Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis.

BACKGROUND: Mortality among patients with severe acute alcoholic hepatitis is high, even among those treated with glucocorticoids. We investigated whether combination therapy with glucocorticoids plus N-acetylcysteine would improve survival. METHODS: We randomly assigned 174 patients to receive prednisolone plus N-acetylcysteine (85 patients) or only prednisolone (89 patients). All patients received 4 weeks of prednisolone. The prednisolone-N-acetylcysteine group received intravenous N-acetylcysteine on day 1 (at a dose of 150, 50, and 100 mg per kilogram of body weight in 250, 500, and 1000 ml of 5% glucose solution over a period of 30 minutes, 4 hours, and 16 hours, respectively) and on days 2 through 5 (100 mg per kilogram per day in 1000 ml of 5% glucose solution). The prednisolone-only group received an infusion in 1000 ml of 5% glucose solution per day on days 1 through 5. The primary outcome was 6-month survival. Secondary outcomes included survival at 1 and 3 months, hepatitis complications, adverse events related to N-acetylcysteine use, and changes in bilirubin levels on days 7 and 14. RESULTS: Mortality was not significantly lower in the prednisolone-N-acetylcysteine group than in the prednisolone-only group at 6 months (27% vs. 38%, P = 0.07). Mortality was significantly lower at 1 month (8% vs. 24%, P = 0.006) but not at 3 months (22% vs. 34%, P = 0.06). Death due to the hepatorenal syndrome was less frequent in the prednisolone-N-acetylcysteine group than in the prednisolone-only group at 6 months (9% vs. 22%, P = 0.02). In a multivariate analysis, factors associated with 6-month survival were a younger age (P<0.001), a shorter prothrombin time (P<0.001), a lower level of bilirubin at baseline (P<0.001), and a decrease in bilirubin on day 14 (P<0.001). Infections were less frequent in the prednisolone-N-acetylcysteine group than in the prednisolone-only group (P = 0.001); other side effects were similar in the two groups. CONCLUSIONS: Although combination therapy with prednisolone plus N-acetylcysteine increased 1-month survival among patients with severe acute alcoholic hepatitis, 6-month survival, the primary outcome, was not improved. (Funded by Programme Hospitalier de Recherche Clinique; AAH-NAC ClinicalTrials.gov number, NCT00863785 .).

Cystic dystrophy of the duodenal wall associated with chronic alcoholic pancreatitis. Clinical features, diagnostic procedures and therapeutic management in a retrospective multicenter series of 23 patients.

AIM OF THE STUDY: The aim of this retrospective multicenter study was to collect data from patients with chronic alcoholic pancreatitis and cystic dystrophy of the duodenal wall in order to better understand the outcome after medical, endoscopic and/or surgical treatment. PATIENTS AND METHODS: The data from medical records of 23 patients consecutively seen in ten primary referral centers from January 1990 to July 2004 were studied. Clinical, biological, and endoscopic features as well as imaging findings were recorded. Response to treatment was noted. RESULTS: Twenty-three patients (20 men), aged 45 years (range: 30-66), with chronic alcohol intake, cystic dystrophy of the duodenal wall, and previously known (N=14) or simultaneously diagnosed (N=9) chronic pancreatitis were included. Symptoms most frequently encountered were abdominal pain (N=22) and weight loss (N=16). An abdominal ultrasound was available for 10 patients, abdominal computed tomography for 22, upper endoscopy for 18, and endoscopic ultrasonography for 22. Endoscopic ultrasonography enabled diagnosis of cystic dystrophy of the duodenal wall in 19/22 patients. Six patients were symptom-free after alcohol withdrawal. Seven patients received octreotide 200 to 400 microg per day, 5 of whom subsequently underwent surgery (71%). Fourteen patients out of 23 were operated on (61%), 11 of whom underwent pancreaticoduodenectomy and remained symptom-free for 47 months follow-up. Mean follow-up was 56 months (range: 2-78) for non surgical patients (39%) and 47 months (range: 12-108) for surgical patients (61%). CONCLUSION: Cystic dystrophy of the duodenal wall complicating chronic alcoholic pancreatitis may be the revealing sign of pancreatitis. Endoscopic ultrasongraphy is the most reliable imaging method for diagnosis. Pancreaticoduodenectomy is the most frequently employed definitive treatment.