Center for Evidence-Based Practice, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA.
J Neurosurg Spine. 2009 Dec;11(6):729-40. doi: 10.3171/2009.6.SPINE08669.
Autograft and allograft, the standard approaches for lumbar fusion procedures, have important disadvantages. Bone graft substitutes such as recombinant human bone morphogenetic proteins (rhBMP-2 and rhBMP-7) have emerged as viable alternatives. The authors conducted a systematic review to compare the efficacy and safety of osteoinductive bone graft substitutes using autografts and allografts in lumbar fusion.
A search for prospective controlled trials was conducted on MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases. Data were extracted for key outcomes including radiographically demonstrated nonunion, Oswestry Disability Index, operating time, blood loss, and length of hospital stay. The quality of randomized controlled trials was assessed using the Jadad scale. Meta-analyses were performed when feasible, and heterogeneity was assessed using the Q statistic and the I(2) statistic.
Seventeen of 732 potential studies met the inclusion criteria, with 9 examining rhBMP-2, 3 examining rhBMP-7, 3 examining demineralized bone matrix, and 2 examining autologous growth factor. Recombinant human BMP-2 significantly decreased radiographic nonunion when compared with autologous iliac crest bone graft (AIBG) in a meta-analysis (relative risk 0.27, 95% CI 0.16-0.46). Stratification of meta-analyses by the type of surgical procedure performed yielded similar results. Funnel plots suggested publication bias. Trials of rhBMP-2 suggested reductions in the operating time and surgical blood loss, with less effect on the length of hospital stay. There was no difference in radiographic nonunion with the use of rhBMP-7 when compared with AIBG (relative risk 1.02, 95% CI 0.52-1.98). Neither rhBMP-2 nor rhBMP-7 demonstrated a significant improvement on the Oswestry Disability Index when compared with AIBG. The limited data on demineralized bone matrix and autologous growth factor showed no significant improvement in radiographic outcomes.
Recombinant human BMP-2 may be an effective alternative to AIBG in lumbar fusion. Data are limited for other bone graft substitutes.
自体移植物和同种异体移植物是腰椎融合术的标准方法，但存在重要的缺点。骨移植替代物，如重组人骨形态发生蛋白（rhBMP-2 和 rhBMP-7）已经成为可行的替代物。作者进行了一项系统评价，以比较使用自体移植物和同种异体移植物进行腰椎融合的骨诱导性骨移植替代物的疗效和安全性。
在 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册数据库中进行了前瞻性对照试验的搜索。提取关键结局的数据，包括影像学显示的不愈合、Oswestry 残疾指数、手术时间、失血量和住院时间。使用 Jadad 量表评估随机对照试验的质量。当可行时进行荟萃分析，并使用 Q 统计量和 I(2)统计量评估异质性。
在 732 项潜在研究中，有 17 项符合纳入标准，其中 9 项研究 rhBMP-2，3 项研究 rhBMP-7，3 项研究脱钙骨基质，2 项研究自体生长因子。荟萃分析显示，与自体髂嵴骨移植物（AIBG）相比，重组人 BMP-2 显著降低了影像学不愈合的发生率（相对风险 0.27，95%CI 0.16-0.46）。按手术类型进行荟萃分析分层得出了类似的结果。漏斗图表明存在发表偏倚。rhBMP-2 的试验表明，手术时间和手术失血量减少，住院时间影响较小。与 AIBG 相比，rhBMP-7 的使用并未导致影像学不愈合率的差异（相对风险 1.02，95%CI 0.52-1.98）。与 AIBG 相比，rhBMP-2 和 rhBMP-7 均未显著改善 Oswestry 残疾指数。关于脱钙骨基质和自体生长因子的有限数据表明，影像学结局无明显改善。
重组人 BMP-2 可能是腰椎融合术的 AIBG 有效替代物。其他骨移植替代物的数据有限。
