romosozumab对器械手术围手术期管理的潜在影响

Koji Ishikawa, Soji Tani, Tomoaki Toyone, Koutaro Tsuchiya, Tomoko Towatari, Yusuke Oshita, Ryo Yamamura, Takashi Nagai, Toshiyuki Shirahata, Katsunori Inagaki, Yoshifumi Kudo
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摘要

背景:年龄相关的骨骼健康变化增加了接受骨科手术的老年患者发生并发症的风险。骨质疏松是一个关键的治疗目标,需要解决,以确保成功的内固定手术。骨科手术中药物干预的有效性,特别是新药romosozumab,仍然是未知的。我们旨在利用基于定量计算机断层扫描(QCT)的有限元方法(FEM)评估3个月romosozumab治疗对脊柱内固定手术相关生物力学参数的影响。方法:这项开放标记的前瞻性研究纳入了81例年龄在60至90岁之间的患者,他们符合骨质疏松症标准,计划接受romosozumab或eldecalcitol治疗。采用血液样本、双能吸收仪(DXA)和QCT对患者进行评估。在基线和治疗后3个月用FEM评估生物力学参数。主要终点是3个月时的生物力学参数,次要终点包括椎弓根周围区域体积骨密度(P-vBMD)和椎体(V-vBMD)的变化。结果:与eldecalcitol相比,Romosozumab治疗在3个月时导致P-vBMD和V-vBMD显著增加。值得注意的是,与eldecalcitol组相比,romosozumab组在3个月时通过FEM估计的所有生物力学参数中显示出更大的改善。结论:Romosozumab显著增加了局部vBMD和生物力学参数,可能在减少骨质疏松患者接受骨科器械手术后并发症方面提供临床益处。本研究强调了romosozumab治疗的新优势,并主张进一步研究其在围手术期管理中的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The potential effect of romosozumab on perioperative management for instrumentation surgery
Background: Age-related changes in bone health increase the risk for complications in elderly patients undergoing orthopedic surgery. Osteoporosis is a key therapeutic target that needs to be addressed to ensure successful instrumentation surgery. The effectiveness of pharmacological interventions in orthopedic surgery, particularly the new drug romosozumab, is still unknown. We aim to evaluate the effect of 3-month romosozumab treatment on biomechanical parameters related to spinal instrumentation surgery, using the Quantitative Computed Tomography (QCT)-based Finite Element Method (FEM). Methods: This open-labeled, prospective study included 81 patients aged 60 to 90 years, who met the osteoporosis criteria and were scheduled for either romosozumab or eldecalcitol treatment. Patients were assessed using blood samples, dual-energy absorptiometry (DXA), and QCT. Biomechanical parameters were evaluated using FEM at baseline and 3 months post-treatment. The primary endpoints were biomechanical parameters at 3 months, while secondary endpoints included changes in regional volumetric bone mineral density around the pedicle (P-vBMD) and vertebral body (V-vBMD). Results: Romosozumab treatment led to significant gains in P-vBMD, and V-vBMD compared to eldecalcitol at 3 months. Notably, the romosozumab group showed greater improvements in all biomechanical parameters estimated by FEM at 3 months compared to the eldecalcitol group. Conclusion: Romosozumab significantly increased the regional vBMD as well as biomechanical parameters, potentially offering clinical benefits in reducing post-operative complications in patients with osteoporosis undergoing orthopedic instrumentation surgery. This study highlights the novel advantages of romosozumab treatment and advocates further research on its effectiveness in perioperative management.
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