Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis: A Randomized Controlled Trial
- Yim, Hyung Joon; Suh, Sang Jun; Jung, Young Kul; Yim, Sun Young; Seo, Yeon Seok; Lee, Yu Rim; Park, Soo Young; Jang, Jae Young; Kim, Young Seok; Kim, Hong Soo; Kim, Byung Ik; Um, Soon Ho
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- NATURE PUBLISHING GROUP
- AMERICAN JOURNAL OF GASTROENTEROLOGY, v.113, no.8, pp.1167 - 1176
- Journal Title
- AMERICAN JOURNAL OF GASTROENTEROLOGY
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- End Page
- OBJECTIVES: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. METHODS: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein <= 1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm(3). Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. RESULTS: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1: 1 ratio (62: 62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3% vs. 5.3%, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7% vs. 73.7%, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. CONCLUSION: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.
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- 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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