国产西罗莫司洗脱支架与紫杉醇洗脱支架临床效果比较研究  

Compare homemade sirolimus-eluting stent to paclitaxel-eluting stent with clinical effect

作　　者：乔树宾[1] 侯青[1] 徐波[1] 陈珏[1] 刘海波[1] 杨跃进[1] 吴永健[1] 袁晋青[1] 吴元[1] 戴军[1] 尤士杰[1] 张沛[1] 高展[1] 马卫华[1] 窦克非[1] 邱洪[1] 慕朝伟[1] 陈纪林[1] 高润霖[1] 

机构地区：[1]中国医学科学院中国协和医科大学阜外心血管病医院冠心病诊治中心,北京市100037

出　　处：《中国介入心脏病学杂志》2007年第1期1-4,共4页Chinese Journal of Interventional Cardiology

基　　金：科技部社会公益基金(2002DIB40092)

摘　　要：目的比较国产西罗莫司洗脱支架(FBS)和进口紫杉醇洗脱支架(PES)治疗冠状动脉狭窄的效果。方法选择阜外心血管病医院2004年4月至2005年8月连续接受国产西罗莫司洗脱支架或紫杉醇洗脱支架治疗,并且进行冠状动脉造影随访的228例冠心病患者。排除支架置入失败、位置不理想者。所有的患者术后均接受阿司匹林300mg/d、氯吡格雷75mg/d等规范药物治疗。患者在支架术后6个月后接受冠状动脉造影随访。结果共228例患者(198名男性,30名女性)314个靶病变接受治疗并完成造影随访。其中C型病变占总数的40.1%,平均术前参考血管直径2.80±0.47mm。平均每个病变支架长度25.90±14.54mm。228例患者中118例置入紫杉醇洗脱支架,100例置入西罗莫司洗脱支架。两组在患者基本条件方面,国产西罗莫司洗脱支架组患者年龄大于紫杉醇洗脱支架组,紫杉醇洗脱支架组有更多的2型糖尿患者;在病变基本条件方面,国产西罗莫司洗脱支架组病变更多偏心性病变,其他没有差别。6个月后随访结果国产西罗莫司洗脱支架组的支架再狭窄率明显低于紫杉醇洗脱支架组(5.3%比21.9%,P<0.001)。国产西罗莫司洗脱支架组的靶病变血管重建率(TLR)明显低于紫杉醇洗脱支架组(3.8%比13.1%,P<0.001)。国产西罗莫司洗脱支架组支架内晚期腔径丢失明显小于紫杉醇洗脱支架组(0.18±0.41mm比0.58±0.69mm,P<0.001)。结论国产西罗莫司涂层支架用于临床实践有良好的疗效。Objective To compare homemade Sirolimus-eluting stentt （FBS） with imported Paelitaxel-elufing stent （PES） in clinical effect. Methods Two hundred and twenty eight consecutive patients were enrolled in our hospital from April 2004 to August 2005, who received either FBS or SES and completed the 6-month-follow up angiography. All patients received medical treatment according to the guidelines as aspirin 300 mg and elopidogrel 75 nag once daily not less than 6 months after the procedure. The patients were followed up clinically for about 6 to 12 months. Results A total of 314 lesions in the 228 patients （ 198 male and 30 female） were treated and among which 40.1% were type C lesions. The average referenced vessel diameter was 2. 80 ＋ 0. 47 mm. The average stent length of per lesion was 25.90 ± 14. 54 ram. There were 22.0% of lesions treated with overlapping stenting. In patients baseline characteristics, more patients in the PES group were co-morbidded with type 2 diabutes mellitus compared with the FBS group. In lesion baseline characteristics, there were no difference between the FBS group and the PES group. After 6-12 months, the restenosis rate in the FBS group is less than that in the PES group （5.3% vs 21.9%, P 〈 0. 001 ）. There were obvious superiority in terms of TLR in the FBS group than the PES （3.8% vs 13.1%, P〈0. 001）. The in-stent late loss of the PES group is greater than that of the FBS group （0.58 ±0.69 mm vs0. 18 ±0.41 mm,P〈0.001）. Conclusion Homemade sirolimus-eluting stents （FBS） shows comparable clinical outcomes with paelitaxel-eluting stents （PES）.

关 键 词：支架 冠状动脉再狭窄 冠状血管造影术 冠状动脉疾病 

分 类 号：R654.2[医药卫生—外科学]