Неалкогольная жировая болезнь печени как причина и следствие кардиометаболических осложнений. Особенности фармакотерапии. Место урсодезоксихолевой кислоты
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Maevskaya M.V., Ivashkin V.T., Ivashkin K.V., et al. Non-alcoholic fatty liver disease as a cause and consequence of cardio-metabolic complications. Role of the ursodeoxicholic acid in the pharmacotherapy. Therapeutic Archive. 2019; 91 (2): 8–117. DOI: 10.26442/00403660.2019.02.000122
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Ключевые слова: неалкогольная жировая болезнь печени, урсодезоксихолевая кислота, артериальная гипертензия, инсулинорезистентность.
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The article presents an update of the role of non-alcoholic fatty liver disease (NAFLD) in cardiometabolic diseases and events: arterial hypertension and components of the metabolic syndrome. A review of NAFLD modern pharmacotherapy has been conducted. Particular attention is paid to the place of ursodeoxycholic acid in the complex treatment of NAFLD.
Key words: non-alcoholic fatty liver disease, ursodeoxycholic acid, arterial hypertension, insulin resistance.
2. Драпкина О.М., Ивашкин В.Т. Эпидемиологические особенности неалкогольной жировой болезни печени в России (результаты открытого многоцентрового проспективного исследования-наблюдения DIREGL 01903). Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2014;24(4):32-8 [Drapkina OM, Ivashkin VT. Epidemiologic features of non-alcoholic fatty liver disease in Russia (Results of open multicenter prospective observational study DIREG L 01903). Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii = The Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2014;24(4):32-8 (In Russ.)].
3. Комова А.Г., Маевская М.В., Ивашкин В.Т. Принципы эффективной диагностики диффузных заболеваний печени на амбулаторном этапе. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2014;24(5):36-41 [Komova AG, Mayevskaya MV, Ivashkin VT. Principles of effective out-patient diagnostics of diffuse liver diseases. Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii = The Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2014;24(5):36-41 (In Russ.)].
4. Lonardo A, Nascimbeni F, Mantovani A, Targher G. Hypertension, diabetes, atherosclerosis and NASH: Cause or consequence? J Hepatol. 2018;68(2):335-52. doi: 10.1016/j.jhep.2017.09.021
5. Статистика смертности в России за 2016 год (Ссылка активна на 30.09.2018) [Statistica smjertnosti v Rossii za 2016 god [Statistics of mortality in Russia for 2016]. Accessed September 30, 2018. (In Russ.)]. https://ritual.ru/poleznaya-informacia/articles/statistika-smertnosti-v-rossii/
6. Sung KS, Wild SY, Byrne CD. Development of new fatty liver, or resolution of existing fatty liver, over five years of follow-up, and risk of incident hypertension. J Hepatol. 2014;60(5):1040-5. doi: 10.1016/j.jhep.2014.01.009
7. Joshiji H, Kuriyama S, Yoshii J, Ikenaka Y, Noguchi R, Nakatani T, et al. Angiotensin-II type 1 receptor interaction is a major regulator for liver fibrosis development in rats. Hepatology. 2001;34:745-50. doi: 10.1053/jhep.2001.28231
8. Huh JH, Ahn SV, Koh SB, Choi E, Kim JY, Sung KC, et al. A prospective study of fatty liver index and incident hypertension: the KoGES-ARIRANG study. PLoS One. 2015;10:e0143560. doi: 10.1371/journal.pone.0143560
9. Targher G, Marchesini G, Byrne CD. Risk of type 2 diabetes in patients with non-alcoholic fatty liver disease: Causal association or epiphenomenon? Diabetes Metab. 2016;42:142-56. doi: 10.1016/j.diabet.2016.04.002
10. Targher G, Bertolini I, Padovani R, Rodella S, Tessari R, Zenari L, et al. Prevalence of nonalcoholic fatty liver disease and its association with cardiovascular disease among type 2 diabetic patients. Diabetes Care. 2007;30:1212-8. doi: 10.2337/dc06-2247
11. Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson I, et al. Clinical model for NASH and advanced fibrosis in adult patients with diabetes and NAFLD: guidelines for referral in NAFLD. Diabetes Care. 2015;38:1347-55. doi: 10.2337/dc14-1239
12. Portillo-Sanchez P, Bril F, Maximos M, Lomonaco R, Biernacki D, Orsak B, et al. High prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus and normal plasma aminotransferase levels. J Clin Endocrinol Metab. 2015;100:2231-8. doi: 10.1210/jc.2015-1966
13. Harman DJ, Kaye PV, Harris R, Suzuki A, Gazis A, Aithal GP. Prevalence and natural history of histologically proven chronic liver disease in a longitudinal cohort of patients with type 1 diabetes. Hepatology. 2014;60:158-68. doi: 10.1002/hep.27098
14. Chen SC, Tsai SP, Jhao JY, Jiang WK, Tsao CK, Chang LY. Liver fat, hepatic enzymes, alkaline phosphatase and risk of incident type 2 diabetes: a prospective study of 132,377 adults. Sci Rep. 2017;7:4649. doi: 10.1038/s41598-017-04631-7
15. Bjorkstrom K, Stal P, Hultcranz R, Hagstrom H. Histological scores for fat and fibrosis associate with development of type 2 diabetes in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2017;15:1461-8. doi: 10.1016/j.cgh.2017.04.040
16. Sung KC, Wild SH, Byrne CD. Resolution of fatty liver and risk of incident diabetes. J Clin Endocrinol Metab. 2013;98:3637-43. doi: 10.1210/jc.2013-1519
17. Yamazaki H, Tsuboya T, Tsuji K, Dohke M, Maguchi H. Independent association between improvement of nonalcoholic fatty liver disease and reduced incidence of type 2 diabetes. Diabetes Care. 2015;38:1673-9. doi: 10.2337/dc15-0140
18. Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016;65:589-600. doi: 10.1016/j.jhep.2016.05.013
19. Pais R, Giral P, Khan JF, Rosenbaum D, Housset Ch, Poynard Th, Ratziu V. Fatty liver is an independent predictor of early carotid atherosclerosis. J Hepatol. 2016;65(1):95-102. doi: 10.1016/j.jhep.2016.02.023
20. Hirschfield GM, Beuers U, Corpechot C, Invernizzi P, Jones D, Marzioni M, Schramm C. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-72. doi: 10.1016/j.jhep.2017.03.022
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(2):372-84. doi: 10.1016/j.jhep.2010.04.008
22. Mueller M, Thorrel A, Claudel T, Jha P, Koefeler H. Ursodeoxycholic acid exerts farnesoid X receptor-antagonistic effects on bile acid and lipid metabolism in morbid obesity. J Hepatol. 2015;62(6):1398-404. doi: 10.1016/j.jhep.2014.12.034
23. Zun Xiang, Yi-peng Chen, Kui-fen Ma, Yue-fang Ye, Lin Zheng, Yi-da Yang, You-ming Li, Xi Jin. The role of Ursodeoxycholic acid in non-alcoholic steatohepatitis: a systematic review. BMC Gastroenterol. 2013;13:140. doi: 10.1186/1471-230X-13-140
24. Liu J, Lu H, Lu YF, Lei X, Cui JY, Ellis E. Potency of individual bile acids to regulate bile acid synthesis and transport genes in primary human hepatocyte cultures. Toxicol Sci. 2014;141(2):538-46. doi: 10.1093/toxsci/kfu151
25. Ratziu V, Ledinghen V, Oberti F, Mathurin P, Wartelle-Bladou C, Renou C, Sogni P, Maynard M, Larrey D, Serfaty L, Bonnefont-Rousselot D, Bastard JP. A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis. J Hepatol. 2011;54(5):1011-9. doi: 10.1016/j.jhep.2010.08.030
26. Ozel Coskin BD, Yucesov M, Gursoy S, Baskol M, Yurci A, Yaqbasan A, Dogan S, Baskol G. Effects of ursodeoxycholic acid therapy on carotid intima media thickness, apolipoprotein A1, apolipoprotein B, and apolipoprotein B/A1 ratio in nonalcoholic steatohepatitis. J Gastroenterol Hepatol. 2015;27(2):142-9. doi: 10.1097/MEG.0000000000000264
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28. Кутишенко Н.П., Марцевич С.Ю., Лерман О.В., Балашов И.С., Невзорова В.А., Резник И.И., Шавкута Г.В., Яхонтов Д.А., рабочая группа исследования РАКУРС. Повышение эффективности гиполипидемической терапии у пациентов высокого сердечно-сосудистого риска с сочетанной патологией печени (результаты дополнительного анализа исследования РАКУРС). Рациональная фармакотерапия в кардиологии. 2015;11(3):297-303 [Kutishenko NP, Martsevich SYu, Lerman OV, Balashov IS, Nevzorova VA, Reznik II, Shavkuta GV, Yakhontov DA. The improvement of lipid-lowerig therapy effectiveness in patients with high cardiovascular risk and concomitant liver disease (result of additional analysis of the Rakurs study). Ratsional'naya Farmakoterapiya v Kardiologii = Rational Pharmacotherapy in Cardiology. 2015;11(3):297-303 (In Russ.)]. doi: 10.20996/1819-6446-2015-11-3-297-303
29. Martsevich S, Nadinskaya M, Kutishtnko N, et al Ursodeoxycholic acid influence in efficacy and satety of statin therapy in patients with high risk of cardiovascular events and non-alcoholic fatty liver disease: the RACURS stude (post-hoc-analysis). UEG J. 2015;3 Suppl. 1:PO624. doi: 10.1177/2050640615601623
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32. Lazaridis KN, Gores GJ, Lindor KD. Ursodeoxycholic acid «mechanisms of action and clinical use in hepatobiliary disorders. J Hepatol. 2001;35(1):134-46. doi: 10.1016/S0168-8278(01)00092-7
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37. Kong X, Kong Y, Zhang F, Wang T, Yan J. Evaluating the effectiveness and safety of ursodeoxycholic acid in treatment of intrahepatic cholestasis of pregnancy: A meta-analysis (a prisma-compliant study). Medicine (Baltimore). 2016:95(40):e4949. doi: 10.1097/MD.0000000000004949
38. Parízek A, Simják P, Cerný A, Sestinová A, Zdenková A, Hill M, Dusková M, Vlk R, Kokrdová Z, Koucký M, Vítek L. Efficacy and safety of ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy. Ann Hepatolog. 2016;15(5):757-61. doi: 10.5604/16652681.1212562
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1. Ivashkin VT, Mayevskaya MV, Pavlov ChS, Tikhonov IN, Shirokova YeN, Buyeverov AO, Drapkina OM, Shulpekova YuО, Tsukanov VV, Mammayev SN, Mayev IV, Palgova LK. Diagnostics and treatment of non-alcoholic fatty liver disease: clinical guidelines of the Russian Scientific Liver Society and the Russian gastroenterological association. Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii = The Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2016;26(2):24-42 (In Russ.)
2. Drapkina OM, Ivashkin VT. Epidemiologic features of non-alcoholic fatty liver disease in Russia (Results of open multicenter prospective observational study DIREG L 01903). Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii = The Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2014;24(4):32-8 (In Russ.)
3. Komova AG, Mayevskaya MV, Ivashkin VT. Principles of effective out-patient diagnostics of diffuse liver diseases. Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii = The Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2014;24(5):36-41 (In Russ.)
4. Lonardo A, Nascimbeni F, Mantovani A, Targher G. Hypertension, diabetes, atherosclerosis and NASH: Cause or consequence? J Hepatol. 2018;68(2):335-52. doi: 10.1016/j.jhep.2017.09.021
5. Statistica smjertnosti v Rossii za 2016 god [Statistics of mortality in Russia for 2016]. Accessed September 30, 2018. (In Russ.) https://ritual.ru/poleznaya-informacia/articles/statistika-smertnosti-v-rossii/
6. Sung KS, Wild SY, Byrne CD. Development of new fatty liver, or resolution of existing fatty liver, over five years of follow-up, and risk of incident hypertension. J Hepatol. 2014;60(5):1040-5. doi: 10.1016/j.jhep.2014.01.009
7. Joshiji H, Kuriyama S, Yoshii J, Ikenaka Y, Noguchi R, Nakatani T, et al. Angiotensin-II type 1 receptor interaction is a major regulator for liver fibrosis development in rats. Hepatology. 2001;34:745-50. doi: 10.1053/jhep.2001.28231
8. Huh JH, Ahn SV, Koh SB, Choi E, Kim JY, Sung KC, et al. A prospective study of fatty liver index and incident hypertension: the KoGES-ARIRANG study. PLoS One. 2015;10:e0143560. doi: 10.1371/journal.pone.0143560
9. Targher G, Marchesini G, Byrne CD. Risk of type 2 diabetes in patients with non-alcoholic fatty liver disease: Causal association or epiphenomenon? Diabetes Metab. 2016;42:142-56. doi: 10.1016/j.diabet.2016.04.002
10. Targher G, Bertolini I, Padovani R, Rodella S, Tessari R, Zenari L, et al. Prevalence of nonalcoholic fatty liver disease and its association with cardiovascular disease among type 2 diabetic patients. Diabetes Care. 2007;30:1212-8. doi: 10.2337/dc06-2247
11. Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson I, et al. Clinical model for NASH and advanced fibrosis in adult patients with diabetes and NAFLD: guidelines for referral in NAFLD. Diabetes Care. 2015;38:1347-55. doi: 10.2337/dc14-1239
12. Portillo-Sanchez P, Bril F, Maximos M, Lomonaco R, Biernacki D, Orsak B, et al. High prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus and normal plasma aminotransferase levels. J Clin Endocrinol Metab. 2015;100:2231-8. doi: 10.1210/jc.2015-1966
13. Harman DJ, Kaye PV, Harris R, Suzuki A, Gazis A, Aithal GP. Prevalence and natural history of histologically proven chronic liver disease in a longitudinal cohort of patients with type 1 diabetes. Hepatology. 2014;60:158-68. doi: 10.1002/hep.27098
14. Chen SC, Tsai SP, Jhao JY, Jiang WK, Tsao CK, Chang LY. Liver fat, hepatic enzymes, alkaline phosphatase and risk of incident type 2 diabetes: a prospective study of 132,377 adults. Sci Rep. 2017;7:4649. doi: 10.1038/s41598-017-04631-7
15. Bjorkstrom K, Stal P, Hultcranz R, Hagstrom H. Histological scores for fat and fibrosis associate with development of type 2 diabetes in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2017;15:1461-8. doi: 10.1016/j.cgh.2017.04.040
16. Sung KC, Wild SH, Byrne CD. Resolution of fatty liver and risk of incident diabetes. J Clin Endocrinol Metab. 2013;98:3637-43. doi: 10.1210/jc.2013-1519
17. Yamazaki H, Tsuboya T, Tsuji K, Dohke M, Maguchi H. Independent association between improvement of nonalcoholic fatty liver disease and reduced incidence of type 2 diabetes. Diabetes Care. 2015;38:1673-9. doi: 10.2337/dc15-0140
18. Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016;65:589-600. doi: 10.1016/j.jhep.2016.05.013
19. Pais R, Giral P, Khan JF, Rosenbaum D, Housset Ch, Poynard Th, Ratziu V. Fatty liver is an independent predictor of early carotid atherosclerosis. J Hepatol. 2016;65(1):95-102. doi: 10.1016/j.jhep.2016.02.023
20. Hirschfield GM, Beuers U, Corpechot C, Invernizzi P, Jones D, Marzioni M, Schramm C. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-72. doi: 10.1016/j.jhep.2017.03.022
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(2):372-84. doi: 10.1016/j.jhep.2010.04.008
22. Mueller M, Thorrel A, Claudel T, Jha P, Koefeler H. Ursodeoxycholic acid exerts farnesoid X receptor-antagonistic effects on bile acid and lipid metabolism in morbid obesity. J Hepatol. 2015;62(6):1398-404. doi: 10.1016/j.jhep.2014.12.034
23. Zun Xiang, Yi-peng Chen, Kui-fen Ma, Yue-fang Ye, Lin Zheng, Yi-da Yang, You-ming Li, Xi Jin. The role of Ursodeoxycholic acid in non-alcoholic steatohepatitis: a systematic review. BMC Gastroenterol. 2013;13:140. doi: 10.1186/1471-230X-13-140
24. Liu J, Lu H, Lu YF, Lei X, Cui JY, Ellis E. Potency of individual bile acids to regulate bile acid synthesis and transport genes in primary human hepatocyte cultures. Toxicol Sci. 2014;141(2):538-46. doi: 10.1093/toxsci/kfu151
25. Ratziu V, Ledinghen V, Oberti F, Mathurin P, Wartelle-Bladou C, Renou C, Sogni P, Maynard M, Larrey D, Serfaty L, Bonnefont-Rousselot D, Bastard JP. A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis. J Hepatol. 2011;54(5):1011-9. doi: 10.1016/j.jhep.2010.08.030
26. Ozel Coskin BD, Yucesov M, Gursoy S, Baskol M, Yurci A, Yaqbasan A, Dogan S, Baskol G. Effects of ursodeoxycholic acid therapy on carotid intima media thickness, apolipoprotein A1, apolipoprotein B, and apolipoprotein B/A1 ratio in nonalcoholic steatohepatitis. J Gastroenterol Hepatol. 2015;27(2):142-9. doi: 10.1097/MEG.0000000000000264
27. Martsevich SYu, Kutishenko NP, Drozdova LYu, Lerman OV, Nevzorova VA, Reznik II, Shavkuta GV, Yahontov DA, Working Group of RAKURS study. Study of ursodeoxycholic acid influence on efficacy and safety of statin therapy in patients with diseases of the liver, gall bladder and/or biliary tract (the RAKURS study). Ratsional'naya Farmakoterapiya v Kardiologii = Rational Pharmacotherapy in Cardiology. 2014;10(2):147-52 (In Russ.) doi: 10.20996/1819-6446-2014-10-2-147-152
28. Kutishenko NP, Martsevich SYu, Lerman OV, Balashov IS, Nevzorova VA, Reznik II, Shavkuta GV, Yakhontov DA. The improvement of lipid-lowerig therapy effectiveness in patients with high cardiovascular risk and concomitant liver disease (result of additional analysis of the Rakurs study). Ratsional'naya Farmakoterapiya v Kardiologii = Rational Pharmacotherapy in Cardiology. 2015;11(3):297-303 (In Russ.)]. doi: 10.20996/1819-6446-2015-11-3-297-303
29. Martsevich S, Nadinskaya M, Kutishtnko N, et al Ursodeoxycholic acid influence in efficacy and satety of statin therapy in patients with high risk of cardiovascular events and non-alcoholic fatty liver disease: the RACURS stude (post-hoc-analysis). UEG J. 2015;3 Suppl. 1:PO624. doi: 10.1177/2050640615601623
30. Bojtsov SА, Chuchalin АG, eds. Dispansernoe nablyudenie bol'nykh khronicheskimi neinfektsionnymi zabolevaniyami i patsientov s vysokim riskom ikh razvitiya: Metodicheskie rekomendatsii [Clinical supervision of patients with chronic non-communicable diseases and patients at high risk of their development: Guidelines]. 2014: 112 p. (Accessed 30.09.2018) (In Russ.) https://www.gnicpm.ru/UserFiles/ Metod_rek_disp_nabl.pdf
31. Ezhov MV, Sergienko IV, Aronov DM, et al. Diagnostics and correction of lipid metabolism disorders in order to prevent and treat atherosclerosis. Russian recommendations. VI revision. Ateroskleroz i Dislipidemii = Atherosclerosis and Dyslipidaemias. 2017;3(28):5-28 (In Russ.)
32. Lazaridis KN, Gores GJ, Lindor KD. Ursodeoxycholic acid «mechanisms of action and clinical use in hepatobiliary disorders. J Hepatol. 2001;35(1):134-46. doi: 10.1016/S0168-8278(01)00092-7
33. Drug-Induced Liver Injury Network (DILIN) (Accessed September 30, 2018). http://www.dilin.org/publications/dilin-publications/
34. UDCA toxicity. UpToDate (Accessed September 30, 2018). https://www.uptodate.com/contents/search?search=UDCA%20%20toxicity&sp=0&source=USER_...
35. Ursodiol. Livertox. Clinical and research information on drug-induced liver injury (Accessed September 30, 2018). https://livertox.nih.gov/Ursodiol.htm
36. WHO pharmaceuticals newsletter. 2012;(1):1-27 (Accessed September 30, 2018). http://apps.who.int/iris/handle/10665/255530
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38. Parízek A, Simják P, Cerný A, Sestinová A, Zdenková A, Hill M, Dusková M, Vlk R, Kokrdová Z, Koucký M, Vítek L. Efficacy and safety of ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy. Ann Hepatolog. 2016;15(5):757-61. doi: 10.5604/16652681.1212562
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ФГАОУ ВО «Первый Московский медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
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M.V. Maevskaya, V.T. Ivashkin, K.V. Ivashkin, V.D. Lunkov, E.O. Liusina, V.N. Zozula, V.I. Leshchenko
I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia