Bracken M B
Department of Epidemiology and Public Health, Yale School of Medicine, 60 College street, Box 20834, New Haven, Connecticut, 06520-8034, USA.
Cochrane Database Syst Rev. 2002(3):CD001046. doi: 10.1002/14651858.CD001046.
Acute spinal cord injury is a devastating condition typically affecting young people with a preponderance being male. Steroid treatment in the early hours of the injury is aimed at reducing the extent of permanent paralysis during the rest of the patient's life.
To review randomized trials of steroids for acute spinal cord injury.
The review draws on the search strategy developed by the Cochrane Injuries Group. In addition, files of the National Acute Spinal Cord Injury Study have been reviewed and a Medline search conducted.
All published or unpublished randomized controlled trials of steroid treatment for acute spinal cord injury in any language.
Data have been abstracted from original trial reports. For the NASCIS, Japanese and French trials, additional data (e.g. SDs) have been obtained from the original authors.
There are few trials in this area of medical care. Only one steroid has been extensively studied, methylprednisolone sodium succinate, which has been shown to improve neurologic outcome up to one year post injury if administered within eight hours of injury and in a dose regimen of: bolus 30mg/kg administered over 15 minutes with a maintenance infusion of 5.4 mg/kg per hour infused for 23 hours. The initial North American trial was replicated in a Japanese trial but not in the one from France. Data has been obtained from the latter studies to permit appropriate meta-analysis of all three trials. This analysis indicates significant recovery in motor function after methylprednisolone therapy when administration commences within eight hours of injury. A more recent trial indicates that if methylprednisolone therapy is given for an additional 24 hours (for a total of 48 hours), additional improvement in motor neurologic function and functional status is observed. This is particularly observed if treatment cannot be started until between three to eight hours after injury. The same methylprednisolone therapy has been found effective in whiplash injuries and a modified regimen found to improve recovery after surgery for lumbar disc disease.
REVIEWER'S CONCLUSIONS: High dose methylprednisolone steroid therapy is the only pharmacological therapy shown to have efficacy in a Phase Three randomized trial when it can be administered within eight hours of injury. A recent trial indicates additional benefit by extending the maintenance dose from 24 to 48 hours if start of treatment must be delayed to between three and eight hours after injury. There is an urgent need for more randomized trials of pharmacological therapy for acute spinal cord injury.
急性脊髓损伤是一种严重的疾病，通常影响年轻人，男性更为多见。在损伤后的早期进行类固醇治疗旨在减少患者余生永久性瘫痪的程度。
综述类固醇治疗急性脊髓损伤的随机试验。
本综述采用了Cochrane损伤小组制定的检索策略。此外，还查阅了国家急性脊髓损伤研究的档案并进行了Medline检索。
所有已发表或未发表的、采用任何语言的类固醇治疗急性脊髓损伤的随机对照试验。
数据已从原始试验报告中提取。对于国家急性脊髓损伤研究（NASCIS）、日本和法国的试验，已从原始作者处获得了额外的数据（如标准差）。
该医疗领域的试验较少。仅有一种类固醇药物得到了广泛研究，即琥珀酸钠甲泼尼龙，研究表明，如果在损伤后8小时内给药，并采用以下剂量方案：15分钟内静脉推注30mg/kg，随后以每小时5.4mg/kg的速度持续输注23小时，那么在损伤后长达一年的时间里，患者的神经功能预后会得到改善。最初的北美试验在日本试验中得到了重复，但在法国试验中未得到重复。已从后两项研究中获取数据，以便对这三项试验进行适当的荟萃分析。该分析表明，在损伤后8小时内开始使用甲泼尼龙治疗，运动功能会有显著恢复。一项更近的试验表明，如果甲泼尼龙治疗再延长24小时（总共48小时），运动神经功能和功能状态会有进一步改善。如果直到损伤后3至8小时才开始治疗，这种情况尤其明显。已发现相同的甲泼尼龙治疗方案对挥鞭样损伤有效，并且发现一种改良方案可改善腰椎间盘疾病手术后的恢复情况。
高剂量甲泼尼龙类固醇治疗是唯一在三期随机试验中显示出疗效的药物治疗方法，前提是在损伤后8小时内给药。一项更近的试验表明，如果治疗开始时间必须推迟到损伤后3至8小时，将维持剂量从24小时延长至48小时会有额外益处。迫切需要更多关于急性脊髓损伤药物治疗的随机试验。
