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Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment
Silva, Rosiana Estéfane da; Pina Carvalho, Janaína de; Ramalho, Dario Brock; Senna, Maria Camilo Ribeiro de; Moreira, Hugo Silva Assis; Rabello, Ana; Cota, Erika & Cota, Gláucia
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.
Keywords
cutaneous leishmaniasis - therapy - meglumine antimoniate - intralesional infiltration - validation
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