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采用多中心、双盲、随机对照试验,评价西罗莫司洗脱支架(sirolimus BX Velocity eluting stent)的安全性和疗效,西罗莫司诱导对细胞增殖G1后期的抑制作用。对象为单支原发病变小于100%狭窄(直径法)准备行支架植入的心绞痛病人,该病变放置单个18 mm长支架。血管大小2.5-3.5 mm。病人排除左主干病变和急性心肌梗死。主要终点:6个月后血管造影提示最小血管内径(minimal luminal diameter,MLD)的丧失;其他终点:狭窄程度(直径法),最小血管内径再狭窄率(>50%),6个月及1 年后的主要心血管不良事件(死亡,Q波型心肌梗死,肌酸激酶(creatine kinase,CK)超出2倍基础值,并且肌酸激酶同工酶-MB,CK-MB)升高大于基础值。
A multicenter, double-blind, randomized controlled trial was conducted to evaluate the safety and efficacy of sirolimus eluting stent (sirolimus eluting stent) and the inhibitory effect of sirolimus on the later phase of G1 cell proliferation. Subjects were angioplasty patients with a single primary lesion less than 100% stenosis (diameter method) undergoing stent implantation of a single 18 mm long stent. Blood vessel size 2.5-3.5 mm. Patients excluded left main disease and acute myocardial infarction. Primary endpoint: angiography 6 months after surgery revealed minimal luminal diameter (MLD) loss; other end points: stenosis (diameter), minimum vascular restenosis (> 50%), 6 months and 1 Years after the major cardiovascular adverse events (death, Q-wave MI, creatine kinase (CK) exceeding 2-fold basal values and creatine kinase MB, CK-MB) increased more than basal value.