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Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial.
Lago, Tainã; Peixoto, Fábio; Mambelli, Fábio; Carvalho, Lucas P; Guimarães, Luiz Henrique; Carvalho, Augusto M; Cardoso, Luciana; Machado, Paulo R L; Scott, Phillip; Lago, Jamile; Andrade, Juvana M; Fahel, Júlia S; Oliveira, Sérgio C; Carvalho, Edgar M.
Afiliação
  • Lago T; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; Post Graduate Program of Health Sciences, Federal University of Bahia, Salvador, Bahia, Brazil.
  • Peixoto F; Gonçalo Moniz Institute, Fiocruz, Salvador, Bahia, Brazil.
  • Mambelli F; Federal University of Minas Gerais, Belo Horizonte, Brazil.
  • Carvalho LP; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; Post Graduate Program of Health Sciences, Federal University of Bahia, Salvador, Bahia, Brazil; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Minist
  • Guimarães LH; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Brazil; Federal University of the Recôncavo da Bahia, Cruz das Almas, Bahia, Brazil.
  • Carvalho AM; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Brazil; Gonçalo Moniz Institute, Fiocruz, Salvador, Bahia, Brazil.
  • Cardoso L; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Bra
  • Machado PRL; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Bra
  • Scott P; Department of Pathobiology, School of Veterinary Medicine, University of Pennsylvania, PA, USA.
  • Lago J; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; Post Graduate Program of Health Sciences, Federal University of Bahia, Salvador, Bahia, Brazil.
  • Andrade JM; Federal University of Minas Gerais, Belo Horizonte, Brazil.
  • Fahel JS; Federal University of Minas Gerais, Belo Horizonte, Brazil.
  • Oliveira SC; Federal University of Minas Gerais, Belo Horizonte, Brazil; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Brazil; University of São Paulo, São Paulo, Brazil.
  • Carvalho EM; Immunology Service of University Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Bahia, Brazil; National Institute of Science and Technology of Tropical Diseases (INCT-DT), Ministry of Science, Technology, Innovations and Communications, CNPq, Brasília, Distrito Federal, Bra
Int J Infect Dis ; 147: 107206, 2024 Aug 13.
Article em En | MEDLINE | ID: mdl-39147194
ABSTRACT

BACKGROUND:

Cutaneous leishmaniasis (CL) caused by Leishmania (Viannia) braziliensis is associated with an inflammatory response. Granzyme (GzmB) and IL-1ß play a key role in the pathology. Meglumine antimoniate (MA) is the first-choice drug for the treatment of CL, but therapy failure is observed in up to 50% of the cases. The protein, rSm29 of Schistosoma mansoni, down-modulates pro-inflammatory cytokine production. We evaluate if the combination of topical rSm29 plus MA increases the cure rate of CL.

METHODS:

In this randomized clinical trial, 91 CL patients were allocated in 3 groups. All cases received MA (20 mg/kg/weight) for 20 days. Group 1 used topical rSm29 (10 µg), group 2 a placebo topically applied, and group 3 received only MA.

RESULTS:

The cure rate on day 90 was 71% in subjects treated with rSm29 plus MA, and 43% in patients who received MA plus placebo or MA alone (P < 0.05). There was a decrease in GzmB and an increase in IFN-γ (P < 0.05) in supernatants of skin biopsies of the lesions obtained on D7 of therapy (P < 0.05) in patients who received rSm29.

CONCLUSION:

rSm29 associated with MA reduces GzmB levels, is more effective than MA alone, and decreases CL healing time. CLINICAL TRIALS REGISTRATION ClinicalTrial.gov under NCT06000514.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Int J Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Canadá
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Int J Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Canadá