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Critical Care

, 12:R61

First Online: 30 April 2008Received: 01 November 2007Revised: 16 January 2008


BackgroundSevere traumatic brain injury TBI has been increasing with greater incidence of injuries from traffic or sporting accidents. Although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI.

MethodsA total of 159 patients who arrived within 8 hours of injury with a Glasgow Coma Score ≤ 8 were enrolled in the study. A prospective, randomized, placebo-controlled trial of progesterone was conducted in the Neurotrauma Center of our teaching hospital. The patients were randomized to receive either progesterone or placebo. The primary endpoint was the Glasgow Outcome Scale score 3 months after brain injury. Secondary efficacy endpoints included the modified Functional Independence Measure score and mortality. In a follow-up protocol at 6 months, the Glasgow Outcome Scale and the modified Functional Independence Measure scores were again determined.

ResultsOf the 159 patients randomized, 82 received progesterone and 77 received placebo. The demographic characteristics, the mechanism of injury, and the time of treatment were compared for the two groups. After 3 months and 6 months of treatment, the dichotomized Glasgow Outcome Scale score analysis exhibited more favorable outcomes among the patients who were given progesterone compared with the control individuals P = 0.034 and P = 0.048, respectively. The modified Functional Independence Measure scores in the progesterone group were higher than those in the placebo group at both 3-month and 6-month follow-up P < 0.05 and P < 0.01. The mortality rate of the progesterone group was significantly lower than that of the placebo group at 6-month follow-up P < 0.05. The mean intracranial pressure values 72 hours and 7 days after injury were lower in the progesterone group than in the placebo group, but there was no statistical significance between the two groups P > 0.05. Instances of complications and adverse events associated with the administration of progesterone were not found.

ConclusionOur data suggest that acute severe TBI patients with administration of progesterone hold improved neurologic outcomes for up to 6 months. These results provide information important for further large and multicenter clinical trials on progesterone as a promising neuroprotective drug.

Trial RegistrationACTRN12607000545460.

AbbreviationsFIMFunctional Independence Measure

GCSGlasgow Coma Scale

GOSGlasgow Outcome Scale

ICPintracranial pressure

TBItraumatic brain injury.

Electronic supplementary materialThe online version of this article doi:10.1186-cc6887 contains supplementary material, which is available to authorized users.

Guomin Xiao, Weiqi Yan contributed equally to this work.

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Autor: Guomin Xiao - Jing Wei - Weiqi Yan - Weimin Wang - Zhenhui Lu


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