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 levéis (<15 g/L) with advanced liver failure (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or impaired renal function (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <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 percent vs 61 percent, P <0.001) and hepatorenal syndrome (28 percent vs 41 percent, P 0.02), and improved the 3-month (94 percent vs 62 percent, P 0.003) and the 1-year (60 percent vs 48 percent, P 0.05) 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.