Methylprednisolone or tirilazad mesylate administration after acute spinalcord injury: 1-year follow up - Results of the third National Acute SpinalCord Injury randomized controlled trial
Mb. Bracken et al., Methylprednisolone or tirilazad mesylate administration after acute spinalcord injury: 1-year follow up - Results of the third National Acute SpinalCord Injury randomized controlled trial, J NEUROSURG, 89(5), 1998, pp. 699-706
Object. A randomized double-blind clinical trial was conducted to compare n
eurological and functional recovery and morbidity and mortality rates 1 yea
r 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 g
roups. Patients for whom treatment was delayed more than 3 hours experience
d diminished motor function recovery in the 24MP group, but those in the 48
MP group showed greater I-year motor recovery (recovery scores of 13.7 and
19, respectively, p = 0.053). A greater percentage of patients improving th
ree or more neurological grades was also observed in the 48MP group (p = 0.
073). In general, patients treated with 48TM recovered equally when compare
d 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 unle
ss there are complicating medical factors.