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Background: Spontaneous bacterial peritonitis (SBP) heralds increased mortality in cirrhosis, mandating strategies for prophylaxis. Norfloxacin has been the recommended choice for SBP prevention. However, its use has raised concerns about antibiotic resistance. Rifaximin has been suggested as an alternative. We investigated the efficacy of rifaximin against norfloxacin in primary and secondary prophylaxis of SBP. Methods: In this open-labeled randomized trial, patients with either advanced cirrhosis having ascitic fluid protein levels (<1.5 g/l), Child-Pugh score ≥9 points, serum bilirubin ≥3 mg/dl or impaired renal function (primary prophylaxis group), or those with prior SBP (secondary prophylaxis group) received either norfloxacin (400 mg once daily) or rifaximin (550 mg twice daily). All patients were followed for six months, with the primary endpoint being the development of incident SBP. Results: 142 patients were assessed for eligibility, of which 132 met the enrolment criteria; 12 were lost to follow-up, while 4 discontinued treatment. In patients on primary prophylaxis, occurrence of SBP was similar (14.3% vs. 24.3%, P = 0.5), whereas in secondary prophylaxis SBP recurrence was lower with rifaximin (7% vs. 39% P = 0.004). Rifaximin significantly reduced the odds for SBP development in secondary prophylaxis [OR (95% CI0.14 (0.02-0.73; P = 0.02)]. Patients receiving rifaximin as secondary prophylaxis also had fewer episodes of hepatic encephalopathy (23.1% vs. 51.5%, P = 0.02). 180-day survival between the arms in either group was similar (P = 0.5, P = 0.2). Conclusion: In comparison to norfloxacin, rifaximin significantly reduces incident events of SBP, as well as HE when used as a secondary prophylaxis, whereas for primary prophylaxis both have similar effects (NCT03695705). Clinical trial registration: ClinicalTrials.gov number: NCT03695705.
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BACKGROUND/AIM: : Portal hypertension and variceal hemorrhage (VH) are significant complications in biliary atresia (BA). The study aims to evaluate risk factors and noninvasive markers that predict actual VH for the first time in children with BA without prior endoscopic surveillance or treatment. METHODS: Retrospective review was performed of patients diagnosed with BA from 1989 to 2016 at a single center. Primary outcome was the first episode of VH. Patients were stratified into VH and non-VH groups according to the development of VH, and laboratory and ultrasonographic data were analyzed at 2 time points: pre-VH and the last follow-up. Existing indices, varices prediction rule (VPR), and aspartate aminotransferase (AST)-platelet ratio index (APRI) were also applied retrospectively to evaluate their performance in prediction of VH in our cohort. RESULTS: Seventy-two patients were included; 16 patients developed the first VH at median age of 5.5 years. On univariate analysis, serum albumin (P = 0.034), AST (P = 0.017), hemoglobin (P = 0.019), platelet count (P = <0.001), spleen size Z-score (P = <0.001), and rate of splenic enlargement (P = 0.006) were associated with VH. On multivariable regression analysis, only platelet count was independently predictive (P = 0.041). The optimal cutoff values for prediction of the first VH were platelet count ≤100 × 109/L (sensitivity 75.0%, specificity 80.4%, positive predictive value [PPV] 52.2%, negative predictive value [NPV] 91.8%), VPR ≤3.0 (sensitivity 81.3%, specificity 85.7%, PPV 61.9%, NPV 94.1%), and APRI ≥3.0 (sensitivity 81.3%, specificity 76.8%, PPV 50.0%, NPV 93.5%). CONCLUSIONS: Platelet count <100 × 109/L and VPR <3.0 are simple, reproducible and effective noninvasive markers in predicting the first episode of acute VH in children with BA and may be used in pediatrics for the selection of patients to undergo primary prophylactic endoscopic therapy.
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Model for end-stage liver disease (MELD) score, initially developed to predict survival following transjugular intrahepatic portosystemic shunt was subsequently found to be accurate predictor of mortality amongst patents with end-stage liver disease. Since 2002, MELD score using 3 objective variables (serum bilirubin, serum creatinine, and institutional normalized ratio) has been used worldwide for listing and transplanting patients with end-stage liver disease allowing transplanting sicker patients first irrespective of the wait time on the list. MELD score has also been shown to be accurate predictor of survival amongst patients with alcoholic hepatitis, following variceal hemorrhage, infections in cirrhosis, after surgery in patients with cirrhosis including liver resection, trauma, and hepatorenal syndrome (HRS). Although, MELD score is closest to the ideal score, there are some limitations including its inaccuracy in predicting survival in 15-20% cases. Over the last decade, many efforts have been made to further improve and refine MELD score. Until, a better score is developed, liver allocation would continue based on the currently used MELD score.