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Nitrofurantoin-induced liver injury: long-term follow-up in two prospective DILI registries.
No full textNitrofurantoin is a synthetic antibiotic that is recommended as first-choice treatment for uncomplicated urinary tract infections. The prescription of this drug has increased dramatically, especially in Latin American countries. We described the demographics, clinical characteristics, biochemical features, and outcome of nitrofurantoin-induced liver injury. We analyzed 23 cases from the Latin American DILI Network (LATINDILI) and the Spanish DILI Registry. Causality was assessed with the RUCAM and RECAM scale. Of the 23 DILI cases included in our series, 96% patients were women, and the mean age of the whole cohort was 61 years. The median time of drug exposure was 175 days (interquartile range [IQR] 96-760), with 11 patients who were prescribed nitrofurantoin for more than six months. Hepatocellular damage was the most frequent pattern of liver injury (83%), and nearly half of the patients had an asymptomatic presentation (52%). Neither death nor liver transplantation was documented in this series. Overall, 65% of the patients (n = 15) presented with positive autoantibody titres. The median time to resolution was 81 days (IQR 57-141), and 15 patients (83%) recovered within six months. Five patients (22%) developed nitrofurantoin-induced autoimmune-like hepatitis (NI-AILH), of whom two were characterized by a persistent increase in transaminases that required immunosuppressive treatment to achieve normalization of liver enzymes. Clinicians who prescribe nitrofurantoin should be aware that patients who had taken nitrofurantoin for a long term may be at risk of developing nitrofurantoin-induced autoimmune-like hepatitis.S
Correction: Ventral hernia repair in high-risk patients and contaminated fields using a single mesh: proportional meta-analysis.
No full textChallenges for Economic Evaluations of Advanced Therapy Medicinal Products: A Systematic Review
No full textObjectives
Advanced therapy medicinal products (ATMPs) are drugs for human use for the treatment of chronic, degenerative, or life-threatening diseases that are based on genes, tissues, or cells. This article aimed to identify and critically review published economic analyses of ATMPs.
Methods
A systematic review of economic analyses of ATMPs was undertaken. Study characteristics, design, sources of data, resources and unit costs, modeling and extrapolation methods, study results, and sensitivity analyses were assessed.
Results
A total of 46 economic analyses of ATMP (from 45 articles) were included; 4 were cell therapy medicinal products, 33 gene therapy medicinal products, and 9 tissue-engineered products. 30 therapies had commercial marketing approval; 39 studies were cost-utility analysis, 5 were cost-effectiveness analysis, and 2 were cost only studies. Four studies predicted that the ATMP offered a step change in the management of the condition and 10 studies estimated that the ATMP would offer a lower mean cost.
Conclusions
Comparison with historical controls, pooling of data, and use of techniques such as mixture cure fraction models should be used cautiously. Sensitivity analyses should be used across a plausible range of prices. Clinical studies need to be designed to align with health technology assessment requirements, including generic quality of life, and payers should aim for clarity of criteria. Regulators and national payers should aim for compatibility of registers to allow interchange of data. Given the increasing reliance on industry-funded economic analyses, careful critical review is recommended.This work was supported by grant PID2019-105597RA100 from the Spanish Ministry of Science, Innovation and Universities.Ye
Vol. 28, nº 43. Vigilancia de infección respiratoria aguda en Andalucía. Temporada 2023-24
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 42/2023 y acumulado desde la semana 01/2023. Datos provisionales. Incluye además el artículo titulado “Vigilancia de infección respiratoria aguda en Andalucía. Temporada 2023-24”, de “Virtudes Gallardo García, Esteban Pérez Morilla”.Ye
Vol. 28, nº 44. Servicios de prevención de riesgos laborales en la provincia de Cádiz
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 43/2023 y acumulado desde la semana 01/2023. Datos provisionales. Incluye además el artículo titulado “Servicios de prevención de riesgos laborales en la provincia de Cádiz”, de “Cristina Resines Pradera”.Ye
Vol. 28, nº 15. Leptospirosis: zoonosis emergente. Situación actual. Presentación de la Guía "Leptospirosis en los humedales. Guía para el equipo de salud"
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 14/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Leptospirosis: zoonosis emergente. Situación actual. Presentación de la Guía "Leptospirosis en los humedales. Guía para el equipo de salud", de "FJ. Bernal Vela, MC Gómez-Martín".Ye
Vol. 28, nº 08. Situación epidemiológica de la Hepatitis C en el Distrito AP Sevilla y posibilidades de mejorar la vigilancia y el control.
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 07/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Situación epidemiológica de la Hepatitis C en el Distrito AP Sevilla y posibilidades de mejorar la vigilancia y el control", de M. Luque Rodríguez, M. (1), Oliva Diego, P. (1), Rodríguez Baleato, L.M. (1), Rodríguez Benjumea, A.(2), Roldán Garrido, E. (2) y Briones Pérez de la Blanca, E. (2).(1) MIR de Medicina Preventiva y Salud Pública. (2) Epidemiología. Unidad de Salud Pública Distrito Sevilla.Ye
Valor de la hemodiálisis concertada y la hospitalaria mediante un análisis de decisión multicriterio
No full textObjective
To evaluate the value of the provision of contracted versus hospital dialysis services for the treatment of chronic kidney disease in Spain using the multicriteria decision analysis methodology.
Method
The EVIDEM (Evidence and Value: Impact on Decision Making) evaluation framework was used to calculate the estimated value of both dialysis delivery models (arranged vs. hospital) through a virtual workshop in which different profiles participated: directors and managers, professionals and heads of units and representatives of patients and relatives. The scores were combined using an additive lineal model, which combined the weight of the model with the individual score of the criteria, and each value was transformed to a scale between 0 and 1.
Results
The estimated value for arranged dialysis was 0.29 (DS: ±0.2) and 0.39 (DS: ±0.2) for hospital dialysis. All profiles gave a higher value to hospital hemodialysis compared to contracted hemodialysis. The highest value for hospital dialysis was for patients (0.44), with the lowest mean value for directors (0.36) and the range for arranged dialysis being between patients (0.31) and intermediate positions (0.27).
Conclusions
Hospital hemodialysis obtained a higher value than concerted dialysis. In general, the panelists affirmed that it is a useful and interesting exercise and that, to a certain extent, it provides security in decision-making, since it allows ordering, rationalizing and considering, in an explicit and transparent manner, the different criteria involved.Ye
Manual de estándares urbanísticos para potenciar la salud en nuestras ciudades
No full textDirección General de Salud Pública y Ordenación FarmacéuticaLa publicación del presente manual responde a la voluntad de la Consejería de Salud y Consumo de realizar una contribución a la generación de entornos de vida saludable en las ciudades andaluzas, dando además respuesta al requisito legal establecido en el Decreto 51/2017, de 28 de marzo, de desarrollo de los derechos y responsabilidades de la ciudadanía en relación con la salud pública.Ye
Vol. 28, nº 26. Análisis de la situación epidemiológica y protocolo de gastroenteritis en residencias de mayores en el distrito sanitario Granada metropolitano, 2023
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 25/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Análisis de la situación epidemiológica y protocolo de gastroenteritis en residencias de mayores en el distrito sanitario Granada metropolitano, 2023", de "Eva Soler, Juan Pedro Castilla, Francisco Martín, Javier Pérez, Basilio Gómez, Mª Ángeles Rubín, Diego Almagro"Ye