瑞舒伐他汀钙治疗原发性高胆固醇血症量效关系和安全性研究

Clinical Study for Dose-Effect and Safety of Rosuvastatin in Patients With Primary Hypercholesterolemia

目的:评价瑞舒伐他汀治疗原发性高胆固醇血症患者的疗效、量效关系和安全性。方法:采用随机、双盲双模拟、阳性药平行对照的多中心临床研究方法。原发性高胆固醇血症患者经筛查后符合入选标准者以1∶1∶1随机分为阿托伐他汀钙10mg组(每晚8:00～10:00口服阿托伐他汀钙10mg,n=104),瑞舒伐他汀钙10mg组(每晚8:00～10:00口服瑞舒伐他汀钙10mg,n=110),瑞舒伐他汀钙5mg组(每晚8:00～10:00口服瑞舒伐他汀钙5mg,n=101)。进入为期8周的药物治疗期。结果:用药8周后低密度脂蛋白胆固醇(LDL-C)水平的基线变化率阿托伐他汀钙10mg组为(-36.5±17.1)%;瑞舒伐他汀钙10mg组为(-43.6±18.7)%,5mg组为(-42.5±17.0)%。瑞舒伐他汀钙10mg组和5mg组均大于阿托伐他汀钙10mg组,差异有统计学意义(P<0.05),瑞舒伐他汀钙10mg和5mg组之间差异无统计学意义。三组与安全性有关的实验室异常发生率相当。结论:在治疗原发性高胆固醇血症方面,瑞舒伐他汀钙每天5mg或10mg剂量的降血脂疗效优于阿托伐他汀钙每天10mg剂量,安全性相当。

Objective ： To evaluate the dose-effect and the safety of Rosuvastatin in patients with primary hypercholesterolemia. Methods：We performed a multi-center clinical investigation of a randomized, double-blind and double-dummy positive drug parallel comparison. The screened eligible patients with primary hypercholesterolemia were randomized as（ 1： 1：1 ） for the medication of Rosuvastatin （ 10 mg/day） group, n = 110, Rosuvastatin [5 rag/day） group, n = 101, and Atorvastatin （ 10 rag/day） group,n = 104,for 8 weeks of oral administration. Results ：After 8 weeks treatment, LDL-C decreased significantly in both Rosuvastatin groups （10 rag/day and 5 rag/day） than those of Atorvastatin group（ -45.6 ± 18.7）% and （ -42. 5 ±17.0）% vs. （ -36. 5 ± 17. 1 ）% ,both P 〈0. 05. There was no statistic difference between Rosuvastatin （5 rag/day） and （ 10 mg/day） groups in LDL-C reduction. The side effect occurrence was similar in three groups. Conclusion：Rosuvastatin （5 mg/day and 10 mg/day） presented the better effect on decreasing the blood lipid level compared with Atovastatin （ 10 mg/day） in patients with primary hypercholesterolemia. The medication safety was similar in three experimental groups.