急性冠状动脉综合征早期应用阿托伐他汀治疗的作用和安全性的临床研究

The Clinical Effect and Safety in Treatment with Atorvastatin in Patients of Acute Coronary Syndrome

目的 探讨急性冠状动脉综合征 (ACS)早期应用阿托伐他汀治疗的益处及安全性。方法 将 15 1例ACS病人随机单盲分为两组。治疗组 76例 ,每日给予阿托伐他汀 (10～2 0 )mg。对照组 75例 ,安慰剂每日 1粒。随访 1年 ,观察两组住院期及随访期心脑血管事件、调降脂效果及药物不良反应。结果 治疗组用阿托伐他汀治疗 6周和 1年 ,均显著降低血总胆固醇 (TC)、三酰甘油 (TG)、低密度脂蛋白胆固醇 (LDL)、载脂蛋白B(ApoB)水平 ,升高高密度脂蛋白胆固醇 (HDL )、载脂蛋白A1(ApoA1) (P均 <0 .0 1)。且与对照组相比 ,有统计学意义 (P <0 .0 1)。治疗组住院期反复心绞痛发作、心力衰竭 (HF)、心律失常发生危险明显较对照组减少(P <0 .0 5 )。随访期复发性心绞痛、非致死性心肌梗死、HF、需做经皮腔内冠脉成形术 /冠脉旁路移植术 (PT CA/CABG)、因缺血发作需再住院治疗和心律失常发生明显比对照组减少(P <0 .0 5 )。同时 ,阿托伐他汀治疗 6周后 ,血纤溶酶原激活物抑制剂 -1(PAI -1)、纤维蛋白原 (FG)、D -二聚体、C -反应蛋白 (CRP)较治疗前明显降低 (P <0 .0 1) ,且与对照组有统计学意义 (P <0 .0 1)。同时ACS早期应用阿托伐他汀不良反应轻微 ,与对照组相似。结论 ACS早期应用阿托伐他汀治疗有效、安全 ,可减少住?

Objective To evaluate the safety and efficacy in early use with atorvastatin in patients suffering from acute coronary syndrome (ACS). Methods 151 patients with acute coronary syndrome were divided into two group randomly: Therapy group (n=76) was treated with atorvastatin 10-20mg per day. Control group (n=75) was given with placebo. The levels of plasma lipid,C-reaction protein (CRP),fibrinogen (FIB),D-dimer were tested before and after treatment. Following up for 1 year the cardiovascular events or the incidence of stroke and the drug adverse reaction were monitored.Results The levels of total cholesterol(TC),triglyceride (TG),LDL cholesterol,apolipoprotein β were significantly decreased in therapy group after 6 months and 1 year treatment with atorvastatin comparing with control group (P<0.01). The HDL cholesterol and apolipoprotein A_1 were higher significantly in therapy group comparing with control group (P<0.01). The angina pectoris,heart failure and arrhythmia were decreased after treatment with atorvastatin during hospitalization (P<0.05). In the period of following up the cardiovascular events such as recurrent angina pectoris,non-fatal acute myocardial infarction,chronic heart failure,percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting and re-hospitalization were significantly lower in therapy group after 6 months treatment (P<0.05). The plasminogen activator inhibitor-1 (PAI-1),fibrinogen (FG),D-dimer,C-reaction protein were lower than before treatment in therapy group (P<0.01),and it was significantly lower comparing to control group (P<0.01). The results suggest that there are anti-inflammation and inhibitive coagulation effects after early atorvastatin treatment. Comparison to the control group there are no significantly in adverse reaction in atorvastatin treatment. Conclusion There are safety,efficacy and lower adverse reaction in early use with 10-20mg per day atorvastatin treatment in patients suffering from acute coronary syndrome.