匹伐他汀治疗原发性高胆固醇血症的疗效与安全性评价

Evaluation of the efficacy and safety of pitavastatin in treating primary hypercholesterolemia

目的评价匹伐他汀治疗原发性高胆固醇血症的疗效和安全性。方法随机、单盲(对研究者设盲)、阳性药物平行对照。46例原发性高胆固醇血症患者随机分为匹伐他汀(2和4 mg)组和阿托伐他汀(10 mg)组,研究为期8周,观察治疗前后患者血脂[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)、甘油三酯(TG)]、丙氨酸氨基转移酶/天冬氨酸氨基转移酶(ALT/AST)及磷酸肌酸激酶(CPK)水平的变化。结果治疗4和8周各组TC、LDL-C水平均明显降低(P<0.01),且4周与8周无显著差异:治疗8周各组LDL-C达标率分别为62.5%、66.7%和86.7%;但3组HDL-C和TG水平治疗前后无明显变化。匹伐他汀(2 mg)组1例出现CPK水平异常升高,停药2周后恢复正常。结论匹伐他汀能有效降低原发性高胆固醇血症患者的TC和LDL-C水平,疗效与阿托伐他汀相似,且基本安全。

Objective To evaluate the clinical effect and safety of pitavastatin in the treatment of primary hypercholesterolemia. Methods A randomized, single-blind to investigator trial was conducted. 46 patients with primary hypercholesterolemia were randomized into pitavastatin （2, 4 mg） groups and atorvastatin （10 mg） group. The levels of total cholesterol （TC）, high density lipoprotein cholesterol （HDL-C）, low density lipoprotein cholesterol （LDL-C）, triglycerides （TG）, alanine aminotansferase/aspartate aminotransferase （ALT/AST）, creatine phosphokinase （CPK） were measured before and after 8 weeks of treatment. Results The levels of TC, LDL-C decreased in pitavastatin （2, 4 mg） groups and atorvastatin （10 mg） group after 4 and 8 weeks of treatment （P〈0.01）. There were no significant differences in TC, LDL-C levels of 3 groups between 4 weeks and 8 weeks. The LDL-C target level was attained 62. 5%, 66.7%, 86. 7% in pitavastatin （2, 4 mg） groups and atorvastatin （10 mg） group. There were no significant differences in HDL-C, TG levels of 3 groups between 8 weeks and baseline. CPK level increased in 1 patient from pitavastatin （2 mg） group and returned to normal level after 2 weeks medicine withdraw. Conclusion Pitavastatin 2 or 4 mg once daily were safe and efficacious in reducing TC, LDL-C levels as compared with atorvastatin 10 mg daily.