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Рецепт. 2021; 24: 811-821

Оценка эффективности Метовитана в комплексном лечении пациентов с неалкогольным стеатогепатитом

Скрыпник И. Н., Маслова А. С., Щербак О. В., Приходько Н. П.

https://doi.org/10.34883/PI.2021.24.6.004

Аннотация

Введение. В последние десятилетия во всем мире наблюдается рост заболеваемости неалкогольной жировой болезнью печени (НАЖБП), что тесно связано с ростом количества лиц с избыточным весом и ожирением в популяции. НАЖБП, и особенно ее прогрессирующая форма – неалкогольный стеатогепатит (НАСГ), относится к весомым факторам риска возникновения кардиоваскулярных заболеваний.

Цель. Исследовать динамику показателей функционального состояния печени и липидного профиля у пациентов с НАСГ на фоне включения в состав комплексной терапии препарата Метовитан.

Материалы и методы. Нами было обследовано 36 пациентов с НАСГ, из них 58,3% (21/36) составили мужчины, 41,7% (15/36) – женщины. Средний возраст пациентов – 46,32 (СI 95% 42,97–49,64) года. Выделена основная группа (ОГ): 36 пациентов с НАСГ, которым назначали Метовитан в дозе 1 капсула 3 раза, и контрольная группа (КГ) – 18 практически здоровых лиц. Пациентов обследовали дважды: до лечения и через пять недель. Всем пациентам ОГ назначали розувастатин 10 мг/сутки. Проводили измерения роста, веса пациентов, подсчитывали индекс массы тела. Определяли активность аланиновой (АЛТ), аспарагиновой аминотрансфераз (АСТ), гамма-глутамилтранспептидазы (ГГТП), щелочной фосфатазы (ЩФ), содержание общего билирубина в сыворотке крови пациентов. Липидный спектр крови оценивали по содержанию общего холестерина (ХС), холестерина липопротеидов низкой плотности (ХС ЛПНП), холестерина липопротеидов высокой плотности (ХС ЛПВП), триглицеридов (ТГ) в сыворотке крови.

Результаты. При первичном обследовании пациентов с НАСГ зафиксировано наличие избыточного веса (у 47,3% пациентов) и ожирения (у 44,4% пациентов), что сопровождалось увеличением активности АЛТ, АСТ, ГГТП и ЩФ в сыворотке крови пациентов ОГ (р<0,05) и нарушениями липидного обмена.

На фоне комплексного лечения с включением Метовитана у пациентов с НАСГ наблюдалось снижение веса на 5%, уменьшение активности АЛТ и АСТ в сыворотке крови в 1,4 и 1,8 раза (р<0,0001) соответственно, ГГТП в 2,5 раза (р=0,001) по сравнению с первоначальным обследованием. Одновременно у пациентов с НАСГ зафиксировано снижение содержания ХС в сыворотке крови в 1,3 раза (р<0,0001), ХС ЛПНП – в 1,7 раза (р<0,0001), ТГ – в 1,4 раза (р<0,0005) при одновременном увеличении концентрации ХС ЛПВП в 1,2 раза (р<0,0001).

Заключение. Назначение комплексного лечения пациентам с НАСГ с модификацией образа жизни, диетическими рекомендациями и включением статинов и Метовитана (DL-метионин, витамины Е, В1, В3, цинк) способствует снижению веса пациентов, улучшению функционального состояния печени и показателей липидного профиля.

Список литературы

1. Skrypnyk I., Shcherbak O., Maslova H. (2017) Vplyv nealkoholnoho steatohepatytu na kharakter perebihu ta prohresuvannia ishemichnoi khvoroby sertsia [The nonalcoholic steatohepatitis influence on the course and progression of ischemic heart disease]. Wiadomości Lekarskie, no 2 (I), pp. 236–40. (in Ukrainian)

2. Unified clinical protocol "Non-alcoholic steatohepatitis". Decree of the Ministry of Health of Ukraine No. 826 dated 06.11.2014. (in Ukrainian)

3. Fadeenko G.D., Kushnir I.E., Mozhina T.L., Chernova V.M., Solomenceva T.A. (2019) Rol’ syvorotochnyh biomarkerov v diagnostike nealkogol’noj zhirovoj bolezni pecheni [The role of serum biomarkers in the diagnosis of nonalcoholic fatty liver disease]. Suchasna gastroenterologіya, no 3, pp. 58–65. (in Russian)

4. Eslam M., Sanyal A.J., George J. (2020) MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology, no 158 (7), pp. 1999–2014.

5. European Association for the study of the liver (2016) EASL Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. Journal of hepatology, no 64, pp. 1388–1402.

6. Francque S.M., Marchesini G., Kautz A., Walmsley M., Dorner R., Lazarus J.V. (2021) Non-alcoholic fatty liver disease: A patient guideline. JHEP Reports, no 3 (5). Available at: https://doi.org/10.1016/j.jhepr.2021.100322.

7. Huang T.D., Behary J., Zekry A. (2020) Non-alcoholic Fatty Liver disease: a review of epidemiology, risk factors, diagnosis and management. Intern Med J., no 50 (9), pp. 1038–47.

8. Ismaiel A., Dumitrascu D.L. (2019) Cardiovascular Risk in fatty liver disease: The Liver-Heart Axis – Literature Review. Front Med., no 6, p. 202.

9. Kanda T., Goto T., Hirotsu Y., Masuzaki R., Moriyama M., Omata M. (2020) Molecular Mechanisms: Connections between Nonalcoholic Fatty Liver disease, Steatohepatitis and Hepatocellular Carcinoma. Int J Mol Sci., no 21 (4), p. 1525.

10. Katsiki N., Mikhalidis D.P., Mantzoros C.S. (2016) Non-alcoholic fatty liver disease and dyslipidemia: An update. Metabolism, no 65 (8), pp. 1109–23.

11. Kwok R., Tse Y.K., Wong G.L.H., Ha Y., Lee A.U., Ngu M.C. (2014) Systematic review with meta-analysis: non-invasive assessment of non-alcoholic fatty liver disease – the role of transient elastography and plasma cytokeratin-18 fragments. Alimentary Pharmacology and Therapeutics, no 39 (3), pp. 254–69.

12. Marcellin P., Kutala B.K. (2018) Liver diseases: a major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int., no 38 (suppl. 1), pp. 2–6.

13. Tenfold increase in childhood and adolescent obesity in four decades: new study by Imperial College London and WHO 11 October 2017 News Release LONDON. Available at: https://www.who.int/news/item/11-10-2017-tenfold-increase-in-childhood-and-adolescent-obesity-in-four-decadesnew-study-by-imperial-college-london-and-who.

14. World Health Organization (WHO) Obesity and overweight. Available at: http://www.who.int/news-room/fact-sheets/detail/obesity-andoverweight.

15. World Obesity Facts. Available at: https://renewbariatrics.com/obesity-rank-by-countries/.

16. Wu J., Li H., Xu Z., Ran L., Kong L.Q. (2021) Population-specific cut-off points of fatty liver index for the diagnosis of hepatic steatosis. J Hepatol., no 75 (3), pp. 726–8.

17. Younossi Z., Anstee Q.M., Marietti M., Hardy T., Henry L., Eslam M. (2018) Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol., no 15 (1), pp. 11–20.

18. Younossi Z., Tacke F., Arrese M., Sharma B.C., Mostafa I., Bugianesi E. (2019) Global perspectives on non-alcoholic fatty liver disease and nonalcoholic steatohepatitis. Hepatology, no 69 (6), pp. 2672–82.

19. Younossi Z.M., Koenig A.B., Abdelatif D., Fazel Y., Henry L., Wymer M. (2016) Global epidemiology of nonalcoholic fatty liver disease – Metaanalytic assessment of prevalence incidence, and outcomes. Hepatology, no 64 (1), pp. 73–84.

20. Younossi Z.M. (2019) Non-alcoholic fatty liver disease – A global public health perspective. Journal of hepatology, no 70 (3), pp. 531–44.

21. Yumuk V., Tsigos C., Fried M., Schindler K., Busetto L., Micic D. (2015) European Guidelines for Obesity Management in Adults. Obes Facts, no 8 (6), pp. 402–24.

Recipe. 2021; 24: 811-821

Evaluation of the Effectiveness of Methovitane in Comprehensive Treatment of Patients with Non-Alcoholic Steatohepatitis

Skrypnyk I. , Maslova G. , Shcherbak O. , Prykhodko N.

https://doi.org/10.34883/PI.2021.24.6.004

Abstract

Introduction. In recent decades, there has been considerable increase of the nonalcoholic fatty liver disease (NAFLD) incidence worldwide due to the increasingly of overweighting and obesity in population. NAFLD and its progressive form nonalcoholic steatohepatitis (NASH) are important risk factors for cardiovascular disease.

Purpose. To study the dynamics of the liver function and lipid profile tests in patients with NASH in the complex therapy with Metovitan.

Materials and methods. 36 patients with NASH were examined. 58.3% (21/36) of them were men and 41.7% (15/36) were women. The mean age of patients was 46.32 (95% CI 42.97–49.64). The main study group (MG) included 36 patients with NASH, were prescribed Metovitan 1 capsule 3 times a day. The control group (CG) included almost healthy individuals, n=18. The patients were examined twice: before treatment and after five-week therapy. Rosuvastatin 10 mg once daily has been prescribed for all patients of the MG. Measuring a patient’s body weight and height were taken and calculated body mass index (BMI). The level of alanine aminotransferases (ALT), asparagine aminotransferases (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin (TB) in patient’s serum were determined. Blood lipid spectrum was assessed by total cholesterol, low-density lipoprotein cholesterol (LDL cholesterol), high-density lipoprotein cholesterol (HDL cholesterol), triglycerides (TG) in the serum.

Results. The initial examination of patients with NASH revealed overweight (in 47.3%) and obesity (in 44.4%) of the patients. It has been accompanied by increasing of ALT, AST, GGT and ALP in the serum of patients of MG (p<0.05) and lipid metabolism disorders. Losing 5% of total body weight and decrease of ALT and AST serum activity by 1.4 and 1.8 times (p<0.0001), respectively, GGT by 2.5 times (p=0.001) was shown in the group of NASH patients with Metovitan complex treatment in comparison to the initial examination. Simultaneously reducing of serum cholesterol levels by 1.3 times (p<0.0001), LDL cholesterol – 1.7 times (p<0.0001), TG – 1.4 times (р<0.0005) and increasing of HDL cholesterol by 1.2 times (p<0.0001) was detected in NASH patients.

Conclusion. Comprehensive treatment of the NASH patients with lifestyle modifications, dietary recommendations and the inclusion of statins and Metovitan (DL-methionine, vitamin E, B1, B3, zinc) promote weight loss, improve liver function and lipid profile.

References

1. Skrypnyk I., Shcherbak O., Maslova H. (2017) Vplyv nealkoholnoho steatohepatytu na kharakter perebihu ta prohresuvannia ishemichnoi khvoroby sertsia [The nonalcoholic steatohepatitis influence on the course and progression of ischemic heart disease]. Wiadomości Lekarskie, no 2 (I), pp. 236–40. (in Ukrainian)

2. Unified clinical protocol "Non-alcoholic steatohepatitis". Decree of the Ministry of Health of Ukraine No. 826 dated 06.11.2014. (in Ukrainian)

3. Fadeenko G.D., Kushnir I.E., Mozhina T.L., Chernova V.M., Solomenceva T.A. (2019) Rol’ syvorotochnyh biomarkerov v diagnostike nealkogol’noj zhirovoj bolezni pecheni [The role of serum biomarkers in the diagnosis of nonalcoholic fatty liver disease]. Suchasna gastroenterologіya, no 3, pp. 58–65. (in Russian)

4. Eslam M., Sanyal A.J., George J. (2020) MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology, no 158 (7), pp. 1999–2014.

5. European Association for the study of the liver (2016) EASL Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. Journal of hepatology, no 64, pp. 1388–1402.

6. Francque S.M., Marchesini G., Kautz A., Walmsley M., Dorner R., Lazarus J.V. (2021) Non-alcoholic fatty liver disease: A patient guideline. JHEP Reports, no 3 (5). Available at: https://doi.org/10.1016/j.jhepr.2021.100322.

7. Huang T.D., Behary J., Zekry A. (2020) Non-alcoholic Fatty Liver disease: a review of epidemiology, risk factors, diagnosis and management. Intern Med J., no 50 (9), pp. 1038–47.

8. Ismaiel A., Dumitrascu D.L. (2019) Cardiovascular Risk in fatty liver disease: The Liver-Heart Axis – Literature Review. Front Med., no 6, p. 202.

9. Kanda T., Goto T., Hirotsu Y., Masuzaki R., Moriyama M., Omata M. (2020) Molecular Mechanisms: Connections between Nonalcoholic Fatty Liver disease, Steatohepatitis and Hepatocellular Carcinoma. Int J Mol Sci., no 21 (4), p. 1525.

10. Katsiki N., Mikhalidis D.P., Mantzoros C.S. (2016) Non-alcoholic fatty liver disease and dyslipidemia: An update. Metabolism, no 65 (8), pp. 1109–23.

11. Kwok R., Tse Y.K., Wong G.L.H., Ha Y., Lee A.U., Ngu M.C. (2014) Systematic review with meta-analysis: non-invasive assessment of non-alcoholic fatty liver disease – the role of transient elastography and plasma cytokeratin-18 fragments. Alimentary Pharmacology and Therapeutics, no 39 (3), pp. 254–69.

12. Marcellin P., Kutala B.K. (2018) Liver diseases: a major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int., no 38 (suppl. 1), pp. 2–6.

13. Tenfold increase in childhood and adolescent obesity in four decades: new study by Imperial College London and WHO 11 October 2017 News Release LONDON. Available at: https://www.who.int/news/item/11-10-2017-tenfold-increase-in-childhood-and-adolescent-obesity-in-four-decadesnew-study-by-imperial-college-london-and-who.

14. World Health Organization (WHO) Obesity and overweight. Available at: http://www.who.int/news-room/fact-sheets/detail/obesity-andoverweight.

15. World Obesity Facts. Available at: https://renewbariatrics.com/obesity-rank-by-countries/.

16. Wu J., Li H., Xu Z., Ran L., Kong L.Q. (2021) Population-specific cut-off points of fatty liver index for the diagnosis of hepatic steatosis. J Hepatol., no 75 (3), pp. 726–8.

17. Younossi Z., Anstee Q.M., Marietti M., Hardy T., Henry L., Eslam M. (2018) Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol., no 15 (1), pp. 11–20.

18. Younossi Z., Tacke F., Arrese M., Sharma B.C., Mostafa I., Bugianesi E. (2019) Global perspectives on non-alcoholic fatty liver disease and nonalcoholic steatohepatitis. Hepatology, no 69 (6), pp. 2672–82.

19. Younossi Z.M., Koenig A.B., Abdelatif D., Fazel Y., Henry L., Wymer M. (2016) Global epidemiology of nonalcoholic fatty liver disease – Metaanalytic assessment of prevalence incidence, and outcomes. Hepatology, no 64 (1), pp. 73–84.

20. Younossi Z.M. (2019) Non-alcoholic fatty liver disease – A global public health perspective. Journal of hepatology, no 70 (3), pp. 531–44.

21. Yumuk V., Tsigos C., Fried M., Schindler K., Busetto L., Micic D. (2015) European Guidelines for Obesity Management in Adults. Obes Facts, no 8 (6), pp. 402–24.