3D打印人工椎体在脊柱肿瘤全脊椎切除术脊柱重建中有效性与安全性的Meta分析

Meta-analysis of the efficacy and safety of 3D printed artificial vertebral body in spinal reconstruction after total en bloc spondylectomy for spinal tumors

中文关键词:  脊柱肿瘤  3D打印  人工椎体  全脊椎切除术  Meta分析

英文关键词:Spinal tumor  3D printed  Artificial vertebral body  Total en bloc spondylectomy  Meta-analysis

中文摘要:

  【摘要】 目的：系统分析3D打印人工椎体在脊柱肿瘤全脊椎切除术（total en bloc spondylectomy，TES）脊柱重建中的有效性与安全性。方法：通过检索PubMed、Embase、Cochrane Library、Web of Science、中国生物医学文献数据库（CBM）、中国知网（CNKI）、万方数据库和维普系列数据库，收集各数据库建库至2022年8月有关脊柱肿瘤TES中应用3D打印人工椎体脊柱重建的文献，研究类型为非随机对照试验，包括双臂试验（依据置入物不同分为3D组与钛网组）和单臂试验，采用非随机研究方法学指数（methodological index for non-randomized studies，MINORS）对纳入研究进行质量评价。提取纳入研究的结局指标：手术时间、术中出血量、早期并发症发生率、椎体融合率、内置物沉降率、脊髓损伤Frankel分级（A～E级分别计分1～5分）。使用Stata 14.0软件对相关指标进行Meta分析。结果：共有13篇相关文献被纳入，8项研究为临床单臂试验，文献评分为12～13分，均为中等质量研究，总样本量为140例；5项研究为临床双臂试验，文献评分为19～20分，均为高质量研究，3D组的总样本量为115例，钛网组总样本量为126例。Meta分析结果显示：双臂试验示3D组的手术时间（MD=-287.14，95%CI -391.30~-182.99，P=0.00）、术中出血量（MD=-2.87，95%CI -5.11~-0.63，P=0.01）低于钛网组；单臂试验示早期并发症发生率为23%（95％CI 0.16～0.31），双臂试验示两组早期并发症发生率（RR=0.56，95%CI 0.32~1.00，P=0.05）无显著性差异；单臂试验示术后脊髓损伤Frankel分级较术前获得约1个等级的改善（MD=1.04，95%CI 0.32～1.76，P=0.03），双臂试验结果示两组术后脊髓损伤Frankel分级无显著性差异（MD=-0.13，95%CI -0.45～0.19，P=0.42）；单臂试验示与相邻椎体的融合率为93%（95％CI 0.79～1.00），双臂试验仅1篇文献报告了融合率，故未进行Meta分析；单臂试验示置入物沉降率为4%（95％CI 0.01～0.07），双臂试验示3D组置入物沉降率低于钛网组（RR=0.15，95%CI 0.05～0.45，P=0.001）。结论：3D打印人工椎体在脊柱肿瘤TES脊柱重建中应用具有手术时间短，术中出血量少，与相邻椎体融合率高，置入物沉降率低等优势，术后脊髓损伤神经功能恢复好，疗效较为显著。

英文摘要:

  【Abstract】 Objectives: To systematically analyze the clinical efficacy and safety of 3D printed artificial vertebral body in spinal reconstruction after total en bloc spondylectomy(TES) for spinal neoplasms. Methods: Databases such as PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine(CBM), CNKI, Wanfang, and VIP were searched to collect the clinical literature on the implantation of 3D-printed artificial vertebral body in spinal reconstruction after TES of spinal tumors from the establishment of each database to August 2022. The study type was non-randomized controlled trial, including double-arm trial(divided into 3D group and titanium mesh group according to different implants) and single-arm trial. The methodological index for non-randomized studies(MINORS) was used to assess the quality of the included studies. The data of outcome indicators of the included studies were extracted, including operative time, intraoperative blood loss, early complication rate, fusion rate of adjacent vertebral body, subsidence rate of implants, Frankel classification of spinal cord injury(A-E grade scored 1-5 points). Stata 14.0 software was used for meta-analysis. Results: A total of 13 relavant literature were included, 8 of which were single-arm clinical trials with a total sample size of 140 cases, and they were of moderate-quality with a literature score of 12-13 points each; and 5 of which were double-arm clinical trials with a total sample size of 115 cases in the 3D group and 126 cases in the titanium mesh group, and they were of high-quality with a literature score of 19-20 points each. The results of meta-analysis: double-arm trial showed lower operative time(MD=-287.14, 95%CI -391.30 to -182.99, P=0.00) and intraoperative blood loss(MD=-2.87, 95%CI -5.11 to -0.63, P=0.01) in the 3D group than in the titanium mesh group; single-arm trial showed the early complication rate was 23%(95％CI 0.16 to 0.31), and double-arm trial showed no significant difference in the early complication rate between the two groups(RR=0.56，95%CI 0.32 to 1.00, P=0.05); single-arm trial showed the Frankel classification of postoperative spinal cord injury was improved by about 1 grade than preoperation(MD=1.04, 95%CI 0.32 to 1.76, P=0.03), and double-arm trial showed no significant difference in the Frankel grade of postoperative spinal cord injury between the two groups(MD=-0.13, 95%CI -0.45 to 0.19, P=0.42); single-arm trial showed that the fusion rate with adjacent vertebral bodies was 93%(95%CI 0.79 to 1.00), while only 1 literature in double-arm trial reported fusion rate, so meta-analysis was not performed; single-arm trial showed that the subsidence rate of implants was 4%(95％CI 0.01 to 0.07), and double-arm trial showed the subsidence rate of implants in the 3D group was lower than that in the titanium mesh group(RR=0.15, 95%CI 0.05 to 0.45, P=0.001). Conclusions: The 3D-printed artificial vertebrae prosthesis in spinal reconstruction after TES of spinal tumors has the advantages of a short operative time, little intraoperative blood loss, high fusion rate of adjacent vertebrae, low subsidence rate of implants, good neurological function recovery of spinal cord injury after surgery, and significant curative effect.