Plasma de convaleciente para el tratamiento de la COVID-19: Protocolo para el acceso y uso en Venezuela / Convalescent Plasma for the Treatment of COVID-19: Protocol for access and use in Venezuela

En diciembre 2019, en Wuhan, China, se registró un aumento inusual de casos de infección respiratoria aguda de rápida progresión y alta letalidad. Al poco tiempo es identificado el agente causal, un coronavirus denominado SARS-CoV-2 y se caracteriza una nueva enfermedad, COVID-19. En ausencia hasta el momento de tratamientos específicos, eficaces y seguros, se justifica explorar alternativas científicamente fundamentadas a nuestro alcance como el uso de Plasma de Convaleciente (PC-CoV19) como coadyuvante para el tratamiento de la COVID-19. El plasma de pacientes recuperados de una enfermedad infecciosa, Plasma de Convaleciente, ha sido utilizado en el tratamiento de patologías infecciosas. Hay antecedentes inmediatos de su uso en enfermedades producidas por otro tipo de coronavirus y se registran experiencias y estudios clínicos con resultados preliminares durante esta pandemia. Quimbiotec, empresa productora de hemoderivados y fármacos recombinantes del Estado venezolano, y el Banco Municipal de Sangre, definen un protocolo para promover condiciones para la aféresis, procesamiento, conservación, almacenamiento, distribución, transfusión y evaluación de la seguridad y eficacia del PC-CoV19 como alternativa en el tratamiento de la COVID-19 en Venezuela. Se incluye la identificación de capacidades y de talento, la estructura física, equipos y especialistas necesarios, así como la definición de procesos para establecer rutinas controladas y auditables para sentar bases del acceso y uso del PC-CoV19 en el Sistema Nacional de Salud de Venezuela y preparar el diseño y ejecución de estudios clínicos. Se presenta el Protocolo y algunos nudos críticos en su ejecución a la fecha, herramientas y estrategias utilizadas para su solución(AU)

On December 2019, in Wuhan, China, there was an unusual increase in cases of a fast-progressing acute respiratory infection with high fatality rate. Soon after, the causing agent is identiied, a coronavirus called SARS-CoV-2, and a new disease, COVID-19 is characterized. Currently, in the absence of specific, effective and safe treatments, it is justified to explore all scientifically based alternatives available to us, such as the use of Convalescent Plasma (PC-CoV19) as acoadjutant treatment of COVID-19.Plasma from patients who have recovered from an infectious disease, Convalescent Plasma, has been used in the treatment of other infectious disease. There is recent history of its use in diseases caused by another type of coronavirus, and clinical experiences and studies have already been published with preliminary results during this pandemic. Quimbiotec, a Venezuelan State public company that produces blood products and recombinant drugs, and Banco Municipal de Sangre, deined a protocol to promote conditions for aphaeresis, processing, conservation, storage, distribution, transfusion, and evaluation of safety and eficacy of PC-CoV19 as an alternative for the treatment of COVID-19 in Venezuela. This protocol includes identification of capacities, physical structure, equipment and skills, talent, professionals needed, as well as a definition of processes to establish controlled and auditable routines to lay the foundations for access and use of PC-CoV19 in the Venezuela Health System, and prepare the design and implementation of clinical studies. The protocol and currently critical points in its implementation, as well as tools and strategies used for its solution, are presented(AU)

Incorporando nuevas evidencias sobre medicamentos inhalados en la EPOC. Asociación Latinoamericana de Tórax (ALAT) 2019 / Incorporating New Evidence on Inhaled Medications in COPD. The Latin American Chest Association (ALAT) 2019

Este documento sobre EPOC de la Asociación Latinoamericana de Tórax (ALAT) 2019 analiza las nuevas evidencias de medicación inhalada utilizando la metodología de preguntas clínicas en formato PICO. Surgen de este análisis los siguientes puntos claves: 1) no hay evidencia que compare el uso de broncodilatadores de acción corta vs. larga en pacientes con EPOC leve; en aquellos con EPOC moderada-grave existe mayor beneficio de los broncodilatadores de acción larga, 2) beneficios similares de la monoterapia con antimuscarínicos de acción prolongada (LAMA) y la terapia combinada β2-agonistas de acción larga/corticosteroides inhalados (LABA/CIS), asociada esta última a mayor riesgo de neumonía, 3) mayores beneficios del LABA/LAMA en función pulmonar y riesgo de exacerbación vs. LABA/CIS (esta última con mayor riesgo de neumonía) y 4) mayores beneficios de la terapia LAMA/LABA/CIS comparada con LABA/LAMA sobre el riesgo de exacerbaciones moderadas-severas. En relación al rol de los eosinófilos para guiar el uso de los CIS: debe considerarse su retiro cuando la indicación inicial fue errada o sin respuesta, en pacientes con efectos secundarios como neumonía, y en aquellos con bajo riesgo de exacerbación con recuento de eosinófilos en sangre < 300 cél/μl. Incorporando estas evidencias según la gravedad de la obstrucción, síntomas y riesgo de exacerbaciones se genera un algoritmo para el uso de medicación inhalada en la EPOC

This document on COPD from the Latin American Chest Association (ALAT-2019) uses PICO methodology to analyze new evidence on inhaled medication and answer clinical questions. The following key points emerged from this analysis: 1) evidence is lacking on the comparison of short-acting vs. long-acting bronchodilators in patients with mild COPD; patients with moderate-to-severe COPD obtain greater benefit from long-acting bronchodilators; 2) the benefits of monotherapy with long-acting antimuscarinic agents (LAMA) and combined therapy with long-acting β2-agonists and inhaled corticosteroids (LABA/ICS) are similar, although the latter is associated with a greater risk of pneumonia; 3) LABA/LAMA offer greater benefits in terms of lung function and risk of exacerbation than LABA/ICS (the latter involve an increased risk of pneumonia), 4) LAMA/LABA/ICS have greater therapeutic benefits than LABA/LAMA on the risk of moderate-severe exacerbations. With regard to the role of eosinophils in guiding the use of ICS, ICS withdrawal must be considered when the initial indication was wrong or no response is elicited, in patients with side effects such as pneumonia, and in patients with a low risk of exacerbation and an eosinophil blood count of <300 cells/μl. All this evidence, categorized according to the severity of the obstruction, symptoms, and risk of exacerbations, has been used to generate an algorithm for the use of inhaled medication in COPD

Incorporating New Evidence on Inhaled Medications in COPD. The Latin American Chest Association (ALAT) 2019. / Incorporando nuevas evidencias sobre medicamentos inhalados en la EPOC. Asociación Latinoamericana de Tórax (ALAT) 2019.

This document on COPD from the Latin American Chest Association (ALAT-2019) uses PICO methodology to analyze new evidence on inhaled medication and answer clinical questions. The following key points emerged from this analysis: 1) evidence is lacking on the comparison of short-acting vs. long-acting bronchodilators in patients with mild COPD; patients with moderate-to-severe COPD obtain greater benefit from long-acting bronchodilators; 2) the benefits of monotherapy with long-acting antimuscarinic agents (LAMA) and combined therapy with long-acting ß2-agonists and inhaled corticosteroids (LABA/ICS) are similar, although the latter is associated with a greater risk of pneumonia; 3) LABA/LAMA offer greater benefits in terms of lung function and risk of exacerbation than LABA/ICS (the latter involve an increased risk of pneumonia), 4) LAMA/LABA/ICS have greater therapeutic benefits than LABA/LAMA on the risk of moderate-severe exacerbations. With regard to the role of eosinophils in guiding the use of ICS, ICS withdrawal must be considered when the initial indication was wrong or no response is elicited, in patients with side effects such as pneumonia, and in patients with a low risk of exacerbation and an eosinophil blood count of <300 cells/µl. All this evidence, categorized according to the severity of the obstruction, symptoms, and risk of exacerbations, has been used to generate an algorithm for the use of inhaled medication in COPD.

Guía de práctica clínica de la enfermedad pulmonar obstructiva crónica (EPOC) ALAT-2014: preguntas y respuestas / ALAT-2014 chronic obstructive pulmonary disease (COPD) clinical practice guidelines: questions and answers

La guía de práctica clínica de enfermedad pulmonar obstructiva crónica (EPOC) ALAT 2014 fue elaborada contestando preguntas clínicas en formato PICO a través del análisis de evidencias sobre factores de riesgo, búsqueda de casos, evaluación pronóstica, tratamiento y exacerbaciones. La evidencia indica que existen factores de riesgo diferentes al tabaco, diferencias según el género, soporta la búsqueda activa de casos en población de riesgo y el valor predictivo de los índices multidimensionales. En la EPOC estable se encuentran similares beneficios de la monoterapia broncodilatadora (LAMA o LABA) sobre la disnea, función pulmonar o calidad de vida, y mayor efectividad del LAMA para prevenir exacerbaciones. La doble terapia broncodilatadora tiene mayores beneficios comparada con la monoterapia. La eficacia de la terapia con LAMA y la combinación LABA/CI es similar, con mayor riesgo de neumonía con la combinación LABA/CI. Existe limitada información sobre la eficacia y la seguridad de la triple terapia. La evidencia soporta el uso de vacunación contra la influenza en todos los pacientes y contra neumococo en < 65 años y/o con obstrucción grave. Los antibióticos profilácticos pueden disminuir la frecuencia de exacerbaciones en pacientes de riesgo. Está justificado el uso de corticosteroides sistémicos y antibióticos en exacerbaciones que requieren tratamiento intrahospitalario y en algunas de tratamiento ambulatorio

ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients <65years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics are justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting

ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers.

ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients <65years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics are justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting.