Author | Cruz, Rossilene | |
Author | Bührer-Sékula, Samira | |
Author | Penna, Gerson Oliveira | |
Author | Moraes, Maria Elisabete Amaral de | |
Author | Gonçalves, Heitor de Sá | |
Author | Stefani, Mariane Martins de Araújo | |
Author | Penna, Maria Lucia Fernandes | |
Author | Pontes, Maria Araci de Andrade | |
Author | Talhari, Sinésio | |
Access date | 2020-05-07T15:04:07Z | |
Available date | 2020-05-07T15:04:07Z | |
Document date | 2018 | |
Citation | CRUZ, Rossilene Conceição da Silva et al. Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach. Anais Brasileiros de Dermatologia, Rio de Janeiro, v.93, n.3, p. 377-384, maio/jun. 2018. | pt_BR |
ISSN | 1806-4841 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/41147 | |
Sponsorship | DECIT/MS/CNPq | pt_BR |
Language | eng | pt_BR |
Publisher | Sociedade Brasileira de Dermatologia | pt_BR |
Rights | open access | pt_BR |
MeSH | Clofazimine | pt_BR |
MeSH | Dapsone | pt_BR |
MeSH | Drug Therapy, Combination | pt_BR |
MeSH | Hemoglobins | pt_BR |
MeSH | Leprostatic Agents | pt_BR |
MeSH | Leprosy | pt_BR |
MeSH | Rifampin | pt_BR |
MeSH | Risk Factors | pt_BR |
MeSH | Treatment Outcome | pt_BR |
MeSH | Drug Monitoring | pt_BR |
MeSH | Communicable Diseases | pt_BR |
MeSH | Neglected Diseases | pt_BR |
Title | Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach | pt_BR |
Type | Article | pt_BR |
DOI | 10.1590/abd1806-4841.20186709 | |
Abstract | BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). Patients and methods: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients. | pt_BR |
Affilliation | Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Fundação de Medicina Tropical. Programa de Pós-Graduação. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Programa de Pós-Graduação em Medicina Tropical. Goiânia, GO, Brasil / Universidade do Estado do Amazonas. Fundação de Medicina Tropical. Programa de Pós-Graduação. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil / Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. | pt_BR |
Affilliation | Universidade Federal do Ceará. Unidade de Farmacologia Clínica. Fortaleza, CE, Brasil / Universidade Federal do Ceará. Faculdade de Medicina. Departamento de Fisiologia e Farmacologia. Programa de Pós-Graduação em Farmacologia. Fortaleza, CE, Brasil. | pt_BR |
Affilliation | Centro de Dermatologia Dona Libânia. Ambulatório de Dermatologia. Fortaleza, CE, Brasil. | pt_BR |
Affilliation | Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Goiânia, GO, Brasil. | pt_BR |
Affilliation | Universidade Federal Fluminense. Departamento de Epidemiologia e Estatística. Niterói, RJ, Brasil. | pt_BR |
Affilliation | Centro de Dermatologia Dona Libânia. Ambulatório de Dermatologia. Fortaleza, CE, Brasil. | pt_BR |
Affilliation | Universidade Nilton Linsm, Manaus, AM, Brasil / Universidade do Estado do Amazonas. Fundação de Medicina Tropical. Programa de Pós-Graduação. Manaus, AM, Brasil. | pt_BR |
Subject | Abnormalities | pt_BR |
Subject | Drug-induced | pt_BR |
Subject | Drug monitoring | pt_BR |
Subject | Leprosy | pt_BR |
Subject | Therapeutics | pt_BR |
DeCS | Hanseníase | pt_BR |
DeCS | Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos | pt_BR |
DeCS | Monitoramento de Medicamentos | pt_BR |
DeCS | Resultado do Tratamento | pt_BR |
DeCS | Doenças Transmissíveis | pt_BR |
DeCS | Doenças Negligenciadas | pt_BR |