Effects of physical exercise on mental health and general self-efficacy of city residents in COVID-19

The purpose of this study was to investigate the relationship and impact of residents' self-efficacy and mental health in the context of COVID-19. A quantitative research approach is used in this study. This study investigated residents with a general self-efficacy questionnaire to explore the predictive effect of self-efficacy on mental health. Therefore, a questionnaires survey is employed in this study to collect primary data. While data collection, the cross-sectional research design was used, and data analysis was carried out using a statistical tool. There was a significant negative association between the epidemic's risk perception and the score of the SCL.90. The standardized burden of understanding the epidemic on its latent variables was more than 0.65 in the measurement model, indicating that the 90 percent confidence intervals for the three mediation paths did not include 0, confirming the mediation effect's establishment. This study reveals the relationship between self-efficacy and mental health and its mechanism of action, inspiring the maintenance of residents' mental health during the period of the new crown. It is concluded that there was a significant positive correlation between self-efficacy and understanding of the epidemic situation.(AU)

Blood glucose related adverse drug reaction of antitumor monoclonal antibodies: a retrospective analysis using Vigibase

Abstract On the increasing prevalence of using mAbs (monoclonal antibodies) in cancer therapy and the severe risk of hyperglycemia, we aimed to analyze the main clinical ADRs of mAbs, with a focus on adverse hyperglycemic events associated with currently clinically used mAbs. mAbs as well as target information were selected from Martinadale book and published articles. Drug approving information was collected from each government website, and ADR statistic data were collected from VigibaseR, comparing with Adverse Event Reporting System of US FDA. Top 10 mAbs were classified within listing in total ADR records, ADRs per year, hyperglycemic ADR records. Vigibase data were updated onto 15 Feb 2019. 20 mAbs were analyzed with 263217 ADR reports, wherein 16751 records on Metabolism and nutrition disorders and 1444 records on Glucose metabolism disorders. The geographic, age, gender distributions and annual ADR report numbers were listed respectively. Of the top 10, Rituximab, Bevacizumab and Nivolumab were on the top 3 in total ADR record and hyperglycemic record. Top 3 record results were similar in Vigibase and FDA database. It is of increasing importance for clinicians to be aware of early detection, patient management, or drug selection strategies when using mAbs, particularly within the high glycemic risk-reported mAbs, to improve the efficacy and tolerability of mAbs regiment and optimize patient outcomes.

Vacuna antigripal trivalente de alta dosis. Eficacia y efectividad / High-dose trivalent influenza vaccine. Efficacy and effectiveness

La gripe estacional es un importante problema de salud pública, particularmente en las personas mayores. La vacuna antigripal es la forma más efectiva de prevenir la infección por el virus de la gripe y sus complicaciones, pero debido al fenómeno de inmunosenescencia asociado a la edad, las personas mayores no responden eficientemente a la inmunización. En 2009 se aprobó en EE. UU. una vacuna antigripal trivalente de alta dosis (IIV3-HD), con una concentración cuatro veces mayor de antígeno que la vacuna estándar, para la inmunización de personas ≥ 65 años. En numerosos ensayos clínicos llevados a cabo en diferentes temporadas, y utilizando diferentes metodologías, se ha demostrado que la vacuna IIV3-HD es, además de segura, más inmunogénica y más efectiva que la vacuna de dosis estándar previniendo la gripe y sus complicaciones en personas mayores. En este trabajo se hace una revisión de la evidencia científica disponible sobre la eficacia y efectividad de la vacuna antigripal de alta dosis en personas ≥ 65 años, incluyendo información de ensayos clínicos aleatorizados, estudios observacionales de práctica clínica real y revisiones sistemáticas y meta-análisis

Seasonal influenza is a major public health problem, particularly in older people. Influenza vaccine is the most effective way to prevent influenza virus infection and its complications, but due to immunosenescence, older people do not respond efficiently to immunization. In 2009, a high-dose trivalent influenza vaccine (IIV3-HD), containing four times more antigen than the standard-dose vaccine, was approved in the United States for the immunization of people aged 65 years and over. Numerous clinical trials, carried out at different seasons and using different methodologies, have shown that the IIV3-HD vaccine is, as well as safe, more immunogenic and more effective than the standard-dose vaccine in preventing influenza virus infection and its complications in older people. This paper reviews the available evidence on the efficacy and effectiveness of the IIV3-HD influenza vaccine in the elderly, with information from randomized clinical trials, as well as observational studies of real-world clinical practice and in systematic reviews/meta-analyses

Evaluación de la efectividad de un programa de Actividad Física de los participantes de un programa implantado en un empresa / Evaluation of changes in physical activity among participants in a company-based program

Objetivos: Evaluar los cambios en la actividad física de los participantes de un programa de actividad física (Mueve-T) implantado en el medio laboral. Métodos: En marzo del 2014, se iniciaron las actividades del programa Mueve-T con los objetivos de sensibilizar a los trabajadores en la práctica de la actividad física y conseguir una mejora en el nivel de actividad. Para evaluar su efectividad se utilizó el Cuestionario IPAQ (International Physical Activity Questionnaire) antes de iniciarse el programa (2014) y a los dos años (2016). Se realiza la comparación entre años ajustando un modelo logístico de medidas repetidas de dos poblaciones de trabajadores de distintos centros de trabajo de la misma empresa con respuesta ordinal politómica para IPAQ (nivel bajo o inactivo, moderado y alto), para toda la población y estratificado por sexo, centro de trabajo y puesto de trabajo. Resultados: Se incluyen los 314 trabajadores que respondieron el cuestionario en los dos años. En 2014 un 35,35% de los encuestados reportaron un nivel bajo de actividad, un 39,50% moderado y un 25,15 un nivel alto. En 2016 un 36,30% reportaron nivel bajo de actividad, un 39,80% nivel moderado y un 23, 90% un nivel alto. El análisis de respuesta entre años no ha mostrado evidencia de cambio entre años (p=ns). No se han encontrado diferencias por sexo, pero sí una menor actividad en determinados centros y puestos de trabajo. Conclusiones: Si valoramos los resultados del programa y su efectividad con el cuestionario IPAQ, observamos que estadísticamente no muestran cambio en actividad física estadísticamente significativo; pero si hay cambios en el nivel de actividad manteniéndose y aumentando en un grupo de trabajadores, a su vez consideran el programa efectivo y desean continuar con las actividades. Para obtener un aumento del nivel de actividad física se precisaría de un periodo más largo de evaluación

Objective: To analyze the effectiveness of a company-based physical activity program using the International Physical Activity Questionnaire (IPAQ) questionnaire. Methods: In March 2014 we implemented a company-based physical activity program (Mueve-T, by its Spanish acronym) with the objective of increasing awareness of physical activity among employees, and measuring improvements in activity level. To evaluate the effectiveness of the program, we administered the IPAQ Questionnaire, before the program began in 2014 and two years later, in 2016. Descriptive summary statistics included frequencies, percentages and bar charts. To compare pre- and post-intervention results, we used a logistic repeated measures model, adjusted for two populations, with an ordinal polytomous response for IPAQ (low or inactive, moderate and high), applied to the overall study population and further examined by sex, workplace and job. Results: A total of 746 participants responded in 2014 and 563 in 2016. Only 314 respondents completed both surveys. In 2014, 35.4% of the respondents reported a low level of activity, moderate was 39.5% and highwas, 25.2%. In 2016, 36.3% reported a low level of activity, moderate was 39.8% and a high level was indicated by 23.9%. Overall, there were no significant differences in physical activity levels between the pre- and post-intervention period, among those who participated in both surveys. Likewise, there were no significant differences when this result was examined by sex, although employees sales or commercial tasks has lower levels of physical activity as compared to other centers or jobs. Conclusions: The results did not find this intervention program to be effective in increasing levels of physical activity. The differences found among the sales and commercial task employees could have been due to differences in the effect on awareness achieved by companywide information dissemination (e.g., newsletters, talks, intranet notes, etc.) as compared to specific individual activities (e.g., (yoga classes, zumba, cycling, walks, etc.). A longer evaluation period is needed to confirm these findings

Registro ágil de productos médicos clase I y II por sistema digital Helena (primer semestre 2018) / Quick registration of medical devices class I and II by HELENA digital system (first semester 2018)

El presente trabajo tiene como objetivo describir y analizar la cantidad de trámites realizados en el primer semestre del año 2018 en el marco de la Disposición ANMAT Nº 5706/17, a través del Sistema digital HELENA de Registro Electrónico de Productos Médicos. Para ello se exploró la base de datos de la biblioteca virtual que proporciona el sistema. Se relevaron los productos de clase de riesgo I-II y las modificaciones ágiles de los productos de clase de riesgo III-IV. El informe de gestión reveló que la mayoría de las gestiones realizadas fueron registros iniciales de productos médicos estériles y descartables provenientes de la Republica Oriental de China y de Estados Unidos, por el contrario, el número de las modificaciones ágiles fue marginal y correspondió, mayoritariamente, a cambios de rótulos e instrucciones de uso y vida útil de importados clase III.

The objective of this paper is to describe and analyze the number of procedures carried out in the first semester of 2018 within the framework of the ANMAT regulation Nº5706/17 through the HELENA Electronic Registration Digital System of Medical Devices. For this purpose, the database of the virtual library provided by the system was explored. The products from class I-II and the agile modifications of products from class III-IV were gathered. The management report revealed that most of the procedures carried out were initial records of sterile and disposable medical devices from the Republic of China and the United States, on the contrary, the number of the agile modifications was marginal and it was mostly due to a change of labels, instructions for use and useful life of class III importers.

Utilidad de sarilumab en la terapia de la artritis reumatoide / Usefulness of sarilumab in the treatment of rheumatoid arthritis

En junio de 2017, la European Medicines Agency aprobó sarilumab para el tratamiento de la artritis reumatoide, un nuevo anticuerpo monoclonal (subtipo IgG1) totalmente humano, que impide la unión de la interleucina (IL) 6 a las formas soluble y unida a la membrana del receptor de la IL-6, e inhibe la señal a través de IL-6. Administrado cada 2 semanas en dosis de 200 mg (con una dosis de 150 mg cada 2 semanas para el tratamiento de anormalidades de laboratorio), tiene una afinidad por el receptor muy elevada y ha demostrado ser un fármaco eficaz y seguro en el tratamiento de la artritis reumatoide. Esta eficacia se ha demostrado en diferentes ensayos clínicos evaluados en distintos escenarios: falta de respuesta a metotrexato, intolerancia y/o fallo a antifactor de necrosis tumoral alfa y en pacientes con intolerancia a metotrexato. Su doble dosis, su doble dispositivo de administración, su mecanismo dual y su beneficio reconocido lo sitúan como una nueva alternativa potencial en el tratamiento de la artritis reumatoide

In June 2017, the EMA approved sarilumab for the treatment of rheumatoid arthritis, a new monoclonal (subtype IgG1) fully human antibody directed against the alpha subunit of the interleukin-6 receptor complex that inhibits the signal through IL-6. The drug is administered every other week at a dose of 200 mg (or a dose of 150 mg every two weeks if there are laboratory abnormalities), shows very high affinity for the receptor and has proven to be an effective and safe drug in the treatment of rheumatoid arthritis (RA). Its efficacy has been demonstrated in several clinical trials in a variety of scenarios (lack of response to MTX, intolerance and / or failure to anti-TNF). Due to its double dose, the availability of two different devices for its administration, and its dual signaling mode of action and recognised benefit, sarilumab is a new potential alternative in the treatment of RA

Effects of a positive emotion-based adjuvant psychological therapy in colorectal cancer patients: a pilot study / Efectos de una terapia psicológica adyuvante en pacientes con cáncer colorrectal: un estudio piloto

Objective: To examine the effectiveness of an "Enhancing Positive Emotions Procedure" (EPEP) based on positive psychology and cognitive behavioral therapy in relieving distress at the time of adjuvant chemotherapy treatment in colorectal cancer patients (CRC). It is expected that EPEP will increase quality of life and positive affect in CRC patients during chemotherapy treatment intervention and at 1 month follow-up. Method: A group of 24 CRC patients received the EPEP procedure (intervention group), whereas another group of 20 CRC patients did not receive the EPEP (control group). Quality of life (EORTC-QLQC30), and mood (PANAS) were assessed in three moments: prior to enter the study (T1), at the end of the time required to apply the EPEP (T2, 6 weeks after T1), and, at follow-up (T3, one-month after T2). Patient’s assessments of the EPEP (improving in mood states, and significance of the attention received) were assessed with Lickert scales. Results: Insomnia was reduced in the intervention group. Treatment group had better scores on positive affect although there were no significantly differences between groups and over time. There was a trend to better scores at T2 and T3 for the intervention group on global health status, physical, role, and social functioning scales. Patients stated that positive mood was enhanced and that EPEP was an important resource Conclusions: CRC patients receiving EPEP during chemotherapy believed that this intervention was important. Furthermore, EPEP seems to improve positive affect and quality of life. EPEP has potential benefits, and its implementation to CRC patients should be considered

Objetivo: Examinar la eficacia de un programa basado en la Psicología Positiva y en la terapia cognitivo-conductual (EPEP) para incrementar emociones positivas y reducir malestar en pacientes de cáncer colorrectal (CRC) que reciben quimioterapia adyuvante. Se espera que el EPEP mejore calidad de vida y estados de ánimo durante la quimioterapia y en el seguimiento un mes después. Método: Un grupo de 24 CRC recibió el EPEP (grupo de intervención: GI), y otro grupo de 20 CRC no recibió el EPEP (grupo control: GC). Se evaluaron la calidad de vida (EORTC-QLQC30) y los estados de ánimo (PANAS) en tres momentos: al entrar en el estudio (T1); 6 semanas después, tiempo de aplicación del EPEP (T2), y un mes después del T2 (seguimiento:T3). Las opiniones de los pacientes sobre el EPEP (mejoría del estado de ánimo e importancia de la atención recibida) fueron evaluadas con escalas Lickert. Resultados: El GI mostró mejores puntuaciones en estado de ánimo positivo, aunque sin diferencias significativas con el GC. Las puntuaciones en T2 y T3 tendían a ser mejores en el GI en nivel global de salud, y en las escalas física, social y de rol, El GI redujo el nivel de insomnio. Los pacientes indicaron que el EPEP era importante y mejoraba el estado de ánimo. Conclusiones: Los datos sugieren que el EPEP mejora el estado de ánimo positivo y la calidad de vida, y los pacientes lo consideraron importante y útil. El EPEP es potencialmente beneficioso y debería considerarse la posibilidad de implementarlo en pacientes CRC

Vacuna frente al virus del papiloma humano. Eficacia y seguridad / Human papillomavirus vaccine. Efficacy and safety

Las vacunas profilácticas frente al virus del papiloma humano (VPH) se consideran la intervención más efectiva para el control de la carga de enfermedad relacionada con el VPH. Este artículo revisa los principales ensayos clínicos de fase ii/iii realizados con la vacuna bivalente (VPH 16/18), tetravalente (VPH 6/11/16/18) y la recientemente aprobada vacuna nonavalente (VPH 6/11/16/18/31/33/45/52/58).Los ensayos clínicos de fase ii y iii con las vacunas bivalente y tetravalente demuestran la seguridad, inmunogenicidad y eficacia de ambas vacunas en la prevención de infecciones por VPH y lesiones precancerosas, especialmente si se administran en adolescentes antes de la exposición al virus. Los ensayos clínicos con la vacuna nonavalente también muestran su seguridad, inmunogenicidad y eficacia en la prevención de infección y enfermedad asociada con los tipos vacunales, y sugieren el potencial de la vacuna para reducir la carga de enfermedad asociada al VPH. Informes poscomercialización en países con programas de vacunación sistemática y altas coberturas sugieren una efectividad muy alta a nivel poblacional, con descensos en la prevalencia de los VPH relacionados con la vacuna, y en la incidencia de verrugas genitales y lesiones cervicales de alto grado

Human papillomavirus (HPV) related disease remains a major cause of morbidity and mortality worldwide. Prophylactic vaccines have been recognized as the most effective intervention to control for HPV-related diseases. This article reviews the major phase ii/iii trials of the bivalent (HPVs 16/18), quadrivalent (HPVs 6/11/16/18), and the recently approved 9-valent vaccine (HPVs 6/11/16/18/31/33/45/52/58).Large trials have been conducted showing the safety, immunogenicity and high efficacy of the bivalent and quadrivalent vaccines in the prevention of pre-invasive lesions and infection, especially when administered at young ages before exposure to HPV. Trials of the 9-valent vaccine have also demonstrated the safety, immunogenicity and efficacy of the vaccine in the prevention of infection and disease associated with the vaccine types, and its potential to substantially increase the overall prevention of HPV-related diseases. Post-licensure country reports have shown the recent and early impact of these vaccines at population level after the implementation of established HPV vaccination programs, including decreases in the prevalence of vaccine HPV types, the incidence of genital warts, and the incidence of high-grade cervical abnormalities. If widely implemented, current HPV vaccines may drastically reduce the incidence of cervical cancer and other HPV-related cancers and diseases

Tratamiento de quemadura de segundo grado con gel de áloe vera. Un caso clínico / Tratamento de queimadura de segundo grau com gel de Aloe vera. Relatório de um caso clínico / Treatment of second-degree burn with aloe vera gel. A case report

Se describe un caso clínico de una quemadura de segundo grado tratada exclusivamente con gel de áloe vera, realizando un seguimiento del mismo durante un mes para poder detectar posibles complicaciones. Se evidenció un rápido alivio del dolor así como una buena cicatrización, demostrando una evidente eficacia del gel de áloe (AU)

Neste artigo descreve-se a evolução de um caso clínico de uma queimadura de segundo grau tratada exclusivamente com gel de Aloe vera. O doente foi acompanhado durante um mês para se poderem detectar possíveis complicações. Foi evidente um rápido alívio da dor, bem como uma boa cicatrização, o que demonstra a eficácia do gel de aloé

Treatment of second-degree burn with aloe vera gel. A case report. A clinical case of a second degree burn treated exclusively with aloe vera gel is described tracking the same for a month to detect possible complications. Rapid pain relief and good healing was evident, showing an apparent effectiveness of aloe gel (AU)

Análisis del rendimiento en salto vertical, agilidad, velocidad y velocidad de golpeo en jóvenes futbolistas: influencia de la edad / Performance analysis using vertical jump, agility, speed and kicking speed in young soccer players: Influence of age

Objetivo: Analizar la influencia de la categoría de edad en la capacidad de salto, sprint, agilidad y velocidad de golpeo en futbolistas jóvenes. Método: Estudio transversal en el que participaron 36 jugadores de nivel subélite provenientes de las categorías inferiores (cadete y juvenil) de equipos de fútbol andaluces (edad: 15,87 ± 1,43 años; masa corporal: 65,38 ± 10,84 kg; altura: 1,71 ± 0,06 m). Se evaluó la composición corporal, el rendimiento en salto vertical (CMJ), la agilidad mediante el test de Balsom, velocidad de sprint en 5, 10, 20 y 30 m y la velocidad de golpeo con ambas piernas. Resultados: Los análisis mostraron que los jugadores juveniles tienen mayor rendimiento en los test de CMJ, agilidad y velocidad de golpeo con ambas piernas que los cadetes. No se aprecian diferencias significativas (p -0,05) en la prueba de velocidad, aunque se evidencia una clara tendencia a favor de los juveniles. Conclusión: Existe efecto de la edad durante la etapa de la adolescencia sobre la capacidad de salto, la agilidad, la velocidad de golpeo y, en menor medida, sobre la velocidad de jóvenes jugadores de fútbol, además de asociación entre las capacidades condicionales más influyentes en el rendimiento del futbolista

Objective: The main objective of this paper was to analyze the influence of age-category in vertical jump ability, sprint, agility and kicking speed in young soccer players. Method: A total of 36 soccer players of sub-elite level from an Andalusian soccer academic participated voluntarily in this cross-sectional study (age: 15.87 ± 1.43 years; body mass: 65.38 ± 10.84 kg; height: 1.71 ± 0.06 m). Body composition, vertical jump performance (CMJ), agility using the Balsom Agility Test, 5, 10, 20 and 30 meters sprint, and kicking speed with both legs. Results: Analysis showed that under-18 players obtained a greater performance in CMJ, agility and kicking speed than under-16 players. No significant differences (P-0.05) were found in the speed test, although a clear trend in favour of under-18 players was seen. Conclusion: It is concluded that there are age-related effects on jump ability, agility, kicking speed and speed in young soccer players during adolescence, and that this association between different physical capacities is more influenced in soccer performance

Evidencia disponible acerca del uso del agonista B3- adrenoceptor selectivo mirabegrón para el tratamiento de la vejiga hiperactiva / Evidence available on the use of the selective B3- adrenoceptor agonist mirabegron for the treatment of overactive bladder

Contexto: Mirabegrón, agonista adrenoreceptor β3, supone el último desarrollo farmacológico para el tratamiento de la vejiga hiperactiva (VH).Objetivo: Presentar la evidencia disponible respecto a la eficacia y tolerancia de mirabegrón y discutir el potencial de dicho tratamiento en nuestro entorno. Adquisición de evidencia: Se revisan 11 estudios llevados a cabo con mirabegrón en pacientes con VH (2 fase II , 9 fase III ), todos en comparación con placebo y 6 de ellos incluyeron también tolterodina como brazo adicional. Se hace mayor énfasis en los principales ensayos fase III llevados a cabo en Europa, EE. UU. y Australia que evalúan la eficacia y seguridad a 12 semanas (NCT00662909, NCT00689104, NCT00912964) y la seguridad a 12 meses (NCT00688688). Se dispone también del análisis combinado de dichos estudios a 12 semanas, enfatizando en la eficacia global (FAS), la eficacia relativa a la incontinencia (FAS- I) y la seguridad (SAF). Más del 50% de los pacientes había abandonado previamente la medicación anticolinérgica para VH, lo que permite también obtener datos acerca de la efectividad de mirabegrón en pacientes tratados previamente con anticolinérgicos. Síntesis de evidencia: Mirabegrón es un fármaco eficaz que muestra una reducción estadísticamente significativa en número de episodios de incontinencia y en frecuencia miccional a partir de la 4.a semana, con mayor porcentaje tanto de pacientes secos como de pacientes con reducción ≥ 50% en número de episodios de incontinencia que placebo. La eficacia de mirabegrón 50 y 100 mg en la reducción en episodios de incontinencia sucede en pacientes nuevos y que han recibido antimuscarínicos, siendo la diferencia media ajustada y la mejora en la frecuencia miccional mayor en pacientes tratados. Su tolerancia es muy similar a placebo, particularmente para los efectos adversos de los antimuscarínicos (boca seca, estreñimiento y visión borrosa). Se aprecia un cambio mínimo no clínicamente significativo en la presión arterial sistólica, en la diastólica y en el pulso. Su eficacia se mantiene a largo plazo. Mirabegrón a dosis de 50 y 100 mg presenta mejoría frente placebo en la satisfacción del paciente, en la calidad de vida relacionada con la salud (HRQoL), en las molestias de síntomas y en la percepción del paciente de la condición vesical (PPBC). En el estudio europeo fase III a 12 semanas tolterodina proporcionó mejoría en menor medida que mirabegrón frente a placebo en la satisfacción del paciente, HRQoL, molestia de síntomas y PPBC (AU)

Context: Mirabegron, the selective β3-adrenoceptor agonist, heralds the latest development for the treatment of overactive bladder (OAB). Objective: To present the evidence available on the efficacy and tolerability of mirabegron and to discuss this treatment's potential in our setting. Evidence acquisition: We reviewed 11 studies conducted with mirabegron in patients with OAB (2 phase II, 9 phase III, all studies were compared to placebo with 6 studies also including tolterodine as an additional arm. Greater emphasis shall be given to the main phase III trials performed in Europe, the USA and Australia evaluating efficacy and safety after 12 weeks (NCT00662909, NCT00689104, NCT00912964) and safety after 12 months (NCT00688688). The combined analyses of these 12-week studies are also available, with emphasis on global efficacy (FAS), efficacy with regard to incontinence (FAS I ) and safety (SAF). More than 50% of patients had previously discontinued anticholinergics medication for OAB, thus allowing us to obtain data on the effectiveness of mirabegron in patients already treated with anticholinergics. Evidence synthesis: Mirabegron is an efficacious drug which presents a statistically significant reduction in the number of incontinence episodes and in urinary frequency as of 4 weeks, with a higher percentage of dry patients and a higher percentage of patients with reduction ≥50% in the number of incontinence episodes than placebo. The efficacy of mirabegron 50 and 100 mg in the reduction of incontinence episodes occurs in de novo patients and who have received antimuscarinics, with adjusted mean difference and improvement in urinary frequency greater in treated patients. Its tolerability is very similar to placebo particularly for the adverse effects of the antimuscarinics (dry mouth, constipation and blurred vision). A minimal, non-clinically significant change is observed in systolic and diastolic blood pressure and pulse. Its efficacy is long-term. Mirabegron at the doses of 50 and 100 mg presents an improvement versus placebo in patient satisfaction, health-related quality of life (HRQoL), symptom bother and patient's perception of bladder condition (PPBC). In the 12-week phase III European study tolterodine deliverred a lesser degree of improvement than mirabegron versus placebo in patient satisfaction, HRQoL, symptom bother and PPBC. Conclusions: Mirabegron is the first of a new class of compounds with a novel mechanism of action that is different to the antimuscarinics. It presents significant and clinically important efficacy in the treatment of the symptoms of OAB. It has advantages with regard to the results described by the patient in treatment satisfaction. Studies on its combined use with anticholinergics are ongoing (AU)

Eficacia y seguridad a largo plazo de etanercept en la psoriasis / Long term efficacy and safety of etanercept in psoriasis

Existen numerosos estudios que demuestran que etanercept es un medicamento eficaz y seguro para el tratamiento de la psoriasis moderada a grave a corto plazo. Sin embargo, la psoriasis es una enfermedad con curso crónico o recurrente, asociada a artritis y comorbilidades que merman la salud y la calidad de vida de los pacientes, requiriendo a menudo tratamiento a largo plazo, ya sea de forma continua o intermitente. Los datos disponibles sobre el empleo de etanercept como tratamiento de la psoriasis a largo plazo, incluso en dosis altas, demuestran un buen perfil de eficacia y seguridad. La mitad de los pacientes obtienen una mejoría PASI (Psoriasis Area and Severity Index) 75 durante tratamientos prolongados hasta 96 meses. La respuesta PASI 75 es superior en pautas continuas que en pautas intermitentes (con pausas). La mayoría de los pacientes mantienen la respuesta a largo plazo, aunque en algunos se observa una disminución de la eficacia, como ocurre con otros inhibidores del factor de necrosis tumoral. La experiencia acumulada con etanercept en otras enfermedades inflamatorias crónicas también respalda este buen perfil de seguridad (AU)

There are many studies that have shown that etanercept is an effective and safe drug for the short-term treatment of moderate to severe psoriasis. However, psoriasis is a disease with a chronic or recurrent course associated to arthritis and comorbidities that diminish the patient's health and quality of life and that often requires either continuous or intermittent long-term treatment. The data available on the use of etanercept in the long-term treatment of psoriasis, even at high doses, have shown that it has a good efficacy and safety profile. Half of the patients obtained a 75% improvement on the Psoriasis Area and Severity Index (PASI-75 during prolonged treatments of up to 96 months. The PASI 75 response is higher in continuous regimes than in intermittent ones (with pauses). Most of the patients maintain the response at long-term, although a decrease in efficacy is observed in some of them, as occurs with other tumor necrosis factor inhibitors. Accumulated experience with etanercept in other chronic inflammatory diseases also supports this good safety profile (AU)

Uso intermitente de etanercept en psoriasis / Intermittent use of etanercept in psoriasis

Para el tratamiento de la psoriasis en placas moderada-grave en España, hasta hace muy poco, únicamente estaba aprobado el uso de etanercept de forma intermitente o en ciclos de tratamiento no superiores a 24 semanas. A partir de septiembre de 2009 se aprobó su administración ininterrumpida para aquellos pacientes con psoriasis moderada-grave que, a criterio médico, así lo requieran. Esta decisión está avalada por los resultados de varios estudios que evaluaban la eficacia y seguridad de etanercept a corto y largo plazo, en terapia continua o intermitente. El estudio CRYSTEL evalúa la eficacia y seguridad de etanercept en tratamiento continuo o intermitente durante 54 semanas. Los resultados demostraron que tanto los pacientes que recibieron tratamiento continuo como los que recibieron tratamiento intermitente experimentaron mejorías significativas en su enfermedad y se mostraron muy satisfechos con el resultado, sin observarse hallazgos inesperados de seguridad en ambos grupos (AU)

Systemic treatment for psoriasis has radically changed since the emergence of new biological therapies. One of these biological agents is etanercept. Until recently, the use of etanercept for treatment of moderate-to-severe psoriasis in Spain was only approved in an intermittent way or in cycles of treatment (not exceeding 24 weeks). However, from September 2009, its administration has been also approved in a continuous way for patients who require it. This decision is based on the results of several studies that evaluate the efficacy and safety of etanercept administrated in short and long term and in a continuous or intermittent therapy. One of these studies is Crystel study, what evaluates the efficacy and safety of continuous and paused etanercept regimens in psoriasis patients for 54-week-period. Crystel study results showed that both continuous and paused etanercept therapies improved PGA and PASI scores and patient satisfaction rates, no unexpected adverse effects were observed. Therefore, doctors may use one treatment or another according to patients needs (AU)

Functional effectiveness of threat appeals in exercise promotion messages

As more than 70% of individuals in Western societies can be categorized as sedentary and inactivity has been recognized to lead to a series of serious physical and psychological disorders, the importance of physical activity promotion is ever more emphasized. Many social marketing campaigns use threat (or fear) appeals to promote healthy behaviors. Theoretical models, such as the Extended Parallel Process Model integrate concepts as ‘perceived threat’ and ‘perceived efficacy’ to explain how such messages operate and can cause diverse behavioral reactions. It is however still not entirely clear how these different aspects are valuated and combined to determine desired versus undesired response behaviors in individuals. In a functional integration task, threat-appeal based exercise promotion messages varying in psychological threat and efficacy content were shown to sedentary employees in order to assess how they affect their intention to engage in physical exercise. Our results show that individuals can be categorized in 4 different clusters depending on the way they valuate threat and efficacy appeals: i.e. individuals sensitive to both types of cues, those sensitive to either the threat or the efficacy component in the message and those insensitive to either one of them. As different segments of receivers of the message react differently to threat and efficacy combinations, it is concluded that different approaches to designing effective mass media campaigns may be required for effective exercise promotion(AU)

Relationship between the level of self-efficacy performance indicators, and participation in youth basketball

The present study analyzed the relationship between the level of self-efficacy of the player with the ball inbasketball, various performance indicators, and individual participation of the youth player in competition, with the goal ofbeing able to establish initial values that help to define game styles and systems that are adapted to the characteristics ofthe youth player. In order to evaluate the levels of self-efficacy, a questionnaire was administered to 187 players from theunder-16 age category. From a total of 22 games, the following variables related to the individual performance of theplayer were analyzed: a) points scored; b) shot attempts and shots made of 1, 2, and 3 points; c) efficacy percentage of 1, 2,and 3-point shots; d) rebounds made; and e) personal fouls received. With regard to participation, the following variableswere analyzed: f) minutes played; g) total time of ball possession; h) number of ball possessions; i) number of passesreceived; and j) number of offensive phases in which the player participates. The results indicate that the performance andparticipation variables correctly classify 74.2% when differentiating between players with high and low levels of selfefficacy.The players with high levels of self-efficacy presented higher values in the different performance and participationvariables than the players with low levels of self-efficacy(AU)

Monitorización ambulatoria del pH esofágico con pH-metría sin sonda (sistema Bravo®). Estudio de tolerancia, seguridad y eficacia / Outpatient monitoring of oesophageal pH with a catheter-free pH-meter (Bravo® System). A Study of tolerance, safety and efficacy

Fundamento y objetivo. Recientemente se ha desarrollado un nuevo sistema de pH-metría esofágica ambulatoria sin catéter, el sistema Bravo®. El objetivo de este estudio es comprobar la tolerancia, la seguridad y la eficacia del sistema en la medición del reflujo gastroesofágico, en comparación con la pH-metría convencional. Pacientes y método. El estudio se realizó en un grupo control constituido por 10 voluntarios sanos (grupo 1) y en un grupo de 40 pacientes con síntomas de enfermedad por reflujo gastroesofágico (grupos 2 y 3). A todos los pacientes se les realizó endoscopia digestiva alta, manometría esofágica y pH-metría esofágica convencional y/o pH-metría sin catéter con el sistema Bravo®. Todos los pacientes a los que se realizaron ambas pruebas (grupos 1 y 3) rellenaron un cuestionario sobre molestias físicas y alteraciones de su actividad diaria. Resultados. La tolerancia de la prueba fue mejor con el sistema Bravo® en 9 de los 10 parámetros estudiados. En el grupo de voluntarios sanos (grupo 1), la mediana (intervalo) del porcentaje total de pH < 4 fue del 1,1% (0,5-3,1%) con la pH convencional y el 1,7% (0-3,4%) con el sistema Bravo®. En cuanto a los pacientes con síntomas de enfermedad con reflujo gastroesofágico (grupo 2) a los que se realizó sólo un tipo de pH-metría, el reflujo ácido fue significativamente mayor en los pacientes con esófago de Barrett que en el resto de los grupos, tanto con la pH convencional como con el Bravo®. Si analizamos al grupo de pacientes con enfermedad por reflujo gastroesofágico a los que se realizaron ambas técnicas (grupo 3), 7 de los 10 pacientes tenían un reflujo patológico que sólo se evidenció al realizar pH-metría con el sistema Bravo®. Conclusiones. La pH-metría sin sonda (Bravo®) es mejor tolerada y de mayor satisfacción para los voluntarios sanos y los pacientes que la pH-metría convencional, en ocasiones incluso es más eficaz para el estudio del reflujo ácido por la menor frecuencia de resultados negativos (AU)

Background and objective. A new catheter-free outpatient oesophageal pH-meter system (Bravo®), has recently been developed. The objective of this study is to test the tolerance, safety and efficacy of the system in the measurement of gastric-oesophageal reflux by comparing it with a conventional pH system. Patients and method. The study was performed on a control group consisting of 10 healthy volunteers (group 1) and in a group of 40 patients with symptoms of gastric-oesophageal reflux disease (groups 2 and 3). An upper digestive sytem endoscopy, oesophageal manometry and oesophageal pH measurements with a conventional system and/or with the Bravo® catheter-free system, was performed on all patients. All patients who had both tests done (groups 1 and 2) filled in a questionnaire on any physical problems and changes in their daily activity. Results. The test tolerance was higher with the Bravo® system in the 9 parameters studied. In the group of healthy volunteers (group 1), the median (range) of the total percentage of pH < 4 was 1.1% (0.5-3.1) with the conventional pH and 1.7% (0-3.4) with the Bravo®. When comparing the patients with symptoms of gastric-oesophageal reflux disease (group 2) with those who had only one type of pH measurement made, the acid reflux was significantly higher in patients with Barrett’s oesophagus than in the rest of the groups, with conventional pH as well as with the Bravo®. If we analyse the patient group with disease due to gastric-oesophageal reflux with those on whom both techniques were used (group 3), 7 of the 10 patients had a pathological reflux that only showed up on measuring pH with the Bravo® system. Conclusions. Catheter-free pH measurements (Bravo®) is better tolerated and with better satisfaction for the healthy volunteers and patients than with conventional PH, even, on occasions being more efficient for studying acid reflux due to the lower incidence of negative results (AU)

Eficacia de la periodización del entrenamiento sobre la potencia máxima / Efficacy of periodized programson power training

El objetivo de este artículo es comparar la eficacia de los programas periodizados respecto a los no periodizados durante 5 semanas de entrenamiento en participantes físicamente activos con la intención de mejorar la potencia máxima de ejecución en el ejercicio de press de banca. 22 sujetos participaron en la investigación divididos en dos grupos, grupo 1(n=9, 2 mujeres y 7 hombres, edad 21.6 ± 1.1 años) cuyo tratamiento era un programa de entrenamiento no periodizado y grupo 2 (n=13, 3 mujeres y 10 hombres, edad 21.8 ± 1.4 años) con un tratamiento de programa de entrenamiento periodizado. El modelo no periodizado realizó 5 series de 6 repeticiones 2 veces/sem. durante 5 semanas, reevaluando la máxima potencia a las 2,5 semanas. El modelo periodizado se realizaron en la 1ª semana: 5 series de6 repeticiones; 2ª semana: 4x5; 3ª sem: 5x7; 4ª sem.: 5x8; 5ª sem.: 4x6, reevaluando la potencia a la mitad del estudio. El volumen y la intensidad total fueron igualados. Los resultados muestran como la potencia en la medición intermedia aumentó significativamente (p<0.05) un 13,26% respecto a la medición pretest en el modelo periodizado, mientras que en el no periodizado el incremento porcentual significativo fue de un 19,83%. En la medición final respecto a la intermedia la potencia disminuyó significativamente (p<0.05) un 10,21% en el modelo no periodizado. Concluimos que no existen diferencias significativas en las ganancias de potencia máxima entre ambos grupos, estimando asimismo que los resultados en sujetos no entrenados muestran limitaciones en la aplicabilidad de éstos a deportistas altamente entrenados (AU)

Periodization is one of the most important concepts in training. The purpose of this study was to compare periodized programs (PG) and non periodized programs (NPG) for gains maximal power in bench press. 22 subjects (sport sciences students) were randomly assigned to non periodized program (n=9; 2females and 7males; age 21.6 ± 1.1 years) or periodized program (n=13, 3 females; 10 males)age 21.8 ± 1.4 years). The non periodized program performed 5set of6 repetitions 2 days per week during 5 weeks changing the maximal power every 2,5 weeks. The periodized program performed (1st week: 5sets x 6 rept.;2nd week: 4x5;3th week: 5x7; 4 week:5x8; 5 week:4x6) changing the maximal power every 2,5 weeks. Volume and intensity were equated for each training program. After the end of the training programs, a testing session was performed to obtain the maximal power in bench press exercise. PG and NPG increased(p<.05) the maximal power after 2.5 training weeks (15.3% and 24.7%, respectively), without significant differences between groups. However, in the 2.5 next weeks, the maximal power increased 2.9% in PG, although this increase was not significant, while a decrease (10.2%; p<.05) in the maximal power happened in the NPG. PG and NPG increased(p <.05) the maximal power after 5 training weeks (18.6% and 11.9%, respectively), without significant differences between groups. In conclusion, so much a periodized training program like one non periodized training program producedim provements in the maximal power in bench press exercise in these participants, without significant differences between groups. Anyway, the results obtained in this type of subjects showed limitations in the applicability to highly trained sportsmen (AU)

Estudio de eficacia y tolerabilidad del anillo vaginal (NuvaRing®) en anticoncepción (ETN@) / Study of the tolerability of the vaginal ring (NuvaRing®) in contraception (ETN@)

Objetivo: Valorar la tolerabilidad del anillo vaginal anticonceptivo (AVA) en una muestra representativa de la población femenina española que utiliza anticoncepción hormonal. Sujetos y métodos: Estudio observacional, prospectivo, multicéntrico realizado en consultas de ginecología y planificación familiar, tanto públicas como privadas, sobre una muestra de 896 mujeres que solicitaron anticoncepción hormonal durante el primer semestre de 2003, eligieron el AVA y fueron seguidas durante 6 ciclos. Para el análisis de los datos se utilizó el paquete estadístico SPSS mediante el cálculo de la t de Student para el análisis comparativo de los datos cuantitativos y de la χ2 de Pearson para las variables cualitativas. Resultados: Tras 6 ciclos de uso, el 72% de las mujeres continúa utilizando el AVA. Sólo el 5% de las mujeres presentaba sangrado intermenstrual a los 6 ciclos y el 85,5% consideró el AVA como el mejor método anticonceptivo, tras su uso. Conclusiones: El AVA es bien tolerado por las mujeres debido a la escasa incidencia de sangrado intermenstrual y al alto grado de satisfacción que genera en sus usuarias

Objective: To evaluate the tolerability of the contraceptive vaginal ring in a representative simple of the Spanish women willing hormonal contraception. Subjects and methods: Observational, prospective, multicenter study carried out in the first six months of 2003 in 896 women starting the use of the vaginal ring and followed during 6 cycles. Results: After 6 cycles of use 72% of women were using the ring. The 5% of women experienced intermenstrual bleeding and 85.5% considered the vaginal ring as the best contraceptive method. Conclusions: The contraceptive vaginal ring is well tolerated by women due to the low incidence of intermenstrual bleeding and the high grade of satisfaction