Epstein Nancy E
Neurological Surgery, The Albert Einstein College of Medicine, Bronx, NY 10451, and Winthrop University Hospital, Mineola, NY 11501, USA.
Surg Neurol Int. 2011 Jan 24;2:10. doi: 10.4103/2152-7806.76147.
INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an "off-label" capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a "large" INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized "off-label".
This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.
There are multiple cons of utilizing INFUSE in an "off-label" capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel-bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined.
More surgeons need to question the safety, efficacy, and appropriate "off-label" use of INFUSE in all spine surgeries.
INFUSE（重组人骨形态发生蛋白-2 [rh-BMP-2]；美敦力公司，美国田纳西州孟菲斯）仅被美国食品药品监督管理局（FDA）批准与腰椎锥形融合器（LT Cage；美敦力公司）联合使用，用于进行单节段前路腰椎椎间融合术（ALIF：L2 - S1节段）。然而，INFUSE却被广泛用于颈椎、胸椎和腰椎的前路和/或后路手术的“非适应证”用途。尽管如此，医疗保险和其他保险公司现在越来越多地拒绝为医院报销在“非适应证”使用INFUSE时的费用（医院购买一支“大剂量”INFUSE的平均成本，不计间接费用为5000 - 6000美元）。
本评论文章审视了几项代表性研究，这些研究列举了在脊柱手术中使用INFUSE的相关弊端、禁忌证、并发症和成本因素。
在脊柱手术中以“非适应证”方式使用INFUSE存在多种弊端。直接禁忌证包括妊娠、对钛过敏、对牛I型胶原或rhBMP - 2过敏、感染、肿瘤、肝脏或肾脏疾病、免疫抑制（如狼疮、HIV/AIDS）；接受放疗、化疗或类固醇治疗的患者也存在禁忌证。报道的并发症包括过度/异位骨形成、瘫痪（脊髓、神经损伤）、硬脊膜撕裂、膀胱和性功能障碍、呼吸衰竭、相邻组织炎症、胎儿发育并发症、瘢痕、出血过多，甚至死亡。并发症在前路颈椎手术中非常普遍，以至于许多外科医生不再在该区域使用它。同样，INFUSE在后路腰椎椎间融合术（PLIF）和经椎间孔腰椎椎间融合术（TLIF）中的并发症及适应证也应重新审视。
更多外科医生需要质疑在所有脊柱手术中使用INFUSE的安全性、有效性以及适当的“非适应证”使用情况。
