Padronização dos critérios de seleção em estudos sobre medicações nasais
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Data
2009-12-01
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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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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
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Brazilian Journal of Otorhinolaryngology, v. 75, n. 6, 2009.