等剂量国产与进口氯吡格雷对急诊PCI术后影响的等效性比较

Compare isoeffects and safety of isodose domestic clopidogrel and imported clopidogrel on emergent directed PCI in AMI patients

目的 探讨等剂量国产氯吡格雷（泰嘉）和进口氯吡格雷（波立维）对急性心肌梗死（AMI）患者急诊经皮冠状动脉内介入治疗（PCI）术后疗效及安全性是否相同.方法 前瞻性入选204例接受急诊PCI治疗的AMI患者,分为泰嘉组（123例）及波立维组（81例）,在急诊室给予300 mg负荷剂量,序贯75 mg/d,随访3～28个月,观察急性、亚急性、晚期、极晚期支架内血栓和心肌梗死、心源性死亡、脑卒中的联合终点不良心脏事件（MACE）的影响以及出血等相关副作用的影响.结果.泰嘉组和波立维组均无支架内血栓和出血事件;波立维组有2例心源性死亡,分别为心源性休克及心脏破裂;两组靶血管重建及联合终点事件发生率,经统计学检验,差异无统计学意义（χ2分别为0.000和0.921,P值分别为0.989和0.337）;两组之间累积MACE经Kaplan-Meier生存分析计算,绘制K-M曲线,经Log Rank比较,差异无统计学意义（χ2=0.679,P=0.410）.结论.等剂量国产与进口氯吡格雷对AMI患者急诊直接PCI术后疗效及安全性相似.

Objective To compare the efficacy and safety of domestic elopidogrel （ TalcomTM ） and imported clopidogrel （PlavixTM） on directed PCI in AM1 patients. Methods 204 patients with AMI to undergo directed CAG ＋ PCI were divided to two groups, including TalcomTM group （n =123 ） and PlavixTM group （ n = 81 ）. 300 mg loading dose clopidogrel was oral before PCI in emergency room and 75 mg/d tbreword one year. There were follow - up 3 - 28 month to survey the incidence rate of MACE of combination end point of acute, subacute, late stage, very late stage stent thrombus and AMI, cardiac death, stroke and correlated adverse reaction of bleed, major bleed, gastrointestinal complaint, and etc. Results There were not stent thrombus and bleed event both TalcomTM group and PlavixTM group. There are two patients death of cardiac shock and heart rupture in PlavixTM group. There were no significant differences in the incidence of target vessel revascularization and combination end point between TalcomTM group and PlavixTM group （X2 value 0. 000 and 0. 921 ,P value 0. 989 and 0. 337）. There were no significant differences in accumulation MACE hazard analysis by Kaplan - Meier survival analysis （X2 0.679, P =0. 410）. Conclusion Effects and safety of isodose TalcomTM used in AMI patients that underwent emergent directed PCI are similar to those of PlavixTM.