西立伐他汀和普伐他汀治疗原发性高胆固醇血症患者长期疗效和安全性比较

The long term efficacy and safety of cerivastatin in comparision with pravastatin in treatment of primary hypercholesterolemia

目的 :比较西立伐他汀和普伐他汀治疗原发性高胆固醇血症的长期疗效和安全性。方法 :共有 45 0例随机给予西立伐他汀或普伐他汀 ,起始剂量分别为 0 .1mg或 10mg/d ,6周后剂量加倍 ,再过 6周剂量再次加倍至 0 .4mg/d ,普伐他汀 40mg/d。结果 :0 .1mg西立伐他汀和 10mg普伐他汀降低LDL C分别为 2 4.7%与 2 3.2 % ;0 .2mg西立伐他汀和 2 0mg普伐他汀降低LDL C分别为 30 .1%和 2 8.1% ;而 0 .4mg西立伐他汀和 40mg普伐他汀降低LDL C分别为 35 .0 %与 32 .0 % ,具有显著性差异 (P =0 .0 2 0 6 )。这两种药物均可显著降低总胆固醇 ,升高HDL C和降低甘油三酯。与基础值相比 ,LDL C降低 40 %的相应比例分别为 :0 .1mg西立伐他汀为 4.1% ,10mg普伐他汀为 6 .8% ;0 .2mg西立伐他汀为 17.8% ,2 0mg普伐他汀为 13 .3 % ;0 .4mg西立伐他汀为 37.4% ,40mg普伐他汀为 2 3.8%。这两种药物的不良反应无显著差异。结论 :0 .1,0 .2mg西立伐他汀降低LDL C的作用至少分别和 10 ,2 0mg普伐他汀一样有效 ,而 0 .4mg西立伐他汀降低LDL C的效果比 40mg普伐他汀好 (P <0 .0 2 )。

Objectives:As stated in the title.Methods:450 patients were randomly divided to receive an initial dose of 0.1 mg cerivatatin of 10 mg pravastatin and the dose was doubled every 6 weeks until a final dose of 0.4 mg cerivastatin or 40 mg prqavastaintin was reached. Results:The decrease in LDLC% for cerivastatin of 0.1 mg ,0.2 mg and 0.4 mg doses were 24.7%,30.1%,and 35.0% respectively;for pravastatin of 10 mg,20 mg and 40 mg doses were 23.2%,28.1% and 32.0% respectively.Both agents can significantly reduce TC,increase HDLC and reduce triglyseride.No significant difference in side effect incidence between agents was observed.Conclusions:In decrease of LDLC,cerivastatin in doses of 0.1 mg and 0.2 mg was at least as effective as pravastatin in doses of 10 mg and 20 mg and cerivastatin dose of 0.4 mg was superior to that of pravastatin in dose of 40 mg(P< 0.02).