3D打印匹配式人工椎体的设计及临床应用短期疗效  

Evaluation of short-term effects on 3D printing patient-matched artificial vertebral body in clinical research and application

作　　者：李小康 石磊[2] 栗向东 黄海[1] 武琦 汤小东[3] 郭征 Li Xiaokang;Shi Lei;Li Xiangdong;Huang Hai;Wu Qi;Tang Xiaodong;Guo Zheng(Department of Orthopaedics,Tangdu Hospital,Airforce Military Medical University(Previous workplace was Department of Orthopaedics,Xijing Hospital,Fourth Military Medical University),Xi'an 710038,China;Department of Orthopaedics,Xijing Hospital,Fourth Military Medical University,Xi'an 710032,China;Peking University People's Hospital,Beijing 100044,China)

机构地区：[1]中国人民解放军空军军医大学唐都医院骨科,西安710038 [2]中国人民解放军空军军医大学西京医院骨科,西安710032 [3]北京大学人民医院骨肿瘤科,北京100044

出　　处：《中华骨科杂志》2024年第6期354-361,共8页Chinese Journal of Orthopaedics

基　　金：国家重点研发计划(2017YFC1104901)。

摘　　要：目的探讨3D打印匹配式人工椎体临床应用有效性及短期安全性评价。方法回顾性分析2021年9月至2022年7月于空军军医大学西京医院和北京大学人民医院于肿瘤切除后采用3D打印匹配式人工椎体重建脊柱稳定性的脊柱肿瘤患者12例,男7例、女5例,年龄为(42.17±14.56)岁(范围18~65岁)。所有患者均接受椎体整块切除(total en bloc spondylectomy,TES),以3D打印匹配式人工椎体重建脊柱。术后3、6个月采用Brantigan-Steffee的影像学融合标准评价融合效果,术后3、6个月采用日本骨科协会(Japanese Orthopaedic Association,JOA)功能评分,术后3个月采用视觉模拟评分法(visual analogue scale,VAS),术后3、6个月采用椎体间高度变化,分别与术前比较进行疗效评价,记录不良事件并进行安全性评价。结果12例均顺利完成手术,手术部位分别为胸椎6例、胸腰段3例、腰椎3例。所有患者均获得随访,随访时间为(23.92±3.23)个月(范围19~29个月),所有患者期间均未出现肿瘤复发转移。术后6个月时12例Brantigan-Steffee的影像学融合标准均为全部融合。术后6个月JOA评分优10例、良1例、差1例。术前及术后3个月的VAS分别为(4.08±2.47)、(1.83±1.59)分,差异有统计学意义(t=2.635,P=0.023)。术前、术后第15天、术后3个月及术后6个月椎体间高度分别为32.75(25.94,68.20)、41.09(30.55,70.20)、40.70(30.23,67.83)和40.74(30.23,67.08)mm,差异无统计学意义(χ^(2)=0.768,P=0.857)。术后未发生内植物相关不良事件。结论采用3D打印匹配式人工椎体可用于脊柱肿瘤切除后脊柱稳定性重建,具有满意的短期疗效和安全性。ObjectiveTo evaluate the short-term efficacy and safety of 3D printing patient-matched artificial vertebral body in clinical research and application.MethodsA total of 12 patients with spinal tumors were enrolled 7 males(58.33%)and 5 females(41.67%),aged from 18 to 65 years old in The First Affiliated Hospital of Air Force military Medical University(hereinafter referred to as Xijing Hospital)and Peking University people's Hospital from September 2021 to July 2022.The spinal vertebra defect were restored by using 3D printing patient-matched artificial vertebral body after tumor resection.All patients who accepted TES and 3D printing patient-matched artificial vertebral body implantation were included according to the inclusion and exclusion criteria.The bone interface fusion was evaluated by the imaging fusion criteria of Brantigan and Steffee at 3 and 6 months after operation,the curative effect was evaluated by comparing Japanese Orthopaedic Association(JOA)score at 3 and 6 months after operation,visual analogue scale(VAS)3 months after operation and intervertebral height at 3 and 6 months after operation with those before operation,and the safety was evaluated by adverse event recording.ResultsAll 12 patients completed the operation successfully,and the operation sites were thoracic vertebrae in 6 cases(50%),thoracolumbar in 3 cases(25%)and lumbar vertebrae in 3 cases(25%).All patients were followed up.The mean follow-up time was 23.92±3.23 months(range,19-29 months).No tumor recurrence or metastasis was observed during this period.All patients were followed up at 15 days,3 months and 6 months after operation.During the 6-month follow-up,X ray results showed that interface of bone and the vertebral body were fused in all of the 12 patients,and the effective rate of fusion was 100%.The 95%confidence interval is calculated to be(75.6%-100%).Six months after operation,the improvement rate of JOA score was excellent in 10 cases,good in 1 case,poor in 1 case,and the excellent and good rate was 91.66%.The preoperat

关 键 词：脊椎肿瘤 打印 三维 有效性研究 人工椎体 

分 类 号：R738.1[医药卫生—肿瘤]