Early complications of high-dose methylprednisolone sodium succinate treatment in the follow-up of acute cervical spinal cord injury.
METHODS
A prospective, randomized, and double-blind study comparing high-dose methylprednisolone sodium succinate (MPSS) with placebo, in the treatment of patients with acute cervical spinal cord injury.


OBJECTIVE
To evaluate the complications of high-dose MPSS in patients with acute cervical spinal cord injury when administered within 8 hours of injury.


BACKGROUND
High-dose therapy with MPSS has been demonstrated to improve the recovery of motor function in patients with acute cervical spinal cord injury. However, little is known about the follow-up complications.


METHODS
Forty-six patients, 42 men and 4 women (mean age, 60.6 years; range, 18-84), were included in the study: 23 in the MPSS group and 23 in the placebo group. They were treated without surgery for spinal cord injury in the cervical spine, and were enrolled in the trial if a diagnosis had been made and treatment had begun within 8 hours. Complications of high-dose therapy with MPSS were compared with placebo treatment throughout the study period and up to 2 months after injury.


RESULTS
The MPSS group had 13 patients (56.5%) with complications, whereas the placebo group had 8 (34.8%). The difference between the two groups was not statistically significant (P = 0.139). There were eight instances of pulmonary complication with MPSS (34.8%) and one instance (4.34%) with placebo (P = 0.009). There were four instances of gastrointestinal complication (17.4%) with MPSS and none with placebo (P = 0.036). Pulmonary (complications were more prevalent in patients aged more than 60 years (P = 0.029).


CONCLUSIONS
Aged patients with cervical spinal injury may be more likely to have pulmonary side effects (P = 0.029) after high-dose therapy with MPSS and thus deserve special care.
Department of Orthopaedic Surgery, Wakayama Medical College, Wakayama City, Wakayama, Japan. tmatsumo@rush.edu
T
T
Matsumoto
T
T
Tamaki
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Kawakami
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M
Yoshida
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M
Ando
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Yamada
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002574:Cervical Vertebrae / Q000293:injuries*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000503:physiopathology; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced / Q000503:physiopathology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects*; D008875:Middle Aged; D011446:Prospective Studies; D012737:Sex Factors; D013116:Spinal Cord / Q000187:drug effects* / Q000473:pathology / Q000503:physiopathology; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D013997:Time Factors
D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone