n-HA/PA66生物材料修复骨巨细胞瘤骨缺损效果的临床研究

目的观察颗粒型纳米羟基磷灰石/聚酰胺66(n-HA/PA66)修复骨巨细胞瘤骨缺损的生物安全性和临床效果。方法选取2007年12月至2011年5月于我院行病灶刮除、颗粒型n-HA/PA66填充植骨术的骨巨细胞瘤患者48例,术前及术后做血常规、肝肾功、钙磷及免疫相关检查,术后1周,1、3、6、12月及以后每6月行影像学检查。将1例复发患者再手术时取出的含有n-HA/PA66复合生物材料的骨组织行组织学检查。结果 3例失访,45例获得随访。患者术前、术后的血常规、肝肾功、钙磷、免疫指标均无明显变化。除1例复发外,余影像学示材料颗粒随时间逐渐融合,植骨区密度逐渐增高,与宿主骨界限逐渐模糊。术后1年,植骨区密度接近正常骨密度。组织学检查示:成骨细胞爬入材料的孔隙内,周围钙盐沉着明显,大量骨细胞镶嵌于材料中,材料与新生骨及周围组织结合紧密。结论 n-HA/PA66具有良好的生物安全性和组织相容性,良好的骨传导性及成骨活性,是一种理想的骨修复材料。

Repairing bone defect with nano-hydroxyapatite and polyamide 66 composite after giant cell tumor operations

Objective To evaluate the clinical effectiveness and safety of using granular type nano-hydroxyapatite and polyamide 66(n-HA/PA66)composite in repairing bone defects caused by gaint cell tumors.Methods 48 patients with giant cell tumors,who underwent lesion curettage,inactivation and cavities fill-in with granular type n-HA/PA66 from December 2007 to May 2011,were followed up.Routine blood tests,liver and kidney functions,serum calcium and phosphorus,and immunologic parameters were examined before and after the surgeries.Radiological examinations were carried out 1 week and 1,3,6 and 12 months post operations to monitor the bone repairing process.The n-HA/ PA66 in bone issues was detected with hematoxylin-eosin staining.Results 45 patients completed the follow-up.No significant abnormalities in routine blood tests,serum calcium and phosphorus,and immunologic parameters were found pre-and post-operations.Nor abnormal liver and kidney functional lesions were identified.The radiological examination showed gradual increase in the density of the focal zone after bone implanting operations.The bone density of the implanted areas got close to normal 1 year after operations.The histological examination found that osteoblasts grew into the hole of n-HA/PA66;calcium was deposited on the materials;and large amount of osteocytes inlaid into the composite.The composite was integrated into new bone and surrounding tissues.Conclusion n-HA/PA66 has good biocompatibility and biological safety.It also has good osteoconduction and osteogenesis activity.The n-HA/PA66 composite is one perfect bone repair material.