Abstract
The clinical efficacy, safety and usefulness of biapenem (BIPM), a carbapenem antibiotic for injection, were evaluated in lower respiratory infections in a comparative study with imipenem/cilasstatin (IPM/CS). BIPM and IPM/CS were administered by intravenous drip infusion at a dose of 300 mg twice daily and 500 mg/500 mg twice daily. The duration of treatment was within 14 days. The following results were obtained. 1. A total of 214 cases were enrolled in this study, consisting of 103 in the BIPM group and 111 in the IPM/CS group. The clinical efficacy was evaluated in 88 of the BIPM group and 93 of the IPM/CS group, the overall safety was evaluated in 101 of the BIPM group and 110 of the IPM/CS group, and the usefulness was evaluated in 89 of the BIPM group and 101 of the IPM/CS group. 2. The clinical efficacy rates were 93.2% (82/88) in the BIPM group and 91.4% (85/93) in the IPM/CS group. The 90% confidence interval of the difference between the two groups was -5.8% to 9.4%, and the clinical non inferiority of BIPM to IPM/CS was demonstrated. For the evaluation of early onset after 3 days of treatment, the early clinical efficacy rates were 84.1% (74/88) in the BIPM group and 76.3% (71/93) in the IPM/CS group, with no significant difference between the two groups. 3. The bacteriological eradication rates were 89.1% (41/46) in the BIPM group and 97.5% (39/40) in the IPM/CS group, with no significant difference between the two groups. 4. Side effects were observed at a rate of 1.9% (2/103)in the BIPM group and 6.3% (7/111) in the IPM/CS group, with no significant difference between the two groups. Abnormal laboratory findings were observed at a rate of 26.2% (27/103) in the BIPM group and 43.2% (48/111) in the IPM/CS group, with significant difference between the two groups. The safety rates were 98.0% (99/101) in the BIPM group and 96.4% (106/110) in the IPM/CS group, with no significant difference between the two groups. 5. The usefulness rates were 88.8% (79/89) in the BIPM group and 81.2% (82/101) in the IPM/CS group, with no significant difference between the two groups. These results demonstrate that BIPM is a useful drug for the treatment of lower respiratory tract infections.
Original language | English |
---|---|
Pages (from-to) | 45-67 |
Number of pages | 23 |
Journal | Japanese Journal of Chemotherapy |
Volume | 48 |
Issue number | 1 |
Publication status | Published - 2000 |
Externally published | Yes |
Keywords
- Biapenem
- Imipenem/cilastatin
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)