基于单组目标值法益肾祛浊方治疗肥胖型PCOS异常子宫出血疗效及代谢机制研究  

Efficacy and metabolic mechanism of decoction for replenishing kidney and dispelling turbid on abnormal uterine bleeding in obese PCOS based on single-arm objective performance criteria

作　　者：高征[1,2] 李梦元 张雅冬 梁婧翘[1] 许昕 GAO Zheng;LI Mengyuan;ZHANG Yadong;LIANG Jingqiao;XU Xin(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Clinical School of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]首都医科大学中医药临床医学院,北京100010

出　　处：《现代中西医结合杂志》2024年第20期2775-2787,共13页Modern Journal of Integrated Traditional Chinese and Western Medicine

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];北京中医医院院级课题暨两院合作项目(LYYB202203)。

摘　　要：目的采用单组目标值法,探讨益肾祛浊方治疗肥胖型多囊卵巢综合征(PCOS)异常子宫出血的临床疗效及安全性,并运用代谢组学技术探讨其作用机制。方法选取2022年1月—2023年6月在首都医科大学附属北京中医医院妇科门诊确诊为肥胖型PCOS异常子宫出血,辨证为脾肾两虚、阳明浊热证的患者80例,给予益肾祛浊方治疗12周。观察治疗前后血清性激素[睾酮(T)、卵泡刺激素(FSH)、黄体生成素(LH)、雌二醇(E_(2))、孕酮(P)、抗苗勒管激素(AMH)]水平、妊娠率、基础体温(BBT)排卵率、月经失血图(PBAC)评分、出血时间、中医证候积分、肥胖指标[体重、体质指数(BMI)、腰围、臀围、腰臀比]、糖脂代谢指标[空腹胰岛素(FINS)、空腹血糖(FPG)、胰岛素抵抗指数(HOMA-IR)、总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、载脂蛋白A1(Apo A1)、载脂蛋白B(Apo B)、小而密低密度脂蛋白胆固醇(sd LDL-C)、同型半胱氨酸(Hcy)]、超声检查指标(子宫内膜厚度、卵巢体积、卵泡数目)、炎症因子指标[白细胞介素(IL)-2、IL-4、IL-6、IL-17、肿瘤坏死因子-α(TNF-α)]及安全性,并运用代谢组学技术筛选患者治疗前后粪便差异代谢物及通路。结果治疗12周后血清T水平为(60.13±26.49)ng/dL,95%置信区间上限低于目标值,点估计值优于靶值。治疗后妊娠率达到26.67%(8/30);BBT排卵率及血清HDL-C、Apo A1水平均明显高于治疗前(P均<0.05),PBAC评分、中医证候积分、出血时间、体重、BMI、腰围、臀围、腰臀比及血清LH、LH/FSH、FPG、FINS、HOMA-IR、TC、LDL-C、Apo B、sd LDL-C、IL-2、IL-6、TNF-α水平均明显低于治疗前(P均<0.05),卵泡数目明显少于治疗前(P<0.05);无严重不良反应。治疗前后粪便代谢组学研究共鉴定出96种差异代谢物,筛选出71条通路。结论益肾祛浊方可有效治疗肥胖型PCOS患者的肥胖及异常子宫�Objective It is to explore the clinical efficacy and safety of decoction for replenishing kidney and dispelling turbid in the treatment of abnormal uterine bleeding in obese polycystic ovary syndrome(PCOS)by single-arm objective performance criteria,and to explore its mechanism by metabolomics technology.Methods Eighty patients who were diagnosed as obese PCOS with abnormal uterine bleeding and identified as syndrome of splee-kidney deficiency and Yangming turbid-heat in the gynecology outpatient clinic of Beijing Hospital of Traditional Chinese Medicine from January 2022 to June 2023 were selected and treated with decoction for replenishing kidney and dispelling turbid for 12 weeks.The serum levels of sex hormones[testosterone(T),follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E_(2)),progesterone(P),anti-mullerian hormone(AMH)]before and after treatment,pregnancy rate after treatment,basal body temperature(BBT)ovulation rate,Pictorial Blood Loss Assessment Chart(PBAC)scores,bleeding time,Chinese medicine syndrome scores,obesity indicators[weight,body mass index(BMI),waist circumference,hip circumference,waist-to-hip ratio],indicators of glucose and lipid metabolism[fasting insulin(FINS),fasting glucose(FPG),insulin resistance index(HOMA-IR),total cholesterol(TC),triacylglycerol(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),apolipoprotein A1(Apo A1),apolipoprotein B(Apo B),small dense-low-density lipoprotein cholesterol(sdLDL-C),homocysteine(Hcy)],ultrasonographic indicators(endometrial thickness,ovarian volume,follicle number),inflammatory factor indicators[interleukin(IL)-2,IL-4,IL-6,IL-17,tumor necrosis factor-α(TNF-α)]before and after treatment and safety were observed,and metabolomics was used to screen the fecal differential metabolites and pathways before and after treatment in the patients.Results The serum level of T was(60.13±26.49)ng/dL after 12 weeks of treatment,its upper limit of the 95%confidence interval was lower than the target

关 键 词：多囊卵巢综合征 异常子宫出血 肥胖 益肾祛浊方 代谢组学 

分 类 号：R711.75[医药卫生—妇产科学]