Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2018 |
| Outros Autores: | , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/41147 |
Resumo: | DECIT/MS/CNPq |
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Cruz, RossileneBührer-Sékula, SamiraPenna, Gerson OliveiraMoraes, Maria Elisabete Amaral deGonçalves, Heitor de SáStefani, Mariane Martins de AraújoPenna, Maria Lucia FernandesPontes, Maria Araci de AndradeTalhari, Sinésio2020-05-07T15:04:07Z2020-05-07T15:04:07Z2018CRUZ, 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. 2018.1806-4841https://www.arca.fiocruz.br/handle/icict/4114710.1590/abd1806-4841.20186709DECIT/MS/CNPqFundação 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.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.Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil / Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil.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.Centro de Dermatologia Dona Libânia. Ambulatório de Dermatologia. Fortaleza, CE, Brasil.Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Goiânia, GO, Brasil.Universidade Federal Fluminense. Departamento de Epidemiologia e Estatística. Niterói, RJ, Brasil.Centro de Dermatologia Dona Libânia. Ambulatório de Dermatologia. Fortaleza, CE, Brasil.Universidade Nilton Linsm, Manaus, AM, Brasil / Universidade do Estado do Amazonas. Fundação de Medicina Tropical. Programa de Pós-Graduação. Manaus, AM, Brasil.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.engSociedade Brasileira de DermatologiaClofazimineDapsoneDrug Therapy, CombinationHemoglobinsLeprostatic AgentsLeprosyRifampinRisk FactorsTreatment OutcomeDrug MonitoringCommunicable DiseasesNeglected DiseasesAbnormalitiesDrug-inducedDrug monitoringLeprosyTherapeuticsHanseníaseEfeitos Colaterais e Reações Adversas Relacionados a MedicamentosMonitoramento de MedicamentosResultado do TratamentoDoenças TransmissíveisDoenças NegligenciadasClinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approachinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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| dc.title.pt_BR.fl_str_mv |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| title |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| spellingShingle |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach Cruz, Rossilene Clofazimine Dapsone Drug Therapy, Combination Hemoglobins Leprostatic Agents Leprosy Rifampin Risk Factors Treatment Outcome Drug Monitoring Communicable Diseases Neglected Diseases Abnormalities Drug-induced Drug monitoring Leprosy Therapeutics Hanseníase Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento de Medicamentos Resultado do Tratamento Doenças Transmissíveis Doenças Negligenciadas |
| title_short |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| title_full |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| title_fullStr |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| title_full_unstemmed |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| title_sort |
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach |
| author |
Cruz, Rossilene |
| author_facet |
Cruz, Rossilene Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lucia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| author_role |
author |
| author2 |
Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lucia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| author2_role |
author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Cruz, Rossilene Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lucia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| dc.subject.mesh.pt_BR.fl_str_mv |
Clofazimine Dapsone Drug Therapy, Combination Hemoglobins Leprostatic Agents Leprosy Rifampin Risk Factors Treatment Outcome Drug Monitoring Communicable Diseases Neglected Diseases |
| topic |
Clofazimine Dapsone Drug Therapy, Combination Hemoglobins Leprostatic Agents Leprosy Rifampin Risk Factors Treatment Outcome Drug Monitoring Communicable Diseases Neglected Diseases Abnormalities Drug-induced Drug monitoring Leprosy Therapeutics Hanseníase Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento de Medicamentos Resultado do Tratamento Doenças Transmissíveis Doenças Negligenciadas |
| dc.subject.en.pt_BR.fl_str_mv |
Abnormalities Drug-induced Drug monitoring Leprosy Therapeutics |
| dc.subject.decs.pt_BR.fl_str_mv |
Hanseníase Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Monitoramento de Medicamentos Resultado do Tratamento Doenças Transmissíveis Doenças Negligenciadas |
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DECIT/MS/CNPq |
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2018 |
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2018 |
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2020-05-07T15:04:07Z |
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2020-05-07T15:04:07Z |
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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. |
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https://www.arca.fiocruz.br/handle/icict/41147 |
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1806-4841 |
| dc.identifier.doi.none.fl_str_mv |
10.1590/abd1806-4841.20186709 |
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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. 1806-4841 10.1590/abd1806-4841.20186709 |
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Sociedade Brasileira de Dermatologia |
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Sociedade Brasileira de Dermatologia |
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