Department of Orthopedic Surgery, Michigan State University, McLaren Oakland, Pontiac, MI, USA.
Curr Rev Musculoskelet Med. 2014 Sep;7(3):208-19. doi: 10.1007/s12178-014-9224-0.
Recombinant human bone morphogenetic protein - 2 (rh-BMP-2) was first approved by the United States Food and Drug Administration (FDA) in 2002 for use in anterior lumbar interbody fusions. Since that time, it has been estimated that "off label" use accounts for 85 % of applications. Original, industry sponsored studies demonstrated superior fusion rates with decreased incidence of complications when compared with traditional iliac crest bone graft. These studies have been criticized for potential bias and newer research has detailed potential complications as well as alternative applications. Potential off label uses of rhBMP-2 include: anterior lumbar fusions, single level posterior lumbar fusions, multiple level posterior lumbar fusions, posterior cervical fusions, long deformity fusions, in the presence of vertebral osteomyelitis, and in patients with history of malignancy. A review of the literature related to rhBMP-2 was conducted to evaluate its use for the above-mentioned applications with a special focus on fusion rates, observed complications, and clinical or radiographic outcomes.
重组人骨形态发生蛋白-2（rh-BMP-2）于 2002 年首次获得美国食品和药物管理局（FDA）批准，用于前路腰椎椎间融合术。自那时以来，据估计“超适应证”使用占应用的 85%。最初，由行业赞助的研究表明，与传统的髂嵴骨移植物相比，rh-BMP-2 具有更高的融合率和更低的并发症发生率。这些研究因潜在的偏倚而受到批评，而新的研究则详细介绍了潜在的并发症和替代应用。rhBMP-2 的潜在超适应证用途包括：前路腰椎融合术、单节段后路腰椎融合术、多节段后路腰椎融合术、后路颈椎融合术、长节段畸形融合术、在存在椎体骨髓炎的情况下，以及在有恶性肿瘤病史的患者中。对与 rhBMP-2 相关的文献进行了回顾，以评估其在上述应用中的使用情况，特别关注融合率、观察到的并发症以及临床或影像学结果。
