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dc.contributor.authorSampaio, Raimunda Nonata Ribeiropt_BR
dc.contributor.authorSilva, Juliana Saboia Fontenele ept_BR
dc.contributor.authorPaula, Carmen Dea Ribeiro dept_BR
dc.contributor.authorPorto, Cláudiapt_BR
dc.contributor.authorMotta, Jorgeth de Oliveira Carneiro dapt_BR
dc.contributor.authorPereira, Ledice Inacia de Araujopt_BR
dc.contributor.authorMartins, Sofia Salespt_BR
dc.contributor.authorBarroso, Daniel Holandapt_BR
dc.contributor.authorFreire, Gustavo Subtil Magalhãespt_BR
dc.contributor.authorGomes, Ciro Martinspt_BR
dc.date.accessioned2020-01-24T10:29:59Z-
dc.date.available2020-01-24T10:29:59Z-
dc.date.issued2019pt_BR
dc.identifier.citationSAMPAIO, Raimunda Nonata Ribeiro et al. A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis. Revista da Sociedade Brasileira de Medicina Tropical. v. 52, e20180292, 2019. DOI: https://doi.org/10.1590/0037-8682-0292-2018. Disponível em: http://scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822019000100315. Acesso em: 23 janeiro 2020.pt_BR
dc.identifier.urihttps://repositorio.unb.br/handle/10482/36245-
dc.language.isoenpt_BR
dc.publisherSociedade Brasileira de Medicina Tropical - SBMTpt_BR
dc.rightsAcesso Abertopt_BR
dc.titleA randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasispt_BR
dc.typeArtigopt_BR
dc.subject.keywordLeishmaniosept_BR
dc.subject.keywordLeishmaniose tegumentar americanapt_BR
dc.subject.keywordEnsaios clínicospt_BR
dc.subject.keywordTerapêuticapt_BR
dc.subject.keywordMedicamentospt_BR
dc.rights.licenseOPEN ACCESS - https://creativecommons.org/licenses/by/4.0/. (CC BY).-
dc.identifier.doihttps://doi.org/10.1590/0037-8682-0292-2018pt_BR
dc.description.abstract1INTRODUCTION: The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study. METHODS: We performed a randomized clinical trial with two parallel groups. The tested intervention consisted of miltefosine 1.3-2 mg/kg/day (two capsules) for 28 days or intravenous 20 mg SbV/kg/day of meglumine antimoniate (N-MA) for 30 days. The final endpoint was defined as complete healing of the lesion four years after treatment. We also analyzed an early endpoint at 90 days after treatment. RESULTS: Forty patients were included in this study: each experimental group comprised 20 patients. Applying a multivariate model in an intention-to-treat analysis, we observed that patients treated with miltefosine had a cure probability 2.08 times greater (95% confidence interval [CI] = 1.03-4.18) than those treated with N-MA at 90 days after treatment. At the final endpoint, we observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33-1.32). With respect to adverse reactions, significant differences between groups were related to gastrointestinal effects, which were more frequent in the miltefosine group. CONCLUSIONS: Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up.-
dc.identifier.orcidhttp://orcid.org/0000-0002-8223-0058-
dc.description.unidadeFaculdade de Medicina (FMD)-
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