دورية أكاديمية
Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.
| العنوان: | Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial. |
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| المؤلفون: | Fehlings MG; Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.; Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada., Pedro KM; Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.; Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada., Alvi MA; Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.; Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada., Badhiwala JH; Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada., Ahn H; Division of Orthopaedic Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada., Farhadi HF; Department of Neurological Surgery, Ohio State University, Columbus., Shaffrey CI; Department of Neurosurgery, University of Virginia, Charlottesville., Nassr A; Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota., Mummaneni P; Department of Neurosurgery, University of California, San Francisco., Arnold PM; Department of Neurosurgery, Kansas University Medical Center, Kansas City., Jacobs WB; Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada., Riew KD; Department of Orthopedic Surgery, Columbia University, New York, New York., Kelly M; Department of Orthopaedic Surgery, University of California, San Diego., Brodke DS; Department of Orthopaedics, University of Utah, Salt Lake City., Vaccaro AR; Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, Pennsylvania., Hilibrand AS; Department of Neurosurgery, Louisiana State University, New Orleans., Wilson J; Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania., Harrop JS; Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, Pennsylvania., Yoon ST; Department of Orthopaedics, Emory University, Atlanta, Georgia., Kim KD; Department of Neurological Surgery, University of California, Davis, Sacramento., Fourney DR; Division of Neurosurgery, University of Saskatchewan, Saskatoon, Saskatchewan, Canada., Santaguida C; Department of Neurology and Neurosurgery, McGill University Health Centre, Montreal, Quebec, Canada., Massicotte EM; Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.; Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada., Huang P; Department of Oncology, Johns Hopkins University, Baltimore, Maryland.; Department of Biostatistics, Johns Hopkins University, Baltimore, Maryland. |
| المصدر: | JAMA network open [JAMA Netw Open] 2024 Jun 03; Vol. 7 (6), pp. e2415643. Date of Electronic Publication: 2024 Jun 03. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, IL : American Medical Association, [2018]- |
| مواضيع طبية MeSH: | Riluzole*/therapeutic use , Cervical Vertebrae*/surgery, Humans ; Male ; Female ; Middle Aged ; Double-Blind Method ; Aged ; Spinal Cord Diseases/surgery ; Spinal Cord Diseases/drug therapy ; Spondylosis/surgery ; Spondylosis/drug therapy ; Treatment Outcome ; Neuroprotective Agents/therapeutic use |
| مستخلص: | Importance: 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. Objective: 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. Design, Setting, and Participants: 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. Intervention: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures: 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). Results: 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). Conclusions and Relevance: 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. |
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| المشرفين على المادة: | 7LJ087RS6F (Riluzole) 0 (Neuroprotective Agents) |
| تواريخ الأحداث: | Date Created: 20240621 Date Completed: 20240621 Latest Revision: 20240624 |
| رمز التحديث: | 20240624 |
| مُعرف محوري في PubMed: | PMC11193126 |
| DOI: | 10.1001/jamanetworkopen.2024.15643 |
| PMID: | 38904964 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2574-3805 |
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| DOI: | 10.1001/jamanetworkopen.2024.15643 |