医用纯镁骨植入后降解产物的体内代谢及重要脏器分布的定量评价  

Metabolism of the degradation products and quantitative evaluation of the distribution in important organs of medical pure magnesium for bone implantation in vivo

作　　者：陆华[1] 俞懿强[1] 隋佰延 刘昕[1] 孙皎[1] Lu hua;Yu Yiqiang;Sui Baiyan;Liu Xin;Sun Jiao(Department of Dental Materials,Ninth People’s Hospital,Shanghai Jiaotong University School of Medicine,National Clinical Research Centre of Stomatology,Shanghai Key Laboratory of Stomatology&Shanghai Research Institute of Stomatology,Shanghai Biomaterials Research&Testing Center,Shanghai 200011)

机构地区：[1]上海交通大学医学院附属第九人民医院口腔医学院口腔材料科,国家口腔疾病临床医学研究中心,上海市口腔医学重点实验室,上海市口腔医学研究所,上海生物材料研究测试中心,上海200011

出　　处：《口腔材料器械杂志》2021年第3期155-160,共6页Chinese Journal of Dental Materials and Devices

基　　金：上海市科委项目(编号:18DZ2201500)。

摘　　要：目的探讨医用纯镁主要降解产物的体内代谢过程及其在重要脏器中的蓄积和分布,为医用纯镁的临床应用提供安全性依据。方法选择医用纯镁骨植入材料,参照ISO 10993-6标准,以HDPE为对照材料,运用ICP-MS研究兔骨植入4 w、12 w和26 w后主要降解产物Mg^(2+)的体内分布、血镁和尿镁的浓度变化。运用全自动生化分析仪分析26 w骨植入前、后不同时间点的血镁、尿镁和主要血生化指标(ALT、AST和肌酐)的变化趋势。结果ICP结果显示:与对照相比,植入后4 w、12 w、26 w体内重要脏器(心、肝、脾、肾、肺)组织中的Mg^(2+)浓度未发生显著变化(P>0.05);血液中Mg^(2+)浓度未发生显著升高或降低(P>0.05);而尿液中Mg^(2+)浓度在植入后4 w和12 w时有升高趋势,差异具有统计学意义(P<0.05),到26 w时恢复到正常水平。生化分析结果显示:26 w骨植入前后不同时间点的血镁未见显著变化,尿镁浓度在6 w、8 w时出现短时的小幅上升,之后又恢复到植入前的水平;植入前、后不同时间点的ALT、AST和肌酐水平未见显著性变化(P>0.05)。结论在本试验条件下,医用纯镁的主要降解产物Mg^(2+)可能经肾脏代谢后由尿液排出,未在血液和体内重要脏器发生蓄积。Objective The aim of this study was to investigate the metabolic process of the main degradation products of medical pure magnesium by detecting the accumulation and distribution of Mg^(2+)in important organs,providing an important scientific basis for their clinical application.Methods According to the ISO 10993-6 standard,the in vivo distribution,the concentration changes in blood and urine of Mg^(2+)released by the medical pure magnesium was compared with that of the negative control(HDPE)using ICP-MS after bone implant at 4 w,12 w and 26 w.By using automatic biochemical analyzer analysis,the blood magnesium,urinary magnesium and main blood biochemical indicators(ALT,AST and creatinine)of different time points were detected before and after 26 w bone implantation.Results ICP results showed that there was no significant change of Mg^(2+)concentration in the important organs(heart,liver,spleen,kidney,lung)compared with the negative control at 4 w,12 w,after 26 w(P>0.05).There was no significant increase or decrease of Mg^(2+)concentration in the blood(P>0.05).And the Mg^(2+)concentration in the urine had a rising trend after 4 w and 12 w(P<0.05),while recover to normal at 26 w.By the biochemical analysis,it showed that the level of blood magnesium had not changed significantly before and at 26 w after the bone implant.While the urinary magnesium concentration at 6 w and 8 w had risen slightly in short time,and then recover to the normal level.The concentration of ALT,AST and creatinine had no significant changes before and after implantation.Conclusions Under the conditions of this study,Mg^(2+),the main degradation products of the medical pure magnesium,may be discharged by urine after metabolism and had not accumulated in the blood and vital organs in the body.

关 键 词：医用纯镁 骨植入 降解产物 体内代谢分布 ICP-MS 

分 类 号：R318.08[医药卫生—生物医学工程]