Presse medicale (Paris, France : 1983) · 1996
[Treatment of non-complicated acute cystitis in women: lomefloxacin versus pefloxacin].
Клиническое исследованиеСравнительное исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Guibert J, Capron M H, Giacomino A
Аннотация
OBJECTIVES: Compare the acceptability of a 3-day regimen with that of a single-dose regimen of fluoroquinolones for the treatment of lower urinary tract infection in women.
METHODS: A multicentric, randomized open trial was conduced in 595 patients by general practitioners to determine acceptability, efficacy and tolerance of lomefloxacine 400 mg in a once a day dose given for three days compared with a once-a-day 800 mg dose of pefloxacin for the treatment of lower urinary tract infection in women.
RESULTS: The delay to symptom relief was greater than 24 hours in both treatment groups. Symptom relief was observed after treatment onset in only 23% of the patients. Clinical success rate at day 14 was 94.2% for lomefloxacin and 95.7% for pefloxacin. The rates of bacteriological eradication were 90.6% and 92.8% respectively with no significant difference. Adverse events were reported in 27.1% and 33.3% of the patients respectively, digestive disorders (abdominal pain, nausea) and neurosensorial disorders (headache, dizziness) predominated. There was no serious adverse event. The incidence of adverse events related to the treatment according to the investigator was smaller with lomefloxacin (16.1%) than with pefloxacin (23.5%) (p = 0.026).
CONCLUSION: Acceptability, assessed at day 14, was not significantly different between the two treatment groups. Lomefloxacin was the only antibiotic currently authorized for use in a three-day regimen for the treatment of lower urinary tract infections.
METHODS: A multicentric, randomized open trial was conduced in 595 patients by general practitioners to determine acceptability, efficacy and tolerance of lomefloxacine 400 mg in a once a day dose given for three days compared with a once-a-day 800 mg dose of pefloxacin for the treatment of lower urinary tract infection in women.
RESULTS: The delay to symptom relief was greater than 24 hours in both treatment groups. Symptom relief was observed after treatment onset in only 23% of the patients. Clinical success rate at day 14 was 94.2% for lomefloxacin and 95.7% for pefloxacin. The rates of bacteriological eradication were 90.6% and 92.8% respectively with no significant difference. Adverse events were reported in 27.1% and 33.3% of the patients respectively, digestive disorders (abdominal pain, nausea) and neurosensorial disorders (headache, dizziness) predominated. There was no serious adverse event. The incidence of adverse events related to the treatment according to the investigator was smaller with lomefloxacin (16.1%) than with pefloxacin (23.5%) (p = 0.026).
CONCLUSION: Acceptability, assessed at day 14, was not significantly different between the two treatment groups. Lomefloxacin was the only antibiotic currently authorized for use in a three-day regimen for the treatment of lower urinary tract infections.