纳米羟基磷灰石/聚酰胺66在胸腰椎结核病灶清除术后椎体重建应用中的长期临床观察

修  鹏1、2，宋跃明1、2，李  涛1、2，杨  曦1、2，周忠杰1、2，王  亮1、2，刘  浩1、2，刘立岷1、2，

龚  全1、2，曾建成1、2，孔清泉1、2

（1 四川大学华西医院骨科；2 四川大学华西医院骨科研究所 610041 成都市）

基金项目：国家科技支撑计划课题（编号：2007BAE131304）

第一作者简介：男（1985-），博士，

研究方向：脊柱退变、肿瘤、畸形、创伤等

电话：（028）85422573  

E-mail：xiup200303@126.com

通讯作者：宋跃明  

E-mail：hy_sym@163.com；李涛  

E-mail：litao55@hotmail.com

【摘要】 目的：探讨纳米羟基磷灰石/聚酰胺66（nano-hydroxyapatite polyamide 66，n-HA/PA66）椎间支撑体在胸腰椎结核病灶清除术后椎体重建应用中的长期疗效。方法：2009年6月~2010年6月，前瞻性地纳入胸腰椎脊柱结核患者18例，其中男9例，女9例，年龄18~63岁，平均40.6±7.8岁。手术节段胸椎（T3~T10）8例，胸腰段（T11~L2）8例，腰椎（L3~L4）2例；神经功能ASIA分级：C级4例，D级9例，E级5例；合并冷脓肿形成15例，椎管内受累13例，窦道形成2例。患者均采用前路病灶清除、n-HA/PA66椎间支撑体结合自体骨椎间植骨、前路内固定术治疗，术后规律抗结核治疗18个月，术后3个月、6个月、1年及之后每年通过门诊或电话随访记录患者的胸背痛VAS评分、神经功能（按照ASIA分级）变化；并根据X线片及CT观察植骨融合、支撑体下沉、后凸畸形纠正和维持的情况。结果：所有患者均成功完成手术，除2例术后出现胸腔积液外，无严重并发症出现；本组病例随访5~10年，平均7.5±1.8年。除1例术前为ASIA分级C级的患者恢复为D级外，其余病例均恢复为E级；胸背痛VAS评分由术前7.0±1.8分缓解为术后2.4±0.6分，至末次随访时为1.4±0.4分；术前后凸为11°~82°（31.0°±11.6°），术后即刻为2°~46°（18.2°±9.6°），后凸矫正10°~36°（13.0°±8.3°），末次随访时后凸为3°~56°（22.5°±8.1°），后凸丢失1°~11°（4.3°±0.8°）；术后6个月10例（56%）获得骨性融合，术后1年17例（94%）获得融合，术后2年所有病例均获得融合，骨融合发生较慢主要见于2个以上运动节段病椎切除重建的病例；支撑体下沉发生11例（61%），主要发生于术后6个月以内，下沉0~6mm（3.0±0.7mm），1例椎旁脓肿复发和窦道形成，经过换用二线抗结核药物、加强营养、换药等处理治愈。结论：经过5年以上的长期随访证实，n-HA/PA66椎体支撑体可安全有效地应用于胸腰椎结核病灶清除术后前柱重建。

【关键词】 脊柱结核；前路手术；纳米羟基磷灰石/聚酰胺66

doi：10.3969/j.issn.1004-406X.2020.10.04

中图分类号：R529.2，R687.3    

文献标识码：A    

文章编号：1004-406X（2020）-10-0888-08

Anterior reconstruction of spinal defect using nano-hydroxyapatite polyamide 66 cage for thoracolumbar tuberculosis: a long-term follow-up study/XIU Peng, SONG Yueming, LI Tao, et al//Chinese Journal of Spine and Spinal Cord, 2020, 30(10): 888-895

【Abstract】 Objectives: To evaluate the safety, reliability of n-HA/PA66 cage in the management of thoracolumbar tuberculosis after a long-term follow-up study. Methods: 18 patients with spinal tuberculosis, including 9 males and 9 females, were treated using debridement and strut graft with n-HA/PA66 cage combined with anterior instrumentations. The average age was 40.6±7.8 years (range, 18 to 63). The surgical levels included thoracic spine (T3-T10) in 8 cases, thoracolumbar spine (T11-L1) in 8 cases, and lumbar spine (L2-L4) in 2 cases. Kyphosis deformity presented in 13 patients with a Cobb angle of 31.0°±11.6°(range, 11° to 82°). According to ASIA grading system, neurological status was grade C in 4 patients, grade D in 9 and grade E in 5. Cold abscess formation, spinal canal involvement and sinus tract formation were found in 15, 13 and 2 patients respectively. Routine anterior debridement, inter-body strut graft and fixation with screw-rod system were applied. Anti-tuberculosis chemotherapy was continued for at least 18 months postoperatively. Results: All patients were successfully managed with this procedure. Except for 2 patients with pleural effusion post operation, no serious complications occurred. They were followed up for 7.5±1.8 years (range, 5 to 10 years). Except for one patient who had the preoperative ASIA grade improved from C to D, all other patients with neurologic deficit improved to normal at the last visit. The VAS score of back pain was relieved from 7.0±1.8 (range, 5 to 9) points to 2.4±0.6 (range, 0 to 3) points after surgery, an it was 1.4±0.4(range, 0 to 3) points at the final visit. The kyphosis was 31.0°±11.6° (range, 11° to 82°) before operation, and it was 18.2°±9.6° (range, 2° to 46°) immediately after operation with correction of 13.0°±8.3° (range, 10° to 36°). The kyphosis deteriorated to 22°±8.1° (range, 3° to 56°) at final follow-up with correction loss of 4.3°±0.8° (range, 1° to 11°). Bone fusion was achieved in 10 cases(56%) at 6 months after operation and in 17 cases (94%) at 1 year after operation. All cases achieved bony fusion in 2 years after operation. Delayed bone fusion was mainly noted in patients requiring 2 or more spinal motion segments reconstruction. In addition, 11 cases (61%) developed subsidence of cage mainly within 6 months after operation. The average subsidence was about 3.0±0.7mm(range, 0-6mm). One case of paravertebral abscess recurrence and sinus formation was noted and the patient was cured by the application of second-line anti-tuberculosis drugs, nutritional support and dressing change. Conclusions: According to middle to long term follow-up, N-HA/PA66 cagecan safely and effectively applied in the reconstruction of spinal stability following debridement of thoracolumbar tuberculosis.

【Key words】 Spinal tuberculosis; Anterior approach; Nano-hydroxyapatite/polyamide 66

【Author′s address】 Department of Orthopedics, West China Hospital, Sichun University, Chengdu, 610041, China

图1  a n-HA/PA66椎体支撑体 b术中置入n-HA/PA66支撑体

Figure 1  a Sample picture of n-HA/PA66 cage b Intraoperative photograph showing the implantation of n-HA/PA66 cage following debridement of thoracic spinal tuberculosis

图2  患者男性，54岁 a 术前正侧位X线片示T7、T8骨质破坏、椎间隙变窄、后凸畸形 b 术前CT显示骨质破坏、死骨形成伴椎旁冷脓肿形成 c 术中切除T7、T8两个病椎及上下3个椎间盘（3个节段重建），采用支撑体填充肋骨重建，术后3个月正侧位X线片 d 术后3个月CT显示植骨未愈合 e 术后18个月支撑体上下界面均愈合，但支撑体下缘有下沉 f 术后10年显示植骨愈合良好，纳米生物材料与骨界面良好整合

Figure 2  Male, 54 years old a Preoperative AP and lateral X-ray showing destruction of T7-8 intervertebral disc and adjacent vertebral bodies b Computed tomography of the lesion showed the destruction and bone sequestration accompanied by paravertebral cold abscess formation c X-ray at 3-month after surgery d CT view at 3 months after surgery showing non-fusion of the graft e CT scans at 18 months after surgery showing fusion of the graft and subsidence of the graft into the lower vertebral body f CT scans at 10 years after surgery showing well incorporation of the graft

图3  患者男性，28岁 a 术前正侧位X线片示L2~L3椎骨质破坏、椎间隙变窄 b 术前CT显示L2~L3骨质破坏伴死骨形成 c 术后当时正侧位X线片 d 术后3个月CT显示植骨未愈合 e 术后6个月CT示支撑体愈合 f 术后5年CT显示支撑体上下界面愈合良好，支撑体已经有被骨整合吸收的趋势

Figure 3  Male, 28 years old a Preoperative AP and lateral X-ray showed destruction of L2-L3 intervertebral disc and adjacent vertebral bodies b Computed tomography of the lesion showed the destruction and sequestrum formation c X-ray immediate after surgery d CT view at 3 months after surgery showed non-fusion of the graft e CT scans at 6 months after surgery showed the fusion of the graft f CT scans at 5 years after surgery showed well incorporation of the graft