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Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil
BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Sociedade Brasileira de Dermatologia
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3750881/ https://www.ncbi.nlm.nih.gov/pubmed/23739719 http://dx.doi.org/10.1590/S0365-05962013000200003 |
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author | Maia, Marina Valente Cunha, Maria da Graça Souza Cunha, Carolina Souza |
author_facet | Maia, Marina Valente Cunha, Maria da Graça Souza Cunha, Carolina Souza |
author_sort | Maia, Marina Valente |
collection | PubMed |
description | BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multi-drug therapy. |
format | Online Article Text |
id | pubmed-3750881 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Sociedade Brasileira de Dermatologia |
record_format | MEDLINE/PubMed |
spelling | pubmed-37508812013-09-18 Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil Maia, Marina Valente Cunha, Maria da Graça Souza Cunha, Carolina Souza An Bras Dermatol Investigation BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multi-drug therapy. Sociedade Brasileira de Dermatologia 2013 /pmc/articles/PMC3750881/ /pubmed/23739719 http://dx.doi.org/10.1590/S0365-05962013000200003 Text en ©2013 by Anais Brasileiros de Dermatologia http://creativecommons.org/licenses/by-nc/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Investigation Maia, Marina Valente Cunha, Maria da Graça Souza Cunha, Carolina Souza Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil |
title | Adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
Manaus, Amazonas, Brazil |
title_full | Adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
Manaus, Amazonas, Brazil |
title_fullStr | Adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
Manaus, Amazonas, Brazil |
title_full_unstemmed | Adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
Manaus, Amazonas, Brazil |
title_short | Adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
Manaus, Amazonas, Brazil |
title_sort | adverse effects of alternative therapy (minocycline, ofloxacin, and
clofazimine) in multibacillary leprosy patients in a recognized health care unit in
manaus, amazonas, brazil |
topic | Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3750881/ https://www.ncbi.nlm.nih.gov/pubmed/23739719 http://dx.doi.org/10.1590/S0365-05962013000200003 |
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