HE预示肝硬化预后不良。治疗HE的药物主要在于减少血氨水平。利福昔明和乳果糖均对于治疗HE有效。本实验在于比较利福昔明联合乳果糖与单独应用乳果糖治疗HE的有效性和安全性。这是一项前瞻性双盲随机对照实验。120名明显HE的患者随机分为2组：A组：63名，乳果糖联合利福昔明，1200mg/day.B组：57名，乳果糖联合安慰剂。第一个观察指标为HE的完全恢复。第二项观察指标为死亡率和住院天数。共120名患者纳入实验。37名处于CTP评分B级，83名处于CTP评分C级。平均CTP评分为9.7±2.8，平均MELD评分为24.6±4.2。入院时，22名患者处于HE2期，40名处于3期，58名处于4期。A组患者中有48（76%）名获得HE的完全恢复，而B组仅有29（50.8%）名得到恢复（P<0.004）。乳果糖联合利福昔明治疗组，相较于乳果糖联合安慰剂治疗组，其死亡率明显下降(23.8% vs. 49.1%, P<0.05). B组患者中因为败血症死亡的人数比A组明显增多(group A vs. group B: 7:17, P=0.01),然而，两者因消化道出血和肝肾综合征死亡的人数无差异。乳果糖联合利福昔明组患者的住院天数较短(5.8±3.4 vs. 8.2±4.6 days, P=0.001). 治疗HE，乳果糖联合利福昔明比单独使用乳果糖更加有效。
OBJECTIVES:Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximinplus lactulose vs. lactulose alone for treatment of overt HE.METHODS:In this prospective double-blind randomized controlled trial, 120 patients withovert HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay.RESULTS:A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plusrifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs. 8.2±4.6 days, P=0.001).CONCLUSION:Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.
吉林大学第一医院肝病科 Pingsay 摘译
本文首次发表于[Am J Gastroenterol. 2013 Jul 23]
本文首次发表于[Am J Gastroenterol. 2013 Jul 23]
A Randomized, Double-Blind, Controlled Trial Comparing Rifaximin Plus Lactulose With Lactulose Alone inTreatment of Overt Hepatic Encephalopathy.
AbstractOBJECTIVES:Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximinplus lactulose vs. lactulose alone for treatment of overt HE.METHODS:In this prospective double-blind randomized controlled trial, 120 patients withovert HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay.RESULTS:A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plusrifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs. 8.2±4.6 days, P=0.001).CONCLUSION:Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.
