[Oral pefloxacin in the treatment of acute gastroenteritis].

UNLABELLED

In the case of travellers' diarrhoea, in order to reduce to a minimum the period of sickness and temporary invalidity, suitable therapy needs to be undertaken, involving the reintegration of fluids and electrolytes, as well as antibiotic treatment whose spectrum of action covers the most commonly isolated microorganisms. The aim of the study was to verify the rapidity of the antibacterial action of pefloxacin in the treatment of this type of gastrointestinal infection.

MATERIALS AND METHODS

The patients enrolled were treated for 5 days with pefloxacin in tablets containing 400 mg of the active agent, given orally. Treatment involved a first dose of 800 mg (2 tablets in a single administration), followed by 400 mg twice a day (1 tablet every 12 hours). Administration was carried out prevalently at mealtimes. At the end of treatment a two-week follow-up period was scheduled. At the beginning of the study, and after 5 days' treatment, a coproculture was carried out, with identification of the germ responsible for the infection. The study was carried out in accordance with the principles of the Helsinki declaration and its revisions, in particular each patient gave his/her informed consent to participate in the trial.

RESULTS

Thirty patients enrolled in the study (16 males, 14 females), of mean age 48.2 years (18-82 min-max), mean weight of 66.3 kg (46-88 min-max), suffering from acute gastroenteritis. The coproculture carried out at the baseline for all patients led to the isolation in 10 patients, of 10 pefloxacin-sensitive GRAM-negative bacterial strains: Salmonella spp. in 6 cases, Shigella spp. in 2, Escherichia coli in 1 and Yersinia enterocolitica in 1. At the end of treatment and follow-up the coproculture indicated that all the germs isolated initially had been eradicated and no cases of superinfection or reinfection occurred. The number of daily evacuations gradually decreased from a mean of 6.8 at the baseline to 1.1 on the fifth day (p<0.0001). The consistency of faeces had increased in a significant fashion by the third day and at the end of treatment 93.3% of patients had well-formed faeces. In the course of treatment abdominal pain, nausea and vomiting decreased progressively and body temperature returned within normal limits by the third day. Safety was excellent in 93.3% of patients, with one case of nausea and one of erythema, which resolved spontaneously in the course of treatment. At the end of treatment with pefloxacin, the physician expressed his final judgment of efficacy, which was excellent in 86.7% of cases (26/30) and good in 13.3% (4/30), in accordance with the clinical evaluation of recovery in 93.3% of cases (28/30) and of improvement in 6.7% (2/30).

CONCLUSIONS

In forms of acute gastroenteritis in which coproculture shows the presence of germs sensitive to pefloxacin, the use of this quinolone guarantees a high percentage of success with a short course of treatment.