Author | Silva, Rosiana Estéfane da | |
Author | Carvalho, Janaína de Pina | |
Author | Ramalho, Dario Brock | |
Author | Senna, Maria Camilo Ribeiro De | |
Author | Moreira, Hugo Silva Assis | |
Author | Rabello, Ana Lúcia Teles | |
Author | Cota, Érika | |
Author | Cota, Gláucia Fernandes | |
Access date | 2018-03-07T17:17:25Z | |
Available date | 2018-03-07T17:17:25Z | |
Document date | 2018 | |
Citation | SILVA, Rosiana Estéfane da et al. Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 2, p. 71-79, 2018. | pt_BR |
ISSN | 0074-0276 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/25172 | |
Language | eng | pt_BR |
Publisher | Fundação Oswaldo Cruz | pt_BR |
Rights | open access | pt_BR |
Subject in Portuguese | Leishmaniose Cutânea | pt_BR |
Subject in Portuguese | Terapia | pt_BR |
Subject in Portuguese | Antimoniato de Meglumina | pt_BR |
Subject in Portuguese | Infiltração Intralesional | pt_BR |
Subject in Portuguese | Validação | pt_BR |
Title | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment | pt_BR |
Type | Article | pt_BR |
DOI | 10.1590/0074-027601700125 | |
Abstract | BACKGROUND: Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES: This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS: The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed. FINDINGS: The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result. CONCLUSIONS: The procedure is reproducible and can be used by professionals without previous training with high success and safety rates. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Affilliation | Universidade Federal do Rio Grande do Sul. Instituto de Informática. Porto Alegre, RS, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil. | pt_BR |
Subject | Cutaneous leishmaniasis | pt_BR |
Subject | Therapy | pt_BR |
Subject | Meglumine antimoniate | pt_BR |
Subject | Intralesional infiltration | pt_BR |
Subject | Validation | pt_BR |