Publicação: Padronização dos critérios de seleção em estudos sobre medicações nasais
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Data
2009-12-01
Orientador
Coorientador
Pós-graduação
Curso de graduação
Título da Revista
ISSN da Revista
Título de Volume
Editor
Tipo
Artigo
Direito de acesso
Acesso aberto
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.
Descrição
Palavras-chave
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
Idioma
Português
Como citar
Brazilian Journal of Otorhinolaryngology, v. 75, n. 6, 2009.
