冠状动脉支架术后进口氯吡格雷（波立维）与国产氯吡格雷（泰嘉）抗血小板治疗的对照研究

目的比较冠状动脉支架术后进口氯吡格雷（波立维）和国产氯吡格雷（泰嘉）抗血小板治疗的可行性和有效性。方法收集2007年7月至2008年8月在北京安贞医院行冠状动脉支架术患者264例,计算机随机分为波立维组（n=144）及泰嘉组（n=120）。波立维组所有病例均采用标准阿司匹林、波立维两联抗血小板治疗;泰嘉组患者接受标准阿司匹林、泰嘉两联抗血小板治疗。氯吡格雷抵抗（CR）定义为氯吡格雷治疗24 h后血小板聚集率（PAR）降低〈10%。CR患者在标准两联治疗基础上增加剂量（阿司匹林剂量不变,波立维或泰嘉加量）。研究主要终点为随访1年时的心性死亡、非致死性心肌梗死（MI）、靶血管重建（TVR）、卒中。次要终点为随访1年时的出血事件、外周动脉闭塞及因不良反应停药。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,波立维组心性死亡、非致死性MI、脑卒中发生率（分别为0.67%、1.20%、0.67%）与泰嘉组（分别为0.82%、1.64%、0.82%）比较差异无统计学意义（P〉0.05）。波立维组出血事件发生率、靶血管重建率、外周动脉闭塞发生率（分别为0.67%、3.48%、0.67%）与泰嘉组（分别为0.82%、3.28%、0.82%）比较差异亦无统计学意义（P=0.613,P=0.958,P=0.857）。Kaplan-Meier生存分析显示波立维组与泰嘉组累积风险率差异无统计学意义（P=0.521）。波立维组及泰嘉组CR患者分别为5例和4例。两组CR患者PAR在两联治疗基础上增加剂量治疗后分别为（78.2%±11.9%,76.2%±10.5%）显著低于单纯应用两联标准抗血小板治疗分别为（80.8%±13.2%,81.8%±12.2%,P〈0.001）。结论PCI术后接受波立维或泰嘉及阿司匹林二联抗血小板治疗可有效地减少主要心脑血管事件发生率,根据PAR检测结果调整抗血小板治疗方案可能更有利于改善CR患者的长期预后。

Comparison of antiplatelet therapy with PLAVIX or domestic Clopidogrel Bisulfate for patients undergoing coronary stenting:a randomized controlled trial

Objective To explore the feasibility and efficacy of antiplatelet therapy with 2 different brands of clopidogrel bisulfate. Methods Between July 2007 and August 2008, a total of 264 patients who underwent coronary stenting in Anzhen Hospital in Beijing were enrolled. Patients were randomly assigned to receive PLAVIX （PLAVIX group, n = 144 ） or domestic Clopidogrel Bisulfate antiplatelet therapy （Clopidogrel Bisulfate group, n = 120 ）. Clopidogrel resistance （ CR ） was defined as a less than 10% reduction of platelet aggregation at 24 h after clopidogrel treatment. The antiplatelet regimen for CR patients was dual antipahelet therapy plus extra dose of Plavix or domestic clopidogrel bisulfate, whereas non-CR patients received standard dual antiplatelet therapy. The primary endpoint was major adverse cardiac and cerebral events （MACCE） at 1 year, defined as the composite analysis of death, non-fatal myocardial infarction （MI） or stroke. Sencondary endpoint was the composite analysis of hemorrhagic events, revascularization or peripheral artery occlusion. Results The baseline clinical characteristics, angiography and PCI result was comparable between the two groups. At one-year follow-up, no significant difference existed in cardiac death rate （0. 67% vs 0. 82% ）, non-fatal MI （ 1.20% vs 1.64% ） and stroke （0. 67% vs 0. 82%, P 〉0.05）, as well as in the composite of MACCE （0. 47% vs 1.14% ） between the two groups. Also, no significant difference existed in the rate of target vessel revascularization （3.48% vs 3.28%, P = 0. 958）, occlusion of lower extremity artery （0. 67% vs 0. 82%, P = 0. 857） and hemorrhagic events （0. 67% vs 0. 82%, P = 0. 613 ） between the two groups. Kaplan-Meier survival analysis showed the cumulative hazard rate for the MACCE was similar （ P = 0. 521 ）. There were 5 and 4 CR patients in the Plavix group and the clopidogrel bisulfate group, respectively. Dose enlargement in addition to dual antiplatelet therapy decreased significantly the PA