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Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data

Results of the second National Acute Spinal Cord Injury Study

Michael B. Bracken, Mary Jo Shepard, William F. Collins Jr., Theodore R. Holford, David S. Baskin, Howard M. Eisenberg, Eugene Flamm, Linda Leo-Summers, Joseph C. Maroon, Lawrence F. Marshall, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin C. Wagner Jr., James L. Wilberger, H. Richard Winn, and Wise Young

✓ The 1-year follow-up data of a multicenter randomized controlled trial of methylprednisolone (30 mg/kg bolus and 5.4 mg/kg/hr for 23 hours) or naloxone (5.4 mg/kg bolus and 4.0 mg/kg/hr for 23 hours) treatment for acute spinal cord injury are reported and compared with placebo results. In patients treated with methylprednisolone within 8 hours of injury, increased recovery of neurological function was seen at 6 weeks and at 6 months and continued to be observed 1 year after injury. For motor function, this difference was statistically significant (p = 0.030), and was found in patients with total sensory and motor loss in the emergency room (p = 0.019) and in those with some preservation of motor and sensory function (p = 0.024). Naloxone-treated patients did not show significantly greater recovery. Patients treated after 8 hours of injury recovered less motor function if receiving methylprednisolone (p = 0.08) or naloxone (p = 0.10) as compared with those given placebo. Complication and mortality rates were similar in either group of treated patients as compared with the placebo group. The authors conclude that treatment with the study dose of methylprednisolone is indicated for acute spinal cord trauma, but only if it can be started within 8 hours of injury.