首都医科大学学报 ›› 2025, Vol. 46 ›› Issue (4): 607-613.doi: 10.3969/j.issn.1006-7795.2025.04.004

• 更年期妇科内分泌与生育力保护 • 上一篇    下一篇

单用屈螺酮炔雌醇片或联合奥利司他对超重/肥胖多囊卵巢综合征患者排卵恢复率及代谢指标比较

蒋玲玲1,阮祥燕1,2*,李妍秋1,张明珍1,王泽铖1,金婧1,田玄玄1,柳岸鸣1,Alfred O. Mueck1,2   

  1. 1.首都医科大学附属北京妇产医院/北京妇幼保健院内分泌科， 北京 100026; 2. 德国图宾根大学妇产医院妇女健康部与妇女健康研究中心，图宾根 D-72076
  • 收稿日期:2025-01-08 出版日期:2025-08-21 发布日期:2025-08-29
  • 通讯作者: 阮祥燕 E-mail:ruanxiangyan@ccmu.edu.cn
  • 基金资助:
    北京市医院管理局“登峰”计划专项经费资助（DFL-20181401），北京市卫生健康委员会北京市研究型病房示范建设项目（BCRW202109）。

Comparison of ethinyl-estradiol/drospirenone tablets alone or in combination with orlistat on ovulation recovery rate and metabolic indices in overweight/obese patients with polycystic ovary syndrome

Jiang Lingling1, Ruan Xiangyan1,2*, Li Yanqiu1,  Zhang Mingzhen1,  Wang Zecheng1,  Jin Jing1, Tian Xuanxuan1,  Liu Anming1, Alfred O. Mueck1,2   

  1. 1.Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University. Beijing Maternal and Child Health Care Hospital, Beijing 100026, China ；2.Department of Women's Health, Research Centre for Women's Health and University Women's Hospital of Tuebingen, University Hospitals of Tuebingen, Tuebingen D-72076, Germany
  • Received:2025-01-08 Online:2025-08-21 Published:2025-08-29
  • Supported by:
    This study was supported  by Beijing Municipal Administration of Hospitals’ Ascent Plan  (DFL-20181401), Beijing Municipal Health Commission, Demonstration Construction Project of Clinical Research Ward (BCRW202109).

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摘要： 目的  本研究旨在探索屈螺酮炔雌醇片（ethinylestradiol/drospirenone，EE/DRSP）联合奥利司他与单用EE/DRSP对多囊卵巢综合征（polycystic ovary syndrome, PCOS）患者排卵恢复率及代谢指标比较。方法  本研究为随机对照临床试验，研究根据2004年国际鹿特丹标准，于2020 年 10 月至 2023 年 12 月期间，在首都医科大学附属北京妇产医院内分泌科门诊招募了180例20~40岁的超重/肥胖PCOS患者，研究对象按 1∶2 的比例，采用抽签法随机分为2组，其中60例患者单独应用EE/DRSP治疗（EE 20 μg, DRSP 3 mg），120例患者接受EE/DRSP联合奥利司他治疗（360 mg/d）。研究分别在治疗前、治疗后12周测量患者身高、体质量、腰围、臀围、血压，实验室检测项目包括：促卵泡激素、黄体生成素、空腹胰岛素、胰岛素抵抗指数、雄激素指数、丙氨酸氨基转移酶、门冬氨酸氨基转移酶、γ-谷氨酰转肽酶、空腹血糖、总胆固醇、三酰甘油、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、脂蛋白(a) 、性激素结合球蛋白、总睾酮、游离睾酮。治疗12周后停药观察自然排卵情况。结果  通过12周治疗后，EE/DRSP联合奥利司他组的排卵率达到70.8%，而单独使用EE/DRSP组的自然排卵率仅为35%，表明EE/DRSP联合奥利司他治疗后排卵率显著增加。治疗12周后两组均显示总睾酮、游离睾酮、低密度脂蛋白胆固醇浓度显著下降（P均<0.05），EE/DRSP联合奥利司他组体质量指数、腰围、空腹胰岛素、胰岛素抵抗指数下降幅度大于单用EE/DRSP组（P<0.05）。两组治疗后均显示高密度脂蛋白、三酰甘油浓度显著升高（P均<0.05），总胆固醇、空腹血糖无显著变化（P均>0.05）。 结论  12周治疗后，EE/DRSP联合奥利司他能显著提高PCOS患者的排卵率，并在降低雄激素水平、体质量、胰岛素抵抗及低密度脂蛋白水平优于单用EE/DRSP方案。

关键词: 多囊卵巢综合征, 屈螺酮炔雌醇片, 代谢, 奥利司他, 肥胖, 排卵恢复率

Abstract: Objective  To compare ovulation recovery rate and metabolic indicators between ethinyl-estradiol/drospirenone (EE/DRSP) combined with orlistat and EE/DRSP alone in overweight/obese patients with polycystic ovary syndrome (PCOS). Methods  This study was a randomized controlled clinical trial conducted based on the 2004 Rotterdam criteria. From October 2020 to December 2023, 180 overweight/obese PCOS patients aged 20-40 were recruited from the Department of Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University. The patients were randomly divided into two groups in a 1∶2 ratio. Among them, 60 patients received treatment with EE/DRSP (EE20 μg,DRSP 3 mg), while 120 patients received a combination treatment of EE/DRSP and orlistat (360 mg/d). The height, weight, waist circumference, hip circumference, and blood pressure of the patients were measured before treatment and after 12 weeks of treatment. Laboratory tests included measurements of follicle-stimulating hormone (FSH), luteinizing hormone (LH), fasting insulin（FINS）, homeostasis model assessment of insulin resistance (HOMA-IR), free androgen index (FAI), alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), fasting plasma glucose (FPG), total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), lipoprotein(a) ［Lp(a)］, sex hormone-binding globulin (SHBG), total testosterone (T), and free testosterone (FT). After 12 weeks of treatment, the medication was discontinued, and natural ovulation was observed. Results  After 12 weeks of treatment, the ovulation rate of the EE/DRSP combined with orlistat group reached 70.8%, while the natural ovulation rate of the EE/DRSP group alone was only 35%, indicating that the ovulation rate was significantly increased after EE/DRSP combined with orlistat treatment. After 12 weeks of treatment, both groups showed a significant decrease in total testosterone, free testosterone, and low-density lipoprotein levels (all P<0.05), and the decrease in BMI, waist circumference, fasting insulin, and HOMA-IR in the EE/DRSP combined with orlistat group was greater than that in the EE/DRSP group alone (P<0.05). After treatment, both groups showed a significant increase in high-density lipoprotein and triglyceride levels (all P<0.05), with no significant changes in total cholesterol and fasting blood glucose (all P>0.05). Conclusion  After 12 weeks of treatment, EE/DRSP combined with orlistat can significantly improve the ovulation rate of PCOS patients. It is superior to EE/DRSP alone in reducing androgen levels, body weight, insulin resistance, and low-density lipoprotein levels. 

Key words: polycystic ovary syndrome, ethinyl-estradiol/drospirenone (EE/DRSP), metabolism, orlistat, obesity, ovulation recovery rate

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