Service des Maladies de l'Appareil digestif, Hôpital Huriez, Rue Polonovski, F-59037 Lille, France.
Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.
A meta-analysis was performed using individual patient data from the five most recent randomised controlled trials (RCTs) which evaluated corticosteroids in severe alcoholic hepatitis (Maddrey discriminant function (DF) ≥ 32 or encephalopathy). This approach overcomes limitations associated with the use of literature data and improves the relevance of the study and estimates of effect size.
To compare 28-day survival between corticosteroid- and non-corticosteroid-treated patients and to analyse the response to treatment using the Lille model.
Individual patient data were obtained from five RCTs comparing corticosteroid treatment with placebo (n=3), enteral nutrition (n=1) or an antioxidant cocktail (n=1).
221 patients allocated to corticosteroid treatment and 197 allocated to non-corticosteroid treatment were analysed. The two groups were similar at baseline. 28-day survival was higher in corticosteroid-treated patients than in non-corticosteroid-treated patients (79.97±2.8% vs 65.7±3.4%, p=0.0005). In multivariate analysis, corticosteroids (p=0.005), DF (p=0.006), leucocytes (p=0.004), Lille score (p<0.00001) and encephalopathy (p=0.003) were independently predictive of 28-day survival. A subgroup analysis was performed according to the percentile distribution of the Lille score. Patients were classified as complete responders (Lille score ≤ 0.16; ≤ 35th percentile), partial responders (Lille score 0.16-0.56; 35th-70th percentile) and null responders (Lille ≥ 0.56; ≥ 70th percentile). 28-day survival was strongly associated with these groupings (91.1±2.7% vs 79.4±3.8% vs 53.3±5.1%, p<0.0001). Corticosteroids had a significant effect on 28-day survival in complete responders (HR 0.18, p=0.006) and in partial responders (HR 0.38, p=0.04) but not in null responders.
Analysis of individual data from five RCTs showed that corticosteroids significantly improve 28-day survival in patients with severe alcoholic hepatitis. The survival benefit is mainly observed in patients classified as responders by the Lille model.
使用来自五项最新随机对照试验（RCT）的个体患者数据进行了一项荟萃分析，这些试验评估了皮质类固醇在严重酒精性肝炎（Maddrey 判别函数（DF）≥32 或肝性脑病）中的作用。这种方法克服了使用文献数据的局限性，并提高了研究的相关性和效应大小的估计值。
比较皮质类固醇治疗和非皮质类固醇治疗患者的 28 天生存率，并使用 Lille 模型分析治疗反应。
从五项比较皮质类固醇治疗与安慰剂（n=3）、肠内营养（n=1）或抗氧化鸡尾酒（n=1）的 RCT 中获取个体患者数据。
分析了 221 例皮质类固醇治疗组和 197 例非皮质类固醇治疗组患者。两组患者基线相似。皮质类固醇治疗组患者的 28 天生存率高于非皮质类固醇治疗组（79.97±2.8%比 65.7±3.4%，p=0.0005）。多变量分析显示，皮质类固醇（p=0.005）、DF（p=0.006）、白细胞（p=0.004）、Lille 评分（p<0.00001）和肝性脑病（p=0.003）是 28 天生存率的独立预测因素。根据 Lille 评分的百分位分布进行了亚组分析。患者分为完全缓解者（Lille 评分≤0.16；≤第 35 百分位）、部分缓解者（Lille 评分 0.16-0.56；第 35-70 百分位）和无反应者（Lille≥0.56；≥第 70 百分位）。28 天生存率与这些分组密切相关（91.1±2.7%比 79.4±3.8%比 53.3±5.1%，p<0.0001）。皮质类固醇对完全缓解者（HR 0.18，p=0.006）和部分缓解者（HR 0.38，p=0.04）的 28 天生存率有显著影响，但对无反应者无影响。
对五项 RCT 的个体数据进行分析显示，皮质类固醇可显著提高严重酒精性肝炎患者的 28 天生存率。生存获益主要见于 Lille 模型定义的应答者患者。
