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Methylprednisolone Therapy in Patients with Severe Alcoholic Hepatitis

医学 安慰剂 甲基强的松龙 内科学 肝性脑病 酒精性肝炎 临床终点 随机对照试验 肝炎 外科 皮质类固醇 胃肠病学 随机化 酒精性肝病 肝硬化 替代医学 病理
作者
Robert L. Carithers,H. Franklin Herlong,Anna Mae Diehl,Ellen W. Shaw,Burton Combes,Harold J. Fallon,Willis C. Maddrey
出处
期刊:Annals of Internal Medicine [American College of Physicians]
卷期号:110 (9): 685-685 被引量:487
标识
DOI:10.7326/0003-4819-110-9-685
摘要

To determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis.Randomized, double-blind, placebo-controlled multicenter trial.Four university teaching hospitals.We enrolled 66 patients with alcoholic hepatitis and either spontaneous hepatic encephalopathy or a discriminant function value greater than 32, calculated using the formula: 4.6 (prothrombin time - control time) + serum bilirubin [in mumol/L]/17.1. Fifty-nine patients (89%) completed the study. Two patients withdrew from the trial. The other 64 patients were hospitalized for the duration of the trial; however, treatment was discontinued in 5 patients because of potential drug toxicity.Patients were randomly assigned to receive either methylprednisolone (32 mg) or placebo within 7 days of admission. Treatment was given for 28 days. The doses were then tapered over 2 weeks and discontinued.The endpoint of the study was death. Of the 31 recipients of placebo, 11 (35%) died within 28 days of randomization compared with 2 (6%) of the 35 patients given methylprednisolone (P = 0.006). The 95% CI for the difference in mortality was 12% to 70%. In the patients with spontaneous hepatic encephalopathy at entry, 9 of 19 recipients of placebo died (47%) compared with 1 (7%) of the 14 patients given methylprednisolone (P = 0.02). The 95% CI for the difference in mortality was 14% to 66%. The Cox proportional hazards regression model showed the advantage of methylprednisolone over placebo after adjustment for other potentially important prognostic variables (P = 0.004).Methylprednisolone therapy decreases short-term mortality in patients with severe alcoholic hepatitis manifested either by spontaneous hepatic encephalopathy or a markedly elevated discriminant function value.
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