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首页> 外文期刊>Orthopedic Research and Reviews >Role of osteogenic protein-1/bone morphogenetic protein-7 in spinal fusion
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Role of osteogenic protein-1/bone morphogenetic protein-7 in spinal fusion

机译：成骨蛋白-1 /骨形态发生蛋白7在脊柱融合中的作用

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Abstract: Osteogenic protein-1 (OP-1), also known as bone morphogenetic protein-7 (BMP-7), is a protein in the TGF-β family of cellular proteins that has shown potential for application in patients undergoing spinal fusion due to its proven osteoinductive effects, particularly in patients with spondylolisthesis. OP-1 initiates numerous processes at the cellular level, acting on mesenchymal stem cells (MSCs), osteoblasts, and osteoclasts to stimulate bone growth. Animal studies of OP-1 have provided strong evidence for the ability of OP-1 to initiate ossification in posterolateral arthrodesis. Promising findings in early clinical trials with OP-1 prompted FDA approval for use in long bone nonunions in 2001 and subsequently for revision posterolateral arthrodesis in 2004 under a conditional Humanitarian Device Exemption. Larger clinical trials have recently shown no notable safety concerns or increases in adverse events associated with OP-1. However, a recent clinical trial has not conclusively demonstrated the noninferiority of OP-1 compared to autograft in revision posterolateral arthrodesis. The future of OP-1 application in patients with spondylolisthesis thus remains uncertain with the recent rejection of Premarket Approval (PMA) status by the FDA (April 2009). Further investigation of its treatment success and immunological consequences appears warranted to establish FDA approval for its use in its current form.
机译：摘要：成骨蛋白1（OP-1），也称为骨形态发生蛋白7（BMP-7），是TGF-β细胞蛋白家族的一种蛋白，已显示出可用于因脊柱融合术而发生的患者其已证实的骨诱导作用，特别是在腰椎滑脱患者中。 OP-1在细胞水平上启动许多过程，作用于间充质干细胞（MSC），成骨细胞和破骨细胞以刺激骨骼生长。 OP-1的动物研究为OP-1在后外侧关节固定中引起骨化的能力提供了有力的证据。 OP-1早期临床试验中有希望的发现促使FDA于2001年批准将其用于长骨骨不连，随后于2004年在有条件的人道主义器械豁免的情况下用于后外侧关节固定术的修订。最近的大型临床试验表明，与OP-1相关的安全性或不良事件没有增加。然而，最近的一项临床试验尚未得出结论，在自体后外侧关节固定术中，OP-1与自体移植相比具有非劣效性。因此，由于FDA最近拒绝了上市前批准（PMA）状态，脊柱滑脱患者OP-1的应用前景仍然不确定（2009年4月）。似乎有必要进一步研究其治疗成功性和免疫学后果，以确立FDA批准以其当前形式使用它。

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