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Title: [Efficacy and metabolic safety of long-term treatment with ethinyl oestradiol/cyproterone and desogestrel/ethinyl oestradiol tablets in women with polycystic ovary syndrome].
Author: Zhang J, Su M, Xu L, Yang Z, Yin W, Nie Y, Qiao X, Cheng R, Ma Y.
Journal: Nan Fang Yi Ke Da Xue Xue Bao; 2018 Jul 30; 38(8):917-922. PubMed ID: 30187872.
Abstract:
OBJECTIVE: To evaluate the efficacy and metabolic safety of long-term treatment with ethinyl oestradiol/cyproteroneand desogestrel/ethinyl oestradiol tablets in women with polycystic ovary syndrome (PCOS). METHODS: Women with PCOSfrom West China Second Hospital of Sichuan University enrolled between September, 2011 and August, 2013 were randomlyallocated to receive either ethinyl oestradiol/cyproterone tablets (Group A, n=355) or desogestrel/ethinyl oestradiol tablets(Group B, n=357) for a prospective observation period of 6 months. Women with insulin resistance also received metformin. Atbaseline, 3 months, and 6 months, the patients were evaluated for menstruation, acne score, body mass index (BMI), waist-tohip ratio (WHR), plasma levels of sex hormones, fasting blood glucose (FPG), HOMA-insulin resistance index (HOMA-IR), serum lipid, ovarian volume, and the number of ovarian follicles. RESULTS: All the patients had a regular menstrual cycle aftertreatments. Testosterone level, acne score, LH/FSH, ovarian volume, and the number of follicles decreased significantly afterthe treatments without significant differences between the two groups. Significant increases were noted in TG, TCh, LDL, HDL, and AIP, and HDL level in group A as compared with group B (P < 0.001). FPG decreased in both groups, and wassignificantly lower in group B at 6 months (P < 0.05). BMI and WHR decreased in all the patients with insulin resistance aftercombination treatment with metformin (P < 0.05), but increased significantly in patients without insulin resistance (P < 0.05). Ingroup A, HOMA- IR significantly increased in patientswithout insulin resistance at 3 months (P < 0.05), whereas asignificant increase was not observed until 6 months ingroup B (P < 0.05). CONCLUSIONS: Both ethinyl oestradiol/cyproterone tablets and desogestrel/ethinyl oestradioltablets can relieve the symptoms of PCOS, but it isadvisable to assess the risk of cardiovascular diseasebefore the treatments. 目的: 观察炔雌醇环丙孕酮片和去氧孕烯炔雌醇片的长期应用对多囊卵巢综合征的疗效及代谢安全性评估。方法: 本研究纳入2011年9月~2013年8月在四川大学华西第二医院门诊就诊、符合多囊卵巢综合征诊断的患者712例，按随机序列将其分成炔雌醇环丙孕酮片组（A组）355例和去氧孕烯炔雌醇片组（B组）357例，并对伴胰岛素抵抗的患者联合二甲双胍治疗。于入组前、治疗第3月、第6月时收集所有患者月经情况、痤疮评分、体质量指数（BMI）、腰臀比（WHR）、卵巢超声、血清性激素、空腹血糖（FPG）、稳态模型评估的胰岛素抵抗指数（HOMA-IR）及血脂等资料，观察治疗后以上指标的变化，并分析组间差异。结果: 两组治疗后均建立了规律的月经周期，睾酮水平、痤疮评分降低，卵巢体积变小，卵泡数量减少，黄体生成素与卵泡刺激素比值（LH/FSH）下降；高密度脂蛋白（HDL）、低密度脂蛋白（LDL）、甘油三酯（TG）、总胆固醇（TCh）、动脉硬化指数（AIP）上升，A组HDL的上升趋势较B组更为显著（P < 0.001）；FPG下降，且在治疗6月时B组较A组下降更明显（P < 0.05）。两组中伴胰岛素抵抗而联合应用了二甲双胍的患者，BMI、WHR明显下降（P < 0.05）；而非胰岛素抵抗的患者，则出现相反的趋势改变（P < 0.05）。两组中伴胰岛素抵抗而联合应用了二甲双胍的患者，HOMA-IR呈下降趋势，但差异无统计学意义；A组非胰岛素抵抗的患者，治疗3月后HOMA-IR显著上升，差异有统计学意义（P < 0.05），而B组非胰岛素抵抗的患者，治疗6月后才呈现出相同趋势的变化，差异有统计学意义（P < 0.05）。结论: 炔雌醇环丙孕酮片与去氧孕烯炔雌醇片的长期应用均能改善多囊卵巢综合征的症状，但治疗时应注意评估心血管疾病发生的风险。

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