摘要
目的观察瑞舒伐他汀钙(降血脂药)治疗原发性高胆固醇血症的疗效和安全性。方法用随机双盲双模拟阳性药平行对照的多中心研究,共入选341人,随机分配到低、高剂量瑞舒伐他汀钙(5,10mg.d-1;n=113,114)试验组和阿托伐他汀钙(10mg.d-1,n=114)对照组;治疗8周后,若低密度脂蛋白胆固醇(LDL-C)较治疗前基线值下降<30%,则低、高剂量试验组的剂量均增加1倍,而对照组剂量不变,连续服4周,观察疗效和安全性。结果治疗8周后,3组LDL-C水平较基线均明显下降;高剂量试验组与对照组比较差异有统计学意义。治疗12周后,3组不良反应发生率差异无统计学意义。结论瑞舒伐他汀钙治疗原发性高胆固醇血症效果优于同剂量阿托伐他汀钙,且安全性及耐受性类似。
Objective To evaluate the efficacy and safety of rosuvastatin in the treatment of hypercholestrolemia. Methods A double - blind randomized multi-center clinical trial was conducted for treatment of 341 patients with hypercholesterolemia. Patients were randomized into three groups, trial group to receive rosuvastatin （5,10 mg·d^-1 ; n = 113, 114） or control group to receive atorvastatin 10 mg·d^-1 （n = 114） for 8 weeks. If the LDL - C levels not decrease 30% in rosuvastatin groups were titrated doubling dosage for additional 4 weeks. Results The LDL -C levels was decreased after 8 weeks in each group, high dose trial group was better than control group. There were no drug related adverce drug reaction found during the study in three groups. Conclusion Rosuvastatin had an excellent clinical efficacy and good safety in treating patients with hypercholesterolemia.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2010年第5期326-329,共4页
The Chinese Journal of Clinical Pharmacology
