辐照和EO灭菌对SIS材料免疫原性的对比研究

免疫反应大小是决定可植入生物材料能否开展临床应用的关键因素之一。研究评估了辐照和环氧乙烷（EO）两种灭菌方式处理后的小肠黏膜下层（SIS）脱细胞外基质材料在体内的免疫反应，旨在为其临床试验的开展提供可行依据。将两种灭菌方式处理的SIS脱细胞外基质材料皮下植入到BALB/c小鼠，第14和28天取样后，系统性地评估了其免疫反应。与仅手术不植入材料的阴性对照组相比，免疫器官（脾和淋巴结）的形态、质量、细胞数、淋巴细胞的体外增殖及酶联免疫吸附检测结果均无显著性差异，证明两种灭菌方式处理后的SIS脱细胞外基质材料都不会对小鼠引起明显的免疫排斥反应。流式细胞术分析及局部H&E染色结果表明，经EO灭菌处理的SIS脱细胞外基质材料对小鼠的免疫刺激更小，是更适用于此材料的灭菌方法。研究结果为SIS脱细胞外基质材料的灭菌程序及其临床应用提供了支持。 

Comparative study on immunoreactions of small intestinal submucosa by irradiation and ethylene oxide sterilization treatments

Foreign body reaction is one of the key factors limiting the application of implantable biomaterials. This study evaluates the in vivo immune response of acellular Small Intestinal Submucosa (SIS) materials treated with irradiation and Ethylene Oxide (EO) sterilization technology for providing a basis for clinical trials. The sterilized materials are subcutaneously implanted into BALB/c mice for 14 or 28 days. Compared with negative controlgroup, there is no difference in the size, weight, cell numbers, lymphocytes proliferation and enzyme-linked immunosorbent assay of the immune organs for two sterilized materials on mice. These results prove that the SIS materials treated by two sterilization methods do not cause obvious inflammatory reaction. Flow cytometry analysis and H&E staining results show that the materials sterilized by EO have less immune stimulation to mice. It means that EO treatment is a safer and more reliable sterilization method for SIS material, providing a prospect for sterilization procedure and clinical application of acellular SIS materials.