补肾化痰活血方治疗多囊卵巢综合征合并胰岛素抵抗不孕症的临床研究

Clinical effect of Bushen Huatan Huoxue Decoction treating polycystic ovary syndrome with insulin resistance infertility

关键词:  补肾化痰活血方  PCOS  胰岛素抵抗  妊娠率  子宫内膜血流

Key words:  Bushen Huatan Huoxue Decoction  PCOS  insulin resistance  pregnancy rate  endometrial blood flow

摘要:

[目的] 观察补肾化痰活血方治疗多囊卵巢综合征合并胰岛素抵抗（PCOS-IR）不孕症的临床疗效。[方法] 将62例肾虚痰瘀型PCOS-IR不孕症患者随机分为治疗Ⅰ组和治疗Ⅱ组，每组各31例。两组均给予基础干预，治疗Ⅰ组给予二甲双胍，治疗Ⅱ组给予补肾化痰活血方，治疗及随访周期均为3个月。统计两组的妊娠及排卵情况，比较两组治疗前后身体质量指数（BMI）、中医证候积分、糖代谢指标[空腹血糖（FBG）、空腹胰岛素（FINS）、胰岛素抵抗指数（HOMA-IR）]、性激素水平[睾酮（T）、促黄体生成素（LH）、促卵泡刺激素（FSH）、LH/FSH、雌二醇（E₂）、催乳素（PRL）]、着床期（排卵后6~9 d）子宫内膜三维超声参数[厚度、分型、容积、血管化指数（VI）、血流指数（FI）、血管化-血流指数（VFI）]和不良反应。[结果] 与治疗前比较，治疗后两组的BMI、中医证候积分、FINS、HOMA-IR、LH、LH/FSH水平均降低（P＜0.01或P＜0.05），且治疗Ⅱ组的中医证候积分降低显著（P＜0.01）。与治疗Ⅰ组比较，治疗Ⅱ组的周期排卵率较高，但比较后差异无统计学意义（P＞0.05），着床期子宫内膜血流参数VI、VFI水平较高（P＜0.05）。治疗结束及随访后，治疗Ⅱ组的临床妊娠率分别为61.54%（16/26）和73.08%（19/26），明显高于治疗Ⅰ组对应时间节点的妊娠率[33.33%（8/24）和41.67%（10/24）]，差异有统计学意义（P＜0.05），且胚胎停育率更低（P＜0.05）。治疗Ⅱ组的不良反应率显著低于治疗Ⅰ组（15.38% vs 41.67%，P＜0.05）。[结论] 补肾化痰活血方治疗肾虚痰瘀型PCOS-IR不孕症临床效果良好，能够改善胰岛素抵抗及肥胖体征，调节内分泌紊乱，显著增加着床期子宫内膜血流灌注，提高临床妊娠率并改善妊娠结局，且不良反应小，值得推广应用。

Abstract:

[Objective] To observe the clinical effects of Bushen Huatan Huoxue Decoction（BHHD） in the treatment of polycystic ovary syndrome with insulin resistance（PCOS-IR） infertility and its effect on endometrial receptivity. [Methods] A randomized controlled trial was conducted，62 PCOS-IR infertility patients with kidney deficiency and phlegm stasis were divided into treatment groupⅠand treatment groupⅡ，31 in each group. On the premise of routine intervention，metformin was used in groupⅠ，and BHHD was used in groupⅡ. The treatment and follow-up period were 3 months. The cycle ovulation rate and clinical pregnancy rate were recorded. The body mass index（BMI），traditional Chinese medicine（TCM） syndrome score，glucose metabolism indexes [fasting blood glucose（FBG），fasting insulin（FINS），insulin resistance index（HOMA-IR）]，sex hormone levels [testosterone（T），luteinizing hormone（LH），follicle stimulating hormone（FSH），LH/FSH，estradiol（E2），prolactin（PRL）]，three-dimensional ultrasound parameters of endometrium [thickness， classification，volume，vascularization index（VI），flow index（FI），vascularization-flow index（VFI）] during implantation（6-9 days after ovulation） and adverse effects rate were detected and compared between the two groups of patients before and after the treatments. [Results] Compared with before treatment in the same group，the levels of TCM syndrome score，BMI，FINS，HOMA-IR，LH and LH/FSH of patients in two groups were reduced（P＜0.01，P＜0.05），and TCM syndrome score in groupⅡwas obviously reduced（P＜0.01）. There was no significant difference in cycle ovulation rate between the two groups（P＞0.05），and the level of VI and VFI in groupⅡ were significantly improved compared with the groupⅠ（P＜0.05）. The clinical pregnancy rate of groupⅡ was 61.54%（16/26） and 73.08%（19/26） after treatment and follow-up，which was significantly higher than the clinical pregnancy rate at the corresponding time point in treatment groupⅠ [33.33%（8/24） and 41.67%（10/24）]（P＜0.05），and the embryo abortion rate was lower（P＜0.05）. The adverse reaction rate of groupⅡ was significantly lower than that of groupⅠ（15.38% vs 41.67%，P＜0.05）. [Conclusion] BHHD could improve the clinical symptoms of PCOS-IR infertility patients with kidney deficiency and phlegm stasis，improved insulin resistance and obesity signs，regulated reproductive endocrine disorders，significant increased endometrial blood perfusion during implantation，promoted clinical pregnancy rate，improved pregnancy outcome and reduced the incidence of adverse reactions，and is worthy of clinical popularization and application.