补肾调经汤联合雌孕激素替代治疗卵巢功能早衰临床研究

Clinical study of Bushen-Tiaojing Decoction combined with estrogen and progesterone replacement therapy in the treatment of premature ovarian failure

目的:评价补肾调经汤联合雌孕激素替代治疗卵巢功能早衰(premature ovarian failure, POF)的疗效。方法:将符合入选标准的2017年6月-2018年6月本院102例患者按随机数字表法分为2组,每组51例。对照组采用雌孕激素替代治疗,研究组在对照组基础上加用补肾调经汤。2组均连续治疗3个周期。分别于治疗前后进行中医症状评分,采用超声仪监测卵巢体积和卵泡数量,采用彩色多普勒超声诊断仪测量并计算卵巢间质动脉血流阻力指数(resistance index, RI)、卵巢间质动脉血流搏动指数(pulsation index, PI)、舒张末期血流速度(end-diastolic blood flow velocity, EDV)及收缩期峰值血流速度(peak systolic blood flow velocity, PSV),观察并记录治疗期间的不良反应,评价临床疗效。结果:研究组总有效率为90.2%(46/51)、对照组为70.6%(36/51),2组比较差异有统计学意义( χ2=6.220, P=0.013)。研究组治疗后中医症状评分低于对照组( t=9.216, P<0.01)。治疗后,研究组卵巢体积[(6.10±1.53)cm 3比(5.19±1.31)cm 3, t=3.226]大于对照组,卵泡数量[(5.72±1.66)个比(4.11±0.98)个, t=5.964]高于对照组( P<0.01);RI[(0.61±0.04)比(0.69±0.05), t=8.922]、PI[(1.30±0.07)比(1.75±0.09), t=28.186]低于对照组( P<0.01),EDV[(7.53±1.12)cm/s比(5.28±1.02)cm/s, t=10.607]、PSV[(22.74±3.19)cm/s比(19.33±2.70)cm/s, t=5.827]高于对照组( P<0.01)。研究组治疗期间不良反应发生率为13.7%(7/51)、对照组为9.8%(5/51),2组比较差异无统计学差异( χ2=0.378, P=0.539)。 结论:补肾调经汤联合雌孕激素替代治疗可有效减轻POF患者的临床症状,改善卵巢及其间质动脉血流状况,且安全性较好。

Objective To evaluate the effect of Bushen-Tiaojing Decoction combined with estrogen and progesterone replacement therapy in the treatment of premature ovarian failure(POF).Methods A total of 102 patients who met the inclusion criteria in our hospital from June 2017 to June 2018 were divided into two groups according to the random number table method,51 cases in each group.The control group was treated with estrogen and progesterone replacement therapy.The study group was treated with Bushen-Tiaojing Decoction on the basis of the control group.Both groups were treated for 3 cycles.Before and after treatment,the TCM symptom scores were evaluated.The ovarian volume and the follicles number were monitored by ultrasound.The resistance index(RI),pulse index(PI)and end diastolic blood flow velocity(EDV)and peak systolic blood flow velocity(PSV)were measured and calculated by color Doppler ultrasound.The adverse reactions during treatment were observed and recorded,and the clinical efficacy was evaluated.Results The total effective rate of the study group was 90.2%(46/51)and that of the control group was 70.6%(36/51),and the difference between the two groups was statistically significant(χ2=6.220,P=0.013).The TCM symptoms scores in the study group after treatment were significantly lower than that of the control group(t=9.216,P<0.01).After treatment,the ovarian volume(6.10±1.53 cm3vs.5.19±1.31 cm3,t=3.226)of the study group was significantly larger than that of the control group,and the follicles number(5.72±1.66 vs.4.11±0.98,t=5.964)was significantly more than that of the control group(P<0.01).The RI(0.61±0.04 vs.0.69±0.05,t=8.922),PI(1.30±0.07 vs.1.75±0.09,t=28.186)of the study group were significantly lower than those in the control group(P<0.01),EDV(7.53±1.12 cm/s vs.5.28±1.02 cm/s,t=10.607),PSV(22.74±3.19 cm/s vs.19.33±2.70 cm/s,t=5.827)were significantly higher than those in the control group(P<0.01).The incidence of adverse reactions was 13.7%(7/51)in the study group and 9.8%(5/51)in the control group,and there was no significant difference between the two group(χ2=0.378,P=0.539).Conclusions Bushen-Tiaojing Decoction combined with estrogen and progesterone replacement can reduce the clinical symptoms of patients with POF,improve the blood flow of ovary and its interstitial artery,and has shown safety.