Summary
The efficacy and tolerability of fosfomycin trometamol in a single dose of 3 g was compared with norfloxacin 400 mg b.i.d. for seven days in the treatment of adult female patients with uncomplicated urinary infections. 158 female patients with a mean age of 30 years who presented symptoms of dysuria and frequency with documented pyuria and bacteriuria on urinalysis (≥ 105 cfu/ml of urine) were initially included in the study. The total number of clinically and bacteriologically evaluable patients was 111, of which 61 received fosfomycin trometamol and 50 norfloxacin. One to two days after the double blind medication schedule for seven days, 55 of 60 patients (92%) in the fosfomycin trometamol group and 48 of 50 patients (96%) in the norfloxacin group were clinically cured. 37 patients without significant bacteriuria showed a clinical cure rate of over 90% in both therapy groups. Two to three days after the single dose treatment with fosfomycin trometamol the initial infecting pathogen was eradicated in 60 of the 61 patients (98%). One to two days after a seven day treatment with norfloxacin 48 of 50 patients (96%) showed an eradication of the initial infecting pathogen. Six weeks after the start of therapy 39/60 patients (65%) and 32/49 (65%) in the fosfomycin trometamol and norfloxacin groups respectively, remained free from urinary infection. The reinfection rate in both treatment groups was approximately 25%. The relapse rate in the post treatment evaluation period of four weeks was relatively low in both therapy groups, 5/49 patients (10%) in the norfloxacin group and 3/55 patients (6%) in the fosfomycin trometamol group, respectively. Adverse effects, which were classified as ‘probably’ drug related, were mentioned by 10/79 of the patients (13%) and by 2/79 of the patients (3%) in the fosfomycin trometamol and norfloxacin groups, respectively. In 3/79 (3%) of the patients in the fosfomycin trometamol group the side effects were reported on the actual day of (single dose) treatment. Fosfomycin trometamol in a single dose of 3 g is as effective as norfloxacin 400 mg b.i.d. for seven days in the treatment of adult female patients with uncomplicated urinary infections.
Zusammenfassung
Die Wirksamkeit und Verträglichkeit einer Einzeldosis von 3 g Fosfomycin Trometamol wurde mit derjenigen einer siebentägigen Behandlung mit zweimal täglich 400 mg Norfloxacin bei erwachsenen Patientinnen mit unkomplizierter Harnwegsinfektion verglichen. Die Zahl der in die Studie einbezogenen Patientinnen (mittleres Alter: 30 Jahre; Symptomatik: Dysurie und Polyurie; Harnbefund: Pyurie, Bakteriurie (≥ 105 KBE/ml Urin) betrug 158. Insgesamt konnten davon 111 klinisch und bakteriologisch ausgewertet werden, von diesen erhielten 61 Fosfomycin Trometamol und 50 Norfloxacin. Die Medikation wurde nach Doppelblindverfahren sieben Tage lang durchgeführt. Ein bis zwei Tage nach Therapieende wurden 55 der 60 mit Fosfomycin Trometamol behandelten Patientinnen (92%) und 48 der 50 mit Norfloxacin behandelten Patientinnen (96%) als klinisch geheilt beurteilt. 37 Patientinnen, bei denen zu Therapiebeginn keine signifikante Bakteriurie nachgewiesen werden konnte, waren in beiden Therapiegruppen zu 90% von ihren Beschwerden befreit. Zwei bis drei Tage nach Verabreichung der Fosfomycin Trometamol Einzeldosis war in 60 der 61 Fälle (98%) der Erreger nicht mehr nachzuweisen. Die Eradikation des initial identifizierten Erregers wurde ein bis zwei Tage nach der siebentägigen Norfloxacin-Behandlung für 48 der 50 Patientinnen (96%) gesichert. Die Harnwegsinfektion war auch sechs Wochen nach Therapiebeginn bei 39/60 Patientinnen (65%) der Fosfomycin Trometamol-Gruppe und 32/49 Patientinnen (65%) der Norfloxacin-Gruppe beseitigt. In beiden Gruppen kam es bei etwa 25% der Frauen zu einer Reinfektion. Rezidive traten hingegen in der Beobachtungsphase von vier Wochen nach Therapieende nur selten auf bei 5/49 Patientinnen der Norfloxacin-Gruppe (10%) und 3/55 der Fosfomycin Trometamol-Gruppe (6%). Über Nebenwirkungen, die „wahrscheinlich“ im Zusammenhang mit der Therapie standen, klagten 10/79 Patientinnen der Fosfomycin Trometamol-Gruppe (13%) und 2/79 Patientinnen der Norfloxacin-Gruppe (3%). In 3/79 Fällen der Fosfomycin Trometamol Gruppe (3%) wurde am Therapietag (Einzeldosis) selbst von Nebenwirkungen berichtet. In der Therapie unkomplizierter Harnwegsinfektionen bei erwachsenen Frauen ist eine Einzeldosis von 3 g Fosfomycin Trometamol ebenso wirksam wie eine siebentägige Behandlung mit zweimal täglich 400 mg Norfloxacin.
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Boerema, J.B.J., Willems, F.T.C. Fosfomycin trometamol in a single dose versus norfloxacin for seven days in the treatment of uncomplicated urinary infections in general practice. Infection 18 (Suppl 2), S80–S88 (1990). https://doi.org/10.1007/BF01643433
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DOI: https://doi.org/10.1007/BF01643433