Rifaximin Treatment in Hepatic Encephalopathy
Rifaximin Treatment in Hepatic Encephalopathy
复制标题
利福昔明治疗肝性脑病
DOI：
10.1056/nejmoa0907893
复制
发表时间：
2010-03-25
影响因子：
158.5
通讯作者：
Forbes, William P.
中科院分区：
文献类型：
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作者：
Bass, Nathan M.;Mullen, Kevin D.;Forbes, William P.
肝性脑病是肝硬化的一种慢性衰弱并发症。利福昔明是一种吸收最少的抗生素，其在治疗急性肝性脑病中的疗效有据可查，但其预防该病的疗效尚未建立。METHODS在这项随机、双盲、安慰剂对照试验中，我们将299例慢性肝病引起的复发性肝性脑病缓解的患者随机分配接受利福昔明，剂量为550 mg每日两次（140例患者）或安慰剂（159例患者），持续6个月。主要疗效终点是肝性脑病首次突破性发作的时间。关键的次要终点是到首次住院治疗肝性脑病的时间。与安慰剂相比，利福昔明治疗6个月后显著降低了肝性脑病发作的风险（利福昔明的风险比为0.42; 95%可信区间[CI]为0.28 - 0.64; P
BACKGROUNDHepatic encephalopathy is a chronically debilitating complication of hepatic cirrhosis. The efficacy of rifaximin, a minimally absorbed antibiotic, is well documented in the treatment of acute hepatic encephalopathy, but its efficacy for prevention of the disease has not been established.METHODSIn this randomized, double-blind, placebo-controlled trial, we randomly assigned 299 patients who were in remission from recurrent hepatic encephalopathy resulting from chronic liver disease to receive either rifaximin, at a dose of 550 mg twice daily ( 140 patients), or placebo ( 159 patients) for 6 months. The primary efficacy end point was the time to the first breakthrough episode of hepatic encephalopathy. The key secondary end point was the time to the first hospitalization involving hepatic encephalopathy.RESULTSRifaximin significantly reduced the risk of an episode of hepatic encephalopathy, as compared with placebo, over a 6-month period ( hazard ratio with rifaximin, 0.42; 95% confidence interval [CI], 0.28 to 0.64; P