[国产辛伐他汀调脂作用的多中心随机对照临床试验]

[A multicenter randomized controlled clinical trial on lipids regulating effects of domestic simvastatin].

作者信息

Tong N, Ran X, Chen P, Li G, Tian H

机构信息

Department of Endocrinology, First Affiliated Hospital, WCUMS, Chengdu 610041, China.

出版信息

Hua Xi Yi Ke Da Xue Xue Bao. 2001 Mar;32(1):111-3.

PMID:12733372

Abstract

OBJECTIVE

This clinical trial was designed to assess the lipids regulating effects of domestic simvastatin (DS, produced by Chengdu Huayu Pharmaceutical Co.) in patients with hyperlipidemia.

METHODS

160 hyperlipidemic patients were randomly divided into 3 groups (A, B and C). Groups A and B were subjected to single-blind trial; group C was for open trial. Group A took DS 10 mg q.n., group B Zocor 10 mg q.n. and group C DS 10 mg q.n. respectively for 8 weeks. All the patients were followed up at the 4th week and 8th week. 155 patients finished 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 group A, B and C decreased 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 decreased by 23.02%, 27.84% and 24.43%, respectively; there was no significant difference among the three groups (P > 0.05). At the 8th week, serum TC in groups 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 three groups was observed (P > 0.05). The incidence rates of side effects in the three groups were similar. The clinical effects were more significant at the 8th week than at the 4th week for Zocor and DS.

CONCLUSION

These data suggest that DS is as effective and safe as Zocor in clinical use for lipids regulating serum.

摘要

目的

本临床试验旨在评估国产辛伐他汀（DS，由成都华宇制药有限公司生产）对高脂血症患者的血脂调节作用。

方法

160例高脂血症患者随机分为3组（A组、B组和C组）。A组和B组进行单盲试验；C组为开放试验。A组每晚服用DS 10 mg，B组每晚服用舒降之10 mg，C组每晚服用DS 10 mg，共8周。所有患者在第4周和第8周进行随访。155例患者完成试验，其中A组59例，B组47例，C组39例。

结果

第4周时，A组、B组和C组的血清总胆固醇（TC）分别下降了16.88%、19.23%和14.10%；血清甘油三酯（TG）分别下降了19.27%、15.66%和17.96%；高密度脂蛋白胆固醇（HDL-C）分别升高了7.69%、7.46%和6.69%；低密度脂蛋白胆固醇（LDL-C）分别下降了23.02%、27.84%和24.43%；三组间差异无统计学意义（P>0.05）。第8周时，A组、B组和C组的血清TC分别下降了25.03%、26.53%和25.22%；TG分别下降了23.85%、24.74%和24.75%；HDL-C分别升高了9.23%、8.95%和8.39%；LDL-C分别下降了33.72%、35.50%和30.99%；三组间仍无显著差异（P>0.05）。三组的副作用发生率相似。舒降之和DS在第8周时的临床效果比第4周时更显著。