纳米羟基磷灰石/聚酰胺66骨填充材料修复肢体良性骨肿瘤术后骨缺损的疗效分析

n-HA/PA66 in repairing bone defect due to benign tumors

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 evaluate the clinical effect and safety of nano-hydroxyapatite polyamide 66 （n-HA/PA 66 ） composite in repairing bone defects due to benign bone tumors and lesion resection, and to determine the indications. Methods From November 2007 to March 2009, 45 patients （ 28 males, 17 females ; age range ： 18 - 60 years, aver age 36 years） with the bone defects due to benign bone tumors and lesion resection were treated with the n-HA/PA66. Among the 45 patients, 16 had giant cell tumor, 8 had bone cysts, 8 had fibrous dysplasia, and 13 had chondroblastoma. The tumors ranged in size from 1.0cm×1.0cm ×1.5 cmto9.0cm ×3.0cm ×3.0cm, with the location of the distal femur in 12 patients, the proximal femur in 7, the proximal tibia in 15, the proximal humerus in 4, the calcaneus in 2, the ulna in 1, the radius in 1, the metacarpal bone in 1, the phalanges of the finger in 1 and the talus in 1. The bone defect ranged in size from 2.0cm ×1.5 cm × 2. 0 cm to 11.0 cm ×3.5 cm × 3.5 cm. All benign bone tumors underwent the curettage, inactivation measures and then the tumor cavities were filled up with the artificial bone. Of all the patients, 14 benign bone tumors also placed internal fixation, and 6 placed both variant bone plates and internal fixation. Results Five patients lost to follow. Others were evaluated at a mean follow up ofT. 2 months （range： 3 - 17 months）. All the incisions healed by the first intention. None developed infection, non-specific inflammatory reaction and rejection reaction. Both preoperative and postoperative results of the full set of immunization had no significant abnormalities. All patients had no obvious liver and kidney functional lesion. X-ray and CT showed that at l month after operation, the density of the focal zone increased gradually. The junction of bone graft and autogenous bone became vague and a few newly formed bone callus was found; 3 months after operation, the density of the focal zone increased significantly, and focal zone began to center and fuse into pieces from the interspace surrounding the particulate bone graft, and more newly formed bone callus fusion shadow; 6 months after operation, the density of the focal zone increased significantly and a great quantity of newly formed bone callus were found. Bone defect got healing at 2 -6 months postoperatively, average 2.8 months. Bone healing rate was 94. 5%. Conclusion The n-HA/PA66 has good biocompatibility, no obvious non-specific inflammatory reaction and rejection reaction, and can be effectively used for repairing the bone defects due to cystic benign bone tumors and tumor-like lesion.