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2030-12-31
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- INI - Artigos de Periódicos [3460]
- MG - IRR - Artigos de Periódicos [4112]
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A RANDOMIZED, CONTROLLED, NONINFERIORITY, MULTICENTER TRIAL OF SYSTEMIC VS INTRALESIONAL TREATMENT WITH MEGLUMINE ANTIMONIATE FOR CUTANEOUS LEISHMANIASIS IN BRAZIL
Author
Lyra, Marcelo R.
Oliveira, Liliane F. A.
Schubach, Armando O.
Sampaio, Raimunda N. R.
Rodrigues, Bruna C.
Hueb, Marcia
Cota, Gláucia
Silva, Rosiana E.
Francesconi, Fabio
Pompilio, Maurício A.
França, Adriana O.
Amato, Valdir S.
Souza, Regina M.
Oliveira, Raquel V. C.
Valete, Cláudia M.
Pimentel, Maria I. F.
Oliveira, Liliane F. A.
Schubach, Armando O.
Sampaio, Raimunda N. R.
Rodrigues, Bruna C.
Hueb, Marcia
Cota, Gláucia
Silva, Rosiana E.
Francesconi, Fabio
Pompilio, Maurício A.
França, Adriana O.
Amato, Valdir S.
Souza, Regina M.
Oliveira, Raquel V. C.
Valete, Cláudia M.
Pimentel, Maria I. F.
Affilliation
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil.
University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil.
Federal University of Mato Grosso. Julio Muller University Hospital. Internal Medicine Department. Cuiabá, MT, Brazil.
Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil.
Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil.
Heitor Vieira Dourado Tropical Medicine Foundation. Dermatology Department. Manaus, AM, Brazil / Federal University of Amazonas. Dermatology Department. Manaus, AM, Brazil.
Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil.
Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil.
University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil.
University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Epidemiology. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil / Federal University of Rio de Janeiro. Faculty of Medicine. Department of Otorhinolaryngology and Ophthalmology. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil.
University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil.
Federal University of Mato Grosso. Julio Muller University Hospital. Internal Medicine Department. Cuiabá, MT, Brazil.
Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil.
Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil.
Heitor Vieira Dourado Tropical Medicine Foundation. Dermatology Department. Manaus, AM, Brazil / Federal University of Amazonas. Dermatology Department. Manaus, AM, Brazil.
Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil.
Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil.
University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil.
University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Epidemiology. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil / Federal University of Rio de Janeiro. Faculty of Medicine. Department of Otorhinolaryngology and Ophthalmology. Rio de Janeiro, RJ, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil.
Abstract
Background: Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL). Uncontrolled studies suggest that intralesional MA (IL-MA) may be noninferior and safer than systemic MA (S-MA). Methods: Multicenter, randomized, controlled, open-label, phase 3 clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared with S-MA (10-20 mg Sb5+/kg/day, 20 days) for CL, with noninferiority margin of 20%. Primary and secondary outcomes were definitive cure at day 180 and epithelialization rate at day 90 of treatment, respectively. A 2-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AEs) were monitored according to the Division of AIDS AE grading system. Results: We evaluated 135 patients. The cure rates (95% confidence interval) for IL-MA and S-MA treatment were, respectively, 82.8% (70.5-91.4) and 67.8% (53.3-78.3) per protocol (PP) and 70.6% (58.3-81.0) and 59.7% (47.0-71.5) per intention to treat (ITT). The epithelialization rates of the IL-MA and S-MA treatment were, respectively, 79.3% (66.6-88 + 8) and 71.2% (57.9-82.2) PP and 69.1% (55.2-78.5) and 64.2% (50.0-74.2) ITT. AEs in the IL-MA and S-MA groups were, respectively, clinical, 45.6% and 80.6%; laboratory, 26.5% and 73.1%; and electrocardiogram, 8.8% and 25.4%. Ten participants in the S-MA group and 1 in the IL-MA group were discontinued due to severe or persistent AEs. Conclusions: IL-MA provides a similar cure rate and results in less toxicity compared with S-MA and may be used as first-line therapy for CL patients.
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