[Preventive myocardial revascularization prior to abdominal aortic repair in patients without cardiac symptoms: long-term results]. / Profilakticheskaya revaskulyarizatsiya miokarda pered rezektsiei anevrizmy bryushnoi aorty u kardiologicheski asimptomnykh bol'nykh: otdalennye rezul'taty.

OBJECTIVE: To evaluate the long-term influence of preoperative invasive coronary screening and preventive myocardial revascularization on mortality and cardiac complications after open surgery for abdominal aortic aneurysms (AAA). MATERIAL AND METHODS: We present long-term outcomes after open surgery for AAA between 2011 and 2022. Patients without clinical or objective signs of coronary artery disease were included. In the 1st group, routine coronary angiography was performed before surgery. Prophylactic myocardial revascularization was performed in 12 cases. Long-term data on 45 patients were obtained. In the 2nd group, 53 patients underwent repair without invasive coronary screening, and data on 48 patients were obtained in this group. RESULTS: The median follow-up was 32 and 79 months, respectively. Kaplan-Meyer overall 48-month survival was 87.3% and 82.1%, respectively (p=0.278). In the first group, 2 patients developed angina pectoris in the same period. In the second group, we observed 2 cases of myocardial infarction and 3 cases of angina pectoris without infarction. Analysis of survival curves found no significant differences (p=0.165). CONCLUSION: In our study, invasive coronary screening and preventive myocardial revascularization in patients without clinical and objective signs of coronary artery did not improve 4-year long-term period after abdominal aortic repair. Perhaps, differences will appear after 4 years, and this requires further follow-up after coronary angiography. However, there is a tendency towards more common onsets of coronary artery disease that dictates the need for cardiac monitoring of such patients.

[Fifteen-year results of bilateral and unilateral internal mammary artery grafting]. / Pyatnadtsatiletnie rezul'taty revaskulyarizatsii miokarda s ispol'zovaniem dvukh i odnoi vnutrennei grudnoi arterii.

OBJECTIVE: To evaluate the clinical effectiveness of bilateral internal mammary artery grafting over long-term (15 years) postoperative period. MATERIAL AND METHODS: There were 276 patients divided into two groups: 135 patients (group A) underwent bilateral internal mammary artery grafting and 141 patients (group B) underwent unilateral internal mammary artery grafting together with venous bypass grafts. On-pump surgeries and cardioplegia, parallel CPB and on-pump procedures were performed in equal proportions. Mean age of patients was 57.3±7.6 years. Diabetes mellitus was detected in 21 (15.5%) and 24 (19.1%) patients, respectively (p>0.05). Mean LV ejection fraction was 55.4±9.9%, revascularization index - 3.1±0.8 and 3.0±0.7, respectively. In the 1st group, 43 patients underwent bilateral internal mammary artery grafting alone. Autovenous grafts were additionally used in other 84 patients. RESULTS: Ten-year survival exceeded 90% in both groups. Freedom from adverse cardiac events after 15 years was significantly higher in group A (77.3% vs. 59.3%, p=0.018). In group A, 16 patients died throughout this period due to cancer (50%), myocardial infarction (12.5%), stroke (18.8%) and complications of diabetes mellitus (6.3%). In group B, 22 patients died mainly from cardiac causes (myocardial infarction - 40.9%, cancer - 27.3%). CONCLUSION: Bilateral internal mammary artery grafting has obvious advantages over traditional coronary artery bypass grafting. If we take into account higher proportion of cardiac causes in structure of mortality in group B, we can talk about positive impact of bilateral internal mammary artery grafting not only on the quality of life, but also on life expectancy in long-term postoperative period.

El registro continuado de los efectos adversos mejora los resultados quirúrgicos / Continuous monitoring of adverse effects improves surgical outcomes

Antecedentes: Se ha debatido mucho sobre las ventajas e inconvenientes del uso de bases administrativas o de registros clínicos en los programas de mejora de la atención médica. El objetivo de este estudio ha sido revisar la implementación y los resultados de una política de evaluación continua, mediante un registro mantenido por profesionales de un Servicio de Cirugía. Material y métodos: Se incluyeron, de forma prospectiva, todos los pacientes ingresados en el servicio entre los años 2003 y 2022. Se anotaron todos los efectos adversos (EA) acaecidos durante el ingreso, la estancia en centros de convalecencia o en su domicilio durante un periodo mínimo de 30 días tras el alta. Resultados: De 60.125 registros, en 16.802 (27,9%) se registraron 24.846 EA. Hubo un aumento progresivo del número de EA registrados por ingreso (1,17 en 2003 vs. 1,93 en 2022) con una disminución de 26% de los registros con EA (35% en 2003 hasta 25,8% en 2022), de 57,5% en las reoperaciones (de 8 a 3,4%, respectivamente), y de 80% en la mortalidad (de 1,8 a 1%, respectivamente). Es de remarcar la reducción significativa de los EA graves, observada entre los años 2011 y el 2022 (56 vs. 15,6%). Conclusión: Un registro prospectivo de EA creado y mantenido por profesionales del servicio, junto con la presentación y discusión abierta y trasparente de los resultados, produce una mejora sostenida de los resultados en un servicio quirúrgico de un hospital universitario.(AU)

Background: There has been significant debate about the advantages and disadvantages of using administrative databases or clinical registries in healthcare improvement programs. The aim of this study was to review the implementation and outcomes of an accountability policy through a registry maintained by professionals of the surgical department.Materials and methods: All patients admitted to the department between 2003 and 2022 were prospectively included. All adverse events (AEs) occurring during the admission, convalescent care in facilities, or at home for a minimum period of 30 days after discharge were recorded. Results: Out of 60,125 records, 24,846 AEs were documented in 16,802 cases (27.9%). There was a progressive increase in the number of AEs recorded per admission (1.17 in 2003 vs. 1.93 in 2022) with a 26% decrease in entries with AEs (from 35% in 2003 to 25.8% in 2022), a 57.5% decrease in reoperations (from 8.0% to 3.4%, respectively), and an 80% decrease in mortality (from 1.8% to 1%, respectively). It is noteworthy that a significant reduction in severe AEs was observed between 2011 and 2022 (56% vs. 15.6%). Conclusion: A prospective registry of AEs created and maintained by health professionals, along with transparent presentation and discussion of the results, leads to sustained improvement in outcomes in a surgical department of a university hospital.(AU)

The "Phase Down" of Dental Amalgam Restorations - What are the Criteria for Replacement and Indication?

ABSTRACT Objective: To guide professionals about the criteria for replacing amalgam restorations and inform them about the new guidelines regarding the use/indication of this (amalgam) material after the Minamata Convention - COP-4. Material and Methods: The articles were selected from the databases (PubMed, Scielo, Bireme), and relevant articles on the subject between the years 2003-2021 were selected. Recently, social media have been flooded with dental treatments that aim to perform restorations only with composite resins or other types of esthetic material and completely replace all dental amalgam restorations, irrespective of their time in place, size, and functionality. Results: Although improperly, it has been noted that this information reaches patients, and they are led to believe in the inaccurate data that is passed on, such as, for example, (that amalgam leads to) permanent contamination by mercury, causing systemic problems and the loss of the tooth. Conclusion: The "phase down" of amalgam in research and teaching has previously been observed in several countries worldwide; however, its use is still necessary given particular circumstances, which, theoretically, make it a material with exact indication.

Childhood abuse and opioid prescription use in adulthood: Differences between non-Hispanic Whites and non-Hispanic Blacks in the United States.

Despite the rapid rise in opioid prescription medication usage, little research has examined the role of early life adversity, such as childhood abuse, particularly in the context of race, in opioid prescription usage in adulthood. Guided by the life course perspective, the current study investigates whether experiencing childhood abuse increases the risk of opioid prescription use in adulthood and whether this association varies by race. Data were sourced from the second wave of the Midlife in the United States (MIDUS) study (2004-2005). The analytic sample consisted of two groups: non-Hispanic Whites (n = 714) and non-Hispanic Blacks (n = 151). Opioid prescription use was identified from the participants' medication list using the MULTUM Lexicon Drug Database Classification System. Three types of childhood abuse-emotional, physical, and sexual-were assessed via summary scales derived from the Childhood Trauma Questionnaire. The results indicate a significant interaction between childhood physical abuse and race. Among non-Hispanic Whites, higher exposure to physical abuse during childhood was associated with greater odds of opioid prescription use in adulthood, even after adjusting for chronic pain, physical and mental health, and sociodemographic characteristics. However, the association between childhood physical abuse and opioid prescription use in adulthood was non-significant among non-Hispanic Black individuals. These findings underscore the long-term adverse health effects of physical abuse in childhood, particularly for non-Hispanic Whites, and suggest support for developing and implementing tailored intervention strategies.

Efectos adversos de la radiación cósmica en personal aeronáutico: Revisión Sistemática / Side effects of cosmic radiation on aeronautic personnel: Systematic Review

Introducción: El personal de vuelo y astronautas estan sometidos a exposición ocupacional a radiación cósmica que podría producir la aparición de efectos patológicos. Hasta el momento, la evidencia disponible se orienta al estudio de patologías específicas sin recoger todos los posibles efectos adversos.Método: Revisión sistemática (RS) de la literatura publicada hasta enero 2023. Las bases de datos consultadas fue-ron PubMed, EMBASE, LILACS y Cochrane. Los descriptores utilizados fueron “Adverse effects”, “Cosmic Radiation”, y “Aeronautic”. Se incluyeron estudios con información sobre eventos adversos de la radiación cósmica en trabaja-dores expuestos. Se evaluó la calidad de la evidencia.Resultados: Se incluyeron 27 estudios (11 RS y 16 observacionales). Algunos estudios encontraron que los traba-jadores aeronáuticos tenían mayor riesgo neoplásico (cáncer de mama, cerebro, leucemia y melanoma) y de cata-ratas nucleares. Sin embargo, otros estudios no describieron el desarrollo de enfermedades neoplásicas ni otras patologías estudiadas (genéticas, ginecológicas o cardiovasculares) por radiaciones ionizantes. La calidad de las RS (AMSTAR–2) fue críticamente baja en la mayoría, y los estudios observacionales (STROBE) obtuvieron una media de alrededor del 72%.Conclusiones: La evidencia disponible no permite encontrar causalidad directa entre exposición a radiación cós-mica y aparición de patologías en personal expuesto. Se consideran necesarios nuevos estudios bien diseñados (AU)

Introduction: Aircrew and astronauts are subject to cosmic radiation as part of their jobs and could be associated with various pathological effects. Until now, available evidence is oriented to the study of specific pathologies with-out consideration of all possible adverse effects.Method: A systematic review (SR) from literature found until 2023 January. The databases included were PubMed, EMBASE, LILACS and Cochrane. The following descriptors used “Adverse effects” “Cosmic Radiation” and “Aeronau-tic”. Included studies had information on adverse effects of cosmic radiation in exposed workers. We assessed the quality of the evidence.Results: 27 studies were included (11 SR and 16 observational). Some articles determined that aeronautic person-nel have a higher cancer risk (breast, brain, leukemia and melanoma) and nuclear cataracts. However, other studies did not describe neoplastic diseases or other studied pathologies (genetics, gynecological, cardiovascular) due to ionizing radiation. The quality of the SR (AMSTAR-2) was critically low in the vast majority and the average quality for observational studies (STROBE) around 72%.Conclusions: Available evidence does not allow us to find direct causality between exposure to cosmic radiation and the appearance of pathologies in exposed personnel. New well-designed studies considered necessary. (AU)

[Response to the letter to the editor of "Commentary on the COVID-19 mRNA vaccine reactogenicity study"]. / Respuesta a la carta al editor de "Comentario al Estudio de reactogenicidad de la vacuna ARNm de COVID-19".

Dear Editor, Our study aims to compare the short-term adverse effects and their consequences between the RNAm vaccines Commirnaty® (Pfizer) and Spikevax® (Moderna), as well as these short-term adverse effects and their consequences between the first and second doses of these vaccines with each other. Possible long-term adverse effects were not the subject of our study….

Querido editor, Nuestro estudio tiene por objetivo, comparar los efectos adversos a corto plazo y sus consecuencias entre las vacunas RNAm, Commirnaty® (Pfizer) y Spikevax® (Moderna), así como, estos efectos adversos a corto plazo y sus consecuencias entre la primera y la segunda dosis de las citadas vacunas entre sí. Los posibles efectos adversos a largo plazo no eran objeto de nuestro estudio….

Experiencia ibérica con PASCAL para la reparación percutánea borde a borde en insuficiencia mitral / Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

Introducción y objetivos: PASCAL es un dispositivo novedoso de terapia mitral transcatéter basada en la reparación borde a borde. Algunas características únicas podrían tener un impacto relevante en sus resultados. Hay pocos datos sobre los resultados clínicos en registros de la vida real. El objetivo de este estudio es publicar la experiencia ibérica precoz (centros de España y Portugal) del sistema PASCAL. Métodos: Se incluyó prospectivamente a los pacientes tratados consecutivamente de insuficiencia mitral (IM) grave sintomática en 10 centros. El objetivo primario de eficacia fue el éxito técnico y el grado de regurgitación al alta. El objetivo primario de seguridad fueron los eventos adversos mayores (MAE) a 30 días. Resultados: Se incluyó a 68 pacientes (75 [68-81] años, 38% mujeres, EuroSCORE II 4,5%). La IM fue degenerativa en el 25% de los casos, funcional en el 65%, y mixta en el 10%. El 71% de pacientes estaban en clase funcional New York Heart Association (NYHA)≥III. El éxito técnico fue del 96% y la captura independiente se usó en el 73% de los procedimientos. Toda la población tratada obtuvo una IM al alta≤2+ (100%) y no hubo muertes intrahospitalarias. A los 30 días, los MAE fueron del 5,9%, la mortalidad global del 1,6%, el 98% estuvieron en clase NYHA≤II y el 95% tuvieron IM≤2+ (p <0,001). Conclusiones: El sistema PASCAL de terapia transcatéter mitral fue efectivo y seguro, con elevado éxito técnico y baja tasa de MAE. A los 30 días la IM se redujo significativamente, y hubo una mejoría en la clase funcional.(AU)

Introduction and objectives: The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Methods: Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. Results: We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). Conclusions: Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.(AU)

Corticosteroid safety in COVID-19 patients: a pharmacovigilance study / Seguridad de corticoesteroides en pacientes con COVID-19: un estudio de farmacovigilancia

The use of oral and intravenous corticosteroids as a treatment for SARS-CoV-2 infection has been shown to inhibit the exaggerated inflammatory response, reducing symptoms and days of hospitalization of patients. However, its use is controversial because not enough clinical studies have been made to verify the safety of the drugs. Objective: To assess the safety profile of corticosteroids treatment, at high and low doses, in suspected or confirmed patients with COVID-19, determining the most frequent side effects in patients, and assessing whether the administration of the drugs represents a greater benefit than the risk of presenting these effects. Methods: Ambispective study of active pharmacovigilance at a cohort of confirmed or suspected COVID-19 patients, treated with intravenous and oral corticosteroids. 366 patients were evaluated and divided into 3 groups: use of methylprednisolone (155 mg average) every 24 hours for 3 days, dexamethasone (6 mg) every 24 hours for 10 days, and a control group. Results: The distribution of the cases with hyperglycemia was 33 in high doses and 82 with low doses of corticosteroids and both high and low doses have a similar distribution in cases of infections. When evaluating the harshness and severity of hyperglycemia in the two groups with corticosteroids, it is observed that patients with high doses present more harsh (48%). In case of harshness and severity of infections it is observed that patients with high doses present more harsh (62%) and more severe (79%) cases than those who were administered low doses. (AU)

El uso de corticoides orales e intravenosos como tratamiento para la infección por SARS-CoV-2 ha demostrado inhibir la respuesta inflamatoria exagerada, reduciendo los síntomas y los días de hospitalización de los pacientes. Sin embargo, su uso es controvertido porque no se han realizado suficientes estudios clínicos para verificar la seguridad de los medicamentos. Objetivo: Evaluar el perfil de seguridad del tratamiento con corticoides, a dosis altas y bajas, en pacientes con sospecha o confirmación de COVID-19, determinando los efectos secundarios más frecuentes en los pacientes, y valorando si la administración de los fármacos representa un mayor beneficio que el riesgo de presentar estos efectos. Métodos: Estudio ambispectivo de farmacovigilancia activa en una cohorte de pacientes confirmados o sospechosos de COVID-19, tratados con corticoides intravenosos y orales. Se evaluaron 366 pacientes y se dividieron en 3 grupos: uso de metilprednisolona (155 mg promedio) cada 24 horas por 3 días, dexametasona (6 mg) cada 24 horas por 10 días y un grupo control. Resultados: La distribución de los casos con hiperglucemia fue de 33 casos usando dosis altas y 82 con dosis bajas de corticoides, tanto las dosis altas como las bajas tienen la misma distribución en los casos de infecciones. Al evaluar la severidad y gravedad de la hiperglucemia en los dos grupos con corticoides, se observa que los pacientes con dosis altas presentan mayor gravedad (48%). En caso de severidad y gravedad de las infecciones se observa que los pacientes con dosis altas presentan casos más graves (62%) y más severos (79%) que los que recibieron dosis bajas. (AU)

Évaluation de la prescription et de l'utilisation des benzodiazépines dans la ville de Sidi Bel-Abbès / Evaluation of the prescription and use of benzodiazepines in Sidi Bel-Abbes city

Introduction :Une forte consommation des benzodiazépines (BZDs) a été remarquée en dehors parfois des règles de recommandations de prescription, ce qui rend leur consommation un problème majeur de santé publique. La présente étude a eu pour objectif d'évaluer la prescription et l'usage des BZDs dans la ville de Sidi Bel-Abbès. Méthodes-Il s'agissait d'une étude descriptive transversale réalisée du 01 Février 2018 au 30 Juin 2018 évaluant la prescription et l'usage des BZDs dans la ville de Sidi Bel-Abbès au moyen d'un questionnaire distribué aux patients de l'hôpital psychiatrique, du service de psychiatrie du CHU et aux pharmaciens d'officine.Le critère de jugement principal était l'évaluation de la prescription et de l'utilisation des BZDs dans cette ville. La saisie et l'analyse des données ont été réalisées par le logiciel SPSS. Résultats-Au total, 353 patients traités au moins par une BZD ont été inclus dont 178 hommes. Le taux de prescription des BZDs était de 1.10, des jeunes (59,77 %) et des personnes mariées (60,34%) constituaient les consommateurs privilégiés. La prescription était l'apanage des psychiatres, en monothérapie (07,42%), la molé cule la plus fréquemment prescrite était le Bromazépam (31,07%) et la prise noc turne était la plus importante (49,01%). Les BZDs étaient utilisées pour combattre l'insomnie (25,21%), l'anxiété (16,43%), pour une durée de plus d'une année (57,79 %). Conclusion-La prescription et l'utilisation des BZDs dans la ville de Sidi Bel-Abbès s'est avérée importante. L'insomnie et l'anxiété constituaient les principales raisons de leur utilisation, et le Bromazépam était la molécule la plus fréquemment utilisée .

Introduction-A high consumption of benzodiazepines (BZDs) has been noticed so metimes outside the rules of prescription recommendations, which makes their consumption a major public health problem. The present study aimed to evaluate the prescription and use of BZDs in Sidi Bel-Abbès city. Methods-: This was a descriptive cross-sectional study carried out from February 01st, 2018 to June 30th, 2018 evaluating the prescription and use of BZDs in of Sidi Bel-Abbès by means of a questionnaire distributed to patients from the psychiatric hospital, the CHU psychiatry department and community pharmacists. The primary endpoint was the assessment of the prescription and use of BZDs in this city. Data entry and analysis were performed using SPSS software. Results-A total of 353 patients treated with at least one BZD were included, including 178 men. The prescription rate of BZDs was 1.10, young people (59.77%) and married people (60.34%) were the privileged consumers. The prescription was the prerogative of psychiatrists, in monotherapy (07.42%), the molecule most frequent ly prescribed was Bromazepam (31.07%) and night intake was the most important (49.01%). BZDs were used to combat insomnia (25.21%), anxiety (16.43%), for a period of more than a year (57.79%). Conclusion-The prescription and use of BZDs in Sidi Bel-Abbès has proven to be important. Insomnia and anxiety were the main reasons for their use, and Bromazepam was the most molecule frequently used.

Terapias cuádruples son superiores a terapia triple estándar en primera línea de erradicación de Helicobacter pylori en Chile / Quadruple therapies are superior to standard triple therapy for Helicobacter pylori first-line eradication in Chile

Introducción: La infección por Helicobacter pylori afecta aproximadamente al 70% de la población chilena. Es un problema de salud pública cuyo tratamiento de erradicación forma parte de políticas públicas en Chile. Objetivos: Caracterizar los esquemas de erradicación de primera línea de H. pylori más utilizados en nuestro medio y evaluar su eficacia. Métodos: Se realizó un estudio observacional retrospectivo donde, en pacientes con infección por H. pylori certificada, se evaluó el esquema de erradicación indicado por el médico tratante, su eficacia, adherencia y efectos adversos. Resultados: Se analizaron 242 pacientes y 4 esquemas de erradicación; terapia triple estándar, terapia dual, concomitante y cuadriterapia con bismuto. Se observaron tasas de erradicación de 81,9% (IC 95% 74,44-87,63), 88,5% (IC 95% 73,13-95,67), 93,7% (IC 95% 78,07-98,44) y 97,6% (IC 95% 84,81-99,67) respectivamente, siendo más eficaces la terapia concomitante (RR: 1,14; IC 95% 1,01-1,29; p=0,028) y cuadriterapia con bismuto (RR: 1,19; IC 95% 1,09-1,31; p<0,001) que la triple terapia estándar. La tasa de efectos adversos reportados fue de 58,5% (IC 95% 50,66-65,92), 35,4% (IC 95% 24,6-48,11), 22,9% (IC 95% 11,81-37,14) y 63,4% (IC 95% 47,8-76,64), para la terapia triple estándar, dual, concomitante, y cuádruple con bismuto, respectivamente. La terapia dual y concomitante tuvieron menos efectos adversos en comparación con la terapia estándar. Conclusiones: Las cuadriterapias son superiores a la triple terapia estándar por lo que deberían ser consideradas como tratamiento de primera línea en Chile. La terapia dual es promisoria. Más estudios serán requeridos para determinar qué esquemas son más costo-efectivos.(AU)

Introduction: Helicobacter pylori infection affects approximately 70% of the Chilean population. It is a public health problem whose eradication treatment is part of the explicit health guarantees in Chile. Objectives: Characterize the most widely used H. pylori first-line eradication therapies in our environment and evaluate their efficacy. Methods: A retrospective observational study was carried out where, in patients with certified H. pylori infection, the eradication therapy indicated by the treating physician, its efficacy, adherence and adverse effects, in addition to the eradication certification method used, were evaluated. Results: 242 patients and 4 main therapies were analyzed: standard triple therapy, dual therapy, concomitant therapy, and bismuth quadruple therapy. Eradication rates of 81.9% (95% CI 74.44–87.63), 88.5% (95% CI 73.13–95.67), 93.7% (95% CI 78.07–98.44) and 97.6% (95% CI 84.81–99.67) were observed respectively, with concomitant therapy (RR: 1.14; 95% CI 1.01–1.29; p=.028) and quadruple therapy with bismuth (RR: 1.19; 95% CI 1.09–1.31; p<.001) being significantly more effective than standard triple therapy. Regarding the rate of reported adverse effects, it was 58.5% (95% CI 50.66–65.92), 35.4% (95% CI 24.6–48.11), 22.9% (95% CI 81–37.14) and 63.4% (95% CI 47.8–76.64), having the dual and concomitant therapy significantly fewer adverse effects compared with standard therapy. Conclusions: Quadruple therapies are superior to standard triple therapy and should be considered as first-line treatment in Chile. Dual therapy is promising. More studies will be required to determine which therapies are most cost-effective.(AU)

Reacción cútanea debida a remdesivir en paciente con enfermedad por SARS-CoV-2 / Skin reaction due to remdesivir in a patient with SARS-CoV-2 disease

En diciembre de 2019 se detectó por primera vez en la ciudad china de Wuhan una nueva enfermedad infecciosa con el nombre oficial de COVID-19, causada por un nuevo tipo de coronavirus denominado virus SARS-CoV-2, la infección se ha propagado rápida y extensamente por todo el mundo, por lo que el 11 de marzo de 2020 la Organización Mundial de la Salud la declaró pandemia. Al tratarse de una nueva infección, no existe por el momento evidencia que permita recomendar un tratamiento específico, en la actualidad el único medicamento con indicación autorizada por la Agencia Europea de Medicamentos (EMA) es el remdesivir. A continuación presentamos el caso de una reacción adversa a remdesivir, si bien no fue grave, cabe destacar la importancia de notificar efectos adversos y más en medicamentos novedosos como este. (AU)

In December 2019, a new infectious disease with the official name of COVID-19 was detected for the first time in the Chinese city of Wuhan, caused by a new type of coronavirus called SARS-CoV-2 virus, the infection has spread rapidly and widely throughout the world, which is why on March 11, 2020, the World Health Organization declared it a pandemic. As it is a new infection, there is currently no evidence to recommend a specific treatment, currently the only drug with an indication authorized by the European Medicines Agency (EMA) is remdesivir.We present the case of an adverse reaction to remdesivir, although it was not serious, it is worth highlighting the importance of reporting adverse effects and more in novel drugs like this one. (AU)

Late effects of high-dose methotrexate treatment in childhood cancer survivors-a systematic review.

BACKGROUND: High-dose methotrexate (HD-MTX) is used in the treatment of different childhood cancers, including leukemia, the most common cancer type and is commonly defined as an intravenous dose of at least 1 g/m2 body surface area per application. A systematic review on late effects on different organs due to HD-MTX is lacking. METHOD: We conducted a systematic literature search in PubMed, including studies published in English or German between 1985 and 2020. The population of each study had to consist of at least 75% childhood cancer survivors (CCSs) who had completed the cancer treatment at least twelve months before late effects were assessed and who had received HD-MTX. The literature search was not restricted to specific cancer diagnosis or organ systems at risk for late effects. We excluded case reports, case series, commentaries, editorial letters, poster abstracts, narrative reviews and studies only reporting prevalence of late effects. We followed PRISMA guidelines, assessed the quality of the eligible studies according to GRADE criteria and registered the protocol on PROSPERO (ID: CRD42020212262). RESULTS: We included 15 out of 1731 identified studies. Most studies included CCSs diagnosed with acute lymphoblastic leukemia (n = 12). The included studies investigated late effects of HD-MTX on central nervous system (n = 10), renal (n = 2) and bone health (n = 3). Nine studies showed adverse outcomes in neuropsychological testing in exposed compared to non-exposed CCSs, healthy controls or reference values. No study revealed lower bone density or worse renal function in exposed CCSs. As a limitation, the overall quality of the studies per organ system was low to very low, mainly due to selection bias, missing adjustment for important confounders and low precision. CONCLUSIONS: CCSs treated with HD-MTX might benefit from neuropsychological testing, to intervene early in case of abnormal results. Methodological shortcomings and heterogeneity of the tests used made it impossible to determine the most appropriate test. Based on the few studies on renal function and bone health, regular screening for dysfunction seems not to be justified. Only screening for neurocognitive late effects is warranted in CCSs treated with HD-MTX.

Long-term Outcomes of Adults With Tricuspid Regurgitation Following Transcatheter Atrial Septal Defect Closure.

BACKGROUND: Functional tricuspid regurgitation (TR) is a common pathophysiologic condition in adults with ostium secundum atrial septal defect (ASD). The aim of this study was to evaluate long-term outcomes following transcatheter ASD closure, which have not been well studied among patients with significant TR. METHODS: We reviewed consecutive adult patients who underwent transcatheter ASD closure at Toronto General Hospital, Ontario, Canada, from 1998 to 2016. We linked our hospital registry with Ontario population-based health administrative databases to collect longitudinal data on inpatient and outpatient health care utilisation and vital status. RESULTS: In this cohort study of 949 patients, 199 (22%) had moderate to severe TR before transcatheter ASD closure. A significant proportion of patients (61%) showed improvement in TR severity to at least mild TR after ASD intervention. At a median follow-up of 10.9 years, patients with baseline mild or no TR, compared with those with greater than moderate TR, had significantly lower rates of all-cause mortality (6.8 vs 22.5 per 1000 person-years [PY]; P < 0.001), composite hospitalisation for atrial fibrillation (AF) or heart failure (HF) (22.3 vs 49.1 per 1000 PY; P < 0.001), and new onset of AF (10.4 vs 20.2 per 1000 PY; P = 0.002) and HF (5.0 vs 9.2 per 1000 PY; P = 0.039). Preprocedural TR was independently associated with higher all-cause mortality (adjusted hazard ratio 1.69, 95% confidence interval 1.08-2.62). CONCLUSIONS: TR severity was independently associated with a higher risk of mortality and morbidity. Further investigation of earlier device closure or concomitant tricuspid valve intervention may be of interest.

Association of Hormonal Contraceptive Use With Adverse Health Outcomes: An Umbrella Review of Meta-analyses of Randomized Clinical Trials and Cohort Studies.

Importance: Meta-analyses have reported conflicting data on the safety of hormonal contraception, but the quality of evidence for the associations between hormonal contraceptive use and adverse health outcomes has not been quantified in aggregate. Objective: To grade the evidence from meta-analyses of randomized clinical trials (RCTs) and cohort studies that assessed the associations between hormonal contraceptive use and adverse health outcomes among women. Data Sources: MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched from database inception to August 2020. Search terms included hormonal contraception, contraceptive agents, progesterone, desogestrel, norethindrone, megestrol, algestone, norprogesterones, and levonorgestrel combined with terms such as systematic review or meta-analysis. Evidence Review: The methodological quality of each meta-analysis was graded using the Assessment of Multiple Systematic Reviews, version 2, which rated quality as critically low, low, moderate, or high. The Grading of Recommendation, Assessment, Development and Evaluations approach was used to assess the certainty of evidence in meta-analyses of RCTs, with evidence graded as very low, low, moderate, or high. Evidence of associations from meta-analyses of cohort studies was ranked according to established criteria as nonsignificant, weak, suggestive, highly suggestive, or convincing. Results: A total of 2996 records were screened; of those, 310 full-text articles were assessed for eligibility, and 58 articles (13 meta-analyses of RCTs and 45 meta-analyses of cohort studies) were selected for evidence synthesis. Sixty associations were described in meta-analyses of RCTs, and 96 associations were described in meta-analyses of cohort studies. Among meta-analyses of RCTs, 14 of the 60 associations were nominally statistically significant (P ≤ .05); no associations between hormonal contraceptive use and adverse outcomes were supported by high-quality evidence. The association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use (odds ratio [OR], 0.22; 95% CI, 0.13-0.38) was graded as having high-quality evidence, and this evidence ranking was retained in the subgroup analysis. Among meta-analyses of cohort studies, 40 of the 96 associations were nominally statistically significant; however, no associations between hormonal contraceptive use and adverse outcomes were supported by convincing evidence in the primary and subgroup analyses. The risk of venous thromboembolism among those using vs not using oral contraception (OR, 2.42; 95% CI, 1.76-3.32) was initially supported by highly suggestive evidence, but this evidence was downgraded to weak in the sensitivity analysis. Conclusions And Relevance: The results of this umbrella review supported preexisting understandings of the risks and benefits associated with hormonal contraceptive use. Overall, the associations between hormonal contraceptive use and cardiovascular risk, cancer risk, and other major adverse health outcomes were not supported by high-quality evidence.

Association between type 2 diabetes and long-term outcomes in middle-aged and older trauma patients.

BACKGROUND: Diabetes is associated with increased hospital complications and mortality following trauma. However, there is limited research on the longer-term recovery of trauma patients with diabetes. The aim of this study was to explore the association between type 2 diabetes (T2D) and in-hospital and 24-month outcomes in major trauma patients. METHODS: In this cohort study using the Victorian State Trauma Registry, middle-aged and older adults (≥45 years) with major trauma were followed up at 24 months postinjury. Logistic regression (univariable and multivariable) analyses were used to determine the association between diabetes status and 24-month patient-reported outcomes. In-hospital outcomes were compared between groups using χ2 tests. RESULTS: Of the 11,490 participants who survived to hospital discharge, 8,493 survived to 24 months postinjury and were followed up at that time point: 953 people (11%) with and 7540 (89%) without T2D. People with T2D had a higher in-hospital death rate (19%) compared with people without T2D (16%; p < 0.001). After adjusting for confounders, people with T2D had poorer outcomes 24 months postinjury than people without T2D, with respect to functional recovery (Glasgow Outcome Scale Extended) (adjusted odds ratio [AOR], 0.58; 95% confidence interval [CI], 0.48-0.69) and return to work/study (AOR, 0.51; 95% CI, 0.37-0.71]). People with T2D experienced higher odds of problems with mobility (AOR, 1.92; 95% CI, 1.60-2.30), self-care (AOR, 1.94; 95% CI, 1.64, 2.29), usual activities (AOR, 1.50; 95% CI, 1.26-1.79), pain and discomfort (AOR, 1.75; 95% CI, 1.49-2.07), anxiety and depression (AOR, 1.45; 95% CI, 1.24, 1.70), and self-reported disability (AOR, 1.51; 95% CI, 1.28-1.79) than people without T2D. CONCLUSION: Major trauma patients with T2D have a poorer prognosis than patients without T2D, both during their hospital admission and 24 months postinjury. Patients with T2D may need additional health care and support following trauma to reach their recovery potential. LEVEL OF EVIDENCE: Prognostic, level III.

Long-term outcomes of truncus arteriosus repair: A modulated renewal competing risks analysis.

OBJECTIVE: In this study, we sought to identify independent risk factors for mortality and reintervention after early surgical correction of truncus arteriosus using a novel statistical method. METHODS: Patients undergoing neonatal/infant truncus arteriosus repair between January 1984 and December 2018 were reviewed retrospectively. An innovative statistical strategy was applied integrating competing risks analysis with modulated renewal for time-to-event modeling. RESULTS: A total of 204 patients were included in the study. Mortality occurred in 32 patients (15%). Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were significantly associated with overall mortality (right ventricle to pulmonary artery conduit size: hazard ratio, 1.34; 95% confidence interval, 1.08-1.66, P = .008; truncal valve insufficiency: hazard ratio, 2.5; 95% confidence interval, 1.13-5.53, P = .024). truncal valve insufficiency at birth, truncal valve intervention at index repair, and number of cusps (4 vs 3) were associated with truncal valve reoperations (truncal valve insufficiency: hazard ratio, 2.38; 95%, confidence interval, 1.13-5.01, P = .02; cusp number: hazard ratio, 6.62; 95% confidence interval, 2.54-17.3, P < .001). Right ventricle to pulmonary artery conduit size 11 mm or less was associated with a higher risk of early catheter-based reintervention (hazard ratio, 1.54; 95% confidence interval, 1.04-2.28, P = .03) and reoperation (hazard ratio, 1.96; 95% confidence interval, 1.33-2.89, P = .001) on the right ventricle to pulmonary artery conduit. CONCLUSIONS: Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were associated with overall mortality after truncus arteriosus repair. Quadricuspid truncal valve, the presence of truncal valve insufficiency at the time of diagnosis, and truncal valve intervention at index repair were associated with an increased risk of reoperation. The size of the right ventricle to pulmonary artery conduit at index surgery is the single most important factor for early reoperation and catheter-based reintervention on the conduit.

Capsule Endoscopy Is Useful for Postoperative Tight Control Management in Patients with Crohn's Disease.

BACKGROUND: In Crohn's disease, postoperative endoscopic activity of small bowel lesions outside the scope of ileocolonoscopy has been insufficiently studied. AIMS: We aimed to assess this postoperative activity using capsule endoscopy (CE) and analyze the association between treatment optimization based on CE findings and the long-term course. METHODS: In patients who underwent intestinal resection, we performed CE and assessed the endoscopic activity using the Lewis score within 3 months postoperatively (1st CE) and during follow-up. Postoperative treatments were adjusted according to clinical symptoms or CE findings (severity of 1st CE or worsening of follow-up CEs). Hospitalization, repeat surgery, or endoscopic dilation defined the primary outcome. RESULTS: Among the CE group (N = 48), 85.7% (1st CE) and 79.2% (2nd CE) exhibited endoscopic activities indicating residual or recurrent lesions. Postoperative treatments were adjusted according to clinical symptoms in the non-CE group (N = 57) and clinical symptoms or CE findings in the CE group. Compared to the non-CE group, the CE group had significantly fewer primary outcomes. Patients with treatment adjustments based on CE findings had even lower primary outcome rate. Multivariate analysis identified the CE group as an independent protective factor (hazard ratio = 0.45, 95% confidence interval = 0.20-0.96). Treatment adjustments based on CE findings showed a stronger protective effect (0.30, 0.10-0.75). CONCLUSIONS: Postoperative repeated CE enabled us to assess residual and recurrent lesions accurately before clinical symptoms appeared. The regular assessment of endoscopic activity and subsequent treatment optimization have the potential for improving postoperative course.