The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers
The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers
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DOI：
10.1097/brs.0b013e318074c366
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发表时间：
2007-07-01
期刊：
影响因子：
3
通讯作者：
Carreon, Leah Y.
中科院分区：
文献类型：
--
作者：
Glassman, Steven D.;Dimar, John R., III;Carreon, Leah Y.
研究设计.作为IRB批准的、FDA监管的、随机、非盲IDE试验的一部分，对前瞻性收集的数据进行回顾性审查，研究rhBMP-2基质用于腰椎融合。本研究的目的是在一项单节段腰椎融合随机IDE试验中，在接受rhBMP-2基质（AMPLIFY）或髂嵴植骨治疗的大量患者中，检查吸烟对融合率和结局的影响。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。目前还不清楚是否在人类中会看到类似的益处，如果是这样，需要什么样的BMP制剂和量来实现这种改善。我们回顾了148例患者的临床和影像学记录，这些患者在三个脊柱中心接受了单节段内固定腰椎融合术，作为正在进行的FDA监管IDE试验的一部分。临床结局指标包括奥斯韦斯特里功能障碍指数、SF-36、背痛和腿痛评分。影像学指标为屈曲-伸展位平片和精细切割计算机断层扫描（矢状面和冠状面重建）。融合成功与否由独立的放射科医师进行评估。术后2年，rhBMP-2组所有55例非吸烟者均实现了牢固融合（100%）。rhBMP-2组21例吸烟者中有20例成功融合（95.2%）。髂嵴植骨（ICBG）组51例非吸烟者中有48例（94.1%）实现融合，但ICBG组21例吸烟者中仅16例（76.2%）实现融合。本研究的结果表明，rhBMP-2可以提高吸烟者接受单节段后外侧腰椎融合术的融合率。尽管使用rhBMP-2改善了融合率，但吸烟者的临床结局指标仍受到不利影响。
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.