Pros, cons, and costs of INFUSE in spinal surgery.
Pros, cons, and costs of INFUSE in spinal surgery.
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DOI：
10.4103/2152-7806.76147
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发表时间：
2011-01-24
影响因子：
--
通讯作者：
Epstein, Nancy E
中科院分区：
文献类型：
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作者：
Epstein, Nancy E
背景：INFUSE（重组人骨形态发生蛋白-2 [mh - bmp -2]； Medtronic, Memphis， TN， USA）被美国联邦药物管理局（FDA）批准仅用于腰椎锥形融合器（LT Cage; Medtronic）进行单节段腰椎前路椎间融合（ALIF: L2-S1水平）。然而，INFUSE被广泛应用于前路和/或后路颈椎、胸椎和腰椎手术。然而，医疗保险和其他保险公司现在越来越多地拒绝向医院报销“标签外”使用的INFUSE（“大型”INFUSE的平均费用为5000-6000美元，不包括管理费用）。方法：这篇评论回顾了几项有代表性的研究，引用了在脊柱手术中使用INFUSE的缺点、禁忌症、并发症和成本因素。结果：在脊柱手术中使用“超说明书”容量的INFUSE有多个缺点。直接禁忌症包括怀孕、对钛过敏、对牛I型胶原蛋白或rhBMP-2过敏、感染、肿瘤、肝脏或肾脏疾病、免疫抑制（如狼疮、艾滋病毒/艾滋病）；禁忌症也见于接受放疗、化疗或类固醇治疗的患者。报道的并发症包括增生/异位骨形成、麻痹（脊髓、神经损伤）、硬脑膜撕裂、肠膀胱和性功能障碍、呼吸衰竭、邻近组织炎症、胎儿发育并发症、疤痕、大出血，甚至死亡。颈椎前路的并发症非常普遍，许多外科医生不再在这个区域使用它。同样，后路腰椎椎间融合术（PLIFs）和椎间孔腰椎椎间融合术（TLIFs）的INFUSE并发症和适应症也应重新检查。结论：更多的外科医生需要对所有脊柱手术中使用INFUSE的安全性、有效性和适当的“说明书外”使用提出质疑。
BACKGROUND: 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".METHODS: This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.RESULTS: 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.CONCLUSIONS: More surgeons need to question the safety, efficacy, and appropriate "off-label" use of INFUSE in all spine surgeries.