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去氧孕烯炔雌醇、醋酸环丙孕酮和屈螺酮复方口服避孕药治疗多囊卵巢综合征的疗效比较研究。

Comparative study of the therapeutic effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone in patients with polycystic ovary syndrome.

机构信息

Department of Obstetrics and Gynaecology, SC Das Memorial Medical and Research Center, Jodhpur Park, Kolkata, India.

出版信息

Fertil Steril. 2012 Oct;98(4):1053-9. doi: 10.1016/j.fertnstert.2012.06.035. Epub 2012 Jul 13.

DOI:10.1016/j.fertnstert.2012.06.035
PMID:22795636
Abstract

OBJECTIVE

To compare the effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone, in polycystic ovary syndrome (PCOS), after 6 and 12 months of therapy.

DESIGN

Double-blind randomized controlled trial.

SETTING

Gynecologic clinic of the first author.

PATIENT(S): Women (n = 171) with PCOS (Androgen Excess Society criteria, 2006).

INTERVENTION(S): The three-arm trial involved 58, 56, and 57 cases in desogestrel, cyproterone acetate, and drospirenone groups, respectively. Body mass index, abdominal circumference, hirsutism score (modified Ferriman Galwey), acne and acanthosis nigricans scores, and blood pressure were noted. Blood levels of total T, sex hormone-binding globulin, fasting glucose, and fasting insulin were measured. Free androgen index, glucose-insulin ratio, and homeostasis model assessment-insulin resistance were calculated. Follow-up was after 6 and 12 months of treatment.

MAIN OUTCOME MEASURE(S): Primarily, absolute change in the Free Androgen Index score between the three groups and, secondarily, changes in the clinical and other hormonal and biochemical parameters were studied.

RESULT(S): Six months of treatment showed similar effects. After 12 months, cyproterone acetate significantly decreased the modified Ferriman Galwey score (change = -5.29) compared with both desogestrel (change = -1.69) and drospirenone (change = -2.12); cyproterone acetate significantly increased sex hormone-binding globulin (change = 142.91) compared with desogestrel (change = 99.53); drospirenone significantly increased sex hormone-binding globulin (change = 131.52) compared with desogestrel; and cyproterone acetate significantly decreased the Free Androgen Index (change = -10.57) compared with desogestrel (change = -5.58).

CONCLUSION(S): No difference in effects after 6 months. At 12 months, cyproterone acetate showed the strongest antiandrogen activities. Effects on metabolic parameters were identical.

CLINICAL TRIAL REGISTRATION NUMBER

CTRI/2010/091/000332.

摘要

目的

比较屈螺酮炔雌醇、醋酸环丙孕酮和drospirenone 三种口服避孕药治疗多囊卵巢综合征(PCOS)的效果,分别在治疗 6 个月和 12 个月时进行评估。

设计

双盲随机对照试验。

地点

第一作者所在妇科诊所。

患者

符合雄激素过多协会标准(2006 年)的 171 名 PCOS 患者。

干预

三组试验中,屈螺酮炔雌醇组、醋酸环丙孕酮组和 drospirenone 组分别有 58、56 和 57 例患者。观察体重指数、腰围、多毛症评分(改良 Ferriman-Galwey 评分)、痤疮和黑棘皮病评分以及血压。检测总 T、性激素结合球蛋白、空腹血糖和空腹胰岛素水平。计算游离雄激素指数、血糖-胰岛素比值和稳态模型评估-胰岛素抵抗。随访时间为治疗后 6 个月和 12 个月。

主要观察指标

主要观察三组间游离雄激素指数评分的绝对变化,次要观察临床和其他激素及生化参数的变化。

结果

治疗 6 个月时三组的效果相似。治疗 12 个月时,与屈螺酮炔雌醇组(变化= -1.69)和 drospirenone 组(变化= -2.12)相比,醋酸环丙孕酮组显著降低改良 Ferriman-Galwey 评分(变化=-5.29);与屈螺酮炔雌醇组(变化=99.53)相比,醋酸环丙孕酮组显著增加性激素结合球蛋白(变化=142.91);与屈螺酮炔雌醇组相比,drospirenone 组显著增加性激素结合球蛋白(变化=131.52);与屈螺酮炔雌醇组相比,醋酸环丙孕酮组显著降低游离雄激素指数(变化=-10.57)。

结论

治疗 6 个月时三组效果无差异。治疗 12 个月时,醋酸环丙孕酮显示出最强的抗雄激素活性。对代谢参数的影响相同。

临床试验注册号

CTRI/2010/091/000332。

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