Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia
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 Ame...
- Autores:
-
López Carvajal, Liliana
Robledo Restrepo, Sara María
Vélez Bernal, Iván Darío
Cruz, Claudia
Godoy, Gonzalo
- Tipo de recurso:
- Article of investigation
- Fecha de publicación:
- 2013
- Institución:
- Universidad de Antioquia
- Repositorio:
- Repositorio UdeA
- Idioma:
- eng
- OAI Identifier:
- oai:bibliotecadigital.udea.edu.co:10495/35030
- Acceso en línea:
- https://hdl.handle.net/10495/35030
- Palabra clave:
- Hyperthermia, Induced
Hipertermia Inducida
Leishmaniasis, Cutaneous
Leishmaniasis Cutánea
Efficacy
Eficacia
Safety
Seguridad
Therapeutics
Terapéutica
Miltefosina
- Rights
- openAccess
- License
- http://creativecommons.org/licenses/by-nc/2.5/co/
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Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| dc.title.translated.spa.fl_str_mv |
Termoterapia efectiva y más segura que la miltefosina en el tratamiento de la Leishmaniasis cutánea en Colombia |
| title |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| spellingShingle |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia Hyperthermia, Induced Hipertermia Inducida Leishmaniasis, Cutaneous Leishmaniasis Cutánea Efficacy Eficacia Safety Seguridad Therapeutics Terapéutica Miltefosina |
| title_short |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| title_full |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| title_fullStr |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| title_full_unstemmed |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| title_sort |
Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in Colombia |
| dc.creator.fl_str_mv |
López Carvajal, Liliana Robledo Restrepo, Sara María Vélez Bernal, Iván Darío Cruz, Claudia Godoy, Gonzalo |
| dc.contributor.author.none.fl_str_mv |
López Carvajal, Liliana Robledo Restrepo, Sara María Vélez Bernal, Iván Darío Cruz, Claudia Godoy, Gonzalo |
| dc.contributor.researchgroup.spa.fl_str_mv |
Programa de Estudio y Control de Enfermedades Tropicales (PECET) |
| dc.subject.decs.none.fl_str_mv |
Hyperthermia, Induced Hipertermia Inducida Leishmaniasis, Cutaneous Leishmaniasis Cutánea Efficacy Eficacia Safety Seguridad Therapeutics Terapéutica |
| topic |
Hyperthermia, Induced Hipertermia Inducida Leishmaniasis, Cutaneous Leishmaniasis Cutánea Efficacy Eficacia Safety Seguridad Therapeutics Terapéutica Miltefosina |
| dc.subject.proposal.spa.fl_str_mv |
Miltefosina |
| 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 |
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2013 |
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2013 |
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2023-05-16T16:44:07Z |
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2023-05-16T16:44:07Z |
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Artículo de investigación |
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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. |
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0036-4665 |
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https://hdl.handle.net/10495/35030 |
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10.1590/S0036-46652013000300011 |
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1678-9946 |
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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. 0036-4665 10.1590/S0036-46652013000300011 1678-9946 |
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eng |
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Rev. Inst. Med. Trop. São Paulo. |
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Universidade de São Paulo, Instituto de Medicina Tropical de São Paulo |
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López Carvajal, LilianaRobledo Restrepo, Sara MaríaVélez Bernal, Iván DaríoCruz, ClaudiaGodoy, GonzaloPrograma de Estudio y Control de Enfermedades Tropicales (PECET)2023-05-16T16:44:07Z2023-05-16T16:44:07Z2013López 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/S0036-46652013000300011.0036-4665https://hdl.handle.net/10495/3503010.1590/S0036-466520130003000111678-9946ABSTRACT: 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 treatmentsRESUMEN: 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 evaluadosCOL00150998application/pdfengUniversidade de São Paulo, Instituto de Medicina Tropical de São PauloSão Paulo, Brasilsin facultad - programahttp://creativecommons.org/licenses/by-nc/2.5/co/https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Thermotherapy Effective and Safer than Miltefosine in the Treatment of Cutaneous Leishmaniasis in ColombiaTermoterapia efectiva y más segura que la miltefosina en el tratamiento de la Leishmaniasis cutánea en ColombiaArtículo de investigaciónhttp://purl.org/coar/resource_type/c_2df8fbb1https://purl.org/redcol/resource_type/ARThttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionHyperthermia, InducedHipertermia InducidaLeishmaniasis, CutaneousLeishmaniasis CutáneaEfficacyEficaciaSafetySeguridadTherapeuticsTerapéuticaMiltefosinaRev. Inst. Med. Trop. São Paulo.204319755Revista do Instituto de Medicina Tropical de Sao PauloPublicationLICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://bibliotecadigital.udea.edu.co/bitstreams/27f30532-312d-4869-9b91-a206843420ec/download8a4605be74aa9ea9d79846c1fba20a33MD53falseAnonymousREADORIGINALLópezLiliana_2013_ThermotherapySaferColombia.pdfLópezLiliana_2013_ThermotherapySaferColombia.pdfArtículo de investigaciónapplication/pdf559716https://bibliotecadigital.udea.edu.co/bitstreams/5c4df9bf-f7c1-43c5-910d-f6fe48e78085/download18cd8e4e6fad73635b3901a89dc9519aMD51trueAnonymousREADCC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8933https://bibliotecadigital.udea.edu.co/bitstreams/d11c89f3-e2e1-4c49-9dc9-4ba03e04631b/downloadc0c92b0ffc8b7d22d9cf56754a416a76MD52falseAnonymousREADTEXTLópezLiliana_2013_ThermotherapySaferColombia.pdf.txtLópezLiliana_2013_ThermotherapySaferColombia.pdf.txtExtracted texttext/plain39355https://bibliotecadigital.udea.edu.co/bitstreams/b2d6f570-e20c-429b-9c87-8bf33a0062cb/download588f8e5ceaa75078bf63758dcd4b72d4MD54falseAnonymousREADTHUMBNAILLópezLiliana_2013_ThermotherapySaferColombia.pdf.jpgLópezLiliana_2013_ThermotherapySaferColombia.pdf.jpgGenerated Thumbnailimage/jpeg14588https://bibliotecadigital.udea.edu.co/bitstreams/0d3f5aed-e739-4707-8a07-bf43dd406540/download7216afe802d9302c63a5b43b81135a60MD55falseAnonymousREAD10495/35030oai:bibliotecadigital.udea.edu.co:10495/350302025-03-26 21:24:41.375http://creativecommons.org/licenses/by-nc/2.5/co/open.accesshttps://bibliotecadigital.udea.edu.coRepositorio Institucional de la Universidad de Antioquiaaplicacionbibliotecadigitalbiblioteca@udea.edu.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 |