辛伐他汀国产与进口制剂调脂的疗效和安全性对比

目的观察比较辛伐他汀(simvastatin)国产制剂(商品名理舒达)与进口制剂(商品名舒降之)对老年高脂血症患者在强化调脂下的疗效和安全性。方法将100例老年高脂血症患者以随机数字表法分为理舒达组(n=50)及舒降脂组(n=50),分别口服理舒达或舒降脂,剂量40mg/d。观察用药2周、4周及8周患者的血清总胆固醇、低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)、高密度脂蛋白胆固醇(high-density lipoprotein cholesterol HDL-C)及甘油三酯变化。结果两种辛伐他汀制剂均能显著降低总胆固醇(P<0.01)、LDL-C(P<0.01)和甘油三酯(P<0.01);理舒达作用等效于舒降脂(P>0.05);两种辛伐他汀制剂均能升高HDL-C水平,差异无统计学意义(P>0.05)。患者耐受性良好。结论辛伐他汀国产制剂理舒达强化调脂疗效肯定、副作用小,与其进口产品舒降脂比较疗效基本相同。

Comparative study of the effects and the safty of domestic and imported simvastatin in aged patients with hyperlipidemia

Objectives To investigate the effects and the safty of domestic and imported simvastatin(Zocord) in aged patients with hyperlipidemia. Methods One hundred aged patients with hyperlipidemia were randomly assigned into domestic simvastatin group (ra=50)and imported simvastatin group (n=50). They were given domestic and imported simvastatin respectively, 40 mg qn for 8 weeks. Serum levels of total cholesterol (TC), triglyceride (TG) , Low density lipoprotein cholesterol(LDL-C) and high density lipoprotein cholesterol(HDL-C) were measured at the ends of 2 ,4 and 8 weeks of the trial period. Results At the end of 2,4 and 8 week treatment,levels of TC,LDL-C and TG in both groups significantly reduced(P<0.01),while HDL-C significantly raised (P<0. 01). These results did not differ significantly between two groups (P>0.05) .There was no obvious side effects during the period of homemade-simvastatin and zocord treatment and the patient's tolerance was good. Conclusions Domestic simvastatin has satisfactory lipid-regulating effects and safty similar to those of its imported counterpart.