Song Do Seon, Yang Jin Mo, Jung Young Kul, Yim Hyung Joon, Kim Hee Yeon, Kim Chang Wook, Kim Soon Sun, Cheong Jae Youn, Lee Hae Lim, Lee Sung Won, Yoo Jeong-Ju, Kim Sang Gyune, Kim Young Seok
Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, South Korea.
Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.
Ann Hepatol. 2025 Jan-Jun;30(1):101749. doi: 10.1016/j.aohep.2024.101749. Epub 2024 Dec 9.
The short-term mortality of severe alcohol-associated hepatitis (SAH) is high, but there are no effective treatments to improve short-term mortality other than corticosteroids. This study investigated the effects of adding rifaximin to standard treatment in patients with SAH.
In this randomized controlled open-label trial, patients with SAH (Maddrey's discriminant function≥32) were randomized to the rifaximin or control group. Patients were simultaneously treated with corticosteroid or pentoxifylline as standard treatment for 4 weeks. Randomization was stratified by SAH treatment.
A total of 50 patients were enrolled in this study (29 in the control group and 21 in the rifaximin group). The mean Model for End-stage Liver Disease (MELD) scores were 24.4 and 27.5 in the control and rifaximin groups, respectively (P = 0.106). There were no significant differences in 6-month Liver Transplantation (LT)-free survival rate between the two groups (P = 0.502). When stratified by SAH treatment, there was no significant difference in 6-month LT-free survival rate between the control and rifaximin treatment groups (P = 0.186 in the corticosteroid group and P = 0.548 in the pentoxifylline group). There were no significant differences in the occurrence of liver-related complications between the two groups (all Ps>0.05). The MELD score was the only independent factor for 6-month LT-free survival (hazard ratio 1.188, 95 % confidence interval 1.094-1.289, P<0.001), and rifaximin was not.
In patients with SAH, adding rifaximin to corticosteroid or pentoxifylline had no survival benefit and no preventive effect on the development of liver-related complications. The MELD score was the only significant factor for short-term mortality.
The study was registered on ClinicalTrials.gov (number: NCT02485106).
严重酒精性肝炎（SAH）的短期死亡率很高，但除皮质类固醇外，尚无有效治疗方法可提高短期死亡率。本研究调查了在SAH患者的标准治疗中加用利福昔明的效果。
在这项随机对照开放标签试验中，SAH患者（马德雷判别函数≥32）被随机分为利福昔明组或对照组。患者同时接受皮质类固醇或己酮可可碱作为标准治疗，为期4周。随机分组按SAH治疗进行分层。
本研究共纳入50例患者（对照组29例，利福昔明组21例）。对照组和利福昔明组的终末期肝病模型（MELD）平均评分分别为24.4和27.5（P = 0.106）。两组6个月无肝移植（LT）生存率无显著差异（P = 0.502）。按SAH治疗分层时，对照组和利福昔明治疗组6个月无LT生存率无显著差异（皮质类固醇组P = 0.186，己酮可可碱组P = 0.548）。两组肝脏相关并发症的发生率无显著差异（所有P>0.05）。MELD评分是6个月无LT生存的唯一独立因素（风险比1.188，95%置信区间1.094 - 1.289，P<0.001），而利福昔明不是。
在SAH患者中，在皮质类固醇或己酮可可碱治疗基础上加用利福昔明对生存无益处，对肝脏相关并发症的发生也无预防作用。MELD评分是短期死亡率的唯一显著因素。
该研究已在ClinicalTrials.gov上注册（编号：NCT02485106）。
