The clinical efficacy, safety and usefulness of cefoselis (FK 037, CFSL), a new parenteral cephalosporin, were evaluated in bacterial pneumonia in a comparative study with ceftazidime (CAZ). Each drug was administered by intravenous drip infusion at a dose of 1.0 g (potency), twice daily for 14 days. The following results were obtained. 1. Of the total 178 patients enrolled, 138 were evaluated for clinical efficacy and the efficacy rates ('good' and better responses) were 91.9% (68/74) in the CFSL group and 92.2% (59/64) in the CAZ group. 2. Bacteriological effects (eradication rates) were 100% (18/18) in the CFSL group and 96.0% (24/25) in the CAZ group. 3. Adverse reactions occurred in 3 of the 66 patients (3.5%) in the CFSL group and in 3 of the 84 patients (3.6%) in the CAZ group. The incidence of abnormal laboratory findings was 20.9% (18/86) in the CFSL group and 19.0% (15/79) in the CAZ group. The safety rate ('safe' in the overall safety rating) was 77.9% (67/86) in the CFSL group and 81.0% (64/79) in the CAZ group. 4. Usefulness rates ('useful' and better responses) were 89.2% (66/74) in the CFSL group and 87.5% (56/64) in the CAZ group. No significant difference was observed between the two groups in any of the above ratings. The results indicate that cefoselis is as useful as ceftazidime for the treatment of bacterial pneumonia. This paper reports clinical results excluding cases violating Good Clinical Practice (GCP) found after publication of our previous paper in 'Jpn. J. Chemother.' (Vol. 43, No. 4, 1995).
|Number of pages||18|
|Journal||Japanese Journal of Chemotherapy|
|Publication status||Published - 1996|
- FK 037
ASJC Scopus subject areas
- Pharmacology (medical)