首页|期刊导航|中国临床药理学杂志|司美格鲁肽联合来曲唑治疗肥胖型多囊卵巢综合征伴胰岛素抵抗患者的临床研究

司美格鲁肽联合来曲唑治疗肥胖型多囊卵巢综合征伴胰岛素抵抗患者的临床研究OA

Clinical trial of semaglutide in combination with letrozole for the treatment of polycystic ovary syndrome in patients with insulin resistance

中文摘要英文摘要

目的 观察司美格鲁肽注射液联合来曲唑片治疗肥胖型多囊卵巢综合征伴胰岛素抵抗(PCOS-IR)的临床疗效和安全性.方法 将PCOS-IR患者根据治疗方法分为试验组与对照组.对照组口服地屈孕酮片(每次10mg,bid)诱导撤退出血14 d,于撤退出血第5 d起口服来曲唑片(2.5 mg·d-1,连用5 d).停药2d后超声监测,主导卵泡≥ 18 mm时肌注注射用绒毛膜促性腺激素1.0 × 104 U诱发排卵,若无排卵,则于下1个月经周期递增来曲唑片药量至7.5 mg·d-1.试验组皮下注射司美格鲁肽(每次0.25 mg,每周1次,连续4 w,第5周起每次0.5 mg,每周1次,连续8 w).停药1 w(洗脱期)后,按对照组相同方案诱发排卵.2组均共用药3~6个月经周期,达到排卵或妊娠即终止用药.比较2组临床疗效、临床表征、生殖激素水平、胰岛素抵抗(IR)、炎症指标水平、卵泡发育情况并进行安全性评价.结果 共纳入93例,对照组48例,试验组45例.治疗后,对照组和试验组的疗效总有效率分别为70.83%(34例/48例)和88.89%(40例/45 例);Rosenfield痤疮评分别为(1.56±0.62)和(1.29±0.59)分;Ferriman-Gallwey 毛发评分分别为(13.31±3.25)和(11.89±2.85)分;促卵泡激素分别为(6.86±1.24)和(7.50±1.13)IU·L-1;促黄体生成素分别为(8.18±1.52)和(7.48±1.63)IU·L-1;空腹血糖(FPG)水平分别为(4.86±0.97)和(4.36±0.69)mmol·L-1;空腹胰岛素(FINS)水平分别为(9.25±1.96)和(8.41±1.87)μIU·mL-1;胰岛素抵抗指数分别为1.83±0.39和1.63±0.27;血管内皮生长因子分别为(92.17±10.82)和(87.45±10.36)ng·L-1;白细胞介素-6 分别为(6.74±0.93)和(6.32±0.99)pg·mL-1;卵泡数量分别为(8.44±1.35)和(7.93±1.01)个;最大卵泡直径分别为(11.68±2.44)和(13.05±2.69)mm;试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).试验组与对照组的药物不良反应总发生率分别为8.89%(4例/45例)和10.42%(5例/48例)(P>0.05).结论 司美格鲁肽联合来曲唑治疗PCOS-IR患者的疗效显著,能够有效改善IR状态,对非妊娠期或哺乳期妇女安全性较好.

Objective To observe the efficacy of semaglutide injection combined with letrozole tablet in the treatment of obese polycystic ovary syndrome with insulin resistance(PCOS-IR)patients.Methods Patients with PCOS-IR were divided into treatment group and control group according to the treatment regimen.The control group was administered oral dydrogesterone tablets(10 mg per dose,twice daily)for 14 days to induce withdrawal bleeding.Starting from the 5th day of withdrawal bleeding,letrozole tablets were given orally at a dose of 2.5 mg per day for 5 consecutive days.Two days after drug withdrawal,transvaginal ultrasound monitoring was performed.When the dominant follicle reached or exceeded 18 mm in diameter,human chorionic gonadotropin for injection(1.0 × 104 U)was intramuscularly injected to induce ovulation.If ovulation did not occur,the dose of letrozole tablets was increased to 7.5 mg per day in the next menstrual cycle.The treatment group received subcutaneous injections of semaglutide(0.25 mg per dose,once weekly for 4 consecutive weeks;starting from the 5th week,the dose was adjusted to 0.5 mg per dose,once weekly for another 8 consecutive weeks).After a 1-week drug withdrawal period(washout period),the same ovulation induction protocol as that for the control group was adopted.Both groups received treatment for 3 to 6 menstrual cycles,and the medication was discontinued immediately once ovulation or pregnancy was achieved.Clinical efficacy,clinical manifestations,reproductive hormone levels,insulin resistance,inflammatory marker levels,follicular development,and the adverse drug reactions were compared between the two groups.Results A total of 93 cases were included,with 48 cases in the control group and 45 cases in the treatment group.After treatment,the total effective rates of the control group and the treatment group were 70.83%(34 cases/48 cases)and 88.89%(40 cases/45 cases),respectively;the Rosenfield acne scores were(1.56±0.62)and(1.29±0.59)points,respectively;the Ferriman-Gallwey hair scores were(13.31±3.25)and(11.89±2.85)points,respectively;the follicle-stimulating hormone was(6.86±1.24)and(7.50±1.13)IU·L-1,respectively;the levels of luteinizing hormone were(8.18±1.52)and(7.48±1.63)IU·L-1,respectively;the levels of fasting blood glucose(FPG)levels were(4.86±0.97)and(4.36±0.69)mmol·L-1,respectively;the fasting insulin(FINS)levels were(9.25±1.96)and(8.41±1.87)μIU·mL-1,respectively;the insulin resistance indexes were 1.83±0.39 and 1.63±0.27,respectively;the vascular endothelial growth factors were(92.17±10.82)and(87.45±10.36)ng·L-1,respectively;the levels of interleukin-6 were(6.74±0.93)and(6.32±0.99)pg·mL-1,respectively;the number of follicles were(8.44±1.35)and(7.93±1.01),respectively;the maximum follicle diameters were(11.68±2.44)and(13.05±2.69)mm,respectively;the above indicators in the treatment group were compared with those in the control group and it showed statistically significant differences(all P<0.05).The total incidences of adverse drug reactions in the experimental group and the control group were 8.89%(4 cases/45 cases)and 10.42%(5 cases/48 cases)(P>0.05).Conclusion Semaglutide injection combined with letrozole tablets has significant efficacy in the treatment of PCOS-IR patients,can effectively improve insulin resistance,and has relatively good safety in non-pregnant or non-lactating women.

刘文鑫;李珊;王利飞

邢台市人民医院 生殖医学科,河北邢台 054001邢台市人民医院 质控办,河北邢台 054001邢台市人民医院 妇一科,河北邢台 054001

医药卫生

司美格鲁肽注射液来曲唑片肥胖型多囊卵巢综合征胰岛素抵抗

semaglutide injectionletrozole tabletpolycystic ovary syndromeinsulin resistance

《中国临床药理学杂志》 2026 (4)

472-478,7

邢台市重点研发计划自筹基金资助项目(2023ZC045)

10.13699/j.cnki.1001-6821.2026.04.004

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