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Title: Long-term effects of combined simvastatin and metformin treatment on the clinical abnormalities and ovulation dysfunction in single young women with polycystic ovary syndrome.
Author: Seyam E, Hefzy E.
Journal: Gynecol Endocrinol; 2018 Dec; 34(12):1073-1080. PubMed ID: 30044162.
Abstract:
The aim of the current work was to investigate the value of the long term effects of combined use of simvastatin and metformin treatment for a year versus the effects of their individual treatment on the clinical, biochemical abnormalities, and ovulation dysfunction in young single women with polycystic ovary syndrome (PCOS). It was a randomized, double-blind controlled study. Where two hundreds (n = 200) single young women with PCOS were randomized into seventy (n = 70) women using simvastatin 20 mg daily combined with metformin 500 mg three times daily considered as group A (study group), and another 2 sixty five (n = 65) women groups using simvastatin and metformin individually as a single treatment use, and considered as groups (B & C), respectively. Medications period extended for twelve months treatment period. The primary outcome measures were the changes in serum androgen levels (testosterone, androstendione, and dehydro-epiandrostenion sulfate-DHEAS), LH, FSH, LH/FSH ratio, and insulin resistance (IR), in addition to menstrual regularity, hirsutism, BMI, and W/H ratio. Spontaneous ovulation, confirmed with both trans-abdominal sonography (TAS) and luteal serum progesterone as well had been also evaluated. After 12 months' treatment, in group A serum testosterone showed significant decline by 37%, with significant drop in LH serum level (51%) and a marked decline of the LH/FSH ratio (53%). IR showed a significant improvement in groups A and C but still relatively higher in group B. There was also a clear decrease of total cholesterol (36%), low-density lipoprotein (LDL; 48%), and triglycerides (26%), and increased high-density lipoprotein (HDL) by 24% in groups A and B. Improved menstrual regularity and decreased hirsutism, acne, ovarian volume, and BMI had been significantly noticed in the study groups A and C, although still relatively higher in group C. Spontaneous ovulation had been confirmed in group A: songoraphically (TAS), and biochemically (progesterone >10 ng) in 10 women after the first six months treatment, and 26 at the end of 12 months treatment, compared to 5 & 8 in group B, and 2 & 5 in group C, respectively. Combined simvastatin and metformin treatment showed significant improvement of PCOS clinical and ovarian dysfunction abnormalities much better than their individual treatment. 摘要我们研究的目的是评价辛伐他汀和二甲双胍联合应用一年与单独用这两药治疗年轻单身多囊卵巢综合征（PCOS）患者相比, 在临床、生化异常和排卵功能障碍方面的长期影响。这是一项随机、双盲对照研究。200名单身年轻PCOS患者随机分为三组：A组（研究组, n=70）接受辛伐他汀20mg/日+二甲双胍500mg 3次/日, B组和C组（均为n=65）分别接受辛伐他汀或二甲双胍单一用药。药物治疗周期为12个月。主要的结果包括血清雄激素水平（睾酮、雄烯二酮、硫酸脱氢表雄酮）、LH、FSH、LH/FSH和胰岛素抵抗（IR）的变化, 还包括月经周期规律性、多毛、BMI和腰臀比的变化。自发性排卵通过经腹部超声检查（TAS）和黄体期血清孕酮值评估。经过12个月的治疗后, A组血清睾酮显著下降37%, 同时血清LH显著降低（51%）、LH/FSH 明显下降（53%）。A组和C组的IR明显改善, 而B组的IR仍然相对较高。在A组和B组, 总胆固醇（36%）、低密度脂蛋白（LDL, 48%）和甘油三酯（26%）也明显下降, 而高密度脂蛋白（HDL）升高24%。在A组和C组, 月经规律性显著提高而多毛、痤疮、卵巢体积和BMI显著降低, 尽管C组仍然相对较高。通过超声（TAS）和生化（孕酮>10ng）检查, 在A组有10名患者经过最初6个月的治疗后存在自发性排卵, 26名患者经过12个月的治疗后存在自发性排卵, 而B组的例数分别为5和8, C组的例数分别为2和5。辛伐他汀联合二甲双胍可以显著改善PCOS患者的临床特征和卵巢功能障碍, 疗效显著优于单一用药。.

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