不同剂量阿托伐他汀对≥85岁急性冠脉综合征患者疗效和安全性研究

Efficacy and safety of different dosage of atorvastation on the elderly patients aged 85 and over with acute coronary syndrome

目的评价不同剂量阿托伐他汀对≥85岁老年急性冠脉综合征(ACS)患者的疗效和安全性。方法采用随机、开放的方法,选取77例≥85岁老年ACS住院患者,分别给予阿托伐他汀10、20、40 mg/d睡前服用。治疗2周后观察高敏C-反应蛋白(hs-CRP)、白介素-6(IL-6)、血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDLC)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、肌酸激酶(CK)、肌酐(Cr)、空腹血糖(FBG)水平,并比较各剂量组间的差异。结果 3组治疗后hs-CRP、IL-6水平显著下降(P<0.05或P<0.01),降低呈剂量依赖性(P<0.01),20 mg组和40 mg组治疗后TC、LDL-C水平较治疗前显著降低(P<0.01)。10 mg组和20 mg组中无因ALT和(或)AST增高>3倍正常上限而停药者,40 mg组有2例因ALT增高>3倍正常上限而停药。3组患者CK、Cr、FBG水平差异无统计学意义(P>0.05),3组均未出现他汀类药物引起的肌损害。结论≥85岁老年ACS患者早期应用阿托伐他汀是有效的。阿托伐他汀10 mg、20 mg对于≥85岁老年ACS患者安全性良好,40 mg组转氨酶升高,不良反应有所增多。

Objective To evaluate the efficacy and safety of different dosage of atorvastatin on the elderly patients aged 85 and over with acute coronary syndrome （ACS）. Methods Sixty-eight patients aged 85 and over with ACS were randomly divided into three groups and were given atorvastain 10 mg/d,20 mg/d or 40 mg/d before sleep for 2 weeks, respectively. The levels of high-sensitivity C-reactive protein （hs-CRP）, interleukin-6 （IL-6）, serum total cholesterol （TC） , low-density lipoprotein cholesterol （ LDL-C ） , alanine aminotransferase （ALT） , creatine kinase （CK） , creatinine （Cr） and fasting blood glucose（FBG） were detected and compared between the three groups. Results After 2 weeks＇ treatment, the level of hs-CRP, IL-6 were decreased significantly at a dose-dependent manner（P〈0. 05 or P〈0.01 ）. The level of TC, LDL-C in 20 mg group and 40 mg group were decreased significantly（P〈0.01 ）. There were no patients in 20 mg group and 10 mg group with increased ALT and （or） AST more than 3 times the upper limit of normal. Three patients in 40 mg group discontinued the medication because the level of ALT and （or） AST increased more than 3 times of the upper limit of normal. There was no statistical significance between the three groups in the levels of CK, CR and FBG（P〉0. 05）. The three groups had no muscle damage induced by stains. Conclusions Early application of atorvastain in the elderly patients aged 85 and over with ACS is effective. 20 mg or 10 mg atorvastain is safe, and 40 mg atorvastain will increase the liver enzymes.