慢性気道感染症に対するgrepafloxacinとofloxacinの二重盲検比較試験

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  • Double-blind study on grepafloxacin in chronic respiratory tract infection.

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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.<BR>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.<BR>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.<BR>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.<BR>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.<BR>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.

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