McKay William F, Peckham Steven M, Badura Jeffrey M
Medtronic Spinal and Biologics, 1800 Pyramid Place, Memphis, TN, 38132, USA,
Int Orthop. 2007 Dec;31(6):729-34. doi: 10.1007/s00264-007-0418-6. Epub 2007 Jul 17.
The combination of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) carrier has been shown to induce bone formation in a number of preclinical and clinical investigations. In 2002, rhBMP-2/ACS at a 1.5-mg/cc concentration (INFUSE Bone Graft, Medtronic Spinal and Biologics, Memphis, TN) was FDA-approved as an autograft replacement for certain interbody spinal fusion procedures. In 2004, INFUSE Bone Graft was approved for open tibial fractures with an intermedullary (IM) nail fixation. Most recently, in March 2007, INFUSE Bone Graft was approved as an alternative to autogenous bone grafts for sinus augmentations, and for localised alveolar ridge augmentations for defects associated with extraction sockets. The culmination of extensive preclinical and clinical research and three FDA approvals makes rhBMP-2 one of the most studied, published and significant advances in orthopaedics. This review article summarises a number of clinical findings of rhBMP-2/ACS, including the FDA-approved investigational device exemption (IDE) studies used in gaining the aforementioned approvals.
在多项临床前和临床研究中，已证实重组人骨形态发生蛋白-2（rhBMP-2）与可吸收胶原海绵（ACS）载体联合使用可诱导骨形成。2002年，浓度为1.5毫克/立方厘米的rhBMP-2/ACS（INFUSE骨移植材料，美敦力脊柱与生物制品公司，田纳西州孟菲斯）被美国食品药品监督管理局（FDA）批准作为某些椎间融合手术的自体骨替代物。2004年，INFUSE骨移植材料被批准用于髓内（IM）钉固定的开放性胫骨骨折。最近，在2007年3月，INFUSE骨移植材料被批准作为自体骨移植的替代物用于鼻窦增高术，以及用于与拔牙窝相关的局限性牙槽嵴增高术。广泛的临床前和临床研究以及三项FDA批准的成果使rhBMP-2成为骨科领域研究最多、发表文献最多且意义重大的进展之一。这篇综述文章总结了rhBMP-2/ACS的一些临床研究结果，包括在获得上述批准过程中使用的FDA批准的研究性器械豁免（IDE）研究。
