Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.

Abstract

BACKGROUND & AIMS:

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.

• Authors: Javier Fernández, Miquel Navasa, Ramón Planas, Silvia Montoliu, David Monfort, German Soriano, Carmen Vila, Alberto Pardo, Enrique Quintero, Victor Vargas, Jose Such, Pere Ginès, Vicente Arroyo
• Journal: Gastroenterology (Gastroenterology) Vol. 133 Issue 3 Pg. 818-24 (Sep 2007) ISSN: 0016-5085 [Print] United States
• PMID: 17854593 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Norfloxacin

Topics

• Aged
• Anti-Infective Agents (therapeutic use)
• Antibiotic Prophylaxis
• Double-Blind Method
• Female
• Hepatorenal Syndrome (etiology, physiopathology, prevention & control)
• Humans
• Liver Cirrhosis (complications, physiopathology)
• Male
• Middle Aged
• Norfloxacin (therapeutic use)
• Peritonitis (etiology, microbiology, physiopathology, prevention & control)
• Risk Factors
• Survival Analysis