辛伐他汀(舒降之)治疗原发性高胆固醇血症的临床比较研究

目的：比较国产辛伐他汀与进口辛伐他汀治疗原发性高胆固醇血症的疗效及安全性。方法：采用开放区组随机对照、多中心的临床设计。１５０例高胆 固醇血症病人分为验证组（５０例）、对照组（４８例）和开放组（５２例），剂量均为每晚顿服１０ｍｇ，服药８周。结果：验证组与对照组服药前后比较，血清总胆 固醇（ＴＣ）分别降低２６．３６％和２８．３％，低密度脂蛋白胆固醇（ＬＤＬ－Ｃ）分别降低３３．１７％和３５．５１％；验

Comparative study of domestic and imported simvastatin on primary hypercholesterolemia

OBJECTIVE:To investigate the effects and the safety of domestic and imported simvastatin on patients with primary hypercholesterolemia.METHOD:The study was a multicenter,randomized,controlled and opened clinical trial.The 150 patients were divided into three groups,experimental group(50 patients),controlled group(48 patients) and opened group(52 patients).Each patient was treated with domestic or imported simvastatin 10mg once a day in the evening for 8 weeks.RESULTS:The total effective rate of decreasing TC was 92.00% and 97.92% in experimental and controlled group respectively(P<0.05).The adverse reaction rate was 9.62% and 13.72% in both gropus,respectively(P<0.05).CONCLUSION:The effects and the safety of domestic simvastatin on hypercholesterolemia were similar to those of imported simvastatin.