RESUMEN
OBJECTIVE: Cranberry prophylaxis of recurrent urinary tract infection in infants has proven effective in the experimental model of the adult. There are few data on its efficacy, safety and recommended dose in the pediatric population. METHODS: A controlled, double-blind Phase III clinical trial was conducted on children older than 1 month of age to evaluate the efficacy and safety of cranberry in recurrent urinary tract infection. The assumption was of the non-inferiority of cranberry versus trimethoprim. Statistical analysis was performed using Kaplan Meier analysis. RESULTS: A total of 85 patients under 1 year of age and 107 over 1 year were recruited. Trimethoprim was prescribed to 75 patients and 117 received cranberry. The cumulative rate of urinary infection associated with cranberry prophylaxis in children under 1 year was 46% (95% CI; 23-70) in children and 17% (95% CI; 0-38) in girls, effectively at doses inferior to trimethoprim. In children over 1 year-old cranberry was not inferior to trimethoprim, with a cumulative rate of urine infection of 26% (95% CI; 12-41). The cranberry was well tolerated and with no new adverse effects. CONCLUSIONS: Our study confirms that cranberry is safe and effective in the prophylaxis of recurrent urinary tract infection in infants and children. With the doses used, their efficiency is not less than that observed for trimethoprim among those over 1 year-old. (Clinical Trials Registry ISRCTN16968287).
Asunto(s)
Jugos de Frutas y Vegetales , Fitoterapia , Infecciones Urinarias/prevención & control , Vaccinium macrocarpon , Adolescente , Niño , Preescolar , Árboles de Decisión , Método Doble Ciego , Femenino , Jugos de Frutas y Vegetales/efectos adversos , Humanos , Lactante , Masculino , Recurrencia , Resultado del TratamientoRESUMEN
OBJECTIVE: Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. MATERIAL AND METHODS: Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. RESULTS: No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients with bacteriuria in A was greater than that of FMT in B (69.2% vs. 41.9%; P=.0004). CONCLUSIONS: Antibiotic prophylaxis with FMT (2 doses of 3g) in prostate biopsy is an alternative as effective and safe as ciprofloxacin (10 doses of 500 mg), which carries lower rate of resistance. According to our experience, this drug is a safe, well-tolerated, and easily manageable prophylactic option, facilitating patient compliance. More prospective multicenter studies are necessary to confirm these findings.
Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica , Ciprofloxacina/uso terapéutico , Fosfomicina/uso terapéutico , Próstata/patología , Neoplasias de la Próstata/patología , Anciano , Anciano de 80 o más Años , Antibacterianos/efectos adversos , Biopsia/métodos , Ciprofloxacina/efectos adversos , Fosfomicina/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recto , Método Simple Ciego , Resultado del TratamientoRESUMEN
The use of antibiotic prophylaxis has been questioned in the inguinal herniorrhaphy with mesh. The aim of this paper is to give account of the efficiency of antibiotic prophylaxis (AP) in the prevention of wound infection in the elective inguinal herniorrhaphy with mesh under local anaesthesia in an ambulatory basis. In the present observacional analytic study, 955 patients were operated upon with a mesh technique during a 10 year period, .in the CRS Hernia Centre in Santiago. In the first group of 250 patients, lgr Cefazolin® was administered iv one hour before the operation, in the second group of 710 patients no antibiotics were used. Demographic variables, associated diseases, the length of surgery were comparable in both groups. The same team of surgeons work in both groups. Wound infection was defined as the presence of pus in the surgical wound associated with a positive bacterial culture. The rate of wound infections was 1.05 percent of the first and 0.35 percent of the second group. This difference was no significant (p < 0.08). The isolated germ was a Staphylo-coccus aureus in all cases. The treatment was ambulatory in all cases. The rate of haematoma and funiculo-testicular fluxion were low. We conclude that the rate of wound infection in mesh herniorrhaphies is low and that the antibiotic prophylaxis does not improve these results. Its routine use in these patients is not justified.
Introducción: El uso de la profilaxis antibiótica en la cirugía hemiaria con malla es controversial. El propósito del presente estudio es establecer la efectividad de la profilaxis antibiótica (PA) en la prevención de la infección del sitio operatorio (ISO) en la herniorrafía con malla efectuada en forma ambulatoria con anestesia local. Material y Método: El estudio observacional analítico se realizó dentro del Programa de Cirugía Ambulatoria del CRS Cordillera, en dos grupos consecutivos de pacientes, el primero que se sometió a PA mediante lgr de Cefazolina® intravenosa, inmediatamente antes del procedimiento quirúrgico, y el segundo en el que se prescindió de ella. Los controles postoperatorios se efectuaron al 7º y 30º día por un cirujano del grupo. Se diagnosticó ISO con la presencia de exudado purulento, con cultivo bacteriano positivo. Resultados: El estudio se efectuó en 955 pacientes operados entre 1998 y 2008. En el primer grupo, constituido por 245 pacientes se usó PA, en el segundo grupo de 710 pacientes se prescindió de ella. Las variables demográficas, antecedentes mórbidos y la duración del acto quirúrgico fueron comparables en ambos grupos. Se registraron 2 casos de infección en el primer grupo (1,05 por ciento) y dos en el segundo (0,35). Esta diferencia no fue significativa. El germen aislado fue en todos los casos el estafilococo dorado. Conclusiones: La tasa ISO en la hemiorrafia inguinal electiva ambulatoria con malla es baja y no se modificó con el uso de PA. Su empleo indiscriminado no aparece justificado en estos pacientes.