Evaluation of Flomoxef (FMOX) in the treatment of purulent otitis media

A double-blind comparative clinical trial with Cefotiam (CTM)

Abstract

The clinical efficacy, safety, safety and usefulness of Flomoxef (FMOX) in treating suppurative otitis media (acute otitis media and acute exacerbation of chronic otitis media) were investigated by means of a double-blind comparative clinical trial using Cefotiam (CTM) as the control antibiotic. The total daily dosage for both antibiotics was 2 grams (potency), administered by intravenous injection in two 1 gram doses. Treatment was usually continued for seven consecutive days. The total number of patients in the study was 234.186 of these patients were used to analyze the clinical efficacy (94: FMOX analysis, 92 CTM analysis). 1. Committee analysis of the clinical efficacy of treatment for both acute and chronic forms of purulent otitis media showed efficacy rates of 58.5% for the FMOX group and 54.3% for the CTM group. Efficacy rates determined by the investigators' evaluations gave FMOX an efficacy of 68.1% and CTM, 59.8%. The differences in efficacy of the two drugs for both analyses were not statistically significant. For treatment of acute exacerbation of chronic suppurative otitis media, the committee rated FMOX to have a clinical efficacy of 57.5%, and CTM, 50.0%. The efficacy of FMOX was significantly higher (p=0.031). For cases of acute purulent otitis media, the committee rated the efficacy of FMOX to be 64.3% and CTM to be 90.0%. In these cases, the efficacy rate of CTM was significantly higher (p=0.032). 2. The bacterial eradication rates were not significantly different. Eradication of the causative microbes was 67.1% for the FMOX group and 61.4% in the CTM group. 3. Side effects developed in 7 Patients undergoing FMOX treatment, and in 4 patients undergoing CTM treatment. Abnormal laboratory test values were detected in 6 FMOX patients and 7 CTM patients. There were no significant differences between the two groups with regard to the incidence of side effects or abnormal laboratory findings. On the basis of the above results, FMOX is concluded to be an antibiotic whose usefulness can be favorably compared to CTM in treating types of suppurative otitis media, including acute exacerbation of chronic suppurative otitis media.