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Clinical Efficacy and Adverse Reactions of Lianggu Decoction Combined with Clomiphene in the Treatment of Patients with Obesity Related PCOS infertility

  

  1. 1.Pharmacy Department,Ulanqab Central Hospital,Ulanqab 012099,China;2.Reproductive Medicine Department,Cangzhou Integrated Traditional Chinese and Western Medicine Hospital,Cangzhou 061013,China
  • Received:2024-11-15 Revised:2024-12-19 Accepted:2025-01-09
  • Contact: WANG Yan,Deputy chief technician;E-mail:wyan567@sina.com

两固汤联合克罗米芬治疗肥胖型 PCOS 不孕症患者临床疗效及不良反应研究

  

  1. 1.012099 内蒙古乌兰察布市,乌兰察布市中心医院药剂科;2.061013 河北省沧州市,沧州中西医结合医院生殖医学科
  • 通讯作者: 王琰,副主任技师;E-mail:wyan567@sina.com
  • 基金资助:
    河北省中医药管理局中医药类科学研究课题计划资助项目(2024483)

Abstract: Background Polycystic ovary syndrome(PCOS) is an extremely common endocrine disorder among women of reproductive age. Patients with obese PCOS often experience insulin resistance,leading to dysregulation of glucose and lipid metabolism,abnormal pancreatic function and subsequently ovulatory disorders,resulting in infertility. Clomiphene can improve ovulatory function in PCOS patients,but it is also associated with a variety of adverse effects with long-term use,and the phenomenon of clomiphene resistance can easily occur. Currently,the clinical efficacy and adverse reactions of Lianggu Decoction in the intervention of obesity PCOS infertility are not clear. Objective To investigate the effects of Lianggua decoction combined with Clomiphene on insulin resistance,ovarian blood flow dynamics,and pregnancy in obese PCOS infertile patients. Methods A total of 127 obese PCOS infertile patients admitted to Reproductive Medicine Department of Cangzhou Integrated Traditional Chinese and Western Medicine Hospital from February 2022 to December 2023 were selected as the research object. According to the random grouping principle,they were divided into an observation group of 63 cases and a control group of 64 cases. The control group was treated with clomiphene,starting on the 5th day of menstruation,at a dosage of 40 mg per time,twice a day for a continuous 5 days. The observation group was treated with Lianggu Decoction in addition to the treatment received by the control group,taking 150 mL of the decoction brewed from traditional Chinese medicinal herbs,twice a day,warm and taken in the morning and evening for a continuous 14 days. The treatment cycle lasted one month,and both groups of patients underwent continuous treatment for 3 cycles. The differences in laboratory test indicators between the two groups including fasting insulin (FINS),insulin resistance index(HOMA-IR),pancreatic β-cell function index(HOMA-β),fasting blood glucose (FPG),triglycerides(TG),total cholesterol(TC),body mass index(BMI),ovarian hemodynamic indicators [peak systolic velocity(PVS),resistance index(RI),pulsatility index(PI),estrogen(E2),luteinizing hormone(LH),testosterone(T),follicle-stimulating hormone(FSH) were compared. Ovulation rate,pregnancy rate and abortion rate were used as outcome indexes,clinical efficacy and incidence of adverse reactions were recorded,and the differences between the two groups were compared. Results After 3 cycles of treatment,the experimental group had lower levels of BMI,FPG,TG,TC,FINS,HOMA-IR,RI,serum E2,T,LH,and FSH compared to the control group,while the HOMA-β,PVS,and PI were higher than those in the control group,with all differences reaching statistical significance (P<0.05). The ovulation rate and clinical pregnancy rate in the experimental group were higher than in the control group,while the miscarriage rate was lower in the experimental group,with all differences being statistically significant(P<0.05). The total effective rate in the experimental group was higher than that in the control group,and the difference was statistically significant(χ2 =6.698,P<0.05). The incidence of adverse reactions in the experimental group showed no statistical difference compared to the control group(χ2 =0.192,P>0.05). Conclusion The combination of Lianggua Tang and Clomiphene is effective in treating obese PCOS infertility,improving insulin resistance,glucose and lipid metabolism,hormone levels,and ovarian blood flow dynamics,and increasing pregnancy rate.

Key words: Polycystic ovary syndrome, Lianggu Decoction, Clomiphene, Insulin resistance, Pregnancy

摘要: 背景 多囊卵巢综合征(PCOS)是在育龄期女性中极为普遍的内分泌紊乱疾病,肥胖型PCOS患者常伴有胰岛素抵抗,引起糖脂代谢紊乱、胰岛功能异常,进而引起排卵障碍,并导致不孕。克罗米芬可以改善PCOS患者的排卵功能,但长期应用不良反应较多,容易出现克罗米芬抵抗现象。目前两固汤干预肥胖型PCOS不孕症的临床疗效及不良反应尚不明确。目的 探讨两固汤联合克罗米芬对肥胖型PCOS不孕症患者胰岛素抵抗、卵巢血流动力学及妊娠的影响。方法 选取2022年2月—2023年12月于沧州中西医结合医院生殖医学科就诊的127例肥胖型PCOS不孕症患者为研究对象。根据随机分组方法,将患者分为试验组63例、对照组64例。对照组采用克罗米芬治疗,于月经第5 d开始服用,40 mg/次,2次/d,连续服用5 d。试验组在对照组基础上加用两固汤治疗,两固汤中药材煎煮后取150 mL药汁,2次/d,早晚温服,连续服用14 d。以1个月为治疗周期,两组患者均连续治疗3个周期。比较治疗前后两组空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)、胰岛β细胞功能指数(HOMA-β)、空腹血糖(FPG)、三酰甘油(TG)、总胆固醇(TC)、身体质量指数(BMI)、卵巢收缩期最大峰值流速(PVS)、阻力指数(RI)、搏动指数(PI)、血清雌激素(E2)、黄体生成素(LH)、睾酮(T)、促卵泡生成素(FSH)等实验检查指标差异。以排卵率、妊娠率及流产率为结局指标,记录临床疗效及不良反应发生率,并比较两组差异。结果 治疗3个周期后,试验组BMI、FPG、TG、TC、FINS、HOMA-IR、RI、血清E2、T、LH、FSH水平低于对照组,HOMA-β、PVS、PI高于对照组,差异均有统计学意义(P <0.05)。试验组患者排卵率、临床妊娠率高于对照组,流产率低于对照组,差异均具有统计学意义(P <0.05)。试验组总有效率高于对照组,差异有统计学意义(χ2=6.698,P <0.05)。试验组与对照组不良反应发生率比较,差异无统计学差异(χ2=0.192,P >0.05)。结论 两固汤联合克罗米芬治疗肥胖型PCOS不孕症效果好,能有效改善患者的胰岛素抵抗、糖脂代谢、性激素水平及卵巢血流动力学,提高妊娠率。

关键词: 多囊卵巢综合征, 两固汤, 克罗米芬, 胰岛素抵抗, 妊娠

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