阿托伐他汀对北方汉族人群急性缺血性脑血管病有效性和安全性的初步研究

Preliminary study on the efficacy and safety of atorvastatin in northern Han patients with acute ischemic cerebrovascular disease

目的根据不同危险因素分层,观察北方汉族人群缺血性脑血管病急性期不同剂量阿托伐他汀治疗的有效性和安全性。方法选择2013年10月-2014年1月在沈阳军区总医院住院治疗的急性缺血性脑血管病患者160例,按危险因素及病情分为三组,即阿托伐他汀20mg(n=50)、40mg(n=50)、60mg(n=60)治疗组。分别检测治疗前后患者血脂、肝功能、肾功能、肌酶、超敏C反应蛋白(h CRP)水平和美国国立卫生研究院卒中量表(NIHSS)评分。结果不同剂量组治疗后血脂水平均降低,总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)明显降低,差异有统计学意义(P<0.05),而甘油三酯(TG)下降幅度较小,差异无统计学意义(P>0.05)。60mg组LDL-C达标率最高。与治疗前相比,不同剂量组治疗后丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)水平升高,总胆红素(TBil)、直接胆红素(DBil)水平降低(P<0.05);血清尿素氮(BUN)、肌酐(Cr)水平下降(P<0.05),肾小球滤过率(GFR)变化无统计学意义(P>0.05);20mg组和40mg组肌酸激酶(CK)水平降低(P<0.05),而40mg组和60mg组肌酸激酶同工酶(CKMB)水平升高(P<0.05);20mg组和40mg组h CRP水平有所降低,60mg组h CRP水平有所升高,但差异均无统计学意义(P>0.05);NHISS评分明显下降(P<0.05),但各剂量组间差异无统计学意义(P=0.157)。结论三种剂量的阿托伐他汀治疗均可安全有效地降低血脂水平,改善神经功能缺损评分,并在一定程度上降低h CRP水平,其中60mg组LDL-C水平达标率最高,NIHSS降低幅度最大。但能否长期服用大剂量阿托伐他汀治疗尚需进一步研究确定。

Objective Depending on the stratification of risk factors, to observe the efficacy and safety of different doses of atorvastatin in patients of northern Han population with acute ischemic cerebrovascular disease. Methods One hundred and sixty patients with acute ischemic cerebrovascular disease, admitted from Oct. 2013 to Jan. 2014, were involved in present study, and they were divided into three groups according to the etiology and pathogenesis. In addition to routine treatment, three groups of patients were given 20mg（n=50）, 40mg（n=50） and 60mg（n=60） atorvastatin, respectively. Lipids contents, liver function, renal function, muscle enzymes, high sensitivity C reactive protein（h CRP） levels, and NIH Stroke scale（NIHSS） score were determined respectively before treatment and before discharge from the hospital. Results Blood lipid levels were reduced in all the 3 groups, total cholesterol（TC）, high density lipoprotein cholesterol-C（HDL-C） and low density lipoprotein cholesterol-C（LDL-C） lowered obviously with significant difference among the 3 groups（P〈0.05）; while the triglyceride（TG） level showed less lowering, and no statistical difference was found among groups（P〈0.05）. The highest compliance rate of LDL-C was observed in 60 mg group. Compared with those before treatment, the mean levels of alanine aminotransferase（ALT） and aspartate aminotransferase（AST） were elevated, and that of total bilirubin（TBil） and direct bilirubin（DBil） declined after treatment（P〈0.05）. The levels of blood urea nitrogen（BUN） and creatinine（Cr） were lowered, while that of glomerular filtration rate（GFR） increased compared with those before treatment, but there was no significant difference among groups（P〈0.05）. The average level of creatine kinase（CK） was lowered（P〈0.05）, while that of creatine kinase-MB（CK-MB） became higher（P〈0.01） after treatment as compared with that before treatment. After treatment, the level of hypersensitive C-reactive protein（h CRP） declined in 20 mg and 40 mg group, and increased in 60 mg group, but the changes showed no significant difference among the 3 groups（P〈0.05）. NIHSS scores were decreased in a dose-dependent manner after treatment with no significant difference among the 3 groups（P=0.157）. Conclusions Atorvastatin can safely and effectively reduce the blood lipid levels, improve the neurological deficits, and reduce the h CRP level to certain extent. Administration of 60 mg of atorvastatin may result in highest compliance rate of LDL-C and the greatest degree of improvement of NIHSS. However, further study should be untaken to demonstrate if the long-term and high-dose medication of atorvastatin is safe and effective for ischemic stroke.