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国产替罗非班在急性冠状动脉综合征应用注册研究

The prospective register study of domestic tirofiban for clinical application in acute coronary syndrome

摘要:

目的 明确国产替罗非班在国内急性冠状动脉综合征(ACS)患者中的应用现状,了解其安全性并分析出血性事件的原因以及影响因素.方法 记录全国15家医院诊断为急性ST段抬高型心肌梗死和中高危非ST段抬高心肌梗死/不稳定性心绞痛使用国产替罗非班患者的药物使用情况、住院期间出血事件和主要心脏不良事件(MACE),并在30 d时进行随访.结果 (1)共入组患者927例,其中241例(26.0%)术前使用替罗非班,567例(61.2%)术中使用;737例(79.5%)使用规范剂量,人均维持时间(30.4±14.2)h,人均总剂量(339.3±182.9)rnl.(2)住院期间患者大出血4例(0.4%),37例(4.0%)发生MACE.(3)随访30 d大出血1例(0.1%),MACE 9例(1.0%).结论 在绝大多数患者都使用双联口服抗血小板药物的情况下,加用国产替罗非班的安全性较好,大出血发 生率处于同类研究的低水平.

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Objective To evaluate the current clinical application of domestic tirofiban in patients with acute coronary syndrome (ACS) and to explore its safety profile focused on the common causes and correlation factors for the hemorrhagic events.Methods The patients diagnosed as ST-elevation myocardial infarction (STEMI) and medium to high risk non-ST-elevation myocardial infarction (NSTEMI)/ unstable angina(UA) in 15 hospitals from September 2009 to December 2011 and given domestic tirofiban,were enrolled in this study.The following data were carefully collected:demographic data,comorbidities,concomitant medications,laboratory data,interventional treatment,application of tirofiban,hemorrhagic events and major adverse cardiac events(MACE) in hospital and at day 30 after discharge.Results (1) A total of 927 patients were enrolled in the study.The domestic tirofiban was given to 241 subjects (26.0%) before the intervention,567 subjects (61.2%) during the intervention and 89 subjects (9.6%) after the intervention.The standardized application was performed in 737 subjects (79.5%) with the loading dose of 10 μg/kg and the maintenance dose of 0.15 μg · kg-1 · min-1 In all the subjects,the average maintenance time was (30.4 ± 14.2) hours with the average dose of (339.3 ± 182.9)ml.(2)During hospitalization,major bleeding happened in 4 cases(0.4%) and major adverse cardiac events (MACE) in 37 cases (4.0%).(3)At day 30 after discharge,1 cases (0.1%)was reported with major bleeding and 9 cases (1.0%) with MACE.(3)The least MACE was showed in the preoperative tirofiban group (2.5%) and followed by the intraoperative group (4.1%) and the postopcrative group (9.0%).Compared with the non-standardized application group,MACE was significantly decreased in the standardized application group (2.44% vs 10.00%,P < 0.05).Conclusions The standardized application of the domestic tirofiban could decrease the incidence of MACE.Taken into account the combination therapy of clopidogrel and aspirin in the vast majority of patients,the domestic tirofiban exhibits a good safety profile with a relatively lower incidence of bleeding than the similar clinical studies.

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