国产氯吡格雷（泰嘉）与进口氯吡格雷（波立维）PCI术后应用的有效性和安全性对照研究  

Comparison of efficacy and security with PLAVIX or domestic clopidogrel bisulfate for patients undergoing coronary stenting

作　　者：李鹏[1] 王文红[1] 刘勇[1] 

机构地区：[1]沈阳市红十字会医院心内科,辽宁省110013

出　　处：《中国心血管病研究》2010年第7期506-508,共3页Chinese Journal of Cardiovascular Research

摘　　要：目的 比较冠状动脉支架后国产氯吡格雷（泰嘉）与进口氯吡格雷（波立维）抗血小板治疗的有效性及安全性.方法 选取2008年1月至2009年2月在沈阳市红十字会医院行冠状动脉支架术患者168例,随机分为泰嘉组80例,波立维组88例.泰嘉组患者接受标准阿司匹林治疗及术后服用泰嘉75mg,1次/d,6个月后改为50 mg,1次/d;波立维组患者采用标准阿司匹林、波立维两联抗血小板治疗.研究主要终点为随访1年时的心源性死亡、非致死性心梗（MI）、靶血管重建（TVR）及脑卒中;次要终点为随访1年时的出血事件及不良反应停药.结果 两组临床基线资料、冠状动脉造影及PCI结果差异无统计学意义.随访1年时心源性死亡、MI、TVR及脑卒中发生率泰嘉组分别为4.20%、0、12.50%和1.25%,波立维组分别为3.70%、0、10.00%和1.13%,二者相比差异无统计学意义;两组出血事件发生率比较差异亦无统计学意义.结论 冠脉药物洗脱支架（DES）术后联合应用国产氯吡格雷（泰嘉）或进口氯吡格雷（波立维）及阿司匹林抗血小板治疗安全有效.Objective To explore the efficacy and security of antiplatelet therapy with two different brands of clopidogzel bisulfate. Methods Between Jan. 2008 and Feb.2009, 168 patients who underwent coronary stenting in Shen Yang Red Cross Hospital were enrulled. Patients were randomly assigned to receive domestic Clopidogrel Bisulfate（group A, n=80） or PLAVIX （group B, n=88） antipltclet therapy. Patients of group A were assigned to take Tai Jia 75 mg/d for 6 months, after that to take Tai Jia 50 mg/d, accumulated about 12 months. Patients of group B were assigned to take PLAVIX 75 mg/d for at least one year. Two groups all took Asprin 100 mg/d at the same time. The primary endpoint was major adverse cardiac and cerebral events （MACE） at 1 year, defined as the composite analysis of death, non fatal myocardial infarction（MI ） or stroke. Secondary endpoint was the composite analysis of hemorrhage events and revascularzation. Results The baseline clinical characteristics angiography and PCI result were comparable between the two groups. At one-year follow-up, no significant difference existed in cardiac death rate （4.2% vs 3.7%）, non fatal MI （0 vs 0） and stroke （1.25% vs 1.13%）, TVR （12.5% vs 10.0%）, P〉0.05. The hemorrhage events were no significant difference too. Conclusion The domestic clopidogrel bisulfate is efficacious and safe for patients undergoing drug eluting stent.

关 键 词：血小板聚集抑制剂 血管成形术 经腔 经皮冠状动脉 

分 类 号：R542.22[医药卫生—心血管疾病]