Enteral nutrition with or without N-acetylcysteine in the treatment of severe acute alcoholic hepatitis: A randomized multicenter controlled trial
Enteral nutrition with or without N-acetylcysteine in the treatment of severe acute alcoholic hepatitis: A randomized multicenter controlled trial
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DOI：
10.1016/j.jhep.2010.05.030
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发表时间：
2010-12-01
影响因子：
25.7
通讯作者：
Le Moine, Olivier
中科院分区：
文献类型：
--
作者：
Moreno, Christophe;Langlet, Philippe;Le Moine, Olivier
研究背景和意义重症急性酒精性肝炎与高死亡率相关，氧化应激参与了急性酒精性肝炎的发病机制，既往研究结果也提示肠内营养支持可提高重症急性酒精性肝炎患者的生存率。乙酰半胱氨酸联合充足的营养支持治疗重症急性酒精性肝炎方法活组织检查证实的急性酒精性肝炎患者和mDF >= 32的患者随机接受N-乙酰半胱氨酸治疗，主要终点为6个月生存率，次要终点为生物学指标的变化和感染率。结果52例患者随机入组研究两组在基线特征上无差异，N-乙酰半胱氨酸组和对照组1个月和6个月的生存率分别为702%和83.8%。（p = 0.26）和624 vs 67.1%（p = 0.60）两组早期生物学变化、1个月感染率和肝肾综合征发生率无差异。乙酰半胱氨酸治疗14天对急性酒精性重型肝炎患者既无生存益处，也无早期生物学改善然而，这些结果必须谨慎看待，因为该研究缺乏动力（C）2010年欧洲肝脏研究协会Elsevier B V出版版权所有
Background & Alms Severe acute alcoholic hepatitis is associated with a high mortality rate Oxidative stress is involved in the pathogenesis of acute alcoholic hepatitis Previous findings had also suggested that enteral nutritional support might increase survival in patients with severe acute alcoholic hepatitis Therefore the aim of the present study was to evaluate the efficacy of N-acetylcysteine in combination with adequate nutritional support in patients with severe acute alcoholic hepatitisMethods Patients with biopsy-proven acute alcoholic hepatitis and mDF >= 32 were randomized to receive N-acetylcysteine intravenously or a placebo perfusion along with adequate nutritional support for 14 days The primary endpoint was 6-month survival secondary endpoints were biological parameter evolution and infection rateResults Fifty-two patients were randomized in the study (28 into the N-acetylcysteine arm 24 into the control arm) and among them five were excluded from the analysis for protocol violation The two groups did not differ in baseline characteristics Survival rates at 1 and 6 months in N-acetylcysteine and control groups were 702 vs 83 8% (p = 0 26) and 624 vs 67 1% (p = 0 60) respectively Early biological changes documented infection rate at 1 month and incidence of hepatorenal syndrome did not differ between the two groupsConclusions In this study high doses of Intravenous N-acetylcysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe acute alcoholic hepatitis patients with adequate nutritional support However these results must be viewed with caution since the study suffered from a lack of power (C) 2010 European Association for the Study of the Liver Published by Elsevier B V All rights reserved