屈螺酮炔雌醇片(Ⅱ)的临床应用现状与评价

Clinical Application and Evaluation of Drospirenone and Ethinylestradiol Tablets(Ⅱ)

屈螺酮炔雌醇片(Ⅱ)是一款包含3mg屈螺酮和20μg炔雌醇的低剂量口服复方避孕药,其给药方式采用独特的24+4模式,即24天活性药物连续给药加4天安慰剂使用。其中的屈螺酮为螺内酯的衍生物,药理活性和女性自身孕酮极为相似,此外还具有抗盐皮质激素和抗雄激素的作用。屈螺酮炔雌醇片(Ⅱ)在2014年被国家食品药品监督管理局批准在中国上市,商标名为优思悦?,用于女性避孕和希望使用口服避孕药进行避孕的女性的中度痤疮治疗。在其他国家,该药还可以用来改善经前情绪障碍(Premenstrual dysphoric disorder,PMDD)和缓解痛经。大量临床试验证实,优思悦?可以提供高效避孕,改善PMDD和痤疮,同时它还具有良好的耐受性,不良反应与其他复方口服避孕药类似,且多发生在最初使用期间。

Drospirenone and Ethinylestradiol Tablets(Ⅱ)(Yaz?,with Drospirenone3mg and ethinylestradiol20μg)is a low-dose combined oral contraceptive(COC)administered in a regimen of24/4day regimen(24days of active tablets followed by a4-day hormone-free interval).Drospirenone is a17α-spirolactone derivative and an analogue of17α-spironolactone that resembles endogenous progesterone and has antimineralocorticoid and anti-androgenic properties.YAZ?is approved in Chinain2014for the prevention of pregnancy in women,and for the treatment of moderate acne vulgaris in women who wish to use an oral contraceptive for contraception.In other countries,it can also be applied for the treatment of the symptoms of premenstrual dysphoric disorder(PMDD)and dysmenorrhea.Clinical trials indicate that YAZ?is a good long-term contraceptive option,and additionally offers relief of symptoms that characterize PMDD and has a favorable effect on moderate acne vulgarism.It was generally well tolerated,with adverse events generally typical of those experienced with other COCs and which were most likely to occur in the first few cycles.