摘要
目的:比较不同剂量的氟伐他汀(fluvastatin)与普伐他汀(pravastatin)治疗原发性高胆固醇血症的疗效及安全性。方法:按随机双盲平行对照法,经4周安慰剂期后,将129例原发性高胆固醇血症的患者分成2组,经4周安慰剂期后;双盲期试验组口服氟伐他汀40mg、每日1次,对照组口服普伐他汀20mg、每日1次,疗程均为6周;增量双盲期根据血清总胆固醇情况两组部分患者加量、部分维持原剂量再用药6周。测定治疗前、中、后血清各项血脂指标及其它相关指标。结果:与治疗前相比,服药12周后试验组总胆固醇均值下降18%,低密度脂蛋白胆固醇均值下降24%(P均<0.001);甘油三酯均值下降12%(P<0.05);高密度脂蛋白胆固醇均值升高5%(P<0.05)。对照组总胆固醇均值下降20%,低密度脂蛋白胆固醇均值下降30%(P<0.001),甘油三酯均值下降16%(P<0.01),高密度脂蛋白胆固醇均值升高15%(P<0.01)。组间比较两者降低总胆固醇、甘油三酯和低密度脂蛋白胆固醇的作用在统计学上无显著差别(P>0.05)。两组副反应发生率分别为6.0%和4.2%(P>0.05)。主要表现为胃肠系统副反应,均可耐受?
Objective:To assess the efficacy and safety of fluvastatin and pravastatin on lipid profiles in patients with primary hypercholesterolemia. Methods:A total of 129 patients in a 12 week,double blind,parallel group study were randomized to fluvastatin(40mg,qd) or pravastatin(20mg,qd)after a single blind,4 week placebo run in phase.Total cholesterol(TC),low density lipoprotein cholesterol(LDL C),high density lipoprotein cholesterol (HDL C),and triglycerides were measured before,during and after the treatment. Results:Compared with baseline,total cholesterol and LDL C were decreased by 18% and 24% with fluvastatin,and by 20% and 30% with pravastatin,respectively (all p <0 001);HDL C was increased by 5% with fluvastatin ( p <0 05) and 15% with pravastatin ( p <0 01);the triglyceride was decreased by 12% with fluvastatin( p <0 05) and 16% with prava statin ( p <0 01).There were no significant differences between 2 groups in the mentioned parameters.A tolerable adverse effect occurred mainly in digestive system in both groups by 6 0% and 4.2%,respectively( p >0 05). Conclusion:A dose of 40—80 mg fluvastatin per day for 12 weeks can decrease serum TC,LDL C and triglyceride level safely and tolerably in patients with primary hypercholesterolemia.The efficacy of fluvastatin on TC,TG and LDL C is comparable to that of pravastatin but it is relatively lower on HDL C.
出处
《中国循环杂志》
CSCD
北大核心
1998年第3期134-136,共3页
Chinese Circulation Journal
关键词
高胆固醇血症
原发性
药物疗法
氟伐他汀
Primary hypercholesterolemia
Total cholesterol
Fluvastatin
Pravastatin