Dong Wei, Chen Yun-dai, Qian Geng, Guo Jin-cheng, Qi Guo-xian, Yang Ming
Department of Cardiology, Chinese PLA General Hospital, Beijing 100853, China.
Department of Cardiology, Chinese PLA General Hospital, Beijing 100853, China. Email:
Zhonghua Nei Ke Za Zhi. 2013 Oct;52(10):815-8.
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.
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.
(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 postoperative 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).
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.
评估国产替罗非班在急性冠脉综合征（ACS）患者中的当前临床应用情况，并探讨其安全性，重点关注出血事件的常见原因及相关因素。
选取2009年9月至2011年12月期间在15家医院诊断为ST段抬高型心肌梗死（STEMI）及中高危非ST段抬高型心肌梗死（NSTEMI）/不稳定型心绞痛（UA）且使用国产替罗非班的患者纳入本研究。仔细收集以下数据：人口统计学数据、合并症、伴随用药、实验室数据、介入治疗、替罗非班应用情况、住院期间及出院后30天的出血事件和主要不良心脏事件（MACE）。
（1）共纳入927例患者。干预前241例（26.0%）使用国产替罗非班，干预期间567例（61.2%），干预后89例（9.6%）。737例（79.5%）患者进行了标准化应用，负荷剂量为10μg/kg，维持剂量为0.15μg·kg⁻¹·min⁻¹。所有患者中，平均维持时间为（30.4±14.2）小时，平均剂量为（339.3±182.9）ml。（2）住院期间，4例（0.4%）发生大出血，37例（4.0%）发生主要不良心脏事件（MACE）。（3）出院后30天，1例（0.1%）发生大出血，9例（1.0%）发生MACE。（3）术前替罗非班组MACE发生率最低（2.5%），其次是术中组（4.1%）和术后组（9.0%）。与非标准化应用组相比，标准化应用组MACE显著降低（2.44%对10.00%，P<0.05）。
国产替罗非班的标准化应用可降低MACE发生率。考虑到绝大多数患者联合使用氯吡格雷和阿司匹林，国产替罗非班显示出良好的安全性，出血发生率相对低于类似临床研究。
