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Few therapeutic options are available for mucocutaneous leishmaniasis (MCL). We conducted a randomized open trial to evaluate the efficacy, safety, and tolerance of parenteral aminosidine sulphate (AS) 14 mg/kg/d for 21 days compared with intravenous meglumine antimonate (MA) 20 mg/kg/d for 28 days in patients with moderate MCL in Cuzco, Peru. Cure was defined as complete healing with re-epithelialization within 1 year of follow-up. The trial was stopped after 38 patients were enrolled (17 in the MA group and 21 in the AS group) because of marked differences in response. Study groups were comparable in baseline characteristics. Cure rates were 0/21 in the AS group compared with 8/17 (47%, 95% confidence interval: 2371%) in the MA group (P < 0.001). Side effects and laboratory abnormalities were mild in both groups. We conclude that parenteral AS given on its own is not effective for MCL in Peru.
Received January 23, 2007. Accepted for publication February 6, 2007.
Acknowledgments: We thank Julieta Tupayachi for providing technical support in conducting the study.
Financial support: This study was funded by a research grant from the UNDP/WOLRD Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) 930033.
Disclaimer: The authors disclosed no conflict of interest.
* Address correspondence to Carlos Seas, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100. E-mail: cseas{at}upch.edu.pe
Authors addresses: Alejandro Llanos-Cuentas, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100, Peru, Telephone: 51-1-4827739, Fax: 51-1-4823404, E-mail: allanos{at}upch.edu.pe. Juan Echevarria, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100, Peru, Telephone: 51-1-4823910, Fax: 51-1-4823404, E-mail: chito{at}upch.edu.pe. Carlos Seas, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100, Peru, Telephone: 51-1-4823910, Fax: 51-1-4823404, E-mail: cseas{at}upch.edu.pe. Elsa Chang, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100, Peru, Telephone: 51-1-4823910, Fax: 51-1-4823404, E-mail: echangb{at}hotmail.com. Maria Cruz, Departamento de Medicina del Hospital Nacional Sur Este-Essalud Cuzco, Perú, Av Juan Anselmo Alvares S/N, Wanchaq, Cuzco-Perú. Telephone/Fax: 51-84-234724, E-mail: mcruzvene{at}yahoo.com.arg. Eugenia Alvarez, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima AP 4314, Lima 100, Peru, Telephone: 51-1-4823910, Fax: 51-1-4823404, E-mail: eat{at}upch.edu.pe. Ernesto Rosales, Hospital Regional del Cuco, Cusco, Peru Jr. Tacna 886, Peru, Telephone: 511-2632549, Fax: 511-2632549, E-mail: ernestorosales{at}terra.com.pe. Pablo Campos, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru, Telephone: 51-1-3190000, Fax: 51-1-4823404, E-mail: pecampos{at}upch.edu.pe. Anthony Bryceson, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, Telephone: 44-1869-331027, Fax: 44-1869-331027, E-mail: a.bryceson{at}doctors.org.uk.
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