Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos

Detalhes bibliográficos
Autor(a) principal: Pontes, Maria Araci de Andrade
Data de Publicação: 2015
Tipo de documento: Tese
Idioma: por
Título da fonte: Repositório Institucional da Universidade Federal do Ceará (UFC)
Texto Completo: http://www.repositorio.ufc.br/handle/riufc/13853
Resumo: Background: An open label randomized clinical trial to evaluate the effectiveness of an uniform six-months regimen to treat all leprosy patients (U-MDT/CT-BR) is being conducted in two national referral centers of the National Leprosy Control Program. Adding clofazimine to the current treatment for paucibacillary patients causes inquiry into possible increasing adverse effects to MDT. Objective: to describe the adverse effects due to MDT in patients who participated in the Randomized Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), comparing the incidence and severity between those who received uniform regimen (U-MDT) and those who received current WHO regimen (R-MDT). Patients and methods: patients were enrolled in the study from March 2007 to February 2012, and, after the operational classification, were randomly allocated in one group of the study. During treatment, they returned monthly for clinical and laboratorial evaluation, in order to monitor possible adverse effects. Results: 864 patients were included in the study. Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3%, and STGO/STGP above 40Ui/L in 27.3% e 27.7% of patients, respectively. Twenty four patients(2,8%) had dapsone interrupted due to adverse effects, from whom 16.6% for anemia. One case of sulfone syndrome was reported. No differences statically significant were found in adverse effects between the four arms of the study. Conclusions: The similarities in the adverse effects of MDT in all the arms of the study point to the viability of a six-month uniform regimen of treatment for all leprosy patients.
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spelling Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversosClinical study of uniform multidrug therapy for leprosy treatment in Brazil (U- MDT / CT -BR ) : a comparative study of adverse effectsHanseníaseQuimioterapia CombinadaEfeitos Colaterais e Reações Adversas Relacionados a MedicamentosBackground: An open label randomized clinical trial to evaluate the effectiveness of an uniform six-months regimen to treat all leprosy patients (U-MDT/CT-BR) is being conducted in two national referral centers of the National Leprosy Control Program. Adding clofazimine to the current treatment for paucibacillary patients causes inquiry into possible increasing adverse effects to MDT. Objective: to describe the adverse effects due to MDT in patients who participated in the Randomized Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), comparing the incidence and severity between those who received uniform regimen (U-MDT) and those who received current WHO regimen (R-MDT). Patients and methods: patients were enrolled in the study from March 2007 to February 2012, and, after the operational classification, were randomly allocated in one group of the study. During treatment, they returned monthly for clinical and laboratorial evaluation, in order to monitor possible adverse effects. Results: 864 patients were included in the study. Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3%, and STGO/STGP above 40Ui/L in 27.3% e 27.7% of patients, respectively. Twenty four patients(2,8%) had dapsone interrupted due to adverse effects, from whom 16.6% for anemia. One case of sulfone syndrome was reported. No differences statically significant were found in adverse effects between the four arms of the study. Conclusions: The similarities in the adverse effects of MDT in all the arms of the study point to the viability of a six-month uniform regimen of treatment for all leprosy patients.Introdução: Um estudo clinico aberto randomizado para avaliar a viabilidade de um esquema uniforme de 6 meses para tratar todos os pacientes de hanseníase (U-MDT/CT-BR) está sendo desenvolvido desde 2007 em dois centros de referência do Ministério da Saúde. A introdução da clofazimina na terapêutica dos pacientes paucibacilares causa questionamento quanto a possível aumento dos efeitos adversos à MDT. Objetivos: descrever os efeitos adversos secundários à MDT em pacientes que participam do Estudo Clinico Randomizado para Tratamento Uniforme de Multidrogaterapia para Hanseníase no Brasil (U-MDT/CT-BR), comparando sua incidência e gravidade entre os que receberam o esquema uniforme (U-MDT) e os que receberam o tratamento atual recomendado pela OMS (R-MDT). Pacientes e métodos: os pacientes foram recrutados de março de 2007 a fevereiro de 2012 e, após classificação operacional, alocados por randomização aleatória em um dos grupos do estudo. Durante o tratamento, retornaram mensalmente para avaliação clínica e laboratorial, visando o monitoramento de possíveis efeitos adversos. Resultados: foram incluídos 864 pacientes. Pigmentação cutânea (21,7%) e xerose (16,9%) foram as queixas mais frequentes. Os exames laboratoriais mostraram concentração de hemoglobina menor que 10g/dL em 23,3% dos pacientes, e TGO/ TGP acima de 40Ui/L em 27,3% e 27,7% dos pacientes, respectivamente. Vinte e quatro pacientes (2,8%) tiveram a dapsona suspensa por efeitos adversos, dos quais 16 (66,7%) por anemia. Houve um caso de síndrome da sulfona. Não houve diferenças significativas dos efeitos adversos nos quatro braços do estudo. Conclusão: A similaridade dos efeitos adversos à MDT nos quatro braços do estudo apontam para a viabilidade de um esquema uniforme de 6 meses para todos os pacientes de hanseníase.Moraes, Maria Elisabete Amaral dePontes, Maria Araci de Andrade2015-10-28T16:11:54Z2015-10-28T16:11:54Z2015-06-26info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisapplication/pdfPONTES, M. A. A. Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos. 2015. 106 f. Tese (Doutorado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2015.http://www.repositorio.ufc.br/handle/riufc/13853porreponame:Repositório Institucional da Universidade Federal do Ceará (UFC)instname:Universidade Federal do Ceará (UFC)instacron:UFCinfo:eu-repo/semantics/openAccess2019-10-24T17:49:09Zoai:repositorio.ufc.br:riufc/13853Repositório InstitucionalPUBhttp://www.repositorio.ufc.br/ri-oai/requestbu@ufc.br || repositorio@ufc.bropendoar:2024-09-11T18:39:11.944016Repositório Institucional da Universidade Federal do Ceará (UFC) - Universidade Federal do Ceará (UFC)false
dc.title.none.fl_str_mv Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
Clinical study of uniform multidrug therapy for leprosy treatment in Brazil (U- MDT / CT -BR ) : a comparative study of adverse effects
title Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
spellingShingle Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
Pontes, Maria Araci de Andrade
Hanseníase
Quimioterapia Combinada
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
title_short Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
title_full Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
title_fullStr Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
title_full_unstemmed Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
title_sort Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
author Pontes, Maria Araci de Andrade
author_facet Pontes, Maria Araci de Andrade
author_role author
dc.contributor.none.fl_str_mv Moraes, Maria Elisabete Amaral de
dc.contributor.author.fl_str_mv Pontes, Maria Araci de Andrade
dc.subject.por.fl_str_mv Hanseníase
Quimioterapia Combinada
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
topic Hanseníase
Quimioterapia Combinada
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
description Background: An open label randomized clinical trial to evaluate the effectiveness of an uniform six-months regimen to treat all leprosy patients (U-MDT/CT-BR) is being conducted in two national referral centers of the National Leprosy Control Program. Adding clofazimine to the current treatment for paucibacillary patients causes inquiry into possible increasing adverse effects to MDT. Objective: to describe the adverse effects due to MDT in patients who participated in the Randomized Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), comparing the incidence and severity between those who received uniform regimen (U-MDT) and those who received current WHO regimen (R-MDT). Patients and methods: patients were enrolled in the study from March 2007 to February 2012, and, after the operational classification, were randomly allocated in one group of the study. During treatment, they returned monthly for clinical and laboratorial evaluation, in order to monitor possible adverse effects. Results: 864 patients were included in the study. Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3%, and STGO/STGP above 40Ui/L in 27.3% e 27.7% of patients, respectively. Twenty four patients(2,8%) had dapsone interrupted due to adverse effects, from whom 16.6% for anemia. One case of sulfone syndrome was reported. No differences statically significant were found in adverse effects between the four arms of the study. Conclusions: The similarities in the adverse effects of MDT in all the arms of the study point to the viability of a six-month uniform regimen of treatment for all leprosy patients.
publishDate 2015
dc.date.none.fl_str_mv 2015-10-28T16:11:54Z
2015-10-28T16:11:54Z
2015-06-26
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/doctoralThesis
format doctoralThesis
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dc.identifier.uri.fl_str_mv PONTES, M. A. A. Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos. 2015. 106 f. Tese (Doutorado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2015.
http://www.repositorio.ufc.br/handle/riufc/13853
identifier_str_mv PONTES, M. A. A. Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos. 2015. 106 f. Tese (Doutorado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2015.
url http://www.repositorio.ufc.br/handle/riufc/13853
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dc.source.none.fl_str_mv reponame:Repositório Institucional da Universidade Federal do Ceará (UFC)
instname:Universidade Federal do Ceará (UFC)
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instname_str Universidade Federal do Ceará (UFC)
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