1. Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial.
- Author
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Mendes L, Guerra JO, Costa B, Silva ASD, Guerra MDGB, Ortiz J, Doria SS, Silva GVD, de Jesus DV, Barral-Netto M, Penna G, Carvalho EM, and Machado PRL
- Subjects
- Administration, Oral, Administration, Topical, Adolescent, Adult, Antiprotozoal Agents administration & dosage, Female, Granulocyte-Macrophage Colony-Stimulating Factor administration & dosage, Humans, Macrophage Colony-Stimulating Factor administration & dosage, Macrophage Colony-Stimulating Factor therapeutic use, Male, Meglumine Antimoniate administration & dosage, Middle Aged, Phosphorylcholine administration & dosage, Phosphorylcholine therapeutic use, Young Adult, Antiprotozoal Agents therapeutic use, Granulocyte-Macrophage Colony-Stimulating Factor therapeutic use, Leishmaniasis, Cutaneous drug therapy, Meglumine Antimoniate therapeutic use, Phosphorylcholine analogs & derivatives
- Abstract
Objectives: To compare topical granulocyte and macrophage colony-stimulating factor (GM-CSF) and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon., Design: A randomized and double-blinded clinical trial., Results: At 90 days after the initiation of therapy, the cure rates were 66%, 58%, and 52% for the groups P + M, G + M, and MA, respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group as compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups and arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia., Conclusions: Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, because of its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis. (Clinicaltrials.gov Identifier NCT03023111)., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2021
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