替格瑞洛治疗急性ST段抬高型心梗的随机对照研究

A randomized control study of ticagrelor therapy on patients with acute ST-elevation myocardial infarction

目的 :比较替格瑞洛和氯吡格雷对急性ST段抬高性心肌梗死(ST-elevation myocardial infarction,STEMI)患者的临床预后、安全性、血小板最大聚集率(maximum aggregation rate,MAR)及高敏C反应蛋白(high-sensitivity C-reactive protein,hsCRP)的影响。方法 :109例STEMI患者被随机分入替格瑞洛组和氯吡格雷组,替格瑞洛组给予180 mg替格瑞洛顿服、90 mg bid维持,氯吡格雷组给予600 mg氯吡格雷顿服、75 mg qd维持,两组患者均成功接受急诊冠脉介入治疗(percutaneous coronary intervention,PCI)。比较两组30 d的主要心脏不良事件及出血事件的发生率。检测服药前、服药后7 d及30 d的MAR和hsCRP水平。结果:服药后30 d,两组主要心脏不良事件发生率的差异无统计学意义(7.3%vs 1.9%,P=0.363),两组均只发生轻微出血事件,发生率的差异无统计学意义(7.3%vs 14.8%,P=0.208)。在以ADP诱导的血小板聚集率检测中,替格瑞洛组服药7 d及30 d的MAR均显著低于氯吡格雷组[7 d:(22.80±6.37)%vs(30.96±8.90)%,P<0.001;30 d:(22.26±5.85)%vs(30.87±8.54)%,P<0.001]。在服药后7 d和30 d,氯吡格雷组分别有6例(10.9%)和5例(9.1%)患者的血小板聚集抑制率低于30%,而替格瑞洛组无论在7 d还是30 d,均无一例血小板聚集抑制率低于30%。两组患者在服药前、服药7 d及服药30 d的hs-CRP水平的差异无统计学意义(P>0.05)。结论:和氯吡格雷比较,替格瑞洛可以更强地抑制血小板聚集,且两者安全性相似。但未发现替格瑞洛可显著改善STEMI患者的短期预后。

Objective：To compare the effect of ticagrelor and clopidogrel on maximum aggregation rate（MAR） and high-sensitivity C-reactive protein（hs-CRP） of clinical outcomes,security,platelets in patients with acute ST-elevation myocardial infarction（STEMI）.Methods：A total of 109 consecutive patients with STEMI was randomized into two groups. One group received 180 mg loading dose ticagrelor followed by 90 mg twice daily thereafter,while the other received 600 mg clopidogrel followed by 75 mg daily thereafter.The patients of two groups were all successfully underwent acute percutaneous coronary intervention（PCI）. The incidence of major adverse cardiovascular events（MACE） and hemorrhagic events of the two groups were compared after 30 days. MAR and hs-CRP levels were detected before and after 7 days and 30 days with therapy. Results：The differences of MACE and hemorrhage rate during 30 days between two groups were not statistically significant（7.3% vs 1.9%,P = 0.363;7.3% vs 14.8%,P = 0.208）. Baseline characteristics,platelet aggregation and hs-CRP were similar between the two groups. ADP-induced platelet aggregation detection showed that the ticagrelor group has a lower MAR than the clopidogrel group both at 7 days and 30 days after administration [7 days（22.80 ± 6.37）% vs（30.96 ± 8.90）%,P〈0.001;30 days（22.26 ± 5.85）% vs（30.87 ± 8.54）%,P〈0.001]. After 7 and 30 days administration,the inhibitory rate of blood platelet aggregation was lower than 30% in 6 cases（10.9%）and 5 cases（9.1%）of the clopidogrel group,while in the ticagrelor group,no case of platelet aggregation inhibition rate was lower than 30%. The hs-CRP concentration at baseline,7 days and 30 days were similar between two groups（P〈0.05）. Conclusion：Administration of ticagrelorresults in more intense inhibition of platelet aggregation than administration of clopidogrel. The safeties of ticagrelor and clopidogrel are similar. No significant clinical benefit was acquired with ticagrelor in short-term evaluation.