Assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows. The Panel considers that the information provided by the applicant does not fulfil the minimum requirements to support that Formi™ LHS remains safe under the approved conditions for target species, consumers and users. The Panel concludes that the use of Formi™ LHS under the approved conditions remains safe for the environment. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive.

A novel nitroalkene-α-tocopherol analogue inhibits inflammation and ameliorates atherosclerosis in Apo E knockout mice.

BACKGROUND AND PURPOSE: Atherosclerosis is characterized by chronic low-grade inflammation with concomitant lipid accumulation in the arterial wall. Anti-inflammatory and anti-atherogenic properties have been described for a novel class of endogenous nitroalkenes (nitrated-unsaturated fatty acids), formed during inflammation and digestion/absorption processes. The lipid-associated antioxidant α-tocopherol is transported systemically by LDL particles including to the atheroma lesions. To capitalize on the overlapping and complementary salutary properties of endogenous nitroalkenes and α-tocopherol, we designed and synthesized a novel nitroalkene-α-tocopherol analogue (NATOH) to address chronic inflammation and atherosclerosis, particularly at the lesion sites. EXPERIMENTAL APPROACH: We synthesized NATOH, determined its electrophilicity and antioxidant capacity and studied its effects over pro-inflammatory and cytoprotective pathways in macrophages in vitro. Moreover, we demonstrated its incorporation into lipoproteins and tissue both in vitro and in vivo, and determined its effect on atherosclerosis and inflammatory responses in vivo using the Apo E knockout mice model. KEY RESULTS: NATOH exhibited similar antioxidant capacity to α-tocopherol and, due to the presence of the nitroalkenyl group, like endogenous nitroalkenes, it exerted electrophilic reactivity. NATOH was incorporated in vivo into the VLDL/LDL lipoproteins particles to reach the atheroma lesions. Furthermore, oral administration of NATOH down-regulated NF-κB-dependent expression of pro-inflammatory markers (including IL-1ß and adhesion molecules) and ameliorated atherosclerosis in Apo E knockout mice. CONCLUSIONS AND IMPLICATIONS: In toto, the data demonstrate a novel pharmacological strategy for the prevention of atherosclerosis based on a creative, natural and safe drug delivery system of a non-conventional anti-inflammatory compound (NATOH) with significant potential for clinical application.

Zinc as a potential coadjuvant in therapy for type 2 diabetes.

BACKGROUND: Type 2 diabetes is highly prevalent in populations having high rates of overweight and obesity. It is a chronic condition responsible for long-term severe dysfunction of several organs, including the kidneys, heart, blood vessels, and eyes. Although there are a number of pharmacologic products in the market to treat insulin resistance and impaired insulin secretion--the most prominent features of this disease--interventions directed at preserving the integrity and function of beta-cells in the long term are less available. The use of some nutrients with important cellular protective roles that may lead to a preservation of beta-cells has not been fully tested; among these, zinc may be an interesting candidate. OBJECTIVE: To assess the potential of zinc supplementation as coadjuvant to diabetes therapy. METHODS: This article reviews the available information on the use of zinc as part of diabetes therapy. RESULTS: Cellular and animal models provide information on the insulin mimetic action of zinc, as well as its role as a regulator of oxidative stress, inflammation, apoptosis, and insulin secretion. Zinc supplementation studies in humans are limited, although some positive effects have been reported; mainly, a modest but significant reduction in fasting glucose and a trend to decreased glycated hemoglobin (HbA1c). CONCLUSIONS: Zinc supplementation may have beneficial effects on glycemic control. Nevertheless, among the studies considered, the vast majority lasted for 6 months or less, suggesting the importance of conducting long-duration studies given the characteristics of type 2 diabetes as a chronic disease.

Identification of thioredoxin glutathione reductase inhibitors that kill cestode and trematode parasites.

Parasitic flatworms are responsible for serious infectious diseases that affect humans as well as livestock animals in vast regions of the world. Yet, the drug armamentarium available for treatment of these infections is limited: praziquantel is the single drug currently available for 200 million people infected with Schistosoma spp. and there is justified concern about emergence of drug resistance. Thioredoxin glutathione reductase (TGR) is an essential core enzyme for redox homeostasis in flatworm parasites. In this work, we searched for flatworm TGR inhibitors testing compounds belonging to various families known to inhibit thioredoxin reductase or TGR and also additional electrophilic compounds. Several furoxans and one thiadiazole potently inhibited TGRs from both classes of parasitic flatworms: cestoda (tapeworms) and trematoda (flukes), while several benzofuroxans and a quinoxaline moderately inhibited TGRs. Remarkably, five active compounds from diverse families possessed a phenylsulfonyl group, strongly suggesting that this moiety is a new pharmacophore. The most active inhibitors were further characterized and displayed slow and nearly irreversible binding to TGR. These compounds efficiently killed Echinococcus granulosus larval worms and Fasciola hepatica newly excysted juveniles in vitro at a 20 µM concentration. Our results support the concept that the redox metabolism of flatworm parasites is precarious and particularly susceptible to destabilization, show that furoxans can be used to target both flukes and tapeworms, and identified phenylsulfonyl as a new drug-hit moiety for both classes of flatworm parasites.

El mal de ojo y su relación con el marasmo y kwashiorkor: El caso de las madres de Turbo, Antioquia, Colombia / Mal de ojo and its relationship with marasm and kwashiorkor: the Turbo mother’s case

Objetivo: Describir las percepciones y prácticas socio-culturales de las madres frente al proceso de desnutrición aguda grave de los niños: marasmo y kwashiorkor. Metodología: Etnografía descriptiva. Se realizaron 20 entrevistas semiestructuradas, 2 entrevistas grupales y observación en los hogares y en el hospital. El análisis se realizó manualmente. Resultados: Las madres perciben la desnutrición aguda grave como una consecuencia del mal de ojo, el cual afecta a los niños menores de 7 años. El mal de ojo se clasifica como “ojo secador” y “ojo de la calle”. Para las madres, el ojo secador enmagrece totalmente a los niños, lo cual podríamos asimilar al marasmo. No es claro si el ojo de la calle conlleva al kwashiorkor, pero es claro que el kwashirkor es causado por el mal de ojo. Los médicos tradicionales, como los rezanderos, ocupan un lugar importante en el tratamiento de las enfermedades de filiación cultural. Conclusiones: En el modelo biomédico no existen ni el mal de ojo ni la desnutrición como enfermedad. La desnutrición se conceptúa como estado y finalmente se objetiviza en cifras estadísticas, lo cual dificulta la atención integral de los niños. El estudio devela un mundo desconocido por el sistema biomédico, y un mundo de prácticas culturales frente al proceso de desnutrición, que adecuadamente valoradas permitirían mejorar la atención integral y evitar la muerte infantil por desnutrición aguda grave o por el mal de ojo

Objective: To describe perceptions and socio-cultural practices by the mothers facing severe malnutrition in children: Marasm and Kwashiorkor. Methodology: Descriptive ethnography.Twenty semi-structured interviews and two tribal ones were carried. Homes and hospitalized children were observed. Analysis was manually performed. Results: Mother perceives severe malnutrition like “mal de ojo” consequence afflicting children under seven. Mal de ojo is classified as “drying-eye” or as “street-eye”. Mothers think that “drying-eye” emaciates children meaning something like what we call marasm, whereas we cannot tell weather “street-eye” means kwashiorkor; but in any case kwashiorkor is deemed to be caused by mal de ojo. “Traditional” medics like rezanderos perform important tasks in the treatmentof cultural linked illnesses. Conclusions: Malnourishment is considered a “state” and finally it is reduced to statistical data hindering the integral treatment of children. The study reveals a world unknown by the biomedical system and a world of cultural practices facing malnourishment that adequately assessed could improve integral treatment and prevent infant mortality by severe malnourishment or by mal de ojo.

Malaria entre la población Tule (Kuna) del resguardo Caimán Nuevo (Turbo y Necoclí; Antioquia, Colombia), 2003-2004 / Malaria among the Tule (Kuna) people of resguardo Caimán Nuevo (Turbo y Necoclí; Antioquia, Colombia), 2003-2004

Objetivo: Estudiar la incidencia anual de malaria, en 2001-2003, entre los tules del resguardo de Caimán Nuevo.Metodología: Estudio descriptivo: a) retrospectivo: búsqueda de datos en los registros hospitalarios de Turbo y Necoclí y del puesto del Resguardo; b) prospectivo: medir la prevalencia de paludismo con gota gruesa (GG).Resultados: A) Incidencia malárica 2001-2003 según registros de consulta externa hospitalarios. El índice parasitario anual (IPA), por mil personas expuestas, es 154,67 en 2001, 146,89 en 2002 y 601,17 en 2003. B) Según registros de consulta en el puesto del Resguardo, la GG fue positiva en promedio en 39,4 por ciento. C) Prevalencia palúdica según GG por búsqueda activa: 433 GG, positivas 7,16 por ciento. La parasitemia falciparum fue 993 parásitos/µL en promedio, con desviación estándar de 678. 13 por ciento narró antecedentes de malaria en el último mes y 31 por ciento en el último año. De las mujeres adultas, 41 por ciento dijo haber sufrido paludismo gestacional. 76 por ciento de la población utiliza medicina tradicional para prevenir la malaria. Cada caso de malaria tiene incapacidad de 7 días.Discusión: En Urabá hay un IPA promedio >10, pero entre los tules es más elevado. La carencia de la variable grupo étnico en los registros permite que la malaria pase inadvertida para las autoridades de salud; urge una intervención intercultural.

La concepción de la curación Chamánica entre los indígenas Embera de Colombia: un proceso de comunicación socio-cultural y fisiológico / The cure among the Embera indigenous population: a social, cultural and physiological communication process

Este trabajo etnográfico centra su atención en un ritual terapéutico. El artículo describe en detalle un acto de curación realizado por un chamán Embera, de Colombia, a una mujer indígena que se encontraba hospitalizada en estado grave y no estaba respondiendo al tratamiento médico occidental. Se analizan los pasos del ritual en relación con la cultura Embera y se inicia el abordaje de la comprensión de la terapéutica utilizada por el chamánen la cual se observan claramente los momentos de Abreacción. El texto muestra que en la terapéutica indígena la dicotomía cuerpo-alma, individuo-sociedad-cosmos, no se presenta. El proceso curativo indígena, a diferencia del occidental, es de comunicación socio-cultural y fisiológico; es un acto que trasciende fronteras, en la medida que admite tanto la medicina tradicional como la occidental.A lo largo del artículo queda implícito que la medicina tradicional, a pesar del desprestigio y persecución de la cual fue objeto desde hace medio milenio, aún esta activa en el grupo Embera.