Although intralesional meglumine antimoniate (MA) infiltration is considered an
option for cutaneous leishmaniasis (CL) therapy and is widely used in the Old World,
there have been few studies supporting this therapeutic approach in the Americas.
This study aims to describe outcomes and adverse events associated with intralesional
therapy for CL. This retrospective study reviewed the experience of a Brazilian
leishmaniasis reference centre using intralesional MA to treat 31 patients over five
years (2008 and 2013). The median age was 63 years (22-86) and the median duration
time of the lesions up to treatment was 16 weeks. In 22 patients (71%), intralesional
therapy was indicated due to the presence of contraindications or previous serious
adverse events with systemic MA. Other indications were failure of systemic therapy
or ease of administration. Intralesional treatment consisted of one-six infiltrations
(median three) for a period of up to 12 weeks. The initial (three months) and
definitive (six months) cure rates were 70.9% and 67.7%, respectively. Most patients
reported mild discomfort during infiltration and no serious adverse events were
observed. In conclusion, these results show that the intralesional MA efficacy rate
was very similar to that of systemic MA treatment, and reinforce the need for further
studies with adequate design to establish the efficacy and safety of this therapeutic
approach.
BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL.METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations.RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).
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.
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