国产与进口氯吡格雷对冠状动脉支架置入后影响的等效性比较:1798例总结

Equivalence comparison between domestic and imported clopidogrel for percutaneous coronary interventions in 1 798 cases

背景:有研究显示国产氯吡格雷与进口氯吡格雷在冠状动脉支架置入后的应用中具有相似的疗效及安全性,但国内尚缺少二者对冠状动脉支架置入后疗效及安全性的前瞻性大规模、大样本临床对比研究。目的:探讨等剂量国产和进口氯吡格雷对冠状动脉支架置入后的疗效及安全性是否相同。方法:前瞻性入选1 798例接受冠状动脉支架置入治疗的冠状动脉粥样硬化性心脏病患者,分为国产氯吡格雷组(n=1 104)及进口氯吡格雷组(n=694),在冠状动脉支架置入前给予300 mg负荷剂量,序贯75 mg/d,随访3-28个月,观察对急性、亚急性、晚期、极晚期支架内血栓和心肌梗死、心源性死亡、脑卒中联合终点事件及出血等相关不良反应的影响。结果与结论:两组支架内血栓、靶血管重建、心源性死亡、出血和大出血事件及联合终点事件发生率差异无显著性意义,两组无事件生存率差异无显著性意义。两组治疗后的白细胞计数、红细胞计数、血红蛋白、红细胞压积、血小板计数均低于治疗前(P<0.05),且国产氯吡格雷组血红蛋白较进口氯吡格雷组下降明显(P<0.05)。表明等剂量国产与进口氯吡格雷对经皮冠状动脉支架置入后的疗效及安全性相似。

BACKGROUND： A few of studies have showed similar efficacy and safety between domestic clopidogrel（Talcom） and imported clopidogrel（Plavix） in patients after percutaneous coronary intervention, but there is lack of large-scale, large sample, and prospective clinical comparative study in China.OBJECTIVE： To compare the efficacy and safety of Talcom and Plavix on percutaneous coronary intervention.METHODS： Totally 1 798 patients with Coronary atherosclerotic heart disease who received percutaneous coronary interventions were divided to two groups： Talcom group（n=1 104） and Plavix group（n=694）. 300 mg clopidogrel was administrated orally before percutaneous coronary intervention followed by 75 mg/d clopidogrel sequentially for1 year. All the patients were followed for 3-28 months to observe the incidence rate of stent thrombosis at acute,subacute, late, and very late stage, major adverse cardiac events of combination end point（including myocardial infarction, cardiac death, and stroke）, and correlated adverse reactions, such as bleeding.RESULTS AND CONCLUSION： There were no significant differences in the incidence of stent thrombosis, target vessel revascularization, cardiac death, bleeding, major bleeding and major adverse cardiac events of combination end point between Talcom group and Plavix group. In addition, event-free survival also showed no difference between the two groups. After treatment, white blood cell count, erythrocyte count, hemoglobin, hematocrit, platelet count were significantly decreased in both the two groups（P 0.05）. Hemoglobin level in the Talcom group was fewer than that in the Plavix group（P 0.05）. The results suggest that effects and safety of Talcom are similar to those of Plavix for percutaneous coronary interventions.