Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up

Abstract

<jats:sec> <jats:title>Object</jats:title> <jats:p>A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen.</jats:p></jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater 1-year motor recovery (recovery scores of 13.7 and 19, respectively, p = 0.053).A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p = 0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups.</jats:p></jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.</jats:p></jats:sec>

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

“…Three large, double-blind, placebocontrolled pharmaceutical trials focussed on acute neuroprotection and rehabilitation in SCI are reported in the literature; the National Acute Spinal Cord Injury Study (NASCIS), Sygen and GK-11 trials. [2][3][4][5][6][7][8] The data from the placebo-control groups in these studies allow the natural history of recovery from injury to be examined within the context of a randomized controlled trial (RCT). In addition, there have been a number of studies of long-term outcomes after SCI that provide valuable information on expected recovery rates, [10][11][12] as well as some recently unpublished data from the European Multicenter study in Spinal Cord Injury (EMSCI).…”

“…Patients were examined on admission to hospital emergency room, mostly within 12 h after injury, and an average time from injury to treatment of 8.9 h. In this second study, 2,3 487 patients were enrolled, of whom 171 were in the placebo group, and outcomes measured at 6 weeks, 6 months and 1 year. The third NASCIS study 4,5 did not have a placebo-control group, because following its apparent efficacy in the NASCIS II study it was considered that to deny some form of methylprednisolone treatment would be unethical. 2.…”

Traumatic cervical instability associated with cord oedema and temporary quadriparesis

“…15 As long as there is neither compression of the cord nor fracture or instability of the spine, application of high-dose methylprednisolone currently is the only treatment option in case of post-traumatic cord oedema, even though the success of steroid therapy for this indication remains moderate. 7,26 Neurocompression is an indication for operation; however, overt instability of the cervical spine because of discoligamentous injury alone also requires surgery in order to prevent continued damage to the cord. 12 In such conditions, we prefer an anterolateral approach with decompression of the thecal sac by removal of the disrupted disc and the rolled-up parts of the posterior ligament.…”

Setting the stage for functional repair of spinal cord injuries: a cast of thousands

“…The two most widely discussed are the National Acute Spinal Cord Injury Study (NASCIS) trial of high-dose systemic methylprednisolone (MP) 3 and the Sygen s trial of GM-1 gangliosides. 4 GM-1 gangliosides appeared to enhance the rate of recovery from SCI, but did not significantly improve the ultimate functional outcome, whereas MP was reported to improve functional outcome when administered within 8 h of SCI.…”