知母藿藤汤联合仿生物电刺激与西药治疗卵巢储备功能减退不孕症肾虚血瘀证临床研究
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R271.14

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河南省中医药科学研究专项课题(2024ZY3026);河南省科技攻关项目(232102311216)


Clinical Study on Zhimu Huoteng Decoction Combined with Biomimetic Electrical Stimulation and Western Medicine for Infertility Due to Diminished Ovarian Reserve with Kidney Deficiency and Blood Stasis Syndrome
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    摘要:

    目的:观察知母藿藤汤联合仿生物电刺激与西药治疗卵巢储备功能减退不孕症肾虚血瘀证的疗效 与安全性。方法:选取2021年6月—2023年6月郑州市金水区总医院收治的110例卵巢储备功能减退不孕症肾 虚血瘀证患者,随机分为电刺激组和综合组。2组均给予服用戊酸雌二醇片/雌二醇环丙孕酮片与仿生物电刺激 治疗,综合组加予知母藿藤汤治疗。2组均至少治疗3个月经周期。治疗前、治疗3个月经周期后,检测2组患者 的Th1细胞比例、Th2细胞比例、Th1/Th2比值,性激素指标[卵泡刺激素(FSH)、黄体生成素(LH)、FSH/ LH比值、抗米勒管激素(AMH)、雌二醇(E2)]、窦卵泡数量(AFC)、卵巢体积(OV)、卵巢基质动脉血流 参数[收缩期峰值血流速度(PSV)、舒张期末峰值流速(EDV)、卵巢基质血管化指数(VI)、血流指 数(FI)],评估中医证候评分、月经失血图评分,统计临床疗效、妊娠率、流产率、不良反应发生率。结果:治 疗后,综合组总有效率高于电刺激组(P<0.05)。2组Th1细胞比例、Th1/Th2比值均较治疗前降低,Th2细胞 比例均较治疗前升高,差异均有统计学意义(P<0.05)。综合组Th1细胞比例、Th1/Th2比值均低于电刺激组, Th2细胞比例高于电刺激组,差异均有统计学意义(P<0.05)。2组FSH、LH水平及FSH/LH比值均较治疗前降 低,AMH、E2水平均较治疗前升高,差异均有统计学意义(P<0.05)。综合组FSH、LH水平及FSH/LH比值均 低于电刺激组,AMH、E2水平均高于电刺激组,差异均有统计学意义(P<0.05)。2组AFC、OV均较治疗前增 加(P<0.05)。综合组AFC多于电刺激组,OV大于电刺激组,差异均有统计学意义(P<0.05)。2组PSV、 EDV、VI、FI值均较治疗前升高(P<0.05)。综合组PSV、EDV、VI、FI值均高于电刺激组(P<0.05)。2组 中医证候积分均较治疗前降低,月经失血图评分均较治疗前升高,差异均有统计学意义(P<0.05)。综合组中 医证候积分均低于电刺激组,月经失血图评分高于电刺激组,差异均有统计学意义(P<0.05)。综合组妊娠率 高于电刺激组,流产率低于电刺激组,但差异均无统计学意义(P>0.05)。2组不良反应发生率比较,差异无 统计学意义(P>0.05)。结论:应用知母藿藤汤联合仿生物电刺激与西药治疗卵巢储备功能减退不孕症肾虚血 瘀证患者可提高临床疗效,有效改善卵巢功能,维持性激素水平稳定,安全性较好。

    Abstract:

    Abstract:Objective:To observe the efficacy and safety of Zhimu Huoteng Decoction combined with biomimetic electrical stimulation and western medicine in the treatment of infertility due to diminished ovarian reserve (DOR) with kidney deficiency and blood stasis syndrome. Methods:A total of 110 patients with infertility due to DOR with kidney deficiency and blood stasis syndrome admitted to The General Hospital of Jinshui District,Zhengzhou City,from June 2021 to June 2023 were selected and randomly divided into the electrostimulation group and the comprehensive group. Both groups received oral Estradiol Valerate Tablets/Estradiol Cyproterone Acetate Tablets and biomimetic electrical stimulation therapy, while the comprehensive group additionally received Zhimu Huoteng Decoction. Both groups underwent treatment for at least three consecutive menstrual cycles. Before treatment and after three menstrual cycles of treatment, the following were measured in both groups: the proportion of Th1 and Th2 cells and the Th1/Th2 ratio; sex hormone indicators [follicle-stimulating hormone (FSH),luteinizing hormone (LH),FSH/LH ratio,anti- Müllerian hormone (AMH),estradiol(E2)];antral follicle count (AFC);ovarian volume (OV);and ovarian stromal artery blood flow parameters [peak systolic velocity (PSV),end-diastolic velocity (EDV),vascularization index(VI), flow index(FI)]. Traditional Chinese medicine syndrome scores and Pictorial Blood Loss Assessment Chart (PBAC) scores were assessed. Clinical efficacy,pregnancy rate,miscarriage rate,and incidence of adverse reactions were also calculated. Results: After treatment, the total effective rate in the comprehensive group was higher than that in the electrostimulation group (P<0.05). In both groups,the Th1 cell proportion and Th1/Th2 ratio decreased compared to before treatment, while the Th2 cell proportion increased compared to before treatment, with all differences being statistically significant (P<0.05). The Th1 cell proportion and Th1/Th2 ratio in the comprehensive group were lower than those in the electrostimulation group, and the Th2 cell proportion was higher than that in the electrostimulation group, with all differences being statistically significant (P<0.05). FSH levels, LH levels, and FSH/LH ratios decreased in both groups compared to before treatment, while AMH and E2 levels increased compared to before treatment,with all differences being statistically significant (P<0.05). FSH level,LH level and FSH/LH ratio in the comprehensive group were lower than those in the electrostimulation group,while the AMH and E2 levels were higher than those in the electrostimulation group,with all differences being statistically significant (P<0.05). AFC and OV increased in both groups compared to before treatment (P<0.05). AFC was higher and OV was larger in the comprehensive group compared to the electrostimulation group (P<0.05). PSV,EDV,VI,and FI values increased in both groups compared to before treatment (P<0.05). PSV, EDV, VI, and FI values were higher in the comprehensive group than in the electrostimulation group (P<0.05). Traditional Chinese medicine syndrome scores decreased and PBAC scores increased in both groups compared to before treatment (P<0.05). Traditional Chinese medicine syndrome scores were lower and PBAC scores were higher in the comprehensive group compared to the electrostimulation group (P<0.05). The pregnancy rate in the comprehensive group was higher than that in the electrostimulation group, and the miscarriage rate in the comprehensive group was lower than that in the electrostimulation group, but the difference was not statistically significant (P>0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion: The application of Zhimu Huoteng Decoction combined with biomimetic electrical stimulation and western medicine in patients with infertility due to DOR with kidney deficiency and blood stasis syndrome can improve clinical efficacy, effectively enhance ovarian function,maintain stable sex hormone levels,and demonstrates good safety.

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孟萌,韩永梅.知母藿藤汤联合仿生物电刺激与西药治疗卵巢储备功能减退不孕症肾虚血瘀证临床研究[J].新中医,2026,58(2):39-45

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