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目的评估自行设计制作的新型血管内可吸收镁合金支架的生物相容性、有效性和安全性。方法杂种犬35只,每只犬均于冠状动脉和股动脉置入可吸收镁合金支架1枚,分别于术后1、3、5 d和1、2、3、4周,每个时间点5只犬,复查冠状动脉和股动脉,血管造影后取材,分离支架段血管行组织病理观察及计算机图像分析,测量内弹力板面积、管腔面积、内膜增生面积及内膜增生面积百分比。结果 51枚支架成功置入35只犬的冠状动脉和股动脉,各时间点冠状动脉及股动脉造影均证实管腔通畅,无狭窄病变,无血栓形成。组织病理显示,支架置入术后1、3、5 d无内膜增生,仍有支架残留;1周支架完全降解;2周开始出现内膜增生,3周至4周内膜增生相对明显。各时间点均未见明显炎性反应和血栓形成;术后2、3、4周,内膜增生面积分别为(0.04±0.03)mm~2,(0.10±0.03)mm~2,(0.15±0.04)mm~2;内膜增生面积百分比分别为(1.84±1.18)%,(3.72±1.12)%,(6.29±3.36)%,差异有统计学意义(P<0.05)。结论血管内可吸收镁合金支架具有良好的生物相容性,安全有效,易操作,再狭窄程度轻,临床应用前景好。
Objective To evaluate the biocompatibility, effectiveness and safety of a novel endovascular magnesium alloy stent designed and manufactured by ourselves. Methods 35 mongrel dogs, each dog was placed in the coronary artery and femoral artery absorbable magnesium alloy stent 1, respectively, at 1,3,5 d and 1,2,3,4 weeks after surgery, each time point Five dogs, the coronary arteries and femoral arteries were examined. The angiography was taken and the segmental vessel segments were dissected for histopathological observation and computer image analysis. The area of endoluminal plate, luminal area, intimal hyperplasia area and intimal hyperplasia area were measured. Results 51 stents were successfully implanted into the canine coronary arteries and femoral arteries of 35 dogs. Coronary and femoral arteriography showed lumen patency, stenosis-free and thrombosis-free at all time points. Histopathology showed no neointimal hyperplasia at 1, 3, and 5 days after stenting. Stents were still remained. Stents were completely degraded at 1 week. Intimal hyperplasia began at 2 weeks and neointimal hyperplasia was obvious at 3 weeks to 4 weeks. No significant inflammatory reaction and thrombosis occurred at any time point. The area of intimal hyperplasia were (0.04 ± 0.03) mm ~ 2, (0.10 ± 0.03) mm ~ 2, (0.15 ± 0.03) mm ~ 0.04) mm ~ 2. The percentage of intimal hyperplasia area was (1.84 ± 1.18)%, (3.72 ± 1.12)% and (6.29 ± 3.36)%, respectively, with statistical significance (P <0.05). Conclusion Intravascular absorbable magnesium alloy stent has good biocompatibility, safe and effective, easy to operate, light restenosis, good clinical application.