【目的】 探究知柏地黄丸联合芬吗通对卵巢储备功能减退患者卵巢平均容积及卵巢颗粒细胞线粒体活性的影响。 【方法】 选取2022年3月至2023年9月就诊于泰州市中医院妇科的肝肾阴虚型卵巢储备功能减退患者86例，采用随机数字表 法将患者随机分为对照组和观察组，每组个43例。对照组给予芬吗通口服治疗，观察组在对照组的基础上联合知柏地黄丸 口服治疗。以28 d为1个疗程，共治疗3个疗程。检测2组患者治疗后的卵泡液活性氧（ROS）水平及卵巢颗粒细胞线粒体活 性，观察2组患者治疗前后中医证候积分、卵巢功能[卵巢平均容积（OVA）、平均卵巢直径（MOD）、窦卵泡计数（AFC）]、血 清性激素[抗缪勒管激素（AMH）、促卵泡生成素（FSH）、雌二醇（E2）]水平、子宫动脉血流参数[卵巢血流收缩期峰流速 （PSV）、搏动指数（PI）、阻力指数（RI）]的变化情况，评估2组患者的临床疗效及用药安全性。【结果】（1）疗效方面，治疗3个 疗程后，观察组的总有效率为90.70%（39/43），对照组为72.09%（31/43），组间比较（χ2 检验），观察组的疗效明显优于对照组 （P＜0.05）。（2）卵泡液ROS水平及卵巢颗粒细胞线粒体活性方面，治疗3个疗程后，观察组的ROS水平显著低于对照组（P＜ 0.01），颗粒细胞线粒体活性显著高于对照组（P＜0.01）。（3）中医证候积分方面，治疗后，2组患者的月经异常、急躁易怒、 烘热汗出、失眠多梦、烦忧抑郁积分均较治疗前降低（P＜0.05），且观察组对各项中医证候积分的降低幅度均明显优于对照 组（P＜0.05或P＜0.01）。（4）卵巢功能方面，治疗后，2组患者的OAV均较治疗前增大（P＜0.05），MOD均较治疗前延长（P＜ 0.05），AFC均较治疗前增多（P＜0.05），且观察组对各项卵巢功能指标的改善幅度均明显优于对照组（P＜0.05或 P＜0.01）。 （5）性激素水平方面，治疗后，2 组患者的血清 AMH、E2 水平均较治疗前升高（P＜0.05），血清 FSH 水平均较治疗前降低 （P＜0.05），且观察组对血清AMH、E2水平的升高幅度及对血清FSH水平的降低幅度均明显优于对照组（P＜0.01）。（6）子宫 动脉血流参数方面，治疗后，2 组患者的 PSV 均较治疗前升高（P＜0.05），PI、RI 均较治疗前降低（P＜0.05），且观察组对 PSV的升高幅度及对PI、RI的降低幅度均明显优于对照组（P＜0.05或P＜0.01）。（7）安全性方面，对照组的不良反应发生率为 9.30%（4/43），观察组为13.95%（6/43），组间比较，差异无统计学意义（P＞0.05）。【结论】 知柏地黄丸与芬吗通联合可以有效 改善肝肾阴虚型卵巢储备功能减退患者的临床症状，增强卵巢功能及卵巢颗粒细胞线粒体活性。

Objective To investigate the effects of Zhibo Dihuang Pills combined with Femoston on mean ovarian volume and mitochondrial activity of ovarian granulosa cells in patients with diminished ovarian reserve （DOR）. Methods A total of 86 DOR patients with liver-kidney yin deficiency syndrome， treated in the Department of Gynecology at Taizhou Hospital of Traditional Chinese Medicine between March 2022 and September 2023，were randomized into a control group （n=43） and an observation group （n=43） using a random number table method. The control group received oral Femoston，while the observation group received additional oral administration of Zhibo Dihuang Pills. The treatment lasted for three 28-day courses. Follicular fluid reactive oxygen species （ROS） levels and mitochondrial activity of ovarian granulosa cells were measured after treatment. Changes in TCM syndrome scores，ovarian function [ovarian volume average （OVA），mean ovarian diameter （MOD），antral follicle count （AFC）]，serum sex hormone levels [anti-Müllerian hormone （AMH），follicle-stimulating hormone （FSH）， estradiol （E2）]，and uterine artery blood flow parameters [peak systolic velocity （PSV），pulsatility index （PI）， resistance index （RI）] were observed before and after treatment. Clinical efficacy and safety were evaluated. Results （1）Regarding efficacy，after three treatment courses，the total effective rate was 90.70% （39/43） in the observation group and 72.09%（31/43） in the control group. The intergroup comparison （by chi-square test） showed that the observation group demonstrated significantly superior efficacy than the control group（P＜0.05）. （2） For follicular fluid ROS levels and mitochondrial activity of ovarian granulosa cells， the observation group showed significantly lower ROS levels and significantly higher mitochondrial activity than the control group after three treatment courses （P＜0.01）.（3） In terms of TCM syndrome scores， both groups exhibited significant reductions in scores for menstrual abnormalities，irritability，hot flashes and sweating，insomnia with excessive dreaming， and anxiety and depression after three treatment courses （P＜0.05）， with the observation group showing significantly greater reductions than the control group （P＜0.05 or P＜0.01）.（4）Regarding ovarian function，both groups showed significant increases in OAV，MOD，and AFC after treatment （P＜0.05），with the observation group demonstrating significantly greater improvements than the control group （P＜0.05 or P＜ 0.01）.（5） For sex hormone levels，both groups exhibited significant increases in serum AMH and E2 levels and a significant decrease in serum FSH levels after treatment （P＜0.05）， with the observation group showing significantly greater changes than the control group （P＜0.01）.（6） In terms of uterine artery blood flow parameters， both groups showed a significant increase in PSV and significant decreases in PI and RI after treatment （P＜0.05）， with the observation group demonstrating significantly greater improvements than the control group （P＜0.05 or P＜ 0.01）.（7）Regarding safety， the incidence of adverse reactions was 9.30% （4/43） in the control group and 13.95% （6/43） in the observation group，with no statistically significant difference between the groups （P＞0.05）. Conclusion Zhibo Dihuang Pills combined with Femoston can effectively alleviate clinical symptoms， improve ovarian function，and enhance mitochondrial activity of ovarian granulosa cells in DOR patients with liver-kidney yin deficiency syndrome.

R271.9

国家重点研发计划项目（编号：2022YFC3500504）