雷帕霉素药物洗脱支架Firebird与Cypher的临床对比研究

目的对比研究国产雷帕霉素药物洗脱支架（Firebird）与进口雷帕霉素药物洗脱支架（Cypher）的临床应用的安全性及疗效。方法对282例冠心病患者进行介入治疗，其中Firebird组58例，Cypher组168例。金属裸支架（BMS）组56例；比较各组支架术即刻及近期效果。结果3组间患者平均年龄、男性比例、吸烟史、高血压、高血脂、糖尿病、稳定型心绞痛、不稳定型心绞痛、急性ST段抬高心肌梗死和急性非ST段抬高心肌梗死、陈旧心肌梗死数据对比，差异无统计学意义（均P〉0．05）；3组间患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数据对比。差异无统计学意义（均P〉0．05）；平均血管直径和平均靶病变长度对比。差异无统计学意义（均P〉0．05）；3组手术成功率为100％。随访率分别为87．9％、89．3％和89．3％，组间比较差异均无统计学意义；临床随访3～12个月，BMS组较Firebird组和Cypher组心脏事件、再狭窄及靶血管再次血运重建发生率显著升高（P〈0．01），而Firebird组和Cypher组比较，差异无统计学意义（均P〉0．05）。结论Firebird雷帕霉素药物洗脱支架具有良好的安全性及满意的近期疗效，较裸支架可有效降低术后心胜事件及再狭窄的发生率；Firebird与Cypher的临床疗效相似。

Clinical contrast investigation of Firebird and Cypher rapamycin eluting stent

Objective To study and contrast the clinical efficacy of domestic and imported rapamycin drug eluting stent(DES).Methods Two hundred and twenty-two patients in the department from Aug 2003 to Apr 2006 were included.These patients were divided into three groups,58 patients underwent coronary artery stent with Firebird DES(Firebird group),168 patients with Cypher DES(Cypher group) and another 56 patients with Bare mental stent(BMS group).The instant and short term follow-up outcomes were compared among the three groups.Results The differences of mean age,male ratio,smoking history,hypertension,hyperlipemia,diabetes,stable angina,unstable angina,acute STsegment elevation myocardial infarction(STEMI),non-ST-segment elevation myocardial infarction(NSTEMI) and old myocardial infarction were no statistic significance among three groups(P>0.05).The differences of target vessel diameter and target lesion length were no statistic significance among three groups(P>0.05).The differences of single vessel disease,two-vessel disease, three-vessel disease,bifurcate lesion,chronic total occlusion lesion and left main lesion were no statistic significance among three groups(P>0.05).The procedural successful rate 100%,follow up rates(87.9% vs 89.3% vs 89.3%) were not significant statistically among three groups(P>0.05).Clinic follow up 3-12 months,as compared with Firebird group,patients in BMS group had more major adverse cardiovascular events(MACE),higher occurrence rates of restenosis and target vessel revascularization(P<0.01).However,there were no significant differences between Firebird group and Cypher group in any of these parameters.Conclusion The Firebird DES is safe and effective in treating coronary artery lesions with similar outcomes of the Cypher DES,and has low rate of restenosis and MACE comparing the BMS.