Comparative Clinical study of CS-807 and Cefaclor for Bacterial Pneumonia by a Double-Blind Method

Abstract

Efficacy, sefety and usefulness of CS-807, a new oral cephem, in the treatment of bacterial penumonia, were evaluated by the double blind comparative method using cefaclor (CCL) as a reference drug.
Patients with bacterial pneumonia were treated by oral administration of either 100 mg of CS-807 twice a day or of 500 mg of CCL three times a day for 14 days.
The following results were obtained.
1) Out of a total of 186 patients, 144 patients (75 with CS-807: 69 with CCL) were used for comparative evaluation of clinical efficacy. Out of the 144 patients (71 with CS-807: 67 with CCL) had bacterial pneumonia and lung abscess (bacterial pneumonia group) and 6 (4 with CS-807: 2 with CCL) had mycoplasmal pneumonia and primary atypical pneumonia. There was no significant difference in characteristics of the patients between the two treatment groups except that there were a significant number of patients with chest pain in the CCL group than those in the CS-807 group.
2) The clinical efficacy rate judged by committee members in the total cases was 86.7%(65/75) for the CS-807 group and 81.2%(56/69) for the CCL group, respectively. As for the bacterial pneumonia group, the rate was 85.9%(61/71) for the CS-807 group and 82.1%(55/67) for the CCL group, respectively. In both analyses, no significant difference was found between the two grups. According to the judgement by the doctors in charge, the clinical efficacy rate in the total cases was 86.7%(65/75) for the CS-807 group and 83.8%(57/68) for the CCL group, respectively. As for the bacterial pneumonia group, the rate was 85.9%(61/71) for the CS-807 group and 84.8%(56/66) for the CCL group, respectively. There was no significant difference between the two treatment groups in both analyses.
3) As for the bacteriological effectiveness in the bacterial pneumonia group, the eradication rate was 100%(18/18) for the CS-807 group and 85.7%(24/28) for the CCL group, respectively. There was no significant difference between the two treatment groups.
4) The incidence of side effects was 0%(0/89) for the CS-807 group and 3.5%(3/85) for the CCL group, respectively. The incidence of abnormalities in laboratory findings was noted in 19 of 80 cases (23.7%) for the CS-807 group and 21 of 78 cases (26.9%) for the CCL group, respectively. In both analyses, there was no significant difference between the two groups.
5) The utility rate judged by committee members in the total cases was 86.7%(65/75) for the CS-807 group and 77.1%(54/70) for the CCL group, respectively. As for the bacterial pneumonia group, the rate was 85.9%(61/71) for the CS-807 group and 79.1%(53/67) for the CCL group, respectively. In both analyses, no significant difference was found between the two groups. According to the judgement by doctors in charge, the utility rate in the total cases was 86.7%(65/75) for the CS-807 group and 76.8%(53/69), respectively. As for the bacterial pneumonia group, the rate was 85.9%(61/71) for the CS-807 group and 78.8%(52/66) in the CCL group, respectively.
There was no significant difference between the two treatment groups in both analyses.
As described above, the clinical efficacy and safety of CS-807 at a daily dose of 200 mg were equal to those of CCL at a daily dose of 1500 mg. From these results, it is concluded that CS-807 is an oral antibiotic which is very useful in the treatment of bacterial pneumonia.