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73例胸段及胸腰段脊髓损伤早期与晚期手术减压的随机对照试验

A Randomized Controlled Trial of Early versus Late Surgical Decompression for Thoracic and Thoracolumbar Spinal Cord Injury in 73 Patients.

作者信息

Haghnegahdar Ali, Behjat Reza, Saadat Soheil, Badhiwala Jetan, Farrokhi Majid Reza, Niakan Amin, Eghbal Keyvan, Barzideh Ehsan, Shahlaee Abtin, Ghaffarpasand Fariborz, Ghodsi Zahra, Vaccaro Alexander R, Sadeghi-Naini Mohsen, Fehlings Michael G, Guest James David, Derakhshan Pegah, Rahimi-Movaghar Vafa

机构信息

Department of Neurosurgery, Shiraz University of Medical Sciences, Trauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Shiraz, Iran.

Department of Emergency Medicine, University of California, Irvine, Irvine, California, USA.

出版信息

Neurotrauma Rep. 2020 Sep 18;1(1):78-87. doi: 10.1089/neur.2020.0027. eCollection 2020.

Abstract

Convincing clinical evidence exists to support early surgical decompression in the setting of cervical spinal cord injury (SCI). However, clinical evidence on the effect of early surgery in patients with thoracic and thoracolumbar (from T1 to L1 [T1-L1]) SCI is lacking and a critical knowledge gap remains. This randomized controlled trial (RCT) sought to evaluate the safety and efficacy of early (<24 h) compared with late (24-72 h) decompressive surgery after T1-L1 SCI. From 2010 to 2018, patients (≥16 years of age) with acute T1-L1 SCI presenting to a single trauma center were randomized to receive either early (<24 h) or late (24-72 h) surgical decompression. The primary outcome was an ordinal change in American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade at 12-month follow-up. Secondary outcomes included complications and change in ASIA motor score (AMS) at 12 months. Outcome assessors were blinded to treatment assignment. Of 73 individuals whose treatment followed the study protocol, 37 received early surgery and 36 underwent late surgery. The mean age was 29.74 ± 11.4 years. In the early group 45.9% of patients and in the late group 33.3% of patients had a ≥1-grade improvement in AIS (odds ratio [OR] 1.70, 95% confidence interval [CI]: 0.66-4.39,  = 0.271); significantly more patients in the early (24.3%) than late (5.6%) surgery group had a ≥2-grade improvement in AIS (OR 5.46, 95% CI: 1.09-27.38,  = 0.025). There was no statistically significant difference in the secondary outcome measures. Surgical decompression within 24 h of acute traumatic T1-L1 SCI is safe and is associated with improved neurological outcome, defined as at least a 2-grade improvement in AIS at 12 months.

摘要

有令人信服的临床证据支持对颈椎脊髓损伤(SCI)患者进行早期手术减压。然而,关于早期手术对胸段和胸腰段(从T1至L1 [T1-L1])SCI患者影响的临床证据不足,关键的知识空白仍然存在。这项随机对照试验(RCT)旨在评估T1-L1 SCI后早期(<24小时)与晚期(24-72小时)减压手术的安全性和有效性。2010年至2018年,在单一创伤中心就诊的急性T1-L1 SCI患者(≥16岁)被随机分为接受早期(<24小时)或晚期(24-72小时)手术减压。主要结局是在12个月随访时美国脊髓损伤协会(ASIA)损伤量表(AIS)等级的序贯变化。次要结局包括并发症以及12个月时ASIA运动评分(AMS)的变化。结局评估者对治疗分配情况不知情。在73名遵循研究方案接受治疗的个体中,37人接受了早期手术,36人接受了晚期手术。平均年龄为29.74±11.4岁。早期组45.9%的患者和晚期组33.3%的患者AIS改善≥1级(优势比[OR] 1.70,95%置信区间[CI]:0.66-4.39,P = 0.271);早期手术组(24.3%)AIS改善≥2级的患者显著多于晚期手术组(5.6%)(OR 5.46,95% CI:1.09-27.38,P = 0.025)。次要结局指标无统计学显著差异。急性创伤性T1-L1 SCI后24小时内进行手术减压是安全的,并且与神经功能改善相关,定义为12个月时AIS至少改善2级。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/411e/8240887/a9e6fe44b81b/neur.2020.0027_figure1.jpg

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