Flamm Steven L, Mullen Kevin D, Heimanson Zeev, Sanyal Arun J
Northwestern University Feinberg School of Medicine, 676 North Saint Clair, Arkes 19-041, Chicago, IL 60611, USA.
West Virginia University, Morgantown, WV, USA.
Therap Adv Gastroenterol. 2018 Sep 28;11:1756284818800307. doi: 10.1177/1756284818800307. eCollection 2018.
Cirrhosis-related complications are associated with poor prognosis. With our analyses, we examined the potential benefit of rifaximin in reducing the risk of developing cirrhosis-related complications.
Adults with cirrhosis and hepatic encephalopathy (HE) in remission were randomly assigned to receive rifaximin 550 mg twice daily or placebo for 6 months with concomitant lactulose permitted. analyses examined time to cirrhosis-related complications (HE, spontaneous bacterial peritonitis (SBP), variceal bleeding, acute kidney injury/hepatorenal syndrome). Subgroup analyses evaluated efficacy for select baseline disease characteristics.
Of patients receiving rifaximin ( = 140) and placebo ( = 159), 53.6% and 49.1%, respectively, had baseline Model for End-Stage Liver Disease (MELD) score ⩾ 12 and international normalized ratio (INR) ⩾ 1.2. Baseline ascites was observed in 36.4% (rifaximin) and 34.6% (placebo) of patients. In patients with MELD score ⩾ 12 and INR ⩾ 1.2, rifaximin reduced the relative risk (RR) of any first complication experienced during trial by 59% [hazard ratio (HR) = 0.41, 95% confidence interval (CI): 0.25-0.67; < 0.001] placebo. For patients with baseline ascites, rifaximin reduced the RR of any first complication experienced during trial by 42% placebo (HR = 0.58, 95% CI: 0.34-1.0; = 0.045). For some subgroups, there was a decrease in RR of complications of SBP, variceal bleeding, and acute kidney injury/hepatorenal syndrome with rifaximin placebo, although there were few events reported in the study.
Rifaximin may reduce the incidence of cirrhosis-related complications and the recurrence of overt HE.[ClinicalTrials.gov identifier: NCT00298038.].
肝硬化相关并发症与预后不良有关。通过我们的分析,我们研究了利福昔明在降低发生肝硬化相关并发症风险方面的潜在益处。
将处于缓解期的肝硬化合并肝性脑病(HE)的成年人随机分配,分别接受每日两次550毫克利福昔明或安慰剂治疗6个月,同时允许服用乳果糖。分析研究了发生肝硬化相关并发症(肝性脑病、自发性细菌性腹膜炎(SBP)、静脉曲张出血、急性肾损伤/肝肾综合征)的时间。亚组分析评估了特定基线疾病特征的疗效。
接受利福昔明治疗的患者(n = 140)和接受安慰剂治疗的患者(n = 159)中,分别有53.6%和49.1%的患者基线终末期肝病模型(MELD)评分≥12且国际标准化比值(INR)≥1.2。36.4%(利福昔明组)和34.6%(安慰剂组)的患者有基线腹水。在MELD评分≥12且INR≥1.2的患者中,利福昔明使试验期间发生任何首次并发症的相对风险(RR)降低了59%[风险比(HR)= 0.41,95%置信区间(CI):0.25 - 0.67;P < 0.001],优于安慰剂。对于有基线腹水的患者,利福昔明使试验期间发生任何首次并发症的RR比安慰剂降低了42%(HR = 0.58,95% CI:0.34 - 1.0;P = 0.045)。对于一些亚组,利福昔明治疗组的SBP、静脉曲张出血和急性肾损伤/肝肾综合征并发症的RR有所降低,优于安慰剂组,尽管该研究报告的事件较少。
利福昔明可能降低肝硬化相关并发症的发生率和显性肝性脑病的复发率。[临床试验.gov标识符:NCT00298038]