A comparative study of biapenem and imipemem/cilastatin in lower respiratory infections.

Accession number;00A0221182
Title;A comparative study of biapenem and imipemem/cilastatin in lower respiratory infections.
Author; MATSUMOTO FUMIO (Kanagawa Prefect. Hosp. Affil. to Prefect. Nurses Sch.) WATANABE AKIRA (Res. Inst. Tuberculosis and Cancer, Tohoku Univ.) WADA KOICHI (National Sanatorium Nishi-Niigata-Chuo Byoin, JPN) ODAGIRI SHIGEKI (Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center) MIKI FUMIO (Kikkokai Tane Hosp.) MATSUSHIMA TOSHIHARU (Kawasaki Med. Sch.) OIZUMI KOTARO (Kurume Univ., Fac. of Med.) NAKASHIMA MITSUYOSHI (Hamamatsu Univ. Sch. of Med.) YAMAGUCHI KEIZO (Toho Univ., Sch. of Med.)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.48;NO.1;PAGE.45-67(2000)
Figure&Table&Reference;FIG.1, TBL.24, REF.12
Pub. Country;Japan
Language;Japanese
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 300mg twice daily and 500mg/500mg 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.... (author abst.)