Paralytic Shellfish Toxins of Pyrodinium bahamense (Dinophyceae) in the Southeastern Gulf of Mexico.

In September and November 2016, eight marine sampling sites along the coast of the southeastern Gulf of Mexico were monitored for the presence of lipophilic and hydrophilic toxins. Water temperature, salinity, hydrogen potential, dissolved oxygen saturation, inorganic nutrients and phytoplankton abundance were also determined. Two samples filtered through glass fiber filters were used for the extraction and analysis of paralytic shellfish toxins (PSTs) by lateral flow immunochromatography (IFL), HPLC with post-column oxidation and fluorescent detection (FLD) and UHPLC coupled to tandem mass spectrometry (UHPLC-MS/MS). Elevated nutrient contents were associated with the sites of rainwater discharge or those near anthropogenic activities. A predominance of the dinoflagellate Pyrodinium bahamense was found with abundances of up to 104 cells L-1. Identification of the dinoflagellate was corroborated by light and scanning electron microscopy. Samples for toxins were positive by IFL, and the analogs NeoSTX and STX were identified and quantified by HPLC-FLD and UHPLC-MS/MS, with a total PST concentration of 6.5 pg cell-1. This study is the first report that confirms the presence of PSTs in P. bahamense in Mexican waters of the Gulf of Mexico.

Effect of Different N:P Ratios on the Growth, Toxicity, and Toxin Profile of Gymnodinium catenatum (Dinophyceae) Strains from the Gulf of California.

The harmful microalgae Gymnodinium catenatum is a unique naked dinoflagellate that produces paralytic shellfish poisoning toxins (PSTs). This species is common along the coasts of the Mexican Pacific and is responsible for paralytic shellfish poisoning, which has resulted in notable financial losses in both fisheries and aquaculture. In the Gulf of California, G. catenatum has been related to mass mortality events in fish, shrimp, seabirds, and marine mammals. In this study, the growth, toxin profiles, and toxin content of four G. catenatum strains isolated from Bahía de La Paz (BAPAZ) and Bahía de Mazatlán (BAMAZ) were evaluated with different N:P ratios, keeping the phosphorus concentration constant. All strains were cultivated in semi-continuous cultures (200 mL, 21.0 °C, 120 µmol photon m-2s-1, and a 12:12 h light-dark cycle) with f/2 + Se medium using N:P ratios of: 4:1, 8:1, 16:1, 32:1, and 64:1. Paralytic toxins were analyzed by HPLC with fluorescence detection. Maximum cellular abundance and growth were obtained at an N:P ratio of 64:1 (3188 cells mL-1 and 0.34 div day-1) with the BAMAZ and BAPAZ strains. A total of ten saxitoxin analogs dominated by N-sulfocarbamoyl (60-90 mol%), decarbamoyl (10-20 mol%), and carbamoyl (5-10 mol%) toxins were detected. The different N:P ratios did not cause significant changes in the PST content or toxin profiles of the strains from both bays, although they did affect cell abundance.

Evaluation of the Validity of a Food Frequency Questionnaire and 24-Hour Dietary Recall to Assess Dietary Iron Intake in Children and Adolescents from the South American Youth/Child Cardiovascular and Environmental Study.

BACKGROUND: A food frequency questionnaire (FFQ) for South American children and adolescents was developed, but its validity for assessing dietary iron intake has not been evaluated. OBJECTIVE: To evaluate the validity of the FFQ and 24-hour dietary recalls (24h-DR) for assessing dietary iron intake in children and adolescents. DESIGN: The South American Youth/Child Cardiovascular and Environmental study is a multicenter observational study, conducted in five South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Sao Paulo, and Teresina (Brazil). The FFQ assessed dietary intake over the previous 3 months, and the 24h-DR was completed three times (2 weekdays and 1 weekend day) with a minimum 5-day interval between recalls. Blood samples were collected to assess serum iron, ferritin, and hemoglobin levels. PARTICIPANTS AND SETTING: Data of 99 children (aged 3 to 10 years) and 50 adolescents (aged 11 to 17 years) from public and private schools were collected during 2015 to 2017. MAIN OUTCOME MEASURES: Dietary iron intake calculated from the FFQ (using the sum of daily iron intake in all food/food groups) and 24h-DR (mean of 3 days using the multiple source method). STATISTICAL ANALYSES PERFORMED: Dietary iron intake in relation to blood biomarkers were assessed using Spearman rank correlations adjusted for sex, age, and total energy intake, and the quadratic weighted κ coefficients for agreement. RESULTS: Spearman correlations showed very good coefficients (range = 0.78 to 0.85) for the FFQ in both age groups; for the 24h-DR, the coefficients were weak in children and adolescents (range = 0.23 to 0.28). The agreement ranged from 59.9% to 72.9% for the FFQ and from 63.9% to 81.9% for the 24h-DR. CONCLUSION: The South American Youth/Child Cardiovascular and Environmental study FFQ exhibited good validity to rank total dietary iron intake in children and adolescents, and as well as the 24h-DR, presented good strength of agreements when compared with serum iron and ferritin levels.

Psychometric properties of 4-item questionnaire for sleep habits and time in a South American paediatric population.

OBJECTIVES: To assess the psychometric properties of 4-item questionnaire about sleep habits and time in South American children (3-10 years) and adolescents (11-18 years). MATERIAL AND METHODS: We evaluated 459 participants from seven South American cities. Two items from week and weekend days wake up time and bedtime were asked twice, with a 2-week interval. We calculated time spent in bed (subtracting wake up time from bedtime). Participants also answered the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) sleep time questionnaire. RESULTS: The questionnaire showed acceptable temporal stability in children and adolescents on total days (rho≥0.30; p<0.05). For total days, the questionnaire presented acceptable convergent validity only in children (rho from 0.48 to 0.62; p≤0.01) compared with the HELENA questionnaire. CONCLUSION: The 4-item questionnaire is a reliable and valid tool for children; however, its validity is not consistent in adolescents for sleep habits and time.

Assessment of ability of medical and obstetric students to achieve adequate positive pressure ventilation using basic neonatal resuscitation manikins / Evaluación de la habilidad de los estudiantes de medicina y obstetricia para lograr una ventilación con presión positiva adecuada utilizando maniquíes básicos de reanimación neonatal

ABSTRACT Introduction. The ability to perform adequate positive pressure ventilation is necessary for neonatal clinical practice. However, there are few studies on the achievements of undergraduate students on this task. It is necessary to assess health science students' adequate positive pressure ventilation because it is vital at the beginning of their clinical activity. Objective. To evaluate the cognitive and procedural ability related to adequate positive pressure ventilation performed by 6th year medicine students and 4th year obstetrics students at a public university in Lima, Peru. Methods. We surveyed 78 medical and obstetric students in their last years of studies within six months of taking a course on neonatal resuscitation that included positive pressure ventilation theory and practice. Participants voluntarily agreed to participate in this study. Previously, we validated the survey by asking three experienced neonatologists for their expert judgments on improving the survey. The survey consists of three theoretical questions as a cognitive assessment and three practice assessment criteria qualified by observing performance using neonatal manikins. Results. Medicine students had a better practical ability (p <0.001) than obstetrics students, and obstetrics students presented better theoretical knowledge (p = 0.019). However, both groups achieved limited performance within six months of taking the neonatal clinical practice course as 21.8% of all students passed both the theoretical and practical parts of this study. Conclusion. Participants from both schools require further training alternatives to achieve adequate positive pressure ventilation performance.

RESUMEN Introducción. Una adecuada ventilación con presión positiva es necesaria para la práctica clínica neonatal. Sin embargo, pocos estudios describen los logros de estudiantes de pregrado en esta tarea. Es necesario evaluar la adecuada ventilación con presión positiva en los estudiantes de ciencias de la salud porque es una tarea vital al inicio de su actividad clínica. Objetivo. Evaluar habilidades cognitivas y procedimentales relacionadas con la adecuada ventilación con presión positiva de estudiantes del 6º año de medicina y 4º de obstetricia de una universidad pública de Lima, Perú. Métodos. Encuestamos a 78 estudiantes de medicina y obstetricia dentro de los seis meses posteriores a su curso sobre reanimación neonatal que incluía la teoría y la práctica de la ventilación con presión positiva. Los alumnos participaron voluntariamente en este estudio. Previamente, validamos la encuesta con la opinión de tres neonatólogos sobre cómo mejorarla. La encuesta consta de tres preguntas teóricas de evaluación cognitiva y tres criterios de evaluación práctica calificados mediante observación del desempeño en maniquíes. Resultados. Los estudiantes de medicina tuvieron mejor habilidad práctica (p <0.001) y los estudiantes de obstetricia presentaron mejores conocimientos teóricos (p = 0.019). Sin embargo, ambos grupos lograron un rendimiento global limitado debido a que solamente el 21,8% de todos los estudiantes aprobaron simultáneamente las evaluaciones teórica y práctica de este estudio. Conclusión. Los participantes de ambas escuelas requieren más alternativas de entrenamiento para alcanzar un rendimiento adecuado en la realización de la ventilación con presión positiva en maniquíes neonatales.

Launching of the Anaemia Research Peruvian Cohort (ARPEC): a multicentre birth cohort project to explore the iron adaptive homeostasis, infant growth and development in three Peruvian regions.

BACKGROUND: Preventing infantile anaemia and ensuring optimal growth and development during early childhood, particularly in resource-constrained settings, represent an ongoing public health challenge. Current responses are aligned to treatment-based solutions, instead of determining the roles of its inter-related causes. This project aims to assess and understand the complex interplay of eco-bio-social-political factors that determine infantile anaemia to inform policy, research design and prevention practices. METHODS: This is a longitudinal birth cohort study including four components: (1) biological, will assess known blood markers of iron homeostasis and anaemia and stool microbiota to identify and genetically analyse the participants' flora; (2) ecological, will assess and map pollutants in air, water and soil and evaluate features of nutrition and perceived food security; (3) social, which will use different qualitative research methodologies to explore key stakeholders and informants' perceptions related to nutritional, environmental and anaemia topics, participant observations and a participatory approach and (4) a political analysis, to identify and assess the impact of policies, guidelines and programmes at all levels for infantile anaemia in the three regions. Finally, we will also explore the role of social determinants and demographic variables longitudinally for all study participants. This project aims to contribute to the evidence of the inter-related causal factors of infantile anaemia, addressing the complexity of influencing factors from diverse methodological angles. We will assess infantile anaemia in three regions of Peru, including newborns and their mothers as participants, from childbirth until their first year of age. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Research Ethics Committee of the Instituto Nacional de Salud del Niño (Lima, Peru), CIEI-043-2019. An additional opinion has been granted by the Ethical Committee of Queen Mary University of London (London, UK). Dissemination across stakeholders is taking part as a continues part of the research process.

Non-clinical performance and acceptability of a small portable respiratory stimulator device for basic neonatal resuscitation, tested by health personnel / Desempeño no clínico y aceptabilidad de un estimulador respiratorio portátil para reanimación neonatal básica, evaluado en personal de salud

Introducción: La reanimación neonatal demanda dispositivos para apoyo respiratorio que no siempre se encuentran en áreas rurales. Se requieren dispositivos innovadores y el prototipado rápido permite generarlos usando diseños e impresoras tridimensionales (3D). Objetivo: Evaluar el desempeño no clínico y la aceptabilidad por el personal de salud de un dispositivo respiratorio neonatal producido mediante prototipado rápido. Métodos: Estudio observacional, descriptivo, de prueba de concepto desarrollado en dos etapas. Etapa 1: Fabricación del dispositivo con prototipado rápido en impresoras y escáneres tridimensionales (3D). Etapa 2: Demostración del dispositivo durante programas de capacitación en reanimación neonatal para personal de salud en tres regiones del Perú (Tarapoto, Huánuco y Ayacucho). En ambas etapas se evaluó el desempeño del dispositivo conectado a un analizador de flujo de gases. Se administró una encuesta a los trabajadores de salud de Tarapoto y Ayacucho para conocer su aceptabilidad. Resultados: El prototipo desarrollado tiene forma de T con dos fuelles laterales que al presionarse con una sola mano, proyectan aire por el centro hacia un adaptador facial. El uso del prototipo en laboratorio generó un flujo de aire promedio de 4,8 Lt/min (DE ± 1,7) y una presión promedio de 5,9 cm H2O (DE ± 1,4). Este dispositivo fue considerado como "de uso muy simple" en una encuesta de aceptabilidad donde participaron 39 enfermeras y 11 médicos en zonas alejadas de la capital del Perú. Conclusiones: El prototipo evaluado fue aceptado por el personal y tuvo un desempeño capaz de generar un estímulo de la respiración espontánea al nacer.

Introduction: Neonatal resuscitation demands equipment for respiratory support not always available in rural areas. Innovative devices are required, and rapid prototyping allows to generate them using three-dimensional (3D) designs and printers. Objective: To evaluate the non-clinical performance and the acceptability by health personnel of a neonatal respiratory device produced by rapid prototyping. Methods: Observational study, descriptive, of proof of concept developed in two steps. Step 1: Manufacture of the device with rapid prototyping in three-dimensional (3D) scanners and printers. Step 2: Demonstration of the invention during training programs in neonatal resuscitation for health personnel in three regions of Peru (Tarapoto, Huánuco and Ayacucho). In both steps, we evaluated the performance of the device connected to a gas flow analyser. A survey was administered to the health workers of Tarapoto and Ayacucho to know their acceptability. Results: The developed prototype is T-shaped with two side bellows that, when pressed with one hand, project air through the centre towards a facial adapter. The use of the prototype in the laboratory generated an average air flow of 4.8 Lt /min (SD ± 1.7) and an average pressure of 5.9 cm H2O (SD ± 1.4). This device was considered to be "very simple to use" in an acceptability survey involving 39 nurses and 11 doctors in remote areas of the capital of Peru. Conclusions: The evaluated prototype is acceptable by the staff and has a performance capable of generating spontaneous breathing at birth.

Is the Measurement of Blood Pressure by Automatic Monitor in the South American Pediatric Population Accurate? SAYCARE Study.

OBJECTIVE: This study aimed to test the validity of an automatic oscillometric device to measure the blood pressure (BP) in children (n = 191) and adolescents (n = 127) aged 3 to 18 years. METHODS: Systolic BP (SBP) and diastolic BP (DBP) levels were measured simultaneous by automatic device and mercury column with Y-connection. To verify the validity, Bland-Altman plots and limits of agreement of 95% (95% LOA), specificity and sensitivity of the device, and the grade of British Hypertension Society (BHS) criteria were used. RESULTS: The monitor measurements demonstrated lower measurement bias (mean difference [95% LOA]): 1.4 (-9.9 to 12.8) mmHg in children and 4.3 (-7.8 to 16.5) mmHg in adolescents for SBP. For DBP, it was 2.2 (-7.4 to 11.7) mmHg in children and 1.4 (-8.4 to 11.1) mmHg in adolescents. The sensitivity in children was 21.4 (95% CI = 16.3-26.6), and in adolescents, it was 20.0 (95% CI = 13.2-26.8); the specificity was 95.9 (95% CI = 93.4-98.4) in children and 100.0 (95% CI = 100.0-100.0) in adolescents. The monitor-tested ratings are Grade B for SBP in children and SBP and DBP in adolescents and Grade C for DBP in children. CONCLUSIONS: The automatic monitor presented high values of specificity and lower values of sensitivity to the diagnosis of HBP; however, it can be considered accurate (lower measurement bias) and valid for epidemiological and clinical practice in accordance with BHS criteria.

Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study.

BACKGROUND: Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans. METHODS: A phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment. RESULTS: Twenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values. CONCLUSIONS: NeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials RPCEC00000157 , June 10, 2013.

Pharmacokinetic and pharmacodynamic characterization of a novel formulation containing co-formulated interferons alpha-2b and gamma in healthy male volunteers.

BACKGROUND: More potent antitumor activity is desired in Interferon (IFN)-treated cancer patients. This could be achieved by combining IFN alpha and IFN gamma. The aim of this work was to characterize the pharmacokinetics and pharmacodynamics of a novel formulation containing a co-formulated combination of IFNs alpha-2b and gamma (CIGB-128-A). METHODS: A group of nine healthy male subjects received intramuscularly 24.5 × 106 IU of CIGB-128-A. IFN concentrations were evaluated for 48 h. Serum neopterin, beta2-microglobulin (ß2M) and 2'-5' oligoadenylate synthetase (2'-5' OAS), classical IFN-inducible serum markers, were measured during 192 h by enzyme immunoassay and body temperature was used as pharmacodynamic variable as well. RESULTS: Concerning pharmacokinetics, serum IFNs' profiles were better fitted to a mono-compartmental model with consecutive zero order and first order absorption, one bioavailability value. No interferences by simultaneous administered IFNs were observed in their typical similar systemic profiles. Neopterin and ß2M time profiles showed a delay that was efficiently linked to pharmacokinetics by means of a zero order absorption rate constant. Neopterin level was nine-fold higher than initial values, 48 h post-administration, an increment not described before. At this time, mean serum ß2M peaked around the double from baseline. Serum concentrations of the enzyme 2'-5' OAS was still elevated on the 8 day post-injection. The formulation was well tolerated. Most frequent adverse reactions were fever, headache, arthralgia and lymphopenia, mostly mild. CONCLUSIONS: The administration of co-formulated IFN alpha-2b and IFN gamma likely provides improved pharmacodynamic properties that may be beneficial to treat several malignancies. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials RPCEC00000118 , May 24, 2011.

Construcción y validación de un cuestionario para identificación de Factores Asociados al Desempeño Escolar (FADE) / Construction and validation of a questionnaire for identification of factors associated with school performance / Construção e validação de um questionário para identificação de fatores associados ao desempenho escolar (FADE)

Se construyó una prueba psicológica para medir los Factores Asociados al Desempeño Escolar (FADE), siguiendo lineamientos de la Teoría Clásica de los Test y aspectos de medición y evaluación desde una estrategia multi-informante aplicada a los contextos escolares. La finalidad de la prueba es la identificación de debilidades y fortalezas asociadas al desempeño escolar en niños de primer grado de primaria del municipio de Pasto. La muestra utilizada fue de 277 participantes pertenecientes a instituciones públicas de carácter urbano y rural. La confiabilidad calculada a través del coeficiente KR20 fue de .92 para la prueba total. Se obtuvieron evidencias favorables para validez de contenido, criterio y constructo. Se establecieron normas de estandarización para la aplicación y calificación de la prueba. La evidencia encontrada da cuenta de que la prueba resulta útil para su aplicación práctica como herramienta en la evaluación clínica y su uso en investigación.

A psychological test was constructed to measure School Performance Associated Factors (FADE, by its Spanish acronym), following the guidelines of the Classical Theory of Tests and aspects of measuring and assessment from a multiple informant strategy applied to school settings. The purpose of the test is to identify weaknesses and strengths associated with school performance in first grade primary school children from the municipality of Pasto. The sample consisted of 277 participants from public institutions of urban and rural character. The reliability calculated by KR20 coefficient was 0.92 for the total test. Favorable evidence was obtained for content, criteria and construct validity. Standardized rules were established for the test administration and scoring. The evidence found shows that the test is useful for its practical application as a tool for clinical assessment and research.

Construiu-se um teste psicológico para medir os Fatores Associados ao Desempenho Escolar (FADE), seguindo as diretrizes da Teoría Clássica dos Testes e aspectos de medição e avaliação desde uma estratégia multi-informante aplicada aos contextos escolares. A finalidade do teste é a identificação de pontos fortes e pontos fracos associados ao desempenho escolar em crianças do primeiro ano do primário do município de Pasto. A mostra utilizada foi de 277 participantes pertencentes a instituições públicas de caráter urbano e rural. A confiabilidade calculada através do coeficiente KR20 foi de ,92 para a prova total. Obtiveram-se evidências favoráveis para validade de conteúdo, critério e constructo. Estabeleceram-se normas de padronização para a aplicação e qualificação da prova. A evidência encontrada mostra que a prova é útil para sua aplicação prática como ferramenta na avaliação clínica e seu uso em pesquisa.

Pharmacokinetic and pharmacodynamic comparison of two "pegylated" interferon alpha-2 formulations in healthy male volunteers: a randomized, crossover, double-blind study.

BACKGROUND: Interferon (IFN) alpha conjugation to polyethylene glycol (PEG) results in a better pharmacokinetic profile and efficacy. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of a new, locally developed, 40-kDa PEG-IFN alpha-2b preparation with a reference, commercially available PEG-IFN alpha-2a in healthy male volunteers. METHODS: A randomized, crossover, double-blind study with a 3-weeks washout period, was done. A single 180 micrograms PEG-IFN alpha-2 dose was administered subcutaneously in both groups. Sixteen apparently healthy male subjects were included. Serum PEG-IFN concentration was measured during 336 hours by an enzyme immunoassay (EIA). Other clinical and laboratory variables were used as pharmacodynamic and safety criteria. RESULTS: The pharmacokinetic comparison by EIA yielded a high similitude between the formulations. In spite of a high subject variability, the parameters' mean were very close (in all cases p > 0.05): AUC: 53623 vs. 44311 pg.h/mL; Cmax: 333 vs. 271 pg/mL; Tmax: 54 vs. 55 h; half-life (t1/2): 72.4 vs. 64.8 h; terminal elimination rate (lambda): 0.011 vs. 0.014 h(-1); mean residence time (MRT): 135 vs. 123 h for reference and study preparations, respectively. There were no significant differences with respect to the pharmacodynamic variables either: serum neopterin and beta-2 microglobulin levels, stimulation of 2'5' oligoadenylate synthetase expression, and serum IFN antiviral activity. A strong Spearman's rank order correlation (p < 0.01) between the pharmacokinetic and pharmacodynamic concentration-time curves was observed. Both products caused similar leukocyte counts diminution and had similar safety profiles. The most frequent adverse reactions were leukopenia, fever, thrombocytopenia, transaminases increase and asthenia, mostly mild. CONCLUSIONS: Both formulations are fully comparable from the pharmacokinetic, pharmacodynamic, and safety profiles. Efficacy trials can be carried out to confirm clinical similarity.

Bioequivalencia de una formulación cubana de carbamazepina con el producto líder / Bioequivalent of a Cuban formula of Carbamazepine with the leader product

Se demostró la intercambiabilidad terapéutica mediante un estudio de bioequivalencia en 25 voluntarios sanos de una formulación cubana de carbamazepina de 200 mg con respecto al producto innovador (Tegretol®), en condiciones de administración a dosis única; el diseño experimental fue cruzado a doble ciegas y aleatorizado; el periodo de lavado fue de 15 días. Las extracciones para la obtención del plasma, se realizaron a las 0; 0,5; 1; 1,5; 2; 3; 4; 6; 8; 10; 12; 16; 20; 24; 48; 72; 96 y 120 h. Para el análisis se empleó un método analítico por cromatografía líquida de alta eficiencia, isocrático en fase reversa con detección ultravioleta. Se estimaron mediante técnicas no compartimentales los parámetros farmacocinéticos (AUC0-t, AUCt-¥, Cmax, Tmax y T1/2) representativos de la biodisponibilidad en magnitud y velocidad. Sobre la base de los resultados estadísticos, ambas formulaciones resultaron bioequivalentes(AU)

It was possible to demonstrate the therapeutic interchange level by means of a bioequivalence study in 25 healthy volunteers of a Cuban formula of Carbamazepine(200 mg) according to the innovative product (Tegretol®) for a administration of unique dose; the experimental design was of crossed, double-blind and random type; washing period was of 15 days. Extractions for plasma obtaining were performed at 0, 0,5, 1, 1,5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours. In analysis we used an analytical method by high performance liquid chromatography, isocratic type in reverse phase with UV detection. By means of non-compartment techniques pharmacokinetic parameters (AUC0-t, AUC t-¥, Cmax, Tmax, and T½) were estimated, which are representative of bioavailability in magnitude and speed. On the base of statistical results, both formulae were bioequivalent(AU)

Bioequivalencia de una formulación cubana de carbamazepina con el producto líder / Bioequivalent of a Cuban formula of Carbamazepine with the leader product

Se demostró la intercambiabilidad terapéutica mediante un estudio de bioequivalencia en 25 voluntarios sanos de una formulación cubana de carbamazepina de 200 mg con respecto al producto innovador (Tegretol®), en condiciones de administración a dosis única; el diseño experimental fue cruzado a doble ciegas y aleatorizado; el periodo de lavado fue de 15 días. Las extracciones para la obtención del plasma, se realizaron a las 0; 0,5; 1; 1,5; 2; 3; 4; 6; 8; 10; 12; 16; 20; 24; 48; 72; 96 y 120 h. Para el análisis se empleó un método analítico por cromatografía líquida de alta eficiencia, isocrático en fase reversa con detección ultravioleta. Se estimaron mediante técnicas no compartimentales los parámetros farmacocinéticos (AUC0-t, AUCt-¥, Cmax, Tmax y T1/2) representativos de la biodisponibilidad en magnitud y velocidad. Sobre la base de los resultados estadísticos, ambas formulaciones resultaron bioequivalentes.

It was possible to demonstrate the therapeutic interchange level by means of a bioequivalence study in 25 healthy volunteers of a Cuban formula of Carbamazepine(200 mg) according to the innovative product (Tegretol®) for a administration of unique dose; the experimental design was of crossed, double-blind and random type; washing period was of 15 days. Extractions for plasma obtaining were performed at 0, 0,5, 1, 1,5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours. In analysis we used an analytical method by high performance liquid chromatography, isocratic type in reverse phase with UV detection. By means of non-compartment techniques pharmacokinetic parameters (AUC0-t, AUC t-¥, Cmax, Tmax, and T½) were estimated, which are representative of bioavailability in magnitude and speed. On the base of statistical results, both formulae were bioequivalent.

ESTUDIO DRX EN MATERIALES CATALIZADORES Cu-Ni-SiO2 PARA HIDROGENACIÓN DE ACEITE DE SOYA. DESARROLLO DE ESTRUCTURA CRISTALINA Y ACTIVIDAD CATALÍTICA / DRX STUDY IN CATALYSTS MATERIAL Cu-Ni-SiO2 FOR HYDROGENATION OF SOY OIL. DEVELOPMENT OF CRYSTALLINE STRUCTURE AND CATALYTIC ACTIVITY / ESTUDO DRX EM MATERIAIS CATALISADORES Cu-Ni-SiO2 PARA HIDROGENACIÓN DE AZEITE DE SOYA. DESENVOLVIMENTO DE ESTRUTURA CRISTALINA E ATIVIDADE CATALÍTICA

Para buscar elementos experimentales que soporten la hipótesis según la cual se forman estructuras cristalinas Cu-Ni o, eventualmente, Cu-Ni-SiO2 en la síntesis de catalizadores para la hidrogenación de aceite de soya, se prepararon mezclas de estos tres materiales a partir de sales de los metales con sílice (aerosil). Se calcinaron a 270 °C y se redujeron a 330 °C en atmósfera de hidrógeno. En los materiales reducidos se estudió el difractógrama de RX en el rango 37 a 53°, y se comparó con el difractograma de aleaciones Cu-Ni -en las cuales se conoce la formación de cristales mixtos-, y con los difractogramas de los elementos puros Cu y Ni. Los resultados muestran señales de difracción diferentes a las señales de los componentes puros. La actividad catalítica se muestra diferente en los materiales que presentan distorsión en su estructura cristalina.

Looking for experimental facts that support the hypothesis of formation of Cu-Ni or Cu-Ni-SiO2 crystals formation hypo- thesis in the syntesis of catalytic materials for soja oil hydrogenation, different mixtures of the metals nitrates with SiO2 (aerosil), were prepared and calcined at 270 oC, then reduced in hydrogen atmosphere at 330 oC. RX Diffraction registers of the prepared materials, Ni-Cu alloys, Ni and Cu pure metals, show that differences in diffraction signal in prepared materials exist with respect to pure metals. The catalytic activity show differences too.

Para procurar elementos experimentais que suportem a hipótese segundo a qual se formam estruturas cristalinas Cu-Ni ou eventualmente Cu-Ni-SiO2 na síntese de catalisadores para a hidrogenación de azeite de soya, prepararam-se misturas destes três materiais a partir de sais dos metais com sílice (aerosil). Se calcinaron a 270 °C e se reduziram a 330 °C em atmosfera de hidrogênio. Nos materiais reduzidos se estudou o difractógrama de RX na casta 36 a 53 graus, e se comparou com o difractógrama de ligas de metais Cu-Nem, nas quais se conhece a formação de cristais mistos, e com os difractógramas dos elementos puros Cu e Nem. Os resultados mostram que se apresentam sinais de difracção diferentes aos sinais dos componentes puros. A atividade catalítica se mostra diferente nos materiais que apresentam distorção em sua estrutura cristalina.

Bioequivalence of two recombinant granulocyte colony-stimulating factor formulations in healthy male volunteers.

To evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of two recombinant G-CSF formulations in healthy male volunteers, a standard 2-way randomized crossover double-blind study, with a 3 week washout period, was conducted. A single 300 microg G-CSF dose was administered subcutaneously. Hebervital (Heber Biotec, Havana, formulation A) and Neupogen (Hoffmann-La Roche S.A, formulation B) were compared. Twenty-four healthy male volunteers were included. The serum G-CSF level was measured by enzyme immunoassay (EIA) during the first 36 h after administration. Absolute neutrophils (ANC), white blood cells (WBC) and CD34+ cells counts were the pharmacodynamic variables measured up to 120 h. Other clinical and laboratory determinations were used as safety criteria. The pharmacokinetic parameters for formulation A and B were very close to each other (i.e. AUC, 235.9 vs 270.0 ng.h/ml; C(max), 29.2 vs 33.4 ng/ml; T(max), 4.2 vs 4.7 h; half-life, 3.2 vs 2.8 h; CL, 260.9 vs 277.2 ml/h; V(d), 1.2 vs 1.1 l; and MRT, 7.58 vs 7.38 h). The confidence intervals for the means ratio of all these parameters were within or very close to the 0.8-1.25 acceptance range. The pharmacodynamics showed high similarity since ANC and WBC had the same profiles for both products and no differences were detected for the estimated parameters. The CD34+ cells count increments were evident for both formulations in a similar way as well. The treatments were well tolerated. Registered adverse events were similar; back/spine pain was the most frequent. According to the overall results these formulations could be considered as clinically comparable.

Concentraciones referenciales de urea sérica sanguínea en bovinos lecheros de la campiña de Cajamarca / Referential concentrations of ureas sericas blood in bovine milkmen of Cajamarca's field

La concentración de urea en muestras de suero sanguíneo de vacunos lecheros, es un indicador del balance nutricional de proteínas y su relación con el aporte de energía de la dieta. Con el objeto de establecer valores de referencia para las concentraciones de urea en suero sanguíneo, se obtuvo muestras de sangre de vacas Holstein friesian en diferente estados productivos: vaquillonas, vacas en seca, e inicio de la lactación de 11 fundos de la campiña de Cajamarca. En las muestras, previa separación del suero sanguíneo, se determinaron las concentraciones de ures sérica mediante el método de Berthelot ureasa modificado. Los valores de referencia para urea en suero sanguíneo fueron de 3.3-7.7 mmol/l para todos los animales en experimentación con un promedio de 5.5 mmol/l; del mismo modo para cada categoría fue: vacas al inicio de la lactación: 3.7-7.7 mmol/l; vacas en seca: 3.7-6.9 mmol/l y vaquillonas: 2.1-8.1 mmol/l, con promedios de 5.7, 5.3 y 5.1 mmol/l, respectivamente. Los resultados obtenidos permiten entregar valores de referencia para muestras de urea sérica de hatos lecheros; así como, establecer la relación directamente proporcional del aporte proteico de la dieta con el contenido de urea sérica, indicando la posibilidad de usar esta técnica como un método de diagnóstico preliminar de los desbalances de energía: proteína.