Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial

Detalhes bibliográficos
Autor(a) principal: Pedral Sampaio, Diana Brasil
Data de Publicação: 2003
Outros Autores: Martins Netto, Eduardo, Brites, Carlos, Bandeira, Antonio Carlos de Albuquerque, Guerra, Conceição, Barberin, Maria Goreth, Badaró, Roberto José da Silva
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
id UFBA-2_636e896e167371e794f2f4c354ad08de
oai_identifier_str oai:repositorio.ufba.br:ri/6952
network_acronym_str UFBA-2
network_name_str Repositório Institucional da UFBA
repository_id_str 1932
spelling 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
instname_str Universidade Federal da Bahia (UFBA)
instacron_str UFBA
institution UFBA
reponame_str Repositório Institucional da UFBA
collection Repositório Institucional da UFBA
bitstream.url.fl_str_mv https://repositorio.ufba.br/bitstream/ri/6952/1/Pedral-Sampaio%2c%20Diana%20Brasil.pdf
https://repositorio.ufba.br/bitstream/ri/6952/2/license.txt
https://repositorio.ufba.br/bitstream/ri/6952/3/Pedral-Sampaio%2c%20Diana%20Brasil.pdf.txt
bitstream.checksum.fl_str_mv 4a5641cd8abcd1fcf0d101bbe5188501
8bb3e3eb871f5854a9ec419f68651b60
9cfb80288b4189282c4ee4cb040ba3c8
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
MD5
repository.name.fl_str_mv Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)
repository.mail.fl_str_mv
_version_ 1798057584948674560

Registros relacionados