Clinical measurement, statistical analysis, and risk-benefit: Controversies from trials of spinal injury

被引：20

作者：

Bracken, MB

Aldrich, EF

Herr, DL

Hitchon, PW

Holford, TR

Marshall, LF

Nockels, RP

Pascale, V

Shepard, MJ

Sonntag, VKH

Winn, HR

Young, W

机构：

[1] Yale Univ, Sch Med, Dept Epidemiol, New Haven, CT 06520 USA

[2] Yale Univ, Sch Med, Dept Biostat, New Haven, CT 06520 USA

[3] Yale Univ, Sch Med, Dept Neurol, New Haven, CT 06520 USA

[4] Univ Maryland, Dept Emergency Med, Baltimore, MD 21201 USA

[5] Univ Maryland, Dept Neurosurg, Baltimore, MD 21201 USA

[6] Washington Hosp Ctr, Washington, DC 20010 USA

[7] Univ Iowa Hosp & Clin, Iowa City, IA 52242 USA

[8] Univ Calif San Diego, San Diego, CA 92103 USA

[9] Loyola Univ, Med Ctr, Maywood, IL 60153 USA

[10] Barrow Neurol Inst, Phoenix, AZ 85013 USA

[11] Univ Washington, Harborview Med Ctr, Seattle, WA 98104 USA

[12] NYU, Bellevue Med Ctr, New York, NY USA

来源：

JOURNAL OF TRAUMA-INJURY INFECTION AND CRITICAL CARE | 2000年 / 48卷 / 03期

关键词：

acute spinal cord injury; evidence based medicine; methylprednisolone; randomized trial;

D O I：

10.1097/00005373-200003000-00036

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

Background: The National Acute Spinal Cord Injury Studies have been a series of trials assessing the role of pharmacologic agents in the prevention of secondary neuronal damage after acute spinal cord injury, Methods: The trials were multicenter randomized, controlled studies, Results: Two trials have demonstrated the efficacy of high-dose methylprednisolone in improving neurologic and functional recovery and have shown a reassuring safety profile, Conclusion: This study responds to a recent commentary on these trials and examines in particular the roles of clinical measurement, statistical analysis, and risk benefit in assembling evidence for or against innovative therapies.

引用

页码：558 / 561

页数：4

共 25 条

[1]

*AM SPIN INJ ASS, 1992, STAND NEUR FUNCT CLA

[2] A new mechanism of methylprednisolone and other corticosteroids action demonstrated in vitro: Inhibition of a proteinase (calpain) prevents myelin and cytoskeletal protein degradation [J].

Banik, NL ;

Matzelle, D ;

Terry, E ;

Hogan, EL .

BRAIN RESEARCH, 1997, 748 (1-2) :205-210

[3] CORTICOSTEROID TREATMENT OF OPTIC NEURITIS - A NEED TO CHANGE TREATMENT PRACTICES [J].

BECK, RW .

NEUROLOGY, 1992, 42 (06) :1133-1135

[4] EFFICACY OF METHYLPREDNISOLONE IN ACUTE SPINAL-CORD INJURY [J].

BRACKEN, MB ;

COLLINS, WF ;

FREEMAN, DF ;

SHEPARD, MJ ;

WAGNER, FW ;

SILTEN, RM ;

HELLENBRAND, KG ;

RANSOHOFF, J ;

HUNT, WE ;

PEROT, PL ;

GROSSMAN, RG ;

GREEN, BA ;

EISENBERG, HM ;

RIFKINSON, N ;

GOODMAN, JH ;

MEAGHER, JN ;

FISCHER, B ;

CLIFTON, GL ;

FLAMM, ES ;

RAWE, SE .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1984, 251 (01) :45-52

[5] 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

[6] 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

[7] 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

[8] 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

[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, 1999, PHARM TREATMENT ACUT

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