Ethical challenges in research regarding aging population. / Desafíos a la ética en la investigación frente al envejecimiento poblacional.

Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.

El mundo está experimentando un acelerado proceso de envejecimiento poblacional. Este cambio epidemiológico se asocia a la necesidad de incrementar la investigación orientada a mejorar la calidad de vida en las edades avanzadas. Esta investigación requiere de la participación de personas mayores, tanto en áreas del ámbito científico-tecnológico como en el sociocultural. Esta realidad lleva a plantear una serie de interrogantes relacionadas con la forma como se desarrolla esta actividad con las personas mayores, relacionadas con las brechas, desigualdades e inequidades, su vulnerabilidad, su acceso a los productos generados, su capacidad para consentir, entre otros. El objetivo del ensayo es reflexionar acerca de algunas de estas interrogantes, revisando algunos de los preceptos básicos de la ética de la investigación en seres humanos, y plantear algunas necesidades y desafíos para la actualización en las pautas y guías que la orientan. Se espera que las personas mayores que participan en investigación biomédica sean respetadas, se les asegure un adecuado balance riesgo/beneficio y se seleccionen en forma equitativa. Estos principios básicos, aunque reconocidos en términos generales por las guías y regulaciones éticas disponibles, no están completamente garantizados, como evidenció la pandemia de COVID-19. El tema plantea diversos desafíos y amerita su consideración en las pautas y guías éticas para la investigación biomédica con participación de personas mayores.

Desafíos a la ética en la investigación frente al envejecimiento poblacional / Ethical challenges in research regarding aging population

El mundo está experimentando un acelerado proceso de envejecimiento poblacional. Este cambio epidemiológico se asocia a la necesidad de incrementar la investigación orientada a mejorar la calidad de vida en las edades avanzadas. Esta investigación requiere de la participación de personas mayores, tanto en áreas del ámbito científico-tecnológico como en el sociocultural. Esta realidad lleva a plantear una serie de interrogantes relacionadas con la forma como se desarrolla esta actividad con las personas mayores, relacionadas con las brechas, desigualdades e inequidades, su vulnerabilidad, su acceso a los productos generados, su capacidad para consentir, entre otros. El objetivo del ensayo es reflexionar acerca de algunas de estas interrogantes, revisando algunos de los preceptos básicos de la ética de la investigación en seres humanos, y plantear algunas necesidades y desafíos para la actualización en las pautas y guías que la orientan. Se espera que las personas mayores que participan en investigación biomédica sean respetadas, se les asegure un adecuado balance riesgo/beneficio y se seleccionen en forma equitativa. Estos principios básicos, aunque reconocidos en términos generales por las guías y regulaciones éticas disponibles, no están completamente garantizados, como evidenció la pandemia de COVID-19. El tema plantea diversos desafíos y amerita su consideración en las pautas y guías éticas para la investigación biomédica con participación de personas mayores.

Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.

Neurobiology of Disorganized Attachment: A Review of Primary Studies on Human Beings.

This article describes and analyzes various aspects related to the neurobiology of disorganized attachment (DA), which is associated with personality, eating, affective, dissociative, and addictive disorders. We included primary studies in humans, published in PubMed from 2000 to 2022. Eight genetic and one epigenetic study were considered. Three molecular studies describe possible roles of oxytocin and cortisol, seven neurophysiological studies investigated functional correlates, and five morphological studies describe anatomical changes. Findings in candidate genes involved in dopaminergic, serotonergic, and oxytonergic systems have not been able to be replicated in large-scale human studies. Alterations in the functioning of cortisol and oxytocin are preliminary. Neurophysiological studies show changes in subcortical structures (mainly in the hippocampus) and occipital, temporal, parietal, and insular cortices. Since there is a lack of robust evidence on the neurobiology of DA in humans, the possible inferences of these studies are preliminary, which restricts their translation to clinical parameters.

Perfeccionismo, estrés académico y ansiedad social en mujeres estudiantes de medicina y riesgo de padecer un trastorno alimentario: un modelo multivariado / Perfectionism, academic stress and social anxiety in female medical students and the risk for eating disorders

BACKGROUND: Both perfectionism and social anxiety have been described in patients with eating disorders (ED) and medical students. Academic stress also can increase the risk of developing ED. AIM: To analyze the dimensions of perfectionism, social anxiety, and academic stress associated with the risk of developing ED in female medical students. MATERIAL AND METHODS: The Multidimensional Perfectionism Scale, the Liebowitz Social Anxiety Scale, the SISCO academic stress inventory and the Eating Attitudes Test-26, were applied to 163 female medical students from all levels of the career. The groups with and without risk of ED were compared according to these variables. Results: Twenty-four percent of respondents were at risk of ED. There were significant differences between scores of perfectionism, social anxiety, and academic stress between respondents with and without risk for ED. In general, there was a significant correlation among the variables. In a multivariate analysis, the predictors of ED risk were the perception of academic stress (Odds ratio (OR) 1.09; 95% confidence intervals (CI) 1.03-1.16) and personal standards in the context of perfectionism (OR 1.16; 95% CI 1.06-1.27). CONCLUSIONS: A substantial proportion of female medical students were at risk for ED. The risk of ED was determined mainly by academic stress and personal standards in the context of perfectionism. In this sample, social anxiety did not play a relevant role.

Inmunosenescencia, infecciones virales y nutrición: revisión narrativa de la evidencia científica disponible / Immunosenescence, viral infections and nutrition: A narrative review of scientific available evidence

El envejecimiento del sistema inmune o «inmunosenescencia» afecta a la respuesta inmune viral en el adulto mayor, sobre todo si existe fragilidad. Algunos hallazgos destacan un desbalance en los mecanismos pro- y antiinflamatorios, una menor producción y diversificación de linfocitos T, alteración de la inmunovigilancia y en la síntesis de anticuerpos ante la inmunización. En este contexto, la nutrición cobra gran importancia al combatir la sarcopenia y la fragilidad. Algunos componentes alimentarios que contribuyen en la inmunocompetencia son las proteínas, la vitamina D, los ácidos grasos n-3, las vitaminas antioxidantes (vitaminas C y E), el cinc, el selenio y el hierro. En tiempos de pandemia, las recomendaciones nutricionales que apunten a la inmunocompetencia en el adulto mayor deben basarse en estudios clínicos. En este artículo se abordan la inmunosenescencia y su relación con la nutrición, incluyendo intervenciones estudiadas en el contexto de la pandemia por COVID-19. (AU)

Aging of the immune system, or immunosenescence, alters the viral immune response in the elderly, especially when frailty exists. Research findings have demonstrated an imbalance in pro- and anti-inflammatory mechanisms, reduced production and diversification of T lymphocytes, and an alteration in immunovigilance and antibody synthesis. In this context, nutrition has a role in combating sarcopenia and frailty. Some food components that contribute to immune-competence are protein, vitamin D, n-3 fatty acids, antioxidant vitamins (vitamins C and E), zinc, selenium and iron. In times of a pandemic, nutritional recommendations for immune-competence in the elderly should be based on clinical studies. In this article, immunosenescence and its relationship to nutrition are addressed, including interventions studied in the context of the COVID-19 pandemic. (AU)

[Perfectionism, academic stress and social anxiety in female medical students and the risk for eating disorders]. / Perfeccionismo, estrés académico y ansiedad social en mujeres estudiantes de medicina y riesgo de padecer un trastorno alimentario: un modelo multivariado.

BACKGROUND: Both perfectionism and social anxiety have been described in patients with eating disorders (ED) and medical students. Academic stress also can increase the risk of developing ED. AIM: To analyze the dimensions of perfectionism, social anxiety, and academic stress associated with the risk of developing ED in female medical students. MATERIAL AND METHODS: The Multidimensional Perfectionism Scale, the Liebowitz Social Anxiety Scale, the SISCO academic stress inventory and the Eating Attitudes Test-26, were applied to 163 female medical students from all levels of the career. The groups with and without risk of ED were compared according to these variables. RESULTS: Twenty-four percent of respondents were at risk of ED. There were significant differences between scores of perfectionism, social anxiety, and academic stress between respondents with and without risk for ED. In general, there was a significant correlation among the variables. In a multivariate analysis, the predictors of ED risk were the perception of academic stress (Odds ratio (OR) 1.09; 95% confidence intervals (CI) 1.03-1.16) and personal standards in the context of perfectionism (OR 1.16; 95% CI 1.06-1.27). CONCLUSIONS: A substantial proportion of female medical students were at risk for ED. The risk of ED was determined mainly by academic stress and personal standards in the context of perfectionism. In this sample, social anxiety did not play a relevant role.

[Immunosenescence, viral infections and nutrition: A narrative review of scientific available evidence]. / Inmunosenescencia, infecciones virales y nutrición: revisión narrativa de la evidencia científica disponible.

Aging of the immune system, or immunosenescence, alters the viral immune response in the elderly, especially when frailty exists. Research findings have demonstrated an imbalance in pro- and anti-inflammatory mechanisms, reduced production and diversification of T lymphocytes, and an alteration in immunovigilance and antibody synthesis. In this context, nutrition has a role in combating sarcopenia and frailty. Some food components that contribute to immune-competence are protein, vitamin D, n-3 fatty acids, antioxidant vitamins (vitamins C and E), zinc, selenium and iron. In times of a pandemic, nutritional recommendations for immune-competence in the elderly should be based on clinical studies. In this article, immunosenescence and its relationship to nutrition are addressed, including interventions studied in the context of the COVID-19 pandemic.

Healthy sustainable food patterns and systems: a planetary urgency. / Patrones y sistemas alimentarios saludables y sostenibles: una urgencia planetaria.

Food choice impacts human health and planetary sustainability. The feeding patterns that reduce risk factors for noncommunicable diseases and various mortality causes are recognized as healthy eating habits. The average world population is far from reaching these habits due to the lack of access to healthy foods and a high prevalence of malnutrition. Understanding the impact of healthy sustainable food systems is growing worldwide to reach food security for the global population and future generations. A systemic perspective of this concept includes the health and well-being of individuals and the environmental, economic, socio-cultural, public policies context, besides food, agriculture, and ecological sciences. We need to confront the menaces and challenges represented by the ongoing changes of our era, which strongly generate global food insecurity. This issue is relevant not only for human health but also for climate change and other threats, based on modifications in production, handling, and consumption of foods that consider health and welfare impact at individual and planetary levels. In this review, some key concepts related to healthy and sustainable food systems are presented.

La elección de los alimentos a consumir es determinante de la salud humana y la sostenibilidad planetaria. Existen patrones dietéticos que contribuyen a reducir factores de riesgo de enfermedades no transmisibles y algunas causas de mortalidad, denominados “patrones alimentarios saludables”. A nivel global, la población está lejos de alcanzarlos, salvo excepciones, debido a la falta de acceso a una diversidad de alimentos de buena calidad nutricional, y existe una alta prevalencia de malnutrición. Cada vez es más relevante la comprensión del impacto de la implementación de sistemas alimentarios saludables y sostenibles, para alcanzar la seguridad alimentaria en el presente y en las futuras generaciones. Este concepto, de carácter sistémico, abarca no sólo la salud y bienestar de las personas, sino también el contexto ambiental, económico, socio-cultural. Asimismo, involucra un enfoque de políticas públicas, ciencias de los alimentos, agricultura y ecología, entre otras, para enfrentar las amenazas y desafíos que representan los cambios de esta era, los cuales repercuten en inseguridad alimentaria y malnutrición a nivel planetario. En esta revisión se definen conceptos clave relacionados con los patrones alimentarios saludables y sostenibles, aspectos relevantes para la salud humana. También se aborda la urgente necesidad de enfrentar el cambio climático y otras amenazas, basada en transformar las formas de producir, manejar y consumir los alimentos, considerando cómo afectan la salud y el bienestar a nivel individual y planetario.

Diet and depressive disorders

ABSTRACT Background: The importance of foods or food constituents in mental health is increasingly recognized, and "nutritional psychiatry" is a growing discipline. Objective: This narrative review aims to present work supporting associations between food or food constituents and mental health, specifically depressive disorders. Methods: The data presented is derived from preclinical and clinical work, including in vitro and in vivo assays, as well as observational studies and randomized clinical trials of dietary interventions. The focus of the review is the mediation of inflammatory processes and oxidative stress by dietary constituents that are an integral part of a healthy diet, such as the Mediterranean diet and similar. Results and Discussion: We present evidence for the role of the diet in prevention and management of depressive disorders, beyond the effect of individual nutrients. The findings indicate that among the dietary components with higher degree of evidence to influence depressive disorders are long chain n-3 polyunsaturated fatty acids (EPA and DHA), and various dietary bioactive compounds, especially plant-derived secondary metabolites represented by polyphenols such as flavonoids and resveratrol. Conclusion: Diet exerts an important role on mental health, and evidence indicates that some dietary constituents contribute to the prevention of depressive disorders.

Contenido de humedad, proteínas y minerales en diez variedades de quínoa chilena cultivadas en distintas zonas geográficas / Moisture, protein and mineral content of ten varieties of Chilean quinoa grown in different geographic zones

RESUMEN El consumo de quínoa (Chenopodium quínoa Willd) ha aumentado, renovando el interés en su composición y valor nutricional. El objetivo del estudio fue determinar los contenidos de humedad, cenizas, proteínas y algunos minerales (Fe, Zn y Cu) de 10 variedades de quínoa chilena cultivadas en cuatro zonas geográficas, utilizando metodologías analíticas validadas. Las muestras (n=10) de quínoa cultivada en Vallenar, Los Tilos, Hidango y Santa Rosa fueron analizadas en triplicado. Los métodos normalizados aplicados fueron: humedad; cenizas; proteínas; hierro, zinc y cobre, bajo los requisitos de ISO/IEC 17025:2017. Los datos se analizaron usando análisis de varianza para comparar variedades y zonas de cultivo. Las muestras contienen en promedio 16,6 g de proteínas/100 g (14,4-17,5), 8,97 mg de hierro/100 g (7,71-10,76), 3,38 mg de zinc/100 g (2,17-5,30), y 0,83 mg de cobre/100 g (0,60-1,10). Las variedades cultivadas en Vallenar, Los Tilos e Hidango mostraron mayor contenido proteico que las de Santa Rosa (p<0,05). Todas las variedades tienen un contenido destacado de los microminerales cobre, zinc y hierro. Los resultados aportan información relevante sobre el valor nutricional de la quínoa chilena, entregando datos para la actualización de las Tablas de Composición Química de alimentos.

ABSTRACT The intake of quinoa (Chenopodium quinoa Willd) has increased worldwide. Its revival has renewed interest in its composition and nutritional value. The aim of this study was to determine the contents of moisture, ash, protein, and some minerals (Fe, Zn and Cu) of ten varieties of Chilean quinoa grown in various geographical zones, using validated analytical methods under rule ISO/IEC 17025:2017. Grains grown in Vallenar, Los Tilos, Hidango, and Santa Rosa were analyzed in triplicates, using previously validated analytical methodologies and certified reference materials. The normalized methods used were: moisture; ash; protein; mineral, under the ISO/IEC 17025:2017 norm. Data were analyzed using ANOVA to compare varieties and growth zones. The analyzed quinoa grains contain a mean of 16.6 g proteins/100 g (range 14.4-17.5), 8.97 mg iron/100 g (range 7.71-10.76), 3.38 mg zinc/100 g, and 0.83 mg copper/100 g (range 0.60-1.10). The varieties grown in Vallenar, Los Tilos and Hidango showed higher protein content compared to Santa Rosa (p<0.05). All varieties exhibit considerable microminerals content, such as copper, zinc, and iron. These results provide relevant information about the nutritional value of Chilean quinoa and updated reliable data for Food Composition Tables.

Uso de medicamentos y prescripciones potencialmente inadecuadas en adultos mayores autovalentes: estudio transversal descriptivo / Use of drugs and potentially inappropriate prescriptions in autonomous older adults: a descriptive cross-sectional study

Los adultos mayores (AM) presentan multimorbilidad y son vulnerables a las consecuencias de la polifarmacia, incluyendo las prescripciones potencialmente inadecuadas (PPI). El objetivo del estudio fue caracteri-zar a un grupo de AM de un centro de atención primaria de Chile, conocer su terapia farmacológica y pesquisar posibles interacciones medicamentosas. Se realizó un estudio transversal que incluyó a AM del programa Más AM Autovalentes. Se aplicaron instrumentos de recolección de datos y se revisaron sus fichas clínicas, describiendo sus condiciones socioeconómicas, clínicas y uso de medicamentos. Para detectar PPI se aplicaron los criterios de Beers. Se incluyeron 18 AM (94% mujeres), la mayoría con un bajo nivel socioeconómico. Las principales enfermedades crónicas fueron cardiovasculares y endocrino-metabólicas. El 66,7% presentó polifarmacia. Las PPI se relacionaron principalmente a fármacos antidepresivos, antipsicóticos y antiinflamatorios. Las PPI se asocian especialmente a comorbilidades de patologías crónicas, lo que hace necesario monitorizar permanentemente la respuesta de los AM a la terapia administrada (AU)

Older adults (OA) exhibit multimorbidity and are vulnerable to the consequences of polypharmacy, including potentially inappropriate prescriptions (PIP). The aim of the study was to characterize a group of older adults attending a public primary health center in Chile, examine their drug therapy and detect possible PIP. We conducted a descriptive cross-sectional study, including the OA attending the More Autonomous OA Program. Data collecting instruments were applied and the clinical records were revised, describing their socio-economic and clinical conditions and the use of medicines. To detect PIP the Beers' criteria were applied. Eighteen OA (94% women) were included, most of them with low socio-economic level. The main chronic diseases were cardiovascular and endocrine-metabolic; 66.7% presented polypharmacy and PIP were mainly related to the use of antidepressants, antipsychotics and anti-inflammatory drugs. PIP are associated to the comorbidities of chronic diseases, which makes it mandatory to monitor constantly the response of OA to the administered therapy (AU)

Gender, women and scientific research. / Género, mujeres e investigación científica.

Gender is a psychosocial construct referring to the socially built roles, behaviors, expressions and identities of girls, women, boys, men and people with gender diversity, while sex is related to the biological attributes of a woman or a man. Even though the terms sex and gender are often used in a binary way, there is considerable diversity in the way individuals and groups understand, experiment and express them. This narrative review describes some relevant aspects of the subjective difference that exists and favors men over women in the fields of sciences and research, starting from a historical perspective in the light of feminist movements. In particular, women are described as researchers - crea-tors of scientific knowledge, as well as the subjects of analysis. Some conflicts arising from sex bias, applied to biomedical research, are also analyzed, and cases are delivered that exemplify the disarray that has historically accompanied the female gender in this area, its ignorance and little cultural recognition. This review is the last article in a methodological series on general concepts in biostatistics and clinical epidemiology developed by the Chair of Methodology of Scientific Research of the School of Medicine of the Universidad de Valparaiso, Chile, which aims to address a contingent and cross-cutting theme to all scientific research.

El género es una construcción psicosocial referida a los roles, comportamientos, expresiones e identidades socialmente construidos de niñas, mujeres, niños, hombres y personas con diversidad de género, mientras que el sexo se relaciona con los atributos biológicos de una mujer o un hombre. Aun cuando los términos “sexo” y “género” suelen utilizarse de forma binaria, existe una diversidad considerable en la forma en que los individuos y los grupos los entienden, experimentan y expresan. En esta revisión narrativa se describen algunos aspectos relevantes acerca de la diferencia subjetiva que existe y favorece a los hombres frente a las mujeres en el ámbito de las ciencias e investigación, iniciando desde una perspectiva histórica a la luz de los movimientos feministas. En particular, se describe a la mujer en cuanto investigadora y creadora de conocimiento científico, como también en su calidad de sujeto de análisis. Se analizan además algunos conflictos derivados del sesgo de sexo aplicados a la investigación biomédica, y se entregan casos que ejemplifican el desmedro que ha acompañado históricamente al género femenino en este ámbito, su desconocimiento y poco reconocimiento cultural. Esta revisión es la última entrega de una serie metodológica sobre conceptos generales en bioestadística y epidemiología clínica desarrollada por la Cátedra de Metodología de la Investigación Científica de la Escuela de Medicina de la Universidad de Valparaíso, Chile, que pretende abordar una temática contingente y transversal a toda la investigación científica.

Main concepts on bioequivalence and biosimilarity in the Chilean legislation, and current controversies on drug interchangeability. / Conceptos fundamentales de bioequivalencia y biosimilitud en la normativa chilena y controversias sobre intercambiabilidad.

Medicines are an economic good and a fundamental component of public and private spending and health decision-making. Assurance of their quality, efficiency and safety is essential. However, the variety of products on the Chilean market, including innovative and generic productsthe latter accounted for by many products that are certified as bioequivalent while others are notresults in a potentially confusing scenario for consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (applicable to compounds of small molecular size) and biosimilarity (applicable to biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies carried out for this purpose. A direct application of the concept of bioequivalence is interchangeability, defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged, but also facilitate cost savings and access to medicines. Likewise, the implementation of evidence-based guidelines that standardize concepts of interchangeability should be encouraged, as this could lead to a more educated usage and a reduction in the information asymmetry between patients (users) and the industry. The importance of interchangeability of medicines is particularly relevant in two governmental health initiatives in Chile: the Explicit Health Guarantees Plan (GES) and the Financial Protection for Diagnoses and Treatments of High Cost, known as the Ricarte Soto Act. Nonetheless, it is not possible to guarantee that all alternative products to an innovative drug on the Chilean market are bioequivalent. The synthesis of knowledge available on this subject may impact and contribute to decision-making by stakeholders. It could also help to develop better health policies regarding bioequivalent and biosimilar pharmaceutical products in our country.

Los medicamentos constituyen un bien económico que forma parte del gasto público y privado y de la toma de decisiones en salud. El aseguramiento de su calidad, eficacia y seguridad resulta fundamental. Sin embargo, la variada oferta disponible en el mercado chileno, donde se reconocen productos innovadores y genéricos, constituye un escenario confuso para consumidores y proveedores en salud. En esta revisión pretendemos aclarar los conceptos de fármacos bioequivalentes (aplicable a compuestos de tamaño molecular pequeño) y fármacos biosimilares (para compuestos biológicos de mayor complejidad molecular). En ambos casos, el comportamiento en el organismo del principio activo debe ser demostrado mediante estudios realizados para este fin. Una aplicación directa del concepto de bioequivalencia es la intercambiabilidad, definida como la posibilidad de utilizar un producto de un mismo principio activo, mientras la forma farmacéutica y esquema de dosificación sean iguales. Las normas relativas a esta materia y los organismos públicos encargados, no solo debieran garantizar la seguridad y la eficacia en el intercambio entre productos, sino también aspectos relacionados con el costo, la accesibilidad a los fármacos y la implementación de una guía de homogeneización de conceptos y criterios de intercambiabilidad basados en la evidencia, lo cual impactaría en una mejor educación para los usuarios, reduciendo la asimetría de información entre el usuario y la industria. La importancia de la intercambiabilidad destaca en Chile en el contexto del Plan de Garantías Explícitas en Salud (GES) y la Ley de Protección Financiera para Diagnósticos y Tratamientos de Alto Costo en Salud (Ley Ricarte Soto). Sin embargo, no es posible garantizar que todos los productos alternativos al innovador presentes en el mercado chileno son bioequivalentes. El conocimiento disponible en esta temática puede impactar y contribuir a la toma de decisiones en los prescriptores y usuarios, así como en la elaboración de políticas públicas en torno a los productos farmacéuticos bioequivalentes y biosimilares en nuestro país.

In Vitro Assay of Quinoa (Chenopodium quinoa Willd.) and Lupin (Lupinus spp.) Extracts on Human Platelet Aggregation.

Cardiovascular disease (CVD) is the leading cause of death throughout the world. A major risk factor for CVD is platelet aggregation. Various plant extracts exhibit anti-aggregatory action in vitro. The dietary intake of traditional plant crops such as quinoa (Chenopodium quinoa Willd) and lupin (Lupinus spp., Fabaceae family), highly recognized for their high nutritional value, is increasing worldwide. The aim of the study was to assay possible antiplatelet effects of quinoa and lupin bean extracts in vitro. The proximate chemical composition of quinoa grains and the three most widely known lupin cultivars: blue (L. angustifolius), yellow (L. luteus or mutabilis) and white (L. albus) grown in Chile were analyzed. The anti-aggregation activity of the ethanol extracts of the crops was assayed using flow cytometry in ADP-stimulated human platelets, and their inhibition of the maximal platelet aggregation was measured. All the lupin extracts exhibited a significant anti-aggregatory effect (p < 0.0001), while quinoa extracts did not exert this effect compared to control platelets. In conclusion, lupin beans extracts exhibited an anti-aggregatory effect on activated human platelets.

Conceptos fundamentales de bioequivalencia y biosimilitud en la normativa chilena y controversias sobre intercambiabilidad / Chilean legislation on bioequivalence and biosimilarity and current controversies related to drug interchangeability

Los medicamentos constituyen un bien económico que forma parte del gasto público y privado y de la toma de decisiones en salud. El aseguramiento de su calidad, eficacia y seguridad resulta fundamental. Sin embargo, la variada oferta disponible en el mercado chileno, donde se reconocen productos innovadores y genéricos, constituye un escenario confuso para consumidores y proveedores en salud. En esta revisión pretendemos aclarar los conceptos de fármacos bioequivalentes (aplicable a compuestos de tamaño molecular pequeño) y fármacos biosimilares (para compuestos biológicos de mayor complejidad molecular). En ambos casos, el comportamiento en el organismo del principio activo debe ser demostrado mediante estudios realizados para este fin. Una aplicación directa del concepto de bioequivalencia es la intercambiabilidad, definida como la posibilidad de utilizar un producto de un mismo principio activo, mientras la forma farmacéutica y esquema de dosificación sean iguales. Las normas relativas a esta materia y los organismos públicos encargados, no solo debieran garantizar la seguridad y la eficacia en el intercambio entre productos, sino también aspectos relacionados con el costo, la accesibilidad a los fármacos y la implementación de una guía de homogeneización de conceptos y criterios de intercambiabilidad basados en la evidencia, lo cual impactaría en una mejor educación para los usuarios, reduciendo la asimetría de información entre el usuario y la industria. La importancia de la intercambiabilidad destaca en Chile en el contexto del Plan de Garantías Explícitas en Salud (GES) y la Ley de Protección Financiera para Diagnósticos y Tratamientos de Alto Costo en Salud (Ley Ricarte Soto). Sin embargo, no es posible garantizar que todos los productos alternativos al innovador presentes en el mercado chileno son bioequivalentes. El conocimiento disponible en esta temática puede impactar y contribuir a la toma de decisiones en los prescriptores y usuarios, así como en la elaboración de políticas públicas en torno a los productos farmacéuticos bioequivalentes y biosimilares en nuestro país.

Medicines are an economic good and a fundamental component of public and private health spending and decision-making. Assurance of their quality, efficiency, and safety is essential. In Chile, the wide variety of available drugs, including innovator products, and generics­some of which are certified as bioequivalent, while others are not­creates a potentially confusing scenario for both consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (the standard permitting interchangeability for small-molecule drugs) and biosimilarity (the standard permitting interchangeability for biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies designed and carried out for this purpose. Interchangeability is defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged but also facilitate cost savings and access to medicines. Implementation of evidence-based guidelines that standardize concepts of interchangeability could lead to more educated usage and reduced information asymmetry between patients (users) and industry. Drug interchangeability is particularly relevant in two government health initiatives in Chile: the Explicit Guarantees in Health Care (GES) plan, and the Law on Financial Protection for High-Cost Diagnostics and Treatment in Health Care (also known as the "Ricarte Soto Law"). Nonetheless, it is not possible to guarantee that all alternative drug products on the Chilean market are bioequivalents of the reference product. Synthesis of the available knowledge on bioequivalent and biosimilar pharmaceutical products in Chile could facilitate and contribute to stakeholder decision-making and the development of better health policies.

Using systematic reviews in the scientific substantiation of health properties of foods and food constituents. / La revisión sistemática como herramienta para la validación científica de propiedades saludables de los alimentos y factores alimentarios.

Systematic literature reviews are one of the main methodologies used to substantiate the health properties of foods and food constituents purported to affect human physiology. This tool is based on scientific evidence obtained from correctly performed randomized controlled trials. Systematic reviews make it possible to conclude whether there is a causal relationship between food consumed and health effects observed, thus supporting the use of the term “functional foods.” We present and analyze the prinicpal characteristics of, and ways by which, systematic reviews can contribute to the regulatory approval of health claims directed to consumers.

Las revisiones sistemáticas de literatura constituyen una de las principales metodologías utilizadas en la validación de las propiedades saludables de los alimentos, o factores alimentarios, que afectan la fisiología humana. Esta herramienta, basada en la evidencia obtenida a través de ensayos clínicos aleatorizados realizados con un diseño experimental adecuado, permite concluir si existe una relación causal entre el producto consumido y un efecto beneficioso para la salud, principio que sustenta el calificativo de los alimentos como “funcionales”. Se presentan y analizan las características y la forma en la que las revisiones sistemáticas pueden contribuir a que las agencias regulatorias aprueben un mensaje saludable (health claim), dirigido al consumidor.

Considerations for the Development of Innovative Foods to Improve Nutrition in Older Adults.

The population of older adults is growing globally. This increase has led to an accumulation of chronic illnesses, so-called age-related diseases. Diet and nutrition are considered the main drivers of the global burden of diseases, and this situation applies especially to this population segment. It relates directly to the development of coronary heart disease, hypertension, some types of cancer, and type 2 diabetes, among other diseases, while age-associated changes in body composition (bone and muscle mass, fat, sarcopenia) constitute risk factors for functional limitations affecting health status and the quality of life. Older adults present eating and swallowing problems, dry mouth, taste loss, and anorexia among other problems causing "anorexia of aging" that affects their nutritional status. The strategies to overcome these situations are described in this study. The impact of oral food processing on nutrition is discussed, as well as approaches to improve food acceptance through the design of innovative foods. These foods should supply a growing demand as this group represents an increasing segment of the consumer market globally, whose needs must be fulfilled.

Chemical Characterization and Antiplatelet Potential of Bioactive Extract from Tomato Pomace (Byproduct of Tomato Paste).

We examined the ability of tomato pomace extract (by-product) to affect platelet aggregation in healthy humans (clinical pilot study). In phase 1 the tolerance of participants (n = 15; 5 per dose level) ingesting tomato pomace extract across three dose levels (1, 2.5, and 10 g) was evaluated. Phase 2 was a single-blind, placebo-controlled, parallel design human (male, n = 99; 33 per group) pilot intervention trial investigating the acute and repeated dose effects (5 days) of different doses of tomato pomace extract (1 g, 2.5 g or placebo) on platelet aggregation ex vivo. Various flavonoids (coumaric acid, floridzin, floretin, procyanidin B2, luteolin-7-O-glucoside, kaempferol, and quercitin) and nucleosides (adenosine, inosine, and guanosine) were identified in the tomato pomace extract. The clinical study showed that the daily consumption of 1 g of aqueous extract of tomato pomace for 5 days exerted an inhibitory activity on platelet aggregation.

Roles of Phenolic Compounds in the Reduction of Risk Factors of Cardiovascular Diseases.

The population is now living longer during the period classified as "elderly" (60 years and older), exhibiting multimorbidity associated to the lengthening of the average life span. The dietary intake of phenolic compounds (PC) may affect the physiology, disease development and progression during the aging process, reducing risk factors of age related diseases. The aim of this review is to briefly describe some of the possible effects of a series of PC on the reduction of risk factors of the onset of cardiovascular diseases, considering their potential mechanisms of action. The main actions described for PC are associated with reduced platelet activity, anti-inflammatory effects, and the protection from oxidation to reduce LDL and the generation of advanced glycation end products. Preclinical and clinical evidence of the physiological effects of various PC is presented, as well as the health claims approved by regulatory agencies.