调经促孕丸联合西药治疗早发性卵巢功能不全肾阳虚证临床研究

Clinical Study on Tiaojing Cuyun Pills Combined with Western Medicine for Premature Ovarian Insufficiency with Kidney Yang Deficiency Syndrome

目的:观察调经促孕丸联合西药治疗早发性卵巢功能不全(POI)肾阳虚证的临床疗效。方法:采用随机数字表法将120例POI肾阳虚证患者分为对照组、治疗组各60例。对照组口服戊酸雌二醇片、黄体酮胶囊治疗,治疗组在对照组基础上加用调经促孕丸治疗,2组均治疗3个月经周期。比较2组治疗前后月经症状评分、中医证候积分、性激素水平和卵巢超声检查指标,并评估2组临床疗效和不良反应发生情况。结果:治疗组总有效率91.67%,高于对照组76.67%(P<0.05)。治疗后,2组月经症状评分、中医证候积分、卵巢动脉阻力指数(RI)及血清卵泡刺激素(FSH)、促黄体生成素(LH)水平均较治疗前降低(P<0.05),卵巢动脉血流收缩期峰值流速(PSV)及血清雌二醇(E2)、抗苗勒管激素(AMH)水平升高(P<0.05),窦卵泡数量增多(P<0.05);治疗组月经症状评分、中医证候积分、RI及血清FSH、LH水平低于对照组(P<0.05),E2、AMH、PSV水平高于对照组(P<0.05),窦卵泡数量多于对照组(P<0.05)。治疗期间,对照组不良反应发生率3.33%,治疗组不良反应发生率5.00%,2组比较,差异无统计学意义(P>0.05)。结论:调经促孕丸联合西药治疗POI肾阳虚证疗效确切,能够调节患者性激素水平,改善卵巢血供,安全性较高。

Objective:To observe the clinical effect of Tiaojing Cuyun Pills combined with western medicine in the treatment of premature ovarian insufficiency(POI)with kidney yang deficiency syndrome.Methods:A total of 120 POI patients with kidney yang deficiency syndrome were randomly divided into the control group and the treatment group,with 60 cases in each group,using a random number table method.The control group was treated with Estradiol Valerate Tablets and Progesterone Capsules,and the treatment group was treated with Tiaojing Cuyun Pills in addition to the treatment of the control group.The two groups were treated for a total of three menstrual cycles.Compared the menstrual symptom scores,traditional Chinese medicine(TCM)syndrome scores,sex hormone levels,and ovarian ultrasound examination indicators between the two groups before and after treatment,and evaluated the clinical efficacy and incidence of adverse reactions between the two groups.Results:The total effective rate was 91.67%in the treatment group,which was higher than that of 76.67%in the control group(P<0.05).After treatment,the menstrual symptom scores,TCM syndrome scores,ovarian artery resistance index(RI),serum follicle stimulating hormone(FSH),and luteinizing hormone(LH)levels in both groups were decreased when compared with those before treatment(P<0.05),and the peak systolic flow velocity(PSV)of ovarian artery blood flow,serum estradiol(E2),and anti Mullerian hormone(AMH)levels were increased(P<0.05),and the numbers of sinus follicles were increased(P<0.05);the menstrual symptom score,TCM syndrome score,RI,and serum FSH and LH levels in the treatment group were lower than those in the control group(P<0.05),E2,AMH,and PSV levels were higher than those in the control group(P<0.05),and the number of antral follicles was more than that in the control group(P<0.05).During the treatment period,the incidence of adverse reactions was 3.33%in the control group,and 5.00%in the treatment group,there being no significant difference between the two groups(P>0.05).Conclusion:Tiaojing Cuyun Pills combined with western medicine has a definite therapeutic effect on POI with kidney yang deficiency syndrome,which can regulate the patient's sex hormone levels,improve ovarian blood supply,and is relatively safe.