Vaidya Rahul, Carp Julia, Sethi Anil, Bartol Stephen, Craig Joseph, Les Clifford M
Department of Orthopedics, Detroit Receiving Hospital, University Health Center, 4201 St. Antoine Boulevard 6A, Detroit, MI 48201, USA.
Eur Spine J. 2007 Aug;16(8):1257-65. doi: 10.1007/s00586-007-0351-9. Epub 2007 Mar 27.
The use of bone morphogenetic protein-2 (rhBMP-2) in spinal fusion has increased dramatically since an FDA approval for its use in anterior lumbar fusion with the LT cage. There are several reports of its use in transforaminal lumbar interbody fusion, posterolateral fusion, and anterior cervical fusion. Reports on adverse effects of rhBMP-2 when used in spinal fusion are scarce in literature. An Institutional Review Board approved retrospective study was conducted in patients undergoing anterior spinal fusion and instrumentation following diskectomy at a single center. Forty-six consecutive patients were included. Twenty-two patients treated with rhBMP-2 and PEEK cages were compared to 24 in whom allograft spacers and demineralized bone matrix was used. Patients filled out Cervical Oswestry Scores, VAS for arm pain, neck pain, and had radiographs preoperatively as well at every follow up visit. Radiographic examination following surgery revealed end plate resorption in all patients in whom rhBMP-2 was used. This was followed by a period of new bone formation commencing at 6 weeks. In contrast, allograft patients showed a progressive blurring of end plate-allograft junction. Dysphagia was a common complication and it was significantly more frequent and more severe in patients in whom rhBMP-2 was used. Post operative swelling anterior to the vertebral body on lateral cervical spine X-ray was significantly larger in the rhBMP-2 group when measured from 1 to 6 weeks after which it was similar. These effects are possibly due to an early inflammatory response to rhBMP-2 and were observed to be dose related. With the parameters we used, there was no significant difference in the clinical outcome of patients in the two groups at 2 years. The cost of implants in patients treated with rhBMP-2 and PEEK spacers was more than three times the cost of allograft spacers and demineralized bone matrix in 1, 2, and 3-level cases. Despite providing consistently good fusion rates, we have abandoned using rhBMP-2 and PEEK cages for anterior cervical fusion, due to the side effects, high cost, and the availability of a suitable alternative.
自美国食品药品监督管理局(FDA)批准骨形态发生蛋白-2(rhBMP-2)用于与LT椎间融合器联合进行前路腰椎融合以来,其在脊柱融合中的应用急剧增加。有几篇关于其在经椎间孔腰椎椎间融合、后外侧融合和前路颈椎融合中应用的报道。关于rhBMP-2用于脊柱融合时的不良反应的报道在文献中很少见。在一个单一中心,对接受椎间盘切除术后前路脊柱融合和内固定的患者进行了一项经机构审查委员会批准的回顾性研究。纳入了46例连续患者。将22例接受rhBMP-2和聚醚醚酮(PEEK)椎间融合器治疗的患者与24例使用同种异体骨间隔物和脱矿骨基质的患者进行比较。患者填写了颈椎Oswestry评分、手臂疼痛和颈部疼痛的视觉模拟评分(VAS),并在术前以及每次随访时进行了影像学检查。术后影像学检查显示,所有使用rhBMP-2的患者均出现终板吸收。随后在6周时开始有新骨形成期。相比之下,同种异体骨患者的终板-同种异体骨交界处逐渐模糊。吞咽困难是一种常见并发症,在使用rhBMP-2的患者中明显更频繁且更严重。从术后1至6周测量,rhBMP-2组颈椎侧位X线片上椎体前方的术后肿胀明显更大,之后两组相似。这些影响可能是由于对rhBMP-2的早期炎症反应,并且观察到与剂量相关。根据我们使用的参数,两组患者在2年时的临床结果没有显著差异。在1、2和3节段病例中,使用rhBMP-2和PEEK间隔物治疗的患者的植入物成本是同种异体骨间隔物和脱矿骨基质成本的三倍多。尽管rhBMP-2和PEEK椎间融合器始终能提供良好的融合率,但由于其副作用、高成本以及有合适的替代方案,我们已不再将其用于前路颈椎融合。