国产可降解涂层西罗莫司洗脱支架临床应用的可行性和价格优势  

Homemade sirolimus-eluting stent with biodegradable coating: feasibility and price advantage

作　　者：安雅芳[1] 

机构地区：[1]天津市职业病防治院(工人医院)心内科,天津市300020

出　　处：《中国组织工程研究》2017年第6期946-951,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:国产可降解涂层西罗莫司洗脱支架(Tivoli支架)具有价格低廉的优势,其价格仅为进口左他莫司洗脱支架(Endeavor支架)的一半左右。Tivoli支架逐渐被广泛应用于临床,其安全性和有效性将被逐渐认可。目的:探讨国产Tivoli支架临床应用的可行性及对比进口Endeavor支架的价格优势。方法:选择2006年1月至2016年1月天津市职业病防治院(工人医院)心内科收治的共110例冠状动脉粥样硬化性心脏病患者,随机分为2组,分别接受Tivoli支架和Endeavor支架治疗。观察2组患者的手术即刻成功率,术前及术后1周血清C-反应蛋白水平,术后8个月冠状动脉造影结果,术后270 d时的主要不良心脏事件及支架内血栓事件的发生率。结果与结论:12组支架植入成功率均为100%;Tivoli支架患者植入术前与术后1周患者血清C-反应蛋白水平比较差异无显著性意义(P>0.05);2术后8个月,Tivoli组和Endeavor组造影随访率分别为93%(52/56)和93%(50/54),支架内再狭窄的发生率分别为11%(8/52)和3%(2/50)(P=0.370);3术后270 d时随访率为100%,2组均无死亡、心肌梗死和血栓事件发生,主要不良心脏事件的发生率分别为11%(6/56)和7%(4/54)(P=1.000),均为靶病变血运重建;4结果说明,Tivoli支架在冠状动脉病变临床应用中的短期及中期疗效、生物相容性及安全性与进口左他莫司洗脱支架相似,因此其价格优势更加明显。BACKGROUND： The homemade sirolimus-eluting stent with biodegradable coating（Tivoli stent） is cheaper than the imported zotarolimus-eluting stent（Endeavor stent） by half. Tivoli stent has been widely applied in clinic gradually, and its safety and efficacy will be recognized.OBJECTIVE： To explore the feasibility and price advantage of the Tivoli stent versus Endeavor stent. METHODS： 110 patients with coronary heart disease in Tianjin Occupational Diseases Prevention and Therapeutic Hospital（Tianjin Workers＇ Hospital） from January 2006 to January 2016 were selected and randomly allotted to two groups, followed by treated with Tivoli or Endeavor stents, respectively. The procedural success rate, the serum level of C-reactive protein before and 1 week after treatment, coronary angiographic results at 8 months after treatment, as well as the incidence of major adverse cardiac and stent thrombosis events during the 270-day follow-up were observed. RESULTS AND CONCLUSION： The successful rate of stent implantation was 100% in both groups. The serum level of C-reactive protein in the patients subjected to Tivoli stent before and 1 week after operation showed no significant difference（P〈0.05）. The rate of angiographic follow-up in the Tivoli and Endeavor groups was respectively 93%（52/56） and 93（50/54）, and the rate of in-stent stenosis was 11%（8/52） and 3%（2/50）（P=0.370） at 8 weeks postoperatively. All the patients were followed up for 270 days, and there was no death, myocardial infarction or stent thrombosis; the incidence of major adverse cardiac events due to the target lesion revascularization was 11%（6/56） in the Tivoli group and 7%（4/54） in the Endeavor group（ P=1.000）. These results suggest that the short- and mid-term efficacy, biocompatibility and safety of Tivoli stents are similar with those of Endeavor stents, so the price advantage stands out.

关 键 词：西罗莫司 支架 C反应蛋白质 组织工程 生物材料 材料相容性 可降解 C-反应蛋白 冠状动脉造影 主要不良心脏事件 支架内血栓 

分 类 号：R318[医药卫生—生物医学工程]