利福昔明
医学
经颈静脉肝内门体分流术
肝性脑病
内科学
肝硬化
安慰剂
临床终点
胃肠病学
腹水
随机对照试验
人口
外科
门脉高压
病理
替代医学
抗生素
环境卫生
微生物学
生物
作者
Christophe Bureau,Dominique Thabut,Caroline Jézéquel,Isabelle Archambeaud,Louis d’Altéroche,Sébastien Dharancy,Patrick Borentain,Frédéric Oberti,Aurélie Plessier,Victor de Lédinghen,Nathalie Ganne‐Carrié,Nicolas Carbonell,Vanessa Rousseau,Agnès Sommet,Jean Marie Péron,Jean Pierre Vinel
摘要
Background: The efficacy of rifaximin in the secondary prevention of overt hepatic encephalopathy (HE) is well documented, but its effectiveness in preventing a first episode in patients after transjugular intrahepatic portosystemic shunt (TIPS) has not been established. Objective: To determine whether rifaximin prevents overt HE after TIPS compared with placebo. Design: Randomized, double-blind, multicenter, placebo-controlled trial. (ClinicalTrials.gov: NCT02016196) Participants: 197 patients with cirrhosis undergoing TIPS for intractable ascites or prevention of variceal rebleeding. Intervention: Patients were randomly assigned to receive rifaximin (600 mg twice daily) or placebo, beginning 14 days before TIPS and continuing for 168 days after the procedure. Measurements: The primary efficacy end point was incidence of overt HE within 168 days after the TIPS procedure. Results: An episode of overt HE occurred in 34% (95% CI, 25% to 44%) of patients in the rifaximin group (n = 93) and 53% (CI, 43% to 63%) in the placebo group (n = 93) during the postprocedure period (odds ratio, 0.48 [CI, 0.27 to 0.87]). Neither the incidence of adverse events nor transplant-free survival was significantly different between the 2 groups. Limitations: The study's conclusion applies mainly to patients with alcoholic cirrhosis, who made up the study population. The potential benefit of rifaximin 6 months after TIPS and beyond remains to be investigated. Conclusion: In patients with cirrhosis treated with TIPS, rifaximin was well tolerated and reduced the risk for overt HE. Rifaximin should therefore be considered for prophylaxis of post-TIPS HE. Primary Funding Source: French Public Health Ministry.
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