替格瑞洛在中国急性冠脉综合征患者中的早期疗效及安全性观察

Safety and Short-term Efficacy of Ticagrelor in Patients with Acute Coronary Syndromes in Chinese

目的 探讨替格瑞洛在中国急性冠脉综合征（ACS）患者中的早期疗效及总结治疗经验。方法 2012年9月～2013年7月入我院心内科诊断为ACS的患者199例，其中服用替格瑞洛患者96例，服用氯吡格雷患者103例。替格瑞洛组给予180 mg负荷剂量口服，后90 mg每日2次维持。氯吡格雷组给予300/600 mg口服，后服用氯吡格雷维持剂量75 mg每日1次，所有患者均给予阿司匹林。比较两组的基础临床资料，观察两组服药10天、30天、90天的不良事件，并对两组90天的心血管事件和出血情况进行比较。结果 两组间基础临床资料无统计学差异（P〉0.05）。替格瑞洛组心血管死亡（1%：1.9%）、心肌梗死（0%：1%）、卒中（0%：1.9%）、支架内血栓（0%：1%）、再发心绞痛（2.1%：4.9%）少于氯吡格雷组，呼吸困难（2.1%：0%）、次要出血（3.1%：1.0%）和轻微出血（5.2%：2.9%）多于氯吡格雷组，但均无统计学意义（P〉0.05）。替格瑞洛组主要心血管不良事件总和低于氯吡格雷组（3.1%：10.7%），差异有统计学意义（P=0.037）。两组均无主要出血。替格瑞洛组次要出血和轻微出血总和高于氯吡格雷组（8.3%：3.9%），但差异无统计学意义（P=0.188）。结论 替格瑞洛在中国患者中的早期疗效与PLATO（血小板抑制和患者预后研究）研究结果 基本一致，临床疗效确切，具有良好的安全性和耐受性。

Objective To discuss the safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese. Methods A total of 199 acute coronary syndromes patients were enrolled.96 of them were given ticagrelor and the other 103 were given clopidogrel. We observed the adverse events in 10 days, 30 days and 90 days, and compared ticagrelor （180 mg loading dose, 90 mg twice daily thereafter） and clopidogrel （300 to 600 mg loading dose, 75 mg daily thereafter） for the prevention of cardiovascular events and bleeding in 90 days. Results There was no significant difference in basic clinical data and related routine examination results between two groups （P〉0.05）. Patients receiving ticagrelor had lower ratio in cardiovascular death （1%vs. 1.9%）, myocardial infarction （0%vs. 1%）, stroke （0%vs. 1.9%）, stent thrombosis （0%vs. 1%） and recurrent ischemia （2.1% vs. 4.9%） and higher ratio in dyspnea （2.1%vs. 0%）, minor bleeding （3.1%vs. 1.0%） and minimal bleeding （5.2%vs. 2.9%） than those receiving clopidogrel with no significant difference （P〉0.05）. There was no major bleeding in both groups. The ratio of major adverse cardiovascular events was much lower in patients receiving ticagrelor than those receiving clopidogrel （3.1% vs. 10.7%; P=0.037）. The total ratio of minor bleeding and minimal bleeding was higher in those receiving ticagrelor with no significant difference （8.3%, vs. 3.9% with clopidogrel; P=0.188）. Conclusion The safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese were in accordance with PLATO.