【目的】 观察改良的五子衍宗丸联合序贯疗法对脾肾阳虚型卵巢早衰（POF）患者的临床疗效及其对性激素、卵巢超声指 标的影响。【方法】 选取2022年9月至2023年9月在惠州市中医医院就诊的62例脾肾阳虚型POF患者为研究对象，采用随机 数字表法将患者随机分为对照组和观察组，每组各31例。对照组给予雌孕激素序贯疗法治疗，观察组在对照组的基础上加 用改良的五子衍宗丸治疗，疗程均为3个月经周期。观察2组患者治疗前后血清性激素、子宫与卵巢超声检查及血流动力学指 标、中医证候积分、Kupperman评分的变化情况，比较2组患者的排卵率与疗效，并评价2组治疗方案的安全性。【结果】（1）脱落 情况方面，研究期间，共脱落2例，最终纳入60例患者，其中对照组和观察组各30例。（2）疗效方面，治疗3个月经周期后， 观察组的总有效率为 90.00%（27/30），对照组为 76.67%（23/30），组间比较，观察组的总有效率明显高于对照组（P < 0.05）。 （3）性激素水平方面，治疗后，2组患者的血清促卵泡生成素（FSH）、黄体生成素（LH）水平均较治疗前下降（P < 0.05），血清 雌二醇（E2）水平均较治疗前升高（P < 0.05），且观察组对血清FSH、LH水平的下降幅度及对血清E2水平的升高幅度均明显优 于对照组（P < 0.01）。（4）超声检查指标方面，治疗后，2组患者的子宫内膜厚度（EM）、卵巢平均容积（OVA）、卵巢最大平面 的平均卵巢直径（MOD）、基础窦卵泡数（AFC）等超声检查指标均较治疗前升高（P < 0.05），且观察组的升高幅度均明显优于 对照组（P < 0.01）。（5）卵巢血流动力学方面，治疗后，2组患者的卵巢最大血流速度（PSV）均较治疗前升高（P < 0.05），卵巢 阻力指数（RI）、卵巢搏动指数（PI）均较治疗前下降（P < 0.05），且观察组对PSV的升高幅度及对RI、PI的下降幅度均明显优 于对照组（P < 0.01）。（6）Kupperman评分和中医证候积分方面，治疗后，2组患者的Kupperman评分和中医证候积分均较治疗 前下降（P < 0.05），且观察组的下降幅度均明显优于对照组（P < 0.01）。（7）排卵率方面，治疗3个月经周期后，观察组的排卵 率为30.00%（9/30），对照组为10.00%（3/30），组间比较，观察组的排卵率明显高于对照组（P < 0.05）。（8）安全性方面，对照 组的不良反应发生率为6.67%（2/30），观察组为6.67%（2/30），组间比较，差异无统计学意义（P > 0.05）。【结论】 改良的五子 衍宗丸联合雌孕激素序贯疗法可有效调节脾肾阳虚型 POF 患者的性激素水平，促进卵泡发育，显著改善卵巢局部微循环， 提升排卵率，缓解症状体征，且安全性良好。

Objective To investigate the clinical efficacy of modified Wuzi Yanzong Pills combined with sequential therapy for the treatment of patients with premature ovarian failure（POF）of yang deficiency of spleen and kidney type，and to observe their effects on sex hormones and ovarian ultrasound indicators. Methods From September 2022 to September 2023，a total of 62 patients with POF of yang deficiency of spleen and kidney type who attended Huizhou Hospital of Traditional Chinese Medicine were selected as the study objects. The patients were randomly divided into the control group and the observation group by using a table of random numbers，with 31 patients in each group. The control group was treated with estrogen-progestin sequential therapy，and the observation group was treated with modified Wuzi Yanzong Pills on the basis of treatment for the control group. The two groups were treated for three menstrual cycles. Before and after treatment，the changes of serum sex hormones，uterine and ovarian ultrasonography and hemodynamic indicators， traditional Chinese medicine（TCM）syndrome scores， Kupperman score of the two groups were observed. The ovulation rate and therapeutic efficacy of the two groups were compared，and the safety of the therapeutic regimen for the two groups was evaluated. Results（1）Two cases fell off during the study period ， and a total of 60 patients were eventually included in the study ， of which 30 patients in each group.（2）After three menstrual cycles of treatment，the total effective rate of the observation group was 90.00%（27/30）and that of the control group was 76.67%（23/30），and the total effective rate of the observation group was significantly higher than that of the control group（P < 0.05）.（3）After treatment， the serum follicle-stimulating hormone（FSH）and luteinizing hormone（LH）levels of the two groups of patients were decreased compared with those before treatment（P < 0.05），and the serum estradiol（E2）level was increased compared with that before treatment（P < 0.05），the decrease of the serum FSH and LH levels and the increase of the serum E2 level in the observational group were significantly superior to those of the control group（P < 0.01）. （4）After treatment，ultrasonographic indicators such as endometrial thickness（EM），ovarian volume averaged （OVA），mean ovarian diameter（MOD）at the maximum transverse section of the ovary，and antral follicle count （AFC）in the two groups were increased compared with those before treatment（P < 0.05），and the increase in the observation group was significantly superior to that in the control group（P < 0.01）.（5）After treatment，the peak systolic velocity（PSV）of the two groups was increased compared with that before treatment（P < 0.05），and the ovarian resistance index （RI） and ovarian pulsatility index （PI） were decreased compared with those before treatment（P < 0.05），and the increase of PSV and the decrease of RI and the PI in the observation group were significantly superior to those of the control group（P < 0.01）.（6）After treatment，the Kupperman score and TCM syndrome scores of the two groups were decreased compared with those before treatment（P < 0.05）， and the decrease in the observation group was significantly superior to that in the control group（P < 0.01）.（7）After three menstrual cycles of treatment，the ovulation rate of the observation group was 30.00%（9/30），and that of the control group was 10.00%（3/30）. The comparison between the two groups showed that the ovulation rate of the observation group was significantly superior to that of the control group（P < 0.05）.（8）The incidence of adverse reactions in the control group was 6.67%（2 / 30）and that in the observation group was 6.67%（2 / 30）. The comparison between the two groups showed that there being no statistically significant difference （P > 0.05）.Conclusion The modified Wuzi Yanzong Pills combined with estrogen-progestin sequential therapy can effectively regulate the sex hormone levels of patients with POF of yang deficiency of spleen and kidney type，promote the follicular development， significantly improve the ovarian microcirculation， increase the ovulation rate， and relieve symptoms and signs，with good safety.

R271.9

国家自然科学基金项目（编号：81873331）；惠州市医疗卫生领域科技计划项目（编号：2022CZ010164）