Basu Saumyajit, Gohil Kushal, Singh Sanjit, Biswas Amitava, Sarangi Trinanjan, Palit Mainak
Head of Department of Spine Surgery, Kothari Medical Centre, Kolkata, India.
Department of Orthopedics, Grant Government Medical College and Sir JJ Group of Hospitals, Mumbai, India.
Global Spine J. 2025 Jun;15(5):2687-2698. doi: 10.1177/21925682241309303. Epub 2024 Dec 13.
Study designRandomized controlled trial.ObjectivesIn this study, we hypothesize administering fixed-dose intravenous steroid (Methylprednisolone) intraoperatively would reduce neuroinflammation and enhance functional and radiological outcomes in decompressive surgeries for DCM. Primary objectives were to assess effect of intraoperative MP on modified Japanese Orthopedic Association (mJOA) score, Nurick grade, and MRI signal changes.MethodsThis prospective triple-blinded randomized controlled trial included 65 patients allocated into MP (n = 33) and control (n = 32) groups. MP (dose-1g) was administered intraoperatively at the beginning of decompression. Clinical outcome measures included mJOA score, Nurick grading, mJOA recovery rate (mJOA RR), Nurick recovery rate (NRR), and complication rates in both groups at 1-, 3-and 24-month follow-up. Radiological outcome was assessed by analyzing regression of T2W and T1W SI changes on MRI scans as per Chen's grading at 24-months follow-up.ResultsMP group exhibited greater improvement in mJOA scores at 24-months (mean improvement: +6.69 vs +6.42; difference: +0.27, 95% CI: -0.37 to +0.91) but was statistically insignificant ( = .107). Similarly, mJOA-RR showed a moderate effect size of 0.42 (95% CI: 0.04 to 0.80) and 0.37 (95% CI: -0.01 to 0.75) at 1-and 3-months follow-up respectively. NRR improvements were observed, with effect sizes of 0.40 (95% CI: 0.02 to 0.78) and 0.49 (95% CI: 0.11 to 0.87) at 1- and 3-months respectively, but not statistically significant ( = .28). At 24-months, MP group had significantly better MRI outcome (Chen grading: mean change +1.15 vs +0.83; effect size: -0.71, 95% CI: -1.09 to -0.33; = .038).Complication rates were comparable between both groups, emphasizing safety of MP administration.ConclusionAlthough null hypothesis was not proven, intraoperative MP administration in DCM surgery demonstrated safety and suggested potential neuroprotective benefits to enhance clinical recovery and reduce spinal cord signal changes. However, further large-scale, multicentric studies are needed to validate these findings and optimize its dose.
研究设计
随机对照试验。
目的
在本研究中，我们假设术中给予固定剂量的静脉类固醇（甲泼尼龙）可减少神经炎症，并改善脊髓型颈椎病减压手术的功能和影像学结果。主要目的是评估术中使用甲泼尼龙对改良日本骨科协会（mJOA）评分、努里克分级和MRI信号变化的影响。
方法
这项前瞻性三盲随机对照试验纳入了65例患者，分为甲泼尼龙组（n = 33）和对照组（n = 32）。在减压开始时术中给予甲泼尼龙（剂量-1g）。临床结局指标包括mJOA评分、努里克分级、mJOA恢复率（mJOA RR）、努里克恢复率（NRR）以及两组在1个月、3个月和24个月随访时的并发症发生率。通过按照陈式分级分析24个月随访时MRI扫描上T2加权和T1加权信号强度变化的消退情况来评估影像学结局。
结果
甲泼尼龙组在24个月时mJOA评分有更大改善（平均改善：+6.69对+6.42；差异：+0.27，95%CI：-0.37至+0.91），但无统计学意义（P = 0.107）。同样，mJOA-RR在1个月和3个月随访时分别显示中等效应量0.42（95%CI：0.04至0.80）和0.37（95%CI：-0.01至0.75）。观察到NRR有所改善，在1个月和3个月时效应量分别为0.40（95%CI：0.02至0.78）和0.49（95%CI：0.11至0.87），但无统计学意义（P = 0.28）。在24个月时，甲泼尼龙组的MRI结局明显更好（陈式分级：平均变化+1.15对+0.83；效应量：-0.71，95%CI：-1.09至-0.33；P = 0.038）。
两组并发症发生率相当，强调了甲泼尼龙给药的安全性。
结论
尽管原假设未得到证实，但在脊髓型颈椎病手术中术中给予甲泼尼龙显示出安全性，并提示可能具有神经保护作用，有助于促进临床恢复并减少脊髓信号变化。然而，需要进一步的大规模、多中心研究来验证这些发现并优化其剂量。
