国产和进口氯吡格雷在经皮冠状动脉介入治疗中的疗效观察

Study of home - made clopidogrel and imported clopidogrel in the patients after PCI

目的观察国产和进口氯吡格雷对冠心病患者经皮冠状动脉介入治疗（PCI）后抗血小板的临床疗效和安全性。方法将550例冠心病患者随机分为两组，其中国产氯吡格雷治疗组280例，进口氯吡格雷治疗组270例，两组患者均于PCI术前3d开始服用氯吡格雷，首剂300mg，以后每日75mg，共服用3-12个月（裸支架3-6个月，药物涂层支架6-12个月）。观察两组患者PCI术后急性血栓、亚急性血栓、晚期血栓的发生率及临床出血事件包括脑出血、消化道出血及皮下出血。结果两组患者支架内急性血栓、亚急性血栓、晚期血栓的发生率分别为0．35％和0．36％、1％和0．8％、0．7％和0．8％（P均〉0．05）。两组患者消化道出血和皮下出血分别为1．1％和0．8％、1％和1．1％（P均〉0．05）。结论国产和进口两种氯吡格雷的临床疗效基本相同，安全可靠。

Objective To observe the curative effects and safety of home - made clopidogrel （Talcom） and imported clopidogrel { Plavix ） in the patients after percutaneous transluminal coronary angioplasty and stent implantation. Methods A total of 550 coronary heart disease （ CHD ） patients were at random divided into two groups including Talcom group （ n = 280 } and Plavix group （ n = 270 ）. Clopidogrel were prescribed to all CHD patients 3 days before PCI. The first dosage of 300 mg was taken, then 75 mg/d for three months to one year. The events of acute, subacute and late thrombosis in stent were observed. The bleeding events were also observed. Results The incidences of acute, subacute and late thrombosis in stent of two groups were 0.35% vs 0.36%, 1% vs 0.8% and 0.7% vs 0.8% respectively （ all P 〉 0.05 ）. The incidences of bleeding events in two groups including the gastrointestinal and subcutaneous bleeding were 1.1% vs0.8% and 1% vs 1.1% respectively （ all P 〉 0.05 }. Conclusion Two drugs are effectiveness and safety for the treatment of patients after PCI.