辛伐他汀联合依折麦布对男性冠心病患者睾酮水平

Effects of simvastatin combined with ezetimibe on testosterone and blood glucose in male patients with stable coronary artery disease

摘要:

目的：评估辛伐他汀联合依折麦布对男性冠心病患者睾酮水平的影响，同时观察二者联用对患者糖代谢的影响。方法：选取本院2013年6月至2014年6月门诊及住院患者90例查取随机数字表法随机分为2组，试验组予辛伐他汀40 mg/d联合依折麦布10 mg/d治疗，对照组单用辛伐他汀40 mg/d治疗，疗程12周。观察2组患者治疗前后睾酮（testosterone，T）、空腹血糖（fasting blood glucose，FBG）、糖化血红蛋白（glycosylated hemoglobin A1c，HbA1c）的变化及药物不良反应。结果：2组各指标在基线时无统计学差异（P ＞0.05）。经过12周的治疗，2组总胆固醇（total cholesterol，TC）和低密度脂蛋白（low-density lipopro－tein-cholesterol，LDL-C）水平较基线均有明显下降（P＜0.05），其中治疗组较对照组下降更为明显（P＜0.05）。试验组的睾酮水平有轻微下降（P=0.085），而对照组未见明显变化，2组之间比较无差异。2组患者的FBG及HbA1c较治疗前无明显改变。不良反应方面，2组之间没有明显差别（P ＞0.05），不良反应大都发生在治疗初期且较轻微，无需停药都能缓解。结论：辛伐他汀40 mg/d联合依折麦布10 mg/d能够更好的降低冠心病男性患者的LDL-C水平，且对患者的睾酮水平无明显影响，短期内未见二者联用对患者糖代谢有不良影响。

Abstract:

Objective：To evaluate the effect of simvastatin combined with ezetimibe on testosterone values in male patients with stable coronary artery disease（SCAD） and without diabetes；to observe the blood glucose level after the combined therapy. Methods：A sin－gle-center，randomized，open-label trial involving 90 patients was conducted. The patients were randomized into two groups：the trial group received 40 mg per day of simvastatin plus 10 mg per day of ezetimibe and the control group received simvastatin 40 mg per day alone；the treatment in both groups lasted for 12 weeks. Testosterone，fasting blood glucose（FBG），glycosylated hemoglobin A1c（HbA1c），lipid profiles were determined at the enrollment and at the end of the treatment. Results：Both treatments were equally effective in increasing total cholesterol（TC） and low-density lipoprotein-cholesterol（LDL-C）（P＜0.05）. TC and LDL-C levels were lowered in trial group than in control group（P＜0.05）. At the end of study，testosterone levels remained unchanged in control group and slightly decreased in trial group（P=0.085）. No explicit elevation in FBG or HbA1c was observed in both groups after the treatment. Safety and tolerability profiles were similar in the two groups. Conclusion：Simvastatin 40 mg combined with ezetimibe 10 mg can reduce LDL-C without affecting testosterone levels. No side effect in glycometabolism is observed in the short term.