Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: Results of a double-blind, placebo-controlled trial

Abstract

Eighty cirrhotic patients who had recovered from an episode of spontaneous bacterial peritonitis were included in a multicenter, double-blind trial aimed at comparing long-term norfloxacin administration (400 mg/day; 40 patients) vs. placebo (40 patients) in the prevention of spontaneous bacterial peritonitis recurrence. At entry, both groups were similar with respect to clinical and laboratory data, ascitic fluid protein and polymorphonuclear concentrations, number of previous episodes of spontaneous bacterial peritonitis and causative organisms of the index spontaneous bacterial peritonitis. Norfloxacin administration produced a selective intestinal decontamination (elimination of aerobic gram-negative bacilli from the fecal flora without significant changes in other microorganisms) throughout the study in six patients in whom the effect of norfloxacin on the fecal flora was periodically assessed. Fourteen patients from the placebo group (35%) and five from the norfloxacin group (12%) developed spontaneous bacterial peritonitis recurrence during follow-up (chi 2 = 5.97; p = 0.014) (mean follow-up period = 6.4 +/- 0.6 mo; range = 1 to 19 mo). Ten of the 14 spontaneous bacterial peritonitis recurrences in the placebo group and only one of the five spontaneous bacterial peritonitis recurrences in the norfloxacin group were caused by aerobic gram-negative bacilli (chi 2 = 8.87; p = 0.0029). The overall probability of spontaneous bacterial peritonitis recurrence at 1 yr of follow-up was 20% in the norfloxacin group and 68% in the placebo group (p = 0.0063) and the probability of spontaneous bacterial peritonitis recurrence caused by aerobic gram-negative bacilli at 1 yr of follow-up was 3% and 60%, respectively (p = 0.0013).(ABSTRACT TRUNCATED AT 250 WORDS)

Trimethoprim-sulfamethoxazole versus norfloxacin in the prophylaxis of spontaneous bacterial peritonitis in cirrhosis

“…GINÉS et al (16) included 80 patients and the series of GRANGÉ et al (17) was larger, with 107 patients.…”

Prevalência e prognóstico da peritonite bacteriana espontânea: experiência em pacientes internados em um hospital geral de Porto Alegre, RS, Brasil (1991-2000)

“…O uso profilático da norfloxacina de forma mais rotineira nos pacientes com episódio prévio de PBE (42) , nos com proteínas baixa no líquido de ascite (16) e nos com hemorragia digestiva alta, também deveria ter contribuído para a diminuição mais significativa da incidência desta infecção (16,17,33) . Ressalve-se que na reunião do Clube Internacional de Ascite, onde foram definidos os critérios para o diagnóstico, tratamento e profilaxia da PBE, não houve consenso quanto à realização de profilaxia primária a pacientes com proteínas baixas no líquido de ascite (35) .…”

“…A profilaxia foi realizada nos doentes com episódio prévio de PBE e/ou com proteínas do líquido de ascite abaixo de 1 g/dL; a dose utilizada foi a de 400 mg/dia (3,16,30,40) e a aderência ao tratamento foi avaliada pela informação do paciente no momento da admissão hospitalar. Nos casos em que não foi possível obter esta informação (devido à encefalopatia portossistêmica, por exemplo) a pesquisa foi feita junto aos familiares.…”

Effect of cisapride on intestinal bacterial overgrowth and bacterial translocation in cirrhosis

“…1 Spontaneous bacterial peritonitis (SBP) and bacteremia, 2 which are mainly caused by aerobic gram-negative organisms of enteric origin, [1][2][3] largely account for bacterial infections in cirrhosis. For this reason, selective intestinal decontamination with norfloxacin has been successfully used to prevent either SBP recurrence (secondary prophylaxis), 4 or the occurrence of the first episode of SBP in cirrhotic patients with a high risk of acquiring this infection (primary prophylaxis). 5 Selective intestinal decontamination is also effective in preventing bacterial infections in bleeding cirrhotics.…”