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Vol. 16. Issue 1.
Pages 39-49 (January 2005)
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Vol. 16. Issue 1.
Pages 39-49 (January 2005)
Revisión de los ensayos clínicos sobre prevención del daño neurológico en el traumatismo craneoencefálico grave y análisis de su fracaso terapéutico
Overview of the recent clinical triáis in severe head injury and analysis of their therapeutic failure
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G.R. Boto
, P.A. Gómez, R.D. Lobato
Servicio de Neurocirugía. Hospital 12 de Octubre. Madrid
J. De la Cruz*
* Unidad de Epidemiología Clínica. Hospital 12 de Octubre. Madrid
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Resumen

En la pasada “Década del Cerebro” se han sometido a ensayo clínico distintos fármacos neuroprotectores frente al traumatismo craneoencefálico grave (TCEG) sin que ninguno de ellos haya mejorado de manera significativa el pronóstico final de estos pacientes. La eficacia neuroprotectora de estas sustancias, confirmada en los modelos animales, no ha podido trasladarse al ámbito clínico, creando gran decepción en la comunidad científica.

Este trabajo se ha estructurado en tres partes: en la primera, se resumen los mecanismos fisiopatológicos involucrados en el TCEG, diana de los fármacos neuroprotectores. En la segunda parte se revisan cuáles han sido los ensayos clínicos más importantes sobre TCEG llevados a cabo en estos últimos años y en la tercera, se analizan los motivos que pueden explicar el “fracaso” terapéutico de estos fármacos.

Palabras clave:
Ensayos clínicos
Traumatismo craneoencefálico grave
Neuroprotección
Summary

During the past “Decade of the Brain” several neuroprotective agents have been tested in phase III clinical triáis for severe head injury (SHI) but unfortu-nately none of them significantly improved the outcome of these patients. In contrast to the success achieved by these drugs in animal laboratory studies, the results in terms of neuroprotection in the clinical setting have been disappointing.

This paper has been divided in three parts: in the first one, we summarize the pathophysiological mecha-nisms related to SHI, targeted by the neuroprotective agents. In the second part we review the main clinical triáis carried out for SHI to date, and in the third one, we analyze the possible reasons that explain why these agents have failed to show efficacy.

Key words:
Clinical triáis
Severe head injury
Neuroprotection

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