Tkachenko Petr, Maevskaya Marina, Pavlov Alexander, Komkova Inna, Pavlov Chavdar, Ivashkin Vladimir
I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
Hepatol Int. 2016 Nov;10(6):983-987. doi: 10.1007/s12072-016-9751-4. Epub 2016 Jun 23.
PURPOSE/BACKGROUND: Severe alcoholic hepatitis (AH) is a life-threatening liver disease with a potential of 30-40 % mortality at 1 month. While steroids remain to be a first line therapy, they provide only about 50 % survival benefit. The aim of the study was to evaluate the efficacy of glucocorticoids plus S-adenosylmethionine (SAMe), as compared to glucocorticoids alone, in patients with severe alcoholic hepatitis.
Forty patients with severe AH were randomized in two groups and enrolled in the prospective trial. Group 1 (n = 20) patients received prednisolone 40 mg/daily per os, and group 2 (n = 20) patients were managed with prednisolone 40 mg/daily per os plus SAMe 800 mg i.v.
Duration was 28 days.
The response rate assessed by Lille model was significantly higher in the prednisolone plus SAMe group (19 of 20; 95 %) than in the prednisolone group (13 of 20; 65 %), p = 0.044. Two (10 %) patients died, both from the prednisolone group. There were no lethal outcomes in the prednisolone plus SAMe group. The Kaplan-Meier method showed no significant differences between the two groups (p = 0.151, log-rank). Hepatorenal syndrome (HRS) occurred in 20 % in the prednisolone group (4 of 20 patients) while no HRS cases were registered in the prednisolone plus SAMe group (p = 0.035).
Management of severe alcoholic hepatitis with prednisolone plus SAMe was associated with better therapy response (p = 0.044) and less frequent HRS occurrence (p = 0.035). Mortality was not significantly lower in the prednisolone-SAMe group than in the prednisolone-only group at 28 days (10 vs. 0 %, p = 0.151).
目的/背景：重症酒精性肝炎（AH）是一种危及生命的肝脏疾病，1个月时的死亡率可达30%-40%。虽然类固醇仍是一线治疗药物，但仅能提供约50%的生存获益。本研究旨在评估糖皮质激素联合S-腺苷甲硫氨酸（SAMe）与单用糖皮质激素相比，治疗重症酒精性肝炎患者的疗效。
40例重症AH患者被随机分为两组，纳入前瞻性试验。第1组（n=20）患者口服泼尼松龙40mg/日，第2组（n=20）患者口服泼尼松龙40mg/日加静脉注射SAMe 800mg。
疗程为28天。
根据里尔模型评估，泼尼松龙联合SAMe组的缓解率（20例中的19例；95%）显著高于泼尼松龙组（20例中的13例；65%），p=0.044。2例（10%）患者死亡，均来自泼尼松龙组。泼尼松龙联合SAMe组无死亡病例。Kaplan-Meier法显示两组间无显著差异（p=0.151，对数秩检验）。泼尼松龙组20%（20例患者中的4例）发生肝肾综合征（HRS），而泼尼松龙联合SAMe组未记录到HRS病例（p=0.035）。
泼尼松龙联合SAMe治疗重症酒精性肝炎疗效更佳（p=0.044），HRS发生率更低（p=0.035）。28天时，泼尼松龙-SAMe组的死亡率与单用泼尼松龙组相比无显著降低（10%对0%，p=0.151）。
