Padronização dos critérios de seleção em estudos sobre medicações nasais
Autor(a) principal: | |
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Data de Publicação: | 2009 |
Outros Autores: | , , , |
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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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 |