阿托伐他汀治疗高脂血症的疗效和安全性

目的　评价阿托伐他汀（北京红惠生物制药股份有限公司生产，商品名阿乐）治疗高脂血症，特别是高胆固醇血症和混合型高脂血症的疗效和安全性。方法　211例高脂血症患者随机分为两组A组阿托伐他汀组110例（高胆固醇血症和混合型高脂血症分别为58例和52例），给予阿托伐他汀10mg/d；B组辛伐他汀组101例（高胆固醇血症和混合型高脂血症分别为48例和53例），给予辛伐他汀10mg/d。4周后如未达有效标准，均可加量至20mg/d，治疗8周，观察降脂疗效和不良反应。结果　高胆固醇血症用阿托伐他汀治疗，总胆固醇(TC)从(6.59±0.66)mmol/L降至(4.62±1.45)mmol/L（下降29.9%）；低密度脂蛋白胆固醇(LDL-C)从(4.02±0.77)mmol/L降至(2.44±0.64)mmol/L（下降39.3%）；（TC－HDL-C）/HDL-C从3.93±1.22降至2.37±1.54（下降39.7%）（P均＜0.01）。阿托伐他汀降低LDL-C；（TC－HDL-C）/HDL-C作用优于同剂量的辛伐他汀（P均＜0.05）。对于混合型高脂血症患者，阿托伐他汀可使甘油三酯(TG)从(3.17±0.97)mmol/L降低至(2.21±1.03)mmol/L（P＜0.05），作用亦明显优于辛伐他汀（P＜0.05）。结论　(1)阿托伐他汀有明显的降低TC、LDL-C、TG和（TC－HDL-C）/HDL-C作用，降低LDL-C、TG和（TC-HDL-C）/HDL-C作用明显优于同剂量的辛伐他汀，升高HDL-C作用则两组相似；(2)阿托伐他汀不良反应较轻微；(3)阿托伐他汀可用于高胆固醇血症和混合型高脂血症的治疗；(4)推荐常规剂量10mg/d，少数TC、LDL-C较高者可用20mg/d治疗。

The efficacy and safety of atorvastatin in treatment of hyperlipidemia

Objective To evaluate the efficacy and safety of atorvastatin inhyperlipidemia, especially in hypercholesterolemia and combined dyslipidemia. Methods Two hundred and eleven cases with hypercholesterolemia and combined dyslipidemia were randomizedly divided into 2 groups, of which atorvastatin 10 mg/d for 8 weeks in 110 cases (hypercholesterolemia in 58 cases, combined dyslipidemia in 52 cases) and simvastatin (Zocor manufactured by MSD) 10 mg/d for 8 weeks in 101 cases (hypercholesterolemia in 48 cases, combined dyslipidemia in 53 cases). In both groups, 20 mg/d dose was given 4 weeks later if TC reduction was less than 10%. Results After 8 weeks, TC, LDL-C and (TC-HDL-C)/HDL-C in atorvastatin group were significantly decreased: TC from （6.59±0.66） mmol/L to (4.62±1.45) mmol/L (29.9% reduction), LDL-C from (4.02±0.77) mmol/L to (2.44±0.64) mmol/L (39.3% reduction), (TC-HDL-C)/HDL-C from 3.93±1.22 to 2.37±1.54 (39.7%reduction) (all P<0.01), and the efficacy was superior to simvastatin (P<0.05). The HDL-C elevation was not statistically significant in both groups (P>0.05). In combined dyslipidemia atorvastatin significantly decreased TG level from （3.17±0.97） mmol/l to （2.21±1.03） mmol/L (P<0.05), and the efficacy was also superior to simvastatin (P<0.05). Conclusion (1) Atorvastatin is superior to simvastatin in reduction of LDL-C, TG and (TC-HDL-C)/HDL-C and is similar to simvastatin in reduction of TC and elevation of HDL-C. (2)The adverse reactions of atorvastatin are mild and relatively rare. (3) The recommended dose is 10 mg/d, and the dose should be increased to 20 mg/d in minority of cases with markedly increased TC and LDL-C. (4) Atorvastatin can be used in hypercholesterolemia and combined dyslipidemia.