The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial.
Background Recent circumstantial evidence suggests increasing number of Iranian patients with cutaneous leishmaniasis (CL) who are unresponsive to meglumine antimoniate (MA), the first line of treatment in Iran. Oral meltifosine was previously reported to be effective in visceral leishmaniasis as we...
Published in: | PLOS Neglected Tropical Diseases |
---|---|
Main Authors: | , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Public Library of Science (PLoS)
2021
|
Subjects: | |
Online Access: | https://doi.org/10.1371/journal.pntd.0009241 https://doaj.org/article/3db000feaa584ae4ac698d7d3e8c316f |
id |
ftdoajarticles:oai:doaj.org/article:3db000feaa584ae4ac698d7d3e8c316f |
---|---|
record_format |
openpolar |
spelling |
ftdoajarticles:oai:doaj.org/article:3db000feaa584ae4ac698d7d3e8c316f 2023-05-15T15:14:09+02:00 The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. Masoumeh Tayyebi Emadodin Darchini-Maragheh Pouran Layegh Bita Kiafar Vahid Mashayekhi Goyonlo 2021-03-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0009241 https://doaj.org/article/3db000feaa584ae4ac698d7d3e8c316f EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0009241 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0009241 https://doaj.org/article/3db000feaa584ae4ac698d7d3e8c316f PLoS Neglected Tropical Diseases, Vol 15, Iss 3, p e0009241 (2021) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2021 ftdoajarticles https://doi.org/10.1371/journal.pntd.0009241 2022-12-31T05:55:01Z Background Recent circumstantial evidence suggests increasing number of Iranian patients with cutaneous leishmaniasis (CL) who are unresponsive to meglumine antimoniate (MA), the first line of treatment in Iran. Oral meltifosine was previously reported to be effective in visceral leishmaniasis as well CL. The current study is designed to determine efficacy and safety of oral miltefosine for the treatment of anthroponotic cutaneous leishmaniasis (ACL) cases who were refractory to MA in Iran. Methodology/principal findings Miltefosine was orally administered for 27 patients with MA resistant ACL with approved L.tropica infection, at a dosage of ∼2.5 mg/kg daily for 28 days. Patients were evaluated on day 14 and 28, as well as 3, 6 and 12 month post treatment follow up sessions. Laboratory data were performed and repeated at each visit. Data were analyzed using SPSS version 17. Twenty-seven patients including 16 men (59.25%) and 11 women (40.74%) with mean age of 28.56 ± 4.8 (range 3-54 years old) were enrolled. Total number of lesions were 42 (1-4 in each patient). Most of lesions were on face (76.19%). Mean lesions' induration size was 2.38 ± 0.73 cm at the base-line which significantly decreased to1.31 ± 0.58 cm and 0.61 ±0.49 cm after 14 and 28 days of therapy, respectively (p value <0.05). At 12-months follow-up post treatment, 22 patients had definite/partial cure (81.48%) including 17 definitely cured patients, corresponding to a cure rate of 68% on per protocol analysis, and 62.96% according to intention to treat analysis. Recurrence of lesion was only occurred in one patient (3.70%). Nausea was the most subjective complication during the therapy (33.33%). Conclusion Oral miltefosine could be an effective alternative for the treatment of MA-resistant ACL. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 15 3 e0009241 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Masoumeh Tayyebi Emadodin Darchini-Maragheh Pouran Layegh Bita Kiafar Vahid Mashayekhi Goyonlo The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background Recent circumstantial evidence suggests increasing number of Iranian patients with cutaneous leishmaniasis (CL) who are unresponsive to meglumine antimoniate (MA), the first line of treatment in Iran. Oral meltifosine was previously reported to be effective in visceral leishmaniasis as well CL. The current study is designed to determine efficacy and safety of oral miltefosine for the treatment of anthroponotic cutaneous leishmaniasis (ACL) cases who were refractory to MA in Iran. Methodology/principal findings Miltefosine was orally administered for 27 patients with MA resistant ACL with approved L.tropica infection, at a dosage of ∼2.5 mg/kg daily for 28 days. Patients were evaluated on day 14 and 28, as well as 3, 6 and 12 month post treatment follow up sessions. Laboratory data were performed and repeated at each visit. Data were analyzed using SPSS version 17. Twenty-seven patients including 16 men (59.25%) and 11 women (40.74%) with mean age of 28.56 ± 4.8 (range 3-54 years old) were enrolled. Total number of lesions were 42 (1-4 in each patient). Most of lesions were on face (76.19%). Mean lesions' induration size was 2.38 ± 0.73 cm at the base-line which significantly decreased to1.31 ± 0.58 cm and 0.61 ±0.49 cm after 14 and 28 days of therapy, respectively (p value <0.05). At 12-months follow-up post treatment, 22 patients had definite/partial cure (81.48%) including 17 definitely cured patients, corresponding to a cure rate of 68% on per protocol analysis, and 62.96% according to intention to treat analysis. Recurrence of lesion was only occurred in one patient (3.70%). Nausea was the most subjective complication during the therapy (33.33%). Conclusion Oral miltefosine could be an effective alternative for the treatment of MA-resistant ACL. |
format |
Article in Journal/Newspaper |
author |
Masoumeh Tayyebi Emadodin Darchini-Maragheh Pouran Layegh Bita Kiafar Vahid Mashayekhi Goyonlo |
author_facet |
Masoumeh Tayyebi Emadodin Darchini-Maragheh Pouran Layegh Bita Kiafar Vahid Mashayekhi Goyonlo |
author_sort |
Masoumeh Tayyebi |
title |
The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
title_short |
The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
title_full |
The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
title_fullStr |
The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
title_full_unstemmed |
The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial. |
title_sort |
effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: an uncontrolled clinical trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2021 |
url |
https://doi.org/10.1371/journal.pntd.0009241 https://doaj.org/article/3db000feaa584ae4ac698d7d3e8c316f |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 15, Iss 3, p e0009241 (2021) |
op_relation |
https://doi.org/10.1371/journal.pntd.0009241 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0009241 https://doaj.org/article/3db000feaa584ae4ac698d7d3e8c316f |
op_doi |
https://doi.org/10.1371/journal.pntd.0009241 |
container_title |
PLOS Neglected Tropical Diseases |
container_volume |
15 |
container_issue |
3 |
container_start_page |
e0009241 |
_version_ |
1766344636924690432 |