目的：探讨二甲双胍治疗难治性多囊卵巢综合征（ PCOS）的临床疗效以及安全性。方法选择2008年7月至2012年1月武汉市江夏区第一人民医院收治的130例难治性 PCOS患者作为研究对象，将其按随机数表法分成观察组和对照组，各65例。其中对照组单独使用炔雌醇环丙孕酮片治疗，口服治疗，1片／（次・d），治疗6个周期，观察组在对照组的基础上给予二甲双胍治疗，治疗方法为口服二甲双胍肠溶片，2片／次，每日3次，分为早、中、晚三餐进行服用。比较两组患者的临床疗效以及性激素变化水平和不良反应发生情况等。结果观察组总有效率显著高于对照组［87．7％（57／65）比72．3％（47／65）］，差异有统计学意义（P ＜0．05）；两组患者治疗前各激素水平差异无统计学意义（P ＞0．05），治疗后，观察组黄体生成素（LH）、卵泡刺激素（FSH）、雌二醇、睾酮水平均显著低于治疗前（P ＜0．05），治疗后观察组FSH 及雌二醇显著低于对照组［（4．0±0．6） U／L 比（5．0±1．1） U／L、（27±7） pg／L 比（35±5） pg／L］，差异有统计学意义（P ＜0．05）；观察组排卵率、妊娠率均高与对照组患者［78．5％（51／65）比52．3％（34／65），84．6％（55／65）比61．5％（40／65）］，差异有统计学意义（P ＜0．05）；两组治疗期间不良反应症状均较轻，均可自行缓解。结论在使用炔雌醇环丙孕酮片的基础上，加用二甲双胍治疗难治性PCOS，具有显著的疗效，安全性高，适合在临床上推广应用。%Objective To investigate the clinical efficacy and drug safety of metformin in treating refrac-tory polycystic ovary syndrome( PCOS) .Methods Total fo 130 PCOS patients in Jiangxia District First Peo-ple′s Hospital from Jul.2008 to Jan.2012 were included in the study,which according to the random number table method were divided into observation group and control group of 65 cases each.The control group was treated with ethinylestradiol and cyproterone acetate tablets oral treatment , 1 tablet/( d・ time ) , for six cycles,while the observation group was added insulin sensitizer treatment on the basis of the control group′s treatment plan,specifically oral metformin enteric-coated tablets,2 tablets/time,3 times/d,after three meals. The clinical efficacy, sex hormones levels and adverse reactions were compared between the two groups. Results The total effective rate of the observation group was statistically higher than the control group [87.7% (57/65) vs 72.3% (47/65),P <0.05];before treatment there was no statistically significant difference in hormone levels between the two groups(P>0.05),after treatment luteinizing hormone(LH), follicle stimulating hormone(FSH),estradiol(E2),testosterone(T) levels of the observation group were sig-nificantly decreased from before treatment ( P <0.05 ) , after treatment the FSH and E 2 of the observation group were significantly lower than the control group[(4.0 ±0.6) U/L vs (5.0 ±1.1) U/L,(27 ±7) pg/L vs (35 ±5)pg/L] (P<0.05);ovulation rate and pregnancy rate of the observation group were significantly higher than the control group[78.5%(51/65) vs 52.3%(34/65),84.6%(55/65) vs 61.5%(40/65),P<0.05];adverse reactions of both groups were mild,and relieved without intervention/treatment.Conclusion On the basis of the use of ethinylestradiol and cyproterone acetate tablets ,the combination use of metformin for treatment of PCOS,has a significant effect,and high safety,thus is suitable for clinical application .
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