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Resumen En la revisión de borradores de informes para evaluación y posicionamiento de nuevos fármacos en un entorno multidisciplinar, se observan determinados errores de expresión o criterio que se repiten con frecuencia. Principalmente, están relacionados con la consideración de “diferencias” o tendencias no significativas, abuso de la reducción relativa del riesgo, errores en la valoración de resultados por subgrupos sin calcular la interacción estadística, confusiones en la interpretación de las comparaciones indirectas, sobrevaloración de la relevancia clínica con variables subclínicas y afirmaciones sesgadas en el apartado de seguridad, entre otros. También se observa a menudo ambigüedad o inhibición en el posicionamiento, especialmente en situaciones de precariedad en la evidencia disponible. El presente trabajo expone de forma sintética tales errores, aclara algunos términos comunes y propone expresiones o criterios alternativos que se consideran preferibles, con el fin de ofrecer una evaluación para la toma de decisiones en beneficio de los pacientes.

Revista Española de Salud Pública, 2015, 89, 1-10, que componen la calidad de vida (CdV) en las personas con demencia que viven en residencias. El objetivo de este estudio fue describir la CdV e identificar los factores relacionados con ella. Métodos: Muestra compuesta por 525 personas con demencia mayores de 60 años en 14 residencias de España. La CdV se evaluó mediante el EQ-5D (índice y escala visual analógica, EQ-EVA) y Quality of Life in Alzheimer’s Disease (QoL-AD versiones residente y cuidador). También se utilizaron Clinical Dementia Rating Scale (CDR), el índice de Barthel, la escala Cornell de depresión en demencia (CSDD), una versión adaptada de la Cumulative Illness Rating Scale for Geriatrics (CIRS-G), Short Portable Mental Status Questionnaire (SPMSQ) y el Mini Examen Cognoscitivo (MEC). Para determinar la asociación entre variables se utilizó el coeficiente de correlación de Pearson y la prueba t de Student. Resultados: Las escalas presentaron entre ellas correlaciones de 0,17 a 0,50. La puntuación QoL-AD cuidador fue mejor en varones con menos discapacidad y depresión (28,94±4,91, 29,91±4,74 y 28,44±4,94, respectivamente; (p

Objetivo: Desarrollar una suspensión de omeprazol oral destinada a la población pediátrica. Métodos: Para el desarrollo de la formulación se empleó el principio activo en polvo en lugar de pellets, que es lo que habitualmente se utiliza. Por la inestabilidad del fármaco en medio ácido, se desarrolló una preparación de carácter oleoso. Se realizaron estudios para caracterizar el vehículo oleoso, características organolépticas, volumen de sedimentación y se utilizó la técnica de calorimetría diferencial de barrido (DSC) para los estudios de viscosidad y compatibilidad fármaco-excipientes. Resultados: Los porcentajes donde la fórmula no emulsionó fueron: 1,54% de viscosizante y 4,1% de tensioactivo. En el termograma se observó que la temperatura de fusión de pico y los valores de ΔHf entalpía de omeprazol se vieron disminuidos por la presencia de aspartamo y también un cambio en el pico de fusión igual a 10 °C, indicando una posible interacción entre omeprazol y aspartamo. Conclusiones: Hasta donde llegó el estudio se consiguió estabilizar todos los componentes de la fórmula, salvo el edulcorante que debe ser sustituido por otro de potencia similar para llegar a la fórmula deseada., Aim: Develop an oral omeprazole suspension for use in the pediatric population. Methods: For the development of the formulation was used active ingredient in powder instead of pellets, which is usually used. By instability of the drug in acid medium, we developed a preparation of an oily character. Studies were conducted to characterize the oil vehicle, organoleptic characteristics, sedimentation volume and used the technique of differential scanning calorimetry (DSC) for studies of viscosity and drug-excipient compatibility. Results: The percentages in which the emulsified non formula were 1,54% and 4,1% surfactant agent. In the thermogram was observed that the peak melting temperature and enthalpy values of omeprazole were diminished by the presence of aspartame and also a change in the melting peak equal to 10ºC, indicating a possible interaction between omeprazole and aspartame. Conclusions: As far as the study did managed to stabilize all components of the formula, except the sweetener should be replaced by another similar power to reach the desired formula.

To assess the impact of pharmaceutical intervention on the use of sequential therapy (ST) with fluoroquinolones.A prospective comparative study of pharmaceutical intervention in two stages: observational stage and intervention stage for ST promotion.In all, 250 patients receiving intravenous therapy with fluoroquinolones (113 with levofloxacin and 137 with ciprofloxacin) were studied, with 76 and 70 patients, respectively, being eligible for a pharmaceutical intervention program to promote ST. Pharmaceutical intervention showed a decreased duration of intravenous therapy and increased duration of oral therapy for both drugs, as well as decreased medication-related costs, all in a statistically significant manner.ST promotion provides an opportunity to expand the role of hospital pharmacists and to optimize fluoroquinolone-based therapy, which results in decreased intravenous treatments and provides a more cost-effective option.

Hepatic gamma-cystathionase, a rate-limiting enzyme for the synthesis of L-cysteine from L-methionine in the trans-sulphuration pathway, exhibits significantly higher activity in the newly born infant as compared to the fetus. The aim of this work was: 1) To determine whether the increase in gamma-cystathionase activity occurring in the fetal-to-neonatal transition is due to up-regulation of its mRNA and protein, 2) To elucidate the mechanisms responsible for this increase in gamma-cystathionase activity. Our results show that expression of gamma-cystathionase at both the mRNA and protein levels was higher in newborn than in fetal liver. gamma-Cystathionase activity in fetal hepatocytes in vitro increased when incubated with tert-butyl-hydroperoxide at low concentration (0.01 mM). Hence, moderate oxidative stress would act as a signal to up-regulate gamma-cystathionase in the fetal to neonatal transition. Stress hormones, such as phenylephrine or glucagon also increased gamma-cystathionase activity in fetal hepatocytes. We also report a competitive inhibition of purified gamma-cystathionase by L-cysteine, which would help to maintain physiological low L-cysteine levels in hepatocytes. In conclusion, our results show that increased hepatic gamma-cystathionase activity in the fetal-to-neonatal transition is due to up-regulation of its gene expression mediated by stress hormones together with the physiological oxidative stress that occurs at birth.

To clinically assess effectiveness of therapeutic interchange from glibenclamide to gliclazide in the hospital setting.An open-label prospective, randomized study with two groups of patients: a reference group (patients still receiving their previous outpatient regimen of glibenclamide) and an interchange group (patients with gliclazide substituted for glibenclamide according to a hospital-approved interchange protocol). The efficacy endpoint used was blood glucose at 3 and 6 days post-intervention. A patient with blood glucose200 mg/L was considered clinically controlled, and blood glucose changesor30 mg/dL were considered significant.One hundred and sixteen patients were randomized. Blood glucose on the day before the intervention was 177.9 mg/dL +/- 63.4 in the reference group versus 171.3 mg/dL +/- 52.1 in the interchange group (p = 0.92). Mean blood glucose during the first 3 days post-intervention was 156.1 mg/dL +/- 47.5 and 177.7 mg/dL +/- 36.0 (p = 0.14) in the reference and interchange groups, respectively; and mean values for the first 6 days post-intervention were 142.1 mg/dL +/- 36.0 and 172.8 mg/dL +/- 28.2, respectively (p = 0.01). The overall analysis of blood glucose levels showed a better control in the reference group versus baseline values, which was not seen in the interchange group, where blood glucose remained stable and similar to baseline. In no case were 3-day and 6-day blood glucose mean levels above 200 mg/dL, which may be considered acceptable within the hospital setting.Therapeutic interchange may be safely performed with no clinical impairment, but better controls were achieved in the reference group.