国产阿托伐他汀对老年人颈动脉内膜中层厚度影响的随机临床对照研究

Effect of domestic atorvastatin on carotid artery intima-media thickness in elderly patients:A randomized controlled clinical research

目的对比观察国产阿托伐他汀(阿乐)与进口阿托伐他汀(立普妥)对老年人颈动脉内膜中层厚度(IMT)及血脂水平的影响。方法将符合标准的108例患者随机分为2组,治疗组口服阿乐10mg/d(n=57),对照组口服立普妥10mg/d(n=51),疗程24周。观察治疗前、后颈动脉IMT及血脂变化,药物不良反应等。结果 2组药物治疗24周后与治疗前组内比较颈总动脉和双侧颈动脉分叉处IMT有明显改善(P<0.01),颈内动脉IMT无明显改善(P>0.05);2组组间比较IMT则无统计学差异(p>0.05)。治疗24周后2组血脂低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)均明显下降,与治疗前相比有明显统计学差异(P<0.01),2组间无明显差异(P>0.05),不良反应发生率2组比较无明显差异(P>0.05),2组均未发现严重肝肾功受损或肌酶升高。结论国产阿托伐他汀10mg/d对改善我国老年人颈动脉IMT厚度、血脂LDL-C、TC水平与进口阿托伐他汀10mg/d疗效等同,且不良反应小、价格低廉,可作为我国老年人调脂治疗的常规药物。

Objective To explore the effect of domestic atorvastatin and imported atorvastatin on carotid artery inti- ma-media thickness（IMT） and the levels of blood fat in elderly patients. Methods One hundred and eight patients were randomly divided into two groups ：treatment group（ n = 57, receiving domestic atorvastatin therapy for 24 weeks, 10 mg/d） and control group（ n = 51, receiving imported atorvastatin therapy for 24 weeks, 10 mg/d）. During the next 24 weeks, the changes of carotid IMT and the levels of blood fat after treatment and the adverse reactions were observed. Results There was a significant improvement（ P 〈 0. 01 ） in the common carotid artery and its bifurcation IMT after treatment for 24 weeks, whereas there was no significant difference in the internal carotid artery IMT（ P 〉 0. 05 ）. There was no statistical difference in IMT between the two groups （ P 〉 0. 05 ）. After treatment, the levels of LDL-C and TC were significantly de- creased（ P 〈0. 01 ） ,while there was no statistical difference between the two groups（ P 〉 0. 05 ）. And the incidence rate of adverse events between the two groups also had no significant statistical difference（ P 〉 0. 05 ）. No patients showed severe damage of liver function and the increase of creatase. Conclusions Treatment with domestic atorvastatin and imported atorvastatin （ 10 mg/d） have the same effect on IMT and the level of blood fat. Domestic atorvastatin has a good safety and a lower price, and should be the regular medicine for elderly patients.