Double-blind study on grepafloxacin in chronic respiratory tract infection

• Published in: Japanese Journal of Chemotherapy Vol. 45; no. 6; pp. 463 - 483
• 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; 慢性気道感染症
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.45.463

The clinical efficacy, safety, and usefulness of a new quinolone antibacterial agent, greparfloxacin (GPFX), in the treatment of chronic respiratory tract infections were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were administered by the oral route in a daily dose of 300mg q. d. and 200mg t. i. d., respectively, for 14 successive days, in principle. 1. The clinical efficacy rates of GPFX and OFLX in the 190 efficacy-evaluable patients among the 203 patients enrolled in the study were 90.3%(84/93) and 90.7%(88/97), respectively. The difference was not statistically significant, between the two groups, and the 90% confidence interval was-7.3% to 6.5%, demonstrating the clinical equivalency of both drugs. 2. The bacterial eradication rate was 72.9%(35/48) in the GPFX group, and 84.2%(32/38) in the OFLX group. The difference in rates between the two groups was not significant. 3. Adverse reactions were observed in 8.3%(8/96) of the patients in the GPFX group and 4.1%(4/98) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 12.2%(11/90) of the patients in the GPFX group and 6.7%(6/89) of the patients in the OFLX group. There were no significant differences in the occurrence of adverse reactions in the two groups. The safety rate was 79.3%(73/92) in the GPFX group and 88.8%(79/89) in the OFLX group. The rates were not significantly different. 4. The usefulness rate was 86.8%(79/91) in the GPFX group and 87.5%(77/88) in the OFLX group. The difference between the two groups was not statistically significant and the 90% confidence interval of-9.0% to 7.6% demonstrated the clinical equivalency of both drugs. The above results demonstrated that GPFX 300mg q. d. is equivalent in clinical usefulness to OFLX 200mg t. i. d. in the treatment of chronic respiratory tract infections.