BACKGROUND:Lowering blood glucose concentration slows or prevents the development of complications in diabetes. One of the tools to control glucose levels is continuous glucose measurements. A promising technique involves measurements from glucose sensors implanted directly in skin/subcutis. However, in vivo bioinstability and drift in sensor signals have been reported after implantation, suggestively caused by the infiltration of inflammatory cells and adhesion of proteins to sensor membranes. The aim of this study was to evaluate the in vivo biocompatibility of two electrochemical glucose sensors after implantation in the skin of pigs. METHODS:In vivo biocompatibility of in-house fabricated electrochemical glucose sensors and a commercially available continuous glucose monitoring system (CGMS, Medtronic MiniMed, Northridge, CA) implanted 1 h, 2 h, 24 h, 3 days, or 7 days was examined by histological and immunohistochemical techniques. RESULTS:The extent of inflammation increased significantly as a function of time. The inflammation ranged from an acute focal fibrinous/suppurative dermatitis to a chronic fibrinous and granulating foreign body dermatitis 7 days after implantation. Immunohistochemical stainings showed that heterophilic granulocytes, macrophages, and fibrinogen/fibrinogen fragments D and E were consistent findings. Infiltration of CD3epsilon-positive T-cells was primarily confined to day 7 of implantation. In addition, the pro-inflammatory cytokines interleukin-1 and tumor necrosis factor-alpha played a role in the reaction to sensors. CONCLUSION:The reported in vivo bioinstability of sensors is likely to be caused by protein and cellular biofouling on the sensor membrane. Furthermore, the consistent finding of fibrinogen and fibrinogen fragments D and E at the sensor-tissue interface seems to play an important role in the pathogenesis as it possibly maintains the inflammation by promoting the recruitment of inflammatory cells to the implantation site.

译文

背景:降低血糖浓度可减缓或预防糖尿病并发症的发展。控制葡萄糖水平的工具之一是连续的葡萄糖测量。一种有前途的技术涉及直接植入皮肤/皮下组织中的葡萄糖传感器的测量。然而,植入后已有体内生物不稳定性和传感器信号漂移的报道,提示这是由于炎症细胞的浸润和蛋白质与传感器膜的粘附引起的。这项研究的目的是评估两种电化学葡萄糖传感器在猪皮中植入后的体内生物相容性。
方法:采用自制的电化学葡萄糖传感器和植入1 h,2 h,24 h,3天或7天的市售连续葡萄糖监测系统(CGMS,Medtronic MiniMed,Northridge,CA)进行体内生物相容性检查。组织学和免疫组化技术。
结果:炎症程度随时间显着增加。炎症的范围从植入后7天的急性局灶性纤维化/化脓性皮炎到慢性纤维化和肉芽状异物皮炎。免疫组织化学染色显示,嗜异性粒细胞,巨噬细胞以及纤维蛋白原/纤维蛋白原片段D和E是一致的发现。 CD3epsilon阳性T细胞的浸润主要限于植入的第7天。此外,促炎细胞因子白细胞介素-1和肿瘤坏死因子-α在与传感器的反应中也起作用。
结论:已报道的传感器在体内的生物不稳定性可能是由于传感器膜上的蛋白质和细胞生物污损所致。此外,在传感器-组织界面处一致发现纤维蛋白原和纤维蛋白原片段D和E似乎在发病机理中起着重要作用,因为它可能通过促进炎症细胞向植入部位的募集来维持炎症。

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