Background & Aims Episodic hepatic encephalopathy is frequently precipitated by factors that induce circulatory dysfunction, cause oxidative stress-mediated damage or enhance astrocyte swelling. The ...administration of albumin could modify these factors and improve the outcome of hepatic encephalopathy. The aim of this study is to assess the efficacy of albumin in a multicenter, prospective, double-blind, controlled trial ( ClinicalTrials.gov number, NCT00886925 ). Methods Cirrhotic patients with an acute episode of hepatic encephalopathy (grade II–IV) were randomized to receive albumin (1.5 g/kg on day 1 and 1.0 g/kg on day 3) or isotonic saline, in addition to the usual treatment (laxatives, rifaximin 1200 mg per day). The primary end point was the proportion of patients in which encephalopathy was resolved on day 4. The secondary end points included survival, length of hospital stay, and biochemical parameters. Results Fifty-six patients were randomly assigned to albumin (n = 26) or saline (n = 30) stratified by the severity of HE. Both groups were comparable regarding to demographic data, liver function, and precipitating factors. The percentage of patients without hepatic encephalopathy at day 4 did not differ between both groups (albumin: 57.7% vs . saline: 53.3%; p >0.05). However, significant differences in survival were found at day 90 (albumin: 69.2% vs . saline: 40.0%; p = 0.02). Conclusions Albumin does not improve the resolution of hepatic encephalopathy during hospitalization. However, differences in survival after hospitalization suggest that the development of encephalopathy may identify a subgroup of patients with advanced cirrhosis that may benefit from the administration of albumin.
El documento «Guía de excelencia para la realización de ensayos clínicos en farmacia hospitalaria» ha sido elaborado por farmacéuticos de hospital y representantes de la industria farmacéutica. Su ...objetivo es aunar criterios, introducir mejoras en la comunicación, armonizar y digitalizar procesos en todas las fases de desarrollo de un ensayo clínico en los servicios de farmacia hospitalaria.
El presente artículo especial recoge las reflexiones del Grupo de Trabajo de Ensayos Clínicos de la Sociedad Española de Farmacia Hospitalaria acerca del documento. El análisis se basa en su participación en la elaboración de la guía de excelencia, y recoge los aspectos más relevantes de la misma, haciendo referencia también a algunos puntos que, pese a ser motivo de discusión durante el proceso de elaboración del documento, finalmente no se incluyeron, por motivos de síntesis o para un posterior desarrollo y acuerdo.
Reconociendo el indudable valor de un primer documento de consenso, inédito hasta el momento, desde el Grupo de Trabajo de Ensayos Clínicos se ponen de manifiesto también algunos retos a futuro en la gestión de los ensayos clínicos que se presentan para ambos colectivos, farmacia hospitalaria e industria farmacéutica.
En opinión del grupo de trabajo, la apertura de vías de comunicación, tanto con la industria farmacéutica como con otros agentes implicados en la realización de ensayos clínicos, y el consecuente aumento de la visibilidad del farmacéutico de hospital como experto en el manejo del medicamento en investigación, ayudará a mejorar la calidad de la gestión de la medicación de ensayos clínicos en nuestro entorno, así como la asignación de los recursos humanos y los materiales necesarios para alcanzar la excelencia.
The document «Guide to Excellence in the Conduct of Clinical Trials in Hospital Pharmacy» was drawn up by hospital pharmacists and representatives of the pharmaceutical industry. Its objective is to unite criteria, introduce improvements in communication, harmonize and digitalize processes in all phases of development of a clinical trial in hospital pharmacy services.
This special article includes the reflections of the Working Group of the Spanish Society of Hospital Pharmacy about this document. The analysis is based on its participation in the drawing of the guide of excellence, and includes its most relevant aspects, including those which, despite being discussed during the process of preparing the document, were finally not included, for reasons of synthesis or for further analysis and agreement.
While recognizing the undoubted value of a so far unprecedented first document of consensus, the Clinical Trials Working Group also highlights the future challenges that both hospital pharmacists and pharmaceutical companies have ahead in order to improve the quality of the management of clinical trials.
The Clinical Trials Working Group believes that the existence of communication routes both with the pharmaceutical industry and other agents involved in the conducting of clinical trials, as well as the improved visibility of the hospital pharmacist as an expert in the management of investigational medicines, will help achieve a better management of clinical trials in our environment and the assignment of the necessary human and material resources to reach excellence.
Following the low incidence rates of non-SARS-CoV-2 respiratory viruses registered during the strict lockdown enforced in the pandemic, a resurgence of several endemic viruses in Catalonia (Spain) ...was noted during the early summer of 2021. In this study, we investigated whether the circulation of non-SARS-CoV-2 respiratory viruses in Catalonia, assessed by Microbiological Reporting System of Catalonia (MRSC) and the Epidemiological Surveillance Network of Catalonia, was affected by the strict lockdown measures, as well as, the implication of the Coronavirus Disease 19 (COVID-19) de-escalation process in the late season outbreaks registered during the 2020-2021 season. A retrospective comparison of epidemic patterns in the respiratory viruses' incidence, using regional public health surveillance data from MRSC, was performed between weeks 26/2016 to week 27/2021. Data were expressed as the weekly total number of test positivity for individual viruses. A segmented negative binomial regression model was conducted, with two parameters included (level and trend) for each segment of the time series (2020 pre-lockdown, 2020 post-lockdown and 2021). Results were reported as a unit changed in the strict lockdown. A total of 51588 confirmed cases of the different respiratory viruses were included in the analysis, the majority were influenza cases (63.7%). An immediate reduction in the weekly number of cases was observed in 2020 after the COVID-19 outbreak for human adenovirus virus (HAdV) (beta2 = -2.606; P <0.01), human parainfluenza virus (HPIV) (beta2 = -3.023; P <0.01), influenza virus (IFV) (beta2 = -1.259; P <0.01), but not for respiratory syncytial virus (RSV), where the number of cases remained unchanged. During 2020, a significant negative trend was found for RSV (beta3 = -0.170, P <0.01), and a positive trend for HAdV (beta3 = 0.075, P <0.01). During 2021, a significant reduction in the weekly number of cases was also observed for all respiratory viruses, and a borderline non-significant reduction for HPIV (beta3 = -0.027; P = 0.086). Moreover, significant positive trends were found for each viral pathogen, except for influenza during 2020-2021 season, where cases remained close to zero. The respiratory viruses increased activity and their late season epidemic start particularly affected children under 6 years old. Our data not only provides evidence that occurrence of different respiratory virus infections was affected by the strict lockdown taken against SARS-CoV-2 but it also shows a late resurgence of seasonal respiratory viruses' cases during the 2020-2021 season following the relaxation of COVID-19-targeted non-pharmaceutical interventions.
Following the low incidence rates of non-SARS-CoV-2 respiratory viruses registered during the strict lockdown enforced in the pandemic, a resurgence of several endemic viruses in Catalonia (Spain) ...was noted during the early summer of 2021.
In this study, we investigated whether the circulation of non-SARS-CoV-2 respiratory viruses in Catalonia, assessed by Microbiological Reporting System of Catalonia (MRSC) and the Epidemiological Surveillance Network of Catalonia, was affected by the strict lockdown measures, as well as, the implication of the Coronavirus Disease 19 (COVID-19) de-escalation process in the late season outbreaks registered during the 2020-2021 season.
A retrospective comparison of epidemic patterns in the respiratory viruses' incidence, using regional public health surveillance data from MRSC, was performed between weeks 26/2016 to week 27/2021. Data were expressed as the weekly total number of test positivity for individual viruses. A segmented negative binomial regression model was conducted, with two parameters included (level and trend) for each segment of the time series (2020 pre-lockdown, 2020 post-lockdown and 2021). Results were reported as a unit changed in the strict lockdown.
A total of 51588 confirmed cases of the different respiratory viruses were included in the analysis, the majority were influenza cases (63.7%). An immediate reduction in the weekly number of cases was observed in 2020 after the COVID-19 outbreak for human adenovirus virus (HAdV) (β2 = -2.606; P <0.01), human parainfluenza virus (HPIV) (β2 = -3.023; P <0.01), influenza virus (IFV) (β2 = -1.259; P <0.01), but not for respiratory syncytial virus (RSV), where the number of cases remained unchanged. During 2020, a significant negative trend was found for RSV (β3 = -0.170, P <0.01), and a positive trend for HAdV (β3 = 0.075, P <0.01). During 2021, a significant reduction in the weekly number of cases was also observed for all respiratory viruses, and a borderline non-significant reduction for HPIV (β3 = -0.027; P = 0.086). Moreover, significant positive trends were found for each viral pathogen, except for influenza during 2020-2021 season, where cases remained close to zero. The respiratory viruses increased activity and their late season epidemic start particularly affected children under 6 years old.
Our data not only provides evidence that occurrence of different respiratory virus infections was affected by the strict lockdown taken against SARS-CoV-2 but it also shows a late resurgence of seasonal respiratory viruses' cases during the 2020-2021 season following the relaxation of COVID-19-targeted non-pharmaceutical interventions.
The partial remission (PR) phase of type 1 diabetes (T1D) is an underexplored period characterized by endogenous insulin production and downmodulated autoimmunity. To comprehend the mechanisms behind ...this transitory phase and develop precision medicine strategies, biomarker discovery and patient stratification are unmet needs. MicroRNAs (miRNAs) are small RNA molecules that negatively regulate gene expression and modulate several biological processes, functioning as biomarkers for many diseases. Here, we identify and validate a unique miRNA signature during PR in pediatric patients with T1D by employing small RNA sequencing and RT-qPCR. These miRNAs were mainly related to the immune system, metabolism, stress, and apoptosis pathways. The implication in autoimmunity of the most dysregulated miRNA, miR-30d-5p, was evaluated in vivo in the non-obese diabetic mouse. MiR-30d-5p inhibition resulted in increased regulatory T cell percentages in the pancreatic lymph nodes together with a higher expression of
. In the spleen, a decrease in PD-1
T lymphocytes and reduced
expression were observed. Moreover, miR-30d-5p inhibition led to an increased islet leukocytic infiltrate and changes in both effector and memory T lymphocytes. In conclusion, the miRNA signature found during PR shows new putative biomarkers and highlights the immunomodulatory role of miR-30d-5p, elucidating the processes driving this phase.
RESUMEN Este artículo se centra en la identificación y la caracterización paleosísmica de la falla San Mateo, una estructura que se describe por primera vez en este trabajo. Esta falla forma parte ...del sistema de fallas central del graben de Acambay, en el centro de México. Es una falla normal de más de 13 km de largo, con rumbo E-O y buzamiento hacia el sur. Dos trincheras paleosísmicas fueron excavadas en la localidad de La Lechuguilla para determinar la cronología reciente de paleoterremotos asociados a la falla y caracterizar sus parámetros sísmicos. En una de estas trincheras se han reconocido al menos tres paleo-rupturas que ocurrieron entre el Pleistoceno tardío y el Holoceno, según las fechas de radiocarbono obtenidas. El evento más antiguo (Evento 1) se encuentra en el intervalo de 31.0-29.3 cal. ka AP. El Evento 2 se encuentra en el intervalo de 19.1-6.5 cal. ka AP y el fallamiento más joven (Evento 3) en el intervalo de 6.0 a 4.2 cal. ka AP. Estos resultados arrojan un intervalo de recurrencia de ruptura superficial preliminar de aproximadamente 11.57 ± 5.32 ka. Se estima una tasa de deslizamiento vertical de 0.085 ± 0.025 mm/año y una magnitud máxima (Mw ) entre 6.43 y 6.76 a partir del desplazamiento cosísmico promedio de 0.85 ± 0.16 m y una longitud de ruptura de falla de 13 km. En el caso de que la falla tuviera una longitud de ruptura de 25 km, considerando su posible continuación bajo los sedimentos actuales del graben, se podría generar un sismo de magnitud máxima, Mw , de 6.7 ± 0.3. Los resultados de este estudio paleosísmico sugieren que la falla San Mateo representa, junto con otras fallas activas del graben de Acambay, un riesgo sísmico significativo para la población. Finalmente, el presente estudio destaca el carácter reciente de la actividad volcánica en el graben de Acambay.
Fundamentos. Las pandemias requieren una valoracin de su nivel de gravedad. El objetivo fue determinar las caracter sticas de la gripe pand mica en Catalu a. Métodos. Se reali un estudio de ...vigilancia sobre la incidencia de s ndromes gripales y casos graves entre junio del 2009 y mayo del 2010. Una red de 55 m dicos notificaron los s ndromes gripales y recogieron frotis nasofar ngeos. La gravedad de la pandemia se valor a trav s de casos graves confirmados. Se calcularon la letalidad y las tasas de incidencia y de mortalidad. La existencia de diferencias se estudi con el Riesgo Relativo (RR) y su intervalo de confian a (IC) del 95%. Resultados: La incidencia de s ndromes gripales fue muy superior en el grupo de 5 a 14 y de 0 a 4 a os (1227,8 y 1048,4 respectivamente, en la semana de m xima incidencia). De las muestras positivas 477 (52,4%) fueron positivas a virus gripal y la mayor a, 456 (95,6%) lo fueron al virus gripal pand mico A (H1N1) 2009. La incidencia de casos graves fue de 10,3 por 105 y fue superior en ni os (14,5) y adultos menores de 65 a os (10,2) (p<0,0001). La mortalidad global fue del 0,7 por 105 y fue tambi n superior en ni os (0,8) y adultos menores de 65 a os (0,7) pero las diferencias no fueron estad sticamente significativas. La letalidad estimada fue de 0,03% y fue muy superior en el grupo de 15 a 44 a os (0,03%) (RR=3,1; IC95% 1,2-8,3), de 45 a 64 a os (0,11%) (RR=11,9; IC95% 4,332,7) y mayores de 64 a os (0,73%) (RR=79,6; IC95% 25,3-250,9) respecto al grupo de 5 a 14 a os (0,01%). Conclusiones: La incidencia de casos graves hospitali ados fue similar o inferior a la observada en el hemisferio sur. El riesgo inferior de hospitali aci n en los mayores de 64 a os sugiere protecci n relativa de este grupo de edad frente al virus pand mico.
