两种剂量阿托伐他汀钙对75岁以上心血管病中高危患者干预效果的比较

Comparison of lipid modulating effect of two dosages of atorvastatin calcium on patients ≥75 years old with intermediate or high risk stratification for ASCVD

目的比较中、小剂量阿托他汀钙对75岁以上心血管疾病中、高危患者的干预效果和安全性。方法选取龙华街道社区卫生服务中心门诊患者中75周岁以上动脉粥样硬化性心血管病(ASCVD)危险分层为中高危患者262例,随机分为阿托伐他汀钙小剂量组(10 mg/d,10 mg组,n=119)和中剂量组(20 mg/d,20 mg组,n=143),结合生活方式干预12个月,两组人群分别于服药前和服药后12个月时进行血脂、空腹血糖(静脉)、肝和肾功能相关指标检测。结果两组患者在给药前的性别、年龄、主要并发疾病(高血压病、高脂血症)的患病率、吸烟率、低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、空腹葡萄糖(FPG)、丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、γ-谷氨酰转肽酶(γ-GT)和血尿素氮(BUN)差异均无统计学意义,虽然20 mg组血清肌酐(SCr)水平高于10 mg组(P<0.05),但两组血清肌酐(SCr)异常率没有统计学差异。总体而言两种剂量的阿托伐他汀钙片干预12个月均可显著降低TC和LDL-C水平(P<0.01),而其中20 mg组可更显著降低LDL-C,并能更好实现降脂达标率(54.7%)。干预前后以及不同剂量治疗组之间的的FPG、ALT、AST、γ-GT和BUN均无统计学差异,虽然干预后可观察到两组SCr值均高于治疗前,且20 mg组SCr值也显著高于10 mg组,但SCr的异常率在治疗前后和两个治疗组之间均无明显差异。结论阿托伐他汀钙在75岁以上动脉粥样硬化性血管危险分层中、高危人群具有良好的降脂效果,虽可轻微的影响其肾功能而无明显其他副作用。

AIM To compare and to evaluate the therapeutic and side effects of low and middle doses of atorvastatin calcium on patients 75 years or older with cardiovascular diseases. METHODS 262 out patients in our hospital 〉175 years with intermediate or high risk stratification for arteriosclerotic cardio- vascular diseases （ASCVD） were randomized into low （10 mg/d, 10 mg group, n = 119） and middle （20 mg/d, 20 mg group, n --143） doses of atorvastatin calcium treatment groups, which were simultaneously given lifestyle intervention for 12 month. Lipid profile, fasting plasma glucose, liver, and kidney functions were recorded before and after 12 month medication in both groups. RESULTS At baseline, both low and middle atorvastatin calcium groups exhibited almost similar general characters, including gender, age, cardiovascular risk factors, including incidences of hypertension, hyperlipidemia, smoking, lipid profile, fasting blood glucose, liver transaminases, and urea nitrogen. Slightly elevated serum creatinine （ in normal range） was elevated in the middle dosage group （P 〈 0. 05 ）, but the abnormal incidence of it was similar in the two groups. With 1 year of medication, both doses of atorvastatin calcium significantly decreased levels of total cholesterol （ TC ） and low-density lipoprotein cholesterol （LDL-C） （P 〈 0. 01 ）, in which the middle dosage group reached 54.7% compliance rate compared to 37.6% in the lower dosage group （P 〈 0. 01 ）. There were no significant changes in fasting blood glucose, liver transaminases, and urea nitrogen in the two groups. Increased serum creatinine was observed after the administration of atorvastatin calcium in both groups （P 〈0. 05 in 10 mg group, and P 〈0.01 in 20 mg group）, but the abnormal incidence of it showed no differences in successive and different dose treatment in the two groups. CONCLUSION In this comparative study, atorvastatin calcium medication proved to be effective and safe for patients 75 years or older with cardiovascular diseases. Slightly increased serum creatine was observed in both dosing groups of atorvastatin calcium.