摘要
目的探讨经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后的急性冠状动脉综合征(acute coronary syndrome,ACS)患者应用替格瑞洛的临床疗效和安全性。方法纳入ACS并行PCI的患者1200例,随机分为氯吡格雷组(600例)和替格瑞洛组(600例)。随访6个月,观察并记录患者的主要不良心血管事件(包括心原性死亡、支架内血栓形成、心力衰竭、再次血运重建、再发心肌梗死)、出血及一般不良反应的发生情况。结果口服负荷剂量药物后2、24、48 h,替格瑞洛组血小板抑制率均明显高于氯吡格雷组(均P<0.05)。随访期间,两组均未发生死亡、大出血事件。替格瑞洛组主要终点事件发生率低于氯吡格雷组(1个月:0比0.2%,P=0.816;3个月:10.5%比13.1%,P=0.506;6个月:6.9%比9.8%,P=0.447),出血率稍高于氯吡格雷组(1个月:13.5%比12.8%,P=0.836;3个月:12.8%比11.5%,P=0.825;6个月:11.6%比11.4%,P=0.818)。术后1个月替格瑞洛组呼吸困难发生率稍高于氯吡格雷组(4.3%比3.3%,P=0.310),两组术后3、6个月呼吸困难例数均明显减少,且差异无统计学意义(均P>0.05)。两组间1、3、6个月的皮疹发生率比较,差异均无统计学意义(均P>0.05)。结论替格瑞洛较氯吡格雷在ACS患者PCI术后应用的抗血小板聚集作用起效更快更强,且两者的安全性相当。
Objective To explore the clinical efficacy and safety of ticagrelor compared to clopidogrel in acute coronary syndrome（ ACS） patients receiving percutaneous coronary intervention（ PCI）.Methods 1200 ACS patients undergoing PCI were enrolled and randomly divided into clopidogrel group（ n = 600） and ticagrelor group（ n = 600）. All patient were given loading dose of Aspirin 300 mg followed by daily maintenance dose of 100 mg. Pre-operative loading dose of 300 mg followed by daily maintenance dose of 75 mg of clopidogrel versus ticagrelor with pre-operative loading dose of 180 mg followed by maintainance dose of 90 mg two groups twice daily were given in the 2 groups respectively and were continued for 1 year. The MACE rates,rates of bleeding events and other clinical adverse events between the2 groups were compared after 6 months of follow up. Results There were no record of mortality and major bleeding rates between the 2 groups during follow up. The rates of major adverse cardiovascular events were significantly lower in the ticagrelor group than in the clopidogrel group after 6 months（ 6. 9% vs. 9. 8%,P = 0. 447）. Ticagrelor group had higher rates of minor bleeding than the clopidogrel group after 6 months（ 11. 6% vs. 11. 4%,P = 0. 818）. The occurance of dyspnea was higher in the ticagrelor group after 1month compared to the clopidogrel group（ 4. 8% vs. 3. 3%,P = 0. 310）,but showed no significant differences in 3-month and 6-month follow up（ all P〉0. 05）. There was no difference in occurance in skin rash development between the 2 groups（ P〉0. 05）. Conclusions Compared with clopidogrel,ticagrelor showed comparable clinical efficacy and safety.
出处
《中国介入心脏病学杂志》
2015年第8期446-450,共5页
Chinese Journal of Interventional Cardiology
