primary endpoint was change from baseline in prothrombin fragment 1 + 2 (F1 + 2) levels over six months. Results A total of 187 subjects were included in the primary analysis. In all groups, mean F1 + 2 values were elevated after six months of treatment. Changes were comparable between Treatments 1 and 2 (least squares mean change: 170 pmol/L and 158 pmol/L, respectively) but noticeably larger after Treatment 3 (least squares mean change: 592 pmol/L). The haemostatic effects of Treatment 1 were comparable to those of Treatment 2 and noninferior to those of Treatment 3 (lower limit of 95% confidence interval [- 18.3 pmol/L] > - 130 pmol/L). Conclusions The LNG/EE regimens had similar effects on F1 + 2. Noninferiority was demonstrated between extended regimen LNG/EE and DSG/EE.
机译：目的评价与传统的两种传统药物相比，延长91天联合口服避孕药（150μg左炔诺孕酮[LNG] / 30μg炔雌醇[EE]持续84天，然后10μgEE持续7天[治疗1]）的影响21/7疗程（21天150μgLNG / 30μgEE [治疗2]或150μg去氧孕烯[DSG] / 30μgEE [治疗3]，均不含7天激素），涉及多种凝血因子和凝血酶形成标记。方法涉及健康女性（18-40岁）的随机，开放标签，平行分组的比较研究。主要终点是六个月以来凝血酶原片段1 + 2（F1 + 2）水平相对于基线的变化。结果初步分析共纳入187名受试者。在所有组中，治疗六个月后平均F1 + 2值升高。在处理1和处理2之间的变化相当（最小二乘平均变化：分别为170 pmol / L和158 pmol / L），但是在处理3之后显着增大（最小二乘平均变化：592 pmol / L）。治疗1的止血效果与治疗2相当，且不逊于治疗3（95％置信区间下限[-18.3 pmol / L]>-130 pmol / L）。结论LNG / EE方案对F1 + 2的作用相似。延长方案LNG / EE和DSG / EE之间表现出非劣效性。

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