国产与进口辛伐他汀治疗原发性高胆固醇血症疗效比较

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10 mg,疗程8 w k,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。

Comparison of domestic and foreign simvastatin for the treatment of primary hypercholesterolemia

Aim The efficacy and safety of the domestic simvastatin in the treatment of primary hypercho lesterolemia were compared with those of the imported simvastatin.Methods A controlled,multicenter,open-abel and randomized clinicaltrial was performed in 156 patients,of whom 56 received domestic simvastatin,56 took imported simvastatin and 44 in the open group,also took domestic simvastat in in a do se of 10mg·d^-1at night for 8weeks.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 w ere mild in the discomfort of gast rointestine and the increase of CPK.The re 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 was86.36%.Conclusion Domest icsimvastatin is one of the safe and effective drug s to treat the hypercho lesterolemia.