Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.
OBJECTIVE
Norfloxacin is highly effective in preventing spontaneous bacterial peritonitis recurrence in cirrhosis, but its role in the primary prevention of this complication is uncertain.


METHODS
Patients with cirrhosis and low protein ascitic levels (<15 g/L) with advanced liver failure (Child-Pugh score > or = 9 points with serum bilirubin level > or = 3 mg/dL) or impaired renal function (serum creatinine level > or = 1.2 mg/dL, blood urea nitrogen level > or = 25 mg/dL, or serum sodium level < or = 130 mEq/L) were included in a randomized controlled trial aimed at comparing norfloxacin (35 patients) vs placebo (33 patients) in the primary prophylaxis of spontaneous bacterial peritonitis. The main end points of the trial were 3-month and 1-year probability of survival. Secondary end points were 1-year probability of development of spontaneous bacterial peritonitis and hepatorenal syndrome.


RESULTS
Norfloxacin administration reduced the 1-year probability of developing spontaneous bacterial peritonitis (7% vs 61%, P < .001) and hepatorenal syndrome (28% vs 41%, P = .02), and improved the 3-month (94% vs 62%, P = .003) and the 1-year (60% vs 48%, P = .05) probability of survival compared with placebo.


CONCLUSIONS
Primary prophylaxis with norfloxacin has a great impact in the clinical course of patients with advanced cirrhosis. It reduces the incidence of spontaneous bacterial peritonitis, delays the development of hepatorenal syndrome, and improves survival.
Fernández
Javier
J
Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain.
Navasa
Miquel
M
Planas
Ramón
R
Montoliu
Silvia
S
Monfort
David
D
Soriano
German
G
Vila
Carmen
C
Pardo
Alberto
A
Quintero
Enrique
E
Vargas
Victor
V
Such
Jose
J
Ginès
Pere
P
Arroyo
Vicente
V
D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D004311:Double-Blind Method; D005260:Female; D006530:Hepatorenal Syndrome / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009643:Norfloxacin / Q000627:therapeutic use*; D010538:Peritonitis / Q000209:etiology / Q000382:microbiology / Q000503:physiopathology / Q000517:prevention & control*; D012307:Risk Factors; D016019:Survival Analysis
D000890:Anti-Infective Agents; D009643:Norfloxacin