A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: Results of the second national acute spinal cord injury study

New England Journal of Medicine

Volumn 322, Issue 20, 1990, Pages 1405-1411

  Bracken, Michael B ^a   Shepard, Mary jo ^a   Collins, William F ^a   Holford, Theodore R ^a   Young, Wise ^a   Baskin, David S ^a   Eisenberg, Howard M ^a   Flamm, Eugene ^a   Leo Summers, Linda ^a   Maroon, Joseph ^a   Marshall, Lawrence F ^a   Perot, Phanor L ^a   Piepmeier, Joseph ^a   Sonntag, Volker K H ^a   Wagner, Franklin C ^a   Wilberger, Jack E ^a   Winn, H Richard ^a  

^a collaborating centers of the National Acute Spinal Cord Injury Study ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHYLPREDNISOLONE; NALOXONE;

ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SPINAL CORD INJURY;

ACUTE DISEASE; ADOLESCENT; ADULT; COMPARATIVE STUDY; DOUBLE-BLIND METHOD; FEMALE; HUMAN; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAVENOUS; MALE; METHYLPREDNISOLONE; MIDDLE AGE; MOTOR ACTIVITY; MULTICENTER STUDIES; NALOXONE; RANDOMIZED CONTROLLED TRIALS; SENSATION; SPINAL CORD INJURIES; SUPPORT, U.S. GOV'T, P.H.S.; TIME FACTORS;

EID: 0025344617     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJM199005173222001     Document Type: Article

References (34)

1. Collins WF, Piepmeier J, Ogle E. The spinal cord injury problem — a review. Cent Nerv Syst Trauma 1986; 3: 317–31.
2. Ducker TB, Hamit HF. Experimental treatments of acute spinal cord injury. J Neurosurg 1969; 30: 693–7.
3. Bracken MB. Collins WF, Freeman DF, et al. Efficacy of methylprednisolone in acute spinal cord injury. JAMA 1984; 251: 45–52
4. Bracken MB, Shepard MJ, Hellenbrand KG, et al. Methylprednisolone and neurological function one year after spinal cord injury. J Neurosurg 1985; 63: 704–13.
5. Hall ED, Braughler JM. Glucocorticoid mechanisms in acute spinal cord injury: a review and therapeutic rationale. Surg Neurol 1982; 18: 320–7.
6. Braughler JM, Hall ED. Lactate and pyruvate metabolism in injured cat spinal cord before and after a single large intravenous dose of methylprednisolone. J Neurosurg 1983; 59: 256–61.
7. Faden AI, Jacobs TP, Holaday JW. Opiate antagonist improves neurologic recovery after spinal injury. Science 1981; 211: 493–4.
8. Faden AI, Jacobs TP, Mougey E, Holaday JW. Endorphins in experimental spinal injury: therapeutic effects of naloxone. Ann Neurol 1981; 10: 326–32.
9. Young W, Flamm ES, Demopoulos HB, Tomasula JJ, DeCrescito V. Effect of naloxone on posttraumatic ischemia in experimental spinal contusion. J Neurosurg 1981; 55: 209–19.
10. Flamm ES, Young W, Collins WF, Piepmeier J, Clifton GL, Fischer B. A phase 1 trial of naloxone treatment of acute spinal cord injury. J Neurosurg 1985; 63: 390–7.
11. Bracken MB, Webb SB Jr, Wagner FC. Classification of the severity of acute spinal cord injury: implications for management. Paraplegia 1978; 15: 319–26.
12. Efron B. The jackknife, the bootstrap and other resampling plans. Philadelphia: Society for Industrial and Applied Mathematics, 1982.
13. Efron B, Tibshirani R. Bootstrap methods for standard errors, confidence intervals, and other measures of statistical accuracy. Stat Sci 1986; 1: 54–77.
14. Bishop YMM, Fienberg SE, Holland PW. Discrete multivariate analysis: theory and practice. Cambridge, Mass.: MIT Press, 1975.
15. GLIM Working Party. The GLIM system release 3.77, generalised linear interactive modelling. Oxford: Numerical Algorithms Group, 1985.
16. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457–81.
17. Kalbfleisch JD, Prentice LC. The statistical analysis of failure time data. New York: John Wiley, 1980.
18. SAS Institute Inc. SAS/STAT™ guide for personal computers, version 6 edition. Cary, N.C.: SAS Institute, 1987.
19. Bracken MB, Freeman DH Jr, Hellenbrand K. Incidence of acute traumatic hospitalized spinal cord injury in the United States, 1970–77. Am J Epidemiol 1981; 113: 615–22.
20. Wallace MC, Tator CH. Failure of blood transfusion or naloxone to improve clinical recovery after experimental spinal cord injury. Neurosurgery 1986; 19: 489–94.
21. Black P, Markowitz RS, Keller S, Wachs K, Gillespie J, Finkelstein SD. Naloxone and experimental spinal cord injury. I. High dose administration in a static load compression model. Neurosurgery 1986; 19: 905–8.
22. Black. Naloxone and experimental spinal cord injury. II. Megadose treatment in a dynamic load injury model. Neurosurgery 1986; 19: 909–13.
23. Haghighi SS, Chehrazi B. Effect of naloxone in experimental acute spinal cord injury. Neurosurgery 1987; 20: 385–8
24. Young W, Flamm ES, Blight AR, Gruner JA, DeCrescito V. Pharmacological therapy of acute spinal cord injury: studies of high dose methylprednisolone and naloxone. Clin Neurosurg 1986; 34: 675–97
25. Hall ED, Wolf DL, Braughler JM. Effects of a single large dose of methylprednisolone sodium succinate on posttraumatic spinal cord ischemia: dose–response and time-action analysis. J Neurosurg 1984; 61: 124–30
26. Braughler JM, Hall ED, Means ED, Waters TR, Anderson DK. Evaluation of an intensive methylprednisolone sodium succinate dosing regimen in experimental spinal cord injury. J Neurosurg 1987; 67: 102–5.
27. Bracken MB, Hildreth N, Freeman DH Jr, Webb SB. Relationship between neurological and functional status after acute spinal cord injury: an epidemiological study. J Chronic Dis 1980; 33: 115–25.
28. Means ED, Anderson DK, Waters TR, Kalaf F. Effects of methylprednisolone in compression trauma to the feline spinal cord. J Neurosurg 1981; 55: 200–8.
29. Anderson DK, Means ED, Waters TR, Green ES. Microvascular perfusion and metabolism in injured spinal cord after methylprednisolone treatment. J Neurosurg 1983; 56: 106–13
30. Anderson DK, Saunders RD, Demediuk P, et al. Lipid hydrolysis and peroxidation in injured spinal cord: partial protection with methylprednisolone or vitamin E and selenium. Cent Nerv System Trauma 1985; 2: 257–67.
31. Braughler JM, Hall ED. Correlation of methylprednisolone levels in cat spinal cord with its effects on (Na+ + K+)-ATPase, lipid peroxidation, and alpha motor neuron function. J Neurosurg 1983; 56: 838–44.
32. Braughler. Effects of multi-dose methylprednisolone sodium succinate administration on injured cat spinal cord neurofilament degradation and energy metabolism. J Neurosurg 1984; 61: 290–5.
33. Young W, Flamm ES. Effect of high-dose corticosteroid therapy on blood flow, evoked potentials, and extracellular calcium in experimental spinal injury. J Neurosurg 1982; 57: 667–73.
34. Young W. Blood flow, metabolic and neurophysiological mechanisms in spinal cord injury. In: Becker D, Povlishock JT, eds. Central nervous system trauma status report, 1985. Rockville, Md.: National Institutes of Health, 1985:463–73.