钽和钛材料的亚慢性毒性研究  

Study on Subchronic Toxicity of Tantalum and Titanium Materials

作　　者：王旖 张玲 孙媛之 蒋波 曾荣荣 杨柳 范能全 Wang Yi;Zhang Ling;Sun Yuanzhi;Jiang Bo;Zeng Rongrong;Yang Liu;Fan Nengquan(Chongqing Institute for Food and Drug Control,Chongqing 401121,China)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121

出　　处：《医疗装备》2022年第4期28-32,共5页Medical Equipment

基　　金：重庆市科研机构绩效激励引导专项——3D打印多孔钽生物学评价技术研究(cstc2019jxjl130040)。

摘　　要：目的通过新西兰兔肌肉植入钽、钛材料进行亚慢性毒性实验,为这两种医疗器械材料的安全使用提供实验依据。方法36只新西兰兔随机分为假手术对照组、钽材料组、钛材料组,每组12只(雌雄各半)。第1天,3组均行植入手术,假手术对照组不植入任何物体,钽材料组、钛材料组分别于实验动物背部肌肉植入相应供试品;第90天,解剖每组各8只实验动物(雌雄各半),进行血细胞、血清生化指标、脏器体质量比、蛋白芯片及病理组织学检测;第91天,取出剩余实验动物体内植入物,恢复30 d;第121天,解剖剩余实验动物并检测相同项目。实验期间,每天进行一般观察(包括伤口愈合情况、外观体征、行为、饮食、对刺激的反应、分泌物、排泄物等,以及死亡情况)。结果植入和恢复期间,钽材料组、钛材料组与假手术对照组比较,所有指标均无显著差异(P>0.05),未观察到两种材料可能引起的亚慢性毒性反应和延迟毒性反应。结论在该实验条件下,钽材料、钛材料均无亚慢性毒性。Objective Subchronic toxicity test was carried out by implanting tantalum and titanium materials into the muscles of New Zealand rabbits,providing a test basis for the safe use of these two medical device materials.Methods 36 New Zealand rabbits were randomly divided into a sham operation control group,a tantalum material group,and a titanium material group,with 12 rabbits in each group,half female and half male.On the 1st day,all the three groups underwent implantation operation,no objects were implanted in the sham operation control group,while the back muscles were implanted with the corresponding test products for the tantalum material group and the titanium material group.On the 90th day,eight rabbits(half female and half male)were dissected in each group and hematology,blood biochemistry,viscus body mass ratio,protein chip and pathology tests were performed.On the 91st day,the implants in the remaining animals were taken out,and they were left recovered for 30 days,and then they were dissected for the same tests on the 121st day.During the test,general observations(including wound healing conditions,appearance and sign,behavior,diet,reaction to stimulus,secretion and excreta etc.and death)were carried out every day.Results During implantation and recovery,when the indicators in the tantalum material group and the titanium material group were compared with the sham operation control group,the differences were not statistically significant(P>0.05)and no subchronic toxic reactions and delayed toxic reactions caused by the two materials were observed.Conclusion Under the test conditions,tantalum and titanium materials have no subchronic toxicity.

关 键 词：钽材料 钛材料 肌肉植入 亚慢性毒性 蛋白芯片检测 

分 类 号：R318.080[医药卫生—生物医学工程]