不同剂量国产阿托伐他汀治疗急性冠脉综合症的疗效及安全性

The Clinical Efficacy and Safety of Different Doses of Domestic Atorvastatin Treatment for Acute Coronary Syndrome

目的探讨不同剂量国产阿托伐他汀(阿乐)治疗急性冠脉综合症(ACS)患者的疗效和安全性。方法将158例ACS患者随机分为观察组(20 mg)和对照组(10 mg),正规用药8周,观察总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)水平、肝肾功能、C-反应蛋白(CRP)、肌酸肌酶(CK)等各项相关指标及胃肠道不适、肌痛等不良反应(ADR),记录两组患者疗效及不良反应。结果观察组和对照组均能减低血中TC、水平(P<0.01),且观察组比对照组疗效更显著(P<0.01)。观察组AST/ALT升高≥3倍者3例,AST/ALT升高<3倍者6例,胃肠道不适者2例,肌痛者1例,严重不良反应共6例,占7.5%,对照组AST/ALT升高≥3倍者2例,AST/ALT升高<3倍者5例,胃肠道不适者1例,肌痛者2例,严重不良反应共5例,占6.4%,两组不良反应发生率比较差异无统计学意义(P>0.05)。结论增加阿乐剂量可以提高降脂疗效,且不良反应未见明显增加。

Objective To study the efficacy and safety of the different doses of domestic atorvastatin ALe）in treatment of patients with acute coronary syndrome（ACS）. Methods 158 patients with ACS were randomly divided into observation group （20 rag）and the control group （10 rag）, regular medication 8 weeks. Observed the total cholesterol （ TC ）, triglyceride （ TG）, low density lipoprotein- cholesterol （ LDL- C ） lev- els,liver and kidney function, C- reactive protein （ CRP）, creatine kinase （ CK）, and other related indicators and adverse reactions such as gastrointestinal discomfort, myalgia. The curative effect and adverse reactions of two groups of patients were recorded. Results The observation group and control group all could reduce ser- um TC and TG level（ P 〈 0.01 ）, and the curative effect of observe group is more significant than the control group（P 〈0. 01 ）. For observation group,AST/ALT elevations 3 times or more in 3 cases,the AST/ALT eleva- tions less than 3 times in 6 cases,gastrointestinal discomfort in 2 cases, myalgia 1 case, serious adverse reac- tions in total were 6 cases,accounted for 7.5%. For control group, AST/ALT elevations 3 times or more in 2 cases, AST/ALT elevations less than 3 times in 5 cases, gastrointestinal reaction in 1 case, myalgia in 2 cases, serious adverse reactions in total were 5 cases, accounted for 6.4%. The incidence of adverse reactions are similar between the two groups, which has no statistical significance （ P 〉 0.05 ）. Conclusion Increase ALe dose can improve the lipid-lowering efficacy, and adverse reactions has no significant increase.