酒精性肝炎是一种明显的以
ST OPAH是个多中心，2×2析因，双盲的随机试验，旨在评估泼尼松龙（40mg/天，治疗4周）和己酮可可碱（400mg tds，治疗4周）的治疗获益。临床确诊为酒精性肝炎并且DF 232的患者随机分为4组：A组 安慰剂/ 安慰剂；B组 安慰剂/泼尼松龙；C组 己酮可可碱/安慰剂；D组 己酮可可碱/泼尼松龙。主要终点是28天死亡率，次要终点包括90天和1年的死亡率。
经过3年的时间，该试验筛查了65家研究中心的5234例患者。1103例患者被随机化分组，经过筛选，1053例患者的数据可用于主要终点分析。第28天时，A组269例患者中45例(16.7%)患者死亡，B组266例患者中38例(14.3%)患者死亡，C组258例患者中50例(19.4%)患者死亡，D组260例患者中35例(13.5%)患者死亡。己酮可可碱组28天死亡率的优势比是1.07 (95% Cl 0.77-1.49)，p=0.686。泼尼松龙组28天死亡率的优势比是0.72(95% Cl0.52-1.01)，p=0.056。基于疾病严重程度和预后等基线因素（年龄，INR，胆红素，白细胞计数，
我们总结，泼尼松龙组使28天死亡率风险大约下降了39%。然而，超过这段时间获益就不持久了。己酮可可碱对疾病的进展没有影响，不再建议用于严重酒精性肝炎的治疗。
英文原文
Alcoholic hepatitis is a distinct clinical syndrome characterised by jaundice and liver impairment arising on a background of heavy and usually prolonged acohol use. The short term mortality rate in patients with severe disease, defined by a discriminant function (DF) 232, exceeds 30%. Prednisolone and pentoxifylline are both currently recommended for the treatment of severe alcoholic hepatitis but uncertainty persists about their benefit.
ST OPAH was a mutilcentre, 2 x 2 factorial, double blind randomised trial designed to evaluate the therapeutic benefit of both prednisolone (40mg daily for 4 weeks) and pentoxfylline (400mg tds for 4 weeks). Patients with a clinical diagnosis of acoholic hepatitis and a DF 232were randomised to four arms: A placebo/plcebo; B placebo/prednisolone; C pentoxifyline/placebo; D pentoxifylline/prednisolone. The primary endpoint was mortalty at 28 days and secondary endpdnts included mortalty at 90 days and 1 year.
Over a 3 year period in 65 centres 5234 patients were screened for the trial, 1103 were randomised and after withdrawals 1053 were available for primary endpoint analysis. At 28 days in arm A 45 of 269 (16.7%) patients died, in arm B 38 of 266 (14.3%) died, in arm C 50 of 258 (19.4%) died and in arm D 35 of 260 (13.5%) died. For pentoxfylline the odds ratio for 28 day mortalty was 1.07 (95% Cl 0.77-1.49), p=0.686 and for prednisolone the odds ratio was 0.72 (95% Cl 0.52-1.01), p=0.056. In logistic regression analysis accounting for baseline factors of disease severity and prognosis (age, INR, bilirubin, WBC, urea, creatinine and hepatic encephalopathy) the odds ratio for 28 day mortality in the prednisolone treated group was 0.61 (95% Cl 0.41-0.90), p=0.014. At 90 days and 1 year there were no signficant dfferences in mortality rates between the treatment groups. Infection was more common in the prednisolone group (13.5%) than in the no prednisolone group (7.9%), p=0.0026.
We conclude that prednisolone reduces the risk of mortarity at 28 days by approximately 39%. However, this benefit is not sustained beyond this time. Pentoxifylline had no impact on disease progression and should no longer be used for the treatment of severe alcoholic hepatitis.
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