后外侧腰椎融合应用成骨蛋白1与同种自体骨的Meta分析

背景：如何提高腰椎融合术后腰椎融合率、降低并发症是骨科的一个重要课题。目的：通过检索和分析国内外相关文献,评价成骨蛋白1和同种自体骨在后外侧腰椎融合术中的有效性和安全性。方法：计算机检索Pubmed和Embase等数据库并结合手工检索,按照既定的纳入和排除标准查找有关成骨蛋白1和同种自体骨应用于后外侧腰椎融合术方面的相关文献。比较两种不同材料在未融合率、手术时间、出血量、住院天数等方面的差异,对部分数据通过Meta分析方法进行处理,估计结局指标的比值比（OR）及95%可信区间（CI）。结果与结论：纳入4篇文献,共4项随机对照试验,109例患者,使用成骨蛋白1融合的61例,使用同种自体骨融合的48例。研究结果提示使用成骨蛋白1未融合率[OR=1.16,95%CI（0.44,3.07）]、手术时间、术中出血量、平均住院天数、再手术率、Oswestry功能障碍指数与使用同种自体骨比较,差异无显著性意义（P〉0.05）,且纳入的研究均无内植物相关性不良事件的发生。说明成骨蛋白1作为一种安全的骨材料在后外侧腰椎融合术中可能是一种有效的融合物替代品,其主要优势在于避免了髂骨取骨相关并发症的发生,同时满足了融合术对骨量的要求。由于纳入研究较少,需要进一步多中心、大样本的随机对照试验去验证。

Meta analysis on the efficacy of osteogenic protein-1 and autologous bone graft for posterolateral lumbar fusion

BACKGROUND： How to improve lumbar fusion rates and reduce complications after lumbar spinal fusion is an important topic of orthopedics. OBJECTIVE： To collect and analyze the literatures and to evaluate the effectiveness and security of osteogenic protein-1 and autologous bone graft for posterolateral lumbar fusion. METHODS： A computer-based search was performed on PubMed database and Embase database combined with manual search for the articles relate to the effect of osteogenic protein-1 and autologous bone graft for posterolateral lumbar fusion according to the inclusion and exclusion criteria. The radiographically nonunion rate, operating time, blood loss and hospitalization days of these two materials were compared. Parts of the data were processed by Meta-analysis, and the odds ratio and 95% confidence interval of the outcome indicators were estimated. RESULTS AND CONCLUSION： A total of 4 related papers including four randomized control trials were included. There were 109 patients, among them 61 patients were fused with osteogenic protein-1 and 48 patients were fused with autologous bone graft. There was no significant difference of radiographically demonstrated nonunion rate [odds ratio=1.16, 95% confidence interval （0.44, 3.07）], operation time, blood loss, hospitalization days, reoperation rate, Oswestry disability index between osteogenic protein-1 and autologous bone graft （P 0.05）. There was no intervention related adverse event appeared. Osteogenic protein-1 may be an effective and safe alternative to autologous bone graft in posterolateral lumbar fusion. The most important advantage was that the osteogenic protein-1 could avert the morbidity of harvesting bone from the iliac crest and also could meet the need of adequate quantity of bone graft. Current literature needs large, well designed and conducted randomized control trials in clinical appplication.