超低磨损聚乙烯人工关节材料的生物相容性评价

Biocompatibility of the artificial joint material ultra-low-wear polyethylene

[目的]对超低磨损聚乙烯人工关节材料的生物相容性进行初步评价,为进一步的人体试验提供依据。[方法]根据国家GB/T-16886/ISO-10993对医疗器械外科置入物的评价要求,进行体外细胞毒性试验(CCK-8比色法)、溶血试验、急性/慢性全身毒性试验、肌肉置入试验。[结果](1)细胞毒性试验的试验组L929细胞在培养24、48、72 h后相对增殖率依次为95.25%、104.96%、102.81%,显示无细胞毒性;(2)血液相容性试验溶血率为0.81%,提示该材料无溶血作用;(3)急性全身毒性试验试验组小鼠无特殊行为学表现,试验组与对照组小鼠体重增加差异无统计学意义(P>0.05);(4)肌肉置入试验术后病理切片证实该材料置入大鼠体内后炎性细胞反应逐渐减轻;(5)慢性全身毒性试验术后12周试验动物肝肾均无明显病理表现。[结论]该材料具有良好的生物相容性及安全性。

[Objective]This study aimed to preliminarily evaluate the biocompatibility of the artificial joint material ultra-low- wear polyethylene（ ULWPE）,and thus to provide the basis for further human trials. [Method]Cytotoxicity test（ CCK-8 assay）,hemolysis test,acute / chronic toxicity test,muscular implantation test were conducted according to national standard GB / T- 16886 / ISO- 10993 for evaluation requirements of medical surgical implants. [Result]Results of cytotoxicity test in vitro showed that,cultured for 24,48,72 h,the relative growth rate of L929 cells were 95. 25%,104. 96%,and 102. 81%,respectively. Thus the material was not cytotoxic. The hemolysis rate was 0. 81%. Results from acute toxicity test showed that,compared with control group,mice in experimental group showed no special behavior and no statistical difference of weight gain（ P〉0. 05）. Postoperative pathological examination showed the inflammatory reaction after material implantation in rats reduced gradually,and no significant pathological changes were found in liver and kidney of experimental animals. [Conclusion]This novel material has good biocompatibility and biological safety.