A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis
ABSTRACT: A topical nanofiber nitric oxide (NO) releasing patch (≈3.5 μmol NO/cm2/day for 20 days, NOP) was compared with intramuscular meglumine antimoniate (Glucantime, 20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis (CL) caused by Leishmania (V.) panamensis in Santander and...
- Autores:
-
López Jaramillo, Patricio
Rincón Acelas, Melvin Yesid
García Gómez, Ronal Guillermo
Silva, Sandra Y
Smith, Erin
Kampeerapappun, Piyaporn
García, Carlos
Vélez Bernal, Iván Darío
López, Marcos
- Tipo de recurso:
- Article of investigation
- Fecha de publicación:
- 2010
- Institución:
- Universidad de Antioquia
- Repositorio:
- Repositorio UdeA
- Idioma:
- eng
- OAI Identifier:
- oai:bibliotecadigital.udea.edu.co:10495/21295
- Acceso en línea:
- http://hdl.handle.net/10495/21295
- Palabra clave:
- Óxido Nítrico
Nitric Oxide
Ensayo Clínico Controlado
Controlled Clinical Trial
Leishmaniasis Cutánea
Leishmaniasis, Cutaneous
Leishmania
Antimoniato de Meglumina
Meglumine Antimoniate
- Rights
- openAccess
- License
- http://creativecommons.org/licenses/by/2.5/co/
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| dc.title.spa.fl_str_mv |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| title |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| spellingShingle |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis Óxido Nítrico Nitric Oxide Ensayo Clínico Controlado Controlled Clinical Trial Leishmaniasis Cutánea Leishmaniasis, Cutaneous Leishmania Antimoniato de Meglumina Meglumine Antimoniate |
| title_short |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| title_full |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| title_fullStr |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| title_full_unstemmed |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| title_sort |
A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis |
| dc.creator.fl_str_mv |
López Jaramillo, Patricio Rincón Acelas, Melvin Yesid García Gómez, Ronal Guillermo Silva, Sandra Y Smith, Erin Kampeerapappun, Piyaporn García, Carlos Vélez Bernal, Iván Darío López, Marcos |
| dc.contributor.author.none.fl_str_mv |
López Jaramillo, Patricio Rincón Acelas, Melvin Yesid García Gómez, Ronal Guillermo Silva, Sandra Y Smith, Erin Kampeerapappun, Piyaporn García, Carlos Vélez Bernal, Iván Darío López, Marcos |
| dc.subject.decs.none.fl_str_mv |
Óxido Nítrico Nitric Oxide Ensayo Clínico Controlado Controlled Clinical Trial Leishmaniasis Cutánea Leishmaniasis, Cutaneous Leishmania Antimoniato de Meglumina Meglumine Antimoniate |
| topic |
Óxido Nítrico Nitric Oxide Ensayo Clínico Controlado Controlled Clinical Trial Leishmaniasis Cutánea Leishmaniasis, Cutaneous Leishmania Antimoniato de Meglumina Meglumine Antimoniate |
| description |
ABSTRACT: A topical nanofiber nitric oxide (NO) releasing patch (≈3.5 μmol NO/cm2/day for 20 days, NOP) was compared with intramuscular meglumine antimoniate (Glucantime, 20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis (CL) caused by Leishmania (V.) panamensis in Santander and Tolima, Colombia. A double-blind, randomized, placebo-controlled, clinical trial was conducted to determine whether the NOP is as effective as Glucantime for the treatment of CL. Patients were randomly assigned to Glucantime and placebo patches or NOP and placebo of Glucantime. The cure rates after a 3-month follow-up were 94.8% for the group that received Glucantime compared with 37.1% in the NOP group. Despite the lower efficacy of the NOP versus Glucantime, a significantly lower frequency of non-serious adverse events and a reduced variation in serum markers were observed in patients treated with NOP. Treatment of CL with NOP resulted in a lower effectiveness compared with Glucantime; however, the low frequency of adverse events and the facility of topic administration justify the development of new generations of NOP systems for the treatment of CL |
| publishDate |
2010 |
| dc.date.issued.none.fl_str_mv |
2010 |
| dc.date.accessioned.none.fl_str_mv |
2021-07-29T20:13:52Z |
| dc.date.available.none.fl_str_mv |
2021-07-29T20:13:52Z |
| dc.type.spa.fl_str_mv |
info:eu-repo/semantics/article |
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http://purl.org/coar/version/c_970fb48d4fbd8a85 |
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info:eu-repo/semantics/publishedVersion |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
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https://purl.org/redcol/resource_type/ART |
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Artículo de investigación |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
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publishedVersion |
| dc.identifier.citation.spa.fl_str_mv |
López-Jaramillo, P., Rincón, M. Y., García, R. G., Silva, S. Y., Smith, E., Kampeerapappun, P., García, C., Smith, D. J., López, M., & Vélez, I. D. (2010). A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis, The American Society of Tropical Medicine and Hygiene, 83(1), 97-101. Retrieved Jul 29, 2021, from https://www.ajtmh.org/view/journals/tpmd/83/1/article-p97.xml |
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0002-9637 |
| dc.identifier.uri.none.fl_str_mv |
http://hdl.handle.net/10495/21295 |
| dc.identifier.doi.none.fl_str_mv |
10.4269/ajtmh.2010.09-0287 |
| dc.identifier.eissn.none.fl_str_mv |
1476-1645 |
| identifier_str_mv |
López-Jaramillo, P., Rincón, M. Y., García, R. G., Silva, S. Y., Smith, E., Kampeerapappun, P., García, C., Smith, D. J., López, M., & Vélez, I. D. (2010). A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis, The American Society of Tropical Medicine and Hygiene, 83(1), 97-101. Retrieved Jul 29, 2021, from https://www.ajtmh.org/view/journals/tpmd/83/1/article-p97.xml 0002-9637 10.4269/ajtmh.2010.09-0287 1476-1645 |
| url |
http://hdl.handle.net/10495/21295 |
| dc.language.iso.spa.fl_str_mv |
eng |
| language |
eng |
| dc.relation.ispartofjournalabbrev.spa.fl_str_mv |
Am. J. Trop. Med. Hyg. |
| dc.rights.spa.fl_str_mv |
info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by/2.5/co/ |
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https://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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http://creativecommons.org/licenses/by/2.5/co/ http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/ |
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American Society of Tropical Medicine and Hygiene |
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Programa de Estudio y Control de Enfermedades Tropicales (PECET) |
| dc.publisher.place.spa.fl_str_mv |
Baltimore, Estados Unidos |
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Universidad de Antioquia |
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López Jaramillo, PatricioRincón Acelas, Melvin YesidGarcía Gómez, Ronal GuillermoSilva, Sandra YSmith, ErinKampeerapappun, PiyapornGarcía, CarlosVélez Bernal, Iván DaríoLópez, Marcos2021-07-29T20:13:52Z2021-07-29T20:13:52Z2010López-Jaramillo, P., Rincón, M. Y., García, R. G., Silva, S. Y., Smith, E., Kampeerapappun, P., García, C., Smith, D. J., López, M., & Vélez, I. D. (2010). A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis, The American Society of Tropical Medicine and Hygiene, 83(1), 97-101. Retrieved Jul 29, 2021, from https://www.ajtmh.org/view/journals/tpmd/83/1/article-p97.xml0002-9637http://hdl.handle.net/10495/2129510.4269/ajtmh.2010.09-02871476-1645ABSTRACT: A topical nanofiber nitric oxide (NO) releasing patch (≈3.5 μmol NO/cm2/day for 20 days, NOP) was compared with intramuscular meglumine antimoniate (Glucantime, 20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis (CL) caused by Leishmania (V.) panamensis in Santander and Tolima, Colombia. A double-blind, randomized, placebo-controlled, clinical trial was conducted to determine whether the NOP is as effective as Glucantime for the treatment of CL. Patients were randomly assigned to Glucantime and placebo patches or NOP and placebo of Glucantime. The cure rates after a 3-month follow-up were 94.8% for the group that received Glucantime compared with 37.1% in the NOP group. Despite the lower efficacy of the NOP versus Glucantime, a significantly lower frequency of non-serious adverse events and a reduced variation in serum markers were observed in patients treated with NOP. Treatment of CL with NOP resulted in a lower effectiveness compared with Glucantime; however, the low frequency of adverse events and the facility of topic administration justify the development of new generations of NOP systems for the treatment of CLCOL00150995application/pdfengAmerican Society of Tropical Medicine and HygienePrograma de Estudio y Control de Enfermedades Tropicales (PECET)Baltimore, Estados Unidosinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_2df8fbb1https://purl.org/redcol/resource_type/ARTArtículo de investigaciónhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/2.5/co/http://purl.org/coar/access_right/c_abf2https://creativecommons.org/licenses/by/4.0/A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensisÓxido NítricoNitric OxideEnsayo Clínico ControladoControlled Clinical TrialLeishmaniasis CutáneaLeishmaniasis, CutaneousLeishmaniaAntimoniato de MegluminaMeglumine AntimoniateAm. J. Trop. Med. Hyg.American Journal of Tropical Medicine and Hygiene97101831CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8927http://bibliotecadigital.udea.edu.co/bitstream/10495/21295/2/license_rdf1646d1f6b96dbbbc38035efc9239ac9cMD52LICENSElicense.txtlicense.txttext/plain; charset=utf-81748http://bibliotecadigital.udea.edu.co/bitstream/10495/21295/3/license.txt8a4605be74aa9ea9d79846c1fba20a33MD53ORIGINALVelezIvan_ 2010_TreatmentutaneousLeishmaniasis.pdfVelezIvan_ 2010_TreatmentutaneousLeishmaniasis.pdfArtículo de investigaciónapplication/pdf676833http://bibliotecadigital.udea.edu.co/bitstream/10495/21295/1/VelezIvan_%202010_TreatmentutaneousLeishmaniasis.pdf0b1f623fd14580513c17661d87008efbMD5110495/21295oai:bibliotecadigital.udea.edu.co:10495/212952021-07-29 15:13:52.983Repositorio Institucional Universidad de Antioquiaandres.perez@udea.edu.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 |