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目的 了解国产辛伐他汀 ( SS)的调脂疗效。方法 以默沙东生产的舒降之为对照 ,进行多中心随机对照临床观察。将 16 0例高脂血症患者随机分为试验组 (国产 SS,A组 )、对照组 (进口 SS,舒降之 ,B组 )和开放组 (国产 SS,C组 ) ,其中 A、B组为单盲。每例受试者均于每日晚餐后口服 SS10 mg,疗程 8周 ,且保持受试前的饮食和生活习惯不变。分别于受试后的 4周和 8周随访。结果 完成试验 15 5例 ,脱落 5例 (均因病员不合作 )。疗程4周时 ,A、B、C三组的血总胆固醇 ( TC)分别下降 16 .88%、19.2 3%和 14.10 % ,血甘油三酯 ( TG)分别下降19.2 7%、15 .6 6 %和 17.96 % ,HDL- C分别升高 7.6 9%、7.46 %和 6 .6 9% ,L DL- C分别下降 2 3.0 %、2 7.84%和2 4.43% ,三组间比较无显著性差异 ( P>0 .0 5 )。疗程 8周时 ,A、B、C三组的 TC分别下降 2 5 .0 3%、2 6 .5 3%和2 5 .2 2 % ,TG分别下降 2 3.85 %、2 4.74%和 2 4.75 % ;HDL- C分别升高 9.2 3%、8.95 %和 8.89% ,L DL- C分别下降33.72 %、35 .5 0 %和 30 .99% ,三组间比较也无显著性差异 ( P>0 .0 5 )。不良反应主要为消化道症状 ,其发生率 A、B、C三组分别为 2 0 .34 %、2 2 .81%和 17.95 % ,三组间无显著性差异 ( P>0 .0 5 )。 4周与 8周时比较 ,8周的疗效呈?
Objective To understand the lipid-lowering effect of domestic simvastatin (SS). Methods Shu-sheng of Merck produced as a control, multi-center randomized controlled clinical observation. One hundred and sixty patients with hyperlipidemia were randomly divided into experimental group (domestic SS, group A), control group (imported SS, subdural group B) and open group (domestic SS, group C) Group for the single blind. Each participant received SS 10 mg orally daily after dinner for 8 weeks and maintained the same diet and lifestyle as before. They were followed up for 4 weeks and 8 weeks respectively. Results of the trial completed 15 5 cases, 5 cases off (both patients are not cooperative). At 4 weeks after treatment, the blood total cholesterol (TC) in groups A, B and C decreased by 16.88%, 19.2% and 14.10%, while the triglycerides decreased by 19.27% and 15.66 % And 17.96%, respectively, and the levels of HDL-C were increased by 7.69%, 7.46% and 6.96%, respectively, while the levels of DLD-C were decreased by 230%, 2 7.84% and 2.43% respectively. There was no significant difference among the three groups (P> 0.05). After 8 weeks of treatment, the TCs in groups A, B and C decreased by 25.3%, 26.53% and 25.22%, respectively, while TG decreased by 23.85%, 2.74% and 24.575 %, HDL-C increased by 9.2 3%, 8.95% and 8.89%, respectively, and L DL-C decreased by 33.72%, 35.5% and 30.99% respectively. There was no significant difference between the three groups (P> 0 .0 5). Adverse reactions were mainly gastrointestinal symptoms, the incidence of A, B, C three groups were 20.34%, 22.81% and 17.95%, no significant difference between the three groups (P> 0.05) . 4 weeks compared with 8 weeks, 8 weeks of the effect was?