ABSTRACT
Introduction: Since the emergence of the SARS-CoV-2, there have been efforts to develop vaccines to control the COVID-19 pandemic. Objective: The present study assessed the efficacy and safety of the BNT162b2, mRNA-1273, ChAdOx1/AZD1222 and Gam-COVID-Vac rAd26-S/rAd5-S vaccines against the SARS-CoV-2. Materials and methods: We searched PubMed/MEDLINE, Google Scholar, Cochrane, and the WHO International Clinical Trials Registry Platform on March 15, 2021. The search terms used were: "vaccine" OR "vaccination" AND "covid19" OR "coronavirus" OR "sarscov2" AND "bnt162b2" OR "chadox1-S" OR "azd1222" OR "sputnik" OR "Gam-COVID-Vac" OR "mrna" OR "mRNA-1273" . We measured the risk of bias of the studies and the quality of the evidence using GRADE profiles. A qualitative and quantitative analysis of the results of clinical trials is presented. Results: Of the 74 identified studies, 4 were finally included in this review. The efficacies of the BNT162b2, mRNA-1273, ChAdOx1/AZD1222 and Gam-COVID-VacrAd26-S/rAd5-S vaccines against symptomatic COVID-19 were 95,0% (CI95% 90,3-97,6), 94,1% (CI95% 89,3-96,8), 66,7% (CI95% 57,4-74,0), and 91,1% (CI95% 83,8-95,1), respectively. There was moderate certainty of the evidence due to serious indirectness, when we measured the risk of bias of the studies and the quality of the evidence using GRADE profile. The safety profiles were acceptable, and data on serious adverse events (summary RR=0,93; CI95% 0,77-1,12; p=0,16) and deaths from all causes (summary RR=0,70; CI95% 0,33-1,50; p=0°90) showed no significant differences. Conclusion: The results of this review support the level of evidence for the efficacy and safety of the COVID-19 vaccines analysed.
Introducción. Desde que surgió el virus SARS-CoV-2, se han realizado esfuerzos para desarrollar vacunas para controlar la pandemia por COVID-19. Objetivo. Evaluar los datos de la eficacia y seguridad de las vacunas BNT162b2, mRNA-1273, ChAdOx1/AZD1222 y Gam-COVID-Vac rAd26-S/rAd5-S contra el SARS-CoV-2. Materiales y métodos. Se realizaron búsquedas en PubMed/MEDLINE, Google Scholar, Cochrane y la Plataforma de Registro Internacional de Ensayos Clínicos de la OMS el 15 de marzo de 2021. Los términos usados fueron: "vaccine" OR "vaccination" AND "covid19" OR "coronavirus" OR "sarscov2" AND "bnt162b2" OR "chadox1-S" OR "azd1222" OR "sputnik" OR "Gam-COVID-Vac" OR "mrna" OR "mRNA-1273'.' Se midió el riesgo de sesgo de los estudios y la calidad de la información por medio de los perfiles GRADE. Se presenta un análisis cualitativo y cuantitativo de los resultados de los estudios clínicos. Resultados. Se identificaron 74 estudios y se incluyeron 4 en la revisión. La eficacia de las vacunas BNT162b2, mRNA-1273, ChAdOx1/AZD1222 y Gam-COVID-VacrAd26-S/rAd5-S contra la COVID-19 sintomática fue del 95,0 % (IC95% 90,3-97,6), 94,1 % (IC95% 89,3-96,8), 66,7 % (IC95% 57,4-74,0) y 91,1 % (IC95% 83,8-95,1), respectivamente, y hubo una certeza moderada de la información debido a la falta de evidencia directa. Los perfiles de seguridad fueron aceptables, y los eventos adversos graves (RR resumido=0,93; IC95% 0,77-1,12; p=0,16) y muerte por todas las causas (RR resumido=0,70; IC95% 0,33-1,50; p=0,90) no mostraron diferencias significativas. Conclusión. Los resultados de esta revisión respaldan el nivel de evidencia de la eficacia y seguridad de las vacunas COVID-19 que fueron analizadas.
Subject(s)
Vaccines , Coronavirus Infections , Safety , Treatment OutcomeABSTRACT
Abstract In recent months, rare cases of thrombosis at unusual sites associated with thrombocytopenia, occurring within a typical risk window (i.e., 4-28 days) after receiving SARS CoV2 vaccines, have been reported. Healthcare professionals should be prepared to detect these cases on time. The Expert Panel of the Knowledge Management and Transfer Network conducted a free search of the related literature. With the available information and the clinical expertise of the working group, we formulated, reviewed, and endorsed recommendations for the timely suspicion, diagnosis (case definitions, the use of initial laboratory and imaging tests, specific tests), and management of these thrombotic conditions. This document is considered a living document that will be updated as new evidence emerges, and recommendations may change over time.
Resumen En meses recientes se han reportado casos raros de trombocitopenia y trombosis en sitios inusuales, que ocurren dentro de una ventana de riesgo típica ( por ejemplo de 4 a 28 días) luego de recibir vacunas de SARS CoV 2. Los profesionales de la salud deben estar preparados para detectar estos casos a tiempo. Un panel de expertos y una red de transferencia de conocimiento realizó una búsqueda libre de literatura seleccionada. Con la información disponible y la experticia clínica del grupo de trabajo revisamos y dimos recomendaciones para la sospecha temprana, el diagnostico (definición de caso, el uso de pruebas de laboratorio especificas y de imágenes diagnósticas) para le manejo de estas condiciones tromboticas. Este documento es considerado un documento vivo que debe ser actualizado a medida que surja nueva evidencia y las recomendaciones vayan cambiando con el tiempo
ABSTRACT
resumen está disponible en el texto completo
Abstract Introduction: The numbers of SARS-CoV-2 infection in the pediatric population are low so far. There is limited information about the behavior of SARS-CoV-2 in a pediatric patient with chronic kidney disease. Objective: To formulate informed recommendations to the prevention, diagnosis, and management of SARS-CoV-2 infection in pediatric patients with kidney disease or acute kidney injury associated with COVID-19 in Colombia. Methodology: A rapid systematic review was performed in Embase and Pubmed databases and scientific societies, to answer questions prioritized by clinical experts in pediatric nephrology. The quality of the evidence was evaluated with validated tools according to the type of study. The preliminary recommendations were consulted by an expert group. The agreement was defined when approval was obtained from at least 70% of the experts consulted. Results: A response was obtained from ' 9 experts in pediatric nephrology in Colombia, who declared the conflict of interest before the consultation. The range of agreement for the recommendations ranged from 78.9% to '00%. The recommendations did not require a second consultation. Conclusion: The evidence-based recommendations for the management of a patient with kidney disease and COVID-19 in the Colombian context are presented.
Subject(s)
Humans , Male , Female , Child, Preschool , Child , Adolescent , Pediatrics , COVID-19 , Patients , Societies, Scientific , Colombia , Renal Insufficiency, Chronic , Acute Kidney Injury , NephrologyABSTRACT
resumen está disponible en el texto completo
Abstract Introduction: Acute kidney injury is a frequent complication in patients with COVID-19 and its occurrence is a potential indicator of multi-organ dysfunction and disease severity. Objective: Develop, through an expert consensus, evidence-based recommendations for the prevention, diagnosis, and management of acute kidney injury in patients with SARS CoV2 / COVID-19 infection. Materials and methods: Based on a rapid systematic review in Embase and Pubmed databases and documents from scientific societies, we made preliminary recommendations and consulted with an expert group through an online tool. Then we defined agreement after at least 70 % consensus approval. Quality evidence was evaluated according to the type of document included. The strength of the recommendations was graded as strong or weak. Results: Fifty clinical experts declared their conflict of interest; the consultation took place between May 2 and 29, 2020. The range of agreement ranged from 75.5 % to 100 %. Recommendations for prevention, diagnosis and management of acute kidney injury in patients with SARS CoV2 infection are presented. Conclusions: Although the good quality information available regarding acute kidney injury in patients with COVID-19 is scarce, the recommendations of clinical experts will guide clinical decision-making and strategies around patients with this complication, guaranteeing care focused on the people, with high quality standards, and the generation of safety, health and wellness policies for multidisciplinary care teams.
Subject(s)
Humans , Male , Female , COVID-19 , Patients , Colombia , Diagnosis , Acute Kidney InjuryABSTRACT
Resumen Introducción: Las personas con diálisis de mantenimiento se consideran una población en alto riesgo de infección por SARS-CoV-2, complicaciones y muerte. La periodicidad de la diálisis, la organización y la demanda en las unidades de diálisis y las limitaciones de alfabetización en salud poblacional limitan el cumplimiento del aislamiento y el distanciamiento social. Objetivo: Desarrollar, mediante un consenso de expertos, recomendaciones informadas en evidencia para la prevención, el diagnóstico y el manejo de la infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Materiales y métodos: Se realizó una revisión rápida de literatura en Pubmed, Embase y sociedades científicas. La calidad de evidencia fue evaluada según el tipo de estudio incluido. El acuerdo se definió para cada recomendación con umbral de al menos 70% de aprobación. La fuerza de las recomendaciones fue graduada como fuerte o débil. Resultados: El colectivo fue consultado entre el 17 y 19 de mayo de 2020. Se obtuvo respuesta de 44 expertos clínicos que declararon conflicto de interés previo a la consulta. El acuerdo de las recomendaciones estuvo entre 70,5 y 100%. Se presentan las recomendaciones de un colectivo experto para la prevención, el diagnóstico y el manejo de infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Conclusión: Debido a la reciente aparición de la infección por SARS-CoV-2 y las incertidumbres respecto a la prevención, el diagnóstico y el manejo, las recomendaciones presentadas se conciben como un estándar colombiano que permita garantizar un cuidado centrado en las personas con enfermedad renal crónica y la protección de los profesionales de la salud.
Abstract Introduction: People with chronic dialysis are considered a population at high risk of SARS CoV2 infection and its derived complications and death. The need to go to strict dialysis schedules, the high demand in the kidney facilities and the difficulties derived from the time and space organization in the rooms in the face to the pandemic added to the difficult learning, teaching and adapting new protocols manifest the needed of standard recommendation according to this problem in people who couldn't have an ideal isolation. Objective: Develop through an expert consensus, evidence-informed recommendations for the prevention, diagnosis, and management of SARS-CoV-2/COVID-19 infection in patients with chronic kidney disease on Dialysis. Materials and methods: We carried out a quick literature review, PubMed, Embase and scientific societies were consulted. The quality of the evidence was considered according to the type of study included. The agreement threshold defined for each recommendation was > 70% approval among experts. The strength of the recommendations was rated as strong or weak. Results: Between May 17 and 19, 2020, was conformed a team of 44 clinical experts who declared their interest conflict prior to the consultation. The agreement of the recommendations was between 70.5% and 100%. The recommendations were separated in prevention, early identification, and diagnostic, isolation in hemodialysis facilities and peritoneal dialysis, and team protection. Ethical considerations also were included. Conclusion: Due to the recent appearance of SARS-CoV-2 infection and the uncertainties regarding prevention, diagnosis and management, the recommendations presented are conceived as a Colombian standard that allows guaranteeing focused care for people with chronic kidney disease and the protection of health team.
Subject(s)
Humans , Male , Female , Renal Insufficiency, Chronic , COVID-19 , Patients , Renal Dialysis , Colombia , DiagnosisABSTRACT
Resumen Introducción: debido a la emergencia del coronavirus SARS-CoV-2 desde diciembre del 2019, se ha generado un gran volumen de producción científica, en algún caso incierta o controvertida especialmente en el manejo farmacológico de los pacientes con esta infección; por lo tanto, se considera relevante buscar alternativas metodológicas para realizar su síntesis rigurosa, sistemática y de calidad, pero con menor tiempo de ejecución y menor costo. Objetivo: presentar la evidencia disponible respecto al manejo farmacológico de personas con sospecha o diagnóstico de infección respiratoria por SARS-CoV-2 (COVID-19) utilizando el método de revisiones sistemáticas rápidas (RS-R) en medicamentos poten- cialmente eficaces para su manejo. Metodología: se realizó una búsqueda sistemática y estructurada en Medline, Embase, Scopus, Cochrane Library, Clinical trials y Google Scholar en inglés. Los estudios incluidos fueron guías de práctica clínica, consensos, revisiones sistemáticas, metaanálisis, ensayos clínicos y otros estudios primarios. La búsqueda y extracción de datos se realizó por múltiples revisores, pero ninguna fue pareada. Resultados: dieciseis preguntas de interés clínico fueron resueltas, relacionadas con el uso en COVID-19 de lopinavir/ ritonavir, nelfinavir, oseltamivir, remdesivir, ribavirina, teicoplanina, umifenovir, favipiravir, tocilizumab, ivermectina y plasma convaleciente; también se evaluó el uso de medicamentos de soporte e incluidos en el manejo como la dexametasona, así como el uso concomitante de medicamentos que generaron dudas como son los AINES, los IECA y los ARA II. Conclusiones: los resúmenes de evidencia se muestran dentro del escenario de la pandemia como una buena alternativa metodológica para ofrecer información de calidad a corto plazo para los tomadores de decisiones.
Abstract Introduction: Due to the emergence of the SARS-CoV-2 coronavirus since December 2019, a large volume of scientific production has been generated, in some cases uncertain or controversial, especially in the pharmacological management of patients with this infection; therefore, it is considered a relevant search for methodological alternatives to carry out its rigorous, systematic and quality synthesis, but with less execution time and lower cost. Objective: To present the available evidence regarding the pharmacological management of people with suspected or diagnosed respiratory SARS-CoV-2 (COVID-19) using the method of rapid systematic reviews (RS-R) in potentially effective drugs for their management. Methodology: A systematic and structured search was conducted in Medline, Embase, Scopus, Cochrane Library, Clinical trials and Google Scholar in English. Studies included clinical practice guidelines, consensus, systematic reviews, meta-analyses, clinical trials, and other primary studies. Data search and extraction were performed by multiple reviewers, but none were paired. Results: Sixteen questions of clinical interest were resolved, related to the use in COVID-19 of lopinavir/ritonavir, nelfinavir, oseltamivir, remdesivir, ribavirin, teicoplanin, umifenovir, favipiravir, tocilizumab, ivermectin, convalescent plasma; the use of support management drugs such as dexamethasone were also evaluated, as well as the concomitant use of drugs that generated doubts, such as NSAIDs, ACEis, and ARA IIs. Conclusions: Summaries of evidence are within the pandemic scenario as a good methodological alternative to offer quality information in the short term for decision-makers.
Subject(s)
Humans , Male , Female , Drug Therapy , COVID-19 , Antiviral Agents , Patients , Therapeutics , Colombia , Severe Acute Respiratory SyndromeABSTRACT
Resumen Objetivo: Proyectar el comportamiento de factores de riesgo y de la incidencia de dos enfermedades cardiometabólicas, en una población colombiana entre 2017 y 2050. Metodología: Diseño de cohorte abierta basado en un modelo de microsimulación dinámica para la población adulta de Risaralda, Colombia. Los factores de riesgo analizados son tabaquismo, obesidad global, obesidad central y colesterol total. Se creó una población sintética que replica las características demográficas y de salud de Risaralda en 2010, utilizando algoritmos de emparejamiento e imputación estadística. La evolución a lo largo del curso de vida se simuló basada en reglas derivadas de la literatura, con ecuaciones estocásticas y modelos econométricos. Se calcula la incidencia de diabetes tipo II y de eventos cerebrovasculares isquémicos de 2017 a 2050. Resultados: En 2050, 16.7 % serán fumadores, la tercera parte de ellos presentarán obesidad global y más de la mitad presentarán obesidad central. El promedio de colesterol total aumentará 5 mg/dL. Adicionalmente, se espera que entre 2017 y 2050 se presenten 204.966 casos nuevos de diabetes y 65.758 eventos cerebrovasculares isquémicos. Conclusiones: Los estilos de vida y el envejecimiento poblacional, llevarán a mayor exposición a riesgo y aumentarán la velocidad a la que los risaraldenses se enfermarán de Diabetes y experimentarán eventos cerebrovasculares. La obesidad global y central son factores que explicarían esta tendencia. Se requieren intervenciones intersectoriales que protejan a la población y reduzcan cargas fiscales por condiciones evitables.
Abstract Objective: predict the behavior of the risk factors and the incidence of two cardiometabolic diseases in a population from Colombia between 2017 and 2050. Methodology: Follow up of individual's cohort of an artificial society of Risaralda, Colombia, based on a microsimulation model. The risk factors analyzed in this study are tobacco use, obesity, central obesity and total cholesterol. A synthetic population was created to replicate demographic and health characteristics of Risaralda in 2010, using pairing algorithms and statistical imputation. The evolution along the life course was simulated based on rules from scientific literature, with stochastic equations and econometric estimates. The incidence of type II diabetes and ischemic stroke is calculated for the adult population between 2017 to 2050. Results: 16.7% of the adults by 2050 is expected to be smokers, a third of them will have global obesity and more than half will have central obesity. The average level of serum total cholesterol would increase by 5 mg/dL. Additionally, is expected that between 2017 and 2050 there will be 204.966 incident cases of diabetes and 65.758 first-ever ischemic stroke events. Conclusions: Lifestyles and expected population aging will lead to greater risk of disease and will increase the rate at which local people will get diabetes and ischemic stroke. Risk factors like global and central obesity explain this trend. Effective intersectoral interventions are needed to protect the population and reduce tax burden due to preventable conditions.