利福昔明治疗重度酒精性肝炎：一项多中心、随机对照、开放标签的试点试验

IF 3.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Annals of hepatology Pub Date : 2025-01-01 DOI:10.1016/j.aohep.2024.101749

Do Seon Song , Jin Mo Yang , Young Kul Jung , Hyung Joon Yim , Hee Yeon Kim , Chang Wook Kim , Soon Sun Kim , Jae Youn Cheong , Hae Lim Lee , Sung Won Lee , Jeong-Ju Yoo , Sang Gyune Kim , Young Seok Kim

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引用次数: 0

摘要

简介和目的：严重酒精性肝炎（SAH）的短期死亡率很高，但除皮质类固醇外，尚无有效的治疗方法来改善短期死亡率。本研究探讨了在SAH患者的标准治疗中加入利福昔明的效果。材料和方法：在这项随机对照开放标签试验中，SAH （Maddrey’s discriminant function≥32）患者被随机分为利福昔明组或对照组。同时给予皮质类固醇或己酮茶碱作为标准治疗，疗程4周。随机分组按SAH治疗分层。结果：共纳入49例患者（对照组29例，利福昔明组20例）。对照组和利福昔明组终末期肝病模型（MELD）平均评分分别为24.4分和27.8分（P=0.083）。两组患者6个月无肝移植生存率差异无统计学意义（P=0.698）。当按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=0.526，自酮茶碱组P=0.620）。两组患者肝脏相关并发症发生率比较，差异无统计学意义（p < 0.05）。MELD评分是6个月无lt生存的唯一独立因素（风险比1.360,95%可信区间1.021-1.810，P=0.035），而利福昔明则不是。结论：在SAH患者中，在皮质类固醇或己酮茶碱的基础上添加利福昔明对生存没有好处，对肝脏相关并发症的发生也没有预防作用。MELD评分是短期死亡率的唯一显著因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial

查看原文本刊更多论文

Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial

Introduction and Objectives

The short-term mortality of severe alcoholic-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.

Material and Methods

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.

Results

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.

Conclusions

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.

Clinical trial registration

The study was registered on ClinicalTrials.gov (number: NCT02485106).

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来源期刊

Annals of hepatology 医学-胃肠肝病学

CiteScore

7.90

自引率

2.60%

发文量

183

审稿时长

4-8 weeks

期刊介绍： Annals of Hepatology publishes original research on the biology and diseases of the liver in both humans and experimental models. Contributions may be submitted as regular articles. The journal also publishes concise reviews of both basic and clinical topics.