益肾祛浊方对比二甲双胍治疗多囊卵巢综合征合并胰岛素抵抗的随机对照研究  

The Efficacy of Yishen Quzhuo Formula Compared with Metformin in the Treatment of Polycystic Ovary Syndrome with Insulin Resistance:a Randomized Controlled Trial

作　　者：李梦元 高征[1] 梁婧翘 张雅冬[2] 李博[3,4] 许昕 LI Mengyuan;GAO Zheng;LIANG Jingqiao;ZHANG Yadong;LI Bo;XU Xin(Department of Gynecology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Department of Ultrasound,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University/Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China;Beijing Evidence-based Chinese Medicine Center,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院妇科,北京市100010 [2]首都医科大学附属北京中医医院超声科,北京市100010 [3]首都医科大学附属北京中医医院北京市中医药研究所,北京市100010 [4]北京中医药循证医学中心,北京市100010

出　　处：《中国全科医学》2024年第27期3411-3417,3427,共8页Chinese General Practice

基　　金：全国名老中医药专家传承工作室建设项目[国中医办人教函(2021)270号];北京市属医院培育计划(PZ2023018)。

摘　　要：背景多囊卵巢综合征合并胰岛素抵抗(PCOS-IR)是PCOS中治愈难度最大的亚型,病机复杂,个体差异性大。二甲双胍作为一线用药,虽然能够降低血糖和改善胰岛素敏感性,但是对于调节激素失衡、改善卵巢功能等PCOS核心病理作用有限,且胃肠道反应大,患者难以坚持服用。目的评价益肾祛浊方对比二甲双胍治疗PCOS-IR的有效性与安全性。方法前瞻性选取2022年6月—2023年10月首都医科大学附属北京中医医院妇科门诊的102例PCOS-IR患者为研究对象,按照2∶1比例随机分为试验组(n=68)、对照组(n=34)。试验组以益肾祛浊方治疗,对照组以二甲双胍治疗,比较两组患者的排卵率、妊娠率、性激素[卵泡刺激素、促黄体生成素、LH/FSH、睾酮、抗苗勒管激素];糖脂代谢指标;BMI、腰臀比及不良反应发生率。结果治疗后试验组基础体温排卵率较治疗前升高(P<0.05)。试验组有生育需求患者13例,妊娠5例,对照组有生育需求患者5例,妊娠1例。治疗后两组妊娠率比较,差异无统计学意义(χ^(2)=1.154,P>0.05)。治疗后两组患者LH/FSH均较治疗前降低(P<0.05)。治疗后两组患者空腹血糖、空腹胰岛素、胰岛素抵抗指数、总胆固醇、三酰甘油均较治疗前降低(P<0.05)。治疗后两组患者低密度脂蛋白胆固醇、高密度脂蛋白胆固醇与治疗前比较,差异均无统计学意义(P>0.05)。治疗后对照组腰围少于试验组(P<0.05)。治疗后两组患者BMI、腰围、臀围、腰臀比均较治疗前降低(P<0.05)。治疗后试验组患者ALT、尿酸较治疗前降低,对照组UA较治疗前升高(P<0.05)。治疗后两组患者其他指标与治疗前比较,差异均无统计学意义(P>0.05)。治疗期间,患者出现低血糖、乏力、胃脘不适及腹泻等不良反应,试验组不良反应发生率(5/68,7.35%)低于对照组(15/31,48.39%)(χ^(2)=20.404,P<0.001)。结论益肾祛浊方调节激素失衡、改善糖脂代谢异常,治疗PCOSBackground Polycystic ovary syndrome with insulin resistance(PCOS-IR)is recognized as one of the most challenging subtypes of PCOS to treat due to its intricate pathogenesis and significant individual variability.Although Metformin,as a first-line medication,can ameliorate blood glucose levels and enhance insulin sensitivity,its efficacy in regulating hormonal imbalances and improving ovarian function is limited.Additionally,its gastrointestinal side effects often hinder patient adherence.Objective To evaluate the efficacy and safety of Yishen Quzhuo Formula compared to metformin in the treatment of PCOS-IR.Methods A prospective study enrolled 102 PCOS-IR patients from June 2022 to October 2023 at the Department of Gynecology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University.Patients were randomly assigned in a 2∶1 ratio to the experimental group(n=68)treated with Yishen Quzhuo Formula or the control group(n=34)treated with metformin.The comparison was made between the two groups in terms of ovulation rate,pregnancy rate,sex hormones[follicle-stimulating hormone(FSH),luteinizing hormone(LH),LH/FSH ratio,testosterone(T),anti-Müllerian hormone(AMH)],glucose and lipid metabolism indicators,BMI,waist-hip ratio(WHR),and incidence of adverse reactions.Results After treatment,the basal body temperature(BBT)ovulation rate in the experimental group increased compared to before treatment(P<0.05).Among patients with a desire for fertility in the experimental group,13 cases resulted in pregnancy,while in the control group,with 5 such cases,only 1 resulted in pregnancy.The comparison of pregnancy rates between the two groups after treatment showed no statistically significant difference(χ^(2)=1.154,P>0.05).After treatment,both groups showed a decrease in LH/FSH compared to before treatment(P<0.05).Following treatment,both groups showed a decrease in fasting plasma glucose(FPG),fasting insulin(FINS),homeostasis model assessment of insulin resistance(HOMA-IR),total cholesterol(TC),and triglycerides

关 键 词：多囊卵巢综合征 胰岛素抵抗 益肾祛浊方 排卵 葡萄糖代谢障碍 脂代谢障碍 临床研究 随机对照试验 

分 类 号：R711.75[医药卫生—妇产科学]