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3100-12-31
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SAFETY PROFILE OF MEGLUMINE ANTIMONIATE INTRALESIONAL INFILTRATION FOR CUTANEOUS LEISHMANIASIS.
antimony
intralesional infiltration
safety
toxicity
Autor
Afiliación
Fundação Oswaldo Cruz. Instituto René Rachou. Grupo de Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brazil.
Fundação Oswaldo Cruz. Instituto René Rachou. Grupo de Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brazil.
Estado de Minas Gerais. Fundação Hospitalar. Hospital Eduardo de Menezes. Departamento de Doenças Infecciosas. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Departamento de Ciências Farmacêuticas. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Departamento de Ciências Farmacêuticas. Belo Horizonte, MG, Brazil.
Fundação Oswaldo Cruz. Instituto René Rachou. Grupo de Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brazil.
Fundação Oswaldo Cruz. Instituto René Rachou. Grupo de Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brazil.
Estado de Minas Gerais. Fundação Hospitalar. Hospital Eduardo de Menezes. Departamento de Doenças Infecciosas. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Departamento de Ciências Farmacêuticas. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Departamento de Ciências Farmacêuticas. Belo Horizonte, MG, Brazil.
Fundação Oswaldo Cruz. Instituto René Rachou. Grupo de Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brazil.
Resumen en ingles
Objectives: Cutaneous leishmaniasis is a neglected disease, associated with high morbidity, which is partially due to the toxicity of available therapies. The pentavalent antimonial derivatives intralesional infiltration has proven to be as effective as the intravenous drug-based therapy, however, there is a lack of robust safety data.Methods: Phase II, uncontrolled, unicenter clinical trial to assess the safety profile of a standardized meglumine antimionate intralesional therapy, based on weekly infiltrations.Results: Fifty-three patients were studied, predominantly men (60%) and young adults (43.7 ± 17.1 years). Overall, 86.9% of the patients had at least one clinical adverse event. Local events were the most frequent (83%), followed by systemic ones (47.3%). Fourteen participants (26%) presented biochemical abnormalities. In all cases, laboratorial alterations were classified as mild and treatment discontinuation was not required. Differently, the two hypersensitivity (3.8%) reactions observed led to permanent treatment interruption. QTc interval prolongation was recorded in 14 patients (25.5%). The following risk associations to adverse events were identified in the multiple analysis: hypertension with systemic clinical events and smoking with QT interval prolongation.Expert commentary: In general, MA-IL was well tolerated and although associated with local and systemic adverse events, there was a low risk of high intensity or severe complications.
Palabras clave en ingles
Cutaneous leishmaniasisantimony
intralesional infiltration
safety
toxicity
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