依折麦布联合辛伐他汀治疗高胆固醇血症的疗效和安全性研究

Combination of Ezetimibe and Simvastatin on Patients with Hypercholesteremia Effectiveness and Safty of Atorvastatin

目的探讨依折麦布联合辛伐他汀治疗高胆固醇血症的疗效和安全性。方法选择2007年3月—2008年9月我院诊治的原发性高胆固醇血症患者311例,随机分为3组,A(依折麦布)组、B(辛伐他汀)组和C(联合用药)组。分别使用10mg/d依折麦布、不同剂量辛伐他汀、10mg/d依折麦布与不同剂量辛伐他汀联合治疗12周,检测3组患者治疗前后血浆甘油三脂(TC)、高密度脂蛋白(HDL-C),低密度脂蛋白(LDL-C),载脂蛋白B(Apo-B)情况,并分析比较治疗效果及安全性。结果治疗后C组TC、HDL-C、LDL-C和Apo-B与治疗前比较,差异有统计学意义(P<0.05,P<0.01),平均变化量与A组、B组比较,差异有统计学意义(P<0.01)。联合用药的调节程度与辛伐他汀的剂量无关(P>0.05),依折麦布与最小剂量(10mg/d)的辛伐他汀联用降低LDL-C的作用优于大剂量单独辛伐他汀(P<0.01)。C组总有效率为69.8%,明显高于A组和B组(P<0.01)。不良反应的发生率3组间差异无统计学意义(P>0.05)。结论依折麦布联合辛伐他汀具有较好的调节胆固醇代谢的作用,效果显著优于单独使用,其安全性较好。

OBJECTIVE To observe the therapeutic effectiveness and safiy of ezetimibe combined with Simvastatin on patients with hy- percholesteremia. METHODS Hypercholesteremia patients were divided into three groups, A（Ezetimibe） group, B （Simvastatin） group, C （combination） group, which were treated with correspond methods.Twelve weeks later patients＇ plasma level of TC, HDL-C, LDL-C and Apo-B were detected, and the results were analysed.RESULTS： （1）There was significant difference on of patients in group C between pretherapy and post-treatment （P〈0.05, P〈0.01 ） .The difference of average change rates also had statistical significance between patients in three groups （P〈0.01） .（2）There was no relationship between the change level of TC, HDL-C, LDL-C, Apo-B and Simvastatin dosage, in patients of C group. In respect of lowering LDL-C level, Ezetimibe and simvastatin （10 mg/d） was better than Simvastatin （large dosage） . The total effective rate of patients in group C was 69.8%, which were higher than that in group A and B （P〈0.01） .The side effects rates had no difference between three groups statistically （P〉0.05） . CONCLUSION The effect of combination of ezetimibe and simvastatin is better than that ezetimibe and simvastatin alone, in regulating cholesterol metabolism, and combination of Ezetimibe and Simvastatin is safe.