可控性生物吸收镁合金药物洗脱支架动物实验研究

Animal experimental study of controlled bioabsorbable magnesium alloy drug-eluting stents

目的观察可控性生物吸收镁合金药物洗脱支架置入兔腹主动脉的安全性及有效性。方法实验兔32只随机分为观察组、对照组,观察组于腹主动脉置入1个镁合金支架,对照组置入不锈钢裸支架。术后6个月检测两组血生化指标、复查造影,并对局部血管组织标本进行病理观察。结果两组动物精神状况、血生化指标等差异无统计学意义(P>0.05),血管腔内未见血栓性闭塞。病理学显示观察组支架在术后6个月完全降解,局部未见血栓形成及血管塌陷闭塞。两组管腔面积及再狭窄率无显著差异。结论观察至6个月,可控性生物吸收镁合金药物洗脱支架完全降解,动物未出现毒性反应,无支架内血栓,其内膜增生及再狭窄率与不锈钢裸支架相当。

Objective To observe the safety and efficacy of controlled bioabsorbable magnesium alloy drug-eluting stent implantation in rabbit abdominal aorta.Methods Thirty-two experimental rabbits were randomly divided into the observation group and control group.The observation group was implanted by 1 magnesium drug-eluting stent in abdominal aorta,while the control group was implanted by 1 stainless bare metal stent.In postoperative 6 months,blood biochemical indicators were detected in the two groups,the angiography was re-examined and the local vascular tissue samples conducted the pathological observation.Results There was no significant difference in the mental condition and blood biochemical indexes between the two groups(P>0.05).No thrombotic occlusion occurred in the lumen of vessels.The pathology showed that the stents in the observation group were completely degraded in postoperative 6 months,no thrombosis and vascular collapse occlusion were observed in the original stent site,and there was no significant difference in the lumen area and restenosis rate between the two groups.Conclusion The controlled bioabsorbable magnesium alloy drug-eluting stents are completely degraded after 6-months observation.No toxic reaction is observed in the animals,no stent thrombosis is observed,and the rates of intimal hyperplasia and restenosis are similar to those of stainless bare stents.