纳米羟基磷灰石/聚酰胺66复合骨填充材料修复良性骨肿瘤骨缺损临床疗效观察

目的观察颗粒型纳米羟基磷灰石/聚酰胺66(nano-hydroxyapatite/polyamide66,n-HA/PA66)复合骨修复材料修复良性骨肿瘤骨缺损的疗效和生物安全性。方法2003年1月～2005年5月,选取37例良性骨肿瘤患者,男21例,女16例,其中1例为2处病变;年龄19～58岁,平均38.5岁。骨纤维结构不良11例(12侧),骨囊肿14例,骨巨细胞瘤级10例,内生软骨瘤2例。肿瘤大小为1.0cm×0.7cm×0.4cm～10.0cm×4.0cm×3.0cm;肿瘤位于股骨近端12例(13侧),远端7例,胫骨近端9例,肱骨近端5例,指骨2例,掌骨和跟骨各1例。行肿瘤刮除术,瘤腔用颗粒型n-HA/PA66填充,伤口常规缝合;术后观察伤口愈合情况,局部炎性反应,排斥反应,全身毒性,瘤腔愈合和患肢功能的恢复情况。结果术后1例伤口感染,余伤口期愈合。局部炎性反应轻微,无排斥反应和全身毒性反应。术后全部获随访5～33个月,术后3～5.5个月可见新骨长入n-HA/PA66填充区,下肢在术后8个月可完全负重,上肢在术后5个月可完成日常活动。结论颗粒型n-HA/PA66复合骨修复材料具有良好生物安全性、相容性和骨传导性,可用于良性骨肿瘤骨缺损的修复。

CLINICAL OBSERVATION ON NANO-HYDROXYAPATITE AND POLYAMIDE 66 COMPOSITE IN REPAIRING BONE DEFECT DUE TO BENIGN BONE TUMOR

OBJECTIVE: To observe the clinical effect and safety of the nano-hydroxyapatite/polyamide 66 (n-HA/PA66) composite in repairing the bone defects due to benign bone tumors. METHODS: From January 2003 to May 2005, 38 patients (21 males, 16 females; age, 19-58 years, averaged 38.5 years) with the bone defects due to benign bone tumors were treated with the n-HA/PA66 grains. Among the 37 patients, 11 had fibrous dysplasia, 14 had bone cyst, 10 had giant cell tumor of the bone (Grade I ), and 2 had enchondroma. The tumors ranged in size from 1.0 cm x 0.7 cm x 0.4 cm to 10.0 cm x 4.0 cm x 3.0 cm, with the location of the proximal femur in 12 patients, the distal femur in 7, the proximal tibia in 9, the proximal humerus in 5, the phalanges of the finger in 2, the metacarpal bone in 1, and the calcaneus in 1. All the benign bone tumors underwent the curettage treatment, and then the tumor cavities were filled up with the n-HA/PA66 grains. The incision healing, local inflammatory reaction, rejection, toxic reaction, tumor cavity healing, and function recovery of the limbs were all observed after operation. RESULTS: All the patients were followed up for 5-33 months, and all the incisions healed by the first intention except 1 incision, which developed infection. The inflammatory reaction was mild, with no rejection or general toxic reaction. At 3 to 5.5 months(mean 4 months) after operation, osteogenesis was found in the space filled with the n-HA/PA66 grains. Eight months after operation, the patients' lower limbs could bear weights; 5 months after operation, the upper limbs could complete daily work. CONCLUSION: The n-HA/PA66 grains have great biological safety, good biocompatibility, and good bone conduction, which are good materials for the bone repair and reconstruction, and can be safely, and effectively used for repairing the bone defects due to benign bone tumors.