利福昔明对先前乳果糖治疗不耐受或无反应的肝性脑病患者的临床疗效：一项开放标签的试点研究。
Clinical effects of rifaximin in patientswith hepatic encephalopathy intolerant or nonresponsive to previous lactulose treatment: An open-label, pilot study.
作者信息
Sama Claudia, Morselli-Labate Antonio Maria, Pianta Paolo, Lambertini Laura, Berardi Sonia, Martini Gabriella
机构信息
Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy.
出版信息
Curr Ther Res Clin Exp. 2004 Sep;65(5):413-22. doi: 10.1016/j.curtheres.2004.10.002.
BACKGROUND
Hepatic encephalopathy (HE) is a metabolic-neurophysiologicsyndrome that occurs in patients with advanced hepatic disease. One of the main pathogenic mechanisms is represented by circulating toxins produced by the intestinal metabolism of nitrogenous compounds. The therapeutic approach to HE is mainly based on drugs that eliminate ammonia-producing bacteria.
OBJECTIVES
The aim of this study was to evaluate the effects of the nonabsorbable antibiotic rifaximin in patients with HE who were intolerant or nonresponsive to treatment with an oral, nonabsorbable disaccharide (lactulose).
METHODS
This uncontrolled, open-label, pilot study was conducted at the University of Bologna, Bologna, Italy. Patients aged ≥ 18 years with histologically proven liver cirrhosis and HE were studied. All patients were intolerant or nonresponsive to previous treatment with lactulose. Rifaximin tablets were administered to patients at a dosage of 400 mg TID for 10 days. The portal systemic encephalopathy (PSE) index was evaluated at enrollment and at the end of the treatment period. Tolerability was assessed using hematology, biochemistry, and urinalysis and by recording adverse effects (AEs).
RESULTS
Twenty-six patients (18 men, 8 women; mean [SD] age, 55.8 [8.0] years) were enrolled (intolerants, n = 17; nonresponders, n = 9). All patients completed the study. Significant improvement was shown in most of the 5 components of the PSE index after rifaximin administration in both intolerants and nonresponders. At the end of the 10-day treatment period, the PSE index was significantly reduced in both intolerants and nonresponders. Rifaximin was well tolerated; no clinically relevant AEs were observed during the treatment period.
CONCLUSIONS
This pilot study of patients with liver cirrhosis and HE who were intolerant or nonresponsive to previous treatment with an oral, nonabsorbable disaccharide suggests that treatment with rifaximin may be considered as an adjuvant or an alternative treatment in reducing HE.
背景
肝性脑病（HE）是一种发生于晚期肝病患者的代谢性神经生理综合征。主要致病机制之一是含氮化合物肠道代谢产生的循环毒素。HE的治疗方法主要基于消除产氨细菌的药物。
目的
本研究旨在评估不可吸收抗生素利福昔明对不耐受或对口服不可吸收双糖（乳果糖）治疗无反应的HE患者的疗效。
方法
本项非对照、开放标签的试点研究在意大利博洛尼亚大学进行。研究对象为年龄≥18岁、经组织学证实为肝硬化且患有HE的患者。所有患者均不耐受或对先前的乳果糖治疗无反应。利福昔明片以400mg每日三次的剂量给予患者，持续10天。在入组时和治疗期结束时评估门体性脑病（PSE）指数。通过血液学、生物化学和尿液分析以及记录不良反应（AE）来评估耐受性。
结果
共纳入26例患者（18例男性，8例女性；平均[标准差]年龄，55.8[8.0]岁）（不耐受者17例，无反应者9例）。所有患者均完成研究。在不耐受者和无反应者中，给予利福昔明后，PSE指数的5个组成部分中的大多数均有显著改善。在10天治疗期结束时，不耐受者和无反应者的PSE指数均显著降低。利福昔明耐受性良好；治疗期间未观察到临床相关的AE。
结论
这项针对肝硬化和HE患者的试点研究表明，对于不耐受或对先前口服不可吸收双糖治疗无反应的患者，利福昔明治疗可被视为降低HE的辅助治疗或替代治疗。
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