Comparison of Clinical Efficacy of Ofloxacin (OFLX: DL-8280) and Pipemidic Acid (PPA) in Acute Infectious Diarrhea by a Double-Blind Method

Abstract

The effect of ofloxacin (OFLX: DL-8280), a new oral antibacterial agent, was compared with that of pipemidic acid (PPA) on infectious enteritis (bacillary dysentery, campylobacter enteritis and acute enteritis caused by EPEC and ETEC) by a double-blind method.
OFLX was administered in a dose of 600mg/day, and PPA was administered 2, 000mg/day.
The duration of the treatment was five days with both drugs.
Of 251 cases studied, 107 cases were excluded from the analysis of effectiveness.
The effectiveness was evaluated in 144 cases; 77 received OFLX and 67 received PPA.
There was no significant difference between both groups in terms of the background factors.
The results obtained were as follows:
1) OFLX group was as same as PPA group in clinical effect judged by doctors in charge.
2) There was no significant difference between both groups in defervescence, disappearance of bloody stool, decrease in number of defecation and improvement of stool character.
3) Bacteriological effect of OFLX was superior to that of PPA with Shigella spp.
4) Days required for eradication of organisms were shorter for OFLX group than those for PPA group with significant difference in Shigella cases.
5) Side effects were observed in one case of OFLX group (0.8%) and three cases of PPA group (2.6%). No significant difference was seen in their incidences between both groups.
6) Slightly abnormal laboratory findings were seen in eight cases of OFLX group and three cases of PPA group.
7) OFLX group (88.5%) was superior to PPA group (71.4%) in clinical usefulness judeged by doctors in charge.
From these results, OFLX is considered to be very useful medicine in the treatment of patients with bacillary dysentery or carriers.