van Vloten Willem A, van Haselen Christian W, van Zuuren Esther J, Gerlinger Christoph, Heithecker Renate
Department of Dermatology, University Medical Center Utrecht, Netherlands.
Cutis. 2002 Apr;69(4 Suppl):2-15.
A new oral contraceptive has been developed that contains a unique progestogen, drospirenone (DRSP), and that has both antiandrogenic and antimineralocorticoid activity. Our objective was to compare the effect of 30 microg ethinyl estradiol (EE)/3 mg DRSP (EE/DRSP; Yasmin, Schering AG, Berlin, Germany) with that of 35 microg EE/2 mg cyproterone acetate (EE/CPA; Diane-35, Schering AG, Berlin, Germany) on mild-to-moderate cases of acne. Diane-35 is used worldwide (it is not on the market in the United States and Japan) as a hormone treatment for acne, with additional contraceptive benefits. This multicenter, double-blind, randomized study was completed over 9 treatment cycles. A total of 128 women with mild-to-moderate facial acne, with or without seborrhea and/or hirsutism, were randomized. Treatment with either EE/DRSP or EE/CPA was assigned in a 2:1 ratio. Acne lesions, sebum production, and hair growth on the upper lip, chin, and chest were assessed, as well as levels of total and free testosterone, androstenedione, dehydroepiandrosterone sulfate (DHEAS), sex hormone-binding globulin (SHBG), and luteinizing hormone (LH). At study completion, dermatologists, gynecologists, and subjects gave their overall assessment of the effect of treatment on acne. After 9 treatment cycles, the median total acne lesion count was reduced markedly by 62.5% in the EE/DRSP group and 58.8% in the EE/CPA group. A comparison of the 2 groups revealed that EE/DRSP was at least as effective as EE/CPA. Both preparations also reduced sebum production and hair growth on the upper lip and chin. A 3-fold increase in the levels of SHBG was observed in both treatment groups, and levels of androgens and LH decreased. Treatment differences were not seen. Subjective evaluation of the effect of treatment on facial acne by dermatologists, gynecologists, and the subjects themselves indicated an excellent or good improvement for most subjects in both groups. EE/DRSP has been shown to be as effective for treating mild-to-moderate acne as a preparation containing EE/CPA. This new preparation may provide useful hormone therapy for women with androgen-dependent disorders who also require contraception.
一种新型口服避孕药已研发出来,其含有独特的孕激素屈螺酮(DRSP),具有抗雄激素和抗盐皮质激素活性。我们的目的是比较30微克炔雌醇(EE)/3毫克屈螺酮(EE/DRSP;优思明,先灵葆雅公司,德国柏林)与35微克EE/2毫克醋酸环丙孕酮(EE/CPA;达英-35,先灵葆雅公司,德国柏林)对轻至中度痤疮病例的疗效。达英-35在全球范围内(在美国和日本未上市)用作痤疮的激素治疗药物,还具有额外的避孕益处。这项多中心、双盲、随机研究历经9个治疗周期完成。共有128名患有轻至中度面部痤疮、伴有或不伴有皮脂溢和/或多毛症的女性被随机分组。EE/DRSP或EE/CPA治疗的分配比例为2:1。评估了痤疮皮损、皮脂分泌以及上唇、下巴和胸部的毛发生长情况,还检测了总睾酮、游离睾酮、雄烯二酮、硫酸脱氢表雄酮(DHEAS)、性激素结合球蛋白(SHBG)和促黄体生成素(LH)的水平。研究结束时,皮肤科医生、妇科医生和受试者对治疗痤疮的效果给出了总体评价。经过9个治疗周期后,EE/DRSP组的痤疮皮损总数中位数显著减少了62.5%,EE/CPA组减少了58.8%。两组比较显示,EE/DRSP的疗效至少与EE/CPA相当。两种制剂还都减少了上唇和下巴的皮脂分泌和毛发生长。两个治疗组的SHBG水平均升高了3倍,雄激素和LH水平下降。未观察到治疗差异。皮肤科医生、妇科医生以及受试者本人对面部痤疮治疗效果的主观评价表明,两组中的大多数受试者都有显著或良好的改善。已证明EE/DRSP治疗轻至中度痤疮的效果与含EE/CPA的制剂相当。这种新制剂可能为患有雄激素依赖性疾病且需要避孕的女性提供有用的激素治疗。