Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach
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| Publication Date: | 2018 |
| Andre forfattere: | , , , , , , , |
| Format: | Article |
| Sprog: | eng |
| Source: | Repositório Institucional da UnB |
| Download full: | http://repositorio.unb.br/handle/10482/33503 http://dx.doi.org/10.1590/abd1806-4841.20186709 |
Summary: | 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. |
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| author | Cruz, Rossilene Conceição da Silva |
| author2 | Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lúcia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| author2_role | author author author author author author author author |
| author_browse | Bührer-Sékula, Samira Cruz, Rossilene Conceição da Silva Gonçalves, Heitor de Sá Moraes, Maria Elisabete Amaral de Penna, Gerson Oliveira Penna, Maria Lúcia Fernandes Pontes, Maria Araci de Andrade Stefani, Mariane Martins de Araújo Talhari, Sinésio |
| author_facet | Cruz, Rossilene Conceição da Silva Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lúcia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| author_role | author |
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| bitstream.checksumAlgorithm.fl_str_mv | MD5 |
| bitstream.url.fl_str_mv | http://repositorio.unb.br/bitstream/10482/33503/1/ARTIGO_ClinicalTrialUniform.pdf |
| collection | Repositório Institucional da UnB |
| dc.contributor.author.fl_str_mv | Cruz, Rossilene Conceição da Silva Bührer-Sékula, Samira Penna, Gerson Oliveira Moraes, Maria Elisabete Amaral de Gonçalves, Heitor de Sá Stefani, Mariane Martins de Araújo Penna, Maria Lúcia Fernandes Pontes, Maria Araci de Andrade Talhari, Sinésio |
| dc.date.accessioned.fl_str_mv | 2019-01-02T13:52:47Z |
| dc.date.available.fl_str_mv | 2019-01-02T13:52:47Z |
| dc.date.issued.fl_str_mv | 2018 |
| dc.identifier.citation.fl_str_mv | 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. DOI: http://dx.doi.org/10.1590/abd1806-4841.20186709. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962018000300377&lng=en&nrm=iso. Acesso em: 12 abr. 2019. |
| dc.identifier.doi.pt_BR.fl_str_mv | http://dx.doi.org/10.1590/abd1806-4841.20186709 |
| dc.identifier.uri.fl_str_mv | http://repositorio.unb.br/handle/10482/33503 |
| dc.language.iso.fl_str_mv | eng |
| dc.publisher.none.fl_str_mv | Sociedade Brasileira de Dermatologia |
| dc.rights.driver.fl_str_mv | info:eu-repo/semantics/openAccess |
| dc.source.none.fl_str_mv | reponame:Repositório Institucional da UnB instname:Universidade de Brasília (UnB) instacron:UNB |
| dc.subject.keyword.pt_BR.fl_str_mv | Drogas Hanseníase Terapêutica |
| 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 |
| dc.type.driver.fl_str_mv | info:eu-repo/semantics/article |
| dc.type.status.fl_str_mv | info:eu-repo/semantics/publishedVersion |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | UNB_ecbb3a549e5ac2a38c3d48fa0ee8f3a5 |
| identifier_str_mv | 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. DOI: http://dx.doi.org/10.1590/abd1806-4841.20186709. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962018000300377&lng=en&nrm=iso. Acesso em: 12 abr. 2019. |
| instacron_str | UNB |
| institution | UNB |
| instname_str | Universidade de Brasília (UnB) |
| language | eng |
| network_acronym_str | UNB |
| network_name_str | Repositório Institucional da UnB |
| oai_identifier_str | oai:repositorio.unb.br:10482/33503 |
| publishDate | 2018 |
| publishDateSort | 2018 |
| publisher.none.fl_str_mv | Sociedade Brasileira de Dermatologia |
| reponame_str | Repositório Institucional da UnB |
| repository.mail.fl_str_mv | repositorio@unb.br |
| repository.name.fl_str_mv | Repositório Institucional da UnB - Universidade de Brasília (UnB) |
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| spelling | Cruz, Rossilene Conceição da SilvaBührer-Sékula, SamiraPenna, Gerson OliveiraMoraes, Maria Elisabete Amaral deGonçalves, Heitor de SáStefani, Mariane Martins de AraújoPenna, Maria Lúcia FernandesPontes, Maria Araci de AndradeTalhari, Sinésio2019-01-02T13:52:47Z2019-01-02T13:52:47Z2018CRUZ, 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. DOI: http://dx.doi.org/10.1590/abd1806-4841.20186709. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962018000300377&lng=en&nrm=iso. Acesso em: 12 abr. 2019.http://repositorio.unb.br/handle/10482/33503http://dx.doi.org/10.1590/abd1806-4841.20186709Sociedade Brasileira de DermatologiaAnais Brasileiros de Dermatologia - (CC BY NC) - This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial License which permits unrestricted noncommercial use, distribution, and reproduction in any medium provided the original work is properly cited. Fonte: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962018000300377&lng=en&nrm=iso. Acesso em: 12 abr. 2019.info:eu-repo/semantics/openAccessClinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approachinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleDrogasHanseníaseTerapêuticaBACKGROUND: 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.Faculdade de Medicina (FM)engreponame:Repositório Institucional da UnBinstname:Universidade de Brasília (UnB)instacron:UNBORIGINALARTIGO_ClinicalTrialUniform.pdfapplication/pdf473388http://repositorio.unb.br/bitstream/10482/33503/1/ARTIGO_ClinicalTrialUniform.pdf7f8dde2612c8ef6cd0a412ea88f8cb92MD51open access10482/335032025-01-14 12:50:05.51open accessoai:repositorio.unb.br:10482/33503Repositório InstitucionalPUBhttps://repositorio.unb.br/oai/requestrepositorio@unb.bropendoar:2025-01-14T15:50:05Repositório Institucional da UnB - Universidade de Brasília (UnB) |
| spellingShingle | Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach Cruz, Rossilene Conceição da Silva Drogas Hanseníase Terapêutica |
| status_str | publishedVersion |
| title | 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_short | 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 |
| topic | Drogas Hanseníase Terapêutica |
| url | http://repositorio.unb.br/handle/10482/33503 http://dx.doi.org/10.1590/abd1806-4841.20186709 |