EXPERIENCE OF ORNITHINE ASPARTATE (HEPA-MERZ) AND PROBIOTICS BIOFLORUM FORTE IN THE TREATMENT OF NON-SEVERE FORMS OF ALCOHOLIC AND NON-ALCOHOLIC FATTY LIVER DISEASE

Aim: to evaluate the efficacy and tolerability of ornithine aspartate, probiotic Bioflorum Forte and their combination with steatosis and steatohepatitis in patients  with alcohol and non-alcoholic  fatty  liver disease. Materials and methods.  An open, randomized,  comparative  clinical study, which included 30 outpatients and inpatients with a diagnosis of steatosis, steatohepatitis. We analyzed the clinical symptoms, functional state of the liver. With the help of questionnaires  (Grids LeGo and post intoxication alcohol syndrome) have established the presence of chronic alcohol intoxication. Test transmissions of numbers used to characterize the cognitive function, as well as detection  of minimal hepatic encephalopathy. Quality of life was assessed by questionnaire for patients with chronic liver disease — CLDQ (The chronic liver disease questionnaire). The duration of treatment was4 weeks. Results: all three treatment regimens have demonstrated therapeutic  efficacy: clinical improvement, recovery of liver function and results in cognitive function. When combined therapy also produced a significant improvement  in patients’ quality of life. It is shown that  the safety and tolerability of the means employed, adverse events were not reported. Conclusion: the results obtained allow us to recommend the use of ornithine aspartate (Hepa-Merz), both as monotherapy and as part of complex therapy of steatosis,  steatohepatitis with probiotic Bioflorum Forte in patients with alcoholic and non-alcoholic fatty liver disease.

1. Ageyeva Ye.A., Alekseyenko S.A. Application of the oral «L-ornithine-L-aspartate» at hyperammoniemia at chronic liver diseases at precirrhotic stage. Clin. Prospekts Gastro-enterol. Gepatol. 2015; 6: 24-26 [In Russian].

2. Bogomolov P.O., Bueverov S.A., Uvarov O.V., Matsievich M.V. Hyperammonemia in patients with liver disease at dotsirroticheskoy stage: is it possible? Promising clinical gastroenterology hepatology 2015; 5: 3-8 [In Russian].

3. Tkachenko E.I., Suvorov A.N. Intestinal dysbiosis. Diagnostic and treatment manual. Spb.; SpeсLit. 2007. 238 p [In Russian].

4. Ilchenko L.Yu., Shaposhnikova N.A., Vinnytsia E.V., Petrakov A.V., Karlovic T.I. Early diagnosis and treatment of hepatic encephalopathy in patients with chronic liver dis-ease. Hepatology. 2005; 5: 4-9 [In Russian].

5. Ogurtcov P.P., Nuzhnyi V.P. Express-diagnostics (screening), chronic alcohol intoxi-cation in patients with somatic profile. Clinical Pharmacology and Therapeutics. 2001; 1: 34-39 [In Russian].

6. Osipenko M.F., Redkina A.V., Bikbulatova E.K. et al. Evaluation of l-ornithine-l-aspartate in the treatment of NASH. Consilium Medicum Gastroenterol. 2010; 1: 35-38 [In Russian].

7. Solovieva G.A., Kvachenyuk E.L. Hepa-Merz in the treatment of alcoholic and non-alcoholic steatohepatitis. Medications Ukraine. 2011; 7: 64-70 [In Russian].

8. Bedossa PFLIP Pathology Consortium. Utility and appropriateness of the fatty liver inhibition of progression (FLIP) algorithm and steatosis, activity, and fibrosis (SAF) score in the evaluation of biopsies of nonalcoholic fatty liver disease. Hepatol. 2014; 60: 565-575.

9. Bellentani S., Saccoccio G., Masutti F. et al. Prevalence of and risk factors for hepatic steatosis in Northern Italy. Ann. Intern. Med. 2000; 132: 12–117.

10. Häuser W., Schnur M., Steder-Neukamm U. et al. Validation of the German version of the chronic liver disease Questionnaire. Europ. J. Gastroenterol. Hepatol. 2004; 16: 599-606.

11. EASL Clinical Practical Guidelines: Management of Alcoholic Liver Disease. J. Hepatol. 2012; 57: 399–420.

12. EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. Obes. Facts. 2016; 9: 65–90.

13. Fedchuk L., Nascimbeni F., Pais R. et al. Performance and limitations of steatosis bi-omarkers in patients with nonalcoholic fatty liver disease. Aliment. Pharmacol. Ther. 2014; 40: 1209-1222.

14. Grungreiff K., Lambert-Baumann J. Efficacy of L-ornithine-L-aspartate granules in the treatment of chronic liver disease. Med. Welt. 2001; 52: 219-226.

15. Liu Y.L., Reeves H.L., Burt A.D. et al. TM6SF2 rs58542926 influences hepatic fibro-sis progression in patients with non-alcoholic fatty liver disease. Nat. Commun. 2014; 5: 4309-4314.

16. Loomba R., Sanyal A.J. The global NAFLD epidemic. Rev. Recent. Clin. Trials. 2014; 9: 126-133.

17. McGee R.G., Bakens A., Wiley K. et al. Probiotics for patients with hepatic encepha-lopathy (Review) The Cochrane Library 2011, Issue 11. (URL: http://www.thecochranelibrary.com (Дата обращения: 24.06.2016 г.).

18. Non-Alcoholic Fatty Liver Disease: A Practical Guide. ed. G.C. Farrell, A.J. McCullough, Ch.P. Day. Wiley-Blackwell. 2013. 324 p.

19. Ong J.P., Aggarwal A., Krieger D. et al. Correlation between ammonia levels and the severity of hepatic encephalopathy. Am. J. Med. 2003; 114: 188-193.

20. Parekh P.J., Balart L.A. Ammonia and its role in the pathogenesis of hepatic encepha-lopathy. Clin. Liver Dis. 2015; 19: 529-537.

21. Ratziu V., Bellentani S., Cortez-Pinto H., Day C., Marchesini G. A position statement on NAFLD/NASH based on the EASL 2009 special Conference. J. Hepatol. 2010; 53: 372–384.

22. Valenti L., Al-Serri A., Daly A.K. et al. Homozygosity for the patatin-like phospho-lipase-3/adiponutrin I148M polymorphism influences liver fibrosis in patients with nonal-coholic fatty liver disease. Hepatol. 2010; 51: 1209–1217.

23. Vilstrup H., Amodio P., Bajaj J. et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American association of the study of liver diseases and the European association for the study of the liver. Hepatol. 2014; 60: 715-734.

24. Younossi Z.M., Guyatt G., Kiwi M. et al. Development of a disease specific question-naire to measure health related quality of life in patients with chronic liver disease. Gut. 1999; 45: 295-300.