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首页> 外文期刊>Spine >The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers.
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The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers.

机译：rhBMP-2在吸烟者后外侧腰椎融合中的功效。

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STUDY DESIGN: Retrospective review of prospectively collected data, as part of an IRB-approved, FDA-regulated, randomized, nonblinded IDE trial of rhBMP-2 matrix for lumbar spinal fusion. OBJECTIVES: The purpose of this study is to examine the influence of smoking on fusion rate and outcome in a large series of patients treated with an rhBMP-2 matrix (AMPLIFY) or iliac crest bone graft as part of a randomized IDE trial for single-level lumbar fusion. SUMMARY OF BACKGROUND DATA: Preclinical studies suggest that bone morphogenetic proteins (BMPs) are able to reverse the negative influence of nicotine on fusion healing in animal models. It remains unclear if a similar benefit will be seen in humans, and if so, what formulation and amount of BMP will be required to achieve that improvement. METHODS: We reviewed the clinical and radiographic records of 148 patients who underwent single-level instrumented lumbar fusion at three spine centers as part of an ongoing FDA-regulated IDE trial. Clinical outcome measures included Oswestry Disability Index, SF-36, back, and leg pain scores. Radiographic measures were plain radiographs with flexion-extension views and fine cut computed tomography scans with sagittal and coronal reconstruction. Fusion success was determined by independent radiologist readings. RESULTS: At 2 years postoperatively, solid fusion was demonstrated in all 55 nonsmokers in the rhBMP-2 group (100%). Successful fusion was seen in 20 of 21 smokers in the rhBMP-2 group (95.2%). Fusion was achieved in 48 of 51 nonsmokers in the iliac crest bone graft (ICBG) group (94.1%), but only 16 of 21 smokers (76.2%) in the ICBG group. CONCLUSIONS: The results of this study suggest that rhBMP-2 may enhance fusion rate in cigarette smokers undergoing single-level instrumented posterolateral lumbar fusion. Despite the improvement in fusion rate with rhBMP-2, clinical outcomes measures were still adversely affected in smokers.
机译：研究设计：回顾性收集前瞻性收集的数据，这是IRB批准，FDA监管，rhBMP-2基质用于腰椎融合的随机，非盲IDE试验的一部分。目的：本研究的目的是检查在接受rhBMP-2基质（AMPLIFY）或骨植骨治疗的一系列患者中，吸烟对融合率和预后的影响，这是一项针对单个患者的随机IDE试验的一部分水平腰椎融合术。背景数据摘要：临床前研究表明，骨形态发生蛋白（BMP）能够逆转尼古丁对动物模型融合愈合的负面影响。尚不清楚是否会在人类中看到类似的益处，如果是的话，将需要什么配方和量的BMP来实现这种改善。方法：作为正在进行的FDA监管的IDE试验的一部分，我们回顾了148例在三个脊柱中心接受单层仪器腰椎融合术的患者的临床和影像学记录。临床结局指标包括Oswestry残疾指数，SF-36，背部和腿部疼痛评分。放射线测量是具有屈伸视图的普通放射线照相，以及具有矢状和冠状重建的精细切割计算机断层扫描。融合成功与否取决于放射线医师的独立读数。结果：术后2年，rhBMP-2组的所有55名非吸烟者均表现出牢固融合（100％）。 rhBMP-2组的21名吸烟者中有20名成功融合（95.2％）。 51骨移植（ICBG）组的51位非吸烟者中有48位实现融合（94.1％），而ICBG组的21位吸烟者中只有16位（76.2％）实现融合。结论：这项研究的结果表明，rhBMP-2可以提高单水平仪器后外侧腰椎融合的吸烟者的融合率。尽管与rhBMP-2的融合率有所提高，但吸烟者的临床结局指标仍然受到不利影响。

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