Abstract
Introducción
En una investigación previa hemos desarrollado un algoritmo: polyneuropathy selectionmethod (PSM) con 4 parámetros (edad, cHDL, HbA1c y retinopatía diabética) para seleccionar a los pacientes con riesgo de presentar polineuropatía diabética (PND), y un método simplificado para su diagnóstico: outpatient polyneuropathy diagnosis (OPD) con 4 variables (síntomas y 3 pruebas objetivas).
Objetivos
Confirmar la validez de las pruebas convencionales para diagnosticar la PND. Validar el poder discriminatorio del PSM y el poder diagnóstico del OPD mediante la evaluación de su relación con estudios de electrodiagnóstico y la valoración neurológica clínica objetiva. Evaluar la correlación entre la PND y la situación proinflamatoria.
Diseño
Transversal de asociación cruzada para validar el PSM; muestras emparejadas para validar el OPD.
Ámbito
Atención primaria de 3 comarcas.
Sujetos
Para validar el PSM: muestra aleatoria de 75 pacientes del censo de diabéticos tipo 2. Para validar el OPD, 30 pacientes con PND y 30 sin PND seleccionados entre 2 subgrupos de diabéticos no insulinodependientes de nuestro estudio previo.
Método
El diagnóstico de PND se realizará mediante valoración clínica neurológica (síntomas, exploración física y pruebas de sensibilidad) y estudios de electrodiagnóstico (electromiografía [EMG] sensitiva y motora) como «pruebas de referencia». Se determinarán factores de riesgo de neuropatía, macroangiopatía y citocinas proinflamatorias (PCR, TNF fracción soluble, TGF-β1 total) en todos los sujetos.
Resultados esperados
Las pruebas de EMG confirman la capacidad de las pruebas convencionales para diagnosticar la PND. El PSM y el OPD son métodos válidos para seleccionar a los pacientes con riesgo y para diagnosticar la PND. Hay una relación significativa entre PND y las pruebas proinflamatorias.
Palabras clave: Polineuropatía diabética, Diagnóstico, Selección, Riesgo, Prevención
Abstract
Introduction
In a previous study we developed a specific algorithm, the polyneuropathy selection method (PSM) with 4 parameters (age, HDL-C, HbA1c, and retinopathy), to select patients at risk of diabetic polyneuropathy (DPN).We also developed a simplified method for DPN diagnosis: outpatient polyneuropathy diagnosis (OPD), with 4 variables (symptoms and 3 objective tests).
Objectives
To confirm the validity of conventional tests for DPN diagnosis; to validate the discriminatory power of the PSM and the diagnostic value of OPD by evaluating their relationship to electrodiagnosis studies and objective clinical neurological assessment; and to evaluate the correlation of DPN and pro-inflammatory status.
Design
Cross-sectional, crossed association for PSM validation. Paired samples for OPD validation.
Setting
Primary care in 3 counties.
Participants
Random sample of 75 subjects from the type-2 diabetes census for PSM evaluation. Thirty DPN patients and 30 non-DPN patients (from 2 DM2 sub-groups in our earlier study) for OPD evaluation.
Methods
The gold standard for DPN diagnosis will be studied by means of a clinical neurological study (symptoms, physical examination, and sensitivity tests) and electrodiagnosis studies (sensitivity and motor EMG). Risks of neuropathy, macroangiopathy and pro-inflammatory status (PCR, TNF soluble fraction and total TGF-β1) will be studied in every subject.
Expected results
Electrodiagnosis studies should confirm the validity of conventional tests for DPN diagnosis. PSM and OPD will be valid methods for selecting patients at risk and diagnosing DPN. There will be a significant relationship between DPN and pro-inflammatory tests.
Key words: Diabetic polyneuropathy, Diagnosis, Selection, Risk, Prevention
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