A PROSPECTIVE OBSERVATIONAL STUDY ON EFFECTS OF HEPATOPROTECTIVE AGENTS IN ALCOHOLIC LIVER DISEASE AT A TERTIARY CARE HOSPITAL
Abstract
Drug utilization evaluation of hepatoprotective drugs is important in view of the spectrum of effect and associated risks with their therapy. The study was designed to evaluate the effects and adverse effects of hepatoprotective agents. A prospective, observational study was carried out for a period of 6 months at Osmania General Hospital (a tertiary care hospital). 120 patients were evaluated receiving corticosteroids, pentoxifylline, ursodeoxycholic acid for observing a trend in hepatic parameters and its outcomes. Ursodeoxycholic acid (81.66%) was the most commonly prescribed drug in almost all cases of alcoholic liver diseases followed by pentoxifylline (10%) in hepatorenal syndrome and then prednisolone (8.33%) in fatty liver. 67 cases were reported to have the significant drop in liver transaminases and bilirubin levels. Ursodeoxycholic acid resulted in a drop of 25% serum bilirubin and 35% drop in serum ALT (alanine transaminase) and 33% drop in serum AST (aspartate transaminase) in patients in a time gap of 1 week. Among 120 cases 94 were males (78.05%) and 26 females (21.04%) and maximum patients with alcoholic liver disease belonged to age group of 30-40 years (27.6%). Ursodeoxycholic acid (300 mg once daily) is used as an off-label drug for all types of alcoholic liver disease and also for viral hepatitis. Though Ursodeoxycholic acid showed a significant drop in liver transaminases and serum bilirubin levels in cirrhotic patients a better alternative lie in liver transplantation as long as they remain abstinent from alcohol.
Keywords: Alcoholic liver diseases, Hepatoprotective agents, Liver transaminases, Bilirubin, Paired t-test.
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References
2. Morgan MY. Hepatoprotective agents in alcoholic liver disease. J Intern Med 1985; 218: 225–233.
3. Halegoua-De Marzio DL, Fenkel JM. Treatment of severe alcoholic hepatitis with corticosteroids and pentoxifylline. JAMA 2013; 310: 1029-30.
4. Spahr L, Rubbia-Brandt L, Pugin J, Giostra E, Frossard JL, Borisch B, Hadengue A. Rapid changes in alcoholic hepatitis histology under steroids: correlation with soluble intercellular adhesion molecule-1 in hepatic venous blood. J Hepatol 2001; 35: 582–589.
5. Taïeb J, Mathurin P, Elbim C, Cluzel P, Arce-Vicioso M, Bernard B, Opolon P, Gougerot-Pocidalo MA, Poynard T, Chollet-Martin S. Blood neutrophil functions and cytokine release in severe alcoholic hepatitis: effect of corticosteroids. J Hepatol 2000; 32: 579–586.
6. Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009; 137: 541-48.
7. Akriviadis E, Botla R, Briggs W, Han S, Reynolds T, Shakil O. Pentoxifylline improves short-term survival in severe acute alcoholic hepatitis: a double-blind, placebo-controlled trial. Gastroenterology 2000; 119: 1637–1648.
8. Hagey LR, Crombie DL, Espinosa E, Carey MC, Igimi H, Hofmann AF. Ursodeoxycholic acid in the Ursidae: Biliary bile acids of bears, pandas, and related carnivores. J Lipid Res 1993; 34: 1911-7.
9. Bachrach WH, Hofmann AF. Ursodeoxycholic acid in the treatment of cholesterol cholelithiasis. part I. Dig Dis Sci 1982; 27: 737–761.
10. Roma MG, Toledo FD, Boaglio AC, Basiglio CL, Crocenzi FA, Sánchez Pozzi EJ. Ursodeoxycholic acid in cholestasis: Linking action mechanisms to therapeutic applications. Clin Sci (Lond.) 2011; 121: 523–44.
11. Leuschner U, Leuschner M, Sieratzki J, Kurtz W, Hübner K. Gallstone dissolution with ursodeoxycholic acid in patients with chronic active hepatitis and two years follow-up, A pilot study. Dig Dis Sci 1985; 30: 642–49.
12. Heathcote EJ, Cauch-Dudek K, Walker V, Bailey RJ, Blendis LM, Ghent CN et al. The Canadian multicentre double blind randomized controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. Hepatology 1994; 19: 1149–56.
13. Degott C, Zafrani ES, Callard P, Balkau B, Poupon RE, Poupon R. Histopathological study of primary biliary cirrhosis and the effect of ursodeoxycholic acid treatment on histology progression. Hepatology 1999; 29: 1007–1012.
14. Gong Y, Huang ZB, Christensen E, Gluud C. Ursodeoxycholic acid for primary biliary cirrhosis. Cochrane Database Syst Rev 2008; 16: CD000551.
15. Reichen J. Review: ursodeoxycholic acid does not reduce risk for mortality or liver transplantation in primary biliary cirrhosis. ACP J Club 2008; 148: 17.
16. European Association for the Study of the Liver. EASL Clinical Practical Guidelines: Management of alcoholic liver disease. J Hepatol 2012; 57: 399-420.
17. Becker U, Deis A, Sørensen TI, Grønbaek M, Borch-Johnsen K, Müller CF, et al. Prediction of risk of liver disease by alcohol intake, sex, and age: a prospective population study. Hepatology 1996; 23: 1025-29.
18. Tam TW, Midanik LT. The effect of screening on prevalence estimates of alcohol dependence and social consequences. J Stud Alcohol 2000; 61: 617–21.
19. Bernadt MW, Mumford J, Taylor C, Smith B, Murray RM. Comparison of questionnaire and laboratory tests in the detection of excessive drinking and alcoholism. Lancet. 1982; 1: 325-8.
20. Sato N, Lindros KO, Baraona E, Ikejima K, Mezey E, Järveläinen HA, et al. Sex difference in alcohol-related organ injury. Alcohol Clin Exp Res 2001; 25(5 Suppl ISBRA): 40S-45S.
21. Wechsler H, Austin SB. Binge drinking: the five/four measure. J Stud Alcohol 1998; 59: 1224.
22. Barrio E, Tomé S, RodrÃguez I, Gude F, Sánchez-Leira J, Pérez-Becerra E et al. Liver disease in heavy drinkers with and without alcohol withdrawal syndrome. Alcohol Clin Exp Res 2004; 28: 131-6.
23. Vuittonet CL, Halse M, Leggio L, Fricchione SB, Brickley M, Haass-Koffler CL, Tavares T et al. Pharmacotherapy for alcoholic patients with alcoholic liver disease. Am J Health Syst Pharm 2014; 71: 1265-76.
24. Kotb MA. Molecular mechanisms of ursodeoxycholic acid toxicity & side effects: ursodeoxycholic acid freezes regeneration & induces hibernation mode. Int J Mol Sci 2012; 3: 8882-914.
25. Thursz M, Forrest E, Roderick P, Day C, Austin A, O’Grady J et al. The clinical effectiveness and cost-effectiveness of Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2x2 factorial randomised controlled trial. Health Technol Assess 2015; 19: 1-104.

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