Sistema de registro en punto de contacto (POCT) para fenitoína.
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Date
2025
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Publisher
Universidad de Concepción
Abstract
La epilepsia es una de las enfermedades neurodegenerativas más comunes en el mundo, y es caracterizada por la presencia de crisis convulsivas. Como medida para tratar la epilepsia existe una variedad de fármacos que se administran a los pacientes, uno de los más utilizados es la fenitoína, que ha mostrado buenos resultados desde su implementación al uso terapéutico en 1937. Sin embargo, dadas las características de la molécula, pequeños cambios en la dosis administrada pueden desencadenar en grandes variaciones del nivel plasmático del fármaco en el organismo. Ante esto, es crucial monitorear los niveles de fenitoína en los pacientes en tratamiento para evitar casos de intoxicación o incumplimiento del tratamiento.
Dado lo anterior, el presente proyecto se centra en especificar el desarrollo de un dispositivo POCT capaz de monitorear los niveles de fenitoína en sangre a partir de muestras del fármaco, integrando múltiples tecnologías tanto a nivel de hardware como software. El dispositivo fabricado está basado en un circuito amperométrico controlado por un microcontrolador ESP32, el cual se comunica con una aplicación móvil encargada del almacenamiento y despliegue de datos a través de Bluetooth Low Energy.
A nivel de hardware se detalla la configuración del circuito amperométrico, el diseño de la placa de circuito impreso, el ensamble del circuito de alimentación, así como los módulos de comunicación utilizados para garantizar la adecuada transmisión de información.
Por otro lado, a través de la configuración del software del dispositivo, se logran gestionar las operaciones del sistema, desde el control del circuito amperométrico hasta la transmisión y despliegue de resultados. Además, la aplicación móvil desarrollada está diseñada para que el usuario pueda interactuar de manera rápida y eficiente con el dispositivo POCT, permitiendo el almacenamiento, recuperación y visualización de la información referente a cada paciente.
Se realizaron pruebas de calibración y validación para verificar la precisión del dispositivo, obteniendo una correlación logarítmica entre la concentración de fenitoína y el voltaje de reacción, con un coeficiente de correlación de 𝑅2= 0.9956, lo que garantiza la confiabilidad del sistema.
De esta manera, el dispositivo desarrollado permite una detección precisa y rápida de los niveles plasmáticos de fenitoína, demostrando la viabilidad de los dispositivos POCT en el ámbito médico y aportando una herramienta para la monitorización rápida y precisa de fármacos en muestras biológicas.
Epilepsy is one of the most common neurodegenerative diseases in the world, and is characterized by the presence of seizures. As a measure to treat epilepsy there are a variety of drugs that are administered to patients, one of the most widely used is phenytoin, which has shown good results since its implementation in therapeutic use in 1937, however, given the characteristics of the molecule, small changes in the dose administered can lead to large variations in the plasma level of the drug in the body. Therefore, it is crucial to monitor phenytoin levels in patients under treatment to avoid cases of intoxication or non-compliance with treatment. This project is focused on specifying the development of a POCT device capable of monitoring phenytoin levels in blood from plasma samples of patients under treatment with the drug, integrating multiple technologies at hardware and software level. The manufactured device is based on a potentiometric circuit controlled by an ESP32 microcontroller, which communicates with a mobile application in charge of data storage and display through Bluetooth Low Energy. At the hardware level, the configuration of the potentiometric circuit, the design of the printed circuit board, the assembly of the power supply circuit, as well as the communication modules used to guarantee the adequate transmission of information are detailed. Through the configuration of the device software, the system operations are managed, from the control of the potentiometric circuit to the transmission and display of results. then the mobile application developed is designed so that the user can interact quickly and efficiently with the POCT device, allowing the storage, retrieval and visualization of information about each patient. Calibration and validation tests were performed to verify the accuracy of the device, obtaining a logarithmic correlation between phenytoin concentration and reaction voltage, with a correlation coefficient of 𝑅2= 0.9956, which guarantees the reliability of the system. Thus, the developed device allows accurate and rapid detection of phenytoin plasma levels, demonstrating the feasibility of POCT devices in the medical field and providing a tool for rapid and accurate monitoring of drugs in biological samples.
Epilepsy is one of the most common neurodegenerative diseases in the world, and is characterized by the presence of seizures. As a measure to treat epilepsy there are a variety of drugs that are administered to patients, one of the most widely used is phenytoin, which has shown good results since its implementation in therapeutic use in 1937, however, given the characteristics of the molecule, small changes in the dose administered can lead to large variations in the plasma level of the drug in the body. Therefore, it is crucial to monitor phenytoin levels in patients under treatment to avoid cases of intoxication or non-compliance with treatment. This project is focused on specifying the development of a POCT device capable of monitoring phenytoin levels in blood from plasma samples of patients under treatment with the drug, integrating multiple technologies at hardware and software level. The manufactured device is based on a potentiometric circuit controlled by an ESP32 microcontroller, which communicates with a mobile application in charge of data storage and display through Bluetooth Low Energy. At the hardware level, the configuration of the potentiometric circuit, the design of the printed circuit board, the assembly of the power supply circuit, as well as the communication modules used to guarantee the adequate transmission of information are detailed. Through the configuration of the device software, the system operations are managed, from the control of the potentiometric circuit to the transmission and display of results. then the mobile application developed is designed so that the user can interact quickly and efficiently with the POCT device, allowing the storage, retrieval and visualization of information about each patient. Calibration and validation tests were performed to verify the accuracy of the device, obtaining a logarithmic correlation between phenytoin concentration and reaction voltage, with a correlation coefficient of 𝑅2= 0.9956, which guarantees the reliability of the system. Thus, the developed device allows accurate and rapid detection of phenytoin plasma levels, demonstrating the feasibility of POCT devices in the medical field and providing a tool for rapid and accurate monitoring of drugs in biological samples.
Description
Tesis presentada para optar al título de Ingeniero/a Biomédico.
Keywords
Fenitoína Administración y dosis, Fisiología Aparatos e instrumentos