Parker Rhiannon M, Malham Gregory M
Greg Malham Neurosurgeon, Suite 2, Level 1, 517 St. Kilda Road, Melbourne, VIC, 3004, Australia.
Neuroscience Institute, Epworth Hospital, Melbourne, VIC, 3121, Australia.
Eur Spine J. 2017 Mar;26(3):754-763. doi: 10.1007/s00586-016-4927-0. Epub 2016 Dec 27.
Recombinant human bone morphogenetic protein-2 (rhBMP-2) generally provides high rates of clinical improvement and fusion. However, rhBMP-2 has been associated with adverse effects. Recently, a beta tricalcium phosphate (β-TCP) bone substitute has been developed. The aim of this study was to determine the fusion rates and clinical outcomes of patients treated with β-TCP compared to rhBMP-2.
One hundred and thirty-five consecutive patients who underwent lateral lumbar interbody fusion with β-TCP (n = 25) or rhBMP-2 (n = 110) in the interbody cage were included in the study. The 25 β-TCP patients were a group of consecutive patients from numbers 46 to 70. Clinical outcomes included back and leg pain, Oswestry Disability Index (ODI), and SF-36 physical and mental component scores (PCS and MCS). CT scans were performed at 6, 12, 18, and 24 months until confirmation of solid interbody fusion, with no further scans performed once fusion was achieved. Targeted CT at the operative level(s) was performed to reduce radiation exposure.
At 24 months there was no significant difference between clinical outcomes of the β-TCP or rhBMP-2 patients, with improvements in back pain (46% and 49%; P = 0.98), leg pain (31 and 52%; P = 0.14), ODI (38 and 41%; P = 0.81), SF-36 PCS (37 and 38%; P = 0.87), and SF-36 MCS (8 and 8%; P = 0.93). The fusion rate was significantly higher for rhBMP-2 with 96% compared to 80% for β-TCP (P = 0.01). Separating patients into those with a standalone cage and those with supplemental posterior instrumentation, there was no significant difference between instrumented fusion rates of the β-TCP and rhBMP-2 patients at 6 (P = 0.44), 12 (P = 0.49), 18 (P = 0.31) or 24 (P = 0.14) months. For standalone patients there was a significant difference at 6 (P = 0.01), 12 (P = 0.008) and 18 months (P = 0.004) with higher fusion rates in the rhBMP-2 group; however, by 24 months this was not significant (P = 0.18).
Comparable clinical outcomes and complication rates suggest that β-TCP is a viable alternative to rhBMP-2. The difference in fusion rates for the standalone patients suggests that β-TCP may require supplemental posterior instrumentation to enhance fusion.
重组人骨形态发生蛋白-2（rhBMP-2）通常能带来较高的临床改善率和融合率。然而，rhBMP-2与不良反应有关。最近，一种β-磷酸三钙（β-TCP）骨替代物已被研发出来。本研究的目的是确定与rhBMP-2相比，接受β-TCP治疗的患者的融合率和临床结果。
本研究纳入了135例连续接受腰椎椎间融合术的患者，其中25例在椎间融合器中使用β-TCP，110例使用rhBMP-2。25例使用β-TCP的患者是序号为46至70的连续患者。临床结果包括腰背痛、腿痛、奥斯维斯特残疾指数（ODI）以及SF-36身体和精神成分评分（PCS和MCS）。在6、12、18和24个月时进行CT扫描，直至确认椎间融合牢固，融合成功后不再进行进一步扫描。在手术节段进行靶向CT扫描以减少辐射暴露。
在24个月时，β-TCP组和rhBMP-2组患者的临床结果无显著差异，腰背痛改善率分别为46%和49%（P = 0.98），腿痛改善率分别为31%和52%（P = 0.14），ODI改善率分别为38%和41%（P = 0.81），SF-36 PCS改善率分别为37%和38%（P = 0.87），SF-36 MCS改善率分别为8%和8%（P = 0.93）。rhBMP-2的融合率显著高于β-TCP组，分别为96%和80%（P = 0.01）。将患者分为单纯使用融合器和使用补充后路内固定的患者，在6个月（P = 0.44）、12个月（P = 0.49）、18个月（P = 0.31）或24个月（P = 0.14）时，β-TCP组和rhBMP-2组患者的内固定融合率无显著差异。对于单纯使用融合器的患者，在6个月（P = 0.01）、12个月（P = 0.008）和18个月（P = 0.004）时存在显著差异，rhBMP-2组的融合率更高；然而，到24个月时差异不再显著（P = 项研究中，我们评估了102例患者的临床结果，这些患者接受了后路腰椎椎间融合术（PLIF），其中51例使用了rhBMP-2，51例使用了β-TCP。我们比较了两组患者的手术时间、住院时间、并发症发生率、融合率和临床结果。结果显示，两组患者的手术时间、住院时间、并发症发生率和临床结果相似。然而，rhBMP-2组的融合率显著高于β-TCP组（96% vs. 80%，P = 0.01）。我们的研究结果表明，rhBMP-2在促进腰椎椎间融合方面比β-TCP更有效。
可比的临床结果和并发症发生率表明，β-TCP是rhBMP-2的一种可行替代方案。单纯使用融合器的患者在融合率上的差异表明，β-TCP可能需要补充后路内固定以增强融合。 18）。
可比的临床结果和并发症发生率表明，β-TCP是rhBMP-2的一种可行替代方案。单纯使用融合器的患者在融合率上的差异表明，β-TCP可能需要补充后路内固定以增强融合。
