不同剂量阿托伐他汀治疗急性冠脉综合征的疗效比较

Efficacy and safety of different doses of atorvastatin in the treatment of patients with acute coronary syndrome

目的 探讨不同剂量阿托伐他汀对急性冠脉综合征（ASS）患者的疗效及安全性.方法 选取符合ACS诊断的患者134例,在应用抗凝、减低心肌耗氧、扩张血管及降压等治疗基础上,按照治疗剂量不同分为常规治疗组（A组）67例：接受阿托伐他汀钙治疗20 mg/d;强化治疗组（B组）67例：接受阿托伐他汀治疗80 mg/d,共计12周.观察两组患者用药前、后总胆固醇（TC）、三酰甘油（TG）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）水平变化,观察两组患者用药期间不良反应的发生率：包括胃肠道不适、肌痛、皮炎、血清丙氨酸氨基转氨酶（ALT）的浓度〉3倍上限指标（3ULN）、肌酸激酶（CK）〉10 ULN.针对再发心绞痛、心力衰竭、再发心肌梗死及心源性死亡的心血管不良事件发生率随访3个月,对比两组差异.结果 两组治疗前血脂水平差异无统计学意义;A组治疗后[TC（3.63±1.09）mmol/L、LDL-C（2.18±0.91）mmol/L]较治疗前[TC（5.52±1.23）mmol/L、LDL-C（3.87±0.88）mmol/L]显著下降（t=9.413、10.928,均P〈0.01）,TG、HDL-C治疗前后变化差异无统计学意义（P〉0.05）,且B组[TC（3.15±1.13）mmol/L、LDL-C（1.78±0.68）mmol/L]显著低于A组[TC（3.63±1.09）mmol/L、LDL-C（2.18±0.91）mmol/L]（t=2.502、2.882,均P〈0.01）.A组发生胃肠道不适2例、肌痛3例、皮炎2例、ALT〉3 ULN的5例、CK〉10 ULN的0例;B组发生胃肠道不适3例、肌痛4例、皮炎2例、ALT〉3 ULN的9例、CK〉10 ULN的0例.两组患者不良反应的发生率差异无统计学意义（P〉0.05）.随访心血管事件：B组再发心绞痛的发生率（5.9％）明显低于A组发生率（17.9％）,两组差异有统计学意义（χ^2=4.542,P〈0.05）,B组心力衰竭发生的例数少于A组,但两组间差异无统计学意义（P〉0.05）.两组均未发生再发心肌梗死及心源性死亡,组间差异无统计学意义（P〉0.05）.结论 应用强化阿托伐他汀治疗较常规剂量治疗对于血脂控制更好,对于ACS患者再发心血管事件方面获益更多,药物不良反应两者无明显差异,但有待进一步试验观察及严格监测.

Objective To investigate the efficacy and safety of different doses of atorvastatin in the treatment of patients with acute coronary syndromes （ ACS） .Methods 134 ACS patients with cardiogenic shock were randomly divided into two groups .On the basis of treatment of anticoagulation ,reduce myocardial oxygen consumption ,dilation of blood vessels and blood pressure ,the patients were divided into conventional treatment group （group A,67 cases）：given atorvastatin calcium treatment 20mg/d;intensive treatment group（group B,67 cases）：given atorvastatin calcium treatment 80mg/d,the patients were treated for 12 weeks.The levels of TC,TG,LDL-C and HDL -C in the two groups were observed before and after treatment .The incidence of adverse reactions ,including gastrointestinal discom-fort,myalgia,dermatitis,ALT〉3ULN,CK〉10ULN in the two groups was observed .The incidence of adverse events such as recurrent angina , heart failure, recurrent myocardial infarction and cardiac death was followed up for 3 months,the difference between the two groups was compared .Results There was no statistically significant differ-ence in serum lipid level between the two groups before treatment （all P〉0.05）.After treatment,the levels of TC and LDL-C were （3.63 ±1.09） mmol/L,（2.18 ±0.91） mmol/L,which were significantly decreased compared with before treatment [TC （5.52 ±1.23）mmol/L,LDL-C （3.87 ±0.88）mmol/L,t=9.413,10.928,all P〈0.01].TG and HDL-C had no statistically significant differences compared with before treatment （P〉0.05）,and the levels ofTC and LDL-C in group B [（3.15 ±1.13）mmol/L,（1.78 ±0.68）mmol/L] were significantly lower than those in group A [（3.63 ±1.09）mmol/L,（2.18 ±0.91）mmol/L,t=2.502,t=2.882,all P〈0.01].Regarding the adverse drug reactions,in group A,gastrointestinal discomfort in 2 cases,3 cases of myalgia,dermatitis in 2 cases,ALT 〉3ULN in 5 cases,CK〉10ULN 0 case.In group B,gastrointestinal discomfort in 3 cases,4 cases of myalgia,dermatitis in 2 cases,ALT〉3ULN in 9 cases,CK〉10ULN in 0 case.There was no statistically significant difference in the inci-dence rate of adverse reactions between the two groups （P〉0.05）.The incidence rate of recurrent angina in group B （5.9%） was significantly lower than 17.9%in group A （χ^2 =4.542,P〈0.05）.The number of cases of heart fail-ure in group B was less than that in group A , but there was no statistically significant difference between the two groups （P〉0.05）.There was no significant difference in the recurrence of myocardial infarction and cardiac death between the two groups （P〉0.05）.Conclusion Compared with conventional dose of atorvastatin ,ACS patients with enhanced atorvastatin treatment have better control of blood lipids ,less re-cardiovascular events ,adverse drug reac-tions has no significant difference ,but it needs to be further experimental observation and strict monitoring .