术中甲泼尼龙能否改善退行性颈椎病手术的疗效?- 一项前瞻性随机研究。

IF 3 3区 医学 Q2 CLINICAL NEUROLOGY
Global Spine Journal Pub Date : 2025-06-01 Epub Date: 2024-12-13 DOI:10.1177/21925682241309303
Saumyajit Basu, Kushal Gohil, Sanjit Singh, Amitava Biswas, Trinanjan Sarangi, Mainak Palit
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引用次数: 0

摘要

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静脉注射类固醇(甲基强的松龙)可以减少神经炎症,提高DCM减压手术的功能和影像学结果。主要目的是评估术中MP对改良日本骨科协会(mJOA)评分、Nurick分级和MRI信号变化的影响。方法:本前瞻性三盲随机对照试验纳入65例患者,分为MP组(n = 33)和对照组(n = 32)。术中减压开始时给予MP(剂量1g)。临床结果测量包括mJOA评分、Nurick分级、mJOA恢复率(mJOA RR)、Nurick恢复率(NRR)和两组随访1个月、3个月和24个月的并发症发生率。在24个月的随访中,通过分析MRI扫描T2W和T1W SI变化的回归来评估放射学结果。结果:MP组在24个月时mJOA评分有较大改善(平均改善:+6.69 vs +6.42;差异:+0.27,95% CI: -0.37至+0.91),但统计学上不显著(P = .107)。同样,mJOA-RR在随访1个月和3个月时分别显示中等效应值0.42 (95% CI: 0.04至0.80)和0.37 (95% CI: -0.01至0.75)。观察到NRR改善,1个月和3个月的效应值分别为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,MP组的MRI结果明显更好(Chen分级:平均变化+1.15 vs +0.83;效应值:-0.71,95% CI: -1.09 ~ -0.33;P = .038)。两组之间的并发症发生率相当,强调了MP给药的安全性。结论:虽然零假设没有得到证实,但术中给药MP在DCM手术中是安全的,并显示出潜在的神经保护作用,可以增强临床恢复,减少脊髓信号改变。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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Does Intra-Operative Methylprednisolone Improve Outcomes of Surgery for Degenerative Cervical Myelopathy? - A Prospective Randomized Study.

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 (P = .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 (P = .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; P = .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.

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来源期刊
Global Spine Journal
Global Spine Journal Medicine-Surgery
CiteScore
6.20
自引率
8.30%
发文量
278
审稿时长
8 weeks
期刊介绍: Global Spine Journal (GSJ) is the official scientific publication of AOSpine. A peer-reviewed, open access journal, devoted to the study and treatment of spinal disorders, including diagnosis, operative and non-operative treatment options, surgical techniques, and emerging research and clinical developments.GSJ is indexed in PubMedCentral, SCOPUS, and Emerging Sources Citation Index (ESCI).
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