国产与进口辛伐他汀治疗原发性高胆固醇血症的临床疗效比较  

Imported vs domestic simvastatin in treating primary hypercholestrolemia

作　　者：张启高[1] 江时森[1] 陈锐华[1] 张丽蓉[2] 龙明智[3] 杨明智[4] 

机构地区：[1]中国人民解放军南京军区南京总医院,江苏南京210002 [2]南京铁道医学院附属医院,江苏南京210009 [3]南京医科大学第二附属医院,江苏南京210011 [4]南京市胸科医院,江苏南京210024

出　　处：《中国新药与临床杂志》2002年第8期470-472,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :比较国产与进口辛伐他汀的临床疗效、安全性。方法 :将 1 5 9例病人随机分为国产辛伐他汀组 (n =1 0 0 )及进口辛伐他汀组 (n =5 9) ,分别口服国产及进口辛伐他汀 ,每晚 1 0mg ,服用 8wk。观察用药 4wk及 8wk病人血脂的变化。结果 :服药 4wk和 8wk后 2组病人血清总胆固醇 (TC)、三酰甘油 (TG)、低密度脂蛋白胆固醇 (LDL C)水平及TC -HDL C/HDL C明显降低 ,高密度脂蛋白胆固醇 (HDL C)明显升高 ,服药 4wk即有明显疗效 ,不良反应轻 ,2组比较调脂疗效差异无显著意义 (P >0 .0 5 )。结论 :国产辛伐他汀调血脂作用疗效肯定、使用安全 ,与进口辛伐他汀比较基本相当。AIM: To compare the effects and safety of domestic simvastatin with those of importe one in the treatment of hyperlipidemia. METHODS: One hundred and fifty nine patients with hyperlipidemia were randomly divided into domestic simvastatin group( n =100) and imported simvastatin group( n =59). They were given domestic or imported simvastatin respectively, 10 mg qd for 8 wk. Serum lipids were measured at 4 and 8 wk of the trial period. RESULTS: At 4 and 8 wk after receiving domestic or imported simvastatin serum total cholesterol(TC), triacylglyceral(TG), Low density lipoprotein cholesterol(LDL C) and TC-HDL C/ HDL C were decreased signifcantly( P <0.01), HDL C was increased significantly( P <0.01). After 4 wk's treatment, there was siginficant effect and the adverse reactions were mild. There were no obvious differences in lipid regulation between two groups. CONCLUSION: Domestic simvastatin has lipid regulating effects and safety as imported simvastatin does.

关 键 词：辛伐他汀 治疗 原发性高胆固醇血症 临床疗效 高血脂药 高脂血症 

分 类 号：R589.2[医药卫生—内分泌] R972.6[医药卫生—内科学]