Epstein Nancy E
Department of Neurosurgery, The Albert Einstein College of Medicine, Bronx, New York, 10461, and Chief of Neurosurgical Spine/Education; Department of Neuroscience, Winthrop University Hospital, Mineola, NY 11501, USA.
Surg Neurol Int. 2013 Mar 22;4(Suppl 2):S106-8. doi: 10.4103/2152-7806.109452. Print 2013.
In Maerz, Herkowitz and Baker's review, Molecular and Genetic Advances in the Regeneration of the Intervertebral Disc, they also included an assessment of both in vivo and in vitro complications attributed to Bone Morphogenetic Protein ((BMP): BMP-2, BMP-7). This topic is of particular interest to spinal surgeons, as INFUSE/BMP (Medtronic, Memphis, TN, USA) is utilized, mostly off-label in the cervical, thoracic, and lumbar spine, where it has been associated with significant perioperative and postoperative complications.
BMP-2 and BMP-7 are the only human recombinant growth factors approved by the Food and Drug Administration (FDA) for anterior lumbar interbody fusion (ALIF) in combination with the Lumbar Tapered Fusion Device (LT Cage: Medtronic, Memphis, TN, USA). BMP, however, is more typically utilized "off-label" in many other areas of the spine, where it has been associated with numerous complications.
Maerz, et al. documented multiple in vivo and in vitro laboratory-based animal studies dating back to the early 2000's in which BMP (INFUSE is the clinically available product: Medtronic, Memphis, TN) contributed to multiple complications, especially when utilized at higher doses. These complications included; inflammation/inflammatory processes, increased vascularity, fibroblastic proliferation, and catabolism.
Maerz, et al. reviewed the increased risks associated with utilizing high dose BMP=INFUSE in spinal surgery, particularly when utilized "off-label". The authors clearly indicate that BMP/INFUSE should be further investigated (based on the old and new findings) to better determine/confirm its safety, efficacy, and dosing.
在梅尔兹、赫科维茨和贝克的综述《椎间盘再生的分子与遗传学进展》中,他们还评估了归因于骨形态发生蛋白(BMP:BMP - 2、BMP - 7)的体内和体外并发症。这个话题对脊柱外科医生尤为重要,因为INFUSE/BMP(美敦力公司,美国田纳西州孟菲斯)大多在颈椎、胸椎和腰椎手术中被超适应证使用,并且与显著的围手术期和术后并发症相关。
BMP - 2和BMP - 7是美国食品药品监督管理局(FDA)批准的仅有的用于与腰椎锥形融合器(LT Cage:美敦力公司,美国田纳西州孟菲斯)联合进行前路腰椎椎间融合术(ALIF)的人重组生长因子。然而,BMP在脊柱的许多其他区域更常用于“超适应证”,在这些区域它与众多并发症相关。
梅尔兹等人记录了多项可追溯到21世纪初的基于实验室的体内和体外动物研究,其中BMP(INFUSE是临床可用产品:美敦力公司,美国田纳西州孟菲斯)导致了多种并发症,尤其是在高剂量使用时。这些并发症包括:炎症/炎症过程、血管增生、成纤维细胞增殖和分解代谢。
梅尔兹等人回顾了在脊柱手术中使用高剂量BMP - INFUSE相关的增加风险,特别是在“超适应证”使用时。作者明确指出,应基于新老发现对BMP/INFUSE进行进一步研究,以更好地确定/证实其安全性、有效性和剂量。