Fehlings Michael G, Tetreault Lindsay A, Hachem Laureen, Evaniew Nathan, Ganau Mario, McKenna Stephen L, Neal Chris J, Nagoshi Narihito, Rahimi-Movaghar Vafa, Aarabi Bizhan, Hofstetter Christoph P, Wengel Valerie Ter, Nakashima Hiroaki, Martin Allan R, Kirshblum Steven, Rodrigues Pinto Ricardo, Marco Rex A W, Wilson Jefferson R, Kahn David E, Newcombe Virginia F J, Zipser Carl M, Douglas Sam, Kurpad Shekar N, Lu Yi, Saigal Rajiv, Samadani Uzma, Arnold Paul M, Hawryluk Gregory W J, Skelly Andrea C, Kwon Brian K
Department of Surgery, Division of Neurosurgery and Spine Program, University of Toronto, Toronto, ON, Canada.
Division of Neurosurgery, Krembil Neuroscience Centre, Toronto Western Hospital, University Health Network, Toronto, ON, Canada.
Global Spine J. 2024 Mar;14(3_suppl):174S-186S. doi: 10.1177/21925682231181883.
Clinical practice guideline development.
Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI).
A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool.
The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence.
It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.
临床实践指南制定。
急性脊髓损伤(SCI)可导致严重的运动、感觉和自主神经功能障碍;丧失独立性;以及生活质量下降。临床前证据表明,脊髓早期减压可能有助于限制继发性损伤,减少神经组织损伤,并改善功能结局。新出现的证据表明,在损伤后24小时内完成的“早期”手术减压也可改善急性SCI患者的神经功能恢复。本临床实践指南(CPG)的目的是更新2017年关于手术减压时机的建议,并评估关于超早期手术(特别是但不限于急性SCI后<12小时)的证据。
组建了一个多学科的国际指南制定小组(GDG),成员包括脊柱外科医生、神经科医生、重症监护专家、急诊医生、物理医学与康复专业人员以及脊髓损伤患者。根据公认的方法标准进行系统评价,以评估早期(急性SCI后24小时内)或超早期(特别是但不限于急性SCI后12小时内)手术对神经功能恢复、功能结局、管理结局、安全性和成本效益的影响。采用GRADE方法对每项主要结局的各项研究证据的总体强度进行评级。然后,使用“证据到推荐”框架,在考虑利弊平衡、财务影响、患者价值观、可接受性和可行性的基础上制定建议。该指南使用《研究与评价指南评估》(AGREE)II工具进行内部评估。
GDG建议,对于成年急性SCI患者,无论损伤节段如何,早期手术(损伤后≤24小时)应作为首选方案。该建议基于中等强度的证据,表明与24小时后减压的患者相比,在24小时内减压的患者在6个月时(相对危险度:2.76,95%置信区间1.60至4.98)和12个月时(相对危险度:1.95,95%置信区间1.26至3.18)恢复≥2个美国脊髓损伤协会损伤分级(AIS)级别的可能性高出2倍。此外,与损伤后24小时后接受手术的患者相比,接受早期手术的患者在亚洲脊髓损伤运动评分上额外提高了4.50(95% 1.70至7.29)分。GDG还一致认为,由于样本量小、文献中超早期的定义不统一以及证据的不一致性,目前的证据无法支持超早期手术的建议。
建议急性SCI患者在医学上可行的情况下,在损伤后24小时内接受手术。未来需要进行研究,以确定早期手术在不同亚组中的差异有效性以及超早期手术对神经功能恢复的影响。此外,还需要进一步开展工作,以明确有效的脊髓减压的构成要素并实现个体化护理。还认识到需要国际社会共同努力,将这些建议转化为政策。