Double-blind study on grepafloxacin in pneumonia

• Published in: Japanese Journal of Chemotherapy Vol. 45; no. 6; pp. 442 - 462
• 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: grepafloxacin; ofloxacin; OPC-17116; 二重盲検比較試験; 肺炎
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.45.442

The clinical efficacy, safbty, and u8efUlness of a new quinolone synthetic antibacterial agent, grepafloxacin (GPFIX), in the treatment of pneumonia were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were admini8tered by the oral route at a daily dose of 300mg q. d. and 200mg t. i. d., respectively, for 14 successive days, in principle. 1. The clinical efficacy rate of GPFX and OFLXin the 225 efficacy-evaluable patients among the 256 patients enrolled in the study was 96.4%(108/112) and 92.9%(105/113), respectively.The difference between the two groups was not statistically significant, and the 90% confidence interval of-1.4% to 8.4% demonstrated the clinical equivalency of the two drugs. 2. The bacterial eradication rate was 96.4%(27/28) in the GPFX group and 97.0%(32/33) in the OFLX group. The rates were not significantly different. 3. Adverse reactions were observed in 2.4%(3/125) of the patients in the GPFX group and 5.0%(6/120) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 15.8%(19/120) of the patients in the GPFX group and 11.4%(13/114) of the patients in the OFLX group. The differences between the two groups were not statistically significant. The safety rates were 81.8%(98/121) in the GPFX group and 83.5%(96/115) in the OFLX group. The rates were not significantly different. 4. The usefulness rates were 94.5%(104/110) in the GPFX group and 91.0%(101/111) in the OFLX group. The difference between the two groups was not statistically significant, and the 90% confidence interval of-2.2% to 9.3% demonstrated clinical equivalency of the two drugs. The above findings demonstrate that GPFX at 300mg q.d. is equivalent to OFLX at 200mg t.i.d. in clinical usefulness in the treatment of pneumonia.