Department of Neurological Surgery, University of Pittsburgh Medical Center, 200 Lothrup St, Pittsburgh, PA 15213, USA.
Spine J. 2011 Nov;11(11):1027-32. doi: 10.1016/j.spinee.2011.10.006.
Since approval by the Food and Drug Administration in 2002, use of recombinant human bone morphogenetic protein-2 (rhBMP-2) to promote spinal fusion is increasing.
In this comparative analysis, the authors assess fusion rates and clinical outcomes of patients who underwent a presacral axial lumbar interbody fusion (AxiaLIF) (TranS1 Inc., Wilmington, NC, USA) at L5-S1 with posterior instrumentation, with or without rhBMP-2.
Retrospective case-matched chart review.
A matched cohort of 99 patients underwent fusion performed by two surgeons at two institutions (2005-2007): Specifically, 45 patients at The Christ Hospital received rhBMP-2 and 54 patients at the University of Pittsburgh had no rhBMP-2.
Pre- and postoperative visual analog scale (VAS) scores were recorded, as was physiologic data on fusion rates, blood loss, and length of stay. Preoperative and postoperative Oswestry Disability Index (ODI) scores were obtained for patients treated with rhBMP-2. Odom's outcome criteria were obtained at 2-year follow-up for patients without rhBMP-2.
Data were collected prospectively. Demographic data, including sex and age, were matched.
During the 2-year follow-up period, patients noted reduction in back pain and improved functional outcome measures. The most rapid reduction in VAS pain scores and improvement in ODI occurred within the first 3 months after surgery. Mean pre- and postoperative VAS scores improved 59% from 72.9 to 30.1 with rhBMP-2 and 72% from 81.3 to 22.6 without rhBMP-2. In rhBMP-2-treated patients, mean ODI scores were 54.4% preoperatively and 23.7% postoperatively, a 56.4% improvement at 2 years. In the non-rhBMP-2 patients, 80% reported excellent to good results using Odom criteria. Fusion rates were 96% with rhBMP-2 and 93% without rhBMP-2. Operative blood loss averaged 82 cm(3) with and less than 50 cm(3) without rhBMP-2. No differences in hospital length of stay were noted between the two groups or in the fusion rates with pedicle screws or facet screws. No major complications occurred with or without rhBMP-2.
In our case-matched series, clinical outcomes were similar for patients who underwent an AxiaLIF L5-S1 interbody fusion with or without rhBMP-2. The data strongly suggest that there is a high confidence for no effect on fusion rate by using rhBMP-2.
自 2002 年食品和药物管理局批准以来，使用重组人骨形态发生蛋白-2（rhBMP-2）促进脊柱融合的应用正在增加。
在这项对比分析中，作者评估了在 L5-S1 进行前路骶骨腰椎间融合（AxiaLIF）（TranS1 Inc.，北卡罗来纳州威尔明顿，美国）并使用或不使用 rhBMP-2 进行后路器械固定的患者的融合率和临床结果。
回顾性病例匹配图表回顾。
在两个机构（2005-2007 年）由两位外科医生进行融合的匹配队列中有 99 名患者：具体来说，在辛辛那提基督医院的 45 名患者接受了 rhBMP-2，在匹兹堡大学的 54 名患者没有接受 rhBMP-2。
记录术前和术后视觉模拟量表（VAS）评分，以及融合率、失血量和住院时间的生理数据。接受 rhBMP-2 治疗的患者获得了术前和术后 Oswestry 残疾指数（ODI）评分。在没有 rhBMP-2 的患者中，在 2 年随访时获得了 Odom 的结果标准。
数据是前瞻性收集的。匹配了人口统计学数据，包括性别和年龄。
在 2 年的随访期间，患者注意到背部疼痛减轻和功能改善。VAS 疼痛评分和 ODI 改善最快的是在手术后的前 3 个月。接受 rhBMP-2 治疗的患者，术前 VAS 评分从 72.9 降至 30.1，改善了 59%，而未接受 rhBMP-2 治疗的患者从 81.3 降至 22.6，改善了 72%。在接受 rhBMP-2 治疗的患者中，术前 ODI 评分平均为 54.4%，术后为 23.7%，2 年时改善了 56.4%。在未接受 rhBMP-2 治疗的患者中，80%的患者使用 Odom 标准报告结果为优秀或良好。融合率在 rhBMP-2 组为 96%，在无 rhBMP-2 组为 93%。rhBMP-2 组的手术失血量平均为 82cm3，而无 rhBMP-2 组为小于 50cm3。两组之间或使用椎弓根螺钉或关节突螺钉的融合率均无明显差异。rhBMP-2 组和无 rhBMP-2 组均无重大并发症。
在我们的病例匹配系列中，接受 AxiaLIF L5-S1 椎间融合术的患者，无论是否使用 rhBMP-2，其临床结果相似。数据强烈表明，使用 rhBMP-2 对融合率没有影响的置信度很高。
