産婦人科領域感染症に対するｇｒｅｐａｆｌｏｘａｃｉｎとｏｆｌｏｘａｃｉｎの二重盲検比較試験成績

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  • Double-blind comparative study on grepafloxacin and ofloxacin in infectious diseases in the obstetric and gynecological field.

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We conducted a double-blind comparative study of grepafloxacin (GPFX), a new oral quinolone antimicrobial agent, in order to evaluate its clinical efficacy, safety, and usefulness in patients with obstetric and gynecological infections, and used ofloxacin (OFLX) as the reference drug. GPFX and OFLX were administered orally to the patients at doses of 300 mg q. d. and 200 mg t. i. d., respectively, for consecutive 7 days.<BR>1) Clinical efficacy<BR>Of the 244 patients treated with GPFX or OFLX, 201 were included in the evaluation of clinical efficacy. The efficacy rate [(excellent+good)/total] was 98.0%(98/100) in the GPFX group and 93.1%(94/101) in the OFLX group and the difference between the groups not significant. The 90% confidence level for the difference in efficacy ranged from 0.2% to 9.7%. These results domonstrate that the efficacy of GPFX and OFLX is equivalent.<BR>2) Bacteriological effect<BR>The bacteriological effects of GPFX and OFLX were evaluatedin 118 patients. The eradication rates were 89.7%(52/58) and 95.0%(57/60), respectively, showing no significant difference between the groups.<BR>3) Adverse events and abnormal laboratory values<BR>The incidence of adverse events was 7.6%(9/119) in the GPFX group and 6.0%(7/117) in the OFLX group. The incidence of abnormal laboratory valueswas 4.8%(5/104) in the GPFX group and 0.9%(1/108) in the OFLX group. No significant difference was observed between the groups.<BR>4) Safety<BR>The safety rates (safe/total) were 86.8%(92/106) in the GPFX group and 92.7%(101/109) in the OFLX group, showing no significant difference between the groups.<BR>5) Usefulness<BR>The usefulness rates [(very useful+useful)/total] were 91.4%(85/93) in the GPFX group and 90.5%(86/95) in the OFLX group, showing no significant differences between these groups. The 90% confidence level ranged from-6.0% to 7.7%. These results demonstrate that the usefulness of GPFX and OFLX was equivalent.<BR>These above findings confirmed that the clinical usefulnessof GPFX 300 mg q. d. and OFLX 200 mg t. i. d. is equivalent in patients with obstetric and gynecological infections.

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