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Original Articles
Efficacy and Safety of Flomoxef in the Treatment of Bacterial Infections (Phase III clinical trail)
Seungmin Kim, Namjoong Kim, Changdal Yoo, Hanjoo Paik, Eunbong Lee, Myoung-Don Oh, Kangwon Choe
Department of Internal Medicine, Seoul National University College of Medicine
Vol.12 Num.2 (p145~150)
To evaluate efficacy and safety of flomoxef, a new oxacephem antibiotics, aphase 3 clinical trial was done.
Fifty patients with proven or presumptive bacterial infections were randomly assigned to either flomoxef or cefotaxime. Age and sex distributions, underlying diseases and type of infections were similar in two treatment groups. Types of the infections of flomoxef group and cefotaxime group were bacteremia 4, 3; spontaneous bacterial peritonitis 6, 9; UTI 4, 5; pneumonia 4, 3; skin and soft tissue infections 3, 2; and cholangitis 2, 2, respectively.
Clinical response rate was 86% in flomoxef group, and 83% in cefotaxime group. One patient from each group, who was infected with E. faecalis infection, did not respond to the treatment. Two of the flomoxef group had transient elevation of transaminase, and one of the cefotaxime group developed skin rash, which subsided 2 days after discontinuation of the drug.
In conclusion, flomoxef may be safe and effective in the treatment of patients with bacterial infections.
Keywords : flomoxef, oxacephem, cefotaxime, clinical trial