京尼平生物型人工食管生物相容性的实验评价

The Experimental Evaluation of Biocompatibility of the Genipin Biotype Artificial Esophagus

目的:观察京尼平生物型人工食管的生物相容性。方法:应用急性毒性试验、亚急性毒性试验、溶血试验、细胞毒性试验、肌肉植入试验对材料的生物相容性进行评价。结果:材料无急性、亚急性毒性反应,溶血率为0.559%,低于5%,说明其有良好的血液相容性。细胞生长无明显抑制现象,材料细胞毒性评分为0级和1级。材料经肌肉植入1周后,形成纤维囊包裹,有少量淋巴细胞浸润;植入后4周材料周围出现较多淋巴细胞和嗜酸性粒细胞;植入后12周,材料周围淋巴细胞和嗜酸性粒细胞大量减少,组织炎症反应明显减轻。结论:京尼平生物型人工食管具有良好的生物相容性,符合临床应用前标准。

Objective： To investigate the biocompatibility of the genipin biotype artificial esophagus. Methods： The biocompatibility of the genipin biotype artificial esophagus was primarily evaluated using the acute and subacute toxicity tests, hemolysis test and cytotoxicity test and muscle implantation test. Results： No acute or subacute toxicity was revealed with the genipin biotype artificial esophagus; The hemolysis rate was 0. 559% （less than 5% ） ; The cytotoxicity scores were 0 and 1 grade. A mild inflammatory reaction with a small amount of lymphocytic infiltration was observed in rabbit＇ s muscle one week after implantation ; A large number of lymphocytes and eosinophils around the material were observed four weeks after implantation, but the inflammatory reaction reduced significantly 12 weeks after implantation. Conclusion： Our findings show that the genipin biotype artificial esophagus would be a promising biomaterial with good biocompatibility for clinical application.