産婦人科領域におけるgatifloxacinの基礎的・臨床的検討

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  • Basic and Clinical Studies on Gatifloxacin in Obstetrics and Gynecology

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We performed a cliniclal study on gatifloxacin, a new oral fluoroquinolone antimicrobial agent, to evaluate its clinical efficacy, safety and utility in obstetrical and gynecological infections. In addition to clinical utility, its penetration into genital tissues was also examined.<BR>1. Examination of tissue penetration:<BR>After oral administration of 100, 150, and 200 mg of gatifloxacin, the concentration was determined in serum and endometrium, myometrium, cervix uteri, portio vaginalis, ovary, and oviduct. The ratio of serum concentrations were 0.69-3.07 times in each tissue. These results suggest good tissue penetration with gatifloxacin.<BR>2. Examination of clinical effect, bacteriological effect, and safety:<BR>Gatifloxacin at 100, 150, and 200 mg was administered to 121 patients with intrauterine infection, adnexitis, externalia infection, cervicitis, and mastitis, in once or twice a day doses.<BR>(1) Clinical effect: Of 121 cases treated with gatifloxacin, 80 qualified for efficacy evaluation and 41 were excluded.The clinical effect of intrauterine infection, adnexitis, externalia infection, cervicitis, and mastitis was 97.2%(35/36), 92.3%(12/13), 100%(13/13), 100%(12/12), 6/6, resnectively.Total clinical effects were 97.5 %.<BR>(2) Bacteriological effect: The bacteriological effects were evaluated in 45 cases.The overall eradication rate was 88.9%, and the eradication rate against 74 isolated strains was 93.2%.<BR>(3) Safety: Adverse reactions were observed in 2 cases, which were nausea in 1 case and heaviness in the head/systemic fatigue in 1 case.Laboratory findings were noted in cases evaluated.<BR>(4) Utility: Utility was evaluated in 82 cases as follows: markedly useful, 7 cases;useful, 71 cases;slightly useful, 1 case;and useless, 3 cases. The utility rate was 95.1%.<BR>The results of this study indicate that gatifloxacin is clinically useful against obstetric and gynecological infections such as intrauterine infection, adnexitis, externalia infection, cervicitis and mastitis.

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