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Research ArticleLumbar Spine

Ceftriaxone Plus Methylprednisolone Combination Therapy Versus Methylprednisolone Monotherapy in Patients With Acute Spinal Cord Injury: A Randomized, Triple-Blind Clinical Trial

Farhad Mirzaei, Ali Meshkini, Bohlool Habibi, Firooz Salehpour, Ebrahim Rafei, Wouria Fathi, Seyed Hamed Naseri Alavi, Alireza Majdi, Sepide Rahigh-AghsaN and Seyed Ahmad Naseri Alavi
International Journal of Spine Surgery October 2020, 7102; DOI: https://doi.org/10.14444/7102
Farhad Mirzaei
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Ali Meshkini
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Bohlool Habibi
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Firooz Salehpour
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Ebrahim Rafei
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Wouria Fathi
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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Seyed Hamed Naseri Alavi
2Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Iran
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Alireza Majdi
3Neuroscience Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
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Sepide Rahigh-AghsaN
4Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
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Seyed Ahmad Naseri Alavi
1Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
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ABSTRACT

Background Guidelines do not suggest the routine use of methylprednisolone (MP) in patients with acute traumatic spinal cord injury (SCI). We tested the hypothesis regarding whether combination therapy with ceftriaxone and MP is superior to MP monotherapy in patients with acute traumatic SCI.

Methods In a randomized, triple-blind clinical trial, 60 patients with acute (first 8 hours of the injury) traumatic SCI were enrolled at the Tabriz University of Medical Sciences, Tabriz, Iran, between December 2016 and June 2017. Accordingly, the patients were randomly divided into 2 case and control groups (n = 30 each). Upon admission, all included patients received a bolus dose of MP at 33 mg/kg intravenously (IV) for 15 minutes. Then, after 45 minutes, MP infusion was continued for 24 to 48 hours at a 5.4 mg/kg IV dose. The case group received an additional dose of ceftriaxone at 1 g 2 times a day for 7 days through an IV route. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were checked and compared between case and control groups upon admission and on the fourth and eighth days. Also, sensory and motor functions were evaluated according to the American Spinal Injury Association (ASIA) grading score upon admission, on the third and seventh days, upon discharge and 6 months after admission.

Results Analyses showed a significant statistical difference between groups in the changes in CRP levels during days 1 and 4 (P = .001) and also during days 4 and 8 (P = .001). However, no significant statistical difference was detected in ESR levels changes between groups during days 1 and 4 (P = .073), and during days 4 and 8 (P = .069). ASIA scale was found to be significantly different between the MP plus ceftriaxone group and MP monotherapy upon admission and 6 months after treatment (P = .001 for both comparisons). However, the number of variations in the ASIA score had no significant statistical difference between groups 6 months after intervention (P = .465).

Conclusion The addition of ceftriaxone to the routine therapeutic protocol of acute SCI is accompanied by improved inflammation markers and functional outcomes 6 months after the intervention.

  • acute spinal cord injury
  • methylprednisolone
  • ceftriaxone
  • functional outcome
  • inflammation markers

Footnotes

  • Disclosures and COI: The authors received no funding for this study and report no conflicts of interest.

  • This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2020 ISASS.
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International Journal of Spine Surgery: 19 (S2)
International Journal of Spine Surgery
Vol. 19, Issue S2
1 Apr 2025
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Ceftriaxone Plus Methylprednisolone Combination Therapy Versus Methylprednisolone Monotherapy in Patients With Acute Spinal Cord Injury: A Randomized, Triple-Blind Clinical Trial
Farhad Mirzaei, Ali Meshkini, Bohlool Habibi, Firooz Salehpour, Ebrahim Rafei, Wouria Fathi, Seyed Hamed Naseri Alavi, Alireza Majdi, Sepide Rahigh-AghsaN, Seyed Ahmad Naseri Alavi
International Journal of Spine Surgery Oct 2020, 7102; DOI: 10.14444/7102

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Ceftriaxone Plus Methylprednisolone Combination Therapy Versus Methylprednisolone Monotherapy in Patients With Acute Spinal Cord Injury: A Randomized, Triple-Blind Clinical Trial
Farhad Mirzaei, Ali Meshkini, Bohlool Habibi, Firooz Salehpour, Ebrahim Rafei, Wouria Fathi, Seyed Hamed Naseri Alavi, Alireza Majdi, Sepide Rahigh-AghsaN, Seyed Ahmad Naseri Alavi
International Journal of Spine Surgery Oct 2020, 7102; DOI: 10.14444/7102
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Keywords

  • acute spinal cord injury
  • methylprednisolone
  • ceftriaxone
  • functional outcome
  • inflammation markers

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