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目的初步评估和分析纳米羟基磷灰石/聚酰胺66(nano-hydroxyapatite polyamide 66,n-HA/PA66)骨填充材料修复良性骨肿瘤术后骨缺损的临床效果和安全性,并初步确定其适应证。方法2007年11月至2009年4月,应用n-HA/PA66骨填充材料修复45例良性骨肿瘤术后骨缺损,男28例,女17例;年龄18～60岁,平均36岁;骨巨细胞瘤16例,骨囊肿8例,纤维结构不良8例,软骨母细胞瘤13例;股骨远端12例,股骨近端7例,胫骨近端15例,肱骨近端4例,跟骨2例,尺骨、桡骨、掌骨、指骨、距骨各1例;肿瘤刮除、灭活及人工骨植入25例,14例加用内固定,6例加用异体骨板和内固定。肿瘤范围为1.0 cm×1.0 cm×1.5 cm～9.0 cm×3.0 cm×3.0 cm,骨缺损范围为2.0 cm×1.5 cm×2.0 cm～11.0 cm×3.5 cm×3.5 cm。结果除5例失随访外,40例获得随访,随访时间3～17个月,平均7.2个月。伤口均Ⅰ/甲愈合,无一例发生切口感染、非特异炎症反应和排斥反应;术前、术后的血常规和免疫检查均无明显异常;均无明显肝、肾功能损害。X线片和CT检查示:术后病灶区域填充良好,密度较松质骨稍低,材料与瘤壁边界清楚;术后1个月,病灶区密度逐渐升高,可见植骨周围与自体骨结合处模糊,开始有少量新生骨痂形成;术后3个月,病灶区密度明显升高,病灶区从颗粒植骨周围间隙开始向中心融合成片,更多新生骨痂影融合;术后6个月,病灶区密度明显升高,病灶区大量新生骨痂形成。临床骨愈合时间为术后2～6个月,平均2.8个月,愈合率为94.5%。结论n-HA/PA66骨填充材料的生物相容性良好,无明显排斥反应和非特异炎症反应,修复囊性良性骨肿瘤和瘤样病变效果良好。
Objective To preliminary evaluate and analyze the clinical efficacy and safety of nano-hydroxyapatite polyamide 66 (n-HA/PA66) bone filler in the repair of bone defects after benign bone neoplasms, and preliminary determine its adaptation. certificate. Methods From November 2007 to April 2009, n-HA/PA66 bone-filling materials were used to repair 45 patients with benign bone tumors, including 28 males and 17 females. The average age of 36 years was 18 to 60 years. Giant cell tumor in 16 cases, bone cyst in 8 cases, poor fibrous structure in 8 cases, 13 cases of chondroblastoma; 12 cases of distal femur, 7 cases of proximal femur, proximal humerus in 15 cases, proximal humerus in 4 cases, calcaneus In 2 cases, there were 1 ulna, sacrum, metacarpal, phalanx and talus, 25 cases of tumor scraping, inactivation and artificial bone implantation, 14 cases of internal fixation, and 6 cases of allogeneic bone plates and internal fixation. The tumor range was 1.0 cm×1.0 cm×1.5 cm to 9.0 cm×3.0 cm×3.0 cm. The bone defect range was 2.0 cm×1.5 cm×2.0 cm to 11.0 cm×3.5 cm×3.5 cm. Results In addition to 5 cases of follow-up visits, 40 cases were followed up for 3 to 17 months with an average of 7.2 months. All wounds healed with I/O. No incision infection, non-specific inflammatory reaction and rejection reaction occurred. There was no obvious abnormality in blood routine examination and immunological examination before and after surgery. No significant hepatic or renal dysfunction was observed. X-ray and CT examination showed that the lesion area was well-filled, the density was slightly lower than the cancellous bone, and the boundary between the material and the tumor wall was clear. At 1 month after surgery, the density of the lesion area gradually increased, showing the bone graft around and the autologous bone. The junction was blurred and a small amount of new bone formation began to form. At 3 months after operation, the density of the lesion area increased significantly. The lesion area began to fuse to the center from the gap around the bone graft, and more new bone fusion occurred. At 6 months, the density of the lesion area increased significantly, and a large number of new bone callus formed in the lesion area. Clinical bone healing time was 2 to 6 months after surgery, with an average of 2.8 months. The healing rate was 94.5%. Conclusion n-HA/PA66 bone filling material has good biocompatibility, no obvious rejection reaction and non-specific inflammatory reaction, and has good effect on repairing cystic benign bone tumor and tumor-like lesions.