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| 坤泰胶囊干预卵巢储备功能减退相关不孕的临床观察<sub><sup> </sup></sub> |
| Clinical Observation of Kuntai Capsules in the Treatment of Infertility Caused by Diminished Ovarian Reserve of Kidney Yin Deficiency Type |
| 投稿时间：2026-09-25 修订日期：2026-09-25 |
| DOI： |
| 中文关键词: 坤泰胶囊 卵巢储备功能减退 不孕 肾阴虚证 分阶段疗法 免疫活性因子 |
| 英文关键词: Kuntai Capsules diminished ovarian reserve infertility kidney yin deficiency type phased therapy immune-active cytokine |
| 基金项目:河南省医学科技攻关计划（联合共建）项目（编号：LHGJ20234094） |
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| 中文摘要: |
| 目的：探讨坤泰胶囊治疗肾阴虚型卵巢储备功能减退(DOR)相关不孕患者的临床疗效。方法：收集2024年6月-2025年10月就诊的78例肾阴虚型DOR相关不孕患者,随机分为对照组(安慰剂 + 雌孕激素、促排卵分阶段疗法)、观察组(坤泰胶囊+ 雌孕激素、促排卵分阶段疗法)。比较2组治疗前后的月经及肾阴虚证候评分、血清激素[卵泡刺激素(FSH)、黄体生成素(LH)、FSH/LH、雌二醇(E<sub>2</sub>)及抗缪勒管激素(AMH)]水平、超声学指标[窦卵泡计数(AFC)、子宫内膜厚度及卵巢基质血流阻力指数(RI)]、血清免疫活性因子[白介素2(IL-2)、γ干扰素(IFN-γ)、肿瘤坏死因子α(TNF-α)]水平；随访2组患者的临床妊娠结局,计算妊娠率和早期流产率；判定临床疗效并计算总有效率；监测2组患者的体征及不良反应发生情况,初步评价用药方案的安全性。结果：观察组患者总有效率为89.74%,显著高于对照组的71.79%(P < 0.05)；观察组月经不规律、经血异常等症状及肾阴虚证候明显缓解,月经及证候评分较治疗前及对照组均显著降低(P < 0.05)；与治疗前比较,观察组治疗后的血清FSH、LH水平及FSH/LH显著降低(P < 0.05),E<sub>2</sub>水平及子宫内膜厚度则显著增加(P < 0.05)；观察组AMH水平、AFC较治疗前及对照组均显著增加(P < 0.05),RI值则显著降低(P < 0.05)；与治疗前及对照组比较,观察组血清IL-2、IFN-γ、TNF-α水平显著降低(P < 0.05)；观察组临床妊娠率48.72%,显著高于对照组的20.51%(P < 0.05)；2组患者的用药方案安全性良好。结论：坤泰胶囊可有效改善肾阴虚型DOR相关不孕患者的卵巢储备功能及子宫内膜容受性,下调免疫活性因子表达,提高妊娠率与临床总有效率。 |
| 英文摘要: |
| Objective: This study aims to assess the clinical efficacy of Kuntai Capsules in the treatment of infertile patients with diminished ovarian reserve of kidney yin deficiency type (KYD-DOR). Methods: A total of 78 patients diagnosed with KYD-DOR infertility between June 2024 and October 2025 were recruited and randomly allocated to either a control group (receiving placebo in combination with the phased therapy with estrogen-progesterone plus ovulation-inducing drugs) or an observation group (receiving Kuntai Capsules in combination with the phased therapy). Evaluations included calculation of menstrual cycles and syndrome scores, measurement of serum hormones (FSH, LH, E2 and AMH), ultrasound parameters (AFC, endometrial thickness and RI) and immune-active cytokines (IL-2, IFN-γ and TNF-α). Clinical pregnancy outcomes, including pregnancy and early miscarriage rates, were monitored post-treatment. Clinical efficacy was evaluated by calculating the overall response rate in both groups. The safety of the treatment regimen were preliminarily evaluated in both groups. Results: The observation group demonstrated a significantly higher overall response rate (89.74%) compared to the control group (71.79%) (P < 0.05). Notable improvements in kidney yin deficiency syndrome and menstrual symptoms such as irregular menstruation and abnormal menstrual bleeding were observed in the observation group, with significant reductions in menstrual and syndrome scores relative to baseline and the control group (P < 0.05). After the treatment, the observation group exhibited significant decreases in serum FSH, LH and FSH/LH levels (P < 0.05), alongside significant increases in E2 levels and endometrial thickness (P < 0.05). AMH levels and AFC were significantly elevated, while RI values were significantly reduced compared to both pre-treatment values and the control group (P < 0.05). Additionally, serum concentrations of IL-2, IFN-γ, and TNF-α were markedly decreased in the observation group relative to baseline and controls (P < 0.05). The clinical pregnancy rate in the observation group (48.72%) was significantly greater than that in the control group (20.51%) (P < 0.05). The safety profile of the treatment regimen was deemed satisfactory in both groups. Conclusion: Kuntai Capsules effectively enhance ovarian reserve function and endometrial receptivity in patients with KYD-DOR infertility, thereby improving pregnancy rates and overall clinical outcomes. These therapeutic effects may be mediated through the downregulation of immune-active cytokines. |
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