Spine
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Meta Analysis
Methylprednisolone and acute spinal cord injury: an update of the randomized evidence.
Randomized trials are widely recognized as providing the most reliable evidence for assessing efficacy and safety of therapeutic interventions. This evidence base is used to evaluate the current status of methylprednisolone (MPSS) in the early treatment of acute spinal cord injury. ⋯ High-dose MPSS given within 8 hours of acute spinal cord injury is a safe and modestly effective therapy that may result in important clinical recovery for some patients. Further trials are needed to identify superior pharmacologic therapies and to test drugs that may sequentially influence the postinjury cascade.
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Advances in transport, imaging, and stabilization of the injured patient have made the topic of acute management more important than ever in patients with spinal cord injury. Optimal treatment requires prompt delivery of care for life-threatening respiratory and hemodynamic events in a manner that will not further damage the unstable spinal elements. The application of these treatment principles broadly to injured patients is necessitated by our inability to determine, on an acute basis, those patients who might eventually recover meaningful neurologic function from those who will not. ⋯ The second includes the application of resuscitative measures without further damaging the spinal cord and, in some cases, the use of traction and immobilization. In the past these efforts were aimed primarily at increasing the survival rate of patients with spinal cord injury, whereas current care may also play an important role in the eventual recovery of neurologic function. Despite many advances in our understanding of the basic mechanisms of paralysis, clinical management of spinal cord injury remains a significant challenge and one that requires continuing efforts at improving acute and postacute therapies.
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The management of acute spinal cord injury has traditionally concentrated on preventative measures as well as, for the better part of the previous century, conservative care. Pharmacologic interventions, in particular intravenous methylprednisolone therapy, have shown modest improvements in clinical trials and are still undergoing evaluation. More recent interest has focused on the role of surgical reduction and decompression, particularly "early" surgery. ⋯ Whereas there is biologic evidence from experimental studies in animals that early decompression may improve neurologic recovery after SCI, the relevant time frame in humans remains unclear. To date, the role of decompression in patients with SCI is only supported by Class III and limited Class II evidence and accordingly can be considered only a practice option. Accordingly, there is a strong rationale to undertake prospective, controlled trials to evaluate the role and timing of decompression in acute SCI.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The Sygen multicenter acute spinal cord injury study.
Randomized, double-blind, sequential, multicenter clinical trial of two doses of Sygen versus placebo. ⋯ Although not proven in the primary efficacy analysis of this trial, Sygen appears to be beneficial in patients with severe spinal cord injury.
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Multicenter Study
Recruitment and early treatment in a multicenter study of acute spinal cord injury.
Post hoc secondary analysis of data from 1992 to 1998 in the trial of Sygen in Acute Spinal Cord Injury. ⋯ The imbalances in favor of cervical and of complete injuries would make it hard for studies to attain results for SCI in general. The vital signs and time patterns suggest local protocol-driven stabilization to prevent secondary physiologic injury early after SCI. Some features of care vary among centers, but the sparseness of prospective data in specific injury and treatment categories suggests that treatment guidelines have limited empirical support and should be made cautiously.