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雷帕霉素洗脱镁钕锌锆合金支架在猪冠状动脉中的体外和体内降解

In vitro and in vivo degradation of rapamycin-eluting Mg-Nd-Zn-Zr alloy stents in porcine coronary arteries.

作者信息

Shi Yongjuan, Zhang Lei, Chen Jiahui, Zhang Jian, Yuan Feng, Shen Li, Chen Chenxin, Pei Jia, Li Zhonghua, Tan Jinyun, Yuan Guangyin

机构信息

National Engineering Research Center of Light Alloy Net Forming & State Key Laboratory of Metal Matrix Composite, Shanghai Jiao Tong University, Shanghai 200240, China.

Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.

出版信息

Mater Sci Eng C Mater Biol Appl. 2017 Nov 1;80:1-6. doi: 10.1016/j.msec.2017.05.124. Epub 2017 May 19.

Abstract

In this work, rapamycin-eluting poly (d, l-lactic acid) coating (PDLLA/RAPA) was prepared on biodegradable Mg-Nd-Zn-Zr alloy (JDBM) for both in vitro and in vivo investigation of the degradation behaviors of the magnesium alloy stent platform. Electrochemical tests and hydrogen evolution test demonstrated significant in vitro protection of the polymeric coating against magnesium degradation both in short and long term. The 3-month in vivo study on the RAPA-eluting JDBM stent implanted into porcine coronary arteries confirmed its favorable safety, and in the meanwhile revealed similar neointima proliferation compared to the second generation DES Firebird 2 with no occurrence of adverse complications. Moreover, Micro-CT examination combined with IVUS and OCT detection indicated a remarkably lower degradation rate and prolonged radial supporting duration of the drug-eluting JDBM stent as compared to the bare, attributable to the protection of the coating in vivo. Hence, rapamycin-eluting JDBM stents exhibit great potential for clinical application.

摘要

在本研究中,在可生物降解的Mg-Nd-Zn-Zr合金(JDBM)上制备了雷帕霉素洗脱聚(d,l-乳酸)涂层(PDLLA/RAPA),用于体外和体内研究镁合金支架平台的降解行为。电化学测试和析氢测试表明,该聚合物涂层在短期和长期内均能对镁降解起到显著的体外保护作用。对植入猪冠状动脉的雷帕霉素洗脱JDBM支架进行的3个月体内研究证实了其良好的安全性,同时显示与第二代药物洗脱支架Firebird 2相比,新生内膜增殖相似,且未发生不良并发症。此外,微计算机断层扫描(Micro-CT)检查结合血管内超声(IVUS)和光学相干断层扫描(OCT)检测表明,与裸支架相比,药物洗脱JDBM支架的降解速率显著降低,径向支撑持续时间延长,这归因于涂层在体内的保护作用。因此,雷帕霉素洗脱JDBM支架具有巨大的临床应用潜力。

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