不同剂量辛伐他汀调脂治疗冠心病的疗效及安全性研究

The efficacy and safety of different doses of simvastatin in treatment of patients with coronary artery disease

目的 观察冠心病 (CHD)患者中 ,辛伐他汀不同剂量调脂的有效性和安全性。方法 选择确诊为CHD的 114例患者 ,随机 (计算机数字表 )、开放分为辛伐他汀 2 0mg组 (n =5 8)和 10mg组 (n =5 6 ) ,年龄 40～ 86岁 ,平均年龄(6 0 .7± 9.7)岁。均为每晚服药 1次。分别于用药前、用药后第 6、12、2 4周空腹采静脉血清 ,以酶法测定总胆固醇(TC)、低密度脂蛋白胆固醇 (LDL C)、高密度脂蛋白胆固醇 (HDL C)、甘油三酯 (TG)以及肝、肾功能等。结果 (1)用药第 6周始 ,两组TC和LDL C均比用药前明显下降 ,且一直保持到用药 2 4周末 (P均 <0 .0 5 )。 (2 )第 6、12、2 4周的TC、LDL C水平 ,在 2 0mg组比 10mg组明显低 (P <0 .0 5 )。 (3) 2 4周TC达标率 ,2 0mg组明显高于 10mg组(78.2 %比 5 2 .9% ,P <0 .0 5 )。 (4 )两组间谷丙转氨酶 (ALT)升高等副作用未见明显差异。结论 2 0mg辛伐他汀能够安全而且更有效地降低TC和LDL C水平 。

Objective To evaluate the efficacy and safety of different doses of simvastatin in treatment of patients with coronary heart disease(CHD).Methods 114 patients with definite diagnosis of CHD were enrolled and divided into two groups treated with 20 mg (n=58) and 10 mg (n=56) simvastatin,once each night,respectively.The fasting serum levels of total cholesterol(TC),low-density lipoprotein cholesterol (LDL-C),high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) as well as functions of liver and kidney were determined before medication,6th,12th and 24th week after initial medication,respectively.Results The levels of TC and LDL-C were decreased significantly at 6th,12th and 24th week after initial medication (all P<0.05),and at the same time,TC and LDL-C levels in 20 mg group were continuously lower than those in 10 mg group (all P<0.05).The rate of reaching target level of TC or LDL-C(TC<4.68 mmol/L,LDL-C< 2.6 mmol/L) was higher in 20 mg group than in 10 mg group (78.2% vs 52.9%,P<0.05).There were no statistical differences in adverse effects including abnormal liver enzyme between the two groups.Conclusion The simvastatin 20 mg in treatment of CHD is safe and more effective in lowering cholesterol,causing more CHD cases to reach the target level of cholesterol.