The Role of Riluzole in Acute Traumatic Cervical Spinal Cord Injury with Incomplete Neurological Deficit: A Prospective, Randomised Controlled Study,Indian Journal of Orthopaedics

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The Role of Riluzole in Acute Traumatic Cervical Spinal Cord Injury with Incomplete Neurological Deficit: A Prospective, Randomised Controlled Study
Indian Journal of Orthopaedics ( IF 1.1 ) Pub Date : 2022-10-05 , DOI: 10.1007/s43465-022-00758-6
Dinesh Kumarasamy ₁ , Vibhu Krishnan Viswanathan ₁ , Ajoy Prasad Shetty _{1,

2} , Guna K Pratheep ₁ , Rishi Mukesh Kanna ₁ , S Rajasekaran ₁

Affiliation

Introduction

Riluzole, a benzothiazole sodium channel blocker is acknowledged as a neuroprotective agent in spinal cord injury (SCI). Most of this evidence is based on pre-clinical studies and its effectiveness in clinical setting is undetermined, heretofore.

Methods

A prospective, randomised-controlled study was conducted between April 2019 and March 2020 at a tertiary-level centre. Patients aged 18–65 years with sub-axial cervical spine injury, who presented within 72 h of injury with incomplete neuro-deficit, were included. They were randomised into groups A (riluzole was administered) and B (no adjuvants). All patients were followed up at 6 weeks/3/6/12 months, and clinical [ASIA motor/sensory scores/grade, SCIM3, and NRS (neuropathic pain)] and radiological evaluation was performed.

Results

Twenty-three and 20 patients were included in groups A and B. Two in group A were females, while others were males (p = 0.49). Mean age in groups A and B was 47.7 ± 14.8 and 51.2 ± 14.1 years (p = 0.44). Five patients died prior to 6th-week follow-up. Among the others, there was significant improvement in all neurological parameters in both groups (post-injury vs 1-year; motor score: p < 0.001, sensory score: p < 0.001, SCIM3: p < 0.001, NRS: p < 0.001). In both groups, initial significant improvement was noticed even at the 6th-week follow-up, which further continued until the end of 1 year. There was no statistically significant difference between groups A and B with respect to these neurological parameters (motor: p = 0.15, sensory: p = 0.39, SCIM3: p = 0.68, NRS: p = 0.06).

Conclusion

Administration of riluzole did not significantly improve neurological outcome/neuropathic pain in our cohort. Nevertheless, both our groups demonstrated an overall improvement in neurological outcome at 1 year, as compared with immediate post-injury status.

中文翻译：

利鲁唑在伴有不完全神经功能缺损的急性创伤性颈脊髓损伤中的作用：一项前瞻性、随机对照研究

介绍

利鲁唑是一种苯并噻唑钠通道阻滞剂，被认为是脊髓损伤 (SCI) 的神经保护剂。大多数证据都是基于临床前研究，迄今为止其在临床环境中的有效性尚未确定。

方法

2019 年 4 月至 2020 年 3 月期间，在一家三级中心进行了一项前瞻性随机对照研究。纳入的患者年龄为 18-65 岁，患有轴下颈椎损伤，且损伤后 72 小时内出现不完全神经缺陷。他们被随机分为 A 组（给予利鲁唑）和 B 组（无佐剂）。所有患者均在6周/3/6/12个月时进行随访，并进行临床[ASIA运动/感觉评分/等级、SCIM3和NRS（神经性疼痛）]和放射学评估。

结果

A 组和 B 组分别包括 23 名和 20 名患者。A 组中有 2 名患者为女性，其他患者为男性 ( p = 0.49)。A 组和 B 组的平均年龄分别为 47.7 ± 14.8 岁和 51.2 ± 14.1 岁 ( p = 0.44)。五名患者在第六周随访前死亡。其中，两组的所有神经学参数均有显着改善（受伤后与 1 年相比；运动评分：p < 0.001，感觉评分：p < 0.001，SCIM3：p < 0.001，NRS：p < 0.001）。在两组中，即使在第 6 周的随访中也注意到了初步的显着改善，并且这种情况进一步持续到 1 年底。A 组和 B 组之间在这些神经学参数方面没有统计学上的显着差异（运动：p = 0.15，感觉：p = 0.39，SCIM3：p = 0.68，NRS：p = 0.06）。