Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Abstract

BACKGROUNDDespite 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.OBJECTIVESThis 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.METHODSThe 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.FINDINGSThe 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.CONCLUSIONSThe procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis

“…Some studies showed that lesions located on the lower limbs needed more time to heal, and venous stasis may be a delaying factor ( Schubach et al, 2005 ; Silva et al, 2018 ). Although the rate of lower limb lesions was not different between groups, patients in the IL-MA group with lesions on the lower limbs had a lower rate of cure than patients with upper limbs lesions.…”

The Influence of Infection by Different Leishmania (Viannia) braziliensis Isolates on the Pathogenesis of Disseminated Leishmaniasis

“…Parasite factors are also known to influence the pathogenesis of leishmaniasis. As L. (V.) braziliensis is polymorphic, dissimilarity among strains at locus CHR 28/425451 or CHR 32/1356278 has been associated with different clinical forms of disease, as well as failure to antimonial therapy (Queiroz et al, 2012;Guimaraes et al, 2016;Silva et al, 2018). Supporting the notion that differences among same-species of leishmania may influence immune response, SLA prepared using L. (V.) braziliensis isolates from DL patients was found to induce higher TNF production in mononuclear cells from both CL and DL patients than SLA similarly prepared using isolates of L. (V.) braziliensis obtained from CL patients (Leopoldo et al, 2006).…”

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

“…On the other hand, for the intralesional therapeutic modality, one of the main difficulties for comparing different studies is the lack of standardisation of the procedure, not only for the therapeutic regimen but the technique itself. Facing the few detailed descriptions available for the technique in the literature, we recently published a standardisation of the intralesional infiltration procedure and its validation, the protocol that was followed in this study 8 . Even so, one of the issues still to be defined is the best dosing schedule.…”

“…Intervention - The experimental therapeutic intervention consisted of weekly (7 ± 3 days) intralesional infiltration of MA following a previously validated standardised technique 8 ( Fig. 1 ).…”