【摘要】 目的评价国产与进口辛伐他汀片治疗原发性高胆固醇血症的疗效和安全性。方法采用开放、区组随机对照、多中心设计。156例原发性胆固醇血症患者每晚顿服进口或国产辛伐他汀片10mg,疗程8wk,观察并对比调脂疗效和副反应。其中验证组56例、对照组56例、开放组44例。结果验证组与对照组比较 ,服药后血清总胆固醇(TC)分别下降26 73 %和25 62 % ,低密度脂蛋白胆固醇(LDL_C)分别下降40.47 %和36 41 % ,总有效率分别为94 64 %和91 07 % ,两组调脂疗效、各项安全性指标、不良反应均无统计学差异。开放组TC下降25 50 % ,LDL_C下降40 57 % ,总有效率为86 36 % ,不良反应发生率为11 36 %。结论国产辛伐他汀片的治疗作用与安全性和进口辛伐他汀片相同更多还原

【Abstract】 Aim The efficacy and safety of the domestic simvastatin in the treatment of primary hypercholesterolemia were compared with those of the imported simvastatin.Methods A controlled, multicenter, open_label and randomized clinical trial was performed in 156 patients, of whom 56 received domestic simvastatin, 56 took imported simvastatin and 44 in the open group, also took domestic simvastatin in a dose of 10 mg·d-1 at night for 8 weeks.Results In the domestic simvastatin group and the imported simvastatin group the serum total cholesterol(TC) was reduced by 26.73% and 25.62% respectively, and the low density lipoprotein cholesterol (LDL_C) by 40.47% and 36.41% respectively.The total efficacy of the two groups was 94.62% and 91.07% respectively.The side effects were mild in the discomfort of gastrointestine and the increase of CPK.There was no significant difference between two groups about the efficacy and the safety.In the open group TC and LDL_C were reduced by 25.50% and 40.57% respectively, the overall efficacy was 86.36%.Conclusion Domestic simvastatin is one of the safe and effective drugs to treat the hypercholesterolemia.更多还原