Estudo clinico de multidrogaterapia uniforme para o tratamento da hanseníase no Brasil (U-MDT/CT-BR): estudo comparativo dos efeitos adversos
Autor(a) principal: | |
---|---|
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. |
id |
UFC-7_2013412db351593cdeaf6bb94cd21888 |
---|---|
oai_identifier_str |
oai:repositorio.ufc.br:riufc/13853 |
network_acronym_str |
UFC-7 |
network_name_str |
Repositório Institucional da Universidade Federal do Ceará (UFC) |
repository_id_str |
|
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 |
status_str |
publishedVersion |
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 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da Universidade Federal do Ceará (UFC) instname:Universidade Federal do Ceará (UFC) instacron:UFC |
instname_str |
Universidade Federal do Ceará (UFC) |
instacron_str |
UFC |
institution |
UFC |
reponame_str |
Repositório Institucional da Universidade Federal do Ceará (UFC) |
collection |
Repositório Institucional da Universidade Federal do Ceará (UFC) |
repository.name.fl_str_mv |
Repositório Institucional da Universidade Federal do Ceará (UFC) - Universidade Federal do Ceará (UFC) |
repository.mail.fl_str_mv |
bu@ufc.br || repositorio@ufc.br |
_version_ |
1813028892696379392 |