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PHARMACOEPIDEMIOLOGICAL EVALUATION OF HEPATOTROPIC THERAPY IN REAL CLINICAL PRACTICE

https://doi.org/10.17749/2070-4909.2015.8.1.031-038

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Abstract

Chronic liver diseases are a serious problem and a common cause of suffering and death in all countries. Non-alcoholic fatty liver disease (NAFLD) is a major cause of chronic liver diseases. Alcoholic liver disease (ALD) is a disease that occurs in the case of the long-term alcohol consumption. ALD may show signs of fatty liver (steatosis), alcoholic hepatitis and cirrhosis. Increase in the prevalence of ALD is also related to the increased alcohol consumption inRussia. Viral hepatitis is a global problem leading to disability and death. About 500 million people are infected with hepatitis B or C, one million annually die from liver diseases associated with hepatitis (2.7% of all deaths). The use of essential phospholipids (EPL) as hepatotropic therapy is widespread inRussia. However, the real practice on its use had not been systematically studied. Primary objective was to characterize under conditions of real life, the profile of consecutive outpatients with newly diagnosed or known diagnosis of liver conditions with gastrointestinal symptoms and receiving a treatment with EPL as an adjunctive treatment to standard care. Materials and methods. 2450 patients were included in 98 sites. Non-interventional on therapeutic strategy study consisting of two phases: Phase 1 – a cross-sectional study to assess the profile of patients who are prescribed EPL; Phase 2 (prospective ) – the follow-up study on 20% patients participated in the Phase 1to assess compliance treatment regimen. Study results. Steatosis was the most frequent liver disease (59.7% patients). Hepatic diseases related to obesity was 23.8% patients, hepatic diseases related to diabetes – 336/2450 (13.7%). Chronic viral hepatitis observed in 21.7% cases. Taking into account that 15.8% patients suffered from combined pathology, data describing morbidity structure were the following: isolated hepatic steatosis occurred in 46.7% cases, hepatic diseases related to obesity – in 12.8% and hepatic diseases related to diabetes – at 6.4%, chronic viral hepatitis – at 18.3%. Patients most often complained about feeling of pressure in the right epigastric 74.4%, general weakness and apathy – 1497/2450 (61.1%), abdominal distension – 1438/2450 (58.7%), nausea – 51.9%. Almost a third of patients complained of irritability – 35.8%, headache and muscle pain – 35.4% and lack of appetite – 26.9%. The main non-pharmacologic management measures for liver disease were: diet therapy – 1387/2450 (97.4%), complete refusal of alcohol – 1726/2450 (70.5%), daily exercise of moderate intensity – 1495/2450 (61.0%), complete smoking cessation – 608/2450 (24.8%). Most often prescribed treatment for liver diseases were hepatoprotectors at inclusion visit – 2291/2450 (93.5%), hypotensive – 1201/2450 (49.0%), hypolipidemic – 1060/2450 (43.3%), hypoglycemic – 457/2450 (18.7%) drugs. Lipotropic products administered at 319/2450 (13.0%) cases, detoxifying – in 282/2450 (11.5%), antiviral – in 147/2450 (6.0%) and immunotropic – in 73/2450 (3.0%). 

About the Authors

D. V. Blinov
The Russian National Research Medical University named after N.I. Pirogov, Moscow
Russian Federation

Blinov Dmitry Vladislavovich – MD, PhD, Pirogov Russian National Research Medical University (RNRMU) Address: Ostrovitianov str. 1, 117997, Moscow, Russia. E-mail: blinov2010@gmail.com



U. V. Zimovina
First Moscow State Medical Sechenov University
Russian Federation

Zimovina Juliana Vladimirovna – MD, PhD, FirstMoscowMedicalSechenovUniversity. Address: ul. Zemlyanoy Val, 62, p. 1, 109004, Moscow, Russia. E-mail: nevrologia@mail.ru



T. I. Ushakova
LLC “Meditsina”, Moscow
Russian Federation
Ushakova Tat'yana Igorevna – PhD, scientific project coordinator, LLC “Meditsina”. Address: 2nd Tverskaya lane, 10, Moscow, Russia


References

1. Belyakova N.M., Tetova V.B., Aleshkovich T.V. Infektsionnye Bolezni. 2006; 4 (1): 14-16.

2. Bueverov A.O., Bogomolov P.O. Klin. perspektivy gastroenterol. 2009; 1: 3-9.

3. Butorova L.I. Nonalcoholic fatty liver disease as a manifestation of the metabolic syndrome: epidemiology, pathogenesis, clinical manifestations, principles of diagnosis, current treatment options [Nealkogol'naya zhirovaya bolezn' pecheni kak proyavlenie metabolicheskogo sindroma: epidemiologiya, patogenez, osobennosti klinicheskogo proyavleniya, printsipy diagnostiki, sovremennye vozmozhnosti lecheniya]. Moscow. 2012. 52 s.

4. Vasilenko I.A., Dolgova G.V., Sorokoumova G.M., Khairetdinova M.N., Pomerantseva T.Ya. RMZh. 2010; 18 (6): 352-355.

5. Gundermann K.-I. Ross. Med. Vesti. 2009; 2: 1-7.

6. Gurevich K.G. Klinicheskaya farmakokinetika. 2004; 1: 52-57.

7. Drapkina O.M., Ivashkin V.T. RZhGGK. 2014; 4: 32-38.

8. Ivashkin V.T. The study DIREG 2. epidemiological studies on the prevalence of nonalcoholic fatty liver disease and identification of risk factors for the disease among patients outpatient practice. XX Russian Congress "Hepatology today." March 29, 2015 [Issledovanie DIREG 2. Epidemiologicheskoe issledovanie po izucheniyu rasprostranennosti nealkogol'noi zhirovoi bolezni pecheni i opredelenie faktorov riska razvitiya zabolevaniya sredi patsientov ambulatorno-poliklinicheskoi praktiki. XX Rossiiskii kongress «Gepatologiya segodnya». 29 marta 2015 g].

9. Isakov V.A. Eksperimental'naya i klinicheskaya gastroenterologiya. 2007; 2: 3-8.

10. Lipatova L.V. Epilepsiya i paroksizmal'nye sostoyaniya/Epilepsy and paroxysmal conditions. 2010; 3: 20-27.

11. Makarov I.O., Borovkova E.I., Kazakov R.D. Akusherstvo, ginekologiya i reproduktsiya/Obstetrics, gynecology and reproduction. 2012; 4: 18-21.

12. Makarov I.O., Pavlov Ch.S., Shemanaeva T.V., Voevodin S.M., Muravei A.Yu. Akusherstvo, ginekologiya i reproduktsiya/Obstetrics, gynecology and reproduction. 2013; 1: 22-25.

13. Odinak M.M., Bazilevich S.N., Dyskin D.E., Prokudin M.Yu. Epilepsiya i paroksizmal'nye sostoyaniya/Epilepsy and paroxysmal conditions. 2010; 3: 45-50.

14. Polivanov V.A. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya/PHARMACOECONOMICS. Modern pharmacoeconomics and pharmacoepidemiology. 2009; 1: 7-11.

15. Polunina T.E. Gastroenterologiya. 2011; 5: 12-18.

16. Sas E.I., Blinov D.V., Zimovina U.V. Klinicheskie perspektivy gastroenterologii, gepatologii. 2015; 1: 9-17.

17. Smirnova O.M. Lechashchii Vrach. 2011; 3. 1

18. Essentiale Forte N. Instruction for for medical use [Essentsiale Forte N. Instruktsiya po meditsinskomu primeneniyu].

19. Yushchuk N.D., Martynov Yu.V., Znoiko O.O., Klimova E.A., Karetkina G.N., Maksimov S.L., Ivanova L.M., Mazus A.I., Golokhvastova E.L., Ol'shanskii A.Ya. Antiviral therapy of chronic viral hepatitis B and C in HIV-infected patients. Methodical letter. First Moscow State Medical Sechenov University [Protivovirusnaya terapiya khronicheskikh virusnykh gepatitov V i S u VICh-infitsirovannykh patsientov. Metodicheskoe pis'mo. MGMSU]. Moscow. 2006.

20. Arvind N., Savaikar P., Rajkumar J. Therapy for NAFLD. A comparative study of essential phospholipids vs ursodeoxycholic acid. Indian J Clin Pract. 2006; 16: 21-24.

21. Blachier M., Leleu H., Peck-Radosavljevic M., Valla D.-C., Roudot-Thoraval F. The burden of liver disease in Europe: a review of available epidemiological data. The European Association for the Study of the Liver. EASL. 2013.

22. Cairella M., Callisto F., Godi R., Marchini G. Polyunsaturated phosphatidylcholine combined with vitamin B complex in the treatment of patients with disorders of the hepatobiliary function caused by unbalanced nutrition. 1998; 131: 237-246.

23. Chalasani N. et al. The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012; 142: 1592-1609.

24. Du Q. Treatment of 52 cases with hepatic dysfunctional fatty liver with Essentiale®. Chin J Gastro Hepa. 2004; 13: 21-24.

25. EASL Clinical Practical Guidelines: Management of Alcoholic Liver Disease. Journal of Hepatology. 2012; 57: 399-420.

26. EASL Recommendations on Treatment of Hepatitis C. 2014.

27. Fan J.G., Jia J.D., Li Y.M., Wang B.Y., Lu L.G., Shi J.P., et al. Guidelines for the diagnosis and management of nonalcoholic fatty liver disease: update 2010. J Dig Dis. 2011; 12: 38-44.

28. Gonciarz Z., Besser P., Lelek E., Gundermann K.J., Johannes K.J. Randomized placebo-controlled double-blind trial on “essential” phospholipids in the treatment of fatty liver associated with diabetes. Med. Chir. Digest. 1988; 17: 61-85.

29. Gundermann K.J., Kuenker A., Kuntz E., Droździk M. Activity of essential phospholipids (EPL) from soybean in liver diseases. Pharmacol Rep. 2011; 63: 643-659.

30. Ilis V., Begic-Janev A. Therapy of HBsAg-positive chronic active hepatitis. The efficacy of ‘essential” phospholipids. Me Welt. 1991; 42: 523-525.

31. La Brecque et al., World Gastroenterology Organisation Global Guidelines. Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. J Clin Gastroenterol. 2014; 48 (6): 467-473.

32. Liang H. Discussion of treatment of fatty liver using polyene phosphatidylcholine capsules. Chinese Med Fact Mine. 2006; 19: 43.

33. Neuschwander-Tetri B.A., Caldwell S.H. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003; 37: 1202-19.

34. Niederau C., Strohmeyer G., Heintges T., Peter K., Gopfert E. Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double-blind, placebo-controlled trial. Leich Study Group. Hepatogastroenterology. 1998; 45: 797-804.

35. Pacana T., Fuchs M. The cardiovascular link to nonalcoholic fatty liver disease. Clin Liver Dis. 2012; 16: 599-613.

36. Panos M., Polson R., Johnson R., Portmann B., Williams R. polyunsaturated phosphatidylcholine for acute alcoholic hepatitis: a double-blind, randomized, placebo-controlled trial. Eur J Gastroenterol Hepatol.1990; 2: 351-355.

37. Sas E., Grinevich V., Kravchuk O., Efimov O. Polyunsaturated phosphatidylcholine reduces insulin resistance and hepatic fibrosis in patients with alcoholic liver disease. Results of randomized blinded prospective clinical study. Journal of Hepatology. 2011; 54: 207.

38. Schuller P.A., Gonzalez S.M.F. Controlled study with polyunsaturated phosphatidylcholine versus placebo in alcoholic fatty steatosis. Die Medizinische Welt. 1985; 36: 517-521.

39. Un C., Zheng X., Tan Z., Cui F., Zhang R., Zhang H. Clinical observation on polyene phosphatidylcholine and metformin in th treatment of type-2 diabetes and non-alcoholic fatty liver disease. Clin Focus. 2008; 23.

40. von Elm E., Altman D.G., Egger M., Pocock S.J., Gøtzsche P.C., Vandenbroucke J.P.; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008; 61 (4): 344-349.

41. Xu B., Ren C., Long B. Clinical Observation of 24 cases of Essentiale® Treating Alcoholic Fatty Liver. Sichuan Medical Journal. 2007; 28: 1116-1117.

42. Yin D., Kong L. Observation for curative effect of Essentiale® in treatment of fatty liver caused by diabetes mellitus. Med J Q. 2000;15: 277-278

43. Zhang X. Gong D., Wu S., Chen Q. Аndomized, controlled, double-blind, clinical trial of compound polyene phosphaticholine in treating chronic active hepatitis B. Chinese J Pharmacoepidemiol. 1995; 1.


For citation:


Blinov D.V., Zimovina U.V., Ushakova T.I. PHARMACOEPIDEMIOLOGICAL EVALUATION OF HEPATOTROPIC THERAPY IN REAL CLINICAL PRACTICE. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2015;8(1):31-38. (In Russ.) https://doi.org/10.17749/2070-4909.2015.8.1.031-038

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