Phillips Martin, Curtis Howard, Portmann Bernard, Donaldson Nora, Bomford Adrian, O'Grady John
Institute of Liver Studies, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
J Hepatol. 2006 Apr;44(4):784-90. doi: 10.1016/j.jhep.2005.11.039. Epub 2005 Dec 20.
BACKGROUND/AIMS: Severe alcoholic hepatitis is associated with high morbidity and short-term mortality. Corticosteroids are the only widely used therapy but established contraindications to treatment or the risk of serious side-effects limit their use. The perceived need for alternative treatments together with the theoretical benefits of anti-oxidant therapy triggered the design of a randomised clinical trial comparing these treatment modalities.
One hundred and one patients were randomized into a clinical trial of corticosteroids or a novel antioxidant cocktail with a primary endpoint of 30-day mortality.
At 30 days there were 16 deaths (30%) in the corticosteroid treated group compared with 22 deaths (46%) in the antioxidant treated group (P=0.05). The odds of dying by 30 days were 2.4 greater for patients on antioxidants (95% confidence interval 1.0-5.6). A diagnosis of sepsis was made more frequently in the AO group (P=0.05), although microbiologically proven episodes of infection occurred more often in the CS group (P<0.01). The survival advantage for corticosteroid treated patients was lost at 1 year of follow-up (P=0.43).
This study has shown that corticosteroids in the form of prednisolone 30 mg daily are superior to a broad antioxidant cocktail in the treatment of severe alcoholic hepatitis.
背景/目的：重症酒精性肝炎与高发病率和短期死亡率相关。皮质类固醇是唯一广泛使用的治疗方法，但既定的治疗禁忌证或严重副作用风险限制了其使用。对替代治疗的需求以及抗氧化治疗的理论益处促使开展了一项比较这些治疗方式的随机临床试验。
101例患者被随机纳入皮质类固醇或新型抗氧化剂鸡尾酒的临床试验，主要终点为30天死亡率。
30天时，皮质类固醇治疗组有16例死亡（30%），而抗氧化剂治疗组有22例死亡（46%）（P=0.05）。接受抗氧化剂治疗的患者在30天内死亡的几率高出2.4倍（95%置信区间1.0-5.6）。抗氧化剂组（AO组）败血症诊断更为频繁（P=0.05），尽管经微生物学证实的感染发作在皮质类固醇组（CS组）更为常见（P<0.01）。皮质类固醇治疗患者的生存优势在随访1年时消失（P=0.43）。
本研究表明，每日30毫克泼尼松龙形式的皮质类固醇在治疗重症酒精性肝炎方面优于广泛的抗氧化剂鸡尾酒。
