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15 April 1995 | Volume 122 Issue 8 | Pages 595-598
Objective: To assess the efficacy and safety of trimethoprim-sulfamethoxazole for the prevention of spontaneous bacterial peritonitis in patients with cirrhosis and ascites.
Design: A randomized controlled trial.
Setting: University-affiliated Veterans Affairs medical center.
Patients: 60 consecutive patients with cirrhosis and ascites.
Interventions: Consecutive patients were randomly assigned to receive either no prophylaxis or trimethoprim-sulfamethoxazole, one double-strength tablet daily, five times a week (Monday through Friday). Patient entry was stratified by serum bilirubin (>51 µmol/L [>3 mg/dL]), ascitic fluid protein (<1 g/dL), and serum creatinine (>177 µmol/L [>2 mg/dL]) levels to ensure that high-risk patients would be similarly distributed in the two groups. The median duration of follow-up for the study patients was 90 days.
Main Outcome Measures: Spontaneous bacterial peritonitis or spontaneous bacteremia as defined by objective criteria.
Results: Spontaneous bacterial peritonitis or spontaneous bacteremia developed in 27% (8 of 30) of patients who did not receive prophylaxis compared with 3% (1 of 30) of patients receiving trimethoprim-sulfamethoxazole (P = 0.025). Overall, infections developed in 9 of 30 patients (30%) not receiving prophylaxis and in 1 of 30 patients (3%) receiving trimethoprim-sulfamethoxazole (P = 0.012). Death occurred in 6 of 30 patients (20%) who did not receive prophylaxis and in 2 of 30 patients (7%) who received trimethoprim-sulfamethoxazole (P = 0.15). Side effectsparticularly, hematologic toxicitycould not be attributed to trimethoprim-sulfamethoxazole in any patient.
Conclusions: Trimethoprim-sulfamethoxazole was efficacious, safe, and cost-effective for the prevention of spontaneous bacterial peritonitis in patients with cirrhosis.
Author and Article Information
From the Veterans Affairs Medical Center and the University of Pittsburgh, Pittsburgh, Pennsylvania.
BRIEF COMMUNICATION
Trimethoprim-Sulfamethoxazole for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhosis
A Randomized Trial
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Requests for Reprints: Victor L. Yu, MD, Infectious Diseases Section, Veterans Affairs Medical Center, University Drive, Pittsburgh, PA 15240.
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