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目的 :评价乳酸和乙醇酸聚合物携带雷帕霉素并以支架为载体抑制血管新生内膜的作用和预防支架内再狭窄的有效性。方法 :采用随机、双盲试验 ,在 2 0头微型猪的冠状动脉前降支或左旋支分别置入支架 1枚 ,其中金属裸支架 8枚 ;雷帕霉素涂层支架 12枚。涂层材料选用乳酸和乙醇酸聚合物 ,根据两种材料比例将涂层支架分为雷帕霉素缓慢释放涂层支架 (药物剂量 6 5～ 90 μg/支架 ,5枚 )和雷帕霉素快速释放涂层支架 (药物剂量 6 8～ 96 μg/支架 ,7枚 )。2 8d后进行冠状动脉造影 ,术后处死动物 ,取出支架血管 ,进行组织学分析。 结果 :对照组的再狭窄率为 2 5 .0 % (2 /8) ;两组雷帕霉素涂层支架均为 0 %。平均狭窄程度 :对照组为 (31± 2 2 ) % ,雷帕霉素缓慢释放涂层支架组减少了 2 8% (P <0 .0 5 ) ;雷帕霉素快速释放涂层支架组减少了 2 3% (P <0 .0 5 ) ;新生内膜面积 :对照组 (2 .18± 1.0 3)mm2 ;雷帕霉素缓慢释放涂层支架组减少了 1.0 9mm2 (P <0 .0 5 ) ;雷帕霉素快速释放涂层支架组减少了 1.2 4mm2 (P <0 .0 5 )。结论 :乳酸和乙醇酸聚合物携带雷帕霉素涂层支架可以降低支架内的狭窄程度 ,有效地减少血管内新生内膜面积 ,预防支架内的狭窄
OBJECTIVE: To evaluate the effectiveness of lactic acid and glycolic acid polymers in carrying rapamycin and scaffold as carrier to inhibit neointimal formation and prevent in-stent restenosis. Methods: A randomized, double-blind trial was performed on 1 anterior descending coronary artery or left circumflex artery in 20 miniature pigs, including 8 bare metal stents and 12 rapamycin-coated stents. The coating materials were selected from lactic acid and glycolic acid polymer. According to the ratio of the two materials, the coated stents were divided into two groups: slow-release rapamycin coated stent (dose: 65 ~ 90 μg / Fast-release coated stents (drug dose 6 8 ~ 96 μg / stent, 7). 2 8d after coronary angiography, after the animals were sacrificed, remove the stent blood vessels, histological analysis. Results: The restenosis rate in the control group was 25.0% (2/8). Both rapamycin-coated stents were 0%. The average degree of stenosis was (31 ± 22)% in the control group, 28% in the rapamycin slow-release coated stents group (P <0.05), and less in the rapamycin-fast-release coated stents group (P <0.05). The neointimal area was (2.18 ± 1.03) mm2 in the control group and 1.09 mm2 in the slow-release coating group of rapamycin group (P0.01 5); rapamycin rapid release coated stent group reduced 1.2 4mm2 (P <0.05). CONCLUSIONS: The lactic acid and glycolic acid polymer-coated rapamycin-coated stents can reduce the degree of stenosis within the stent, effectively reduce the in-vessel neointimal area, and prevent stenosis within the stent