Presse medicale (Paris, France : 1983) · 2006
[Treatment of acute maxillary sinusitis in adults. Comparison of cefpodoxime-proxetil and amoxicillin-clavulanic acid].
Сравнительное исследованиеОценочное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Polonovski Jean-Michel, El Mellah Mohcen
Аннотация
OBJECTIVE: The aim was to demonstrate the equivalence of the clinical efficacy and safety of cefpodoxime-proxetil (200 mg bid for 5 days) to that of amoxicillin-clavulanic acid (1 g/125 mg bid for 8 days) in adults with acute maxillary sinusitis.
METHOD: In this prospective, multicenter, centrally-randomized, open-label study, 73 general practitioners and 11 ear, nose, and throat specialists included 512 patients with unilateral acute maxillary sinusitis.
RESULTS: The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity.
CONCLUSION: In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8 days with a significantly better safety profile and compliance.
METHOD: In this prospective, multicenter, centrally-randomized, open-label study, 73 general practitioners and 11 ear, nose, and throat specialists included 512 patients with unilateral acute maxillary sinusitis.
RESULTS: The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity.
CONCLUSION: In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8 days with a significantly better safety profile and compliance.