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目的研究应用IN-1233-洗脱覆膜支架预防兔食管模型组织增生的有效性。材料与方法本实验均经地方动物研究委员会批准。在40只雄性新西兰兔(体质量为2.8～3.2kg)体内植入食管支架。用药组(D)采用IN-1233-洗脱覆膜支架(n=20);对照组(C)采用聚氨酯覆膜支架(n=20)。IN-1233-洗脱覆膜支架的药物负荷为10%。将本研究分为4组(n=10):C和D组动物分别在支架植入后4周(C4,D4)和8周(C8,D8)时被分批处死。应用食管X线摄影评估食管直径狭窄的百分比。比较用药组与对照组支架的组织学表现。采用Mann-Whitney U检验评估组间差异。结果支架植入后第4周[C4=(36.15±12.63)%,D4=(7.83±8.12)%,P<0.001]和8周[C8=(50.21±20.43)%,D8=(27.78±14.40)%,P=0.019]时,D组直径狭窄的平均百分数±标准差较C组明显更低。D组的肉芽组织区域所占百分比[C4=(33.07±19.11)%,D4=(21.59±18.22)%,P=0.028;C8=(44.70±21.71)%,D8=(31.97±22.54)%,P=0.131]、上皮层数量(C4=4.77±1.55,D4=3.37±1.73,P=0.002;C8=5.50±1.38,D8=4.50±1.63,P=0.057)和黏膜下纤维化厚度[C4=(2.42±1.08)mm,D4=(1.62±0.77)mm,P=0.006;C8=(2.89±1.00)mm,D8=(2.07±0.71)mm,P=0.007]较C组更低。D组的炎性细胞浸润明显高于C组(C4=2.63±0.81,D4=3.33±1.09,P=0.032;C8=2.20±0.81,D8=3.00±0.95,P=0.012)。结论 IN-1233-洗脱覆膜支架的应用可降低继发于支架植入的兔食管模型的组织增生。
Objective To study the effectiveness of IN-1233-coated stent in preventing the proliferation of rabbit esophageal tissue. Materials and Methods The experiment was approved by the local animal research committee. Esophageal stents were implanted in 40 male New Zealand rabbits (body weight 2.8-2.2 kg). The medication group (D) used IN-1233-eluting stent (n = 20), and the control group (C) polyurethane covered stent (n = 20). The drug loading of the IN-1233-eluting stent was 10%. The study was divided into 4 groups (n = 10): Animals in groups C and D were sacrificed at 4 weeks (C4, D4) and 8 weeks (C8, D8) after stent implantation. Esophageal radiography was used to assess the percentage of esophageal stenosis. The histological features of the scaffolds were compared between the medication group and the control group. Mann-Whitney U test was used to assess differences between groups. Results The fourth week after implantation [C4 = (36.15 ± 12.63)%, D4 = (7.83 ± 8.12)%, P <0.001] and 8 weeks [C8 = (50.21 ± 20.43)%, D8 = (27.78 ± 14.40 )%, P = 0.019], the mean percentage ± standard deviation of diameter stenosis in group D was significantly lower than that in group C. The percentage of granulation tissue in group D [C4 = (33.07 ± 19.11)%, D4 = (21.59 ± 18.22)%, P = 0.028, C8 = 44.70 ± 21.71%, D8 = 31.97 ± 22.54% (C4 = 4.77 ± 1.55, D4 = 3.37 ± 1.73, P = 0.002; C8 = 5.50 ± 1.38, D8 = 4.50 ± 1.63, P = 0.057) and submucosal fibrosis thickness [C4 = (2.42 ± 1.08) mm, D4 = (1.62 ± 0.77) mm, P = 0.006; C8 = (2.89 ± 1.00) mm, D8 = (2.07 ± 0.71) mm, P = 0.007] Inflammatory cell infiltration in group D was significantly higher than in group C (C4 = 2.63 ± 0.81, D4 = 3.33 ± 1.09, P = 0.032; C8 = 2.20 ± 0.81, D8 = 3.00 ± 0.95, P = 0.012). Conclusion The use of IN-1233-eluting stent can reduce the tissue hyperplasia of the rabbit esophagus secondary to stent implantation.