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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
Objective To evaluate the efficacy and safety of domestic and imported simvastatin tablets in the treatment of primary hypercholesterolemia. Methods Open, block randomized controlled, multicenter design. 156 cases of patients with primary cholesterol per night Dunhuang clothing imports or domestic simvastatin tablets 10mg, 8wk course of treatment, observed and compared lipid-lowering efficacy and side effects. Among them, 56 patients in the validation group, 56 patients in the control group and 44 patients in the open group. Results Compared with the control group, the serum total cholesterol (TC) decreased by 26 73% and 25 62%, while the LDL cholesterol decreased by 40.47% and 36 41%, respectively, with a total effective rate of 94 64 % And 91 07%, two groups of lipid-lowering efficacy, the safety indicators, adverse reactions were no significant difference. Open TC decreased 25 50%, LDL_C decreased 40 57%, the total effective rate was 86 36%, the incidence of adverse reactions was 11 36%. Conclusion Domestic simvastatin tablets have the same therapeutic effect and safety as imported simvastatin tablets