Lebl Darren R
Darren R Lebl, Hospital for Special Surgery, New York, NY 10021, United States.
World J Orthop. 2013 Apr 18;4(2):53-7. doi: 10.5312/wjo.v4.i2.53.
The advent of recombinant DNA technology has substantially increased the intra-operative utilization of biologic augmentation in spine surgery over the past several years after the Food and Drug Administration approval of the bone morphogenetic protein (BMP) class of molecules for indications in the lumbar spine. Much less is known about the potential benefits and risks of the "off-label" use of BMP in the cervical spine. The history and relevant literature pertaining to the use of the "off-label" implantation of the BMP class of molecules in the anterior or posterior cervical spine are reviewed and discussed. Early prospective studies of BMP-2 implantation in anterior cervical spine constructs showed encouraging results. Later retrospective studies reported potentially "life threatening complications" resulting in a 2007 public health advisory by the FDA. Limited data regarding BMP-7 in anterior cervical surgery was available with one group reporting a 2.4% early (< 30 d) complication rate (brachialgia and dysphagia). BMP use in the decompressed posterior cervical spine may result in neurologic or wound compromise according to several retrospective reports, however, controlled use has been reported to increase fusion rates in select complex and pediatric patients. There were no cases of de novo neoplasia related to BMP implantation in the cervical spine. BMP-2 use in anterior cervical spine surgery has been associated with a high early complication rate. Definitive recommendations for BMP-7 use in anterior cervical spine surgery cannot be made with current clinical data. According to limited reports, select complex patients who are considered "high risk" for pseudoarthrosis undergoing posterior cervical or occipitocervical arthrodesis or children with congenital or traumatic conditions may be candidates for "off-label" use of BMP in the context of appropriate informed decision making. At the present time, there are no high-level clinical studies on the outcomes and complication rates of BMP implantation in the cervical spine.
在过去几年中，自美国食品药品监督管理局（FDA）批准骨形态发生蛋白（BMP）类分子用于腰椎适应症后，重组DNA技术的出现显著增加了脊柱手术中生物增强技术的术中应用。然而，对于BMP在颈椎“非标签”使用的潜在益处和风险，人们了解得要少得多。本文回顾并讨论了BMP类分子在颈椎前路或后路“非标签”植入的历史及相关文献。早期关于BMP - 2植入颈椎前路结构的前瞻性研究显示了令人鼓舞的结果。后来的回顾性研究报告了潜在的“危及生命的并发症”，导致FDA在2007年发布了公共卫生咨询意见。关于BMP - 7在颈椎前路手术中的数据有限，有一组报告早期（<30天）并发症发生率为2.4%（臂痛和吞咽困难）。根据几份回顾性报告，在减压的颈椎后路使用BMP可能导致神经功能障碍或伤口问题，然而，据报道，在特定的复杂患者和儿科患者中，有控制地使用可提高融合率。颈椎中没有与BMP植入相关的新发肿瘤病例。在颈椎前路手术中使用BMP - 2与较高的早期并发症发生率相关。根据目前的临床数据，无法对BMP - 7在颈椎前路手术中的使用给出明确建议。根据有限的报告，对于被认为在颈椎后路或枕颈关节融合术中发生假关节“高风险”的特定复杂患者，或患有先天性或创伤性疾病的儿童，在适当的知情决策情况下，可能是“非标签”使用BMP的候选者。目前，尚无关于BMP植入颈椎的疗效和并发症发生率的高级别临床研究。
