国产与进口硫酸氢氯吡格雷在经皮冠状动脉介入治疗中应用的有效性和安全性对照研究

目的比较冠状动脉支架术后国产硫酸氢氯吡格雷（泰嘉）与进口硫酸氢氯吡格雷（波立维）临床应用的疗效和安全性。方法人选冠心病接受冠状动脉药物洗脱支架置人术的患者共210例，随机分为泰嘉组103例，波立维组107例。所有入选患者术前1天均应用阿司匹林300mg，1次／d，硫酸氢氯吡格雷首次300mg，以后75mg，1次／d，1年，术后如为三支血管病变，硫酸氢氯吡格雷服用150mg，1次／d，2周后改为75mg，1次，d，至少服用1年。研究主要终点为随访6个月的主要心血管事件（包括死亡、支架内血栓形成、支架内再狭窄、非致死性心肌梗死、靶血管血运重建）、脑卒中的发生率；次要终点为血小板聚集率的变化以及一般出血事件的发生率。结果两组患者主要心血管事件差异无统计学意义（P〉0．05）；随访6个月两组患者的血小板聚集率及一般出血事件的发生率均无统计学差异（P〉0．05）。结论国产硫酸氢氯吡格雷（泰嘉）作为冠状动脉药物洗脱支架术后6个月联合阿司匹林强化抗血小板的药物安全有效。

Comparison of safety and effectiveness between imported clopidogrel and domestic clopidogrel in patients after percutaneous coronary intervention

Objective To compare the clinical safety and effectiveness of domestic clopidogrel （Talcom） and imported clopidogrel （Plavix） in the patients after percutaneous coronary intervention （PCI）. Methods A total of 210 patients with coronary heart disease （CHD） were randomly divided into two groups, including Talcom group （n=103） and Plavix group （n=107）. All patients were given 300 mg of aspirin （once per day）, 300 mg of clopidogrel for the loading dosage and then 75 mg of clopidogrel （once per day） for one year. For patients with triple vessel disease, 300 mg of clopidogrel for the loading dosage, 150 mg of clopidogrel （once per day） for two weeks, and then 75 mg of clopidogrel （once per day） for one year were administrated. The primary endpoints included major adverse cardiac and cerebral events （including cardiac death, stent thrombosis, in-stent restenosis, non-fatal myocardial infarction, target vessel revascularization） and stroke for 6 months. The secondary endpoints were hemorrhage events and change of platelet aggregation rate. Results There was no significant difference in the incidence of major cardiovascular diseases between Talcom group and Plavix group （P 〉 0.05）. As for the rate of platelet aggregation and general incidence of bleeding events at 6 months, no significantly difference was found between the two groups. Conclusion The domestic clopidogrel （Talcom）, as an anti-platelet drug, is safe and effective for patients undergoing drug eluting stent in 6 months.