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Vol. 28, nº 03. Enfermedad neumocócica invasora. Andalucía, año 2021
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 02/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Enfermedad neumocócica invasora. Andalucía, año 2021", de "Virtudes Gallardo García; Nicola Lorusso". Servicio de Vigilancia y Salud Laboral..Ye
Guías para la elaboración de manuscritos y unas pinceladas de lectura crítica
No full textThe biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.El proceso de investigación biomédica debe seguir unos criterios de calidad en su diseño y elaboración, que garanticen que los resultados son creíbles y fiables. Una vez finalizado, llega el momento de escribir un artículo para su publicación. Este debe presentar con suficiente detalle, y de forma clara y transparente, toda la información del trabajo de investigación realizado. De esta forma, los lectores, tras una lectura crítica de lo publicado, podrán juzgar la validez y la relevancia del estudio, y si lo consideran, utilizar los hallazgos. Con el objetivo de mejorar la descripción del proceso de investigación para su publicación, se han desarrollado una serie de guías que, de forma sencilla y estructurada, orientan a los autores a la hora de elaborar un manuscrito. Se presentan en forma de lista, diagrama de flujo, o texto estructurado, y son una ayuda inestimable a la hora de escribir un artículo. Este artículo presenta las guías de elaboración de manuscritos de los diseños más habituales, con sus listas de verificación.Ye
Frequency of microsatellite instability (MSI) in upper tract urothelial carcinoma: comparison of the Bethesda panel and the Idylla MSI assay in a consecutively collected, multi-institutional cohort
No full textAims Upper tract urothelial carcinoma (UTUC) is a rare malignancy with a poor prognosis which occurs sporadically or in few cases results from a genetic disorder called Lynch syndrome. Recently, examination of microsatellite instability (MSI) has gained importance as a biomarker: MSI tumours are associated with a better response to immunomodulative therapies. Limited data are known about the prevalence of MSI in UTUC. New detection methods using the fully automated Idylla MSI Assay facilitate analysis of increased patient numbers. Methods We investigated the frequency of MSI in a multi-institutional cohort of 243 consecutively collected UTUC samples using standard methodology (Bethesda panel), along with immunohistochemistry of mismatch repair (MMR) proteins. The same tumour cohort was retested using the Idylla MSI Assay by Biocartis. Results Using standard methodology, 230/243 tumours were detected as microsatellite stable (MSS), 4/243 tumours as MSI and 9/243 samples as invalid. In comparison, the Idylla MSI Assay identified four additional tumours as MSS, equalling 234/243 tumours; 4/243 were classified as MSI and only 5/243 cases as invalid. At the immunohistochemical level, MSI results were supported in all available cases with a loss in MMR proteins. The overall concordance between the standard and the Idylla MSI Assay was 98.35%. Time to result differed between 3 hours for Idylla MSI Assay and 2 days with the standard methodology. Conclusion Our data indicate a low incidence rate of MSI tumours in patients with UTUC. Furthermore, our findings highlight that Idylla MSI Assay can be applied as an alternative method of MSI analysis for UTUC.S
Vol. 28, nº 13. Casos y brotes por infección relacionada con la asistencia sanitaria (IRAS). Segundo cuatrimestre 2022.
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 12/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Casos y brotes por infección relacionada con la asistencia sanitaria (IRAS). Segundo cuatrimestre 2022", de "María Liébana Rodríguez, Mª Auxiliadora Vergara Díaz, María Sierra Escalera Pérez, Julio López Méndez, Iván Peralta Gálvez, Isabel Mª Vázquez Rincón. Servicio de Vigilancia y Salud Laboral. Dirección. General de Salud Pública y Ordenación Farmacéutica".Ye
Vol. 28, nº 10. Implementación del nuevo modelo de abordaje de las Infecciones de Transmisión Sexual en el Distrito Sanitario de Almería.
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 09/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado "Implementación del nuevo modelo de abordaje de las Infecciones de Transmisión Sexual en el Distrito Sanitario de Almería", de Pilar Barroso García, Juan González Pérez, Celia Moreno Fernández, Elena Rojas Gay, Alejandro Hidalgo Hernández, Noemí Sánchez Contreras. Epidemiología, Distrito Sanitario de Atención Primaria, Almería.Ye
Vol. 28, nº 25. Programa de vacunación frente a neumococo en Andalucía 2023
No full textEnfermedades de Declaración Obligatoria por provincias. Semana 24/2023 y acumulado desde semana 01/2023. Datos provisionales. Incluye además el artículo titulado “Programa de vacunación frente a neumococo en Andalucía 2023", de "María Ángeles Onieva, Daniel Ocaña, Marta Bernal, David Moreno".Ye
Tunneled catheter-related bacteremia in hemodialysis patients: incidence, risk factors and outcomes. A 14-year observational study.
No full textTunneled catheter-related bacteremia represents one of the major complications in patients on hemodialysis, and is associated with increased morbidity and mortality. This study aimed to evaluate the incidence of tunneled catheter-related bacteremia and, secondly, to identify possible factors involved in the first episode of bacteremia. This is a retrospective study of all tunneled catheters inserted between 1 January, 2005 and 31 December, 2019. Data on patients with a tunneled catheter were analyzed for comorbidities, catheter characteristics, microbiological culture results and variables related to the first episode of bacteremia. Patient outcomes were also assessed. In the 14-year period under study, 406 tunneled catheters were implanted in 325 patients. A total of 85 cases of tunneled catheter-related bacteremia were diagnosed, resulting in an incidence of 0.40 per 1000 catheter days (81.1% after 6 months of implantation). The predominant microorganisms isolated were Gram-positive organisms: Staphylococcus epidermidis (48.4%); Staphylococcus aureus (28.0%). We found no significant differences in time to catheter removal for infections or non-infection-related reasons. The jugular vein, the Palindrome® catheter, and being the first vascular access were protective factors for the first episode of bacteremia. The 30-day mortality rate from the first tunneled catheter-related bacteremia was 8.7%. The incidence of bacteremia in our study was low and did not seem to have a relevant impact on catheter survival. S. epidermidis was the most frequently isolated microorganism, followed by S. aureus. We identified Palindrome® catheter, jugular vein, and being the first vascular access as significant protective factors against tunneled catheter-related bacteremia.S
A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy.
No full textPurpose: Disease progression during or after anti-PD-1-based treatment is common in advanced melanoma. Sotigalimab is a CD40 agonist antibody with a unique epitope specificity and Fc receptor binding profile optimized for activation of CD40-expressing antigen-presenting cells. Preclinical data indicated that CD40 agonists combined with anti-PD1 could overcome resistance to anti-PD-1. Patients and Methods: Weconductedamulticenter, open-label, phase II trial to evaluate the combination of sotigalimab 0.3 mg/kg and nivolumab 360 mg every 3 weeks in patients with advanced melanoma following confirmed disease progression on a PD-1 inhibitor. The primary objective was to determine the objective response rate (ORR). Results: Thirty-eight subjects were enrolled and evaluable for safety. Thirty-three were evaluable for activity. Five confirmed partial responses (PR) were observed for an ORR of 15%. Two PRs are ongoing at 45.9þ and 26þ months, whereas the other three responders relapsed at 41.1, 18.7, and 18.4 months. The median durationofresponsewasatleast26months.Twoadditionalpatients had stable disease for >6 months. Thirty-four patients (89%) experienced at least one adverse event (AE), and 13% experienced a grade 3 AE related to sotigalimab. The most common AEs were pyrexia,chills, nausea,fatigue, pruritus,elevatedliverfunction, rash, vomiting, headache, arthralgia, asthenia, myalgia, and diarrhea. There were no treatment-related SAEs, deaths, or discontinuation of sotigalimab due to AEs. Conclusions: Sotigalimab plus nivolumab had a favorable safety profile consistent with the toxicity profiles of each agent. The combination resulted in durable and prolonged responses in a subset of patients with anti-PD-1-resistant melanoma, warranting further evaluation in this setting.The study was funded by Apexigen. Drug support was provided by Apexigen and Bristol Myers Squibb. We acknowledge research funding in part from the Yale Calabresi Immuno-oncology Training Program (K12CA215110; to S.A. Weiss) and the Yale SPORE in Skin Cancer (P50 CA121974; to H.M. Kluger).Ye
Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.
No full textPalbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study. Patients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n = 486) were randomly assigned 1:1 to receive fulvestrant-palbociclib (FP) or letrozole-palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE. A total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P The PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy. NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983)
One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study
No full textObjectives Naloxegol is a peripherally acting mu-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study. Methods This one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky >= 50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L). Results A total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p= 50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L). Results A total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment. The results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.S