Rev. Soc. Esp. Dolor. 2023; 30(4): 227-242 / DOI: 10.20986/resed.2024.4099/2023
Diego Díaz, Carmen Sánchez, Isabel María Fontán, Estefanía Peralta, María Luisa Berraquero, Cristina Naranjo, Alba Violeta Gándara, Bartolomé Fernández
RESUMEN
Objetivos: La infusión intratecal es una terapia ampliamente aceptada para el tratamiento del dolor oncológico refractario, y generalmente se administra mediante dispositivos parcialmente externalizados (DPE) o totalmente internalizados (DTI). El objetivo de este trabajo es establecer las necesidades farmacológicas y de asistencia sanitaria de estos 2 tipos de dispositivos, y determinar si existen realmente existen diferencias significativas entre ellos.
Material y método: Estudio observacional retrospectivo sobre todos los pacientes de nuestra unidad del dolor, mayores de edad, que precisaron terapia de infusión intratecal para dolor oncológico, con un dispositivo de flujo fijo, entre 2009 y 2017. Se establecieron 4 puntos temporales para el seguimiento: previo al implante del dispositivo y los meses 1, 3 y 6 tras el inicio de la terapia. Se registraron datos relacionados con información demográfica y antropométrica, proceso oncológico, control del dolor, dosificación intratecal, modificaciones y número de ajustes de medicación intratecal, y visitas a la unidad del dolor y servicio de urgencias. Para detectar posibles diferencias entre las necesidades farmacológicas y de asistencia sanitaria de los 2 tipos de dispositivo, se realizaron análisis estadístico y modelos de regresión logística, univariante y multivariante, para la predicción de los pacientes que precisan incrementar la dosis de morfina en el mes 1.
Resultados: Se incluyeron 132 pacientes, con EVA medio preimplante de 7,79 y dosis media equipotente de morfina de 257 mg. En 60 casos se implantó un DPE y en 72 un DTI. Tras el implante del dispositivo, se inició la terapia de infusión intratecal con morfina en todos los pacientes, con una dosis media de 1,13 mg/día, sin diferencias entre los grupos DPE y DTI. Al finalizar el primer mes, la puntuación en la EVA había descendido hasta 3,02, con una dosis media de morfina intratecal de 1,80 mg/día. En el mes 6 se objetiva un EVA medio de 2,06, sin diferencia entre los grupos, y con una dosis media diaria de cloruro mórfico de 2,86 mg. El análisis univariante detectó 6 variables predictivas sobre la necesidad de incrementar la dosis de morfina intratecal en el primer mes, pero solo mantuvo su carácter predictivo en el multivariante una mayor dosis de rescate de morfina sistémica en las primeras 24 h tras implantar el dispositivo. El 48 % de los pacientes del grupo DPE no realizó ninguna visita programada a la unidad del dolor, en contraste con el 14,7 % de los que tenían un DTI, una diferencia altamente significativa. Un 72,7 % de nuestros pacientes fallecieron en el hospital.
Conclusiones: La terapia de infusión intratecal es eficaz en el dolor oncológico refractario, pero es necesario aumentar significativamente las dosificaciones intratecales con el paso del tiempo. Los DPE consiguen una estabilización en la dosis efectiva intratecal más rápida, por lo que pueden ser particularmente útiles cuando la esperanza de vida es baja. Sugerimos utilizar la necesidad de rescates con opioides sistémicos en las primeras 24 h como factor predictor de la necesidad de incrementar la dosis de morfina intratecal en el mes 1.
ABSTRACT
Objectives: Intrathecal infusion is a widely accepted therapy for the treatment of refractory cancer pain, and is generally administered by partially externalised (PED) or totally internalised (ITD) devices. The objective of this work is to establish the pharmacological and healthcare needs of these two types of device, and to determine whether there are significant differences between them.
Material and methods: Retrospective observational study of all patients in our pain unit, aged 18 years and older, who required intrathecal infusion therapy for cancer pain, with a fixed flow device, between 2009 and 2017. Four time points were established for follow-up: before device implantation and months 1, 3 and 6 after initiation of therapy. Data related to demographic and anthropometric information, oncological process, pain control, intrathecal dosing, modifications and number of intrathecal medication adjustments, and visits to the pain unit and emergency department were recorded. To detect possible differences between the pharmacological and health care needs of the two types of devices, a statistical analysis was performed and univariate and multivariate logistic regression models were established to predict which patients required an increase in morphine dose at month 1.
Results: One hundred and thirty-two patients were included, with a mean VAS before implantation of 7.79 and a mean equipotent morphine dose of 257 mg. A PED was implanted in 60 cases and an ITD in 72 cases. After device implantation, intrathecal infusion therapy with morphine was started in all patients, with a mean dose of 1.13 mg/day, with no differences between the PED and ITD groups. At the end of the first month, the VAS score had decreased to 3.02, with a mean intrathecal morphine dose of 1.80 mg/day. At month 6, a mean VAS of 2.06 was observed, with no differences between groups, and with a mean daily dose of morphine of 2.86 mg of morphine per day. The univariate analysis detected six variables that predicted the need to increase the intrathecal morphine dose in the first month, but only a higher rescue dose of systemic morphine in the first 24 hours after device implantation remained predictive in the multivariate analysis. Forty-eight percent of the patients in the PED group did not make scheduled visits to the pain unit, compared to 14.7 % of those with an ITD, a highly significant difference. 72.7 % of our patients died in hospital.
Conclusions: Intrathecal infusion therapy is effective in refractory cancer pain, but it is necessary to significantly increase intrathecal doses over time. DPEs achieve a stabilisation in effective intrathecal dose more quickly, so they may be particularly useful when life expectancy is low. We suggest using the need for systemic opioid rescue in the first 24 hours as a predictor of the need to increase the intrathecal morphine dose at month 1.
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