Prescrire Int. 2010 Apr;19(106):65-7.
A monophasic combination of ethinylestradiol plus levonorgestrel or norethisterone is the oral contraceptive with which we have most experience. A quadriphasic combination of estradiol and dienogest was recently authorised in various European Union member states. The results of two non-comparative trials and one comparative trial versus ethinylestradiol + levonorgestrel suggest that the contraceptive efficacy of the estradiol + dienogest combination is no better than that of other oral contraceptives. In addition, there is no tangible difference in regulation of the menstrual cycle compared to the ethinylestradiol + levonorgestrel combination, as assessed by bleeding during and after dosing. The estradiol + dienogest combination has the same frequent and mild adverse effects as other combined contraceptives, such as nausea, breast tenderness and headache. In contrast, little is known of the potential cardiovascular adverse effects of the new combination, including the risk of thrombosis. Use of this quadriphasic combination is inconvenient. The monthly blister pack contains 5 different tablets, with different compositions, that must be taken in exactly the right order. In addition, a woman must follow complicated directions for catching up if she misses a pill, and they differ throughout the cycle. In practice, it is better to continue to use a well-documented combined contraceptive such as the monophasic ethinylestradiol + levonorgestrel combination.
炔雌醇与左炔诺孕酮或炔诺酮的单相复方制剂是我们最常用的口服避孕药。雌二醇与地诺孕素的四相复方制剂最近在欧盟多个成员国获批。两项非对照试验以及一项与炔雌醇 + 左炔诺孕酮对比的对照试验结果表明,雌二醇 + 地诺孕素复方制剂的避孕效果并不优于其他口服避孕药。此外,根据给药期间及之后的出血情况评估,与炔雌醇 + 左炔诺孕酮复方制剂相比,其在调节月经周期方面并无明显差异。雌二醇 + 地诺孕素复方制剂与其他复方避孕药具有相同的常见轻微不良反应,如恶心、乳房胀痛和头痛。相比之下,对于这种新复方制剂潜在的心血管不良反应,包括血栓形成风险,人们知之甚少。使用这种四相复方制剂不太方便。每月的泡罩包装包含5种不同成分的片剂,必须按正确顺序服用。此外,如果女性漏服了药物,必须遵循复杂的补服说明,而且在整个周期中这些说明有所不同。实际上,继续使用像单相炔雌醇 + 左炔诺孕酮复方制剂这样有充分记录的复方避孕药会更好。