Buser Zorica, Hsieh Patrick, Meisel Hans-Joerg, Skelly Andrea C, Brodt Erika D, Brodke Darrel S, Park Jong-Beom, Yoon S Tim, Wang Jeffrey
Department of Orthopaedic Surgery, Keck School of Medicine, 12223University of Southern California, CA, USA.
Department of Neurological Surgery, Keck School of Medicine, 12223University of Southern California, CA, USA.
Global Spine J. 2021 Oct;11(8):1281-1298. doi: 10.1177/2192568220973190. Epub 2020 Nov 18.
Systematic review.
To systematically review, critically appraise and synthesize evidence on use of autologous stem cells sources for fusion in the lumbar spine.
A systematic search of PubMed/MEDLINE, EMBASE and ClinicalTrials.gov through February 20, 2020 was conducted comparing autologous cell grafts to other biologics for lumbar spine fusion. The focus was on studies comparing distinct patient groups.
From 343 potentially relevant citations, 15 studies met the inclusion criteria set a priori. Seven studies compared distinct patient groups, with BMA being used in combination with allograft or autograft not as a standalone material. No economic evaluations were identified. Most observational studies were at moderately high risk of bias. When used for primary lumbar fusion, no statistical differences in outcomes or complications were seen between BMA+autograft/or +allograft compared to autograft/allograft alone. Compared with allograft, data from a RCT suggested statistically better fusion and lower complication rates with concentrated BMA+allograft. When used in revisions, no differences in outcomes were seen between BMA+allograft and either autograft or rh-BMP-2 but fusion rates were lower with BMA+allograft, leading to additional revision surgery.
There was substantial heterogeneity across studies in patient populations, sample size, biologic combinations, and surgical characteristics making direct comparisons difficult. The overall quality of evidence for fusion rates and the safety of BMA in lumbar fusion procedures was considered very low, with studies being at moderately high or high risk of bias.
系统评价。
系统评价、严格评估并综合关于使用自体干细胞来源进行腰椎融合的证据。
通过对PubMed/MEDLINE、EMBASE和ClinicalTrials.gov进行系统检索，截至2020年2月20日，比较自体细胞移植物与其他生物制剂用于腰椎融合的情况。重点是比较不同患者组的研究。
从343条潜在相关引文中，有15项研究符合预先设定的纳入标准。7项研究比较了不同患者组，其中骨髓抽吸物（BMA）与同种异体移植物或自体移植物联合使用，而非作为单一材料使用。未发现经济评估。大多数观察性研究存在中度高偏倚风险。当用于初次腰椎融合时，与单独使用自体移植物/同种异体移植物相比，BMA+自体移植物/或+同种异体移植物在结局或并发症方面未见统计学差异。与同种异体移植物相比，一项随机对照试验（RCT）的数据表明，浓缩BMA+同种异体移植物在统计学上具有更好的融合效果和更低的并发症发生率。当用于翻修手术时，BMA+同种异体移植物与自体移植物或重组人骨形态发生蛋白-2（rh-BMP-2）在结局方面未见差异，但BMA+同种异体移植物的融合率较低，导致额外的翻修手术。
各研究在患者人群、样本量、生物制剂组合和手术特征方面存在很大异质性，难以进行直接比较。关于腰椎融合手术中融合率和BMA安全性的证据总体质量被认为非常低，研究存在中度高或高偏倚风险。
