Steroids for acute spinal cord injury

被引:246
作者
Bracken, Michael B. [1 ]
机构
[1] Yale Univ, Sch Med, Dept Epidemiol & Publ Hlth, New Haven, CT 06520 USA
来源
COCHRANE DATABASE OF SYSTEMATIC REVIEWS | 2012年 / 01期
关键词
RANDOMIZED CONTROLLED-TRIAL; FOLLOW-UP; PHARMACOLOGICAL TREATMENT; NEUROLOGICAL FUNCTION; TIRILAZAD MESYLATE; METHYLPREDNISOLONE; NALOXONE; NASCIS-2;
D O I
10.1002/14651858.CD001046.pub2
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Background Acute spinal cord injury is a devastating condition typically affecting young people, mostly males. Steroid treatment in the early hours after the injury is aimed at reducing the extent of permanent paralysis during the rest of the patient's life. Objectives To review randomized trials of steroids for human acute spinal cord injury. S e a r c h m e t h o d s We searched the Cochrane Injuries Group Specialised Register (searched 02 Aug 2011), The Cochrane Central Register of Controlled Trials 2011, issue 3 (The Cochrane Library), MEDLINE (Ovid) 1948 to July Week 3 2011, EMBASE (Ovid) 1974 to 2011 week 17, ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) 1970 to Aug 2011, ISI Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) 1990 to Aug 2011 and PubMed [www.ncbi.nlm.nih.gov/sites/entrez/] (searched 04 Aug 2011) for records added to PubMed in the last 90 days). Files of the National Acute Spinal Cord Injury Study (NASCIS) were reviewed (NASCIS was founded in 1977 and has tracked trials in this area since that date). We also searched the reference lists of relevant studies and previously published reviews. Selection criteria All randomized controlled trials of steroid treatment for acute spinal cord injury in any language. Data collection and analysis One review author extracted data from trial reports. Japanese and French studies were found through NASCIS and additional data (e. g. SDs) were obtained from the original study authors. Main results Eight trials are included in this review, seven usedmethylprednisolone. Methylprednisolone sodiumsuccinate has been shown to improve neurologic outcome up to one year post-injury if administered within eight hours of injury and in a dose regimen of: bolus 30mg/kg over 15 minutes, with maintenance infusion of 5.4 mg/kg per hour infused for 23 hours. The initial North American trial results were replicated in a Japanese trial but not in the one from France. Data was obtained from the latter studies to permit appropriate metaanalysis of all three trials. This indicated significant recovery in motor function after methylprednisolone therapy, when administration commenced within eight hours of injury. A more recent trial indicates that, if methylprednisolone therapy is given for an additional 24 hours (a total of 48 hours), additional improvement inmotor neurologic function and functional status are observed. This is particularly observed if treatment cannot be started until between three to eight hours after injury. The same methylprednisolone therapy has been found effective in whiplash injuries. A modified regimen was found to improve recovery after surgery for lumbar disc disease. The risk of bias was low in the largest methyprednisolne trials. Overall, there was no evidence of significantly increased complications or mortality from the 23 or 48 hour therapy. Author's conclusions High-dose methylprednisolone steroid therapy is the only pharmacologic therapy shown to have efficacy in a phase three randomized trial when administered within eight hours of injury. One trial indicates additional benefit by extending the maintenance dose from 24 to 48 hours, if start of treatment must be delayed to between three and eight hours after injury. There is an urgent need for more randomized trials of pharmacologic therapy for acute spinal cord injury.
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相关论文
共 29 条
[1]
Berkowitz M., 1992, EC CONSEQUENCES TRAU
[2]
METHYLPREDNISOLONE AND NEUROLOGICAL FUNCTION 1 YEAR AFTER SPINAL-CORD INJURY - RESULTS OF THE NATIONAL ACUTE SPINAL-CORD INJURY STUDY [J].
BRACKEN, MB ;
SHEPARD, MJ ;
HELLENBRAND, KG ;
COLLINS, WF ;
LEO, LS ;
FREEMAN, DF ;
WAGNER, FC ;
FLAMM, ES ;
EISENBERG, HM ;
GOODMAN, JH ;
PEROT, PL ;
GREEN, BA ;
GROSSMAN, RG ;
MEAGHER, JN ;
YOUNG, W ;
FISCHER, B ;
CLIFTON, GL ;
HUNT, WE ;
RIFKINSON, N .
JOURNAL OF NEUROSURGERY, 1985, 63 (05) :704-713
[3]
Methylprednisolone and acute spinal cord injury - An update of the randomized evidence [J].
Bracken, MB .
SPINE, 2001, 26 (24) :S47-S54
[4]
EFFECTS OF TIMING OF METHYLPREDNISOLONE OR NALOXONE ADMINISTRATION ON RECOVERY OF SEGMENTAL AND LONG-TRACT NEUROLOGICAL FUNCTION IN NASCIS-2 [J].
BRACKEN, MB ;
HOLFORD, TR .
JOURNAL OF NEUROSURGERY, 1993, 79 (04) :500-507
[5]
A RANDOMIZED, CONTROLLED TRIAL OF METHYLPREDNISOLONE OR NALOXONE IN THE TREATMENT OF ACUTE SPINAL-CORD INJURY - RESULTS OF THE 2ND NATIONAL ACUTE SPINAL-CORD INJURY STUDY [J].
BRACKEN, MB ;
SHEPARD, MJ ;
COLLINS, WF ;
HOLFORD, TR ;
YOUNG, W ;
BASKIN, DS ;
EISENBERG, HM ;
FLAMM, E ;
LEOSUMMERS, L ;
MAROON, J ;
MARSHALL, LF ;
PEROT, PL ;
PIEPMEIER, J ;
SONNTAG, VKH ;
WAGNER, FC ;
WILBERGER, JE ;
WINN, HR .
NEW ENGLAND JOURNAL OF MEDICINE, 1990, 322 (20) :1405-1411
[6]
Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up - Results of the third National Acute Spinal Cord Injury randomized controlled trial [J].
Bracken, MB ;
Shepard, MJ ;
Holford, TR ;
Leo-Summers, L ;
Aldrich, EF ;
Fazl, M ;
Fehlings, MG ;
Herr, DL ;
Hitchon, PW ;
Marshall, LF ;
Nockels, RP ;
Pascale, V ;
Perot, PL ;
Piepmeier, J ;
Sonntag, VKH ;
Wagner, F ;
Wilberger, JE ;
Winn, HR ;
Young, W .
JOURNAL OF NEUROSURGERY, 1998, 89 (05) :699-706
[7]
METHYLPREDNISOLONE OR NALOXONE TREATMENT AFTER ACUTE SPINAL-CORD INJURY - 1-YEAR FOLLOW-UP DATA - RESULTS OF THE 2ND NATIONAL ACUTE SPINAL-CORD INJURY STUDY [J].
BRACKEN, MB ;
SHEPARD, MJ ;
COLLINS, WF ;
HOLFORD, TR ;
BASKIN, DS ;
EISENBERG, HM ;
FLAMM, E ;
LEOSUMMERS, L ;
MAROON, JC ;
MARSHALL, LF ;
PEROT, PL ;
PIEPMEIER, J ;
SONNTAG, VKH ;
WAGNER, FC ;
WILBERGER, JL ;
WINN, HR ;
YOUNG, W .
JOURNAL OF NEUROSURGERY, 1992, 76 (01) :23-31
[8]
PHARMACOLOGICAL TREATMENT OF ACUTE SPINAL-CORD INJURY - CURRENT STATUS AND FUTURE-PROSPECTS [J].
BRACKEN, MB .
PARAPLEGIA, 1992, 30 (02) :102-107
[9]
Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury - Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial [J].
Bracken, MB ;
Shepard, MJ ;
Holford, TR ;
LeoSummers, L ;
Aldrich, EF ;
Fazl, M ;
Fehlings, M ;
Herr, DL ;
Hitchon, PW ;
Marshall, LF ;
Nockels, RP ;
Pascale, V ;
Perot, PL ;
Piepmeier, J ;
Sonntag, VKH ;
Wagner, F ;
Wilberger, JE ;
Winn, HR ;
Young, W .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1997, 277 (20) :1597-1604
[10]
Bracken MB, 1984, JAMA-J AM MED ASSOC, V251, P45