Monitorización farmacocinética de antagonistas del factor de necrosis tumoral: utilidad clínica en enfermedad inflamatoria intestinal / Pharmacokinetics monitoring of tumour necrosis factor inhibitors: utility in inflammatory bowel disease management

Introducción: El fracaso de la terapia con biológicos en la enfermedad inflamatoria intestinal (EII) es un problema común. La monitorización farmacocinética es una herramienta que podría permitir optimizar estos tratamientos mediante la individualización de la posología en los diferentes escenarios clínicos. Objetivo: Describir las determinaciones de concentraciones séricas de infliximab y adalimumab en pacientes con EII y evaluar el impacto de las recomendaciones farmacocinéticas en la toma de decisiones clínicas y la evolución de los pacientes.Métodos: Estudio trasversal observacional retrospectivo de dos años de duración (2017-2018) de las determinaciones de inhibidores del factor de necrosis tumoral (anti-TNF) realizadas en pacientes del Servicio de Medicina Digestiva de un hospital general. Resultados: Se realizaron 133 determinaciones correspondientes a 66 sujetos (38% tratados con adalimumab; 62% infliximab). El principal motivo de monitorización (>55%) fue la presencia de enfermedad activa. Más de la mitad de los pacientes tenían concentraciones fuera del intervalo terapéutico (el 51% de adalimumab y 37% de infliximab presentaban una exposición subóptima). La recomendación de mantener la pauta posológica previa se propuso en <40% de los informes farmacocinéticos, siendo el grado de aceptación de la recomendación superior al 80% en todos los casos. Los datos analíticos de inflamación se redujeron tras la monitorización sin mostrar significación estadística en todos los casos.Conclusión: La mayoría de pacientes con EII tratados con anti-TNF presentan concentraciones de fármaco inadecuadas. La monitorización ha demostrado ser una herramienta útil para guiar la toma de decisiones terapéuticas y podría contribuir en la mejora de los parámetros clínicos de estos pacientes. (AU)

Introduction: The failure of biologic therapy in inflammatory bowel disease (IBD) is a common problem. The pharmacokinetic monitoring is a useful tool that allows to optimize these treatments.Objective: To describe the pharmacokinetic determinations of plasma concentrations of infliximab and adalimumab in patients with IBD and evaluate its impact on clinical decision.Method: Retrospective, observational study of two years duration (2017-2018) of the tumor necrosis factor (anti-TNF) inhibitor determinations performed in patients of the Digestive Service of a general hospital.Results: A total of 133 determinations were obtained about 66 subjects (38% adalimumab, 62% infliximab). The main reason (>55%) of the request for monitoring was the presence of active disease. More than half of the patients had concentrations outside the therapeutic range (51% of patients with adalimumab and 37% of those with infliximab had plasma levels below the lower range considered suboptimal). The maintenance of the previous dosage was recommended only in <40% of the monitoring and the degree of acceptance of the interventions were more than 80% in all cases. The analytical data of inflammation were reduced after monitoring without showing statistical significance in all cases.Conclusion: Standard anti-TNF regimen was not adequate to obtain range concentrations in more than half of analyzed cases. Monitoring has proven to be very useful in supporting clinical decision and it may promote an improvement in the clinical parameters of patients with IBD. (AU)

[Multiple sclerosis in continental Portugal: analysis of spatio-temporal clusters and spatial variations in time trends of hospitalised patients between 2002 and 2013]. / Esclerosis multiple en Portugal continental: analisis de clusters espaciotemporales y variaciones espaciales en tendencias temporales de los ingresados entre 2002 y 2013.

INTRODUCTION: Multiple sclerosis (MS) is a demyelinating and autoimmune disease with variable progression and high risk of hospital admission. In some studies these hospitalizations may be used as surrogate markers of disease progression, however in Portugal, due to organizational asymmetries and clinical safety choices this relationship is not linear. The admission patterns for this pathology can provide relevant data to the design of disease's management strategies and resource allocation. AIM: To characterize hospital admissions for MS in mainland Portugal between 2002 and 2013 through the cases included in the hospital morbidity database with the code ICD-9-CM 340 as primary diagnosis. PATIENTS AND METHODS: In this study mapping techniques, analysis of spatio-temporal clusters and analysis of spatial variations in temporal trends of hospital admission rates for MS were used. RESULTS: Between 2002 and 2013 the rate of annual hospital admission for MS was 82.2/100,000 hospitalizations, with a decreasing trend of 3.73%/year. Seven spatial-temporal clusters were identified with hospital admission rates for this pathology ranging from 2.27 to 4.23 higher than the national rate. In addition, in this time period four areas with increasing trend in hospital admission rate (+ 0.17 to +11.5%) were detected: Sintra-Cascais-Amadora, Serra da Estrela, Alentejo-Algarve and Tras-os-Montes. CONCLUSION: These data demonstrate the expected asymmetry of organizational differences, environmental, genetic and clinical safety choices. This study allowed the identification of areas and evolutionary trends of hospital admission rates for MS, enabling the design of more focused health interventions.

TITLE: Esclerosis multiple en Portugal continental: analisis de clusters espaciotemporales y variaciones espaciales en tendencias temporales de los ingresados entre 2002 y 2013.Introduccion. La esclerosis multiple (EM) es una enfermedad desmielinizante y autoinmune con progresion variable y alto riesgo de hospitalizacion. En algunos estudios, estos ingresos se utilizan como marcadores sustitutivos de la progresion de la enfermedad, pero en Portugal, debido a las asimetrias organizacionales y las opciones de seguridad clinica, esta relacion no es lineal. El patron de ingresos por EM puede proporcionar datos relevantes para el diseño de estrategias de gestion de la enfermedad y asignacion de recursos. Objetivo. Caracterizar los ingresos por EM en Portugal continental entre 2002 y 2013 a traves de los casos constantes en la base de datos de morbilidad hospitalaria con codigo de diagnostico principal CIE-9-MC 340. Pacientes y metodos. Se utilizaron tecnicas de mapeo, analisis de clusters espaciotemporales y analisis de variaciones espaciales en tendencias temporales de la tasa de ingresos por EM. Resultados. Entre 2002 y 2013, la tasa de ingreso anual por EM fue de 82,2 por 100.000 ingresos, con una tendencia decreciente anual del 3,73%. Se identificaron siete clusters espaciotemporales con tasas de ingresos por esta patologia desde 2,27 a 4,23 superiores a la tasa nacional. Ademas, se detectaron cuatro areas con tendencia creciente en la tasa de ingreso en este periodo temporal (+0,17 a +11,5%): Sintra-Cascais-Amadora, Serra da Estrela, Alentejo-Algarve y Tras-os-Montes. Conclusion. Estos resultados demuestran la asimetria esperada por las diferencias organizativas, factores ambientales, geneticos y opciones de seguridad clinica. Permite la identificacion de areas y tendencias evolutivas de las tasas de ingreso por EM, y posibilita el diseño de intervenciones en salud mas enfocadas.

Signos y síntomas de alarma durante un transfer / No disponible

No disponible

Safety and efficacy of adapalene 0.1% / benzoyl peroxide 2.5% in the long-term treatment of predominantly moderate acne with or without concomitant medication - results from the non-interventional cohort study ELANG.

BACKGROUND: Acne is a chronic inflammatory disease requiring long-term treatment. The fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO) is indicated for the once-daily topical treatment of Acne vulgaris when comedones, papules and pustules are present. OBJECTIVE: The main objectives of this non-interventional study were to assess long-term efficacy and safety of adapalene-BPO in moderate to severe acne with and without concomitant medication. METHODS: Patients with moderate to severe acne received adapalene-BPO alone or in combination with concomitant medication over a course of 9 months. The primary efficacy endpoint was changes in acne severity according to the Leeds Revised Acne Grading System; secondary endpoints included treatment success assessed by the patient and safety. RESULTS: In total, 5131 patients were eligible for efficacy and 5141 for safety evaluation. The majority of patients (78.8%) received adapalene-BPO alone. About 21.2% received adapalene-BPO in combination with another agent, mostly topical antibiotics (8.8%) or systemic antibiotics (8.7%). Mean (±SD) acne severity improved from 5.6 ± 1.5 at baseline to 3.3 ± 1.9 at month 3, and further to 1.9 ± 1.9 at month 9 (both P < 0.0001). The degree of improvement correlated significantly with the severity at baseline. After 3 and 9 months of treatment, the facial skin was cleared completely (no more visible acne lesions) in 420 (8.2%) and 1326 patients (25.8%), respectively. A therapeutic effect was noted by the patients after a median time of 3 weeks (range: from 1 day to 12 weeks). No serious adverse events were reported. Facial skin irritations, mostly mild to moderate, occurred in 49.5% of patients and led to discontinuation in only 1.7% of cases. CONCLUSION: In consistence with previous clinical findings, the use of adapalene-BPO in daily practice routine is safe and effective in the long-term management of patients with moderate to severe acne.

Effect of adapalene 0.1%/benzoyl peroxide 2.5% topical gel on quality of life and treatment adherence during long-term application in patients with predominantly moderate acne with or without concomitant medication - additional results from the non-interventional cohort study ELANG.

BACKGROUND: In addition to physical long-lasting effects such as permanent scarring and disfigurement, acne has acute and long-term psychosocial effects that affect the individual's quality of life. As with other chronic diseases, treatment success is often compromised by poor adherence. OBJECTIVE: Two main objectives of this non-interventional study were to assess the long-term effect of the fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) on quality of life and treatment adherence. METHODS: Patients with moderate to severe facial acne receiving adapalene-BPO alone or in combination with other drugs were enrolled in this non-interventional study. Data were documented at baseline and after 3 and 9 months of adapalene-BPO treatment. The secondary outcomes reported here include quality of life determined by the Cardiff Acne Disability Index (CADI), treatment adherence assessed by the ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux) questionnaire, and patient satisfaction. RESULTS: In total, 5131 patients were included in the efficacy evaluation. After 9 months, mean (±SD) quality of life (CADI) improved significantly from 5.9 ± 3.0 to 2.4 ± 2.7 (P < 0.0001). Patients with more severe acne at baseline tended to achieve a greater improvement in quality of life. Long-term adherence was found to be good in 83.9% of patients. Adherence had a significant effect on efficacy and quality of life (P < 0.0001 respectively). The vast majority of patients (92.1%) reported subjective improvement at the interim analysis. Accordingly, most patients (84.8%) were satisfied or very satisfied with adapalene-BPO by the end of the observation period. CONCLUSION: The clinical improvement of the disease led to an increase in quality of life among acne patients. The treatment success may be a motivation factor for patients to stay adherent over the long-term treatment course, indicating the qualification of adapalene-BPO topical gel as an appropriate medication also in the long-term usage.

[Tobacco dependency and adolescents: a good time to give up smoking? Relation to social and family factors]. / Tabaquismo y adolescentes: 'buen momento para dejar de fumar? Relación con factores sociofamiliares.

OBJECTIVES: To find the prevalence and dependency of adolescents on tobacco, its relation with family and social factors and the motivation for giving up smoking. DESIGN: Cross-sectional, descriptive study using questionnaires. SETTING: Secondary school, Jaén, Spain. PARTICIPANTS AND MEASUREMENTS: A total of 232 students: the questionnaire included questions on age, sex, tobacco consumption, smoking habits of family and friends, and family structure. The following tests were given: the Apgar family (AFT), Fagerström (FT), and Richmond (RT) tests. RESULTS: Mean age 14.1 years old (95% CI, 13.9-14.3; range, 5 years); 57% boys. A 22% (17.1%-24.5%) were smokers, most of whom were boys (65.2%-86.7%; P<.001, *2) and were older than non-smokers (0.7-1.5; P<.001, Student's t). Mean consumption was 9.2 cigarettes a day (7.4-11.0) over 32 months (14.6-49.5). Friends who smoked were more frequent among adolescents who smoked (80.9%-99%) than among non-smokers (57.3%-70.6%; P<.001, *2). Smoking every day increased consumption by 6 cigarettes a day (3.6-9.2; P<.001, Student's t). In 71% (65.3%-76.6%) of families, there were smokers, principally the parents (63.3%-74.6%), who, in 85% (74.2%-95.8%) of cases, disapproved of their son/daughter smoking. Family dysfunction was more frequent in smokers (30% mild [16.1%-43.9%] and 17% severe [5.4%-28.6%]; P<.001, *2). The FT was positive for 12% (2%-22%) and was associated with the consumption of cigarettes per day (r=0.78; P<.05, Pearson). The RT was positive for 22% (15.1%-28.9%): 70% in the contemplation stage (55.6%-84.3%); 17% in preparation (5.4%-28.6%); 13% in action (3%-23%). CONCLUSIONS: The consumption of tobacco among adolescents is related to family function and having friends who smoke. The low dependency and the motivation to change make this stage of life a good moment to concentrate on anti-smoking counselling.

Tabaquismo y adolescentes: ¿buen momento para dejar de fumar? Relación con factores sociofamiliares / Tobacco dependency and adolescents: a good time to give up smoking? Relation to social and family factors

Objetivo. Conocer la prevalencia y la dependencia del tabaquismo entre adolescentes, la relación con factores sociofamiliares y la motivación para abandonar el consumo. Diseño. Estudio descriptivo transversal mediante encuesta. Emplazamiento. Instituto de educación secundaria de Jaén. Sujetos y mediciones. Se estudió a 232 alumnos; se recogen la edad, el sexo, el hábito tabáquico, la estructura familiar y el consumo de la familia y los amigos. Se entregan los tests de Apgar familiar, Fagerström y Richmond. Resultados. Edad media 14,1 años; 57% varones y 43% mujeres. Un 22% (intervalo de confianza [IC] del 95%, 17,1-26,9%) fuma, la mayoría son varones (IC del 95%, 65,2-86,7; p < 0,001, test de la *2) y con mayor edad que los no fumadores (diferencia de 1 año; IC del 95%, 0,7-1,5; p < 0,001 test de la t de Student), consumo medio de 9,2 cigarrillos/día (IC del 95%, 7,4-11,0) y duración de 32 meses (IC del 95%, 14,6-49,5). Los amigos que fuman son más frecuentes entre adolescentes fumadores (IC del 95%, 80,9-99,0) que entre no fumadores (IC del 95%, 57,3-70,6; p < 0,001, test de la *2). Fumar diariamente incrementa el consumo en 6 cigarrillos/día (IC del 95%, 3,6-9,2; p < 0,001, test de la t de Student). Se fuma en un 71% (IC del 95%, 65,3-76,6) de las familias, sobre todo los padres (IC del 95%, 63,3-74,6), la mayoría de los cuales reprueba el tabaquismo de su hijo/a (IC del 95%, 74,2-95,8). La disfunción familiar es más frecuente en fumadores (un 30% disfunción leve [IC del 95%, 16,1-43,9] y un 17% con disfunción grave [IC del 95%, 5,4-28,6]; p < 0,001, test de la *2). Un 12% (IC del 95%, 2-22) da positivo en el test de Fagerström y se asocia con el consumo de cigarrillos/día (r = 0,78; p < 0,05, Pearson). Un 22% tiene un test de Richmond positivo (IC del 95%, 15,1-28,9): el 70% se encuentra en fase de contemplación (IC del 95%, 55,6-84,3), el 17% en fase de preparación (IC del 95%, 5,4-28,6) y el 13% en fase de acción (IC del 95%, 3-23). Conclusiones. El consumo de tabaco entre adolescentes se relaciona con la función familiar y el tabaquismo de los amigos. La baja dependencia y el porcentaje de motivación para el cambio hacen de esta etapa vital un buen momento para incidir en el consejo antitabaco

Objectives. To find the prevalence and dependency of adolescents on tobacco, its relation with family and social factors and the motivation for giving up smoking. Design. Cross-sectional, descriptive study using questionnaires. Setting. Secondary school, Jaén, Spain. Participants and measurements. A total of 232 students: the questionnaire included questions on age, sex, tobacco consumption, smoking habits of family and friends, and family structure. The following tests were given: the Apgar family (AFT), Fagerström (FT), and Richmond (RT) tests. Results. Mean age 14.1 years old (95% CI, 13.9-14.3; range, 5 years); 57% boys. A 22% (17.1%-24.5%) were smokers, most of whom were boys (65.2%-86.7%; P<.001, *2) and were older than non-smokers (0.7-1.5; P<.001, Student's t). Mean consumption was 9.2 cigarettes a day (7.4-11.0) over 32 months (14.6-49.5). Friends who smoked were more frequent among adolescents who smoked (80.9%-99%) than among non-smokers (57.3%-70.6%; P<.001, *2). Smoking every day increased consumption by 6 cigarettes a day (3.6-9.2; P<.001, Student's t). In 71% (65.3%-76.6%) of families, there were smokers, principally the parents (63.3%-74.6%), who, in 85% (74.2%-95.8%) of cases, disapproved of their son/daughter smoking. Family dysfunction was more frequent in smokers (30% mild [16.1%-43.9%] and 17% severe [5.4%-28.6%]; P<.001, *2). The FT was positive for 12% (2%-22%) and was associated with the consumption of cigarettes per day (r=0.78; P<.05, Pearson). The RT was positive for 22% (15.1%-28.9%): 70% in the contemplation stage (55.6%-84.3%); 17% in preparation (5.4%-28.6%); 13% in action (3%-23%). Conclusions. The consumption of tobacco among adolescents is related to family function and having friends who smoke. The low dependency and the motivation to change make this stage of life a good moment to concentrate on anti-smoking counselling

The present environmental scenario of the Nador Lagoon (Morocco).

In this paper, we present a multivariate approach (waters, sediments, microfauna) concerning the environmental state of the Nador Lagoon (NE Morocco). The normal water quality parameters (salinity, pH, nutrients) of the dominant marine flows are altered by local fecal water effluents, urban discharges, sewages derived from a water treatment station, and residues originated in a slaughterhouse. The geochemical analyses carried out in surficial sediment samples show very high concentrations of all metals studied near an old iron mine and moderate contents between Nador and its treatment station. Ostracods are good bioindicators of these environmental impacts, with the presence of a highly brackish assemblage in the quieter, more confined areas or the appearance of opportunistic species under hypoxic conditions. In addition, these microcrustaceans are absent in polluted bottom sediments or areas with high hydrodynamic gradients, whereas they decrease in both density and diversity if the subaerial exposure increases.

Criterios terapéuticos en el síndrome coronario agudo / Therapeutic criteria in the acute coronary syndrome

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Medicamentos que contienen látex: una información necesaria en la guía farmacoterapéutica / Latex-containing drugs: a piece of information to be necessarity included in the Pharmaco-Therapeutic Guide

Introducción: El aumento de la incidencia de alergia al látex, la gravedad de las manifestaciones clínicas y la ausencia de una legislación que regule la advertencia del contenido en látex en medicamentos y productos sanitarios, motivó en nuestro Servicio la consideración de información imprescindible a incluir en la nueva edición de la Guía Farmacoterapéutica del hospital. Método: Elaboración de un listado de medicamentos y soluciones intravenosas susceptibles de contener látex en su material de acondicionamiento. Se agruparon por laboratorio fabricante y se solicitó a cada uno de ellos a través de conversación telefónica, información escrita (fax o carta) acerca del contenido en látex de sus productos. La información se completó con la búsqueda de trabajos publicados en nuestro entorno profesional sobre listados de contenido en látex de especialidades farmacéuticas. Resultados: Se evaluaron: a) un total de 188 especialidades farmacéuticas. Se obtuvo información escrita para 129 de ellas (68,6 por ciento), de las cuales se identificaron como seguras 100 (53,2 por ciento), recogidas en la tabla III, mientras que 29 (15,4 por ciento) se catalogaron como especialidades farmacéuticas con potencial riesgo en pacientes sensibilizados al látex (Tabla IV). No se pudieron clasificar por falta de información 59 (31,4 por ciento). De ellas, se obtuvo información indirecta para 23 (12,2 por ciento) a partir de los listados de fármacos elaborados por distintos Servicios de Farmacia (Tabla V). Mientras que las 36 (19,2 por ciento) restantes quedaron sin catalogar (Tabla VI). b) la información sobre el contenido en látex de las soluciones para infusión intravenosa y para irrigación está documentada por cada laboratorio fabricante y se recoge globalmente en la tabla VII. Conclusiones: Consideramos necesario conocer en un determinado entorno sanitario los medicamentos seguros para pacientes alérgicos al látex, teniendo en cuenta que los únicos elastómeros realmente exentos de látex son los fabricados con gomas sintéticas, siendo la GFT el mejor instrumento de transmisión de dicha información (AU)

Estabilidad de una mezcla de Tobramicina 0,01 mg/ml y Vancomicina 0,05 mg/ml en BSS-PLUS para irrigación-lavado intraocular / Stability of tobramycin 0,01 mg/mL and vancomycin 0,05 mg/mL mixture in BBS-PLUS for intraocular irrigation and washing

Objetivo: Conocer la estabilidad de una mezcla de vancomicina 0,05 mg/ml y tobramicina 0,01 mg/ml en BSS-plus, empleada para irrigación y lavado en cirugía de cataratas.Material y métodos: A partir de seis frascos de BSS-plus, aditivados de Vancomicina y Tobramicina a las concentraciones de 0,05mg/ml y 0,01mg/ml, preparados de idéntica manera, en cabina de flujo laminar horizontal, se estudia la estabilidad en dos condiciones distintas de conservación, a Tª ambiente y en nevera (4º-8ºC), durante 14 días, determinando la concentración de tobramicina por inmunofluorescencia polarizada TDx/FLx y la concentración de vancomicina por cromatografía líquida de alta resolución (HPLC), la ausencia de precipitados por observación visual, el pH y la esterilidad por cultivo microbiológico.Resultados: Ausencia de precipitados en ambas soluciones durante los 14 días del estudio. Incremento progresivo del pH desde 7,4 hasta 8,7 en la solución conservada entre 4-8ºC, que llega hasta 9,2 en la conservada a Tª ambiente. Ausencia de crecimiento bacteriano en todas las muestras. La concentración de tobramicina se mantuvo por encima del 90 por ciento de la concentración inicial al menos durante 14 días en la solución conservada en refrigeración y 12 días a Tª ambiente. La concentración de vancomicina se mantuvo por encima del 90 por ciento de la concentración inicial durante al menos 14 días en la solución conservada en refrigeración y 8 días a Tª ambiente.Conclusión: Se establece una estabilidad de al menos 14 días cuando la mezcla binaria antibiótica se conserva en refrigeración (48ºC) y de 8 días cuando se conserva a Tª ambiente. Estos resultados permiten al Servicio de Farmacia establecer un protocolo de preparación programado de la mezcla de antibióticos en BSS-plus evitando la necesidad de preparar extemporáneamente la solución previa a cada intervención quirúrgica y minimizar los costes de preparación al garantizar que no se pierde ninguna de las soluciones preparadas (AU)

Blocking plasma factors of migration inhibition factor production in patients with cervical carcinoma. A possible role in vivo.

The blocking activity was studied of plasma from patients with cervical carcinoma in a model of migration inhibition factor (MIF) production by normal human leukocytes. At the same time, the patients' in vivo (intradermal reactivity) and in vitro (MIF assay) responses were studied with two common antigens (streptokinase-streptodornase and purified protein derivative). The plasma of 15 of 27 patients with carcinoma was capable of blocking the MIF test of human normal leukocytes. Twelve of 15 patients with blocking factor in their plasma had no or only a slight in vivo response, although they had a good in vitor response. Two patients had blocking factor without any in vivo or in vitro response. Six patients who had in vitro responses and slight or no in vivo responses had no plasma blocking activity. Three patients had neither in vivo nor in vitro responses and lacked blocking activity in their plasma.