替格瑞洛治疗急性冠状动脉综合征的前瞻性研究

Prospective study of ticagrelor in patients with acute coronary syndrome

目的:探讨替格瑞洛治疗中国急性冠状动脉综合征(ACS)患者的临床疗效及安全性。方法:将154例计划行经皮冠状动脉介入治疗术(PCI)的ACS患者随机分为替格瑞洛组(80例)和氯吡格雷组(74例),术前分别给予300mg阿司匹林及180mg替格瑞洛和300mg阿司匹林及600mg氯吡格雷口服,余均按ACS常规治疗,随访12个月,记录两组主要终点(包括心血管死亡、心肌梗死、卒中)及次要终点(包括全因死亡、靶血管再次血运重建、支架内血栓形成、心脏原因再住院、短暂性脑缺血发作、出血、呼吸困难)发生情况,比较两组治疗前后血浆丙氨酸氨基转移酶、直接胆红素、尿酸及肌酐变化。结果:替格瑞洛组12个月全因死亡、靶血管再次血运重建、支架内血栓形成等复合终点发生率显著低于氯吡格雷组(P<0.05),主要终点及主要出血发生率差异无统计学意义(P>0.05),总出血事件及呼吸困难发生率均明显高于氯吡格雷组(P<0.05)。结论:与氯吡格雷相比,替格瑞洛能更有效降低中国ACS患者全因死亡、靶血管再次血运重建、支架内血栓形成等复合终点发生率,但在心血管死亡、心肌梗死、卒中及主要出血发生率方面与氯吡格雷相似,不良反应多较轻微,安全性好。

Objective：To explore the clinical efficacy and safety of ticagrelor in Chinese patients with acute coronary syndromes（ACS）.Method：The 154 patients with ACS planning for percutaneous coronary intervention（PCI）were randomly divided into ticagrelor group（80cases）and clopidogrel group（74cases）.Before PCI,patients in ticagrelor group received 300 mg aspirin and 180 mg ticagrelor,whereas patients in clopidogrel group received 300 mg aspirin and 600 mg clopidogrel.Other treatment methods were based on the conventional treatment of ACS.The primary endpoint（cardiovascular death,myocardial infarction,stroke）and secondary endpoint（allcause death,target vascular reconstruction,stent thrombosis,hospitalized for heart reason,transient ischemic attack,bleeding,dyspnea）were followed prospectively for 12 months.The blood levels of alanine aminotransferase（ALT）,direct bilirubin（DBIL）,uric acid（UA）,and creatinine（Cr）were compared before and after treatment between two groups.Result：The composite of ischemic（all-cause death,target vascular reconstruction,stent thrombosis,hospitalized for heart reason,transient ischemic attack,bleeding,dyspnea）in ticagrelor group were lower than those in clopidogrel group（P〈0.05）.There was no difference in the primary endpoint and major bleeding between two groups.However,the incidence of total bleeding and dyspnea in ticagrelor group were significantly higher than those in clopidogrel group.Conclusion：Compared with clopidogrel,ticagrelor can effectively reduce the incidence of composite of ischemic events in Chinese patients with ACS even though the cardiovascular death,myocardial infarction and stroke incidence was similar between two groups.The adverse reactions were mild.