The safety and efficacy of baclofen to reduce alcohol use in veterans with chronic hepatitis C: a randomized controlled trial
The safety and efficacy of baclofen to reduce alcohol use in veterans with chronic hepatitis C: a randomized controlled trial
复制标题
DOI：
10.1111/add.13787
复制
发表时间：
2017-07-01
期刊：
影响因子：
6
通讯作者：
Dieperink, Eric
中科院分区：
文献类型：
--
作者：
Hauser, Peter;Fuller, Bret;Dieperink, Eric
背景和目的酒精使用障碍（AUDs）在慢性丙型肝炎（HCV）患者中很常见，并加速HCV引起的纤维化和肝硬化的发展。巴氯芬是一种γ-氨基丁酸（GABA）β受体激动剂，与美国食品和药物管理局（FDA）目前批准的AUDs药物不同，因为它主要通过肾脏代谢。这项研究的主要结果是比较巴氯芬与安慰剂在戒酒天数的百分比。设计一项双盲、安慰剂对照的随机试验。设置在美国四个独立的美国退伍军人事务医疗中心的肝病诊所。干预和比较口服巴氯芬剂量为0（安慰剂）或30 mg/天，持续12周，同时进行人工干预。测量主要测量是巴氯芬组和安慰剂组在12周研究期间禁欲天数的百分比[通过时间线跟踪（TLFB）测量]。二次测量的百分比退伍军人谁实现完全禁欲，退伍军人谁实现没有大量饮酒的研究，酒精的渴望，焦虑，抑郁和创伤后应激障碍（PTSD）之间的第4和12周的百分比。FindingsPrimary结局：与安慰剂相比，巴氯芬没有改善禁欲的天数百分比。所有受试者从基线到12周的戒断天数百分比从37.0% [标准误（SE）=2.7]显著降低至68.6%（SE=2.8，F-（1151.1）=66.1，P
Background and AimsAlcohol use disorders (AUDs) are common among people with chronic hepatitis C (HCV) and accelerate the development of fibrosis and cirrhosis caused by HCV. Baclofen, a gamma-aminobutyric acid (GABA) beta-receptor agonist, differs from medications for AUDs currently approved by the United States Food and Drug Administration (FDA), as it is metabolized primarily through the kidneys. The primary outcome of this study was to compare baclofen with a placebo in the percentage of days abstinent from alcohol.DesignA double-blind, placebo-controlled randomized trial.SettingHepatology clinics in four separate US Veteran Affairs Medical Centers in the United States.ParticipantsOne hundred and eighty Veteran men and women older than 18years with chronic HCV, a comorbid AUD and current alcohol use.Intervention and ComparatorOral baclofen was given at dosages of 0 (placebo) or 30mg/day over 12weeks with concomitant manual-guided counseling.MeasurementsThe primary measurement was percentage of days abstinent during the 12-week study period between the baclofen and placebo groups [measured by time-line follow-back (TLFB)]. Secondary measurements were the percentage of Veterans who achieved complete abstinence, the percentage of Veterans who achieved no heavy drinking between weeks 4 and 12 of the study, alcohol craving, anxiety, depression and post-traumatic stress disorder (PTSD).FindingsPrimary outcome: compared with placebo, baclofen did not improve the percentage of days abstinent. For all subjects there were significant reductions from baseline to 12weeks in percentage of days abstinent from 37.0% [standard error (SE)=2.7] to 68.6% (SE=2.8, F-(1151.1)=66.1, P