多囊卵巢综合征女性在卵胞浆内单精子注射周期前服用二甲双胍和辛伐他汀的比较：一项前瞻性、随机临床试验研究。
Comparison of Metformin and Simvastatin Administration in Women With Polycystic Ovary Syndrome Before Intra-Cytoplasmic Sperm Injection Cycle: A Prospective, Randomized, Clinical Trial Study.
作者信息
Pourmatroud Elham, Mohammadjafari Razieh, Roozitalab Mandana
机构信息
Obstetrics and Gynecology Department, Infertility Fellow, Emam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IR Iran.
Obstetrics and Gynecology Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, IR Iran.
出版信息
Iran Red Crescent Med J. 2015 Dec 12;17(12):e20082. doi: 10.5812/ircmj.20082. eCollection 2015 Dec.
BACKGROUND
Drugs administration as a pretreatment regiment before ICSI cycle in PCOs patients could enhance the success rate.
OBJECTIVES
The aim of this study was to compare the effectiveness of metformin with Simvastatin in patients with polycystic ovary syndrome (PCOs) candidates for intra-cytoplasmic sperm injection (ICSI) before starting the cycle.
PATIENTS AND METHODS
In this prospective, double blind, randomized clinical trial the efficacy of these drugs was evaluated in 40 women with PCO syndrome (20 patients in each group; A: simvastatin and B: metformin) candidates for ICSI. In the both groups, metformin and simvastatin administrated for eight weeks before starting the ICSI cycle. Endocrine, metabolic and clinical parameters were measured before and after drug therapy; also, the results of ICSI cycle evaluated in the both groups.
RESULTS
Both drugs improved hirsutism score significantly, but simvastatin better than metformin (Group A, 24.5 ± 3.6 P: 0.0001 VS Group B, 22.9 ± 5.9 P: 0.003). The reduction in body mass index (BMI) was not significant in the groups. Simvastatin reduced some biochemical parameters such as FSH, LH, testosterone, total cholesterol, LDL and increased HDL level significantly, whereas metformin decreased FSH, TG, testosterone and total cholesterol significantly. Overall, respectively 35% and 30% of patients treated with metformin and Simvastatin became pregnant. There was no significant difference between the effects of these two drugs on ICSI cycle results like oocyte in meiosis2 (M2) phase (1.35 ± 1.6 vs. 2 ± 3.87, P value: 0.4) and the number of Grade A, embryo (1.2 ± 1.3 vs. 1.1 ± 1.4, P value: 0.7).
CONCLUSIONS
Simvastatin effectively improved hyperandrogenism signs and symptoms in patients with PCO, but this effect as a pretreatment regiment was not more expressive than metformin in ICSI cycle outcome.
背景
在多囊卵巢综合征（PCOS）患者的卵胞浆内单精子注射（ICSI）周期前进行药物预处理可提高成功率。
目的
本研究旨在比较二甲双胍与辛伐他汀对准备开始ICSI周期的多囊卵巢综合征（PCOS）患者的有效性。
患者与方法
在这项前瞻性、双盲、随机临床试验中，对40例准备进行ICSI的PCOS综合征女性患者（每组20例；A组：辛伐他汀；B组：二甲双胍）评估了这些药物的疗效。两组均在开始ICSI周期前服用二甲双胍和辛伐他汀8周。在药物治疗前后测量内分泌、代谢和临床参数；同时，评估两组ICSI周期的结果。
结果
两种药物均显著改善多毛症评分，但辛伐他汀优于二甲双胍（A组，24.5±3.6，P：0.0001；B组，22.9±5.9，P：0.003）。两组体重指数（BMI）的降低不显著。辛伐他汀显著降低了一些生化参数，如促卵泡激素（FSH）、促黄体生成素（LH）、睾酮、总胆固醇、低密度脂蛋白（LDL），并显著提高了高密度脂蛋白（HDL）水平，而二甲双胍显著降低了FSH、甘油三酯（TG）、睾酮和总胆固醇。总体而言，分别有35%和30%接受二甲双胍和辛伐他汀治疗的患者怀孕。这两种药物对ICSI周期结果的影响，如减数分裂2期（M2）卵母细胞（1.35±1.6对2±3.87，P值：0.4）和A级胚胎数量（1.2±1.3对1.1±1.4，P值：0.7），没有显著差异。
结论
辛伐他汀有效改善了PCOS患者的高雄激素血症体征和症状，但作为预处理方案，在ICSI周期结果方面，其效果并不比二甲双胍更显著。
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