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目的比较三氧化二砷(As_2O_3)控释洗脱支架早期和非早期药物释放防治犬冠状动脉支架术后再狭窄的安全性及疗效。方法将裸支架、聚甲基丙烯酸丁酯/纳米二氧化硅单涂层支架、聚甲基丙烯酸丁酯/纳米二氧化硅-聚乳酸/乙醇酸双涂层支架、As_2O_3(200μg/支架)单涂层及双涂层控释洗脱支架随机置入30只犬冠状动脉回旋支或前降支相应节段,每只动物置入同类支架,分为裸支架组、单涂层组、双涂层组、单涂层 As_2O_3支架组和双涂层 As_2O_3支架组。术后4周处死,取支架血管段组织,观察和分析组织学变化。结果各组平均损伤积分相似。光镜可见新生内膜组织形成,未见内膜下出血和中膜、外膜坏死,无附壁血栓及炎性细胞浸润;扫描电镜显示各组内皮完整,未见血栓形成及白细胞黏附。组织形态学分析结果显示:单涂层 As_2O_3支架组与单涂层组和裸支架组、双涂层 As_2O_3支架组与双涂层组和裸支架组比较,平均新生内膜厚度、新生内膜面积、管腔面积狭窄率明显减少(P<0.01),管腔面积显著增大(P<0.01);单涂层 As_2O_3支架组与双涂层 As_2O_3支架组各指标比较,差异有统计学意义(P<0.05);单、双涂层组与裸支架组比较差异无统计学意义。结论As_2O_3控释洗脱支架安全可行,非早期较早期药物释放防治再狭窄作用更显著。
Objective To compare the safety and efficacy of early and non-early drug release of arsenic trioxide (As_2O_3) controlled release eluting stents in prevention and treatment of restenosis after coronary stenting in dogs. Methods Bare stents, polybutylmethacrylate / nano-silica single-coated stents, polybutylmethacrylate / nanosilica-polylactic acid / glycolic acid double coated stents, As 2 O 3 The coated and double-coated controlled-release eluting stents were randomly placed into the corresponding sections of 30 canine coronary circumflex or anterior descending branches. Each animal was implanted with similar stents, which were divided into bare stent group, single-coated group and double-coated Layer group, monolayer As_2O_3 stent group and double-coated As_2O_3 stent group. After 4 weeks of operation, the vessel segments of the stent were taken and the histological changes were observed and analyzed. Results The average injury scores of each group were similar. No neointimal hemorrhage, neointimal hyperplasia, non-adventitial thrombus and inflammatory cell infiltration were found in the light microscope. Endothelium was intact in each group without thrombus formation and leukocyte adhesion. The results of histomorphology analysis showed that the average neointimal thickness, the neointimal area, the average neointimal thickness, the average neointimal thickness, (P <0.01), and the luminal area was significantly increased (P <0.01). There was significant difference in the indexes of as_2O_3 scaffold group and double-coated As_2O_3 scaffold group (P <0.05). There was no significant difference between single and double-coated group and bare-stent group. Conclusions As_2O_3 controlled release stent is safe and feasible, and the effects of early drug release and restenosis are more significant.