International Collaboration On Repair Discoveries (ICORD), University of British Columbia, and Vancouver Coastal Health, Vancouver, BC, Canada.
Neurorehabil Neural Repair. 2012 Nov-Dec;26(9):1064-71. doi: 10.1177/1545968312447306. Epub 2012 May 30.
For therapeutics directed to the injured spinal cord, a change in neurological impairment has been proposed as a relevant acute clinical study end point. However, changes in neurological function, even if statistically significant, may not be associated with a functional impact, such as a meaningful improvement in items within the self-care subscore of the Spinal Cord Independence Measure (SCIM).
The authors examined the functional significance associated with spontaneously recovering upper-extremity motor function after sensorimotor-complete cervical spinal cord injury (SCI).
Using the European Multi-center Study about Spinal Cord Injury (EMSCI) data set, a retrospective analysis was undertaken of individuals with cervical sensorimotor-complete SCI (initial motor level, C4-C7). Specifically, changes in upper-extremity motor score (UEMS), motor level, and SCIM (total and self-care subscore) were assessed between approximately 1 and 48 weeks after injury (n = 74).
The initial motor level did not significantly influence the total UEMS recovered or number of motor levels recovered. SCIM self-care subscore recovery was significantly greater for those individuals regaining 2 motor levels compared with those recovering only 1 or no motor levels. However, the recovery in the SCIM self-care subscore was not significantly different between individuals recovering only 1 motor level and those individuals who showed no motor-level improvement.
A 2 motor-level improvement indicates a clinically meaningful change and might be considered a primary outcome in acute and subacute interventional trials enrolling individuals with cervical sensorimotor-complete SCI.
对于针对受损脊髓的治疗方法,已经提出了神经功能损伤的变化作为相关的急性临床研究终点。然而,神经功能的变化,即使具有统计学意义,也可能与功能影响无关,例如在脊髓独立性测量(SCIM)的自我护理子评分内的项目有意义的改善。
作者检查了与颈脊髓完全损伤(SCI)后上肢运动功能自发恢复相关的功能意义。
使用欧洲多中心脊髓损伤研究(EMSCI)数据集,对颈感觉运动完全 SCI(初始运动水平,C4-C7)的个体进行了回顾性分析。具体而言,在受伤后约 1 至 48 周之间评估了上肢运动评分(UEMS)、运动水平和 SCIM(总分和自我护理子评分)的变化(n = 74)。
初始运动水平对总 UEMS 的恢复或恢复的运动水平没有显著影响。与仅恢复 1 个或没有运动水平的患者相比,恢复 2 个运动水平的患者的 SCIM 自我护理子评分恢复显著更大。然而,在仅恢复 1 个运动水平的患者和没有运动水平改善的患者之间,SCIM 自我护理子评分的恢复没有显著差异。
2 个运动水平的改善表明有临床意义的变化,并且可能被认为是招募颈感觉运动完全 SCI 患者的急性和亚急性干预试验的主要结局。