Abstract
To evaluate the efficacy, safety and usefulness of S-1108, a new ester-type oral cephem antibiotic, in bacterial pneumonia, we carried out a double-blind comparative study with cefotiam hexetil (CTM-HE) in collaborating institutions. S-1108 at a daily dose of 450 mg (divided in 3 doses) and CTM-HE at a daily dose of 600 mg (divided in 3 doses) were orally administrated for 14 days, and the following results were obtained: 1) The number of patients who were given the study drugs was 132 (S-1108 group: 64, CTM-HE group: 68). The number of evaluable patients for clinical efficacy, side effects, abnormal laboratory values and usefulness were 108 (S-1108 group: 49, CTM-HE group: 59), 126 (S-1108 group: 61, CTM-HE group: 65), 114 (S-1108 group: 61, CTM-HE group: 53) and 109 (S-1108 group: 49, CTM-HE group: 60), respectively. 2) The efficacy rates for bacterial pneumonia were 90.9% in the S-1108 group and 82.1% in the CTM-HE group, showing no significant differences between the two groups. 3) There were no significant differences between the two groups with respect to the degree of improvement in subjective and objective signs, or laboratory values except for ESR on the 7 th and 14 th day of treatment (p=0.0009 and p=0.0068, respectively), and CRP on the 3 rd day and 14th day of treatment (p=0.0160 and p=0.0440, respectively) in all of which S-1108 was superior. 4) As for the bacteriological effects, the elimination rates of causative organisms were 94.7% in the S-1108 group and 73.1% in the CTM-HE group, with no significant differences. 5) Side effects were observed in 3 patients (4.9%) in the S-1108 group and 5 patients (7.7%) in the CTM-HE group, and abnormal changes in laboratory findings in 18 patients (29.5%) in the S-1108 group and 10 patients (18.9%) in the CTM-HE group, again showing no significant differences. 6) The utility rates (satisfaction rate) for bacterial pneumonia were 90.9% in the S-1108 group and 77.2% in the CTM-HE group, with no significant differences between the two groups. The above results indicate that S-1108 in daily doses of 450 mg is as useful as CTM-HE in daily doses of 600 mg in the treatment of bacterial pneumonia.
Original language | English |
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Pages (from-to) | 451-475 |
Number of pages | 25 |
Journal | Chemotherapy |
Volume | 42 |
Issue number | 4 |
DOIs | |
Publication status | Published - 1994 |
Externally published | Yes |
Keywords
- Bacterial penumoniae
- Double blind study
- S-1108
- cefotiam hexetil
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology