| 引用本文： |
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罗壁君,陈维,魏毅东,等.比伐芦定在急性心肌梗死患者介入治疗中的疗效观察[J].同济大学学报（医学版）,2014,35(6):23-28. [点击复制]
- LUO Bi-jun,CHEN Wei,WEI Yi-dong,et al.Comparison of domestic and imported bivalirudin for patients with acute myocardial infarction undergoing percutaneous coronary intervention[J].同济大学学报（医学版）,2014,35(6):23-28. [点击复制]
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| 摘要: |
| 目的比较国产与进口比伐芦定应用于急性心肌梗死（AMI)冠脉介入（PCI)患者住院期间及30 d时的 临床疗效。方法选择2012年7—12月收治的150例12h内出现症状并接受急诊PCI术者为研究对象，随机分 为3组,PCI术前分别应用国产、进口比伐芦定和普通肝素处理，各组患者基线临床特征、冠脉病变无差异。比较各 组住院期间及30d主要临床不良事件发生情况。结果国产/进口比伐芦定组与普通肝素组术中及术后24h内 均无患者死亡、无支架内血栓及再发心肌梗死。24 h内无心力衰竭、心绞痛、恶心及头痛；住院期间不良事件发生 率分别为4. 0% (2/50)、0% (0/50)和4. 0% (2/50)，差异无统计学意义（P = 0. 547,尸> 0.05)。国产比伐芦定组非 致死性心肌梗死1例（1/50),皮肢红疹1例（1/50);普通肝素组死亡1例（1/50)，非活动性消化道出血1例（1/ 50)。30d内各组主要缺血事件发生率分别为0% (0/50)、0% (0/50)和2% (1/50)，无显著统计学差异（尸>0. 05)。 普通肝素组发生缺血性脑卒中丨例（1/50,2%)。3组所有出血事件的发生率为0% ,0%以6%(0例，0例，3例， P =0.047),国产/进口比伐芦定组BARC 1 ~2型，BARC 3型以上出血事件发生率均低于普通肝素组（0% ,0% vj 4% ;0% ,0% vx 2% )，但差异无统计学意义（尸>0. 05)。普通肝素组轻微出血均为非活动性出血2例，严重出血为 消化道出血1例。结论国产比伐芦定应用于AMI患者急诊PCI围手术期，可取得不劣于国外同类产品的抗凝效 果和安全性。 |
| 关键词: 急性心肌梗死 冠脉介入 比伐芦定 |
| DOI：10.3969/j.issnl008 - 0392.2014.06.005 |
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| 基金项目:基金项目：国家自然科学基金(2011BAI11B00) |
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| Comparison of domestic and imported bivalirudin for patients with acute myocardial infarction undergoing percutaneous coronary intervention |
| LUO Bi-jun,CHEN Wei,WEI Yi-dong,li Wei-ming,HOU Lei,MING Qiang |
| (Dept. of Emergency, Tenth People's Hospital, Tongji University, Shanghai 200072, China;2. Dept, of Cardiology, Tenth People’s Hospital, Tongji University, Shanghai 200072, China)) |
| Abstract: |
| Objective To compare the therapeutic effects of imported and domestic bivalirudin for patients with acute myocardial infarction ( AMI) undergoing percutaneous coronary intervention (PCI). Methods One hundred and fifty AMI patients undergoing PCI from July 2012 to December 2012 were randomized assigned to receive imported bivalirudin (n = 50), domestic bivalirudin (n =50) or heparin (n =50) before PCI. There were no significant differences in baseline clinical features and angiographic findings. The adverse cardiovascular events ( death, MI, heart failure, recurrent ischemia) during hospitalization and 30 d after discharge were compared among three groups. Results There were no death，MI or stent thrombosis in three groups during hospitalization and no heart failure, angina pectoris, nausea and headache reported in 24 hours after PCI. The incidence of adverse ischemic events during hospitalization in imported, domestic and heparin groups was 4.0% (2/50)，0.0% (0/50) and 4. 0% (2/50)，respectively (P = 0. 547, P >0.05). In domestic bivalirudin group, there was 1 nonfatal myocardial infarction (1/50)，1 skin rash (1/50). In heparin group, there were 1 death (1/50)，1 non active gastrointestinal hemorrhage ( 1/50) 30 d after discharge. Major ischemic events in each group were 0% (0/50), 0% (0/50) and 2% (1/50) (P >
0.05). In heparin group, there was 1 case of ischemic stroke (1/50，2.0%). The incidence of bleeding events was 0. 0%，0. 0% and 6. 0% in 3 groups (P = 0. 047). The incidence rate of BARC 1 -2 and BARC 3 bleeding events in imported, domestic bivalirudin and heparin groups were 0. 0% ,
0. 0%，4. 0% and 0. 0%，0. 0% , 2. 0% ( P > 0. 05 ). Conclusion Compared with imported bivalirudin, domestic bivalirudin applied to patients with AMI undergoing PCI can obtain the same anticoagulant effects with safety. |
| Key words: acute myocardial infarction PCI bivalirudin |
