生物摩擦腐蚀在骨科领域的相关体外研究进展  

Research Progress of In-vitro Test on Biotribocorrosion in the Field of Orthopaedic Trauma Surgery

作　　者：杨抒 蒲建 张家振 丁金聚 刘斌 YANG Shu;PU Jian;ZHANG Jiazhen;DING Jinju;LIU Bin(GBA Center for Medical Device Evaluation and Inspection,NMPA,Guangdong Shenzhen,518045,China;School of Biomedical Engineering,Shenzhen Campus of Sun Yat-sen University,Guangdong Shenzhen 518107,China;Center for Medical Device Evaluation,Beijing 100076,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评检查大湾区分中心,广东深圳518045 [2]中山大学生物医学工程学院,广东深圳518107 [3]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国医药导刊》2025年第1期27-33,共7页Chinese Journal of Medicinal Guide

摘　　要：金属假体在体内会受到循环载荷、运动和体液等多重因素的影响,进而产生摩擦腐蚀损伤并释放金属离子,导致局部组织的不良反应,诱发假瘤和假体失效。科学、系统地评估金属假体的耐腐蚀性能是保障患者生活质量的有效手段。囿于当前技术,在体实时监测假体的腐蚀行为较难实现,临床上多采用体外测试的方法研究假体的耐腐蚀性能和潜在损伤机理。本研究通过检索、总结、归纳现行的技术标准、测试方法和相关研究文献,聚焦生物摩擦腐蚀在骨科领域的相关体外研究进展,阐述了以髋关节和接骨板为代表的骨科产品在生物摩擦腐蚀方面的体外研究现状和临床风险,并对生物摩擦腐蚀的防护与控制措施进行了探讨,进一步总结了金属植入物在体生物摩擦腐蚀的损伤机制;同时,结合现行审评要求及审评经验探讨了相关产品在注册审评过程中的风险点,指出了当前性能评价方法存在的局限性,以期为制造商进行相关临床前验证研究提供指导建议,为今后建立系统性、层次性的金属假体摩擦腐蚀评价体系提供参考和可行思路。Metal prostheses within the human body are subjected to multiple factors such as cyclic loads,movement,and body fluids,which can lead to tribocorrosion damage and the release of metal ions.This can cause adverse local tissue reaction and induce pseudotu-mors and the failure of the prostheses.Therefore,a scientific and systematic assessment of the corrosion resistance of metal prostheses is an effective means of ensuring the life quality for patients.Due to the limitation of current technology,on-site monitoring of the corrosion behavior of prostheses is difficult to achieve,so scholars tend to use in-vitro testing methods to study the corrosion resistance and poten-tial damage mechanisms of prostheses.This study,through literature search,summary,and induction of current technical standards,testing methods,and related research literature,focuses on the relevant in-vitro research progress of biotribocorrosion in the field of ortho-pedics,elaborates on the status of in-vitro research and clinical risks related to metal corrosion of orthopedic products,such as hip joints and bone plates,and discussed the protection and control measures for biotribocorrosion.The damage mechanism of metal implant tribo-corrosion in-vivo was further summarized.At the same time,the risk points in the process of and review of relevant products were explored in combination with the current review requirements and review experience,and the limitations of the current performance evalu-ation methods were pointed out,to provide guidance suggestions for manufacturers to carry out relevant preclinical verification research,and to provide reference and feasible ideas for the establishment of a systematic and hierarchical evaluation system for prosthesis tribocor-rosion in the future.

关 键 词：生物摩擦腐蚀 医疗器械 体外测试 研究现状 

分 类 号：R314[医药卫生—基础医学] TH117.3[机械工程—机械设计及理论]