瑞舒伐他汀与阿托伐他汀治疗高胆固醇血症的疗效比较

Comparison of efficacy of rosuvastatin and artovastatin in treatment of hypercholesterolemia

目的评价瑞舒伐他汀钙片治疗原发性高胆固醇血症和混合型高脂血症的临床疗效、量效关系及安全性。方法采用随机、双盲双模拟、平行对照的前瞻性研究。经4周调脂药物洗脱的原发性高胆固醇血症和混合型高脂血症患者65例随机分为瑞舒伐他汀5 mg组、10 mg组和阿托伐他汀10 mg组,治疗8周,观察治疗前后血脂指标[(总胆固醇(TC)、高密度脂蛋白-胆固醇(HDL-C)、低密度脂蛋白-胆固醇(LDL-C)、三酰甘油(TG)]、谷丙转氨酶/谷草转氨酶(ALT/AST)及磷酸肌酸激酶(CPK)的变化。结果经过8周的治疗,瑞舒伐他汀5 mg和10 mg组TC,LDL-C均显著下降,LDL-C下降幅度分别为47.1%、48.5%,显著大于阿托伐他汀组的33.7%(P<0.05);瑞舒伐他汀5 mg和10 mg组对TG(-18.67%;-22.727%)以及HDL-C(-1.61%;1.29%)的影响与阿托伐他汀组TG(-30.16%)和HDL-C(-0.98%)差别无统计学意义。研究期间未发现与药物有关的严重不良事件。结论瑞舒伐他汀降低原发性高脂血症患者的TC、LDL-C效果优于阿托伐他汀,且不良反应发生率低。

Objective To compare the efficacy and safety of rosuvastatin and artovastatin for treatment of hypercholesterolemia.Methods In this randomized,double-blind,double-dummy prospective trial,67 patients with primary hypercholesterolemia or mixed hypercholesterolemia were assigned to receive 5mg rosuvastatin（n=22）,10mg rosuvastatin（n=23）or 10mg artovastatin（n=22） for 8 weeks.The levels of TC,LDL-C,HDL-C,TG,CPK and ALT/AST were measured before and after treatment in 3 groups.Results After 8 weeks of treatment,TC and LDL-C decreased significantly in all groups.The percentages of LDL-C reduction in 5mg and 10mg rosuvastatin groups were 47.1% and 48.5% respectively,which were significantly higher than that in 10mg artovastatin group（33.7%,P0.05）.There were no differences in changes of HDL-C and TG levels among 3 groups.Patients in all groups were well tolerated to the treatment.Conclusion Rosuvastatin is more effective in reduction of TC and LDL-C levels than artovastatin for patients with hypercholesterolemia.