title: Continuous versus inpatient prophylaxis of the first episode of spontaneous bacterial peritonitis with norfloxacin.
abstract: Cirrhotic patients with ascites and low ascitic fluid total protein and/or high serum bilirubin levels are at high risk to develop the first episode of spontaneous bacterial peritonitis during long-term follow-up. The aim of the present study was to determine the efficacy of continuous long-term selective intestinal decontamination with norfloxacin in the prevention of this complication. One hundred nine cirrhotic patients with ascites and ascitic fluid total protein levels of < or = 1 g/dL or serum bilirubin levels of > 2.5 mg/dL without previous spontaneous bacterial peritonitis were prospectively randomized into two groups: group 1 (n = 56) received norfloxacin, 400 mg daily administered orally, and group 2 (n = 53) was the long-term control group, receiving norfloxacin only during hospitalization. During a mean follow-up of 43 +/- 3 weeks, there was one spontaneous bacterial peritonitis (1.8%) in group 1 and 9 (16.9%) in group 2 (P < .01). The incidence of community-acquired spontaneous bacterial peritonitis was lower in group 1 (1.8% vs. 13.2%, P < .05), whereas the incidence of nosocomial spontaneous bacterial peritonitis (0% vs. 3.7%) and the incidence of extraperitoneal infections (25% vs. 24.5%) were similar in both groups (P = NS). The actuarial probability of survival at 18 months was 75% in group 1 and 62% in group 2 (P = NS). Resistance to norfloxacin was observed in 9 of 10 (90%) Escherichia coli isolated in infections from group 1 and in 4 of 11 (36.3%) from group 2 (P < .05). The overall incidence of infections caused by norfloxacin-resistant bacteria was higher in group 1 (19.6% vs. 15%), but it did not reach statistical significance. Continuous long-term selective intestinal decontamination with norfloxacin is effective in preventing the first spontaneous bacterial peritonitis in cirrhotic patients at high risk. However, the emergence of infections caused by norfloxacin-resistant bacteria must be weighed carefully against the benefits of continuous long-term prophylaxis.
authors.affiliation: Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Novella
authors.forename: R
authors.initials: R
authors.lastname: Solà
authors.forename: G
authors.initials: G
authors.lastname: Soriano
authors.forename: M
authors.initials: M
authors.lastname: Andreu
authors.forename: J
authors.initials: J
authors.lastname: Gana
authors.forename: J
authors.initials: J
authors.lastname: Ortiz
authors.forename: S
authors.initials: S
authors.lastname: Coll
authors.forename: M
authors.initials: M
authors.lastname: Sàbat
authors.forename: M C
authors.initials: MC
authors.lastname: Vila
authors.forename: C
authors.initials: C
authors.lastname: Guarner
authors.forename: F
authors.initials: F
authors.lastname: Vilardell
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001201:Ascites / Q000150:complications; D001424:Bacterial Infections / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D004352:Drug Resistance, Microbial; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009643:Norfloxacin / Q000627:therapeutic use*; D010538:Peritonitis / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*
chemical_list: D000890:Anti-Infective Agents; D009643:Norfloxacin