Título :	Estudo piloto randomizado e controlado, usando a Associação de Miltefosina e Pentoxfilina para avaliar a cura clinica e efeitos adversos no tratamento de pacientes com Leishmaniose Tegumentar Americana em Área Endemica de L. (V) braziliensis
Autor :	Martins, Sofia Sales
Orientador(es)::	Sampaio, Raimunda Nonata Ribeiro
Assunto::	Leishmaniose tegumentar americana Leishmaniose mucosa Leishmaniose cutânea Miltefosina Pentoxifilina Antimonial pentavalente
Fecha de publicación :	17-ago-2021
Data de defesa::	16-abr-2021
Citación :	MARTINS, Sofia Sales. Estudo piloto randomizado e controlado, usando a Associação de Miltefosina e Pentoxfilina para avaliar a cura clinica e efeitos adversos no tratamento de pacientes com Leishmaniose Tegumentar Americana em Área Endemica de L. (V) braziliensis. 2021. 125 f., il. Tese (Doutorado em Ciências da Saúde)—Universidade de Brasília, Brasília, 2021.
Abstract:	American tegumentary leishmaniasis (ATL) is endemic in Brazil and has a high impact in the country’s public health. Currently, the preconized treatments have elevated frequency of adverse effects (AE) and growing rates of therapeutic failure due to parasitological resistance. Objective: Evaluate the clinical cure and AE of the association of miltefosine and pentoxifylline (M+P) in comparison with the association of intravenous pentavalente antimonial and oral pentoxifylline in the treatment of ATL. Methods: A pilot open- label randomized clinical trial was conduct with ALT patients in two refence treatment center in the central-west region of Brazil. Patients randomized to the experimental group received 50mg of miltefosine twice a day and 400mg of pentoxifylline three times a day. Patients in the A+P group received 20mgSbV/kg/day up to 1215mg/day intravenously and 400mg of pentoxifylline three times a day. Patients with mucosal leishmaniasis (ML) received treatment for 28 days and patients with cutaneous leishmaniasis (CL) for 20 days. Cure was accessed 90 and 180 days after the begin of the treatment and patients were monitored for AD weekly while receiving treatment. Results: Forty-three patient were included, 25 with ML and 18 with CL. L. (V.) braziliensis was identified in all patients with positive PCR (40.9% in the M+P group and 57.14% in the A+P group). The frequency of AE was higher in the A+P group both in the univariate (p=0.003) and the multivariate analysis (p=0.0322). The frequency of treatment interruption due to severe AE was also higher in the A+P group (p=0.027). Patient with CL had a 7.73 times higher risk of cure than patients with ML (p=0.0425) and also a 10.32 times higher risk of AE (p=0.0330). There was no difference between the risk of cure in both treatment groups (p=0.0589). Conclusion: In this pilot randomized clinical trial the M+P treatment had similar cure risk compared to the A+P treatment with lower risk of AE. More studies with higher number of patient and longer follow up are recommended.
metadata.dc.description.unidade:	Faculdade de Ciências da Saúde (FS)
Descripción :	Tese (Doutorado)—Universidade de Brasília, Faculdade de Ciências da Saúde, Programa de Pós-Graduação em Ciências Da Saúde, 2021.
metadata.dc.description.ppg:	Programa de Pós-Graduação em Ciências da Saúde
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