Seyam Emaduldin, Al Gelany Saad, Abd Al Ghaney Ahmed, Mohamed Marwa Abd Allah, Youseff Ayman Moheb, Ibrahim Emad Moussa, Khalifa Eissa M, Hefzy Enas
a Obstetrics and Gynecology Department , Minia University College of Medicine , Minia , Egypt.
b Microbiology and Immunology Department , Fayoum University College of Medicine , Fayoum , Egypt.
Gynecol Endocrinol. 2018 Jul;34(7):589-596. doi: 10.1080/09513590.2017.1418853. Epub 2017 Dec 19.
The aim of the current work was to investigate the effects of prolonged use of Statins on the clinical and biochemical abnormalities and ovulation dysfunction in young single women with polycystic ovary syndrome (PCOS).
It was a randomized, double-blind, placebo-controlled study. Where 200 single young women with PCOS were randomized into either 100 (n = 100) women using Simvastatin 20 mg daily considered as group A (study group), or 100 (n = 100) women using placebo and considered as group B (control group), for six months treatment period. The main 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. Follow-up of spontaneous ovulation, confirmed with both trans-abdominal sonography (TAS) and luteal serum progesterone had been performed as well.
RESULT(S): After 6 months' treatment, in group A serum testosterone showed decreased level by 28%, with significant decrease of LH (40%) and a decline of the LH/FSH ratio (43%). There was also a clear decrease of total cholesterol (26%), low-density lipoprotein (LDL; 39%) and triglycerides (23%). IR did not show a significant difference in the two groups. High-density lipoprotein (HDL) increased by 17%. Improved menstrual regularity and decreased hirsutism, acne, ovarian volume, BMI had been clearly noticed in the study group. Spontaneous ovulation had been confirmed songoraphically (TAS), and biochemically (progesterone >10 ng) in 10 women (10%) in the study group compared to none in the control group.
Long-term Statins' treatment was associated with clear improvement of all PCOS clinical and biochemical abnormalities, in addition to ovarian dysfunction as well.
本研究旨在探讨长期使用他汀类药物对年轻多囊卵巢综合征（PCOS）单身女性临床及生化异常和排卵功能障碍的影响。
这是一项随机、双盲、安慰剂对照研究。200名单身年轻PCOS女性被随机分为两组，100名（n = 100）女性每日服用20毫克辛伐他汀作为A组（研究组），另外100名（n = 100）女性服用安慰剂作为B组（对照组），治疗期为6个月。主要观察指标包括血清雄激素水平（睾酮、雄烯二酮和硫酸脱氢表雄酮 - DHEAS）、促黄体生成素（LH）、促卵泡生成素（FSH）、LH/FSH比值和胰岛素抵抗（IR）的变化，以及月经规律性、多毛症、体重指数（BMI）和腰臀比（W/H）。同时通过经腹超声检查（TAS）和黄体期血清孕酮测定对自然排卵情况进行随访。
治疗6个月后，A组血清睾酮水平下降28%，LH显著下降（40%），LH/FSH比值下降（43%）。总胆固醇（26%）、低密度脂蛋白（LDL；39%）和甘油三酯（23%）也明显降低。两组IR无显著差异。高密度脂蛋白（HDL）升高17%。研究组月经规律性改善，多毛症、痤疮、卵巢体积和BMI均明显下降。研究组有10名女性（10%）经超声（TAS）和生化检查（孕酮>10 ng）证实有自然排卵，而对照组无。
长期他汀类药物治疗除改善卵巢功能障碍外，还能明显改善所有PCOS临床及生化异常。
