摘要
目的观察一种新型可注射型人工髓核材料植入兔体内后的组织学和血液学变化,评价其生物安全性。方法参照医疗器械生物学评价标准,将聚氨酯、硅橡胶及医用植入级高分子聚乙烯制成长1.0cm、直径0.3cm的短柱状受试样品。SPF级新西兰大耳白兔48只,体重2.5～3.0kg,于脊柱两侧距中线2cm处,分离肌肉形成深约1cm空腔。根据植入材料不同,随机分为3组(n=16)。A组:聚氨酯材料;B组:硅橡胶材料;C组:医用植入级高分子聚乙烯,作为对照。术后观察兔一般情况,于术后1、4、12、26周取样品行大体及组织学观察。并于26周检测血常规、生化功能及电解质,观察主要脏器有无病理变化。同时对材料进行理化性质测试,并采用同一批次未经植入的相同材料作为对应阴性对照。结果术后各组动物均存活至实验完成,伤口均Ⅰ期愈合。术后1周各组可见局部肌肉略红肿,4周时消退,12周和26周均可见各组材料周围形成结缔组织包裹。术后26周,各组间血常规、生化功能及电解质比较,差异无统计学意义(P>0.05)。各脏器表面光洁,无破溃、瘀斑,无明显肿胀、充血或出血,未触及结节。各组各脏器占体重百分比差异无统计学意义(P>0.05)。术后1周组织学观察,各组均可见肉芽组织增生和炎性细胞浸润,4周后各组无炎性细胞浸润,材料周围形成纤维囊包裹,囊壁随时间逐渐增厚,12周后达稳定。根据GB/T16175相关标准,A、B组材料炎性反应和纤维囊腔分级与C组一致,均合格。术后26周对脏器组织学观察,未发现特异性病理变化。A组植入前后材料重均分子量及数均分子量差异均无统计学意义(P>0.05),拉伸断裂强度及断裂伸长度差异无统计学意义(P>0.05);B组邵氏硬度差异无统计学意义(P>0.05)。结论新型可注射型人工髓核材料对局部组织和全身脏器功能均未造成损害,具有良好生物相容性和安全性。
Objective To explore the histological and the hematological change of rabbits after implanting novel injectable artificial nucleus prostheses, and to evaluate the biological safety. Methods In accordance with Biological Evaluation of Medical Devices, materials of polyurethane, silicone rubber and macromolecular polyethylene for medical use were made into short column 1 cm in length and 0.3 cm in diameter. Forty-eight SPF New Zealand white rabbits weighing 2.5-3.0 kg were used, and cavity 1 cm in depth was made in the area 2 cm away from the spinal midline by separating muscle. Then according to different material being implanted, the rabbits were divided into 3 groups （n=16）： Group A, polyurethane; group B, silicone rubber; group C, macromolecular polyethylene for medical use as negative control. General condition of the rabbits was observed after operation. Gross and histology observation were conducted 1, 4, 12 and 26 weeks after operation. Blood routine, biochemical function and electrolyte assays were performed 26 weeks after operation to observe pathological changes of organs. Meanwhile, physicochemical properties of the materials were detected, and the material in the same batch was used as negative control. Results All rabbits survived until the end of experiment, and all wounds healed by first intention. In each group, red swollen muscles were observed 1 week after operation and disappeared 4 weeks after operation, connective tissue around the implanted materials occurred 12 and 26 weeks after operation. At 26 weeks after operation, there were no significant differences among three groups in blood routine, biochemical function and electrolyte assays （P 〉 0.05）. Organs had smooth surface without ulceration, ecchymosis, obvious swelling, hyperemia or bleeding, and nodules. There were no significant differences among three groups in percentage weight of each organ （P 〉 0.05）. Histology observation： granulation tissue proliferation and inflammatory cell infiltration were observed in each group 1 week after operation, fibrous capsule formation around the materials and the disappearance of inflammatory cell infiltration were evident 4 weeks after operation, cyst wall grew over time and achieved stability 12 weeks after operation. The inflammatory response and the fiber cyst cavity of groups A and B met the standard of GB/T 16175 and were in line with group C. No specific pathological changes were discovered in the organs 26 weeks after operation. For group A, no significant difference was evident between before and after material implantation in terms of weight average molecular weight, number average molecular weight, tensile strength at break and elongation at break （P 〉0.05）. For group B, no significant difference was evident between before and after material implantation in shore hardness （P〉0.05）. Conclusion Novel injectable nucleus pulposus prostheses do not damage local tissue and function of organs, but provide good biocompatibil ity and biological safety.
出处
《中国修复重建外科杂志》
CAS
CSCD
北大核心
2009年第6期670-676,共7页
Chinese Journal of Reparative and Reconstructive Surgery
基金
国家高技术研究发展计划(863)资助项目(2006AA02Z4D4)~~
关键词
人工髓核
植入实验
生物相容性
兔
Artificial nucleus pulposus
Implant experiment
Biocompatibility
Rabbit
