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目的:评价生物可降解的聚乳酸聚羟基乙酸共聚物(PLGA)涂层雷帕霉素洗脱支架对健康小型猪冠状动脉内膜增生的影响。方法:26只健康小型猪随机分入316L不锈钢裸金属支架组(316 L组)、L605钴铬合金裸金属支架组(L605组)、PLGA涂层L605支架组(PLGA组)和PLGA涂层雷帕霉素洗脱支架组(雷帕霉素组)。各组均包括1周观察终点的猪1只和4周观察终点的猪5只。雷帕霉素组还包括12周观察终点的猪2只。每只猪于左前降支和右冠状动脉各置入同种支架1枚。至观察终点时复查冠状动脉造影并处死取材,通过形态学方法观察内膜增生情况。结果:4周时反映内膜增生的各项指标雷帕霉素组均显著优于其它3组,而其它3组之间没有显著性差异。雷帕霉素组与316L组相比支架上内膜厚度少73%(0.11 mm对0.41 mm),支架间内膜厚度少79%(0.06 mm对0.29 mm),新生内膜面积少69%(0.64 mm2对2.09 mm2),面积狭窄百分比少61%(18.53%对47.27%)。316L组有4例、L605组有3例发生支架内狭窄,而雷帕霉素组无支架内狭窄发生。12周时雷帕霉素组内膜增生有所加重,但较4周时相比除了支架间内膜厚度外其他反映内膜增生的各项指标差异均无统计学意义。结论:采用可降解的PLGA涂层雷帕霉素洗脱支架可以显著抑制健康小型猪冠状动脉支架置入术后4周和12周的内膜增生。
Objective: To evaluate the effect of biodegradable poly (DL-lactide-co-glycolide) (PLGA) -coated rapamycin-eluting stent on coronary intimal hyperplasia in healthy miniature pigs. Methods: Twenty-six healthy piglets were randomly divided into 316L stainless steel bare metal stent group (316L group), L605 cobalt-chromium alloy bare metal stent group (L605 group), PLGA coated L605 stent group (PLGA group) and PLGA coated mine Paclitaxel-eluting stent group (rapamycin group). Each group included 1 pig at the 1-week end point and 5 pigs at the 4-week end point. The rapamycin group also included 2 pigs at the end of 12 weeks of observation. Each pig in the left anterior descending branch and the right coronary artery into the same stent 1. Coronary angiography was performed at the end of observation and sacrificed. Morphology was used to observe the intimal hyperplasia. Results: The indexes of endometrial hyperplasia 4 weeks after rapamycin group were significantly better than the other three groups, while there was no significant difference between the other three groups. In the rapamycin group, stent thickness was 73% (0.11 mm vs. 0.41 mm), stent less 79% (0.06 mm vs 0.29 mm), and neointimal area was 69% less than the 316L group 0.64 mm2 vs. 2.09 mm2), with a 61% reduction in area stenosis (18.53% vs 47.27%). There were 4 cases in the 316L group, 3 cases in the L605 group, and no stenosis in the rapamycin group. At 12 weeks, the endometrial hyperplasia of rapamycin group was aggravated, but there was no significant difference among the other parameters except endometrial thickness reflecting endometrial hyperplasia at 4 weeks. Conclusion: The biodegradable PLGA-coated rapamycin-eluting stent significantly inhibited neointimal hyperplasia at 4 weeks and 12 weeks after implantation of healthy mini-swine coronary stents.