■改良的日本骨科协会(mJOA)量表是用于表示退行性颈椎病(DCM)结果的最常见量表;但是,它缺乏对颈部疼痛评分的考虑,忽略了手术后恢复的多维方面.
■使用综合评估多种结果的全局统计方法,重新评估利鲁唑在DCM脊柱手术患者中的疗效。
这是对利鲁唑在脊髓型颈椎病手术治疗(CSM-PROTECT)试验中的疗效范围内的预设次要终点的次要分析,一个多中心,双盲,2012年1月至2017年5月进行的3期随机临床试验.患有中度至重度脊髓病的DCM的成年手术患者(mJOA量表评分为8-14)被随机分配接受利鲁唑或安慰剂。本研究于2023年7月至12月进行。
■利鲁唑(50毫克,每日两次)或安慰剂共6周,包括手术前2周和手术后4周。
■主要结局指标是从基线到1年随访的临床改善差异,使用全球统计检验(GST)进行评估。36项简短形式健康调查身体成分评分(SF-36PCS),手臂和颈部疼痛数字评定量表(NRS)评分,美国脊柱损伤协会(ASIA)运动评分,和Nurick等级被合并为一个单一的汇总统计,称为整体治疗效果(GTE)。
■总的来说,290例患者(利鲁唑组,141;安慰剂组,149;平均[SD]年龄,59[10.1]岁;161[56%]男性)被包括在内。在1年的随访中,与安慰剂相比,利鲁唑显示出明显更高的全球改善概率(GTE,0.08;95%CI,0.00-0.16;P=0.02)。在35天和6个月时也看到了类似的有利的全球反应(两者的GTE,0.07;95%CI,-0.01至0.15;P=.04),尽管结果没有统计学意义。与安慰剂组相比,利鲁唑治疗的患者在1年内至少有54%的可能性获得更好的结果。1年时的ASIA运动评分和颈部和手臂疼痛NRS组合为检测利鲁唑的益处提供了最适合的简约模型(GTE,0.11;95%CI,0.02-0.16;P=.007)。
■在使用全球结局技术对CSM-PROTECT试验进行的二次分析中,利鲁唑与改善DCM患者的临床预后相关。GST提供了基于概率的结果,能够代表不同的结果量表,应在未来评估脊柱手术结果的研究中予以考虑。
UNASSIGNED: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.
UNASSIGNED: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of
riluzole in patients undergoing spinal surgery for DCM.
UNASSIGNED: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.
UNASSIGNED: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.
UNASSIGNED: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).
UNASSIGNED: Overall, 290 patients (
riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included.
Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant.
Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007).
UNASSIGNED: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.