Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

被引：122
|
作者：
Maas, AIR
Steyerberg, EW
Murray, GD
Bullock, R
Baethmann, A
Marshall, LF
Teasdale, GM
机构：
[1] Erasmus Univ, Acad Hosp Rotterdam Dijkzigt, Dept Neurosurg, NL-3015 GD Rotterdam, Netherlands
[2] Erasmus Univ, Ctr Clin Decis Sci, Dept Publ Hlth, NL-3015 GD Rotterdam, Netherlands
[3] Univ Edinburgh, Sch Med, Med Stat Unit, Edinburgh, Midlothian, Scotland
[4] Univ Glasgow, Dept Neurosurg, Glasgow, Lanark, Scotland
[5] Virginia Commonwealth Univ, Med Coll Virginia, Dept Neurosurg, Richmond, VA 23298 USA
[6] Univ Munich, Klinikum Grosshadern, Inst Chirurg Forsch, D-8000 Munich, Germany
[7] Univ Calif San Diego, Dept Neurol Surg, San Diego, CA 92103 USA
来源：
NEUROSURGERY | 1999年 / 44卷 / 06期
关键词：
clinical trials; head injury; neuroprotection; outcome; prognosis; statistical analysis;
D O I：
10.1097/00006123-199906000-00076
中图分类号：
R74 [神经病学与精神病学];
学科分类号：
摘要：
AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.
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页码：1286 / 1298
页数：13
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