Aplicación Intralesional de Antimoniales en el Tratamiento de Leishmaniasis Cutánea

Abstract

Objetivo: evaluar la eficacia clínica de la aplicación intralesional de 3 versus, 6 inyecciones de Glucantime®, durante una o dos semanas en pacientes con leishmaniasis cutánea. Métodos: estudio de tipo cuasi experimental. Se incluyó a 41 pacientes con leishmaniasis cutánea del área endémica tropical de Cochabamba, Bolivia. Los pacientes, fueron distribuidos aleatoriamente para recibir tratamiento intralesional con Glucantime®, en tres o seis aplicaciones. Todos ellos firmaron un consentimiento escrito de aceptación voluntaria de participar del estudio, que cuenta con el aval del comité de ética de la facultad de medicina UMSS. Resultados: la evaluación realizada a la eficacia clínica, del empleo de tres o seis aplicaciones intralesionales de Glucantime® no encontró diferencias estadísticamente significativas entre ambas. Así mismo, tampoco se encontró diferencias significativas en cuanto a la cicatrización completa alcanzada al primer mes post tratamiento por ambos esquemas de aplicación. Conclusiones: la cicatrización de las úlceras observada en este estudio, se consiguió independiente del esquema de tres o seis aplicaciones intralesionales de Glucantime® y estos resultados son comparables al tratamiento sistémico. Se considera que tres aplicaciones de Glucantime® intralesional es el límite mínimo como tratamiento para leishmaniasis cutánea con una sola úlcera cuyo tamaño sea menor a tres por tres centímetros.

Intralesional Meglumine Antimoniate: Safe, Feasible and Effective Therapy for Cutaneous Leishmaniasis in Bolivia

“…The intralesional treatment comprised 5 applications conducted every other day during 9 days (days: 1; 3; 5; 7; 9). The decision to administer five applications is supported by results of previous essays [ 17 , 19 ] where three or six applications were fulfilled without showing substantial differences in the healing proportion.…”

“…The inclusion criteria of subjects were as follows: no more than 2 ulcers; ulcer diameter no more than 900 mm 2 ; no lymphangitis; no lesions on the face, ears, or neck; persons aged at least 12 [ 17 , 19 ]; and with prior laboratory confirmations of the presence of parasites at the lesion’s edges using smear and culture techniques described elsewhere [ 20 ].…”

“…Training on the intralesional application of meglumine antimoniate was carried out for the health staff of PHCC in situ, which includes an oral presentation of the previous experiences in the matter and the demonstrative application procedure. In addition, an evaluation form of its clinical effectiveness was used, as defined by criteria described elsewhere [ 17 , 19 ]. Briefly, it was considered therapeutic failure when there was more than 50% growth of the original size or incomplete epithelialization 6 months after finishing treatment.…”

“…The monitored adverse effects were as follows: myalgia, anorexia, asthenia, nausea, fever, headaches, burning sensation, and local transient pain [ 17 , 19 ]. Hepatic, renal, and cardiac functional tests were not conducted.…”

“…Moreover, as a second option was available after the therapeutic failure of systemic treatments with meglumine antimoniate in 11 patients that had one or two ulcers covering an area equal or smaller than 900 mm 2 , where healing was accomplished in all cases [ 18 ]. Finally, in a quasi-experimental trial, three and six intralesional applications of meglumine antimoniate were compared, and healing was accomplished 30 days after the conclusion of treatment, independently of the number of applications, reaching 95% of clinical cures [ 19 ].…”