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目的评价国产氯吡格雷治疗不稳定型心绞痛(UAP)的疗效及安全性。方法将200例UAP患者随机分为国产氯吡格雷组(101例)和进口氯吡格雷组(99例)2组。常规治疗给予阿司匹林、倍他乐克、硝酸盐制剂、他汀类药、低分子肝素等,国产氯吡格雷组在常规治疗的基础上给予国产氯吡格雷首剂300mg,以后每次75mg,每日1次,维持1个月。进口氯吡格雷组在常规治疗的基础上给予进口氯吡格雷300mg,以后每次75mg,每日1次,维持1个月。治疗1个月后,观察和比较2组间心绞痛症状、心电图改善的总有效率、心肌再缺血事件及出血事件发生率。结果国产氯吡格雷组与进口氯吡格雷组在胸痛症状改善,心电图ST-T的改变,心肌再缺血事件发生率及出血事件发生率差异无统计学意义。结论国产氯吡格雷治疗UAP与进口氯吡格雷有相同的安全性及疗效。
Objective To evaluate the efficacy and safety of domestic clopidogrel in the treatment of unstable angina pectoris (UAP). Methods 200 patients with UAP were randomly divided into two groups: domestic clopidogrel group (101 cases) and imported clopidogrel group (99 cases). Routine treatment given aspirin, metoprolol, nitrate preparations, statins, low molecular weight heparin, domestic clopidogrel group on the basis of conventional treatment given domestic clopidogrel first dose of 300mg, after each 75mg, daily 1 times, for 1 month. Imported clopidogrel group on the basis of conventional treatment was given imported clopidogrel 300mg, 75mg each time, once daily for 1 month. One month after the treatment, angina pectoris symptoms, the total effective rate of ECG improvement, myocardial ischemic events and the incidence of bleeding events were observed and compared. Results Domestic clopidogrel group and imported clopidogrel group showed no significant difference in chest pain symptom, change of electrocardiogram ST-T, incidence of myocardial ischemic reperfusion and incidence of bleeding. Conclusion Domestic Clopidogrel has the same safety and efficacy as imported Clopidogrel.