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目的 :探讨西立伐他汀治疗原发性高胆固醇血症的有效性及安全性。方法 :分为 3个阶段 ,第一阶段(A阶段 )为 5周的单盲进入阶段 ,第二阶段 (B阶段 )为期 8周 ,将 470例患者随机分为 0 .1mg组 ( 119例 )、0 .2mg组 ( 117例 )、0 .3mg( 116例 )和安慰剂组 ( 118例 ) ,均为 qd ,睡前服用。B阶段结束时 ,LDL C水平较试验前降低≥2 0 %者 ,继续B阶段治疗 (西立伐他汀或安慰剂 ) 16周 (C阶段 ) ,以延长安全性的评价时间。结果 :西立伐他汀各组的LDL C降低百分数分别为 ( 2 1.5± 31.1) % ( 0 .1mg组 ) ,( 2 5 .8± 13.0 ) % ( 0 .2mg组 )和 ( 2 9.5± 2 0 .5 ) % ( 0 .3mg组 ) ,安慰剂组的LDL C较试验前升高 ( 0 .7± 13 .0 ) % ,与各用药组相比 ,P值均为 0 .0 0 0 1。结论 :西立伐他汀治疗高胆固醇血症安全有效
Objective: To investigate the efficacy and safety of cerivastatin in treating primary hypercholesterolemia. Methods: The patients were divided into three stages: the first stage (A stage) was a single blind entry stage for 5 weeks, the second stage (B stage) for 8 weeks, 470 patients were randomly divided into 0 .1mg group (119 cases) , 0.2 mg group (117 cases), 0.3 mg (116 cases) and placebo group (118 cases), both qd, taking at bedtime. At the end of stage B, the level of LDL C was reduced by ≥20% compared with that before the trial, and the duration of phase B treatment (cerivastatin or placebo) was continued for 16 weeks (stage C) to prolong the evaluation period of safety. Results: The percent reduction of LDL C in each group of cerivastatin was (21.5 ± 31.1)% (0.1 mg), (25.8 ± 13.0)% (0.2 mg) and (2 9.5 ± 2) 0.05)% (0.3 mg), LDL C in placebo group was (0.7 ± 13 .0)% higher than that of the placebo group, P value was 0. 0 0 0 1. Conclusion: Cerivastatin is safe and effective in the treatment of hypercholesterolemia