A double-blind comparative study of prulifloxacin and ofloxacin in bacterial pneumonia

• Published in: Japanese Journal of Chemotherapy Vol. 45; no. 5; pp. 271 - 293
• Main Author: Kobayashi, Hiroyuki
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 1997; 公益社団法人 日本化学療法学会
• Subjects: ofloxacin; prulifloxacin; 二重盲検比較試験; 細菌性肺炎
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.45.271

The clinical efficacy, safety and usefulness of prulifloxacin (PUFX, NM 441), a new quinolone, were evaluated in bacterial pneumonia under a double-blind comparative study with ofloxacin (OFLX). PUFX was administered orally at a dose of 300mg twice daily and OFLX at a dose of 200mg three times daily. The following results were obtained. 1. Of the total 201 patients evaluated, 156 were evaluated for clinical efficacy. There was no significant bias among patients'back ground factors between the two groups. 2. The clinical efficacy rates were 96.5%(82/85) in the PUFX group and 93.0%(66/71) in the OFLX group.Both groups showed high efficacy.The clinical equivalency of PUFX to OFLX was confirmed atΔ=10%. 3. The bacteriological elimination rates were 90.3%(28/31) in the PUFX group and 95.2%(20/21) in the OFLX group. 4.Side effects were noted in 2 of 97 patients (2.1%) in the PUFX group and in 3 of 90 patients (3.3%) in the OFLX group. 5. Abnormalities on laboratory findings were observed in 16.0%(15/94) of patients in the PUFX group and in 16.1%(14/87) of patients in the OFLX group. 6. The safety rates (“safe” in the overall safety) were 82.5%(80/97) in the PUFX group and 82.2%(74/90) in the OFLX group. 7. The usefulness rates (markedly useful+useful) were 94.2%(81/86) in the PUFX group and 89.0%(65/73) in the OFLX group. No significant difference was observed between the two groups in any of the above ratings. These results indicate that PUFX is one of the most highly effective drugs for the treatment of bacterial pneumonia.