Chang Ching, Huang Chien-Hao, Tseng Hsiao-Jung, Yang Fang-Chen, Chien Rong-Nan
Division of Hepatology, Department of Gastroenterology and Hepatology, Chang-Gung Memorial Hospital, Linkou Medical Center, Taoyuan 33305, Taiwan.
College of Medicine, Chang-Gung University, Taoyuan 33305, Taiwan.
J Pers Med. 2021 May 27;11(6):478. doi: 10.3390/jpm11060478.
Hepatic encephalopathy (HE), a neuropsychiatric complication of decompensated cirrhosis, is associated with high mortality and high risk of recurrence. Rifaximin add-on to lactulose for 3 to 6 months is recommended for the prevention of recurrent episodes of HE after the second episode. However, whether the combination for more than 6 months is superior to lactulose alone in the maintenance of HE remission is less evident. Therefore, the aim of this study is to evaluate the one-year efficacy of rifaximin add-on to lactulose for the maintenance of HE remission in Taiwan.
We conducted a real-world single-center retrospective cohort study to compare the long-term efficacy of rifaximin add-on to lactulose (group R + L) versus lactulose alone (group L, control group). Furthermore, the treatment efficacy before and after rifaximin add-on to lactulose was also analyzed. The primary endpoint of our study was time to first HE recurrence (Conn score ≥ 2). All patients were followed up every three months until death, and censored at one year if still alive.
12 patients were enrolled in group R + L. Another 31 patients were stratified into group L. Sex, comorbidity, ammonia level, and ascites grade were matched while age, HE grade, and model for end-stage liver disease (MELD) score were adjusted in the multivariable logistic regression model. Compared with group L, significant improvement in the maintenance of HE remission and decreased episodes and days of HE-related hospitalizations were demonstrated in group R + L. The serum ammonia levels were significantly lower at the 3rd and 6th month in group 1. Concerning changes before and after rifaximin add-on in group R + L, mini-mental status examination (MMSE), episodes of hospitalization, and variceal bleeding also improved at 6 and 12 months. Days of hospitalization, serum ammonia levels also improved at 6th month. Except for concern over price, no patients discontinued rifaximin due to adverse events or complications. The above results provide evidence for the one-year use of rifaximin add-on to lactulose in reducing HE recurrence and HE-related hospitalization for patients with decompensated cirrhosis.
肝性脑病（HE）是失代偿期肝硬化的一种神经精神并发症，与高死亡率和高复发风险相关。推荐在乳果糖基础上加用利福昔明治疗3至6个月，以预防第二次发作后HE的复发。然而，超过6个月的联合治疗在维持HE缓解方面是否优于单独使用乳果糖尚不清楚。因此，本研究的目的是评估在台湾地区，在乳果糖基础上加用利福昔明维持HE缓解的一年疗效。
我们进行了一项真实世界的单中心回顾性队列研究，以比较在乳果糖基础上加用利福昔明（R+L组）与单独使用乳果糖（L组，对照组）的长期疗效。此外，还分析了在乳果糖基础上加用利福昔明前后的治疗效果。本研究的主要终点是首次HE复发的时间（Conn评分≥2）。所有患者每三个月随访一次直至死亡，若仍存活则在一年时进行截尾。
R+L组纳入12例患者。另外31例患者被分层至L组。在多变量逻辑回归模型中对性别、合并症、血氨水平和腹水分级进行匹配，同时对年龄、HE分级和终末期肝病模型（MELD）评分进行调整。与L组相比，R+L组在维持HE缓解方面有显著改善，且HE相关住院的发作次数和天数减少。第1组在第3个月和第6个月时血清氨水平显著降低。关于R+L组加用利福昔明前后的变化，简易精神状态检查表（MMSE）、住院发作次数和静脉曲张出血在第6个月和第12个月时也有所改善。住院天数、血清氨水平在第6个月时也有所改善。除了对价格的担忧外，没有患者因不良事件或并发症而停用利福昔明。上述结果为在失代偿期肝硬化患者中使用乳果糖基础上加用利福昔明一年以降低HE复发和HE相关住院提供了证据。
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