ABSTRACT
ABSTRACT Background Several therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil. Methods A panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method. Results Ten technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation. Conclusion To date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments.
ABSTRACT
RESUMO Introdução: Há diversas terapias sendo utilizadas, consideradas ou propostas para o tratamento da COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é fornecer recomendações baseadas nas evidências científicas disponíveis e em sua interpretação transparente, para subsidiar decisões sobre o tratamento farmacológico da COVID-19 no Brasil. Métodos: Um grupo de 27 especialistas e metodologistas integraram a força-tarefa formada pela Associação de Medicina Intensiva Brasileira (AMIB), pela Sociedade Brasileira de Infectologia (SBI) e pela Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). Foram realizadas revisões sistemáticas rápidas, atualizadas até 28 de abril de 2020. A qualidade das evidências e a elaboração das recomendações seguiram o sistema GRADE. As recomendações foram elaboradas nos dias 5, 8 e 13 de maio de 2020. Resultados: Foram geradas 11 recomendações, embasadas em evidência de nível baixo ou muito baixo. Não há indicação para uso de rotina de hidroxicloroquina, cloroquina, azitromicina, lopinavir/ritonavir, corticosteroides ou tocilizumabe no tratamento da COVID-19. Heparina deve ser utilizada em doses profiláticas no paciente hospitalizado, mas não deve ser realizada anticoagulação na ausência de indicação clínica específica. Antibacterianos e oseltamivir devem ser considerados somente nos pacientes em suspeita de coinfecção bacteriana ou por influenza, respectivamente. Conclusão: Até o momento, não há intervenções farmacológicas com efetividade e segurança comprovada que justifiquem seu uso de rotina no tratamento da COVID-19, devendo os pacientes serem tratados preferencialmente no contexto de pesquisa clínica. As recomendações serão revisadas continuamente, de forma a capturar a geração de novas evidências.
ABSTRACT Introduction: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. Methods: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. Results: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. Conclusion: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.
Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Pandemics , COVID-19ABSTRACT
O OBJETIVO deste trabalho é descrever o processo de funcionamento dos alertas para dias de utilização de antimicrobianos terapêuticos e analisar o impacto da implantação destes alertas nas suspensões dos itens. MÉTODOS: O estudo foi conduzido na Sociedade Beneficente de Senhoras Hospital Sírio Libanês em Março de 2015, onde se implementou um programa de controle de antimicrobianos terapêuticos que consistiu nas seguintes intervenções: Apresentação de alertas e análise dos dados de DDD (Dose Diária Definida) nas UTIs. CONCLUSÃO: Pode se dizer que o uso de alertas para dias de utilização de antimicrobianos terapêuticos na prescrição eletrônica associado à intervenção educativa por um infectologista, preservando a autonomia do médico prescritor foram eficazes na redução do consumo de antimicrobiano sem um hospital privado de corpo clínico aberto.
OBJECTIVE: The objective of this study is to describe the operating procedure for alerts to day use of therapeutic antimicrobials and analyze the impact of the implementation of these alerts in the suspensions of the items. METHODS: The study was conducted in the Sociedade Beneficente de Senhoras Hospital Sírio Libanês in March 2015, which implemented a therapeutic antimicrobial control program that consisted of the following interventions: Presentation alertsand analysis of DDD data (Defined Daily Dose) ICUs. CONCLUSION: It can be said that the use of alerts for days of use of therapeutic antimicrobials in CPOE associated with educational intervention for infectious disease, preserving the autonomy of the prescribing physician were effective in reducing antimicrobial consumption in a private hospital to open medical staff.
OBJETIVO: El objetivo de este estudio es describir el procedimiento de funcionamiento de los alertas de día de uso de los antimicrobianos terapéuticos y analizar el impacto de la aplicación de estas alertas en las suspensiones de los mismos. MÉTODOS: El estudio se realizó en la Sociedade Beneficente de Senhoras Hospital Sírio Libanês en 2015 de marzo, lo que puso en práctica un programa de control antimicrobiano terapéutico que constaba de las siguientes intervenciones: alertas de presentación y análisis de los datos DDD (dosis diaria definida) en las UCIs. CONCLUSIÓN: Se puede decir que el uso de alertas para los días de uso de antimicrobianos terapéuticos en CPOE asociado con la intervención educativa para las enfermedades infecciosas, la preservación de la autonomía del médico que prescribe fueron efectivos para reducir el consumo de antimicrobianos en un hospital privado de cuerpo clínico abierto.