We eompared the clinical efficacy, safety and utility of ciprofloxacin (CPFX) in the treatment of patients with obstetrical and gynecological infections with those of cefroxad ine (CXD) in a doubleblind study. As both drugs are oral antimicrobials, the target diseases were intra-uterine infection, adnexitis, bartholinitis and Bartholin's abscess. Patients were given either 200 mg of CPFX or 500 mg of CXD three times a day for 7 days. A total 253 patients were entered into this study and 209 patients were evaluated for efficacy by the committee. The following results were obtained.
1. The clinical efficacy rate on the basis of committee judgement was 79.8%(83/104) in the CPFX group and 75.2%(79/104) in the CXD group. The difference between the groups was not significant. In adnexitis there was a tendency to better results with the CPFX group than the CXD group (p<0.10).
2. The bacteriological eradication rate was 80. 3%(49/61) in the CPFX group and 80. 7%(46/57) in the CXD group. This difference was not significant.
3. Overall clinical efficacy was assessed by the committee on the basis of clinical efficacy and bacteriological response. The overall clinical efficacy rate was 79. 8%(83/104) in the CPFX group and 75.2%(79/105) in the CXD group. Again, this difference was not significant. Classified by diagnosis, the rate in adnexitis was 81.8%(27/33) in the CPFX group and 59. 3%(16/27) in the CXD group. This difference was significant (p<0.05). In intra-uterine infection, the rate was 85.4%(35/41) in the CPFX group and 89.1%(41/46) in the CXD group, and in bartholinitis and Bartholin's abscess it was 70.0%(21/30) in the CPFX group and 68.8%(22/32) in the CXD group. These differences were not significant.
4. The clinical improvement rates according to the doctors in charge were high in both the CPFX group 88.5%(92/104) and the CXD group 83.8%(88/105).
5. Adverse reactions were observed in 2 out of 124 patients (1.6%) given CPFX and in 2 out of 128 patients (1.6%) given CXD. Abnormal changes in laboratory findings were noted in 3 patients (2.5%) on CPFX and in 3 patients (2.3%) on CXD. However no serious adverse reactions or abnormal changes in laboratory findings were observed.
6. The utility rates according to the doctors in charge were satisfactory in both the CPFX group 88.6%(93/105) and the CXD group 83.8%(88/105), There was no significant difference between the groups. In adnexitis, there was a tendency to better results in the CPFX group than the CXD group (p<0.10).
From these results, we conclude that CPFX is useful in the treatment of patients with obstetrical and gynecological infections.
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