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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 compare the efficacy and safety of different doses of fluvastatin and pravastatin in the treatment of primary hypercholesterolemia. Methods: According to a randomized, double-blind, parallel-controlled trial, 129 patients with primary hypercholesterolemia were divided into two groups after 4 weeks of placebo. After 4 weeks of placebo, patients in the double- Statin 40mg, 1 day, the control group oral pravastatin 20mg, 1 day, course of treatment were 6 weeks; incremental double-blind according to serum total cholesterol two groups of patients plus the amount of part of the original dose to maintain the original dose 6 weeks. Determination of serum lipids before, during and after treatment indicators and other related indicators. Results: After 12 weeks of treatment, the mean cholesterol of test group decreased by 18% and the average of LDL cholesterol decreased by 24% (P <0.001), mean of triglyceride decreased by 12% (P <0) .05); mean high-density lipoprotein cholesterol increased by 5% (P <0.05). In the control group, the mean total cholesterol was decreased by 20%, the average LDL cholesterol by 30% (P <0.001), the mean triglyceride by 16% (P <0.01), and the mean high density lipoprotein cholesterol % (P <0.01). There was no statistically significant difference between the two groups in the reduction of total cholesterol, triglyceride and low density lipoprotein cholesterol (P> 0.05). The incidence of side effects in both groups were 6.0% and 4.2%, respectively (P> 0.05). Mainly gastrointestinal side effects, can be tolerated?