Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial
Autor(a) principal: | |
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Data de Publicação: | 2003 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFBA |
Texto Completo: | http://www.repositorio.ufba.br/ri/handle/ri/6952 |
Resumo: | p.245-252 |
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Pedral Sampaio, Diana BrasilMartins Netto, EduardoBrites, CarlosBandeira, Antonio Carlos de AlbuquerqueGuerra, ConceiçãoBarberin, Maria GorethBadaró, Roberto José da SilvaPedral Sampaio, Diana BrasilMartins Netto, EduardoBrites, CarlosBandeira, Antonio Carlos de AlbuquerqueGuerra, ConceiçãoBarberin, Maria GorethBadaró, Roberto José da Silva2012-10-15T19:47:35Z2012-10-15T19:47:35Z2003-081413-8670http://www.repositorio.ufba.br/ri/handle/ri/6952v. 7, n. 4p.245-252It has been postulated that deficient or incomplete clinical and/or microbiological response to tuberculosis treatment is associated with cell-mediated immunological dysfunction involving monocytes and macrophages. A phase 2 safety trial was conducted by treating patients with either recombinant human granulocyte-macrophage colony-stimulating factor (rhu-GM-CSF) or a placebo, both in combination with anti-tuberculosis chemotherapy. Thirty-one patients with documented pulmonary tuberculosis were treated with rifampin/isoniazid for six months, plus pyrazinamide for the first two months. At the beginning of treatment, rhu-GM-CSF (125µg/M2) was randomly assigned to 16 patients and injected subcutaneously twice weekly for four weeks; the other 15 patients received a placebo. The patients were accompanied in the hospital for two weeks, then monthly on an out patient basis, for 12 months. Clinical outcomes were similar in both groups, with no difference in acid-fast bacilli (AFB) clearance in sputum at the end of the fourth week of treatment. Nevertheless, a trend to faster conversion to negative was observed in the rhu-GM-CSF group until the eighth week of treatment (p=0.07), after which all patients converted to AFB negative. Adverse events in the rhu-GM-CSF group were local skin inflammation and an increase in the leukocyte count after each injection, returning to normal 72 hours after rhu-GM-CSF injection. Three patients developed SGOP and SGPT > 2.5 times the normal values. All patients included in the GM-CSF group were culture negative at six months, except one who had primary TB resistance. None of the patients had to discontinue the treatment in either group. We conclude that rhu-GM-CSF adjuvant immunotherapy could be safely explored in a phase 3 trial with patients who have active tuberculosis.Submitted by Texeira Ana (atanateixeira@gmail.com) on 2012-10-15T19:47:35Z No. of bitstreams: 1 Pedral-Sampaio, Diana Brasil.pdf: 46999 bytes, checksum: 4a5641cd8abcd1fcf0d101bbe5188501 (MD5)Made available in DSpace on 2012-10-15T19:47:35Z (GMT). No. of bitstreams: 1 Pedral-Sampaio, Diana Brasil.pdf: 46999 bytes, checksum: 4a5641cd8abcd1fcf0d101bbe5188501 (MD5) Previous issue date: 2003-08SalvadorThe Brazilian Journal of Infectious Diseases and Contexto Publishinghttp://dx.doi.org/10.1590/S1413-86702003000400004reponame:Repositório Institucional da UFBAinstname:Universidade Federal da Bahia (UFBA)instacron:UFBATuberculosisGM-CSFTreatmentUse of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trialBrazilian Journal of Infectious Diseasesinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleenginfo:eu-repo/semantics/openAccessORIGINALPedral-Sampaio, Diana Brasil.pdfPedral-Sampaio, Diana Brasil.pdfapplication/pdf46999https://repositorio.ufba.br/bitstream/ri/6952/1/Pedral-Sampaio%2c%20Diana%20Brasil.pdf4a5641cd8abcd1fcf0d101bbe5188501MD51LICENSElicense.txtlicense.txttext/plain1809https://repositorio.ufba.br/bitstream/ri/6952/2/license.txt8bb3e3eb871f5854a9ec419f68651b60MD52TEXTPedral-Sampaio, Diana Brasil.pdf.txtPedral-Sampaio, Diana Brasil.pdf.txtExtracted texttext/plain26161https://repositorio.ufba.br/bitstream/ri/6952/3/Pedral-Sampaio%2c%20Diana%20Brasil.pdf.txt9cfb80288b4189282c4ee4cb040ba3c8MD53ri/69522022-07-05 14:03:19.725oai:repositorio.ufba.br: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ório InstitucionalPUBhttp://192.188.11.11:8080/oai/requestopendoar:19322022-07-05T17:03:19Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)false |
dc.title.pt_BR.fl_str_mv |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
dc.title.alternative.pt_BR.fl_str_mv |
Brazilian Journal of Infectious Diseases |
title |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
spellingShingle |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial Pedral Sampaio, Diana Brasil Tuberculosis GM-CSF Treatment |
title_short |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
title_full |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
title_fullStr |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
title_full_unstemmed |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
title_sort |
Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial |
author |
Pedral Sampaio, Diana Brasil |
author_facet |
Pedral Sampaio, Diana Brasil Martins Netto, Eduardo Brites, Carlos Bandeira, Antonio Carlos de Albuquerque Guerra, Conceição Barberin, Maria Goreth Badaró, Roberto José da Silva |
author_role |
author |
author2 |
Martins Netto, Eduardo Brites, Carlos Bandeira, Antonio Carlos de Albuquerque Guerra, Conceição Barberin, Maria Goreth Badaró, Roberto José da Silva |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Pedral Sampaio, Diana Brasil Martins Netto, Eduardo Brites, Carlos Bandeira, Antonio Carlos de Albuquerque Guerra, Conceição Barberin, Maria Goreth Badaró, Roberto José da Silva Pedral Sampaio, Diana Brasil Martins Netto, Eduardo Brites, Carlos Bandeira, Antonio Carlos de Albuquerque Guerra, Conceição Barberin, Maria Goreth Badaró, Roberto José da Silva |
dc.subject.por.fl_str_mv |
Tuberculosis GM-CSF Treatment |
topic |
Tuberculosis GM-CSF Treatment |
description |
p.245-252 |
publishDate |
2003 |
dc.date.issued.fl_str_mv |
2003-08 |
dc.date.accessioned.fl_str_mv |
2012-10-15T19:47:35Z |
dc.date.available.fl_str_mv |
2012-10-15T19:47:35Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://www.repositorio.ufba.br/ri/handle/ri/6952 |
dc.identifier.issn.none.fl_str_mv |
1413-8670 |
dc.identifier.number.pt_BR.fl_str_mv |
v. 7, n. 4 |
identifier_str_mv |
1413-8670 v. 7, n. 4 |
url |
http://www.repositorio.ufba.br/ri/handle/ri/6952 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
The Brazilian Journal of Infectious Diseases and Contexto Publishing |
publisher.none.fl_str_mv |
The Brazilian Journal of Infectious Diseases and Contexto Publishing |
dc.source.pt_BR.fl_str_mv |
http://dx.doi.org/10.1590/S1413-86702003000400004 |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UFBA instname:Universidade Federal da Bahia (UFBA) instacron:UFBA |
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Universidade Federal da Bahia (UFBA) |
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UFBA |
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UFBA |
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Repositório Institucional da UFBA |
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Repositório Institucional da UFBA |
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