新一代纳米复合骨填充材料在60例胸腰椎结核手术中的应用

Clinical efficacy of treatment 60 cases of thoracic and lumbar spinal tuberculosis with Nano-hydroxyapatite/polyamide 66 composite bone filling material

目的探讨新一代纳米复合骨填充材料[由纳米羟基磷灰石（n-HA）与聚酰胺66（PA66）复合制成，n-HA／PA66]在胸腰椎结核手术中应用的临床疗效。方法2011年1月至2013年6月在我院行前路手术采用n-HA／PA66复合骨填充材料进行植骨融合治疗的胸、腰椎结核患者60例。其中男36例，女24例；年龄19～75岁，平均年龄（42．4±10．6）岁。病变部位：胸椎29例，胸腰段16例，上腰椎15例；2个椎体47例，3个椎体11例，跳跃型2例。60例患者伴有后凸畸形49例，平均Cobb角（29．3±3．6）。；术前血红细胞沉降率为35～126mm／1h，平均为（59．8±13．9）mm／1h。比较患者术前、术后的Cobb角、血红细胞沉降率及神经功能损害Frankel分级情况，通过对患者术后胸腰椎X线正侧位片及三维CT复查，评价植骨融合及n-HA／PA66复合骨填充材料下沉率等指标对疗效进行判定。结果60例患者随访8～30个月（中位时间17．5个月），切口均一期愈合，未见内固定失败，术后即刻平均Cobb角为（13．1±4．5）°，末次随访时为（14．8±4．0）°，随访丢失为（1．7±0．5）°。31例术前诊断为不完全瘫痪的患者（Frankel分级B、C、D级），末次随访Frankel分级获得了O～2级的提高：其中4例术前B级的患者中1例改善为C级，3例改善为D级；8例C级的患者中3例改善为D级，5例改善为E级；19例D级的患者中18例改善为E级，1例无变化。至末次随访时，依据Brantigan植骨融合分级标准：E级34例、D级23例、C级2例、B级1例；植骨融合率95．0％（57／60例），植骨融合时间4～8个月，中位时间5．5个月。至末次随访发现该复合填充材料下沉距离平均（1．6±0．7）mm，其中2例患者下沉距离〉3mm，下沉率为3．3％（2／60），无移位、破裂及内固定断裂患者；术后血红细胞沉降率恢复正常时间为3～7个月，中位时间4．5个月。结论mHA／PA66复合骨填充材料在胸腰椎结核手术中植骨支撑材料替代方面具有重要的应用价值，临床疗效满意。

Objective To explore the clinical effect of the nano-hydroxyapatite/polyamide 66 （n-HA/PA66） composite in treating thoracolumbar spinal tuberculosis. Methods Sixty patients （36 males, 24 female; age, 19-- 75 years old, averaged （42.4± 10.6） years old） with thoracic or lumbar tuberculosis admitted in Guangzhou Chest Hospital from January 2012 to June 2013, which were received anterior debridement and treated by padding artificial hone by nano-hydroxyapatite/polyamide 66. Among the 60 patients, the lesion located at thoracic vertebra in 29 patients, thoracolumbar in 16 patients, upper lumbar in 15 patients; and in which 2 vertebrae were damaged in 47 patients, 3 vertebrae were damaged in 11 patients, and vertebrae were skipped damaged in 2 patients. There were 49 cases of kyphosis in the 60 patients, the average Cobb angle was （29.3±3.6）°. The erythrocyte sedimentation rate（ESR） was 35--126 mm/1 h before the operation, averaged （59. 8± 13.9） mm/1h The evaluation indicator include the Cobb angle, ESR and the neural function by Frankel system before and after the operation, and the bone graft fusion and the rate of wHA/PA66 composite subsidence by examining the thoracolumbar anterioposterior and lateral film and the three^dimensional CT image. Results The period of follow-up was 8--30 months （the median time 17.5 months）, all the incisions healed by the first intention, there was no failure of internal fixation. The immediate postoperative average Cobb angle was （13.1±4.5）°, the last follow up was （14.8±4.0）°, the lost of Cobb angle was （1.7±0.5）°. By the last follow up, the spinal cord Frankel grading elevated by grade 0 2 respectively in the 31 patients who diagnosed incompletely paralysis（Frankel grade B or C or D）, in which 4 patients of Frankel B pre- operative 1 patients elevated 1 grade and 3 elevated 2 grade, in which 8 patients of Frankel C preoperative 3 patients elevated 1 grade and 5 elevated 2 grade, and 19 patients of Frankel D preoperative 18 patients elevated 1 grade and 1 unchanged. By the final follow-up, the E was 34 patients, the D was 23 patients, the C was 2 patients and the B was 1 patients by the bone graft fusion which was evaluated with Brantign grading criteria, the bone graft fusion rate was 95.0%（57/60）, the bone graft fusion time was 4 8 months （the median time 5.5 months）. The average n HA/PA66 composite subsidence was （1.6-0.7）mm, in which 2 patients＇ subsidence ≥3 mm, the rate of subsidence was 3.3° （2/60）, there were no internal fixation shift or fracture. The time of ESR normalization was 3-- 7 months （the median time 4.5 months）. Conclusion The n-HA/PA6 composite has very important clinical effect in treating thoracolumbar spinal tuberculosis.