Clinical Trial to Reconfirm the Efficacy and Safety of Cefetamet Pivoxil Treatment in Sinusitis Patients: A Double-Blind, Randomized, Parallel Designed, Multicenter, Active Comparator Study (CASIS Study)
- Abstract
- OBJECTIVE: To evaluate the clinical efficacy and safety of cefetamet pivoxil for the treatment of acute bacterial rhinosinusitis in Korean patients compared to treatment with cefdinir. METHODS: A prospective, multicenter, randomized double-blind, comparative study was conducted by the Departments of Otorhinolaryngology-Head and Neck Surgery at 17 hospitals or universities in the Republic of Korea from March 2017 to April 2019. A total of 309 patients were screened and 249 patients participated in the study. RESULTS: Treatment with cefetamet pivoxil for 2 weeks showed 82.4% clinical cure and improvement rates in patients with acute bacterial rhinosinusitis compared to 84.68% in those taking cefdinir for 2 weeks, showing that cefetamet pivoxil administered twice a day for 2 weeks was as effective as cefdinir 3 times a day for 2 weeks for the treatment of acute bacterial rhinosinusitis. The overall adverse reaction rates of both drugs were 10.56% in the cefetamet pivoxil group and 15.49% in the cefdinir group, without serious adverse events or drug reactions. CONCLUSIONS: Cefetamet pivoxil twice a day was as efficacious and safe as cefdinir 3 times a day for the treatment of acute bacterial rhinosinusitis, which suggested that cefetamet pivoxil may be a suitable alternative to cefdinir.
- All Author(s)
- C. S. Park
; J. H. Cho
; H. M. Lee
; K. S. Kim
; J. K. Kim
; D. Y. Kim
; B. J. Baek
; H. J. Kim
; Y. D. Kim
; C. S. Hwang
; S. T. Kim
; S. H. Cho
; Y. M. Kim
; S. H. Lee
; J. H. Jeong
; S. M. In
; B. G. Kim
- Issued Date
- 2021
- Type
- Article
- Keyword
- acute bacterial rhinosinusitis; cefdinir; cefetamet; comparative study; double-blinded method
- ISSN
- 0145-5613
- Citation Title
- Ear, Nose & Throat Journal
- Citation Volume
- 102
- Citation Number
- 2
- Citation Start Page
- 101
- Citation End Page
- 109
- Language(ISO)
- eng
- DOI
- 10.1177/01455613211036236
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2318
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