Un ensayo clínico piloto de la efectividad clínica de dos presentaciones de esomeprazol / Clinical effectiveness of two esomeprazole presentations in a pilot trial

Resumen Introducción: el presente estudio tuvo como fin investigar la efectividad clínica de dos presentaciones de esomeprazol en pacientes con dispepsia de causa no estudiada. Métodos: se realizó un ensayo clínico piloto de dos presentaciones de esomeprazol de 40 mg recibidos diariamente por 28 días. Se eligieron pacientes con diagnóstico de dispepsia no estudiada que asistieron a consulta de gastroenterología en un hospital de referencia. Se evaluaron a los pacientes inicialmente con endoscopia y biopsia, el seguimiento a 2 y 4 semanas con escalas clínicas de síntomas y calidad de vida con cuestionarios validados en español (SODA y QoL-PEI) y eventos adversos. Además, se midieron los niveles de pH gástrico con pH-metrías en 24 horas al día 14 de tratamiento. Se tomaron niveles séricos del medicamento al momento de la evaluación de la pH-metría. Para las escalas clínicas se aplicó un análisis de varianza (ANOVA) de dos factores con medidas repetidas y al encontrar diferencias significativas en los tiempos se realizó una corrección de Bonferroni. Resultados: se aleatorizó un total de 33 pacientes, 16 y 17 pacientes en cada grupo. No hubo diferencias en el porcentaje de inhibición del pH gástrico al día 14 de tratamiento (p = 0,9795). No hubo diferencias en concentraciones de niveles séricos el día 14 (p = 0,2199). No se encontraron diferencias significativas en las escalas de gravedad y calidad de vida en las dos primeras semanas de tratamiento, pero sí en las últimas dos semanas, en las cuales el producto de prueba demostró mayor disminución del dolor (p = 0,0048) y superioridad en conformidad (p = 0,01) en la subescala SODA. No se presentaron eventos adversos serios y no hubo diferencias estadísticas entre la presentación eventos adversos no serios. Conclusiones: los productos de prueba y el de referencia mostraron efectos similares en variables clínicamente relevantes.

Abstract Introduction: This pilot studied the clinical effectiveness of two presentations of esomeprazole in patients with dyspepsia with undiagnosed causes. Methods: We conducted a pilot clinical trial of two 40 mg Esomeprazole presentations. Patients with dyspepsia of unknown cause at a gastroenterology clinic in a referral hospital were included. They received one or the other presentation daily for 28 days. Patients were initially evaluated with endoscopy and biopsy and received follow-up examinations at two and four weeks. Adverse events were recorded, and clinical symptom scales and quality of life questionnaires validated in Spanish (SODA and QoL-PEI) were used. In addition, gastric pH levels were measured continuously for 24 hours on day 14 of treatment. Serum levels of the medication administered were also measured on day 14 of treatment. A two-way repeated measures ANOVA was used to compare mean differences between the two groups. When significant differences in times were found, a Bonferroni correction was made. Results: A total of 33 patients were randomized into two groups: 16 patients in one group and 17 in the other. There were no differences in the percentages of gastric pH inhibition at day 14 of treatment (p = 0.9795). There were no differences in serum level concentrations on day 14 (p = 0.2199). No significant differences were found in severity and quality of life scales in the first two weeks of treatment. However, in the last two weeks of treatment the test product showed a larger decrease in pain (p = 0.0048) and superiority in compliance (p = 0.01) on the SODA subscale. There were no serious adverse events, and there were no statistical differences between the presentations of non-serious adverse events. Conclusions: The Test product and the Reference product showed similar effects on clinically relevant variables.

One-day point prevalence of healthcare-associated infections and antimicrobial use in four countries in Latin America.

BACKGROUND AND AIMS: Experience in the region shows that in some countries there is very good surveillance of Healthcare-associated infections (HAIs) in health services, but there is no national data consistently in all countries. Therefore, we set to estimate the total burden of HAIs and antimicrobial use in acute care hospitals in Brazil, Venezuela, Mexico, and Colombia using the one-day point prevalence methodology. METHODS: The survey was conducted between June and July 2016. In each ward or unit, HAIs and antimicrobial use data were collected on a single day by a trained team of researchers. Also, for each patient, we collected data on risk factors for infections. RESULTS: One out of ten individuals surveyed had at least one healthcare-associated infection (HAI). Pneumonia and surgical site infections were the most relevant among the surveyed countries. Most of the surveyed participants, regardless of their HAI status, received antibiotics except the individuals managed in Brazil. Carbapenems and third-generation Cephalosporins were among the most frequently used antibiotics. CONCLUSION: Our results add to WHO's recent efforts to understand HAIs prevalence and antibiotic consumption in low and middle-income countries, of which we studied three that were not included in their last report.

Características clínicas y paraclínicas de recién nacidos con sepsis en un hospital nivel IV en Cali, Colombia / Clinical and laboratory characteristics of newborns with sepsis in a level IV hospital in Cali, Colombia

Objetivo: Describir las características clínicas y microbiológicas de recién nacidos con sepsis admitidos a UCI neonatal de la Fundación Valle del Lili. Materiales y métodos: estudio retrospectivo descriptivo entre los años 2012 y 2015. Se seleccionaron neonatos con diagnóstico de sepsis con más de tres días de manejo antibiótico. Resultados: Se analizaron datos de las historias de 569 pacientes. El 37.9% (216) de los neonatos tenían peso al nacimiento <1500 g, 29.2% (166) entre 1500-2500 g, y 33.9% (187) >2500 g. Para un total de 396 (69.6%) pacientes con sepsis temprana, 308 (54.1%) con sepsis tardía. Las características clínicas más comunes fueron las respiratorias. El principal diagnóstico de infección en sepsis tardía fue la bacteremia (46.4%), seguido de la infección asociada al catéter (17.8%). El aislamiento más común para sepsis temprana fue Streptococcus agalactiae en el 21.9%, mientras que en sepsis tardía fue Staphylococcus epidermidis en el 22.6%. La mortalidad encontrada en sepsis temprana fue de 8.8% y en tardía de 8.5%. Conclusiones: La sepsis neonatal, a pesar de la mejoría en los controles prenatales, continúa siendo una patología frecuente con un importante porcentaje de morbimortalidad. El Streptococcus agalactiae fue la principal causa de sepsis temprana en nuestros pacientes.

Objective: To describe the clinical and microbiological characteristics of newborns with sepsis admitted to the Neonatal Intensive Care Unit of Fundación Valle del Lili in Cali, Colombia. Methods: Descriptive, observational, retrospective study between 2012 and 2015. We included newborns with diagnosis of sepsis with more than three days of antibiotic management. Results: A total of 569 patients were included, 37.9% (216) of the newborns had a birth weight <1500g, 29.2% (166) between 1500 and 2500g , and 32.9% (187) >2500g. 396 (69.6%) patients with early-onset sepsus, 308 (54.1%) had late-onset sepsis. The most common clinical characteristics were respiratory symptoms. The main diagnosis of infection in late-onset sepsis was bacteremia (46.4%) followed by catheter associated infection (17.8%). The most common blood culture isolation for early-onset sepsis was Streptococcus agalactiae (21.9%) and Staphylococcus epidermidis in late onset sepsis (22.6%). The mortality found in early-onset sepsis was 8.8% and in late-onset sepsis was 8.5%. Conclusions: Neonatal sepsis continue to be a frequent diagnosis with significant morbidity and mortality. Better strategies for the prevention of this entity are required including the prenatal period.

Neumonía por Coxiella burnetii: presentación de un caso y revisiónde la literatura / Coxiella burnetii pneumonia: Case report and literature review

Se presenta el caso de una paciente de sexo femenino de 56 años, previamente asintomática, quien inicia de forma rápidamente progresiva un cuadro clínico de mialgias, artralgias, rash y fiebre alta no cuantificada, que se asocia posteriormente a disnea, tos y dolor abdominal, por lo cual es remitida a un centro hospitalario de alta complejidad de la ciudad de Cali (Colombia). Dado que la paciente, con impresión diagnóstica de neumonía por influenza AH1N1 sobre-infectada, no mejoraba con el tratamiento antibiótico y antiviral propuesto, se sospechó la posibilidad de una neumonía por gérmenes atípicos o la concomitancia de alguna enfermedad del tejido conectivo, por lo cual se solicitaron estudios clínicos adicionales. Se detectaron títulos de anticuerpos del tipo IgM mediante técnica de inmunofluorescencia indirecta (IFI) para Coxiella burnetii con lo que se cambió el tratamiento antibiótico a levofloxacina y doxiciclina, a lo cual la paciente respondió de forma óptima y finalmente pudo ser dada de alta.

We report the case of a female patient of 56 years, previously asymptomatic, who begins rapidly progressive clinical symptoms of myalgia, arthralgia, rash and high fever unquantified, associated later with dyspnea, cough and abdominal pain, so it is sent to a hospital of high complexity of Cali (Colombia). Because the patient with pneumonia diagnostic impression of influenza AH1N1 on-infected, did not improve with antibiotic and antiviral treatment proposed was suspected the possibility of atypical pneumonia germs or concomitant connective tissue disease, so further clinical studies were requested. We detected titers of IgM antibodies by indirect immunofluorescence (IIF) for Coxiella burnetii thus antibiotic treatment was changed to levofloxacin and doxycycline, to which the patient responded optimally and could eventually be released.