Epilepsia infantil: avanza en el Garrahan un ensayo que evalúa los efectos del aceite de cannabis

(CABA) A Cristina Sproviero la alegría se le transformó en angustia cuando supo que su beba de tres meses y medio padecía una forma severa de epilepsia. Después de deambular por distintos consultorios, pidió ayuda en el Hospital Garrahan.

Los cinco años siguientes no fueron fáciles. De la mano de Roberto Caraballo, jefe de Neurología, probaron distintas medicaciones, pero sin éxito. Hasta que, en noviembre, después de empezar a tomar aceite de cannabis, cambió por completo. “Es otra chica -se entusiasma Cristina-. Ahora tiene menos convulsiones, sonríe, se conecta con nosotros”.

La hija de Cristina es uno de los 21 pacientes que ya se enrolaron en un ensayo clínico que intenta evaluar con precisión los efectos del aceite de cannabis en el tratamiento de ciertos cuadros de epilepsia infantil.

Los chicos incluidos presentan encefalopatías epilépticas refractarias al tratamiento farmacológico y a otras terapias, como la dieta cetogénica o la cirugía -explica Caraballo, presidente de la Comisión de Asuntos Latinoamericanos de la Liga Internacional contra la Epilepsia-. Son las formas más severas de epilepsia en pediatría. En este grupo, las crisis frecuentes y las descargas electroencefalográficas llevan a un deterioro cognitivo y conductual.”

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Se calcula que entre el 20 y el 30% de las epilepsias son resistentes al tratamiento: “[El médico] considera que está ante un cuadro de este tipo si el paciente sigue teniendo crisis durante por lo menos un año a pesar de haber probado por lo menos dos medicaciones solas o combinadas -explica el doctor Damián Consalvo, médico del Hospital Ramos Mejía-. También puede darse en adultos”.

En el estudio, que se prolongará durante dos años, no se retira el tratamiento convencional, sino que se agrega aceite de cannabis en una dosis dependiente del peso. “En menores de 45 kg, se comienza con 2,5 mg/kg/día y a niños con peso mayor se les indican 5 mg/kg/ día -detalla Caraballo-. De acuerdo con la respuesta, se va ajustando la dosis hasta un máximo de 25/mg/ día distribuidos en dos tomas.”

El interés en el cannabis medicinal está en alza. Además de su uso en epilepsia, las investigaciones sobre sus virtudes (en el alivio del dolor, la reducción de la inflamación, la estimulación del apetito, la reducción de vómitos y náuseas, entre otros) se multiplican desde hace medio siglo.

Se espera que en marzo la OMS dé a conocer una revisión definitiva sobre la literatura científica en este tema. El año pasado la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) aprobó el primer medicamento conteniendo cannabidiol(CBD), uno de los principios activos de la Cannabis sativa. Aunque lo cierto es que todavía no se entiende muy bien cómo actúa, la evidencia empírica indica que puede ser útil en distintas patologías.

“El cannabis tiene varios componentes activos -destaca Marcelo Rubinstein, profesor de la Facultad de Ciencias Exactas y Naturales de la UBA, e investigador superior del Conicet en el Instituto de Investigaciones en Ingeniería Genética y Biología Molecular-. Los dos principales son el THC, cuyo mecanismo de acción a través de la estimulación de los receptores CB1 y CB2 se conoce muy bien, y que provoca el efecto psicotrópico; y el CBD, que no está claro sobre qué receptores actúa, y que no produce efectos psicoactivos. El aceite que se está utilizando tiene 25 partes de CBD por una de THC. En general, para el dolor, los aceites que andan mejor tienen más THC porque este disminuye la transmisión nerviosa.”

En el país, aunque tanto la Secretaría de Salud como la de Ciencia y Tecnología crearon redes o comisiones de evaluación y asesoramiento, los avances en investigación no progresan. El gobierno de Jujuy, mientras tanto, tomó la delantera firmando un acuerdo con la compañía estadounidense Players Network, del estado de Nevada, y su subsidiaria, Greenleaf Farms, para cultivarla en su finca “El Pongo”, que hasta ahora se dedicaba mayormente a la caña de azúcar y el tabaco.

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La finca tiene 14.000 hectáreas -afirma Gastón Morales, hijo del gobernador y presidente de Cannabis Avatara Sociedad del Estado-. Empezamos con un plan piloto y esperamos alcanzar la escala industrial en agosto. Todas las fases de producción, incluyendo la elaboración del aceite, estarán en manos de esta compañía.”

Según indica Morales, el gobierno de su provincia también firmó cartas de intención con la chilena Knop y la canadiense Aphria (que suministró el aceite para el ensayo en el Hospital Garrahan a través de su subsidiaria ABP) para que estas instalen invernaderos dedicados al cultivo de cannabis en la misma finca. Con ese objetivo les cedería alrededor de tres hectáreas a cada compañía.

“Mucha de la información que circula es anecdótica -dice Gonzalo Arnao, presidente de ABP-. Por eso, parte del compromiso de Aphria es seguir invirtiendo en estudios clínicos, que arrojan la información que necesita la comunidad médica.”

Silvia Kochen, científica del Conicet, directora de la Sección Epilepsia del Hospital Ramos Mejía y del centro de cirugía de la epilepsia para pacientes refractarios del Hospital El Cruce, está intentando iniciar un estudio en adultos.

“Todos seguimos de cerca las investigaciones con gran expectativa -destaca-. Resultados internacionales muestran que en alrededor del 50% de esta población la respuesta es increíble. Es importante que se eliminen las trabas para investigar, porque si no la gente queda desprotegida y cae en las redes de personajes inescrupulosos que hacen promesas infundadas.”

Agrega Caraballo: “Los aceites de cannabis producidos por laboratorios medicinales que cumplen las exigencias obligatorias son similares. Sin embargo, es necesario corroborar la confiabilidad de los productos. El mejor modo es a través de estudios como el que estamos realizando en el hospital”.

Aunque todavía no existen precisiones sobre el costo de estos tratamientos, a los chicos que participen en el ensayo y respondan bien se les otorgará de por vida de manera gratuita. NR

Fuente consultada: La Nación

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