Cefuroxime axetil (CXM-AX) was evaluated objectively for its efficacy, safety and usefulness in suppurative otitis media (acute infections and acute exacerbation of chronic infections), in an intergroup double blind manner using Cefaclor (CCL) as the comparator. In both CXM-AX and CCL groups, the drug was orally administered (after meals) in the dose of 250mg t. i. d., for seven days in principle.
1. As to the clinical effectiveness in all the cases, the efficacy rates of CXM-AX and CCL were 70.3% (83/118) and 57.9% (70/121), respectively, in the assessment by the doctors in charge, and 61.9% (73/118) and 54.5% (66/121), respectively, in the assessment by the committee, with no statistically significant difference between the two treatment groups either in the doctor's or in the committee's assessment (either in χ
2-test or in e-test). However, clinical effectiveness assessed by the committee in the cases of acute exacerbation of chronic suppurative otitis media was significantly better in CXM-AX group (U-test). Also clinical effectiveness in monomicrobial infections by Gram positive organisms was significantly better in CXM-AX group both in the doctor's and the committee's assessments (both in U-test and in χ
2-test).
2. In the overall improvement rates assessed on the 3rd and the 7th day of dosing, no significant difference was observed between the two treatment groups. However, when the improvements in subjective symptoms and objective findings were evaluated on the 7th day, the improvements in feeling of ear obstruction and volume and properties of otorrhea were significantly better in CXM-AX group both in the total cases and in acute exacerbation cases of chronic suppurative otitis media.
3. The bacteriological response was significantly better in CXM-AX group both in all the cases and in the cases of acute exacerbation of chronic suppurative otitis media. The complete bacterial elimination rates (excluding ‘replacement’ of organism) in all the cases. were 70.2% (73/104) in CXM-AX group and 55.6% (60/108) in CCL group, being significantly higher in CXM-AX group. However, in the elimination rates (including ‘replacement’ of organism), there was no significant difference. The bacteriological response of CXM-AX was significantly better than that of CCL in monomicrobial infections by Gram positive organism when it was assessed by infection type, and against
S. aureus when it was assessed for each species isolated.
4. With regard to overall safety, no significant difference was observed between the two groups. Adverse events, mainly gastrointestinal tract symptoms, were observed in 4 cases out of 127 (3.1%) in CXM-AX group, and in 7 cases out of 128 (5.5%) in CCL group, without statistically significant difference. Abnormal laboratory findings were noted only in 1 case in each of the treatment groups.
5. Clinical usefulness was significantly higher in CXM-AX group in all the cases and in the cases of acute exacerbation of chronic suppurative otitis media.
The above results suggest that CXM-AX is a highly useful drug for the treatment of suppurative otitis media.
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