Differences in the distribution of hemoglobin variants according to the geographic regions in a Colombian population

ABSTRACT Introduction: Colombia has been subject to intense genetic and cultural currents due to its geographical location. Hemoglobinopathies are the most common recessive diseases found worldwide and represent an important public health problem, according to the region and ancestry of each country. Objectives: To evaluate the frequency of hemoglobin variants according to the geographical region in a population group adjusted to sex and age in Colombia. Methods: This was a descriptive retrospective study of hemoglobin variants performed by electrophoresis in patients treated at and/or referred to specialized care institutions in Bogota, Colombia between January 2009 and December 2020. Results: A total of 2,224 results were analyzed, 48.4% male and 51.5% female; 63.3% of patients were without alterations, 14.3% presented with thalassemia, 17.3%, HbS, 2.3%, HbS/C, 1.8%, HbC, 0.5%, HbE and 0.5% persistent HbF, with HbS being more prevalent in males (p = 0.005). When assessing the geographical regions of Colombia, a higher prevalence of HbS was found in the Pacific (p = 0.005) and Caribbean regions, while Thalassemia and HbS were more prevalent in the Andean and Orinoquia regions, and it was rare to find any hemoglobinopathies (p = 0.0001) in the Amazonian region. Conclusions: The main hemoglobinopathies found in Colombia are HbS, predominantly in males, and Thalassemia. The distribution of hemoglobinopathies in different geographical regions of Colombia is influenced by ancestry.

Características de la trombosis venosa cerebral en pacientes de dos hospitales universitarios de Colombia en el período 2018-2020 / Characteristics of cerebral venous thrombosis in patients from two university hospitals in Colombia between 2018-2020

Introducción. La trombosis venosa cerebral es una causa infrecuente de enfermedad cerebrovascular que viene en aumento a nivel mundial. A pesar de ello, actualmente, en Colombia no se cuenta con estudios suficientes que nos permitan caracterizar epidemiológicamente la enfermedad en nuestra población para identificar los factores de riesgo y las complicaciones más frecuentes en nuestro medio. Objetivo. Describir las características clínicas, demográficas y radiológicas, y los factores de riesgo de una serie de pacientes con trombosis venosa cerebral de dos hospitales de Colombia. Materiales y métodos. Es un estudio descriptivo retrospectivo de pacientes hospitalizados, atendidos en el servicio de neurología de dos hospitales de Bogotá desde diciembre de 2018 hasta diciembre del 2020. Resultados. Se incluyeron 33 pacientes. Las frecuencias más altas correspondieron a mujeres en edad fértil, en puerperio (n=7; 33,3 %) y pacientes con patologías autoinmunes (n=10; 30,3 %). El síntoma inicial más común fue la cefalea (n=31; 93,9 %), seguido de focalización neurológica (n=9; 27,2%) y crisis epiléptica (n=8; 24,2 %). El 51 % (n=17) de los pacientes tuvo un examen físico normal. El infarto venoso cerebral se presentó en el 21,1 % (n=7), la hemorragia subaracnoidea en el 12,1 % (n=4) y el hematoma intraparenquimatoso en el 9 % (n=3) del total de pacientes. El 60,6 % (n=20) quedó con nivel independiente en la escala funcional de Barthel. Ningún paciente falleció. Conclusiones. Se encontraron características sociodemográficas, clínicas y radiológicas similares a lo reportado en la literatura mundial. Con respecto a las diferencias, se encontró en nuestro estudio compromiso de la circulación venosa cerebral profunda en un porcentaje ligeramente mayor a lo descrito, pero sin aumento de complicaciones, ni mortalidad.

Introduction. Cerebral venous thrombosis is an uncommon cause of cerebrovascular disease, which has been increasing worldwide. In Colombia, there are not enough recent studies that allow us to determine epidemiological characteristics of the disease in our population to identify more frequent risk factors and complications according to our living conditions. Objective. To describe clinical, demographic, and radiographic characteristics, and risk factors in a cohort of patients with cerebral venous thrombosis attended at two hospitals in Colombia. Materials and methods. Retrospective descriptive study with patients treated in the hospitalization neurology service of two hospitals in Bogotá, Colombia from December 2018 to December 2020. Results. Thirty-three patients were included. There was a higher incidence of cerebral venous thrombosis in women of childbearing age in the puerperium (n=7; 33.3%) and associated with autoimmune diseases (n=10; 30.3%). The most common initial symptom was headache (n=31; 93.9 %), followed by neurological focal signs (n=9; 27.2%) and seizures (n=8; 24.2%). Fifty-one percent (n=17) of the patients had a normal physical examination. Cerebral venous infarction occurred in 21.1 % (n=7), subarachnoid hemorrhage in 12.1 % (n=4), and intraparenchymal hematoma in 9 % (n=3) of all the patients. Sixty-point six percent (n=20) of the patients had a total independent Barthel functional scale. None of those died. Conclusions. We found similar sociodemographic, clinical, and radiography characteristics to those reported in the world literature. Regarding the differences, deep cerebral venous circulation was higher than that described in previous studies but without complications increase or mortality.

Asociación entre patrones alimentarios y factores sociodemográficos en la población adulta de Antioquia, Colombia

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.

Parkinson genetico: Reporte de un caso clínico y revisión de la literatura / Genetic Parkinson disease: a case report and literature review

RESUMEN El parkinsonismo constituye un conjunto de signos y síntomas clínicos caracterizados por bradicinesia y temblor en reposo o rigidez, cuya causa más frecuente es la enfermedad de Parkinson (EP). La gran mayoría de los casos de EP son esporádicos, sin embargo, existe una minoría en la cual la etiología se debe a una mutación heredada, ya sea autosómica dominante (AD), autosómica recesiva (AR) o herencia ligada al X. La identificación de estas causas heredables es importante para una adecuada consejería genética y tratamiento. Se presenta el caso de un paciente con EP de inicio temprano en el que se identificó una mutación AD en el gen GIGYF2 o PARK11, asociado a una breve revisión de la literatura

SUMMARY Parkinsonism constitutes a set of clinical signs and symptoms characterized by bradykinesia and tremor at rest and / or rigidity. The main etiology is Parkinson's disease (PD), but there are other causes such as atypical parkinsonism. The vast majority of PD cases are sporadic, however, there is a minority where the etiology is due to an inherited mutation, either autosomal dominant (AD), autosomal recessive (RA), or X-linked inheritance. Identifying these heritable causes is important for proper genetic counseling and treatment. We present the case of a patient with early-onset PD where an AD mutation in the GIGYF2 gene (PARK11) was identified. We subsequently present a brief review of the literature.

Un caso de melanosis neurocutánea: el lado oscuro del nevus melanocítico congénito gigante / A case of neurocutaneous melanosis: the dark side of the giant congenital melanocytic nevus

RESUMEN La melanosis neurocutánea es una facomatosis, no hereditaria, caracterizada por la proliferación de melanocitos y de depósitos de melanina en el sistema nervioso central, asociada a un nevus melanocítico congénito gigante o a múltiples nevus melanocíticos satélites. CASO CLÍNICO. Una mujer joven con nevus melanocítico congénito gigante y satelitosis, presentó hipertensión intracraneana asociada a hidrocefalia comunicante. Se le practicó derivación del líquido cefalorraquídeo con mejoría parcial, luego presentó convulsiones y afectación medular cervical que la llevó a la ventilación mecánica prolongada y finalmente a la muerte. La resonancia magnética evidenció lesiones en las leptomeninges. CONCLUSIONES. La melanosis neurocutánea debe considerarse en pacientes adultos con nevus melanocítico congénito que presenten manifestaciones clínicas neurológicas.

SUMMARY Neurocutaneous melanosis is a non-hereditary phakomatosis, characterized by the proliferation of melanocytes and melanin deposits in the central nervous system associated with a giant congenital melanocytic nevus or multiple melanocytic nevi satellites. CLINICAL CASE. A young woman with congenital giant melanocytic nevus and satelitosis, presented with intracraneal hypertension associated with communicating hydrocephalus. She was treated with cerebrospinal fluid shunt with partial improvement; but she worsened, presenting seizures and later cervical spinal cord involvement that led to prolonged mechanical ventilation and eventually death. MRI showed lesions in leptomeninges. CONCLUSIONS. Neurocutaneous melanosis should be considered in adult patients with congenital melanocytic nevus and clinical neurological manifestations.

Necrosis dérmica como primera manifestación del síndrome de anticuerpos antifosfolípido / Dermal necrosis as the first manifestation of anti-phospholipid antibody syndrome

Resumen El síndrome de anticuerpos antifosfolípidos es una condición de reciente descripción, cuyo diagnóstico se basa en la presencia de eventos trombóticos sin predisposición previa, con positividad de anticuerpos antifosfolípidos. Su presentación clínica incluye gran variedad de patrones, algunos de ellos no incluidos dentro de los criterios clínicos de diagnóstico, pero que deben ser conocidos. El compromiso dérmico es usual como livedo, sin embargo, la necrosis dérmica no es usual. Se presenta un caso de síndrome de anticuerpos antifosfolípidos con necrosis dérmica como manifestación primaria de la enfermedad.

Abstract Antiphospholipid antibodies syndrome is a recently described condition. The diagnosis of this condition is based on the presence of thrombotic events without previous predisposition and the positivity of anti-phospholipid antibodies. Its clinical presentation includes a variety of patterns, some of which are not included within the clinical criteria of the diagnosis, but must be known. Dermal involvement as livedo reticularis is common. However, dermal necrosis is not usual. Thus, a case of antiphospholipid syndrome with dermal necrosis is presented as a primary manifestation of the disease.

Sistema universal de saúde e cobertura universal: desvendando pressupostos e estratégias / Universal health system and universal health coverage: assumptions and strategies

Resumo Nos últimos anos, acirrou-se o debate internacional sobre diferentes concepções de universalidade em saúde, polarizado nas propostas de sistema universal versus cobertura universal em saúde. A concepção de cobertura universal tem sido difundida por organizações internacionais e incorporada às reformas dos sistemas de saúde de alguns países em desenvolvimento, inclusive na América Latina. O artigo explora os pressupostos e as estratégias relacionados à proposta de cobertura universal de saúde. Inicialmente contrastam-se as concepções de universalidade nos modelos de cobertura universal e de sistemas universais de saúde. A seguir, contextualiza-se o debate internacional, incluindo exemplos de diferentes sistemas de saúde. Por fim, discutem-se as implicações da concepção de cobertura universal para o direito à saúde no Brasil. A análise das diferentes concepções de universalidade e das experiências de países evidenciam que arranjos de seguros (privados ou sociais) não superam as fortalezas de sistemas públicos universais de saúde. A compreensão dos projetos em disputa no cenário internacional é fundamental para identificar possibilidades e ameaças à consolidação do Sistema Único de Saúde no Brasil.

Abstract In recent years the international debate about universality in health has been marked by a polarization between ideas based on a universal system, and notions proposing universal health coverage. The concept of universal coverage has been disseminated by international organizations and has been incorporated into health system reforms in several developing countries, including some in Latin America. This article explores the assumptions and strategies related to the proposal of universal health coverage. Firstly, a comparison is provided of the models of universal health coverage and universal health systems. This is followed by a contextualization of the international debate, including examples of different health systems. Finally, the implications of the proposal of universal coverage for the right to health in Brazil are discussed. The analysis of different concepts of universality and the experiences of different countries shows that health insurance-based models, either social or private, are not as satisfactory as public, universal health systems. Greater understanding about ongoing international projects is essential in order to identify the possibilities represented by the consolidation of the Unified Health System (SUS) in Brazil, as well as the risks of dismantling the SUS.

Laudato Si': a bridge towards access to medicines / Laudato Si': uma ponte para acesso a medicamentos

Pope Francis' Encyclical Laudato Si', albeit not explicitly, has drawn attention worldwide to the access to medicines as a fundamental human right, as it raises awareness about the current situation of the world and the poor. The reflections set forward by the Encyclical Laudato Si' bring us to the intersections between trade and health care, and how to correctly frame the need for innovation, affordable and accessible health technologies to those in need and how to reach the poorest of the poor. The issues of how to provide access, promote innovation, stimulate reasonable competitive market forces and ensure viable supply are central to the question of how to address Universal Human Rights. Also in this context, intellectual property has gained particular significance with increased attention to new essential medicines for the treatment of diseases of global incidence, including communicable and non-communicable diseases. This article intends to bring elements for a reflection on the debate on universal access to medicines.

A Encíclica Laudato Si' do Papa Francisco, ainda que não explicitamente, chamou a atenção mundial para o acesso aos medicamentos como um direito humano fundamental, quando conscientiza sobre a situação atual do mundo e dos pobres. As reflexões propostas pela Encíclica Laudato Si' nos trazem as interseções entre o comércio e a saúde, como enquadrar corretamente a necessidade de ter tecnologias de saúde inovadoras, acessíveis aos necessitados e como alcançar os mais pobres dos pobres. As questões sobre maneiras de fornecer acesso, promover inovação, estimular forças de mercado competitivas razoáveis e assegurar fornecimento viável são centrais para a questão de como abordar os Direitos Humanos Universais. Também neste contexto, a propriedade intelectual ganhou particular importância com maior atenção a novos medicamentos essenciais para o tratamento de doenças de incidência global, tanto as transmissíveis como as não transmissíveis. Este artigo pretende trazer elementos de reflexão para o debate sobre o acesso universal a medicamentos.

Hereditary thrombophilia by factor V Leiden G1691A (heterozygous) and FII prothrombin G20210A (homozygous) mutations in a patient with ischemic cerebrovascular accident / Trombofilia hereditária por mutações G1691A do fator V Leiden (heterozigota) e G20210A do FII protrombina (homozigota) em paciente com acidente vascular cerebral isquêmico

ABSTRACT Mutations related to Factor V Leiden (G1691A) and prothrombin (G20210A) are associated with a significantly increased risk of venous thromboembolism. The identification of a patient affected by episodes of venous thromboembolism and carrier of G1691A (heterozygous) and G20210A (homozygous) polymorphisms was determined by molecular tests [real-time polymerase chain reaction (PCR) methodology, Genexpert system] during attendance at the Base Hospital of São José do Rio Preto-SP, Brazil.

RESUMO Mutações relacionadas com o fator V de Leiden (G1691A) e a protrombina (G20210A) estão associadas a um significativo aumento do risco de tromboembolismo venoso. Por meio da realização de exames moleculares [metodologia de reação em cadeia da polimerase (PCR) em tempo real, sistema Genexpert], em pacientes atendidos no Hospital de Base de São José do Rio Preto-SP, Brasil, foi determinada a identificação de uma paciente afetada por episódios de tromboembolismo venoso e portadora dos polimorfismos G1691A (heterozigota) e G20210A (homozigota).

Prevalencia de mercurio y plomo en población general de Bogotá 2012/2013 / Mercury and lead prevalence in a sample of people living in Bogotá, 2012-2013

Objetivos Establecer la prevalencia de mercurio y plomo en población general de Bogotá, posibles efectos en salud y relación con zonas de exposición ambiental. Métodos Estudio transversal, muestra de 401 individuos de población general de Bogotá, distribuida aleatoria y proporcionalmente según localidad y zonas de exposición ambiental de alto, medio y bajo riesgo. Se realizó valoración médica y cuantificación de plomo (sangre) y mercurio (sangre, cabello, orina). Se realizó análisis descriptivo preliminar. Resultados Edad de los participantes: 3-91 años (media 46), ocupación más frecuente ama de casa (45,1 %, n=181); promedios de concentraciones: mercurio en cabello: 1,00 µg/g, sangre: 3,13 µg/L, y orina: 0,29 µg/L; plomo en sangre: 8,62 µg/dL. Individuos con concentraciones superiores a los valores de referencia internacionales: 54 (13,5 %) para mercurio (OMS); 10 (2,5 %) para plomo (CDC). Los hallazgos clínicos son inespecíficos, las zonas de exposición no parecen relacionarse con las concentraciones encontradas. Discusión Un porcentaje importante de individuos presentan concentraciones elevadas de los metales estudiados, lo que resalta la necesidad de identificar y controlar las fuentes ambientales de mercurio y plomo que están afectando a la población general de Bogotá, con posibles consecuencias en su salud.(AU)

Objectives Establishing mercury and lead prevalence in a sample of people living in Bogotá, potential effects on their health and the relationship with areas of environmental exposure. Methods This was a cross-sectional study involving a randomly and proportionally distributed sample of 401 people living in Bogotá, according to locality and their high, medium and low risk environmental exposure. A medical assessment was made and lead (in blood) and mercury levels (blood, hair, urine) quantified. A preliminary descriptive analysis was made. Results The participants were aged 3-91 years-old (mean 46), the most frequently occurring occupation was that of housewife (45.1%, n=181). Mean mercury concentration in hair was 1µg/g, 3.13 µg/L in blood and 0.29 µg/L in urine; lead in blood was found to be 8.62 µg/dL. Fifty-four people (13.5%) had higher concentrations than international reference values for mercury (WHO) and 10 (2.5%) for lead (CDC). Clinical findings were non-specific; exposure areas did not seem to relate to the concentrations found. Discussion A significant percentage of the study population had high mercury and/or lead levels and such high prevalence highlights the need for identifying and controlling sources of exposure to mercury and lead which could have adverse consequences regarding the health of Bogota’s general population.(AU)

Selle apical con MTA en un diente conapexogénesis incompleta: reporte de caso / Apical seal using MTA in a tooth with incomplete apexogenesis: case report

Al momento de la erupción, los dientes permanentes presentan una formación radicular incompleta, lapulpa dental es la responsable de culminar el proceso de formación radicular por medio de la producciónde dentina a partir de los odontoblastos, si esta se ve afectada por traumatismos alterando su vitalidadpuede causar una interrupción en la formación normal de la raíz dental interrumpiendo su apexogénesis.Se presenta un caso de formación radicular incompleta después de realizarse un procedimiento derevascularización en un incisivo lateral derecho con antecedentes de luxación intrusiva. Después de cincoaños de seguimiento radiográfico no presenta cierre apical. Se realiza procedimiento de apexificación conMTA material que puede ser considerado como una opción para el tratamiento de dientes permanentesinmaduros y que han sufrido algún tipo de trauma.

Permanent teeth present an incomplete root formation at the eruption time. The dental pulp completethe process of root formation producing dentine from the odontoblasts whenever it was affected by anyinjury altering its vitality could cause a disruption in the normal formation of the dental root interruptingits apexogénesis. We report a case of incomplete root formation after a revascularization procedureperformed in a right lateral incisor with a history of intrusive luxation. After five years of a radiographicfollow-up, apical closure was not observed. Apexification was therefore performed using MTA materialwhich has properties that could be considered as an option for treatment of immature teeth that havesuffered from some kind of trauma in order to achieve its preservation after losing its pulp vitality.

Inserción laboral, desarrollo profesional y desempeño institucional de las (os) egresadas (os) del Plan Único de Especialización en Enfermería de la ENEO-UNAM: una experiencia de doce años / Labor market integration, professional development, and institutional performance of the graduates from the unique plan of specialization in nursing of the ENEO-UNAM: a 12 year experience

Objetivo: Analizar las características que adopta la Inserción y desempeño laboral así como el Desarrollo profesional de las egresadas(os) del Plan Único de Especialización en Enfermería (PUEE) de la ENEO-UNAM. Marco Teórico. Inserción Laboral es un término usado para referirse al proceso de incorporación de los individuos a la actividad económica. El desarrollo profesional, es el fruto de la carrera, comprende los aspectos que enriquecen a la persona con vistas hacia el logro de metas dentro de la organización. El desempeño institucional incluye acciones o comportamientos de los empleados, relevantes para con los objetivos de la organización medidos en términos de competencias y niveles de contribución. Metodología. Estudio descriptivo y transversal, las variables de la inserción laboral fueron: Centro/institución de trabajo, categoría, antigüedad, salario y funciones principales. Las dimensiones del desarrollo profesional fueron: responsabilidad, autonomía, trabajo en equipo y posicionamiento. Las del desempeño Institucional: características de la Institución empleadora, satisfacción con el desarrollo profesional del egresado, y vinculación con la ENEO. La muestra fue de 417 egresados y trece instituciones encuestadas. Para el Desempeño Institucional se aplicaron 86 cuestionarios, a personal directivo de enfermería tanto de instituciones públicas como privadas. Resultados. La Inserción laboral mostró que la actividad principal desarrollada por los egresados es la atención directa, en Desarrollo Profesional los egresados perciben que la especialidad les habilitó para actuar con responsabilidad, autonomía, y trabajar en equipo, pero en el ámbito laboral el reconocimiento es limitado. El perfil del egresado coincide con lo requerido por las instituciones empleadoras y el desempeño es percibido como bueno.

Objective: Analyze the characteristics of the processes of labor market integration and performance, as well as professional development in the graduates from the Unique Plan of Specialization in Nursing (UPSN) of the ENEO-UNAM. Theoretical Frame: Labor market integration is a term commonly used to refer the process of incorporating individuals into the economic activity. Professional development is the fruit of the career and includes the aspects which enrich the person towards the achievement of goals within the organization. Institutional development includes the actions or behaviors of the employees which are relevant to the objectives of the organization, and which can be measured in terms of competences and contribution levels. Methodology: This is a basic and descriptive study and the measured variables of labor market integration were; center/institution of work, category, seniority, salary, and principal functions; the dimensions of professional development were; responsibility, autonomy, team-work, and position; and the dimensions of institutional performance were; employer characteristics, satisfaction with the graduate's professional performance, and bonds with the ENEO. The sample included 417 graduates from the UPSN, and 13 institutions. To collect data related to institutional performance, 86 questionnaires were given to the directive nursing staff of both the public and private institutions. Results: labor market integration showed that the graduate's principal activity is direct attention. In relation to professional development, graduates perceive that their specialties enable them to perform with responsibility and autonomy, and to work in teams, but also that the acknowledgement is limited. The graduate's profile fits that required from the employer institutions, with a performance perceived as good.

Comparación de la biodisponibilidad y la farmacocinética entre dos formulaciones de tabletas de metforminade 850 mg en voluntarios colombianos sanos / Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers

Purpose: The aim of this study was to compare the bioavailability of two formulations of metformin 850 mg tablets: Glucophage® from Merck Santè laboratories (reference product) and Metformin from Winthrop Pharmaceuticals de Colombia SA (test product) in healthy Colombian volunteers.Methods: A random, double blind, two-period, two-week wash out period, crossover study was performed in 24 healthy male and female volunteers for a single 850-mg dose of metformin tablets administrated with 240 ml of water after 12 hours of fasting. Once the drug was administrated, blood samples were collected before and within 24 hour, and plasma metformin concentration was determined by using a validated HPLC method. Pharmacokinetic parameters such as Cmax, AUC0-96h, AUC0-∞, and Tmax were determined. The formulations were considered bioequivalent if the logarithmic mean ratios of ln-transformed Cmax and AUC0-∞ values were within the equivalence range of 80%-125%.Results: ANOVA analysis of the ln-transformed Cmax and AUC0-∞ indicated that none of the effects examined (formulation, period, within and between-subjet variances and carry over) was statistically significant. The mean (±SD) of Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-∞, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 2.57 (± 0.93) h vs. 2.22 (± 0.94) h were obtained with test and reference formulations, respectively. These pharmacokinetic parameters presented differences with the results from other published papers. The 90% confidence interval of the logarithmic ratio of AUC0-∞ and Cmax was within the range of 80-125%.Conclusions: In this study in healthy Colombian volunteers, a single 850-mg dose of metformin tablet test formulation met the criteria for bioequivalence to the reference formulation based on pharmacokinetic parameters AUC0-∞ and Cmax.

Objetivo: El objetivo de este estudio es comparar la bioequivalencia de dos formulaciones de tabletas de metformina de 850 mg: Glucophage® del Laboratorio Merck Santè (producto de referencia) y metformina de Laboratorios Winthrop Pharmaceuticals de Colombia SA (producto de prueba), en voluntarios colombianos sanos.Métodos: Se realizó un estudio aleatorizado, doble ciego, cruzado, en dos períodos y con un tiempo de lavado de dos semanas, en 24 voluntarios sanos, hombres y mujeres, que recibieron una dosis única de metformina de 850 mg, con 240 ml de agua, después de 12 horas de ayuno. Luego de la administración del medicamento, se recolectaron muestras de sangre durante 24 horas y las concentraciones plasmáticas de metformina se determinaron con un método de HPLC validado. Se calcularon los parámetros farmacocinéticos: Cmax, AUC0-96h, AUC0-∞, y Tmax. Las formulaciones se consideraron bioequivalentes si la relación de la media transformada a ln de Cmax y AUC0-∞ estaba dentro del rango de bioequivalencia de 80% a 125%.Resultados: El Anova de los datos transformados a ln de Cmax y AUC0-∞ indicaron que ninguno de los efectos analizados (formulación, período, variación intra e intersujetos y arrastre) fueron estadísticamente significativos. La media (±SD) de los parámetros obtenidos para los productos de prueba y de referencia, respectivamente, fueron: Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-∞, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 2.57 (± 0.93) h vs. 2.22 (± 0.94) h. El intervalo de confianza de la relación logarítmica del AUC0∞ y Cmax se encontró dentro del rango de 80% a 125%.

Efecto de la inactivación de caries sobre la carga bacteriana intraoral en niños / Effect of inactivation of caries on the intraoral bacterial load in children

El derecho a la salud es un concepto que se trasciende a sí mismo, pues están implícitos derechos sociales, culturales y económicos. La medicina preventiva, dentro de la salud pública, es hoy día el principal objetivo de la mayor parte de los programas sanitarios y constituye el futuro de la medicina. La caries dental puede definirse como una enfermedad de naturaleza infecciosa, que resulta de la interacción de varios factores, ocasionando la pérdida de estructuras dentales mineralizadas, la remoción del tejido con caries y sellado de todas las lesiones es un procedimiento clínico de fundamental importancia, que inhibe el progreso de la lesión y reduce la microbiota bucal cariogénica, una vez que se remueve los nichos de retención bacteriana. Por lo expuesto precedentemente se planteó la realización de este estudio con el objetivo de determinar el efecto de la inactivación de caries sobre la carga bacteriana intraoral en 8 sujetos menores de 6 años de edad, divididos en dos grupos en los que se midió la carga bacteriana intraoral previa y a los 7 días de la inactivación de caries dependiendo si el sujeto correspondía al grupo experimental o control. Posteriormente se procedió al cultivo e identificación de microorganismos y se pudo observar una disminución de recuento microbiano (aerobios y anaerobios) en general en los grupos de control y de estudio, sobre todo en anaerobios. En el grupo de estudio en un caso hubo un aumento. Estos resultados nos sugieren la realización de otros trabajos ampliando el número de muestra y considerando otros factores que permitan obtener conclusiones más contundentes.

A proposal for an evaluation model of pharmaceutical services for malaria / Uma proposta de modelo de avaliação para a assistência farmacêutica na malária

Malaria is a serious public health problem in over 90 countries worldwide. In Brazil the disease is prevalent in the Amazon and the control rationale is based on early diagnosis and treatment. Quality pharmaceutical services are considered a key element for control. A proposal for evaluating pharmaceutical services for malaria is presented here. A theoretical outline composed of a logical model and an indicator framework is discussed and strives to establish a basis for assessment and judgment of the way in which these services are actually delivered. The aim is to contribute to the understanding of pharmaceutical services for malaria and other endemic diseases, complying with the directives of the Brazilian National Medicines Policy.

A malária é um grave problema de saúde pública em cerca de 90 países. No Brasil, a Amazônia congrega o maior número de casos. No país, o racional de enfrentamento se baseia em diagnóstico precoce e tratamento. A assistência farmacêutica de qualidade é considerada elemento-chave para o controle da doença. Apresenta-se uma proposta de avaliação da assistência farmacêutica, composta por um modelo lógico e uma grade de indicadores, discutidos de modo a estabelecer uma base de comparação e julgamento da forma na qual os serviços são ofertados. O objetivo é contribuir para o entendimento da assistência farmacêutica na malária e em outras endemias, atendendo às diretrizes da Política Nacional de Medicamentos.

Alteraciones neuropsicológicas en pacientes con depresión mayor / Neuropsychological disorders in patients with major depression

Objetivos. Comparar el desempeño neuropsicológico entre adultos con Trastorno Depresivo Mayor (TDM) y adultos sin depresión en tres dominios cognitivos: atención, memoria explícita y función ejecutiva. Materiales y métodos. 18 adultos con TDM y 15 adultos sin depresión se evaluaron a través de pruebas neuropsicológicas como Stroop, TMT, TAVEC, figura de Rey, Wisconsin-64, entre otras, y se compararon sus resultados. Resultados. No se encontraron diferencias en memoria explícita, pero sí en una medida de atención sostenida y en las medidas de conceptualización, organización perceptual y análisis/síntesis en función ejecutiva, con peores resultados para los adultos con TDM; las quejas de memoria también fueron significativas en éstos. Conclusiones. Las fallas en memoria, frecuentemente reportadas en los estudios y referidas por los pacientes, pueden deberse principalmente a fallas importantes en la atención o la función ejecutiva, las cuales explicarían las dificultades para la codificación y la evocación de la información.

Objectives. To compare neuropsychological performance between adults with Major Depressive Disorder (MDD) and adults without depression on three cognitive domains: attention, explicit memory and executive function. Materials and methods. 18 MDD adults and 15 adults without depression were evaluated by neuropsychological tests such as Stroop, TMT, TAVEC, Rey figure, Wisconsin-64, and others, and compared their performance. Results. No differences in explicit memory were found, but differences in a sustained attention measure and conceptualization and perceptual organization and analysis/synthesis in executive function, with worse results for MDD adults. Memory complaints were also significant in MDD adults. Conclusions. Memory failures, frequently reported in studies and referred by patients, can be due basically to important failures in attention or executive function, which could explain difficulties for information codification and recall.

Estudio de bioequivalencia de clonazepam, tabletas de 2 mg, en voluntarios sanos colombianos / Bioequivalence study of clonazepam 2 mg tablets in colombian healthy volunteers

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.

Bioequivalencia entre dos formulaciones comerciales de gliclazida en Colombia / Bioequivalence between two commercial formulations of gliclazide in Colombia

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

Estudio de bioequivalencia de dos formulaciones de tabletas de carbamazepina de liberación retardada / Study of bioequivalence of two carbamazepine retard-release tablet formulations

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.