A double-blind comparative study of prulifloxacin and ofloxacin in lower chronic respiratory tract infections

• Published in: Japanese Journal of Chemotherapy Vol. 45; no. 5; pp. 294 - 317
• 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; 慢性下気道感染症
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.45.294

The clinical efficacy, safety and usefulness of prulifloxacin (PUFX, NM 441), a new quinolone, were evaluated in lower chronic respiratory tract infections under a doubleblind 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 211 patients evaluated, 176 were evaluated for clinical efficacy. There was no significant bias among patients'back ground factors between the two groups except “property of sputum” and “chest pain” However, no influence on the drug evaluation from these biases was verified from the viewpoint of the statistical analysis test. 2. The clinical efficacy rates were 94.3%(83/88) in the PUFX group and 96.6%(85/88) in the OFLX group. Both groups showed high efficacy. The clinical equivalency of PUFX to OFLX was confirmed at Δ=10%. 3. The bacteriological elimination rates were 77.5%(31/40) in the PUFX group and 82.5%(33/40) in the OFLX group. 4. Side effects were noted in 1 of 94 patients (1.1%) in the PUFX group and in 5 of 97 patients (5.2%) in the OFLX group. 5. Abnormalities on laboratory findings were observed in 7.9%(7/89) of patients in the PUFX group and in 7.5%(7/93) of patients in the OFLX group. 6. The safety rates (“safe” in the overall safety) were 91.5%(86/94) in the PUFX group and 88.7%(86/97) in the OFLX group. 7. The usefulness rates (markedly useful+useful) were 94.3%(83/88) in the PUFX group and 94.4%(84/89) in the OFLX group. No significant difference was observed between the two groups in any of the above ratings. There results indicate that PUFX is one of the most highly effective drugs for the treatment of lower chronic respiratory tract infections.