新型医用可降解镁合金(JDBM)螺钉的生物安全性研究  

The Biosecurity of the High-Performance Biomedical Magnesium Alloy(JDBM) Screws

作　　者：孔祥东[1] 郝永强[1] 王磊[1] 毛震扬[1] 潘伟[1] 戴尅戎[1] 袁广银[2] 

机构地区：[1]上海交通大学医学院附属第九人民医院骨科,上海市200011 [2]上海交通大学轻合金精密成型国家工程研究中心,上海市200240

出　　处：《组织工程与重建外科杂志》2015年第3期124-127,共4页Journal of Tissue Engineering and Reconstructive Surgery

基　　金：国家重点基础研究发展计划(973项目;2012CB619101);上海交通大学医工交叉重点项目(YG2011ZD06)

摘　　要：目的探讨新型高性能医用镁合金(JDBM)的生物安全性,评估其对动物各脏器功能及局部的影响。方法建立新西兰兔JDBM螺钉股骨植入模型,定时观察伤口愈合及一般状况。检测血常规、凝血功能、肝肾功能、心功能及钙磷镁等,观察材料植入后上述指标的变化。收集心、肝、脾、肺、肾及螺钉周围肌肉软组织标本,行HE染色,对各脏器进行组织学观察。通过X线摄片观察螺钉周围骨质密度的改变,对螺钉的成骨性能进行初步分析。结果血液学检测结果显示,JDBM材料对血常规各项指标、凝血功能、肝肾功能及心功能等均无明显影响;组织学观察显示,各脏器形态学上无明显的病理性改变,同时也未引起局部肌肉软组织的炎症、异物反应;X线片显示,螺钉周围未见明显气体积聚,且降解速度较为缓慢,至6个月时,螺钉依然清晰可见,近骨皮质区见明显的密度增高影,表明此处骨形成较活跃。结论JDBM是一种生物安全性良好的新型医用可降解镁合金材料。Objective To explore the safety of the new high-performance biomedical magnesium alloy （JDBM） in vivo and to evaluate its influence on functions of organs and local response. Methods New Zealand rabbits were used to build the JDBM magnesium alloy implantation model. Regular observation of wound healing and general condition was firstly carried out. And then blood specimen was collected to detect the blood routine, coagulation function, hepatic and renal functions, cardiac function and the content of calcium, phosphate and magnesium. The heart, liver, spleen, lung, kidney and muscle tissues around the screw were collected for HE staining to observe pathological changes. X-ray was carried out to observe the changes in bone density around the screw, and the osteogenesis property of screw was preliminarily analyzed. Results This new material had no effect on the results of blood routine index, coagulation function, hepatic function, renal function and cardiac function. NO pathological changes of organs were observed, and no inflammatory reaction of foreign body was detected in musculi parenchyma as well by histological detection. X-rays showed no significant gas accumulated around the screw and the screw degraded slowly. The screw was clearly visible six months after operation, and an apparent thickening was found near the bone cortex which hinted a relatively strong bone formation. Conclusion JDBM is a new kind of magnesium alloy material with good biosecurity.

关 键 词：镁合金 生物安全性 内固定 动物实验 

分 类 号：R687.32[医药卫生—骨科学]