Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia
Termoterapia efectiva y más segura que la miltefosina en el tratamiento de la Leishmaniasis cutánea en Colombia
| dc.creator | López Carvajal, Liliana | |
| dc.creator | Robledo Restrepo, Sara María | |
| dc.creator | Vélez Bernal, Iván Darío | |
| dc.creator | Cruz, Claudia | |
| dc.creator | Godoy, Gonzalo | |
| dc.date | 2023-05-16T16:44:07Z | |
| dc.date | 2023-05-16T16:44:07Z | |
| dc.date | 2013 | |
| dc.date.accessioned | 2024-04-23T17:48:02Z | |
| dc.date.available | 2024-04-23T17:48:02Z | |
| dc.identifier | López L, Cruz C, Godoy G, Robledo SM, Vélez ID. Thermotherapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia. Rev Inst Med Trop Sao Paulo. 2013;55(3):S0036-46652013000300197. doi: 10.1590/S0036-46652013000300011. | |
| dc.identifier | 0036-4665 | |
| dc.identifier | https://hdl.handle.net/10495/35030 | |
| dc.identifier | 10.1590/S0036-46652013000300011 | |
| dc.identifier | 1678-9946 | |
| dc.identifier.uri | https://repositorioslatinoamericanos.uchile.cl/handle/2250/9229932 | |
| dc.description | ABSTRACT: In Colombia, pentavalent antimonials and miltefosine are the drugs of choice for the treatment of cutaneous leishmaniasis; however, their toxicity, treatment duration, (treatment adherence problems), cost, and decreased parasite sensitivity make the search for alternative treatments of American cutaneous leishmaniasis necessary. Based on the resultsfound in a controlled, open, randomized, phase III clinical trial, the efficacy and safety of miltefosine was compared to that of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia. Adult patients from the Colombian army participated in the study; they received either 50 mg of miltefosine three times per day for 28 days by the oral route (n = 145) or a thermotherapy (Thermomed®) application of 50 °C for 30 seconds over the lesion and surrounding area (n = 149). Both groups were comparable with respect to their sociodemographic, clinical, and parasitological characteristics. The efficacy of miltefosine by protocol and by intention to treat was 70% (85/122 patients) and 69% (85/145 patients), respectively. The adverse effects were primarily gastrointestinal for miltefosine and pain at the lesion site after treatment for thermotherapy. No statistically significant difference was found in the efficacy analysis (intention to treat and protocol) between the two treatments | |
| dc.description | RESUMEN: En Colombia antimoniales pentavalentes y miltefosina son los medicamentos de primera elección para el tratamiento de la leishmaniosis cutánea; sin embargo, su toxicidad, duración (que lleva a problemas de adherencia), costo y la disminución de la sensibilidad de los parásitos a los mismos, hacen necesaria la búsqueda de nuevas alternativas de tratamiento para la leishmaniosis cutánea americana. A partir de resultados derivados de un ensayo clínico controlado abierto, aleatorizado, fase III, se comparó la eficacia y seguridad de la miltefosina con la de la termoterapia, para el tratamiento de la leishmaniosis cutánea en Colombia. Adultos pertenecientes al Ejército de Colombia participaron el estudio. Miltefosina, una cápsula de 50 mg tres veces día durante 28 días, vía oral (n = 145). Termoterapia (Thermomed®) aplicación de 50 °C/30" sobre la lesión y el área circundante (n = 149). Ambos grupos fueron comparables en características sociodemográficas, clínicas y parasitológicas. Eficacia de la miltefosina por protocolo 70% (85/122 pacientes) y 69% (85/145 pacientes) por intención a tratar. Termoterapia eficacia por protocolo 64% (86/134 pacientes) y 58% (86/149 pacientes) por intención a tratar. En miltefosina los eventos adversos fueron principalmente de tipo gastrointestinal y en termoterapia se encontró dolor en el sitio de la lesión luego del tratamiento. En el análisis de eficacia (intención a tratar y protocolo) no se encontró diferencia estadísticamente significativa entre los tratamientos evaluados | |
| dc.description | COL0015099 | |
| dc.format | 8 | |
| dc.format | application/pdf | |
| dc.format | application/pdf | |
| dc.language | eng | |
| dc.publisher | Universidade de São Paulo, Instituto de Medicina Tropical de São Paulo | |
| dc.publisher | Programa de Estudio y Control de Enfermedades Tropicales (PECET) | |
| dc.publisher | São Paulo, Brasil | |
| dc.relation | Rev. Inst. Med. Trop. São Paulo. | |
| dc.rights | info:eu-repo/semantics/openAccess | |
| dc.rights | http://creativecommons.org/licenses/by-nc/2.5/co/ | |
| dc.rights | http://purl.org/coar/access_right/c_abf2 | |
| dc.rights | https://creativecommons.org/licenses/by-nc/4.0/ | |
| dc.subject | Hyperthermia, Induced | |
| dc.subject | Hipertermia Inducida | |
| dc.subject | Leishmaniasis, Cutaneous | |
| dc.subject | Leishmaniasis Cutánea | |
| dc.subject | Efficacy | |
| dc.subject | Eficacia | |
| dc.subject | Safety | |
| dc.subject | Seguridad | |
| dc.subject | Therapeutics | |
| dc.subject | Terapéutica | |
| dc.subject | Miltefosina | |
| dc.title | Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia | |
| dc.title | Termoterapia efectiva y más segura que la miltefosina en el tratamiento de la Leishmaniasis cutánea en Colombia | |
| dc.type | info:eu-repo/semantics/article | |
| dc.type | info:eu-repo/semantics/publishedVersion | |
| dc.type | http://purl.org/coar/resource_type/c_2df8fbb1 | |
| dc.type | https://purl.org/redcol/resource_type/ART | |
| dc.type | Artículo de investigación |