人工髓核材料-聚乙烯醇水凝胶/聚乙烯纤维复合物的生物相容性研究*

目的评估人工髓核材料聚乙烯醇水凝胶／聚乙烯纤维复合物的生物相容性。方法根据ISO10993-1标准，采用细胞毒性试验（琼脂扩散法）、皮内刺激试验、Ame’s致突变试验、微核试验和体内植入（360天）试验对聚乙烯醇水凝胶／聚乙烯纤维复合物的生物相容性进行评估。结果聚乙烯醇水凝胶／聚乙烯纤维复合物的细胞毒性评分小于Ⅰ级，细胞生长无明显抑制现象，对皮内无刺激作用，Ames致突变试验为阴性，微核出现率为3．48‰，无致突变反应。体内植入符合植入材料生物学评价要求。结论聚乙烯醇水凝胶／聚乙烯纤维复合物具有良好的生物安全性，是一种无毒、对皮肤及肌肉、椎间隙无刺激作用的生物医用材料，在动物体内不引起排异反应，可应用于临床。

Evaluation of Biocompatibility of Prosthetic Disc Nucleus Materials(Polyvinyl Alcohol Hydrogel / Ultra-high Molecular Weight Polyethylene)

[Abstract] Objective To investigate the biocompatibility of polyvinyl alcohol hydrogel (PVA) combined with ultra-high molecular weight polyethylene (UHMWP) as prosthetic disc nucleus materials and to ensure it being used in clinic safely and legally. Methods According to the standards of ISO10993-1, the biocompatibility of PVA/UHMWP was evaluated both in vitro and in vivo including cytotoxicity test, primary skin irritant test, Ames test, micronucleus test and long-term intramuscular and lumbar disc space implant test. Results All of those tests showed negative results, indicate that the material has no toxicity, no stimulation and mutation. Neither significant immune reactions nor wear of foreign body were observed by histological technique. Conclusions The prosthetic disc nucleus materials (PVA /UHMWP) has excellent biocompatibility in the level of the systematic, cellular and molecular biology. These results suggest that an artificial prosthetic disc nucleus using PVA/UHMWP might be clinically applicable.