A double-blinded, randomized trial of hydrocortisone in acute hepatic failure

Abstract

The Acute Hepatic Failure Study Group (AHFSG) has conducted a double-blinded, randomized evaluation of hydrocortisone in patients with acute hepatic failure. From July 1975 through August 1978, a 38-month period, 18 medical centers in the United States and one in Canada participated in this trial. A total of 64 patients were accessed and found eligible to participate in the study; two of them were subsequently eliminated from our analysis. Eighteen patients received placebo; 23 received 400 mg hydrocortisone per day, and 21 patients were administered 800 mg hydrocortisone per day. We did not observe any therapeutic effect of hydrocortisone, and the survival rates for placebo versus 400 mg and versus 800 mg hydrocortisone per day were 22%, 9%, and 24%, respectively. Fulminant hepatitis associated with drug hepatotoxicity or non-A, non-B hepatitis seemed to have a worse prognosis than fulminant B, although these differences were not significant. Serum alpha-fetoprotein had a modest prognostic value of survival and seemed to be limited to fulminant B. The AHFSG recommends, therefore, that corticosteroid use in acute hepatic failure with hepatic encephalopathy be discontinued.

Drug-induced liver injury

“…53,54 Two earlier randomised controlled trials (RCTs) showed no benefit of corticosteroids in ALF and even demonstrated a poorer outcome in those with DILI. 55,56 A more recent study from the ALFSG corroborated this, showing no improvement in overall survival in drug-induced, indeterminate or autoimmune ALF (61% versus 66%, p=0.41). 57 In fact, lower survival was observed in those patients with the highest model for end stage liver disease scores (>40) after corticosteroid therapy (30% versus 57%, p=0.03).…”

Etiology and outcome for 295 patients with acute liver failure in the united states

“…The three largest published series from the United States included 31, 34, and 62 patients and reported mortality rates of 97%, 94%, and 82%, respectively. [2][3][4] Hepatitis B and non A non B hepatitis were the most frequent identifiable causes of ALF in these earlier studies, which are now more than 20 years old. Accordingly, there is a shortage of reliable current data from the United States concerning this syndrome.…”

Acute Liver Failure in Adults: Etiology, Clinical Manifestations, Methods of Correction

“…Глюкокортикостероиды часто используют для предотвращения и лечения повышенного ВЧД, обусловленного опухолями мозга и некоторыми инфекциями ЦНС. Однако в контролируемом ис-следовании у пациентов с ОПН не было показано преимуществ в отношении контроля отека мозга или улучшения выживаемости [46]. В связи с этим у больных с ОПН не рекомендуется назначать кор-тикостероиды для контроля повышенного ВЧД.…”