PDF(Pubmed)
Abstract：
METHODS: Clinical practice guideline development.
OBJECTIVE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
方法：制定临床实践指南。
目的：急性脊髓损伤（SCI）可导致破坏性运动，感官,自主神经损伤；丧失独立性；生活质量下降。临床前证据表明，早期脊髓减压可能有助于限制继发性损伤，减少对神经组织的损伤，并改善功能结果。新的证据表明，在受伤后24小时内完成的“早期”手术减压也可以改善急性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年有关手术减压时机的建议，并评估有关超早期手术的证据（特别是，但不限于,急性SCI后<12小时)。
方法：多学科，国际,指南开发小组（GDG）成立，由脊柱外科医生组成，神经学家,重症监护专家,急诊医生,物理医学和康复专业人员，以及患有SCI的个人。根据公认的方法学标准进行了系统评价，以评估早期（急性SCI24小时内）或超早期（特别是，但不限于,在急性SCI）手术后12小时内进行神经系统恢复，功能结果，行政成果,安全,和成本效益。GRADE方法用于对每个主要结局的研究中的总体证据强度进行评分。使用“证据到建议”框架，然后提出了考虑利弊平衡的建议，财务影响，患者价值观,可接受性,和可行性。该指南是使用评估指南研究和评估（AGREE）II工具进行内部评估的。
结果：GDG建议将早期手术（伤后≤24小时）作为成年急性SCI患者的首选选择，无论其水平如何。该建议基于中度证据，表明患者在6个月（RR：2.76，95％CI1.60至4.98）和12个月（RR：1.95，95％CI1.26至3.18）时恢复≥2ASIA损伤评分（AIS）评分的可能性是24小时后的2倍。此外，与受伤后24小时接受手术的患者相比,接受早期手术的患者的ASIA运动评分提高了4.50分(95%,1.70~7.29分).GDG还同意，由于样本量较小，因此无法根据当前证据提出超早期手术的建议，在文献中构成超早的变量定义，以及证据的不一致.
结论：建议急性SCI患者，无论水平如何，在医学上可行的情况下，在受伤后24小时内接受手术。未来的研究需要确定早期手术在不同亚群中的不同有效性以及超早期手术对神经系统恢复的影响。此外，需要进一步的工作来定义什么是有效的脊髓减压和个性化护理。人们还认识到，需要采取协调一致的国际努力将这些建议转化为政策。
目的：急性脊髓损伤（SCI）可导致破坏性运动，感官,自主神经损伤；丧失独立性；生活质量下降。临床前证据表明，早期脊髓减压可能有助于限制继发性损伤，减少对神经组织的损伤，并改善功能结果。新的证据表明，在受伤后24小时内完成的“早期”手术减压也可以改善急性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年有关手术减压时机的建议，并评估有关超早期手术的证据（特别是，但不限于,急性SCI后<12小时)。
方法：多学科，国际,指南开发小组（GDG）成立，由脊柱外科医生组成，神经学家,重症监护专家,急诊医生,物理医学和康复专业人员，以及患有SCI的个人。根据公认的方法学标准进行了系统评价，以评估早期（急性SCI24小时内）或超早期（特别是，但不限于,在急性SCI）手术后12小时内进行神经系统恢复，功能结果，行政成果,安全,和成本效益。GRADE方法用于对每个主要结局的研究中的总体证据强度进行评分。使用“证据到建议”框架，然后提出了考虑利弊平衡的建议，财务影响，患者价值观,可接受性,和可行性。该指南是使用评估指南研究和评估（AGREE）II工具进行内部评估的。
结果：GDG建议将早期手术（伤后≤24小时）作为成年急性SCI患者的首选选择，无论其水平如何。该建议基于中度证据，表明患者在6个月（RR：2.76，95％CI1.60至4.98）和12个月（RR：1.95，95％CI1.26至3.18）时恢复≥2ASIA损伤评分（AIS）评分的可能性是24小时后的2倍。此外，与受伤后24小时接受手术的患者相比,接受早期手术的患者的ASIA运动评分提高了4.50分(95%,1.70~7.29分).GDG还同意，由于样本量较小，因此无法根据当前证据提出超早期手术的建议，在文献中构成超早的变量定义，以及证据的不一致.
结论：建议急性SCI患者，无论水平如何，在医学上可行的情况下，在受伤后24小时内接受手术。未来的研究需要确定早期手术在不同亚群中的不同有效性以及超早期手术对神经系统恢复的影响。此外，需要进一步的工作来定义什么是有效的脊髓减压和个性化护理。人们还认识到，需要采取协调一致的国际努力将这些建议转化为政策。
