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作 者:孙晓霞[1] 盖潇潇[1] 孙立魁[1] 王贤美[1] 仇士东[1] 侯丽[1]
机构地区:[1]国家食品药品监督管理局济南医疗器械质量监督检验中心山东省医疗器械生物学评价重点实验室,山东济南250101
出 处:《西安交通大学学报(医学版)》2016年第1期21-27,共7页Journal of Xi’an Jiaotong University(Medical Sciences)
基 金:山东省自然科学基金青年基金项目(No.ZR2014CQ041);再生型医用置入器械国家工程实验室PI项目(No.2012NELRMD007)~~
摘 要:目的动态评价小鼠植入重组异种骨后的免疫毒性改变,揭示该重组异种骨的免疫学作用机制。方法以广东冠昊生物科技股份有限公司研发的重组异种骨为材料,进行体外检测该重组异种骨的淋巴细胞转化实验;将重组异种骨植入Balb/c小鼠右侧股部肌间隙,分别通过血生化分析仪、ELISA和流式细胞术,于植入后1周、2周、4周动态监测Balb/c小鼠免疫学改变,综合评价该重组异种骨对机体的免疫学影响。结果通过实验发现,该重组异种骨无明显的体外淋巴细胞免疫刺激作用;异种骨植入小鼠后,其血清中C3、IgG、IgM、炎性因子(TNF-α、IL-6)水平以及植入物局部碱性磷酸酶(ALP)含量均与阴性对照组(即假手术组)无明显差异,且该异种骨植入对小鼠外周血单个核细胞(peripheral blood mononuclear cell,PBMC)及其淋巴结淋巴细胞的分群和活化均无显著影响。结论该重组异种骨不能引起体内外的免疫毒性反应,从而为重组异种骨的临床应用提供实验数据和理论依据。Objective To make a dynamic evaluation of the immunotoxicology caused by heterogeneous bone implantation and reveal its immunological mechanisms. Methods Heterogeneous bone was provided by Guangdong Grandhope Biotech Co., Ltd. Immunology of Balb/c mice by blood biochemical analysisi ELISA and flow cytometry after the test of lymphocyte transformation in vitro. We dynamically monitored the immunological changes Balb/c mice after 1 week, 2 weeks and 4 weeks of muscle implantation to evaluate the immunological effect of the heterogeneous bone on the body. Results Our experiments showed that the heterogeneous bone did not cause immune stimulation of lymphocytes in vitro, and there were no differences between implantation of heterogeneous bone and the sham operation in the levels of C3, IgG, IgM, inflammatory factors (TNF-α and IL-6) in serum and ALP in implantation site. Moreover, heterogeneous bone implantation did not affect the proportion or activation of peripheral blood mononuclear Cells (PBMCs) and lymphocytes in the lymph node. Conclusion The heterogeneous bone cannot mediate immunotoxicology in vivo, which may provide experimental data and theoretical basis for clinical application of heterogeneous bone.
分 类 号:R318.08[医药卫生—生物医学工程]
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