RESUMEN
BACKGROUND AND PURPOSE: In the light of increasing resistance to antibiotics used for the treatment of acute urinary tract infections, nitrofurantoin currently experiences a renaissance. Nitrofurantoin shows good efficacy against most bacteria expected in urinary tract infection, and the development of resistance is low. A study on the antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute lower urinary tract infections was conducted in Mexico City, an area where resistance rates of uropathogens to trimethoprim/sulfamethoxazole (cotrimoxazole) are high. PATIENTS AND METHODS: In this open-label, single-arm study 20 adult patients (18 females, 2 males) with positive urine culture were treated orally with nitrofurantoin sustained release 100 mg twice daily for 7 days. Urinary nitrofurantoin concentrations were determined at baseline and day 4 of the study. Primary endpoint was the antimicrobial efficacy of nitrofurantoin at 12 to 16 days after baseline, assessed by changes in urine culture results. RESULTS: In the patient population treated per protocol, primary endpoint analysis revealed a microbial eradication rate of 92.3%. At 35 to 42 days, the eradication rate was 83.3%. At these times, all patients in the per protocol population were free of symptoms. In patients with complicating factors, e.g. diabetic polyneuropathy, both antimicrobial and clinical efficacy appeared to be reduced. Urinary nitrofurantoin concentrations were mostly above minimum inhibitory concentrations of the isolated uropathogens. The study drug was generally well tolerated. Most frequent drug-related adverse event was mild headache, occurring in 10.8% of patients. Two patients discontinued the study due to rash. CONCLUSION: The results of the present study indicate good antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute uncomplicated urinary tract infections as well as acceptable tolerability in adults.
Asunto(s)
Antiinfecciosos Urinarios/uso terapéutico , Bacteriuria/tratamiento farmacológico , Nitrofurantoína/uso terapéutico , Infecciones Urinarias/tratamiento farmacológico , Administración Oral , Adulto , Anciano , Antiinfecciosos Urinarios/efectos adversos , Antiinfecciosos Urinarios/farmacocinética , Bacteriuria/orina , Preparaciones de Acción Retardada , Esquema de Medicación , Femenino , Humanos , Masculino , Tasa de Depuración Metabólica/fisiología , México , Persona de Mediana Edad , Nitrofurantoína/efectos adversos , Nitrofurantoína/farmacocinética , Recurrencia , Resultado del Tratamiento , Infecciones Urinarias/orinaRESUMEN
Time-related concentrations in milk of a combination of trimethoprim-sulphadiazine (TMP-SDZ) intramammary formulated infusion and its relationship with pathogenic bacteria strains minimum inhibitory concentrations (MICs) isolated from clinical mastitis cows were analysed. The MICs study was performed for Escherichia coli, Staphylococcus aureus and Streptococcus sp. strains. The SDZ concentrations in milk were analysed using high-performance liquid chromatography (HPLC) and TMP using a microbiological assay. Ten lactating cows milked three times daily were used in the time-concentration studies of TMP-SDZ. Milk samples (approximately 20 mL) from the treated mammary quarters were taken at 6, 12, 24, 30 and 36 h after first administration. In order to define the withdrawal time, milk samples from the treated mammary quarters were taken at 24, 36, 48, 72, 84 and 96 h, after finishing the therapy. The MICs fluctuated between 1 and 8 microg/mL. Effective therapeutic concentrations lasted for 36 h when intramammary infusion was repeated three times every 12 h. No TMP was detected in milk for 24 h after finishing therapy. Milk SDZ concentrations were below 0.1 microg/mL in all treated cows after 84 h finishing therapy. At 96 h after finishing therapy, no SDZ milk concentrations were found in six animals, although four animals of the experimental group still had concentrations of 0.07 microg/mL.