Erişen Deniz Eren, Zhang Yuqi, Zhang Bingchun, Yang Ke, Chen Shanshan, Wang Xiaolin
School of Materials Science and Engineering, University of Science and Technology of China, 96 Jinzhai Road, Hefei, Anhui, 230026, China.
Shi-changxu Innovation Center for Advanced Materials, Institute of Metal Research, Chinese Academy of Sciences, 72 Wenhua Road, Shenyang, Liaoning, 110016, China.
J Biomed Mater Res B Appl Biomater. 2022 Jan;110(1):239-248. doi: 10.1002/jbm.b.34907. Epub 2021 Jul 8.
Biosafety of AZ31B magnesium (Mg) alloy and the effect of its degradation products on tissues, organs, and whole systems are highly needed to be evaluated before clinical application. This study serves a wide variety of safety evaluations of biodegradable AZ31B alloy on nerve cells. As a result of this in vitro study, the maximum aluminum (Al) ion and Mg ion concentrations in the medium were estimated to be 22 μmol/L and 2.75 mmol/L, respectively, during degradation. In addition, the corresponding cell mortality was observed to be 36% and lower than 5% according to the resistance curves of the cell to Mg and Al ions. Furthermore, the maximum Al ion and Mg ion concentrations in serum and cerebrospinal fluid were detected to be 26.1 μmol/L and 1.2 mmol/L, respectively, for 5 months implantation. Combining the result of in vivo dialysis with the result of ion tolerance assay experiments, the actual death rate of nerve cells is estimated between 4 and 10% in vivo, which is lower than the result of in vitro cytotoxicity evaluation. Moreover, no psychomotor disability during clinical studies is observed. Consequently, stent made of AZ31B alloy with surface treatment is feasible for carotid artery stenosis, and it is safe in terms of cell viability on the nervous system.
在临床应用之前，迫切需要评估AZ31B镁（Mg）合金的生物安全性及其降解产物对组织、器官和整个系统的影响。本研究对可降解AZ31B合金在神经细胞上进行了广泛的安全性评估。作为这项体外研究的结果，在降解过程中，培养基中铝（Al）离子和镁离子的最大浓度分别估计为22μmol/L和2.75mmol/L。此外，根据细胞对镁离子和铝离子的抗性曲线，相应的细胞死亡率分别为36%和低于5%。此外，植入5个月后，血清和脑脊液中铝离子和镁离子的最大浓度分别检测为26.1μmol/L和1.2mmol/L。结合体内透析结果和离子耐受性试验实验结果，估计体内神经细胞的实际死亡率在4%至10%之间，低于体外细胞毒性评估结果。此外，在临床研究中未观察到精神运动障碍。因此，经过表面处理的AZ31B合金制成的支架用于颈动脉狭窄是可行的，并且在神经系统细胞活力方面是安全的。
