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)
- Authors
- Park, Chan-Soon; Cho, Jin Hee; Lee, Heung-Man; Kim, Kyung-Su; Kim, Jin Kook; Kim, Dong-Young; Baek, Byoung Joon; Kim, Hyun Jun; Kim, Yong-Dae; Hwang, Chi Sang; Kim, Seon Tae; Cho, Seok Hyun; Kim, Yong Min; Lee, Seung Hoon; Jeong, Jin Hyeok; In, Seung Min; Kim, Byung Guk
- Issue Date
- Feb-2023
- Publisher
- SAGE PUBLICATIONS INC
- Keywords
- acute bacterial rhinosinusitis; cefdinir; cefetamet; comparative study; double-blinded method
- Citation
- ENT-EAR NOSE & THROAT JOURNAL, v.102, no.2, pp.101 - 109
- Journal Title
- ENT-EAR NOSE & THROAT JOURNAL
- Volume
- 102
- Number
- 2
- Start Page
- 101
- End Page
- 109
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/86901
- DOI
- 10.1177/01455613211036236
- ISSN
- 0145-5613
- 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.
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