药物洗脱冠状动脉支架系统动物实验研究

目的通过观察在猪动脉中置人心畅可降解聚合物涂层药物洗脱冠状动脉支架（天津百畅公司开发）及对照组支架后的植入后管腔丢失、内皮化、炎症反应、损伤及血栓形成情况来评价国产可降解聚合物涂层药物洗脱支架临床应用的可行性。方法将2种共60枚支架分别置入30头猪冠状动脉的前降支、回旋支以及右冠状动脉。支架植入后的2，5，12，25周，将不同数量的猪处死行组织形态学检查，观察炎症、血栓形成情况和内皮化评价。结果支架置入术后的冠脉通畅，无明显狭窄；支架贴血管内壁良好，血管内腔表面光滑；2种支架均无血栓形成，心畅可降解聚合物涂层药物洗脱支架炎症反应及内皮化与对照组无明显差异，其管腔丢失较对照组轻或无明显差异。结论实验提示心畅可降解聚合物涂层药物洗脱支架置入后有良好的血液相容性，生物性能稳定，支架内表面迅速内皮化，血管有良好的开通率。说明可降解聚合物涂层药物洗脱支架是安全、有效的。

Study on the drug during coronary stent in animal

Objective To explore the feasibility of clinical application of biodegradable polymer-coated drug-eluting stent. Methods Thirty each of the drug-eluting stent or bare-metal stents were implanted randomly into the anterior descending arteries, circumflex and right canine coronary arteries of thirty healthy pigs. The pathological examination was taken at 2 weeks to 6 months after coronary angiography to investigate the inflammation, thrombosis and endothelialization. Results Macroscopic observation of the stented arteries demonstrated complete incorporation of stent wires into the arterial wall and smooth vessel lumens. There were no significant differences existing between two kinds of the stents in terms of thrombosis, inflammation and endothelialization. The lumen loss in the biodegradable polymer-coated drug-eluting stent group is less than that in the bare-metal stent group. Conclusion The biodegradable polymer-coated drug-eluting stent is promising with good biocom-patibility, blood compatibility and phyaicochemical stability after being implanted into pig coronary arteries. The blood vessel transplanted with the drug-eluting stents maintains a high patency rate due to rapid endothelialization.