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Master Thesis

Profil de tolérance des corticothérapies par voie nasale en médecine générale

Abstract : Background: In primary care, nasal corticosteroids are widely prescribed. Their tolerance is presumed, but adverse effects (AEs) exist, whose nature, frequency and gravity are still poorly known. The main objective of our study is to establish the safety profile of the nasal corticotherapies by specifying the type of AEs, affected patients and suspected drugs. The secondary objective is to compare these characteristics according to their severity. Methods: This is a descriptive epidemiological study, multicentric from a series of cases of the WHO-pharmacovigilance database reported over the last thirty years. It concerns all reported AEs for which nasal corticosteroids have been suspected. Results: The extraction of the VIGIBASE® database on 08/10/2017 found 81,609 cases concerning corticosteroids, including 460 cases for intranasal use. We retained 334 cases of good quality (0.4%). There were 13% serious AEs. The average age was 56 years old and women were slightly more represented (ratio 0.71). These characteristics were comparable concerning gravity status. The most frequently incriminated drugs were triamcinolone, flunisolide and mometasone. For serious AEs, these are the two last which were most represented. The nature of reported AEs was very various. Non-serious AEs were more often of ENT or respiratory type (35%), or related to a problem of product or use (19%). The serious AEs were more often of general or diverse type (27%). Conclusion: Consequently, the risk of occurrence of potentially serious AEs must be considered for any prescription of intranasal corticotherapy. In general, the declaration of the AEs is an essential step to advance patients safety.
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Master Thesis
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Adeline de Pierrepont. Profil de tolérance des corticothérapies par voie nasale en médecine générale. Médecine humaine et pathologie. 2019. ⟨dumas-02481609⟩

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