Diabetes mellitus tipo 1 y enfermedad celíaca en niños y adolescentes / Type 1 diabetes mellitus and celiac disease in children and adolescents

Introducción: La asociación entre enfermedad celíaca y diabetes mellitus tipo 1 se ha publicado con mayor frecuencia que la enfermedad celíaca aislada, cuya historia natural puede variar considerablemente, con evidencia de síntomas gastrointestinales en la minoría de los pacientes. Objetivo: Caracterizar a pacientes con diabetes mellitus tipo 1 y enfermedad celíaca. Método: Estudio observacional, descriptivo y transversal en 63 niños atendidos en el Hospital Pediátrico Docente Centro Habana entre los años 2016-2017 con diagnóstico de diabetes mellitus tipo 1. Las variables estudiadas se expresaron en valores absolutos y relativa, medida de tendencia central y de dispersión. Resultados: El sexo masculino representó 58,73 por ciento de los pacientes, la mayoría entre 10 y 14 años de edad. El anticuerpo antitransglutaminasa fue positivo en menos de 10 por ciento de los niños, generalmente sin síntomas, signos o hallazgos relacionados con la enfermedad celíaca. La frecuencia de ambas enfermedades en los pacientes estudiados fue de 3,17 por ciento. Conclusiones: La diabetes mellitus tipo 1 predomina en el sexo masculino a diferencia de la enfermedad celíaca que se diagnostica en pacientes femeninas. Los resultados de anticuerpos antitransglutaminasa son negativos en la mayoría de los pacientes mientras que los positivos tienen más de un año de evolución de la diabetes, se encuentran eutróficos o sobrepeso, asintomáticos y con valores ligeramente superiores de hemoglobina glucosilada(AU)

Introduction: The association between celiac disease and type 1 diabetes mellitus has been published more frequently than isolated celiac disease, whose natural history can vary considerably, with evidence of gastrointestinal symptoms in the minority of patients. Objective: To characterize patients with type 1 diabetes mellitus and celiac disease. Method: Observational, descriptive and cross-sectional study in 63 children treated at Centro Habana Pediatric Teaching Hospital between the years 2016-2017 with a diagnosis of type 1 diabetes mellitus. The variables studied were expressed in absolute and relative values, a measure of central tendency and dispersion. Results: Males accounted for 58.73 percent of the patients, most of them between 10 and 14 years old. The anti-transglutaminase antibody was positive in less than 10 percent of the children, usually without symptoms, signs, or findings related to celiac disease. The frequency of both diseases in the patients studied was 3.17 percent. Conclusions: Type 1 diabetes mellitus predominates in males unlike celiac disease which is diagnosed in female patients. The results of anti-transglutaminase antibodies are negative in most patients while the positive ones have more than a year of evolution of diabetes, are eutrophic or overweight, asymptomatic and with slightly higher values of glycosylated hemoglobin(AU)

COVID 19 y Diabetes Mellitus tipo 1 en la infancia. Cuba. Informe preliminar / Covid 19 and Diabetes Mellitus type 1 in childhood. Cuba. Preliminary report

Introducción: en diciembre de 2019 se inició una epidemia por coronavirus SARS-CoV-2, causante de un síndrome de dificultad respiratoria que, posteriormente, se denomina enfermedad COVID-19y que es probable afecta menos a los niños que a los adultos. En Cuba existen aproximadamente 15,246 contagiados menores de 19 años. La diabetes mellitus tipo 1 (DM1) asociada al COVID-19puede representar peligro para la vida del paciente. Objetivo: determinar algunas características de la COVID-19en la población pediátrica estudiada con diabetes mellitus tipo 1 durante el primer año de inicio de la pandemia en Cuba. Método: se seleccionaron al azar los servicios de endocrinología pediátrica de las provincias: Ciego de Ávila, Villa Clara, Pinar del Río y en La Habana (Hospitales Pediátricos Cerro y Centro Habana). Se solicitó cuántos pacientes durante el primer año de la pandemia (marzo 2020-marzo 2021) debutaron con DM1, cuántos en cetosis/cetoacidosis. Estos datos se compararon con el año 2019. Se investigó cuantos niños DM1 ingresaron con Covid 19. Resultados: existió incremento (57.3 %) de los pacientes con debut de DM1 durante el primer año de la pandemia en comparación con 2019. La presencia de cetosis/cetoacidosis aumentó (58.2 %). Se detectó cuatro pacientes con Covid 19 y DM1, (frecuencia baja: 0, 53 %). Conclusiones: el incremento de la DM1 y de cetosis/cetoacidosis pudiera estar relacionado indirectamente con la pandemia por Covid 19, ya sea por stress, confinamiento, alimentación inadecuada o la combinación de estos factores, es prudente tener un seguimiento a mediano y largo plazo de estos pacientes.

Introduction: On December 2019, an epidemic due to the SARS-CoV-2 coronavirus began, causing a respiratory distress syndrome, later it is called the COVID-19disease, it probably affects children less than adults. In Cuba, there are approximately 15,246 infected persons under 19 years of age. Type 1 diabetes mellitus (DM1) associated with COVID-19can be life-threatening. Objective: To determine some characteristics of COVID-19in the pediatric population studied with type 1 diabetes mellitus during the first year of the onset of the pandemic in Cuba. Method: The pediatric endocrinology services of the provinces: Ciego de Ávila, Villa Clara, Pinar del Río and Havana (Hospital Pediátricos Cerro and Centro Habana) were randomly selected. It was requested how many patients during the first year of the pandemic (March 2020-March 2021) debuted with DM1, how many in ketosis / ketoacidosis. These data were compared with 2019. It was investigated how many T1D children were admitted with Covid 19. Results: There was an increase (57.3%) in patients with T1D debut during the first year of the pandemic compared to 2019. The presence of ketosis / ketoacidosis increased (58.2 %). 4 patients with Covid 19 and DM1 were detected (low frequency: 0.53%). Conclusions: The increase in DM1 and ketosis/ketoacidosis could be indirectly related to the Covid 19 pandemic, whether due to stress, confinement, inadequate nutrition or a combination of these factors, it is prudent to have a medium and long-term follow-up of these patients.

Asma y obesidad en pediatría / Asthma and obesity in pediatrics

Introducción: La asociación de asma y obesidad ha aumentado su prevalencia en los últimos años. Objetivos: Caracterizar a niños y adolescentes asmáticos con obesidad asociada. Métodos: Investigación descriptiva, transversal y prospectiva, 2017-2018, Servicio de Neumología, Hospital Pediátrico Universitario Centro Habana. Se evaluaron 43 pacientes asmáticos entre 5 y 18 años de edad con obesidad exógena asociada. Se exploraron edad, sexo, antecedentes familiares de asma y obesidad, severidad y grado de control del asma. Se realizaron estudios para evaluar el metabolismo lipídico y de los hidratos de carbono. Resultados: La distribución por edades fue similar (escolares, adolescencia temprana y tardía), predominó el sexo masculino en escolares: 11 de 16 (68,7 por ciento) y el femenino en la adolescencia tardía: 12 de 15 (80 por ciento). Se refirieron antecedentes familiares de obesidad en 5 (11,6 por ciento) y asma asociada a obesidad en 26 (60,5 por ciento); la mayoría presentaba asma persistente leve: 38 (88,4 por ciento), no controlados: 28 (65,1 por ciento) y parcialmente controlados 10 (23,3 por ciento). Dos pacientes presentaban intolerancia a los hidratos de carbono (4,7 por ciento), uno de ellos con resistencia a la insulina. La dislipidemia fue el trastorno metabólico más frecuente: colesterol sérico elevado en 23 (53,5 por ciento), LDLc alto en 13 (30,2 por ciento) y HDLc bajo en 10 (23,3 por ciento). Conclusiones: Los niños asmáticos con historia familiar de obesidad tienen alto riesgo de ser también obesos, lo cual puede dificultar el control del asma; son frecuentes en ellos las alteraciones metabólicas(AU)

Introduction: The association of asthma and obesity has increased its prevalence in recent years. Objectives: Characterize asthmatic children and adolescents with associated obesity. Methods: Descriptive, cross-sectional and prospective research, 2017 - 2018, Pneumology Service, Centro Habana University Pediatric Hospital. 43 asthmatic patients from 5 to 18 years old with associated exogenous obesity were assessed. Age, sex, family history of asthma and obesity, severity and degree of asthma control were studied. Studies were conducted to evaluate lipid and carbohydrate metabolism. Results: Age distribution was similar (schoolers, early and late adolescence), predominated male sex in schoolchildren (11 of 16 - 68.7 percent) and the female in late adolescence (12 of 15 -80 percent). Family history of obesity was reported in 5 patients (11.6 percent) and obesity-associated asthma in 26 (60.5 percent); most had mild persistent asthma (38 -88.4 percent) poorly controlled: 28 uncontrolled (65.1 percent) and 10 partially controlled (23.3 percent). Two patients had carbohydrate intolerance (4.7 percent), one of them with insulin resistance. Dyslipidemia was the most common metabolic disorder: serum cholesterol increased in 23 - 53.5 percent, high LDLc in 13 - 30.2 percent, and low HDLc in 10 - 23.3 percent. Conclusions: Asthmatic children with a family history of obesity are also at high risk of being obese, which can make difficult to control asthma; metabolic alterations are common in them(Au)

Duración de la onda P en las 12 derivaciones del electrocardiograma y su relación con el tiempo de conducción interauricular en pacientes con taquicardias paroxísticas supraventriculares / P wave duration in the 12 leads of the electrocardiogram and its relationship with interatrial conduction time in patients with paroxysmal supraventricular tachycardias

RESUMEN Introducción: Existen algunos estudios que relacionan parámetros de la onda P con diferentes tiempos de conducción auricular, pero no se han realizado teniendo en cuenta a cada derivación del electrocardiograma. Objetivo: Determinar la duración de la onda P (Pdur) en las 12 derivaciones y relacionarlas con el tiempo de conducción interauricular. Método: Estudio de corte transversal en 153 pacientes adultos con diagnóstico confirmado de taquicardia por reentrada intranodal (TRIN) o vías accesorias mediante estudio electrofisiológico invasivo. Resultados: Al comparar la Pdur entre sustratos arrítmicos por cada derivación, no existieron diferencias significativas, excepto en V6. En las derivaciones DII, DIII, aVR, aVF, V1 y de V3-V6 la Pdur se correlacionó con el tiempo de conducción interauricular en ambos sustratos arrítmicos. En el análisis multivariado, la Pdur constituyó un predictor independiente de tiempos de conducción interauricular ≥ 95 percentil, en las derivaciones de cara inferior y en V3, V5 y V6. Se observaron altos valores del área bajo la curva de la Característica Operativa del Receptor en las derivaciones DII (0,950; p<0,001), DIII (0,850; p<0,001) y V5 (0,891; p<0,001). Conclusiones: No existen diferencias por derivación en la Pdur al comparar casos con TRIN y vías accesorias, excepto en V6. La mayoría de las derivaciones se correlacionaron con el tiempo de conducción interauricular. La Pdur fue un predictor independiente de tiempos de conducción interauricular ≥ 95 percentil. La derivación DII presenta la mayor capacidad discriminativa para encontrar valores prolongados del tiempo de conducción interauricular.

ABSTRACT Introduction: Although some studies relate P wave parameters to different atrial conduction times, they do not consider each electrocardiogram lead separately. Objective: To determine the duration of P wave (Pdur) in the 12 leads of the electrocardiogram and relate it to the interatrial conduction time. Method: We conducted a cross-sectional study in 153 adult patients with confirmed diagnosis of atrioventricular nodal reentry tachycardia (AVNRT) or accessory pathways by invasive electrophysiological study. Results: When comparing the Pdur between arrhythmic substrates by each lead, no significant differences were found, except for V6. In leads II, III, aVR, aVF, V1 and V3-V6, Pdur was correlated with the interatrial conduction time in both arrhythmic substrates. In our multivariate analysis, the Pdur was an independent predictor of interatrial conduction times ≥ 95 percentile in inferior wall leads and in V3, V5 and V6. High values of the area under the receiver operating characteristic curve were observed in II (0.950; p<0.001), III (0.850; p<0.001) and V5 (0.891; p<0.001) leads. Conclusions: The Pdur showed no difference by leads when comparing cases with AVNRT and accessory pathways, except for V6. Most of the leads were correlated with the interatrial conduction time; Pdur was an independent predictor of interatrial conduction times ≥ 95 percentile. Lead II has the greatest discriminatory ability to find prolonged values of interatrial conduction time.

Trabajo metodológico: reclamo para lograr interdisciplinariedad desde el colectivo año de la carrera de Medicina / Methodological work: a claim to achieve interdisciplinarity through the year teaching staff of the medicine career

Fundamento: el trabajo metodológico con enfoque interdisciplinario es una fortaleza para realizar una labor integral desde los colectivos de año de la carrera de Medicina. Objetivo: identificar las necesidades para acometer un trabajo metodológico que sustente la interdisciplinariedad desde el colectivo de año de primer año de la carrera de Medicina en la Universidad de Ciencias Médicas de Villa Clara. Métodos: se realizó una investigación descriptiva con enfoque cualitativo, durante tres cursos (2013-2015). Se utilizaron métodos teóricos: análisis-síntesis e inducción-deducción, y empíricos: el análisis documental para la determinación de los núcleos teóricos de contenidos y sus posibilidades de interrelación, y el trabajo grupal para obtener una información homogénea sobre la problemática analizada. Resultados: se delimitaron las necesidades para lograr la interdisciplinariedad, tanto en su dimensión de proyecto como en la de proceso desde el trabajo metodológico del colectivo de año de primer año de la carrera de Medicina. En los documentos no se evidencia cómo alcanzar la integración disciplinar e interdisciplinar, no se precisa cómo deben integrarse las asignaturas del ciclo entre ellas y entre ciclos, ni se orienta metodológicamente cómo lograrlo. La discusión grupal confirmó estas limitaciones. Conclusiones: la identificación de estas necesidades sirve de diagnóstico y evaluación constante y gradual para lograr la efectividad deseada a través de la planificación y realización de un trabajo metodológico que tribute a la interdisciplinariedad; es un reto a enfrentar en un proceso docente educativo pertinente para contribuir a la formación del médico general desde el primer año de la carrera.

Background: methodological work with interdisciplinary approach is a strength for a comprehensive collective work through the year teaching staff of the medical career. Objective: to identify the needs to undertake methodological work that supports interdisciplinary work through the first year teaching staff of the medical career at Villa Clara University of Medical Sciences. Methods: a descriptive study was carried out within the qualitative approach, for three years (2013-2015). Theoretical methods were used: analysis-synthesis and induction-deduction, and empirical ones documentary analysis for the determination of the theoretical core content and possibilities of interaction and group work to obtain homogeneous information on the issues discussed. Results: the needs to achieve interdisciplinarity through the methodological work were defined, either in its project dimension or in the process one of the first year teaching staff of the medical career. In the documents there is no evidence about how to achieve disciplinary and interdisciplinary integration; it's neither specified how subjects should be integrated among them and between cycles, nor methodologically orientations about how to achieve it. Group discussion confirmed these limitations. Conclusions: the identification of these needs is a diagnostic, steady and gradual assessment to achieve the desired effectiveness through the planning and implementation of a methodological work that tribute to interdisciplinarity; it is a challenge to face in a relevant educational process to contribute to the comprehensive formation of the general practitioner since the first year of the career.

La evaluación del aprendizaje: nuevas tendencias y retos para el profesor / Learning assessment: new trends and challenges for the teacher

La evaluación conduce a la dirección efectiva del proceso enseñanza aprendizaje y a la determinación de su grado de eficiencia. En el presente artículo se reflexiona acerca de algunas tendencias actuales en las prácticas evaluativas, lo que ha traído consigo la aparición de concepciones y propuestas diversas: evaluación cualitativa, alternativa, auténtica y orientada al aprendizaje, que la sitúan en una perspectiva comprehensiva en cuanto a su objeto, funciones, metodología y técnicas, como necesidad de nuevos enfoques en la universidad innovadora. Este contexto de reflexión y cambio evaluativo demandan la autopreparación continua del profesor, confrontación en el colectivo pedagógico y ética profesional.

Learning assessment leads to the effective management of the teaching-learning process and determining its degree of efficiency. In this article we reflect on current trends in assessment practices, which have led to the emergence of concepts and various proposals: qualitative assessment, alternative, authentic and learning-oriented, situating it in a comprehensive perspective on its purpose, functions, methods and techniques, such as need for new approaches to innovative university. This context of reflection and assessment change demand continuous self-preparation of the teacher, confrontation in the teaching staff and professional ethics.

Hiperplasia paratiroidea en un adolescente / Parathyroid hyperplasia in an adolescente

El hiperparatiroidismo primario esporádico es una de las causas de hipercalcemia en la edad pediátrica. Constituye una entidad muy poco frecuente, más aún si es debido a hiperplasia paratiroidea. Se presenta el caso de un adolescente con historia de litiasis renal, hipercalcemia asociada a cifras elevadas de la hormona paratiroidea, e imágenes sugestivas de adenoma en paratiroide inferior izquierda por gammagrafía con sestamibi marcado con tecnecio-99m. Se realizó exéresis quirúrgica de la glándula afectada. El examen anatomo-patológico de la pieza arrojó hiperplasia paratiroidea. La presentación de este caso contribuye al reconocimiento del hiperparatiroidismo primario, entre las posibilidades diagnósticas al evaluar un paciente pediátrico con hipercalcemia(AU)

Sporadic primary hyperparathyroidism is one of the causes of hypercalcemia in pediatric ages. A very uncommon condition, it is even less frequent when caused by parathyroid hyperplasia. A presentation is provided of the case of an adolescent with a history of renal lithiasis, hypercalcemia associated to high parathyroid hormone values, and imaging suggestive of lower left parathyroid adenoma by gammagraphy with sestamibi marked with technetium-99m. Surgical exeresis of the affected gland was performed. Anatomopathological examination of the piece revealed the presence of parathyroid hyperplasia. This case presentation contributes to the recognition of primary hyperparathyroidism as one of the diagnostic possibilities when evaluating a pediatric patient with hypercalcemia(AU)

Síndrome metabólico en la infancia, un enfoque para la atención primaria / Metabolic syndrome in childhood, assessment aimed to the primary health care

La obesidad en niños y adolescentes es un problema de salud a nivel mundial, asociado frecuentemente a diferentes alteraciones clínicas, como el síndrome metabólico, la aterosclerosis temprana, la dislipidemia, la hipertensión arterial y la diabetes mellitus tipo 2. El síndrome metabólico ha sido definido como la asociación de varios factores de riesgo precursores de enfermedad cardiovascular arterosclerótica y de diabetes mellitus tipo 2 en el adulto, sin embargo no hay consenso respecto al diagnóstico en la infancia y la adolescencia. La importancia clínica de este síndrome y su detección temprana, se debe a su creciente prevalencia y a su elevado riesgo cardiovascular, que a su vez, se debe a la suma de sus componentes, que de manera independiente, constituyen factores de riesgo. El tratamiento en este grupo de edades tiene como objetivo la prevención primaria y promover cambios en el estilo de vida.

Obesity in children and adolescents is a health problem worldwide and is often associated to different clinical alterations such as metabolic syndrome, early atherosclerosis, dyslipidemia, blood hypertension and type 2 diabetes mellitus. The metabolic syndrome has been defined as the association of several predisposing risk factors for the atherosclerotic cardiovascular disease and type 2 diabetes mellitus in the adult. However, there is no consensus about diagnosis of this entity at childhood and adolescence. The clinical importance of this syndrome and its early detection come from its growing prevalence and high cardiovascular risk that is due to the combination of all its components which are in turn independent risk factors. The treatment in this group of ages is aimed at primary prevention and at promoting changes in lifestyles.

Incidencia de lipodistrofia insulínica en niños y adolescentes diabéticos tipo 1 / Incidence of insulin lipodystrophy in type 1 diabetes children and adolescents

Introducción: la Diabetes Mellitus tipo 1 se encuentra entre las enfermedades crónicas más frecuentes de la infancia. El diagnóstico de diabetes puede provocar un impacto emocional importante para la familia y el paciente, que una vez diagnosticado necesita administración de insulina de por vida, provocando a largo plazo lesiones en los sitios de inyección. Objetivo: identificar la Incidencia de lipodistrofia insulínica en niños y adolescentes diabéticos tipo 1. Métodos: estudio descriptivo de corte transversal con 60 diabéticos tipo 1, de cinco a 18 años de edad, atendidos en el Hospital Pediátrico de Centro Habana durante 2013. Se realizó examen físico mediante observación y palpación del sitio de inyección para identificar lipodistrofia, se aplicó una encuesta para evaluar los conocimientos y habilidades en la técnica de administración de insulina. Se calculó el índice de incidencia de lipodistrofia, los resultados se expresaron en porcentajes. Resultados: se encontró lipodistrofia insulínica en el 70 por ciento de los pacientes, el 35 por ciento tenía lesiones en dos zonas, el 30 por ciento en una zona y el 5 por ciento en tres regiones, los brazos fueron la región más frecuente; seguida del abdomen, muslos y glúteos. El 83,33 por ciento de los pacientes presentó deficiencias en conocimientos y habilidades del tratamiento insulínico. Conclusiones: en los pacientes estudiados existe alta incidencia de lipodistrofia insulínica, no asociada al tipo de insulina administrada, se encontró deficiencias en conocimientos y aplicación del tratamiento insulínico(AU)

Introduction: Type 1 diabetes mellitus is among the most frequent chronic diseases at childhood. The diagnosis may cause a significant emotional impact on the family and the patient as well, and once diagnosed, this patient will need life-long insulin administration that will lead to long-term injures in the injection sites. Objective: To identify the incidence of insulin lipodystrophy in type 1 diabetes children and adolescents. Methods: Cross-sectional descriptive study performed in 60 type 1 diabetes children aged 1 to 18 years and seen at the pediatric hospital of Centro Habana in 2013. They were physically examined through observation and palpation of the injection site in order to detect lipodystrophy. A survey was also made to evaluate knowledge and skills in administering insulin. The incidence rate of lipodystrophy was estimated and the results were given in percentages. Results: There was insulin lipodystrophy in 70 percent of patients; 35 percent had lesions in two areas; 30 percent in one area and 5 percent in three area; the arms was the most used area followed by abdomen, thighs and buttocks. In this group, 83.33 percent of patients showed deficient knowledge and skills regarding the insulin treatment. Conclusions: Insulin lipodystrophy incidence is high in the studied patients, unrelated to the type of administered insulin; there was poor knowledge and deficiencies in applying the insulin treatment correctly(AU)

Ginecomastia fisiológica puberal / Puberal physiological gynecomastia

La ginecomastia puede ser una variante normal del desarrollo puberal observado en varones adolescentes, y aunque no existen abundantes reportes estadísticos sobre su prevalencia, se ha evaluado un número significativo de pacientes en consultas médicas. Puede presentarse de forma unilateral o bilateral, y usualmente es idiopática. Las concentraciones plasmáticas de hormona luteinizante, testosterona y estradiol se observan dentro de límites normales. Por lo general, involuciona espontáneamente en 1 o 2 años, aunque constituye motivo serio de preocupación en los adolescentes afectados porque altera significativamente su calidad de vida con problemas físicos y emocionales. El tratamiento debe limitarse a aliviar la ansiedad de los pacientes y familiares, y es aconsejable la evaluación periódica. En algunos casos se ha recomendado el uso de medicamentos o la corrección quirúrgica.

Gynecomastia may be a normal variant of the pubertal development observed in male teenagers and, although there are no abundant statistical data on its prevalence, a significant number of patients have been seen at the physician's offices. It may occur unilateral or bilateral and usually idiopathic. The plasma luteinizing hormone, testosterone and stradiol concentrations are within the normal limits. Generally, it disappears spontaneously in one or two years, though it may become a serious concern for affected adolescents since it alters in a significant way their quality of life with physical and emotional problems. The treatment should be restricted to relieving anxiety of patients and families, so it is advisable to carry out systematic assessments. It is recommended to use medication or surgical repair in some cases.

Daily oral emtricitabine/tenofovir preexposure prophylaxis and herpes simplex virus type 2 among men who have sex with men.

BACKGROUND: In addition to protecting against HIV acquisition, antiretroviral preexposure prophylaxis (PrEP) using topical 1% tenofovir gel reduced Herpes simplex virus type 2 (HSV-2) acquisition by 51% among women in the CAPRISA 004 study. We examined the effect of daily oral emtricitabine/tenofovir (FTC/TDF) PrEP on HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial. METHODS: HSV-2 serum testing was performed at screening and every six months. Among HSV-2-seronegative individuals, we used Cox regression models to estimate hazard ratios (HRs) of HSV-2 seroincidence associated with randomization to FTC/TDF. We used multiple imputation and Cox regression to estimate HRs for HSV-2 seroincidence accounting for drug exposure. We assessed ulcer occurrence among participants with prevalent or incident HSV-2 infection. RESULTS: Of the 2,499 participants, 1383 (55.3%) tested HSV-2-seronegative at baseline, 892 (35.7%) tested positive, 223 (8.9%) had indeterminate tests, and one test was not done. Of the 1,347 HSV-2-seronegative participants with follow-up, 125 (9.3%) had incident HSV-2 infection (5.9 per 100 person-years). Compared with participants receiving placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF (HR 1.1, 95% CI: 0.8-1.5; P = 0.64) or among participants receiving FTC/TDF with a concentration of tenofovir diphosphate >16 per million viable cells (HR 1.0, 95% CI: 0.3-3.5; P = 0.95). Among participants with HSV-2 infection, the proportion with ≥1 moderate or severe ulcer adverse event was twice as high in the placebo vs. active arm (5.9% vs. 2.9%, P = 0.02), but there were no differences in the proportions with ≥1 clinical examination during which perianal or groin ulcers were identified. CONCLUSIONS: Tenofovir in daily oral FTC/TDF PrEP may reduce the occurrence of ulcers in individuals with HSV-2 infection but does not protect against HSV-2 incidence among MSM.

No evidence of sexual risk compensation in the iPrEx trial of daily oral HIV preexposure prophylaxis.

OBJECTIVE: Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior. DESIGN AND METHODS: Sexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy. RESULTS: Overall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6-1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5-1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4-1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1-1.7; P = 0.12). CONCLUSIONS: There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.

Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.

Drug concentrations associated with protection from HIV-1 acquisition have not been determined. We evaluated drug concentrations among men who have sex with men in a substudy of the iPrEx trial (1). In this randomized placebo-controlled trial, daily oral doses of emtricitabine/tenofovir disoproxil fumarate were used as pre-exposure prophylaxis (PrEP) in men who have sex with men. Drug was detected less frequently in blood plasma and in viable cryopreserved peripheral blood mononuclear cells (PBMCs) in HIV-infected cases at the visit when HIV was first discovered compared with controls at the matched time point of the study (8% versus 44%; P < 0.001) and in the 90 days before that visit (11% versus 51%; P < 0.001). An intracellular concentration of the active form of tenofovir, tenofovir-diphosphate (TFV-DP), of 16 fmol per million PBMCs was associated with a 90% reduction in HIV acquisition relative to the placebo arm. Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week. Prophylactic benefits were observed over a range of doses and drug concentrations, suggesting ways to optimize PrEP regimens for this population.

Using conjoint analysis to measure the acceptability of rectal microbicides among men who have sex with men in four South American cities.

Conjoint Analysis (CJA), a statistical market-based technique that assesses the value consumers place on product characteristics, may be used to predict acceptability of hypothetical products. Rectal Microbicides (RM)-substances that would prevent HIV infection during receptive anal intercourse-will require acceptability data from potential users in multiple settings to inform the development process by providing valuable information on desirable product characteristics and issues surrounding potential barriers to product use. This study applied CJA to explore the acceptability of eight different hypothetical RM among 128 MSM in Lima and Iquitos, Peru; Guayaquil, Ecuador; and Rio de Janeiro, Brazil. Overall RM acceptability was highest in Guayaquil and lowest in Rio. Product effectiveness had the greatest impact on acceptability in all four cities, but the impact of other product characteristics varied by city. This study demonstrates that MSM from the same region but from different cities place different values on RM characteristics that could impact uptake of an actual RM. Understanding specific consumer preferences is crucial during RM product development, clinical trials and eventual product dissemination.

Necrobiosis lipoídica en la edad pediátrica presentación de un caso / Necrobiosis lipoidica in the pediatric age a case presentation

La Necrobiosis lipoídica es una rara enfermedad de la piel que afecta física y psíquicamente al paciente que la padece y que consiste en una dermatitis granulomatosa crónica de etiología idiopática; se le considera frecuentemente como una complicación de una Diabetes mellitus mal controlada. Se presenta el caso de una adolescente de 17 años, con antecedentes patológicos personales de Diabetes mellitus tipo 1 desde los 6 años, tratada con Insulina, que a pesar de que cumple su tratamiento cuidadosamente y mantiene un control metabólico adecuado comenzó a desarrollar desde los 9 años de edad lesiones de Necrobiosis lipoídica en ambos miembros inferiores.

Necrobiosis Lipoidica is a rare skin disease that affects physically and mentally the patient who suffers from it. It consists of a chronic granulomatous dermatitis of idiopathic etiology. It is frequently considered as a complication of a badly controlled Diabetes Mellitus. A case of a seventeen years old female adolescent is presented. She suffers from type 1 Diabetes Mellitus treated with insulin. The patient follows her treatment carefully and she keeps and adequate metabolic control. In spite of this, at the age of 9 she developed lesions of Necrobiosis Lipoidica in her inferior limbs.

Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

BACKGROUND: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. METHODS: We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. RESULTS: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). CONCLUSIONS: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

Large-scale purification of an antibody directed against hepatitis B surface antigen from transgenic tobacco plants.

The application of bioengineering to plants for production of biological products for human and animal use has expanded in recent years. The reasons for this expansion are several and include advances in the technology for novel production systems and the need for very large quantities of therapeutic proteins. The process of growing pharmaceutical proteins in plants, extracting, and purifying is a hard task considering the lack of available information concerning these topics. In this work, a recombinant murine monoclonal antibody specific for the hepatitis B surface antigen, expressed in stably transformed transgenic Nicotiana tabacum plants, was purified by means of a recombinant protein A Streamline chromatography as the main purification step. The antibody expression level varied with the age of the plants and the number of harvests from 40 to 15microg/ml and the maximum process yield was about 25mg of plantibody/kg of biomass. Protein A Streamline chromatography was successfully used in the purification process yielding a recovery of about 60% and a plantibody SDS-PAGE purity of over 90% but unexpectedly, previous clarification steps could not be totally avoided. The amino acid sequence recognized by this affinity purified plantibody was similar to its murine counterpart verifying the potentiality of plants to replace animals or bioreactors for large-scale production of this monoclonal antibody.