PHARMACOLOGICAL THERAPY OF SPINAL-CORD IN JURY AT THE ACUTE-PHASE

Objectives: To evaluate the effect on neurologic outcome and the safet y of nimodipine (N), methylprednisolone (M), or both (MN) versus no me dical treatment (P) in spinal cord injury at the acute phase. Study de sign: Prospective, randomized clinical trial. Patients: One hundred an d six patients with a spinal trauma, including 48 with paraplegia and 58 with tetraplegia. Method: After eligibility, patients were randomly allocated in one of the following groups: M = methylpredisolone 30 mg .kg(-1) over 1 hour, followed by 5.4 mg.kg(-1).h(-1) for 23 hours, N = nimodipine 0.015 mg.kg(-1).h(-1) over 2 hours followed by 0.03 mg.kg( -1).h(-1) for 7 days, MN or P. Neurologic assessment (ASIA score) was performed by a senior neurologist before treatment and at the I-year f ollow-up. Early spinal decompression and stabilization was performed a s soon as possible after injury. Results: One hundred patients were re assessed at the 1-year follow-up. Neurologic improvement was seen in e ach group (P < 0.0001), however no neurologic benefit from treatment w as observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients), within the first 8 hours did not influence the neurologic outcome. The only predictor of the la tter was the extent of the spinal injury (complete or incomplete lesio n). Conclusion: Currently, no evidence of the benefit of medical treat ment in this indication is existing. Because of the lack of clinical s tudies proving efficacy of pharmacological treatment in this specific pathology, a systematic use of medications cannot be recommended. (C) 1998 Elsevier, Paris.