低剂量利福昔明可预防失代偿性肝硬化患者的并发症并提高

StephenW

Low-dose rifaximin prevents complications and improves survival in patients with decompensated liver cirrhosis

    Xin Zeng, Xia Sheng, Pei-Qin Wang, Hai-Guang Xin, Yi-Bin Guo, Yong Lin, Jia-Wei Zhong, Cheng-Zhi He, Jie Yin, Tao-Tao Liu, Wei-Juan Ma, Xiao Xiao, Pei-Mei Shi, Zong-Li Yuan, Ling Yang, Xiong Ma, Jian-Ming Xu, Xi-Zhong Shen, Chang-Qing Yang, Xuan Zhu, Nong-Hua Lv & Wei-Fen Xie

Hepatology International volume 15, pages155–165(2021)Cite this article

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Abstract
Background and aims

Rifaximin has been recommended as a prophylactic drug for hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP). This study aims to explore whether low-dose rifaximin can prevent overall complications and prolong survival in cirrhotic patients.
Methods

In this multi-centre randomized open-labelled prospective study, 200 patients with decompensated cirrhosis were randomly assigned at a ratio of 1:1. Patients in rifaximin group were administered 400 mg rifaximin twice daily for 6 months, and all other therapeutic strategies were kept unchanged in both groups as long as possible. The primary efficacy endpoints were the incidence of overall complications and liver transplantation-free survival. The secondary endspoints were the incidence of each major cirrhosis-related complication, as well as the Child–Pugh score and class.
Results

The major baseline characteristics were similar in the two groups except for HE. The cumulative incidence and frequency of overall complications were significantly lower in rifaximin group than in the control group (p < 0.001). Though liver transplantation-free survival was not significantly different between the two groups, subgroup analysis showed rifaximin markedly prolonged liver transplantation-free survival in patients with Child–Pugh score ≥ 9 (p = 0.007). Moreover, rifaximin markedly reduced the episodes of ascites exacerbation (p < 0.001), HE (p < 0.001) and gastric variceal bleeding (EGVB, p = 0.031). The incidence of adverse events was similar in the two groups.
Conclusion

Low-dose rifaximin significantly decreases the occurrence of overall complications, leading to prolonged survival in patients with advanced stages of cirrhosis in this trail. Further study should be carried out to compare the effect of this low-dose rifaximin with normal dose (1200 mg/day) rifaximin in preventing cirrhosis-related complications.
Clinical trial number

NCT02190357

StephenW

低剂量利福昔明可预防失代偿性肝硬化患者的并发症并提高其生存率

    曾欣，夏霞，王培勤，辛海光，郭一斌，林勇，钟家伟，何成志，尹洁，刘涛涛，马伟娟，肖晓，石培美，袁宗立，杨凌，马雄，徐建明，沉西中，杨长庆，朱璇，吕农华＆谢卫芬

国际肝病学杂志第15卷，第155-165页（2021年）

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抽象的
背景和目标

利福昔明已被推荐作为肝性脑病（HE）和自发性细菌性腹膜炎（SBP）的预防药物。本研究旨在探讨低剂量利福昔明是否可以预防肝硬化患者的总体并发症并延长生存期。
方法

在这项多中心，开放标签的随机前瞻性研究中，以1：1的比例随机分配了200例失代偿性肝硬化患者。利福昔明组的患者每天两次给予400毫克利福昔明，持续6个月，两组中所有其他治疗策略均应尽可能长期保持不变。主要疗效终点是总体并发症的发生率和无肝移植生存率。次要终点是每种主要肝硬化相关并发症的发生率，以及Child–Pugh评分和等级。
结果

除HE外，两组的主要基线特征相似。利福昔明组的累积并发症发生率和总并发症发生率显着低于对照组（p <0.001）。尽管两组的无肝移植生存率无显着差异，但亚组分析显示，Child-Pugh得分≥9的患者，利福昔明显着延长了无肝移植生存期（p = 0.007）。此外，利福昔明显着减少了腹水急性发作（p <0.001），HE（p <0.001）和胃静脉曲张破裂出血（EGVB，p = 0.031）。两组的不良事件发生率相似。
结论

小剂量的利福昔明显着减少了总体并发症的发生，从而使这条晚期肝硬化晚期患者的生存期延长。应进行进一步研究以比较这种低剂量利福昔明与正常剂量（1200 mg /天）利福昔明在预防肝硬化相关并发症中的作用。
临床试验编号

NCT02190357