title: Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the third National Acute Spinal Cord Injury randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut 06520-8034, USA.
authors.forename: M B
authors.initials: MB
authors.lastname: Bracken
authors.forename: M J
authors.initials: MJ
authors.lastname: Shepard
authors.forename: T R
authors.initials: TR
authors.lastname: Holford
authors.forename: L
authors.initials: L
authors.lastname: Leo-Summers
authors.forename: E F
authors.initials: EF
authors.lastname: Aldrich
authors.forename: M
authors.initials: M
authors.lastname: Fazl
authors.forename: M G
authors.initials: MG
authors.lastname: Fehlings
authors.forename: D L
authors.initials: DL
authors.lastname: Herr
authors.forename: P W
authors.initials: PW
authors.lastname: Hitchon
authors.forename: L F
authors.initials: LF
authors.lastname: Marshall
authors.forename: R P
authors.initials: RP
authors.lastname: Nockels
authors.forename: V
authors.initials: V
authors.lastname: Pascale
authors.forename: P L
authors.initials: PL
authors.lastname: Perot
authors.forename: J
authors.initials: J
authors.lastname: Piepmeier
authors.forename: V K
authors.initials: VK
authors.lastname: Sonntag
authors.forename: F
authors.initials: F
authors.lastname: Wagner
authors.forename: J E
authors.initials: JE
authors.lastname: Wilberger
authors.forename: H R
authors.initials: HR
authors.lastname: Winn
authors.forename: W
authors.initials: W
authors.lastname: Young
mesh_terms: D000203:Activities of Daily Living; D000208:Acute Disease; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009420:Nervous System / Q000503:physiopathology; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011281:Pregnatrienes / Q000009:adverse effects / Q000627:therapeutic use*; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
chemical_list: D018696:Neuroprotective Agents; D011281:Pregnatrienes; D008775:Methylprednisolone; C053355:tirilazad