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Efficacy of Mometasone Furoate Nasal Spray in Delayed Antibiotic Prescriptions for Acute Rhinosinusitis: A Multicenter, Randomized, Open-Label, Comparative, Prospective, Parallel Group Study

Efficacy of Mometasone Furoate Nasal Spray in Delayed Antibiotic Prescriptions for Acute Rhinosinusitis: A Multicenter, Randomized, Open-Label, Comparative, Prospective, Parallel Group Study
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摘要 While their clinical presentation is similar, post-viral rhinosinusitis does not indicate the possible development of bacterial rhinosinusitis which occurs in only 0.5% to 5% of all cases of ARS. However, unreasonable antibacterial therapy is prescribed in 54% to 77% of cases. The perspective is to use delayed antibacterial therapy management. The purpose of the study was to investigate the efficacy of mometasone furoate nasal spray within the delayed prescription approach. Methods: A multicenter, randomized, open-label, comparative, prospective, parallel group study enrolled a total of 156 patients with ARS aged 18 to 60 years, of them 155 patients completed the study. The patients were randomized into the main group of Mometasone Furoate (Flix) Nasal Spray or into the control group of amoxicillin clavulanate tablets while both groups were administered a standard ARS therapy. Findings: The use of MF nasal spray within the delayed antibiotics prescription approach has a significantly higher efficacy compared to the immediate antibiotics prescription in the first days of treatment (p < 0.05). Antibacterial therapy was prescribed to 42.3% of patients in the main group compared to 100.0% of patients in the control group (p < 0.05). It was shown that there were statistically significant differences in the dynamics of changes in the total symptom score between the patients administered antibiotics and the antibiotic-naive patients. Conclusion: The use of MF within the delayed antibiotics prescription approach reliably improves the pattern of symptoms over time at the disease onset and significantly reduces the need for NSAIDs administration and antibiotics prescription frequency. While their clinical presentation is similar, post-viral rhinosinusitis does not indicate the possible development of bacterial rhinosinusitis which occurs in only 0.5% to 5% of all cases of ARS. However, unreasonable antibacterial therapy is prescribed in 54% to 77% of cases. The perspective is to use delayed antibacterial therapy management. The purpose of the study was to investigate the efficacy of mometasone furoate nasal spray within the delayed prescription approach. Methods: A multicenter, randomized, open-label, comparative, prospective, parallel group study enrolled a total of 156 patients with ARS aged 18 to 60 years, of them 155 patients completed the study. The patients were randomized into the main group of Mometasone Furoate (Flix) Nasal Spray or into the control group of amoxicillin clavulanate tablets while both groups were administered a standard ARS therapy. Findings: The use of MF nasal spray within the delayed antibiotics prescription approach has a significantly higher efficacy compared to the immediate antibiotics prescription in the first days of treatment (p < 0.05). Antibacterial therapy was prescribed to 42.3% of patients in the main group compared to 100.0% of patients in the control group (p < 0.05). It was shown that there were statistically significant differences in the dynamics of changes in the total symptom score between the patients administered antibiotics and the antibiotic-naive patients. Conclusion: The use of MF within the delayed antibiotics prescription approach reliably improves the pattern of symptoms over time at the disease onset and significantly reduces the need for NSAIDs administration and antibiotics prescription frequency.
作者 Vasyl Popovych Ivanna Koshel Vitalii Leshak Oleksandr Malofiichuk Liubov Piletska Natalia Kapustina Oksana Martynnyk Volodimir Kuderskyi Vasyl Popovych;Ivanna Koshel;Vitalii Leshak;Oleksandr Malofiichuk;Liubov Piletska;Natalia Kapustina;Oksana Martynnyk;Volodimir Kuderskyi(Head Department of Surgery No. 1, Lviv Medical University, Lviv, Ukraine;E.N.T. Department, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine;E.N.T. Department, Uzhhorod National University, Uzhhorod, Ukraine;Municipal Non-Profit Institution Regional Clinical Hospital n. a. O. F.Herbachevskyi, Zhytomyr Region, Ukraine)
出处 《International Journal of Otolaryngology and Head & Neck Surgery》 2024年第5期321-343,共23页 耳鼻喉(英文)
关键词 RHINOSINUSITIS Mometasone Furoate Delayed Antibiotic Rhinosinusitis Mometasone Furoate Delayed Antibiotic
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