依折麦布联合辛伐他汀对冠心病及糖尿病患者的血LDL-C达标和安全性观察

Influences and safety of ezetimibe combining simvastatin on control rate of LDL-C level in patients with coronary heart disease and diabetes

目的观察依折麦布联合辛伐他汀对冠心病及糖尿病患者血LDL-C达标率和安全性。方法选择血LDL-C未达标的冠心病及糖尿病患者46例,随机分成依折麦布(10mg/d)联合辛伐他汀(20mg/晚)组(联合治疗组)24例和他汀加倍治疗组22例(给予辛伐他汀40mg/晚)。观察两组患者降脂药物治疗后血脂水平变化及第4周、8周、12周时患者血LDL-C达标率、药物不良反应等。结果在降脂治疗第4、8和12周,联合用药组血LDL-C达标率均高于他汀加倍治疗组,第8、12周时两组患者达标率比较有显著统计学差异(P<0.01)。药物治疗12周时,两组患者血脂水平较治疗前均有改善,血LDL-C和TC水平与同组治疗前比较差异有统计学意义(P<0.01～0.05);两组患者药物治疗12周后血LDL-C和TC水平比较亦有显著统计学差异(P<0.01)。联合用药组患者均能耐受降脂治疗,他汀加倍治疗组中有2例(9.1%)患者因不良反应出现减量或停药。结论依折麦布联合辛伐他汀治疗较单纯加大辛伐他汀剂量治疗更能提高患者血LDL-C达标率,且具有良好耐受性。

Objective To observe the influences and safety of ezetimibe combining simvastatin on control rate of level of low-density lipoprotein-cholesterol（LDL-C） in patients with coronary heart disease（CHD） and diabetes.Methods The patients with CHD and diabetes（n=46） whose LDL-C level was not controled well were selected and randomly divided into group of ezetimibe（10 mg/d） combining simvastatin（20 mg/d）（combining group,n=24） and group of simvastatinin in double dose（40 mg/d,simvastatinin group,n=22）.The changes of blood fat level after treatment,control rate of LDL-C level on the 4th week,8th week and 12th week,and adverse reactions were observed in two groups.Results On the 4th week,8th week and 12th week after treatment,the control rate of LDL-C level was higher in combining group than that in simvastatinin group,and on the 8th week and 12th week the difference in the control rate showed a statistical significance between two groups（P〈0.01）.On the 12th week,blood fat level was ameliorated in two groups,and the difference in the levels of LDL-C and total cholesterol（TC） had statistical significance compared with those in the same group before the treatment（P〈0.01 to P〈0.05）.The comparison in the levels of LDL-C and TC showed a significant and statistical difference between two group 12 weeks after treatment（P〈0.01）.The patients could tolerate the treatment in combining group,and in simvastatinin group the drug was increased in dose or ceased in 2 patients（9.1%） because of adverse reactions.Conclusion Ezetimibe combining simvastatin can promote better the control rate of LDL-C level than only simvastatin and can be tolerated well.