Pharmacological therapy of spinal cord injury during the acute phase.
METHODS
Prospective, randomized clinical trial.


METHODS
France.


OBJECTIVE
To evaluate the safety and effect on neurological outcome of nimodipine, methylprednisolone, or both versus no medical treatment in spinal-cord injury during the acute phase.


METHODS
One hundred and six patients who had spinal trauma (including 48 with paraplegia and 58 with tetraplegia) were randomly separated into four groups: M=methylprednisolone (30 mg x kg(-1) over 1 h, followed by 5.4 mg x kg(-1) x h(-1) for 23 h), N=nimodipine (0.015 mg x kg(-1) x h(-1) for 2 h followed by 0.03 mg x kg(-1)h(-1) for 7 days), MN (both agents) or P (neither medication). Neurological assessment (ASIA score) was performed by a blinded senior neurologist before treatment and at 1-year follow-up. Early spinal decompression and stabilization was performed as soon as possible after injury.


RESULTS
One hundred patients were reassessed at 1 year. Neurological improvement was seen in each group (P<0.0001), however no additional neurological benefit from treatment was observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients underwent surgery within 8 h of their accident) did not influence the neurological outcome. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion).


CONCLUSIONS
The present study confirms the absence of benefit of pharmacological therapy in this indication. Because of the paucity of clinical studies that demonstrate the efficacy of pharmacological treatment in spinal injury during the acute phase, systematic use of pharmaceutical agents should be reconsidered.
Pointillart
V
V
Unité de Pathologie Rachidienne, Hôpital Pellegrin, Bordeaux, France.
Petitjean
M E
ME
Wiart
L
L
Vital
J M
JM
Lassié
P
P
Thicoipé
M
M
Dabadie
P
P
D000208:Acute Disease; D000328:Adult; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006801:Humans; D007239:Infections / Q000139:chemically induced; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D009460:Neurologic Examination; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D009553:Nimodipine / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000503:physiopathology; D017211:Treatment Failure
D002121:Calcium Channel Blockers; D018696:Neuroprotective Agents; D009553:Nimodipine; D008775:Methylprednisolone