The efficacy of Miloxacin (MLX), a new synthetic antibacterial agent, was compared with that of Ampicillin (ABPC) for the treatment of bacillary dysentery patients or carriers in a double-blind trial.
MLX and ABPC were administered in a dosage of 2.0/day for a period of 5 days respectively.
Of 176 cases studied, 44 were excluded from the analysis of clinical evaluation.
The subjects of analysis were 132 cases; 62 received MLX and 70 ABPC.
There was no significant difference between the two groups in terms of the background factors, patients characteristics, serotype of Shigellae and resistance pattern, showing comparability of both groups.
The results obtained were as follows:
1) With respect to the efficacy for symptoms as evaluated by the effect on defervescence, disappearance of bloody stool, decrease of number of defecation and improvement in stool character, MLX group was found to be significantly superior to ABPC group in all of these symptoms but defervescence.
2) Effect on bacterial discharge:
Bacteriologically, 95.2% of the cases for MLX group and 54.3% for ABPC group were rated as effective, with significant difference favouring MLX group.
Among the subjects showing ABPC resistance, 100% of the cases for MLX group were rated as effective as compared to 35.7% for ABPC group
Among the subjects susceptible to ABPC, the rate of effective cases was 92.1 % for MLX group and 66.7% for ABPC group.
Thus, bacteriological superiority of MLX group to ABPC group was shown with significant difference.
3) Clinical symptoms as side effects were observed in one case of those receiving MLX (1.1%) and 4 cases receiving ABPC (4.5%).
No major abnormalities of laboratory data due to the drug therapy were observed except for increase of BUN and serum creatinine values in one case receiving ABPC.
The incidence of side effects showed no significant difference begween the two groups.
From these results, MLX is considered to be very useful in the treatment of patients with bacillary dysentery or carriers.
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