Journal of digestive diseases · 2014
A randomized controlled study of trimethoprim-sulfamethoxazole versus norfloxacin for the prevention of infection in cirrhotic patients.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Lontos Steve, Shelton Edward, Angus Peter W, Vaughan Rhys, Roberts Stuart K, Gordon Adam, Gow Paul J
Аннотация
OBJECTIVE: To prospectively compare norfloxacin (N) with trimethoprim-sulfamethoxazole (T-S) in preventing infection in cirrhotic patients.
METHODS: Cirrhotic patients at high risk of spontaneous bacterial peritonitis (SBP) were recruited and assigned N (400 mg daily) or T-S (160/800 mg daily). Patients were followed up for 12 months. The primary end-point was the incidence of infection. Secondary end-points included the incidence of SBP, bacteremia, extraperitoneal infection requiring antibiotic treatment, liver transplantation, death, side effects and rate of resistance to N or T-S.
RESULTS: A total of 80 patients with a mean age of 53.0 ± 9.3 years were prescribed N (n = 40) or T-S (n = 40). Child-Pugh status, model for end-stage liver disease and risk factors for SBP were similar between the groups. There were 10 episodes of infections in the N group and 9 in the T-S group (P = 0.79). Two patients each in the N and T-S group developed SBP (P = 0.60). There was a difference in the rate of transplantation favoring N (P = 0.03) but not death. The number of adverse events for N (n = 7) and T-S (n = 10) were similar (P = 0.59), with T-S being associated with an increased risk of developing a definite or probable adverse event compared to N (22.5% vs 0%, P = 0.01).
CONCLUSIONS: This study failed to demonstrate a difference between N and T-S groups in their effects on preventing infection in patients with liver cirrhosis. T-S can be considered an alternative first-line therapy for infection prophylaxis.
METHODS: Cirrhotic patients at high risk of spontaneous bacterial peritonitis (SBP) were recruited and assigned N (400 mg daily) or T-S (160/800 mg daily). Patients were followed up for 12 months. The primary end-point was the incidence of infection. Secondary end-points included the incidence of SBP, bacteremia, extraperitoneal infection requiring antibiotic treatment, liver transplantation, death, side effects and rate of resistance to N or T-S.
RESULTS: A total of 80 patients with a mean age of 53.0 ± 9.3 years were prescribed N (n = 40) or T-S (n = 40). Child-Pugh status, model for end-stage liver disease and risk factors for SBP were similar between the groups. There were 10 episodes of infections in the N group and 9 in the T-S group (P = 0.79). Two patients each in the N and T-S group developed SBP (P = 0.60). There was a difference in the rate of transplantation favoring N (P = 0.03) but not death. The number of adverse events for N (n = 7) and T-S (n = 10) were similar (P = 0.59), with T-S being associated with an increased risk of developing a definite or probable adverse event compared to N (22.5% vs 0%, P = 0.01).
CONCLUSIONS: This study failed to demonstrate a difference between N and T-S groups in their effects on preventing infection in patients with liver cirrhosis. T-S can be considered an alternative first-line therapy for infection prophylaxis.