Padronização dos critérios de seleção em estudos sobre medicações nasais

Detalhes bibliográficos
Autor(a) principal: Borin, Andrei
Data de Publicação: 2009
Outros Autores: Abib Jr., Eduardo, Araujo, Cleomines Izidio, Martinez, Luis Lopez [UNESP], Rodrigues, Heloisio
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1590/S1808-86942009000600017
http://hdl.handle.net/11449/71343
Resumo: Clinical studies on nasal topical medications require the standardization of nasosinusal normality in order to establish control groups through a specific evaluation of the upper airways. Aim: to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications. Material and Methods: healthy male volunteers of 18 to 50 years of age, asymptomatic from the nasosinusal standpoint were subjected to a sequential and excluding assessment made up of clinical evaluation, immediate hypersensitivity skin test, saccharin test, flexible nasofibroscopy and nasal cytology. Study design: Crosssectional contemporary cohort. Results: Of the 33 people originally enrolled, 14 (42.4%) were excluded for clinical reasons. Of the 19 remaining, 2 (10.5%) had atopy diagnosed in the skin test and were excluded. 17 were tested with saccharin and presented normal mucociliary clearance. Evaluation by nasal endoscopy showed abnormality in 2 cases (11.8%) and these were excluded. The remaining 15 were submitted to nasal cytology, which proved normal, representing 45.5% of those initially included. Conclusion: The proposed protocol for sequential and excluding evaluation was effective in defining candidates for the establishment of control groups in clinical studies on nasal topical medications. © Revista Brasileira de Otorrinolaringologia. All Rights reserved.
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spelling Padronização dos critérios de seleção em estudos sobre medicações nasaisStandardizing selection criteria in nasal medication studiesControl groupsCytologyMucociliary clearanceNoseSkin testsdiagnostic agentsaccharinadolescentadultcase control studycross-sectional studyhumanimmediate type hypersensitivityintranasal drug administrationmalemiddle agedmucociliary clearancepatient selectionskin testAdministration, IntranasalAdolescentAdultCase-Control StudiesCross-Sectional StudiesHumansHypersensitivity, ImmediateMaleMiddle AgedMucociliary ClearancePatient SelectionSaccharinSkin TestsYoung AdultClinical studies on nasal topical medications require the standardization of nasosinusal normality in order to establish control groups through a specific evaluation of the upper airways. Aim: to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications. Material and Methods: healthy male volunteers of 18 to 50 years of age, asymptomatic from the nasosinusal standpoint were subjected to a sequential and excluding assessment made up of clinical evaluation, immediate hypersensitivity skin test, saccharin test, flexible nasofibroscopy and nasal cytology. Study design: Crosssectional contemporary cohort. Results: Of the 33 people originally enrolled, 14 (42.4%) were excluded for clinical reasons. Of the 19 remaining, 2 (10.5%) had atopy diagnosed in the skin test and were excluded. 17 were tested with saccharin and presented normal mucociliary clearance. Evaluation by nasal endoscopy showed abnormality in 2 cases (11.8%) and these were excluded. The remaining 15 were submitted to nasal cytology, which proved normal, representing 45.5% of those initially included. Conclusion: The proposed protocol for sequential and excluding evaluation was effective in defining candidates for the establishment of control groups in clinical studies on nasal topical medications. © Revista Brasileira de Otorrinolaringologia. All Rights reserved.Departamento de Pesquisas Clínicas Libbs Pharmacêutica Ltda., Sao Paulo, SPScentryphar Cliníca Ltda., Campinas, SPFaculdade de Ciências Médicas UNICAMP - Universidade de Campinas, SPCentro de Biociências Aplicado a Pacientes com Necessidades Especiais CEBAPE - FOSJC UNESP - Universidade Estadual Paulista, SPCentro de Biociências Aplicado a Pacientes com Necessidades Especiais CEBAPE - FOSJC UNESP - Universidade Estadual Paulista, SPLibbs Pharmacêutica Ltda.Scentryphar Cliníca Ltda.Universidade Estadual de Campinas (UNICAMP)Universidade Estadual Paulista (Unesp)Borin, AndreiAbib Jr., EduardoAraujo, Cleomines IzidioMartinez, Luis Lopez [UNESP]Rodrigues, Heloisio2014-05-27T11:24:05Z2014-05-27T11:24:05Z2009-12-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1590/S1808-86942009000600017Brazilian Journal of Otorhinolaryngology, v. 75, n. 6, 2009.1808-86941808-8686http://hdl.handle.net/11449/7134310.1590/S1808-86942009000600017S1808-869420090006000172-s2.0-776491607542-s2.0-77649160754.pdfScopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPporengBrazilian Journal of Otorhinolaryngology1.4120,443info:eu-repo/semantics/openAccess2023-10-10T06:09:51Zoai:repositorio.unesp.br:11449/71343Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:34:11.690446Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Padronização dos critérios de seleção em estudos sobre medicações nasais
Standardizing selection criteria in nasal medication studies
title Padronização dos critérios de seleção em estudos sobre medicações nasais
spellingShingle Padronização dos critérios de seleção em estudos sobre medicações nasais
Borin, Andrei
Control groups
Cytology
Mucociliary clearance
Nose
Skin tests
diagnostic agent
saccharin
adolescent
adult
case control study
cross-sectional study
human
immediate type hypersensitivity
intranasal drug administration
male
middle aged
mucociliary clearance
patient selection
skin test
Administration, Intranasal
Adolescent
Adult
Case-Control Studies
Cross-Sectional Studies
Humans
Hypersensitivity, Immediate
Male
Middle Aged
Mucociliary Clearance
Patient Selection
Saccharin
Skin Tests
Young Adult
title_short Padronização dos critérios de seleção em estudos sobre medicações nasais
title_full Padronização dos critérios de seleção em estudos sobre medicações nasais
title_fullStr Padronização dos critérios de seleção em estudos sobre medicações nasais
title_full_unstemmed Padronização dos critérios de seleção em estudos sobre medicações nasais
title_sort Padronização dos critérios de seleção em estudos sobre medicações nasais
author Borin, Andrei
author_facet Borin, Andrei
Abib Jr., Eduardo
Araujo, Cleomines Izidio
Martinez, Luis Lopez [UNESP]
Rodrigues, Heloisio
author_role author
author2 Abib Jr., Eduardo
Araujo, Cleomines Izidio
Martinez, Luis Lopez [UNESP]
Rodrigues, Heloisio
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Libbs Pharmacêutica Ltda.
Scentryphar Cliníca Ltda.
Universidade Estadual de Campinas (UNICAMP)
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Borin, Andrei
Abib Jr., Eduardo
Araujo, Cleomines Izidio
Martinez, Luis Lopez [UNESP]
Rodrigues, Heloisio
dc.subject.por.fl_str_mv Control groups
Cytology
Mucociliary clearance
Nose
Skin tests
diagnostic agent
saccharin
adolescent
adult
case control study
cross-sectional study
human
immediate type hypersensitivity
intranasal drug administration
male
middle aged
mucociliary clearance
patient selection
skin test
Administration, Intranasal
Adolescent
Adult
Case-Control Studies
Cross-Sectional Studies
Humans
Hypersensitivity, Immediate
Male
Middle Aged
Mucociliary Clearance
Patient Selection
Saccharin
Skin Tests
Young Adult
topic Control groups
Cytology
Mucociliary clearance
Nose
Skin tests
diagnostic agent
saccharin
adolescent
adult
case control study
cross-sectional study
human
immediate type hypersensitivity
intranasal drug administration
male
middle aged
mucociliary clearance
patient selection
skin test
Administration, Intranasal
Adolescent
Adult
Case-Control Studies
Cross-Sectional Studies
Humans
Hypersensitivity, Immediate
Male
Middle Aged
Mucociliary Clearance
Patient Selection
Saccharin
Skin Tests
Young Adult
description Clinical studies on nasal topical medications require the standardization of nasosinusal normality in order to establish control groups through a specific evaluation of the upper airways. Aim: to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications. Material and Methods: healthy male volunteers of 18 to 50 years of age, asymptomatic from the nasosinusal standpoint were subjected to a sequential and excluding assessment made up of clinical evaluation, immediate hypersensitivity skin test, saccharin test, flexible nasofibroscopy and nasal cytology. Study design: Crosssectional contemporary cohort. Results: Of the 33 people originally enrolled, 14 (42.4%) were excluded for clinical reasons. Of the 19 remaining, 2 (10.5%) had atopy diagnosed in the skin test and were excluded. 17 were tested with saccharin and presented normal mucociliary clearance. Evaluation by nasal endoscopy showed abnormality in 2 cases (11.8%) and these were excluded. The remaining 15 were submitted to nasal cytology, which proved normal, representing 45.5% of those initially included. Conclusion: The proposed protocol for sequential and excluding evaluation was effective in defining candidates for the establishment of control groups in clinical studies on nasal topical medications. © Revista Brasileira de Otorrinolaringologia. All Rights reserved.
publishDate 2009
dc.date.none.fl_str_mv 2009-12-01
2014-05-27T11:24:05Z
2014-05-27T11:24:05Z
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://dx.doi.org/10.1590/S1808-86942009000600017
Brazilian Journal of Otorhinolaryngology, v. 75, n. 6, 2009.
1808-8694
1808-8686
http://hdl.handle.net/11449/71343
10.1590/S1808-86942009000600017
S1808-86942009000600017
2-s2.0-77649160754
2-s2.0-77649160754.pdf
url http://dx.doi.org/10.1590/S1808-86942009000600017
http://hdl.handle.net/11449/71343
identifier_str_mv Brazilian Journal of Otorhinolaryngology, v. 75, n. 6, 2009.
1808-8694
1808-8686
10.1590/S1808-86942009000600017
S1808-86942009000600017
2-s2.0-77649160754
2-s2.0-77649160754.pdf
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv Brazilian Journal of Otorhinolaryngology
1.412
0,443
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
_version_ 1808128379549908992