Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis

作者：Alexandre Louvet, Julien Labreuche, Thông Dao, Thierry Thévenot, F. Oberti, Christophe Bureau, Thierry Paupard, Éric Nguyen-Khac, Anne Minello, Brigitte Bernard‐Chabert, Rodolphe Anty, F. Wartel, Nicolas Carbonell, Georges‐Philippe Pageaux, Marie‐Noëlle Hilleret, Romain Moirand, Pierre Nahon, Camille Potey, Alain Duhamel, Philippe Mathurin · 发表于：JAMA · 年份：2023 · DOI：10.1001/jama.2023.4902 · 被引用次数：69 · 研究领域：Alcohol Consumption and Health Effects、Alcoholism and Thiamine Deficiency、Liver Disease and Transplantation

Importance: The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear. Objective: To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone. Design, Setting, and Participants: Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score ≥32 and Model for End-stage Liver Disease [MELD] score ≥21) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019. Intervention: Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147). Main Outcome and Measures: The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days. Results: Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and t...