María F García-Bustos1,2,3, Gabriela González-Prieto3, Alberto E Paniz-Mondolfi4, Cecilia Parodi1, Josefina Beckar5, Sibila Monroig6, Federico Ramos1, María C Mora1, Lourdes A Delgado-Noguera7,8, Yoshihisa Hashiguchi9, Daniela Jaime10, Sonia Moreno11, Luisa Ruiz-Morales12, César G Lemir13, Alejandra Barrio3. 1. Instituto de Patología Experimental, Consejo Nacional de Investigaciones Científicas y Técnicas, Salta, Argentina. 2. Escuela Universitaria en Ciencias de la Salud, Universidad Católica de Salta, Salta, Argentina. 3. Facultad de Ciencias de la Salud, Universidad Nacional de Salta, Salta, Argentina. 4. Instituto de Investigaciones Biomédicas IDB, Departamento de Enfermedades Infecciosas y Medicina Tropical, Laboratorio de Patología de Enfermedades Infecciosas, Clínica IDB Cabudare, Cabudare, Venezuela. 5. Servicio de Otorrinolaringología, Hospital San Bernardo, Salta, Argentina. 6. Servicio de Otorrinolaringología, Hospital Papa Francisco, Salta, Argentina. 7. Leishmania Collaborative Network, Emerging Pathogens Division, The Venezuelan Science Incubator, Cabudare, Venezuela. 8. Decanato de Ciencias de la Salud, Universidad Centroccidental Lisandro Alvarado (UCLA), Barquisimeto, Venezuela. 9. Department of Parasitology, Kochi Medical School, Kochi University, Nankoku, Kochi, Japan. 10. Servicio de Dermatología, Hospital Joaquín Castellanos, Güemes, Salta, Argentina. 11. Servicio de Dermatología, Hospital Señor del Milagro, Salta, Argentina. 12. Servicio de Dermatología, Hospital San Bernardo, Salta, Argentina. 13. Servicio de Infectología, Hospital San Bernardo, Salta, Argentina.
Abstract
BACKGROUND: To date, there is no specific literature available on the determinants for therapeutic failure (TF) with meglumine antimoniate (MA) in Northwestern-Argentina. This study aimed to identify epidemiological, clinical, and treatment-related factors that could be involved in TF. METHODOLOGY/PRINCIPAL FINDINGS: We performed a case-control study. Cases were represented by patients who showed TF after administration of the first course of MA treatment, whereas, controls were determined as patients who evolved towards healing after the first MA cycle received. Crude Odds Ratios and their corresponding 90% confidence intervals (CI) were calculated, and risk factors were then tested by multivariate analysis using logistic binary regression. Three hundred and eighty-four patients with a presumptive diagnosis of ACL were recruited, and 153 with a positive diagnosis were selected. We included in the study 71 patients, who underwent specific treatment with MA, presented complete data on response to treatment, and had a minimum post-treatment follow-up of 6 months in cutaneous leishmaniasis, and 12 months in mucosal leishmaniasis. Of these, 34 (47.9%) presented TF. In the initial analysis, TF was significantly associated with the geographical area of disease acquisition (p = 0.036), the presence of mucosal lesions (p = 0.042), the presence of concomitant skin and mucosal lesions (p = 0.002), and lesion age ≥ 6 months (p = 0.018). Risk factors influencing TF in the final multivariate model included the geographical area where the disease was acquired (adjusted Odd Ratio 8.062; 95% CI 1.914-33.959; p = 0.004), and lesion age ≥ 6 months (adjusted Odd Ratio 10.037; 95% CI 1.383-72.843; p = 0.023). CONCLUSIONS/SIGNIFICANCE: The results of the present study suggest the existence of some risk factors linked to TF in Northwestern-Argentina, which deserve further investigation. Herein we recorded a high percentage of TF and we described clinical and epidemiological characteristics associated with TF that could be taken into account improving the clinical management of patients.
BACKGROUND: To date, there is no specific literature available on the determinants for therapeutic failure (TF) with meglumine antimoniate (MA) in Northwestern-Argentina. This study aimed to identify epidemiological, clinical, and treatment-related factors that could be involved in TF. METHODOLOGY/PRINCIPAL FINDINGS: We performed a case-control study. Cases were represented by patients who showed TF after administration of the first course of MA treatment, whereas, controls were determined as patients who evolved towards healing after the first MA cycle received. Crude Odds Ratios and their corresponding 90% confidence intervals (CI) were calculated, and risk factors were then tested by multivariate analysis using logistic binary regression. Three hundred and eighty-four patients with a presumptive diagnosis of ACL were recruited, and 153 with a positive diagnosis were selected. We included in the study 71 patients, who underwent specific treatment with MA, presented complete data on response to treatment, and had a minimum post-treatment follow-up of 6 months in cutaneous leishmaniasis, and 12 months in mucosal leishmaniasis. Of these, 34 (47.9%) presented TF. In the initial analysis, TF was significantly associated with the geographical area of disease acquisition (p = 0.036), the presence of mucosal lesions (p = 0.042), the presence of concomitant skin and mucosal lesions (p = 0.002), and lesion age ≥ 6 months (p = 0.018). Risk factors influencing TF in the final multivariate model included the geographical area where the disease was acquired (adjusted Odd Ratio 8.062; 95% CI 1.914-33.959; p = 0.004), and lesion age ≥ 6 months (adjusted Odd Ratio 10.037; 95% CI 1.383-72.843; p = 0.023). CONCLUSIONS/SIGNIFICANCE: The results of the present study suggest the existence of some risk factors linked to TF in Northwestern-Argentina, which deserve further investigation. Herein we recorded a high percentage of TF and we described clinical and epidemiological characteristics associated with TF that could be taken into account improving the clinical management of patients.
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