The clinical efficacy, safety and usefulness of ciprofloxacin (CPFX), a new oral antimicrobial agent, were compared with those of pipemidic acid (PPA) in the treatment of the patients with infectious enteritis (shigellosis, campylobacter enteritis and acute enteritis by enteropathogenic
E. coli, etc.) by a double-blind method.
CPFX was administered orally in a dose of 300 mg/day, and PPA was administered orally 2000 mg/day. The duration of the treatment was five days.
Of 266 cases studied, 113 cases were excluded from the analysis of effectiveness. The effectiveness was evaluated in 153 cases; 74 received CPFX and 79 received PPA.
There were no significant differences between the two groups in terms of the background characteristics and distribution of MIC's for each drug.
The results obtained were as follows:
1. The bacteriological effect of CPFX was superior to that of PPA in all cases and the patients with
Shigella sp. (p<0.001). The eradication rates of
Shigella sp. were 96.9% in CPFX group and 91.4% in PPA group, respectively.
Duration required for eradication of organisms for CPFX group was significantly shorter than those for PPA group in all cases and the patients with
Shigella sp. (p<0.001).
2. The clinical effect of CPFX group, according to the doctors in charge was similar to that of the PPA group. There were no significant differences between the two groups in defervescence, decrease in number of defecation and improvement of stool character. However, in disappearence of bloody stool within three days, the CPFX group was superior to the PPA group (p<0.05).
3. Side effects were observed in two cases of the CPFX group (1.6%) and one case of the PPA group (0.8%). No significant difference was seen in their incidences between the two groups.
4. Slightly abnormal laboratory findings were seen in 14 cases in each group. No significant difference was seen in their incidences between the two groups.
5. In clinical usefulness judged by doctors in charge, the CPFX group was superior to the PPA group (p<0.001).
From these results, CPFX is considered to be a very useful medicine in treatment of the patients with infectious enteritis and carriers.
View full abstract