Mirzaei Farhad, Meshkini Ali, Habibi Bohlool, Salehpour Firooz, Rafei Ebrahim, Fathi Wouria, Alavi Seyed Hamed Naseri, Majdi Alireza, Rahigh Aghasan Sepideh, Naseri Alavi Seyed Ahmad
Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
Int J Spine Surg. 2020 Oct;14(5):706-712. doi: 10.14444/7102. Epub 2020 Oct 19.
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.
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.
Analyses showed a significant statistical difference between groups in the changes in CRP levels during days 1 and 4 ( = .001) and also during days 4 and 8 ( = .001). However, no significant statistical difference was detected in ESR levels changes between groups during days 1 and 4 ( = .073), and during days 4 and 8 ( = .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 ( = .001 for both comparisons). However, the number of variations in the ASIA score had no significant statistical difference between groups 6 months after intervention ( = .465).
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.
指南并不建议在急性创伤性脊髓损伤（SCI）患者中常规使用甲泼尼龙（MP）。我们检验了关于急性创伤性SCI患者联合使用头孢曲松和MP治疗是否优于MP单一疗法的假设。
在一项随机、三盲临床试验中，2016年12月至2017年6月期间，伊朗大不里士医科大学招募了60例急性（受伤后8小时内）创伤性SCI患者。因此，患者被随机分为2个病例组和对照组（每组n = 30）。入院时，所有纳入患者静脉注射（IV）33 mg/kg的MP大剂量，持续15分钟。然后，45分钟后，以5.4 mg/kg的IV剂量继续输注MP 24至48小时。病例组通过静脉途径额外给予1 g头孢曲松，每日2次，共7天。入院时、第4天和第8天检查并比较病例组和对照组的红细胞沉降率（ESR）和C反应蛋白（CRP）。此外，根据美国脊髓损伤协会（ASIA）分级评分在入院时、第3天和第7天、出院时以及入院后6个月评估感觉和运动功能。
分析显示，第1天和第4天（P = .001）以及第4天和第8天（P = .001）两组间CRP水平变化存在显著统计学差异。然而，第1天和第4天（P = .073）以及第4天和第8天（P = .069）两组间ESR水平变化未检测到显著统计学差异。发现MP加头孢曲松组与MP单一疗法组在入院时和治疗后6个月的ASIA量表存在显著差异（两次比较P均 = .001）。然而，干预6个月后两组间ASIA评分的变化数量无显著统计学差异（P = .465）。
在急性SCI常规治疗方案中添加头孢曲松，干预6个月后炎症标志物和功能结果得到改善。
