ABSTRACT
BACKGROUND: Guillain-Barré Syndrome (GBS) can lead to significant functional impairments, yet little is understood about the recovery phase and long-term consequences for patients in low- and medium-income countries. OBJECTIVE: To evaluate the functional status and identify factors influencing outcomes among patients with GBS in Colombia. METHODS: Telephone interviews were conducted with GBS patients enrolled in the Neuroviruses Emerging in the Americas Study between 2016 and 2020. The investigation encompassed access to health services and functional status assessments, utilizing the modified Rankin Scale (mRS), GBS Disability Score (GDS), Barthel Index (BI), and International Classification of Functioning (ICF). Univariate analysis, principal component analysis, linear discriminant analysis, and linear regression were employed to explore factors influencing functional status. RESULTS: Forty-five patients (mean age = 50[±22] years) with a median time from diagnosis of 28 months (IQR = 9-34) were included. Notably, 22% and 16% of patients did not receive rehabilitation services during the acute episode and post-discharge, respectively. Most patients demonstrated independence in basic daily activities (median BI = 100, IQR = 77.5-100), improvement in disability as the median mRS at follow-up was lower than at onset (1 [IQR = 0-3] vs. 4.5 [IQR = 4-5], p < 0.001), and most were able to walk without assistance (median GDS = 2, IQR = 0-2). A shorter period from disease onset to interview was associated with worse mRS (p = 0.015) and ICF (p = 0.019). Negative outcomes on GDS and ICF were linked to low socioeconomic status, ICF to the severity of weakness at onset, and BI to an older age. CONCLUSIONS: This study underscores that the functional recovery of GBS patients in Colombia is influenced not only by the natural course of the disease but also by socioeconomic factors, emphasizing the crucial role of social determinants of health.
Subject(s)
Guillain-Barre Syndrome , Zika Virus Infection , Humans , Colombia/epidemiology , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/diagnosis , Male , Female , Middle Aged , Zika Virus Infection/epidemiology , Zika Virus Infection/complications , Adult , Aged , Disability Evaluation , Epidemics , Recovery of Function , Functional StatusABSTRACT
Objetivo: identificar los patrones alimentarios de la población adulta Antioqueña y su asociación con variables socioeconómicas. Métodos: estudio transversal con muestra aleatoria de 1.394 adultos de 18 a 59 años, derivados del estudio Perfil alimentario y nutricional de Antioquia 2019. El consumo alimentario fue evaluado con recordatorio de consumo en 24 horas (R24h) y un segundo R24h en día no consecutivo al 25% de la muestra, se cuantificó el consumo de alimentos en gramos, los patrones alimentarios se establecieron mediante análisis factorial por Componentes principales con rotación ortogonal varimax. Para verificar la asociación entre los patrones alimentarios y las variables socioeconómicas se empleó regresión de Poisson por varianza robusta. Resultados: se definieron tres patrones alimentarios que representan el 28,1% de la varianza: "Tradicional" (9,8%), "Regional" (9,7%) y "Prudente" (8,6%). Los dos primeros se asociaron con variables demográficas, como sexo, edad y etnia; mientras que el último se asoció con variables socioeconómicas como escolaridad, ingresos familiares, régimen de seguridad social y clasificación de seguridad alimentaria. Conclusiones: Los hallazgos del presente estudio muestran que la dieta de la población estudiada, sigue unos referentes de tradición alimentaria, reflejados en los patrones Tradicional y Regional, mientras que el patrón Prudente, corresponde a la parte de la población que tiene mejores condiciones socioeconómicas y probablemente lo siguen por recomendación de salud.
Objective: to identify the eating patterns of the adult population from Antioquia, Colombia, and their association with socioeconomic variables. Methods: a cross-sectional study was performed with a random sample of 1,394 adults aged 18 to 59 years, derived from the Antioquia Food and Nutritional Profile 2019 study. Food consumption was evaluated with a 24-hour consumption recall (R24h) and a second R24h on a non-consecutive day at 25% of the sample, food consumption was quantified in grams, and food patterns were established by factorial analysis by Principal Components with varimax orthogonal rotation. To verify the association between eating patterns and socioeconomic variables, Poisson regression was used for robust variance. Results: three eating patterns were defined that represent 28.1% of the variance: "Traditional" (9.8%), "Regional" (9.7%), and "Prudent" (8.6%). The first two were associated with demographic variables, such as gender, age, and ethnicity; while the latter was associated with socioeconomic variables such as schooling, family income, social security system, and food security classification. Conclusions: The findings of this study show that the diet of the population of the study, follows some references to food tradition, reflected in the Traditional and Regional patterns, while the Prudent pattern corresponds to the part of the population that has better socioeconomic conditions, and they probably follow it for health recommendation.
ABSTRACT
Con el fin de determinar la bioequivalencia de dos formulaciones de tabletas de 2 mg de clonazepam: Sedatril®/Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia) como producto de prueba y Rivotril® (Roche Químicos e Farmacéuticas S. A., Río de Janeiro, Brasil), como producto de referencia, se realizó un estudio de bioequivalencia en 26 voluntarios sanos. Los productos de prueba y de referencia se administraron en condiciones de ayuno de acuerdo con un diseño cruzado aleatorio de dosis única, con dos secuencias, dos tratamientos y un período de lavado de 28 días. Las muestras de sangre se obtuvieron desde las 0 hasta las 96 horas después de la administración del medicamento. Los niveles plasmáticos de clonazepam se determinaron con un método validado por cromatografía líquida de alta eficiencia con detección ultravioleta (HPLC/UV, siglas en inglés). Los parámetros farmacocinéticos ABC0-96, ABC0-∞, Cmax, Tmax, t1/2, and ke se determinaron de los perfiles plasmáticos concentración-tiempo por el método no compartimental. El test de bioequivalencia se realizó con los datos transformados a logaritmo natural (ln) de ABC0-∞ and Cmax. Los intervalos de confianza del 90 por ciento para la relación producto de prueba/producto de referencia fueron de 87,9 por ciento a 103,6 por ciento y 84,4 por ciento a 104,0 por ciento, respectivamente. Estos resultados estuvieron dentro de los rangos de aceptación del 80,0 por ciento al 125 por ciento, establecidos por la FDA y se concluyó que ambos productos son bioequivalentes.
In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril®/ Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia) as a test product and Rivotril® (Roche Químicos e Farmacêuticas S. A., Rio de Janeiro, Brazil) as a reference product, a bioavailability study was performed in 26 healthy volunteers. Test and reference products were administered under fasting conditions following a single dose, two-sequences, two treatments, crossover randomized design with a 28-day-washout period. Blood samples were obtained from 0 to 96 hours after dosing. Plasma clonazepam levels were determined by a validated high performance liquid chromatography with UV detection method (HPLC/UV). ABC0-96, ABC0-∞, Cmax, Tmax, t1/2, and ke, pharmacokinetic parameters were determined from plasma level-time profiles by a noncompartmental method. ln-trasformed ABC0-∞ and Cmax were tested for bioequivalence. 90%-confidence intervals for test/reference ratio of these parameters were 87.9% to 103.6% and 84.4% to 104.0%, respectively. These results were within the FDA acceptance range of 80% to 125% and it was concluded that both products were bioequivalent.
Subject(s)
Clonazepam , Chromatography, High Pressure Liquid , Biological Availability , PharmacokineticsABSTRACT
Dos formulaciones comerciales de Gliclazida de 80 mg - tabletas, los productos Glidiab de Tecnoquímicas y Diamicron® de Euroetika-Elsevier, fueron sometidos a estudio para evaluar la equivalencia farmacéutica y la equivalencia biológica.Después de comprobar la equivalencia farmacéutica se llevó a cabo el estudio de la equivalencia biológica en 14 voluntarios sanos; la cuantificación de Gliclazida en plasma se realizó por la técnica de cromatografía líquida de alta resolución (HPLC). Los parámetros farmacocinéticos evaluados fueron: área bajo la curva (AUC) de 0-60 horas, concentración máxima (Cmáx) y el tiempo máximo (tmáx) los cuales se analizaron estadísticamente con intervalos de confianza del 90.0 por ciento y un rango de aceptación para bioequivalencia del 80.0 por ciento al 125.0 por ciento para AUC y Cmáx y del 80.0 por ciento al 120.0 por cinto para el tmáx.Ambas formulaciones presentaron alta variabilidad inter e intrasujeto y se encontró que son bioequivalentes con respecto a AUC, pero no lo son con respecto a Cmáx y tmáx
Two commercial formulations of Gliclazide 80 mg tablets were studied in order to evaluate both pharmaceutical and biological equivalence, Glidiab® Tecnoquímicas Laboratories and Diamicron® Euroetika-Elsevier Laboratories. After proving the pharmaceutical equivalence, a bioequivalence was tested in 14 healthy volunteers and the determination of gliclazide in plasma was carried out by high-performance liquid chromatography (HPLC). The evaluated pharmacokinetic parameters were: area under the curve (AUC) from 0 to 60 hours, maximum concentration (Cmax) and time to maximum concentration (Tmax). In statistical analysis the 90.0% confidence intervals for AUC, Cmax and Tmax, and acceptance range for bioequivalence of 80.0%-125.0% to AUC and Cmax and acceptance range of 80:0%-120.0% to Tmax, were applied. Both formulations presented inter and intra subject high variability and it was found that they are bioequivalent in relation to AUC but they are not bioequivalent in relation to Cmax and Tmax
Subject(s)
Chromatography , Gliclazide , Therapeutic EquivalencyABSTRACT
En 12 voluntarios sanos se efectuó un estudio de bioequivalencia de dos preparados comerciales de carbamazepina en tabletas de liberación retardada. Este estudio permitió comparar la biodisponibilidad de la formulación de referencia Tegretol® Retard de Ciba Geigy elaborado en Colombia por Novartis, y la formulación de prueba Carbamazepina MK Retard, de Tecnoquímicas.Para evaluar la bioequivalencia se determinaron las curvas de concentración plasmática vs tiempo de las dos formulaciones y se calcularon las áreas bajo la curva (AUC) y las concentraciones máximas (Cmáx).Para la formulación de prueba el intervalo de confianza del 90 por ciento para el AUC estuvo entre 95.7 y 100.7 por ciento y para el C(máx) entre el 88.6 y el 106.1 por ciento. Para ambas determinaciones el rango de aceptación, según normas internacionales, está entre 80 y 125 por ciento de la formulación de referencia. Esto demuestra la bioequivalencia de las dos formulaciones.
A study of the bioequivalence of two comercial carbamazepine retard-release formulations was carried out in 12 healthy volunteers. Studies of bioequivalence allow to compare the bioavailability of the innovator formulation with generic, alternative or branch formulations. In order to evaluate the bioequivalence, plasma carbamazepine concentration/time curves were obtained for the Tegretol® Retard Tablets reference formulationand for the test formulation; the area under each curve and the maximum concentration were calculated. After the calculation, statistical analysis of data for the area under the curve of the Carbamazepine Retard Tablets test formulation, was between 95.7% and 100.7 % and the maximum concentration of the test formulation was between 88.6% and 106.1%; both parameters with the 90% confidence interval. Since the acceptance range was determined to be between 80.0% and 125.0% of the reference formulation, we concluded from this study that the two formulations are bioequivalent.