国产辛伐他汀调脂疗效的多中心随机对照临床试验

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

A Multicenter Randomized Controlled Clinical Trial on Lipids Regulating Effects of Domestic Simvastatin

Objective This clinical trial was designed to ass ess the lipids regulating effects of domestic simvastatin (DS, produced by Chen gdu Huayu Pharmaceutical Co.) in patients with hyperlipidemia. Methods 160 hyperlipidemic pati ents were randomly divided into 3 groups (A, B and C). Groups A and B were subje cted to single blind trial; group C was for open trial. Group A took DS 10mg q. n. , group B Zocor 10mg q.n. and group C DS 10mg q.n. respectively for 8 weeks. All the patients were followed up at the 4th week and 8th week. 155 pat ients finish ed the trial with 59 cases in group A, 47 cases in group B and 39 cases in group C. Results At the 4th week, serum total cholesterol (TC) in gr oup A, B and C d ecreased by 16.88%, 19.23% and 14.10%; serum triglycerides (TG) decreased by 19. 27%, 15.66% and 17.96%; HDL C increased by 7.69%, 7.46% and 6 69%; and LDL C decr eased by 23.02%, 27.84% and 24.43%, respectively; there was no significant diffe rence among the three groups ( P >0.05). At the 8 th week, serum TC in gr oups A, B and C decreased by 25.03%, 26 53% and 25.22%. TG decreased by 23.85%, 24.74% and 24.75%; HDL C increased by 9.23%, 8.95% and 8 39%; and LDL C decreased by 33 .72 %, 35.50% and 30.99%, respectively; still, no significant difference among the t hree groups was observed ( P >0.05). The incidence rates of side effects in th e th ree groups were similar. The clinical effects were more significant at the 8th week than at the 4th week for Zocor and DS. Conclusion These dat a suggest that DS is as effective and safe as Zocor in clinical use for lipids r egulating serum.