Prelević G M, Würzburger M I, Balint-Perić L, Puzigaća Z
Endocrinology Department, Zvezdara University Medical Centre, Belgrade University School of Medicine, Yugoslavia.
Gynecol Endocrinol. 1989 Dec;3(4):269-80. doi: 10.3109/09513598909152466.
This study evaluates the effect of an oral contraceptive containing 35 micrograms of ethinyl estradiol and 2 mg of cyproterone acetate (Diane-35) on hormone dynamics, clinical signs of androgenization and ovarian size in patients with polycystic ovary syndrome (PCOS). Forty-six patients with PCOS were treated with Diane-35 for between 9 and 30 cycles without interruption (a total of 688 cycles). Clinical and hormonal evaluations were performed before treatment and every 3rd cycle during the treatment period while ultrasonographic assessment of ovaries was carried out every 6th cycle. A highly significant decrease in the LH/FSH ratio (p less than 0.001) as well as testosterone levels (p less than 0.001) was noticed after the 3rd cycle of Diane-35 administration. The mean serum androstenedione level decreased significantly (p less than 0.025) after the 3rd cycle, and showed a lowering trend thereafter. A significant reduction in serum DHEA-S levels was observed after the 6th cycle of treatment and they also showed a subsequent lowering trend. A highly significant increase in SHBG concentrations (p less than 0.001) was noticed after the 3rd cycle. Most of the patients noticed improvement in hirsutism between the 8th and 12th cycles of treatment. Mean ovarian size decreased significantly (p less than 0.001) after the 6th cycle, the normal size being reached after the 12th cycle of treatment. After the 4th cycle treatment was discontinued in 1 patient due to secondary amenorrhea, and in another 3 patients because of an increase in diastolic blood pressure. In a few patients side-effects such as weight gain, breast tenderness and mood changes in mild form were reported. Three out of 7 patients conceived in the 2nd or 3rd cycle after discontinuing Diane-35 therapy. The results of this study show that a combination of low-dose estrogen and cyproterone acetate (Diane-35) successfully reduces the hormonal disturbances which characterize PCOS. Apart from the normalization of the hormonal profile and the decrease in ovarian size, beneficial effects of Diane-35 were also observed on acne, hirsutism and regulation of the menstrual cycle. Favourable effects were also seen in terms of the pregnancy rate after discontinuation of Diane-35 therapy.
本研究评估了一种含有35微克炔雌醇和2毫克醋酸环丙孕酮的口服避孕药（达英-35）对多囊卵巢综合征（PCOS）患者激素动态、雄激素化临床体征及卵巢大小的影响。46例PCOS患者接受达英-35治疗9至30个周期，无中断（共688个周期）。治疗前及治疗期间每3个周期进行临床和激素评估，每6个周期进行卵巢超声检查。在服用达英-35第3个周期后，LH/FSH比值（p<0.001）以及睾酮水平（p<0.001）显著降低。第3个周期后，血清雄烯二酮平均水平显著降低（p<0.025），此后呈下降趋势。治疗第6个周期后，血清硫酸脱氢表雄酮水平显著降低，且随后也呈下降趋势。第3个周期后，SHBG浓度显著升高（p<0.001）。大多数患者在治疗第8至12个周期之间多毛症状有所改善。第6个周期后，平均卵巢大小显著减小（p<0.001），治疗第12个周期后恢复正常大小。第4个周期后，1例患者因继发性闭经停药，另外3例患者因舒张压升高停药。少数患者报告有体重增加、乳房压痛和轻度情绪变化等副作用。7例患者中有3例在停用达英-35治疗后的第2或第3个周期怀孕。本研究结果表明，低剂量雌激素与醋酸环丙孕酮联合使用（达英-35）成功降低了PCOS特有的激素紊乱。除了激素水平正常化和卵巢大小减小外，达英-35对痤疮、多毛症和月经周期调节也有有益作用。停用达英-35治疗后的妊娠率方面也有良好效果。
