Abstract
A multi-center double-blind three-group comparison study of sulbactam·ampicillin (SBT·ABPC) vs. ampicillin (ABPC) was performed to evaluate their efficacy, safety and usefulness in the treament of patients with respiratory tract infections. The clinical efficacy rated by Investigators' Judgment Committee was compared among three dosage groups of 3g SBT·ABPC, 6g SBT·ABPC and 4g ABPC. In the patients with pulmonary parenchymal infections, the efficacy rate was 82.5%, 92.1% and 94.6%, respectively. In chronic respiratory tract infections, that rate was 86.7%, 81.6% and 82.1%, respectively. All of these three groups showed excellent efficacy rates, and there were no significant differences among them. The bacterial eradication rate was 93.2%, 83.7% and 85.4% respectively, suggesting that there were no significant differences in the bacteriological efficacy among the three dosage groups. The MICs, determined at a central laboratory, indicated that almost all the strains were sensitive to SBT·ABPC and many to ABPC alone. The MICs of ABPC were 25 μg/ml and above against 13 strains, whereas those of SBT·ABPC were 2-to 5-fold lower. All dosage groups exhibited high usefulness rates with a low incidence of side effects and parameter abnormalities in laboratory tests, suggesting no significant differences in safety and usefulness. The results obtained in this study indicate that SBT·ABPC is useful in the treatment of patients with respiratory tract infections.
Original language | English |
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Pages (from-to) | 272-291 |
Number of pages | 20 |
Journal | Chemotherapy |
Volume | 36 |
DOIs | |
Publication status | Published - 1988 |
Externally published | Yes |
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology