大量可降解锌合金板钉体内埋植的早期生物安全性研究

目的:可降解锌合金材料有适中的降解速率,良好的机械性能。目前对于锌合金的体内生物安全性研究多集中于生物体内植入适量的锌合金材料。对于体内植入大量的可降解锌合金材料是否有不良影响,还未见文献报道。本实验从局部和全身反应来研究埋植过量可降解锌合金的早期生物安全性。方法:选取18只新西兰大白兔分为三组,于皮下植入锌合金内固定板及钉各4、6、8块,于术后3月、6月行大体观察,血常规、血生化、血液微量元素检查,内脏和材料周围组织的组织学检查和ICP-OES定量检测内脏锌含量观察锌的脏器蓄积情况,材料称重计算每日释放锌含量。结果:可吸收锌合金材料表面附着的白色粉末状物质随时间增加而增多,去掉表面白色物质后,材料表面愈加粗糙,术后3月、6月的白细胞计数(WBC),红细胞计数(RBC),谷丙转氨酶(ALT),谷草转氨酶(AST),总蛋白(TP),白蛋白(ALB),尿素氮(BUN),肌酐(Cr),血锌,血镁,血钙、血铜与术前相比无统计学差异。术后6月实验动物材料周围组织,心脏、肝脏、脾脏、肺脏、肾脏、性腺未检出异常。术后3月、6月肝脏、肾脏、脾脏的锌离子含量与术前相比无统计学差异。综合计算得到术后3月可降解锌合金内固定板的降解率为9.77±1.64%,术后6月为11.82±1.91%,螺钉的降解率术后3月为0.79±0.66%,术后6月为2.09±1.00%。结论:大量可降解锌合金植入体内的早期生物相容性良好。

Early Biocompatibility Study of a Large Number of Degradable Zinc Alloy Plates and Screws Implanted in vivo

ABSTRACT Objective: Degradable zinc alloy materials have moderate degradation rate and good mechanical properties. At present, the research on the biosafety of zinc alloys mostly focuses on implanting an appropriate amount of zinc alloy materials in vivo. Whether it has adverse effects on the implantation of a large amount of degradable zinc material in the body has not been reported. This experiment investigated the early biosafety of large number of degradable zinc alloy plates and screws implanted in vivo. Methods: Eighteen New Zealand white rabbits were divided into three groups. The zinc alloy plates and screws were implanted subcutaneously in groups of 4, 6, and 8. They were observed at 3 months and 6 months after surgery. Blood routine, blood biochemistry, and blood micronutrient examination, histological examination, and quantitative detection of visceral zinc content, and the plates and screws were weighed to calculate the daily release of zinc. Results: The white powdery substance adhering to the surface of the zinc alloy increased with time. After removing the white substance, the surface of the material became rougher with time. There was no statistical difference pre-operation and post-operation in the white blood cell count (WBC), red blood cell count (RBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein (TP), albumin (ALB), urea nitrogen (BUN), creatinine (Cr), blood zinc, blood magnesium, blood calcium, and blood copper. No abnormalities were detected in the heart, liver, spleen, lung, kidney, testical, ovary and prostate. There was no significant difference in zinc content in liver and kidney pre-operation and post-operation. The degradation rates of the plates in 3 months and 6 months post-operation were 9.77±1.64% and 11.82±1.91%, respectively, and the screws degradation rates were 0.79±0.66% and 2.09±1.00%, respectively. Conclusion: The early biocompatibility of a large amount of degradable zinc alloys implanted in vivo is good.