二甲双胍与吡格列酮治疗多囊卵巢综合征的疗效和安全性

Clinical Efficacy and Safety of Metformin or Pioglitazone in the Treatment of Polycystic Ovary Syndrome

目的探讨了二甲双胍或吡格列酮联合炔雌醇环丙孕酮治疗多囊卵巢综合征(PCOS)的临床疗效,为PCOS的联合用药治疗提供更多的循证医学证据。方法收集笔者医院2014年3月~2016年11月收治的PCOS患者132例,使用数字表法随机分为二甲双胍组和吡格列酮组,每组66例。使用电化学发光法测定卵泡刺激素(FSH)、黄体生成素(LH)、睾酮(T)及雌二醇(E_2)水平。采用比色法测定总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL-C)、高密度脂蛋白(HDL-C)。稳态模型测定胰岛素分泌指数(HOMA-β)和胰岛素抵抗指数(HOMA-IR)。比较两组临床疗效和不良反应。结果治疗前两组间FSH、LH、T和E_2激素水平比较,差异无统计学意义(P>0.05),治疗后两组FSH、LH、T均显著减低和E_2均显著升高(P<0.01),但治疗后两组FSH、LH、T和E_2激素水平比较,差异无统计学意义(P>0.05)。二甲双胍组有效率为90.9%(60/66),吡格列酮组有效率为93.9%(62/66),两组间临床疗效比较,差异无统计学意义(P>0.05)。治疗前两组TC、TG、LDL-C、HDL-C、HOMA-β和HOMA-IR水平比较,差异无统计学意义(P>0.05),治疗后两组TC、TG、LDL-C、HOMA-β和HOMA-IR均显著减低和HDL-C均显著升高(P<0.05和P<0.01),但治疗后两组TC、TG、LDL-C、HOMA-β和HOMA-IR水平比较,差异无统计学意义(P>0.05),治疗后吡格列酮组HDL-C水平显著高于二甲双胍组(P<0.05)。吡格列酮组治疗后BMI为25.64±5.35kg/m^2,显著高于二甲双胍组的21.31±4.13kg/m^2(P<0.05),吡格列酮组治疗期间胃肠道不良反应率为13.6%,显著低于二甲双胍组的27.3%(P<0.05)。结论炔雌醇环丙孕酮联合二甲双胍或吡格列酮治疗PCOS临床疗效显著,但吡格列酮可显著升高HDL-C,具有低的胃肠道不良反应率,而二甲双胍可以减轻患者体重,根据患者的临床特点,可以合理地选择药物联合治疗PCOS。

Objective To observe the clinical efficacy and safety of estradiol and progesterone combined with metformin or pioglita- zone in the treatment of polycystic ovary syndrome（PCOS）. Methods Totally 132 PCOS patients in our hospital were collected in this study. Patients were randomly divided into metformin group and pioglitazone group, 66 cases in each group. The expression of FSH, LH, T, and E2 was detected by electrochemiluminescence. TC, TG, LDL - C, and HDL - C was detected by colorimetry. HOMA - and HOMA- IR were determined by the steady state model. The clinical efficacy and adverse reactions were compared between the two groups. Results FSH, LH, T and E2 levels had no significant difference between the two groups before treatment （P 〉 0.05）. After treat- ment, FSH, LH and T were significantly decreased in the two groups, and E2 were significantly increased （P 〈 0, 01 ）. But, there was no significant differences of FSH, LH, T and E2 levels between the two groups after treatment （P 〉 0.05）. The effective rate in metformin group was 90.9% （60/66） , and in pioglitazone group was 93.9% （62/66）. There was no significant difference between the two groups （P 〉0.05）. There was no significant difference in TC, TG, LDL -C, HOMA - and HOMA -IR levels between the two groups after treatment （P 〉 0.05）. However, the level of HDL- C was significantly higher in pioglitazone group than that in metformin group （P 〈 0.05）. The BMI of pioglitazone group was 25.64 ± 5.35kg/m^2 , which was significantly higher than that of 21.31± 4.13kg/m^2 in met- formin group （P 〈 O. 05）. The gastrointestinal adverse reaction rate was 13.6% in pioglitazone group, which was significantly lower than that of 27.3% in metformin group （ P 〈 0.05）. Conclusion The clinical efficacy of estradiol and progesterone combined with metformin or pioglitazone in treatment of PCOS was significantly. But pioglitazone significantly increased HDL - C, with lower gastrointestinal adverse reaction rate, and metformin can reduce the patient weight.