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Фармакокинетика и фармакодинамика ребамипида. Новые возможности терапии
Фармакокинетика и фармакодинамика ребамипида. Новые возможности терапии
Бакулина Н.В., Тихонов С.В., Оковитый С.В., Лутаенко Е.А., Большаков А.О., Приходько В.А., Некрасова А.С. Фармакокинетика и фармакодинамика ребамипида. Новые возможности терапии. Терапевтический архив. 2022;94(12):1431–1437. DOI: 10.26442/00403660.2022.12.202000
© ООО «КОНСИЛИУМ МЕДИКУМ», 2022 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2022 г.
________________________________________________
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
В 2022 г. в базе данных MedLine насчитывается 570 публикаций, включая 71 рандомизированное клиническое исследование и 6 метаанализов, о молекуле ребамипида. Показания к применению ребамипида – язвенная болезнь желудка, хронический гастрит с повышенной кислотообразующей функцией желудка в стадии обострения, эрозивный гастрит, профилактика повреждений слизистой оболочки желудочно-кишечного тракта на фоне приема нестероидных противовоспалительных лекарственных препаратов, эрадикация Helicobacter pylori. Изучаются эффективность и безопасность ребамипида при подагрическом и ревматоидном артритах, остеоартрите, синдроме Шегрена, бронхиальной астме, витилиго, атеросклерозе, заболеваниях почек и печени; в травматологии – для ускорения костной регенерации, в офтальмологии – для регенерации поврежденного эпителия роговицы, в онкологии – для уменьшения воспаления слизистой оболочки ротовой полости после химиолучевой терапии. В обзорной статье разбираются основные фармакокинетические и фармакодинамические характеристики ребамипида. Понимание фармакодинамики и фармакокинетики позволяет осуществлять индивидуальный подбор терапии, исходя из особенностей организма пациента (пол, возраст, сопутствующая патология); выбирать оптимальный путь введения и режим дозирования; прогнозировать нежелательные эффекты и лекарственные взаимодействия; определяться с новыми показаниями.
Ключевые слова: ребамипид, фармакокинетика, фармакодинамика, всасывание, пресистемный метаболизм, биодоступность, связь с белками, объем распределения, метаболизм, выведение
Keywords: rebamipide, pharmacokinetics, pharmacodynamics, absorption, first pass metabolism, bioavailability, protein binding, volume of distribution, metabolism, excretion
Ключевые слова: ребамипид, фармакокинетика, фармакодинамика, всасывание, пресистемный метаболизм, биодоступность, связь с белками, объем распределения, метаболизм, выведение
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Keywords: rebamipide, pharmacokinetics, pharmacodynamics, absorption, first pass metabolism, bioavailability, protein binding, volume of distribution, metabolism, excretion
Полный текст
Список литературы
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24. Zakaria S, El-Sisi A. Rebamipide retards CCl4-induced hepatic fibrosis in rats: Possible role for PGE2. J Immunotoxicol. 2016;13(4):453-62. DOI:10.3109/1547691X.2015.1128022
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2. Ogino K, Hobara T, Ishiyama H, et al. Antiulcer mechanism of action of rebamipide, a novel antiulcer compound, on diethyldithiocarbamate-induced antral gastric ulcers in rats. Eur J Pharmacol. 1992;212(1):9-13. DOI:10.1016/0014-2999(92)90065-c
3. Arakawa T, Kobayashi K, Yoshikawa T, et al. Rebamipide: overview of its mechanisms of action and efficacy in mucosal protection and ulcer healing. Dig Dis Sci. 1998;43(9 Suppl.):5S-13S.
4. Suzuki M, Miura S, Mori M, et al. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994;35(10):1375-8. DOI:10.1136/gut.35.10.1375
5. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 80-7 (in Russian).
6. Murata H, Yabe Y, Tsuji S, et al. Gastro-protective agent rebamipide induces cyclooxygenease-2 (COX-2) in gastric epithelial cells. Dig Dis Sci. 2005;50 (Suppl. 1):S70-5. DOI:10.1007/s10620-005-2809-0
7. Lee S, Jeong S, Kim W, et al. Rebamipide induces the gastric mucosal protective factor, cyclooxygenase-2, via activation of 5’-AMP-activated protein kinase. Biochem Biophys Res Commun. 2017;483(1):449-55. DOI:10.1016/j.bbrc.2016.12.123
8. Berod L, Friedrich C, Nandan A, et al. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells [published correction appears in Nat Med. 2015 Apr;21(4):414]. Nat Med. 2014;20(11):1327-33. DOI:10.1038/nm.3704
9. Agard M, Asakrah S, Morici LA. PGE(2) suppression of innate immunity during mucosal bacterial infection. Front Cell Infect Microbiol. 2013;3:45. DOI:10.3389/fcimb.2013.00045
10. Katada K, Yoshida N, Isozaki Y, et al. Prevention by rebamipide of acute reflux esophagitis in rats. Dig Dis Sci. 2005;(50 Suppl.)1:S97-103. DOI:10.1007/s10620-005-2813-4
11. Yamane S, Amano H, Ito Y, et al. The role of thromboxane prostanoid receptor signaling in gastric ulcer healing. Int J Exp Pathol. 2022;103(1):4-12. DOI:10.1111/iep.12410
12. Ishihara T, Suemasu S, Asano T, et al. Stimulation of gastric ulcer healing by heat shock protein 70. Biochem Pharmacol. 2011;82(7):728-36. DOI:10.1016/j.bcp.2011.06.030
13. Suzuki T, Yoshida N, Nakabe N, et al. Prophylactic effect of rebamipide on aspirin-induced gastric lesions and disruption of tight junctional protein zonula occludens-1 distribution. J Pharmacol Sci. 2008;106(3):469-77. DOI:10.1254/jphs.FP0071422
14. Tanaka H, Fukuda K, Ishida W, et al. Rebamipide increases barrier function and attenuates TNFα-induced barrier disruption and cytokine expression in human corneal epithelial cells. Br J Ophthalmol. 2013;97(7):912-6. DOI:10.1136/bjophthalmol-2012-302868
15. Andreev DN, Maev IV. Rebamipide: evidence base for use in gastroenterology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(12)97-104 (in Russian). DOI:10.26442/00403660.2020.12.200455
16. Ivashkin VT, Trukhmanov AS, Gonik MI. Rebamipide using in gastroesophageal reflux disease treatment. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(4):98-104 (in Russian). DOI:10.26442/00403660.2020.04.000568
17. Parfenov AI, Belostotsky NI, Khomeriki SG, et al. Rebamipide increases the disaccharidases activity in patients with enteropathy with impaired membrane digestion. Pilot study. Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(2):25-31 (in Russian). DOI:10.26442/00403660.2019.02.000123
18. Tanigawa T, Watanabe T, Higashimori A, et al. Rebamipide ameliorates indomethacin-induced small intestinal damage and proton pump inhibitor-induced exacerbation of this damage by modulation of small intestinal microbiota. PloS One. 2021;16(1):e0245995. DOI:10.1371/journal.pone.0245995
19. Simanenkov VI, Tikhonov SV. Rebamipide: New opportunities of gastroenteroprotection. Terapevticheskii Arkhiv (Ter. Arkh.). 2015;87(12):134-7 (in Russian). DOI:10.17116/terarkh20158712134-137
20. Lai Y, Zhong W, Yu T, et al. Rebamipide Promotes the Regeneration of Aspirin-Induced Small-Intestine Mucosal Injury through Accumulation of β-Catenin. PloS One. 2015;10(7):e0132031. DOI:10.1371/journal.pone.0132031
21. Chiurillo MA. Role of the Wnt/β-catenin pathway in gastric cancer: An in-depth literature review. World J Exp Med. 2015;5(2):84-102. DOI:10.5493/wjem.v5.i2.84
22. White BD, Chien AJ, Dawson DW. Dysregulation of Wnt/β-catenin signaling in gastrointestinal cancers. Gastroenterology. 2012;142(2):219-32. DOI:10.1053/j.gastro.2011.12.001
23. Byun JK, Moon SJ, Jhun JY, et al. Rebamipide attenuates autoimmune arthritis severity in SKG mice via regulation of B cell and antibody production. Clin Exp Immunol. 2014;178(1):9-19. DOI:10.1111/cei.12355
24. Zakaria S, El-Sisi A. Rebamipide retards CCl4-induced hepatic fibrosis in rats: Possible role for PGE2. J Immunotoxicol. 2016;13(4):453-62. DOI:10.3109/1547691X.2015.1128022
25. Lee SM, Kim KH. Rebamipide ameliorates hepatic dysfunction induced by ischemia/reperfusion in rats. Eur J Pharmacol. 1995;294(1):41-6. DOI:10.1016/0014-2999(95)00507-2
26. Elmansy RA, Seleem HS, Mahmoud AR, et al. Rebamipide potentially mitigates methotrexate-induced nephrotoxicity via inhibition of oxidative stress and inflammation: A molecular and histochemical study. Anat Rec (Hoboken). 2021;304(3):647-61. DOI:10.1002/ar.24482
27. Arakaki R, Eguchi H, Yamada A, et al. Anti-inflammatory effects of rebamipide eyedrop administration on ocular lesions in a murine model of primary Sjögren’s syndrome. PloS One. 2014;9(5):e98390. DOI:10.1371/journal.pone.0098390
28. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 56 (in Russian).
29. Currie GM. Pharmacology, Part 2: Introduction to Pharmacokinetics. J Nucl Med Technol. 2018;46(3):221-30. DOI:10.2967/jnmt.117.199638
30. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 22-36 (in Russian).
31. Ngo L, Yoo HD, Tran P, et al. Population pharmacokinetic analysis of rebamipide in healthy Korean subjects with the characterization of atypical complex absorption kinetics. J Pharmacokinet Pharmacodyn. 2017;44(4):291-303. DOI:10.1007/s10928-017-9519-z
32. Guo Y, Wang Y, Xu L. Enhanced bioavailability of rebamipide nanocrystal tablets: formulation and in vitro/in vivo evaluation. Asian J Pharm Sci. 2015;10:223-9. DOI:10.1016/j.ajps.2014.09.006
33. Pond SM, Tozer TN. First-pass elimination. Basic concepts and clinical consequences. Clin Pharmacokinet. 1984;9(1):1-25. DOI:10.2165/00003088-198409010-00001
34. Bhosle VK, Altit G, Autmizguine J, Chemtob S. 18 – Basic Pharmacologic Principles. Eds. RA Polin, SH Abman, DH Rowitch, et al. Fetal and Neonatal Physiology (Fifth Edition). Elsevier, 2017.
35. Kim KT, Lee JY, Park JH, et al. Capmul MCM/Solutol HS15-Based Microemulsion for Enhanced Oral Bioavailability of Rebamipide. J Nanosci Nanotechnol. 2017;17(4):2340-4. DOI:10.1166/ jnn.2017.13314
36. Hasegawa S, Sekino H, Matsuoka O, et al. Bioequivalence of rebamipide granules and tablets in healthy adult male volunteers. Clin Drug Investig. 2003;23(12):771-9. DOI:10.2165/00044011-200323120-00002
37. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Exp Rev Gastroenterol Hepatol. 2010;4(3):261-70. DOI:10.1586/egh.10.25
38. Caldwell J, Gardner I, Swales N. An introduction to drug disposition: the basic principles of absorption, distribution, metabolism, and excretion. Toxicol Pathol. 1995;23(2):102-14. DOI:10.1177/019262339502300202
39. Shioya Y, Shimizu T. High-performance liquid chromatographic procedure for the determination of a new anti-gastric ulcer agent, 2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-ylv]propionic acid, in human plasma and urine. J Chromatogr A. 1988;434(1):283-7. DOI:10.1016/0378-4347(88)80089-6
40. Park NC, Sim SB, Yan BQ, et al. The Antioxidant Effect of Rebamipide in Human Semen Specimens. Korean Journal of Urology. 2002:332-8.
41. Patel M, Taskar KS, Zamek-Gliszczynski MJ. Importance of hepatic transporters in clinical disposition of drugs and their metabolites. J Clin Pharmacol. 2016;56(Suppl. 7):S23-39. DOI:10.1002/jcph.671
42. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 75-8 (in Russian).
43. Koyama N, Sasabe H, Miyamoto G. Involvement of cytochrome P450 in the metabolism of rebamipide by the human liver. Xenobiotica. 2002;32(7):573-86. DOI:10.1080/00498250210130591
44. Lea-Henry TN, Carland JE, Stocker SL, et al. Clinical Pharmacokinetics in Kidney Disease: Fundamental Principles. Clin J Am Soc Nephrol. 2018;13(7):1085-95. DOI:10.2215/CJN.00340118
45. Cho HY, Yoon H, Park GK, Lee YB. Pharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers. Clin Ther. 2009;31(11):2712-21. DOI:10.1016/j.clinthera.2009.11.010
46. Jang E, Park M, Jeong JE, et al. Frequently reported adverse events of rebamipide compared to other drugs for peptic ulcer and gastroesophageal reflux disease. Sci Rep. 2022;12(1):7839. DOI:10.1038/s41598-022-11505-0
47. Simanenkov I, Maev IV, Tkacheva ON, et al. Syndrome of increased epithelial permeability in clinical practice. Multidisciplinary national Consensus. Cardiovascular Therapy and Prevention. 2021;20(1):121-278 (in Russian). DOI:10.15829/1728-8800-2021-2758
48. Murakami I, Zhang R, Kubo M, et al. Rebamipide suppresses mite-induced asthmatic responses in NC/Nga mice. Am J Physiol Lung Cell Mol Physiol. 2015;309(8):L872-8. DOI:10.1152/ajplung.00194.2015
49. Jhun JY, Kwon JE, Kim SY, et al. Rebamipide ameliorates atherosclerosis by controlling lipid metabolism and inflammation. PloS One. 2017;12(2):e0171674. DOI:10.1371/journal.pone.0171674
50. Ohguchi T, Kojima T, Ibrahim O, et al. The effects of 2% rebamipide ophthalmic solution on the tear functions and ocular surface of the superoxide dismutase-1 (sod1) knockout mice. Invest Ophthalmol Vis Sci. 2013;54(12):7793-802. DOI:10.1167/iovs.13-13128
51. Ueta M, Sotozono Ch, Koga Ay, et al. Usefulness of a new therapy using rebamipide eyedrops in patients with VKC/AKC refractory to conventional anti-allergic treatments. Case Reports Allergol Int. 2014;63(1):75-81. DOI:10.2332/allergolint.13-OA-0605
2. Ogino K, Hobara T, Ishiyama H, et al. Antiulcer mechanism of action of rebamipide, a novel antiulcer compound, on diethyldithiocarbamate-induced antral gastric ulcers in rats. Eur J Pharmacol. 1992;212(1):9-13. DOI:10.1016/0014-2999(92)90065-c
3. Arakawa T, Kobayashi K, Yoshikawa T, et al. Rebamipide: overview of its mechanisms of action and efficacy in mucosal protection and ulcer healing. Dig Dis Sci. 1998;43(9 Suppl.):5S-13S.
4. Suzuki M, Miura S, Mori M, et al. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994;35(10):1375-8. DOI:10.1136/gut.35.10.1375
5. Кукес В.Г. Фармакоэкономический анализ. В кн.: Клиническая фармакология: учебник. Под ред. Д.А. Сычева. 5-е изд., испр. и доп. М.: ГЭОТАР-Медиа, 2017; с. 80-7 [Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 80-7 (in Russian)].
6. Murata H, Yabe Y, Tsuji S, et al. Gastro-protective agent rebamipide induces cyclooxygenease-2 (COX-2) in gastric epithelial cells. Dig Dis Sci. 2005;50 (Suppl. 1):S70-5. DOI:10.1007/s10620-005-2809-0
7. Lee S, Jeong S, Kim W, et al. Rebamipide induces the gastric mucosal protective factor, cyclooxygenase-2, via activation of 5’-AMP-activated protein kinase. Biochem Biophys Res Commun. 2017;483(1):449-55. DOI:10.1016/j.bbrc.2016.12.123
8. Berod L, Friedrich C, Nandan A, et al. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells [published correction appears in Nat Med. 2015 Apr;21(4):414]. Nat Med. 2014;20(11):1327-33. DOI:10.1038/nm.3704
9. Agard M, Asakrah S, Morici LA. PGE(2) suppression of innate immunity during mucosal bacterial infection. Front Cell Infect Microbiol. 2013;3:45. DOI:10.3389/fcimb.2013.00045
10. Katada K, Yoshida N, Isozaki Y, et al. Prevention by rebamipide of acute reflux esophagitis in rats. Dig Dis Sci. 2005;(50 Suppl.)1:S97-103. DOI:10.1007/s10620-005-2813-4
11. Yamane S, Amano H, Ito Y, et al. The role of thromboxane prostanoid receptor signaling in gastric ulcer healing. Int J Exp Pathol. 2022;103(1):4-12. DOI:10.1111/iep.12410
12. Ishihara T, Suemasu S, Asano T, et al. Stimulation of gastric ulcer healing by heat shock protein 70. Biochem Pharmacol. 2011;82(7):728-36. DOI:10.1016/j.bcp.2011.06.030
13. Suzuki T, Yoshida N, Nakabe N, et al. Prophylactic effect of rebamipide on aspirin-induced gastric lesions and disruption of tight junctional protein zonula occludens-1 distribution. J Pharmacol Sci. 2008;106(3):469-77. DOI:10.1254/jphs.FP0071422
14. Tanaka H, Fukuda K, Ishida W, et al. Rebamipide increases barrier function and attenuates TNFα-induced barrier disruption and cytokine expression in human corneal epithelial cells. Br J Ophthalmol. 2013;97(7):912-6. DOI:10.1136/bjophthalmol-2012-302868
15. Андреев Д.Н., Маев И.В. Ребамипид: доказательная база применения в гастроэнтерологии. Терапевтический архив. 2020;92(12)97-104 [Andreev DN, Maev IV. Rebamipide: evidence base for use in gastroenterology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(12)97-104 (in Russian)]. DOI:10.26442/00403660.2020.12.200455
16. Ивашкин В.Т., Трухманов А.С., Гоник М.И. Применение ребамипида в лечении гастроэзофагеальной рефлюксной болезни. Терапевтический архив. 2020;92(4):98-104 [Ivashkin VT, Trukhmanov AS, Gonik MI. Rebamipide using in gastroesophageal reflux disease treatment. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(4):98-104 (in Russian)]. DOI:10.26442/00403660.2020.04.000568
17. Парфенов А.И., Белостоцкий Н.И., Хомерики С.Г., и др. Ребамипид повышает активность дисахаридаз у больных энтеропатией с нарушением мембранного пищеварения. Пилотное исследование. Терапевтический архив. 2019;91(2):25-31 [Parfenov AI, Belostotsky NI, Khomeriki SG, et al. Rebamipide increases the disaccharidases activity in patients with enteropathy with impaired membrane digestion. Pilot study. Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(2):25-31 (in Russian)]. DOI:10.26442/00403660.2019.02.000123
18. Tanigawa T, Watanabe T, Higashimori A, et al. Rebamipide ameliorates indomethacin-induced small intestinal damage and proton pump inhibitor-induced exacerbation of this damage by modulation of small intestinal microbiota. PloS One. 2021;16(1):e0245995. DOI:10.1371/journal.pone.0245995
19. Симаненков В.И., Тихонов С.В. Ребамипид – новые возможности гастропротекции. Терапевтический архив. 2015;87(12):134-7 [Simanenkov VI, Tikhonov SV. Rebamipide: New opportunities of gastroenteroprotection. Terapevticheskii Arkhiv (Ter. Arkh.). 2015;87(12):134-7 (in Russian)]. DOI:10.17116/terarkh20158712134-137
20. Lai Y, Zhong W, Yu T, et al. Rebamipide Promotes the Regeneration of Aspirin-Induced Small-Intestine Mucosal Injury through Accumulation of β-Catenin. PloS One. 2015;10(7):e0132031. DOI:10.1371/journal.pone.0132031
21. Chiurillo MA. Role of the Wnt/β-catenin pathway in gastric cancer: An in-depth literature review. World J Exp Med. 2015;5(2):84-102. DOI:10.5493/wjem.v5.i2.84
22. White BD, Chien AJ, Dawson DW. Dysregulation of Wnt/β-catenin signaling in gastrointestinal cancers. Gastroenterology. 2012;142(2):219-32. DOI:10.1053/j.gastro.2011.12.001
23. Byun JK, Moon SJ, Jhun JY, et al. Rebamipide attenuates autoimmune arthritis severity in SKG mice via regulation of B cell and antibody production. Clin Exp Immunol. 2014;178(1):9-19. DOI:10.1111/cei.12355
24. Zakaria S, El-Sisi A. Rebamipide retards CCl4-induced hepatic fibrosis in rats: Possible role for PGE2. J Immunotoxicol. 2016;13(4):453-62. DOI:10.3109/1547691X.2015.1128022
25. Lee SM, Kim KH. Rebamipide ameliorates hepatic dysfunction induced by ischemia/reperfusion in rats. Eur J Pharmacol. 1995;294(1):41-6. DOI:10.1016/0014-2999(95)00507-2
26. Elmansy RA, Seleem HS, Mahmoud AR, et al. Rebamipide potentially mitigates methotrexate-induced nephrotoxicity via inhibition of oxidative stress and inflammation: A molecular and histochemical study. Anat Rec (Hoboken). 2021;304(3):647-61. DOI:10.1002/ar.24482
27. Arakaki R, Eguchi H, Yamada A, et al. Anti-inflammatory effects of rebamipide eyedrop administration on ocular lesions in a murine model of primary Sjögren’s syndrome. PloS One. 2014;9(5):e98390. DOI:10.1371/journal.pone.0098390
28. Кукес В.Г. Фармакоэкономический анализ. В кн.: Клиническая фармакология: учебник. Под ред. Д.А. Сычева. 5-е изд., испр. и доп. М.: ГЭОТАР-Медиа, 2017; с. 56 [Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 56 (in Russian)].
29. Currie GM. Pharmacology, Part 2: Introduction to Pharmacokinetics. J Nucl Med Technol. 2018;46(3):221-30. DOI:10.2967/jnmt.117.199638
30. Кукес В.Г. Фармакоэкономический анализ. В кн.: Клиническая фармакология: учебник. Под ред. Д.А. Сычева. 5-е изд., испр. и доп. М.: ГЭОТАР-Медиа, 2017; с. 22-36 [Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 22-36 (in Russian)].
31. Ngo L, Yoo HD, Tran P, et al. Population pharmacokinetic analysis of rebamipide in healthy Korean subjects with the characterization of atypical complex absorption kinetics. J Pharmacokinet Pharmacodyn. 2017;44(4):291-303. DOI:10.1007/s10928-017-9519-z
32. Guo Y, Wang Y, Xu L. Enhanced bioavailability of rebamipide nanocrystal tablets: formulation and in vitro/in vivo evaluation. Asian J Pharm Sci. 2015;10:223-9. DOI:10.1016/j.ajps.2014.09.006
33. Pond SM, Tozer TN. First-pass elimination. Basic concepts and clinical consequences. Clin Pharmacokinet. 1984;9(1):1-25. DOI:10.2165/00003088-198409010-00001
34. Bhosle VK, Altit G, Autmizguine J, Chemtob S. 18 – Basic Pharmacologic Principles. Eds. RA Polin, SH Abman, DH Rowitch, et al. Fetal and Neonatal Physiology (Fifth Edition). Elsevier, 2017.
35. Kim KT, Lee JY, Park JH, et al. Capmul MCM/Solutol HS15-Based Microemulsion for Enhanced Oral Bioavailability of Rebamipide. J Nanosci Nanotechnol. 2017;17(4):2340-4. DOI:10.1166/ jnn.2017.13314
36. Hasegawa S, Sekino H, Matsuoka O, et al. Bioequivalence of rebamipide granules and tablets in healthy adult male volunteers. Clin Drug Investig. 2003;23(12):771-9. DOI:10.2165/00044011-200323120-00002
37. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Exp Rev Gastroenterol Hepatol. 2010;4(3):261-70. DOI:10.1586/egh.10.25
38. Caldwell J, Gardner I, Swales N. An introduction to drug disposition: the basic principles of absorption, distribution, metabolism, and excretion. Toxicol Pathol. 1995;23(2):102-14. DOI:10.1177/019262339502300202
39. Shioya Y, Shimizu T. High-performance liquid chromatographic procedure for the determination of a new anti-gastric ulcer agent, 2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-ylv]propionic acid, in human plasma and urine. J Chromatogr A. 1988;434(1):283-7. DOI:10.1016/0378-4347(88)80089-6
40. Park NC, Sim SB, Yan BQ, et al. The Antioxidant Effect of Rebamipide in Human Semen Specimens. Korean Journal of Urology. 2002:332-8.
41. Patel M, Taskar KS, Zamek-Gliszczynski MJ. Importance of hepatic transporters in clinical disposition of drugs and their metabolites. J Clin Pharmacol. 2016;56(Suppl. 7):S23-39. DOI:10.1002/jcph.671
42. Кукес В.Г. Фармакоэкономический анализ. В кн.: Клиническая фармакология: учебник. Под ред. Д.А. Сычева. 5-е изд., испр. и доп. М.: ГЭОТАР-Медиа, 2017; с. 75-8 [Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 75-8 (in Russian)].
43. Koyama N, Sasabe H, Miyamoto G. Involvement of cytochrome P450 in the metabolism of rebamipide by the human liver. Xenobiotica. 2002;32(7):573-86. DOI:10.1080/00498250210130591
44. Lea-Henry TN, Carland JE, Stocker SL, et al. Clinical Pharmacokinetics in Kidney Disease: Fundamental Principles. Clin J Am Soc Nephrol. 2018;13(7):1085-95. DOI:10.2215/CJN.00340118
45. Cho HY, Yoon H, Park GK, Lee YB. Pharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers. Clin Ther. 2009;31(11):2712-21. DOI:10.1016/j.clinthera.2009.11.010
46. Jang E, Park M, Jeong JE, et al. Frequently reported adverse events of rebamipide compared to other drugs for peptic ulcer and gastroesophageal reflux disease. Sci Rep. 2022;12(1):7839. DOI:10.1038/s41598-022-11505-0
47. Симаненков В.И., Маев И.В., Ткачева О.Н., и др. Синдром повышенной эпителиальной проницаемости в клинической практике. Мультидисциплинарный национальный консенсус. Кардиоваскулярная терапия и профилактика. 2021;20(1):121-278 [Simanenkov I, Maev IV, Tkacheva ON, et al. Syndrome of increased epithelial permeability in clinical practice. Multidisciplinary national Consensus. Cardiovascular Therapy and Prevention. 2021;20(1):121-278 (in Russian)]. DOI:10.15829/1728-8800-2021-2758
48. Murakami I, Zhang R, Kubo M, et al. Rebamipide suppresses mite-induced asthmatic responses in NC/Nga mice. Am J Physiol Lung Cell Mol Physiol. 2015;309(8):L872-8. DOI:10.1152/ajplung.00194.2015
49. Jhun JY, Kwon JE, Kim SY, et al. Rebamipide ameliorates atherosclerosis by controlling lipid metabolism and inflammation. PloS One. 2017;12(2):e0171674. DOI:10.1371/journal.pone.0171674
50. Ohguchi T, Kojima T, Ibrahim O, et al. The effects of 2% rebamipide ophthalmic solution on the tear functions and ocular surface of the superoxide dismutase-1 (sod1) knockout mice. Invest Ophthalmol Vis Sci. 2013;54(12):7793-802. DOI:10.1167/iovs.13-13128
51. Ueta M, Sotozono Ch, Koga Ay, et al. Usefulness of a new therapy using rebamipide eyedrops in patients with VKC/AKC refractory to conventional anti-allergic treatments. Case Reports Allergol Int. 2014;63(1):75-81. DOI:10.2332/allergolint.13-OA-0605
________________________________________________
2. Ogino K, Hobara T, Ishiyama H, et al. Antiulcer mechanism of action of rebamipide, a novel antiulcer compound, on diethyldithiocarbamate-induced antral gastric ulcers in rats. Eur J Pharmacol. 1992;212(1):9-13. DOI:10.1016/0014-2999(92)90065-c
3. Arakawa T, Kobayashi K, Yoshikawa T, et al. Rebamipide: overview of its mechanisms of action and efficacy in mucosal protection and ulcer healing. Dig Dis Sci. 1998;43(9 Suppl.):5S-13S.
4. Suzuki M, Miura S, Mori M, et al. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994;35(10):1375-8. DOI:10.1136/gut.35.10.1375
5. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 80-7 (in Russian).
6. Murata H, Yabe Y, Tsuji S, et al. Gastro-protective agent rebamipide induces cyclooxygenease-2 (COX-2) in gastric epithelial cells. Dig Dis Sci. 2005;50 (Suppl. 1):S70-5. DOI:10.1007/s10620-005-2809-0
7. Lee S, Jeong S, Kim W, et al. Rebamipide induces the gastric mucosal protective factor, cyclooxygenase-2, via activation of 5’-AMP-activated protein kinase. Biochem Biophys Res Commun. 2017;483(1):449-55. DOI:10.1016/j.bbrc.2016.12.123
8. Berod L, Friedrich C, Nandan A, et al. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells [published correction appears in Nat Med. 2015 Apr;21(4):414]. Nat Med. 2014;20(11):1327-33. DOI:10.1038/nm.3704
9. Agard M, Asakrah S, Morici LA. PGE(2) suppression of innate immunity during mucosal bacterial infection. Front Cell Infect Microbiol. 2013;3:45. DOI:10.3389/fcimb.2013.00045
10. Katada K, Yoshida N, Isozaki Y, et al. Prevention by rebamipide of acute reflux esophagitis in rats. Dig Dis Sci. 2005;(50 Suppl.)1:S97-103. DOI:10.1007/s10620-005-2813-4
11. Yamane S, Amano H, Ito Y, et al. The role of thromboxane prostanoid receptor signaling in gastric ulcer healing. Int J Exp Pathol. 2022;103(1):4-12. DOI:10.1111/iep.12410
12. Ishihara T, Suemasu S, Asano T, et al. Stimulation of gastric ulcer healing by heat shock protein 70. Biochem Pharmacol. 2011;82(7):728-36. DOI:10.1016/j.bcp.2011.06.030
13. Suzuki T, Yoshida N, Nakabe N, et al. Prophylactic effect of rebamipide on aspirin-induced gastric lesions and disruption of tight junctional protein zonula occludens-1 distribution. J Pharmacol Sci. 2008;106(3):469-77. DOI:10.1254/jphs.FP0071422
14. Tanaka H, Fukuda K, Ishida W, et al. Rebamipide increases barrier function and attenuates TNFα-induced barrier disruption and cytokine expression in human corneal epithelial cells. Br J Ophthalmol. 2013;97(7):912-6. DOI:10.1136/bjophthalmol-2012-302868
15. Andreev DN, Maev IV. Rebamipide: evidence base for use in gastroenterology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(12)97-104 (in Russian). DOI:10.26442/00403660.2020.12.200455
16. Ivashkin VT, Trukhmanov AS, Gonik MI. Rebamipide using in gastroesophageal reflux disease treatment. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(4):98-104 (in Russian). DOI:10.26442/00403660.2020.04.000568
17. Parfenov AI, Belostotsky NI, Khomeriki SG, et al. Rebamipide increases the disaccharidases activity in patients with enteropathy with impaired membrane digestion. Pilot study. Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(2):25-31 (in Russian). DOI:10.26442/00403660.2019.02.000123
18. Tanigawa T, Watanabe T, Higashimori A, et al. Rebamipide ameliorates indomethacin-induced small intestinal damage and proton pump inhibitor-induced exacerbation of this damage by modulation of small intestinal microbiota. PloS One. 2021;16(1):e0245995. DOI:10.1371/journal.pone.0245995
19. Simanenkov VI, Tikhonov SV. Rebamipide: New opportunities of gastroenteroprotection. Terapevticheskii Arkhiv (Ter. Arkh.). 2015;87(12):134-7 (in Russian). DOI:10.17116/terarkh20158712134-137
20. Lai Y, Zhong W, Yu T, et al. Rebamipide Promotes the Regeneration of Aspirin-Induced Small-Intestine Mucosal Injury through Accumulation of β-Catenin. PloS One. 2015;10(7):e0132031. DOI:10.1371/journal.pone.0132031
21. Chiurillo MA. Role of the Wnt/β-catenin pathway in gastric cancer: An in-depth literature review. World J Exp Med. 2015;5(2):84-102. DOI:10.5493/wjem.v5.i2.84
22. White BD, Chien AJ, Dawson DW. Dysregulation of Wnt/β-catenin signaling in gastrointestinal cancers. Gastroenterology. 2012;142(2):219-32. DOI:10.1053/j.gastro.2011.12.001
23. Byun JK, Moon SJ, Jhun JY, et al. Rebamipide attenuates autoimmune arthritis severity in SKG mice via regulation of B cell and antibody production. Clin Exp Immunol. 2014;178(1):9-19. DOI:10.1111/cei.12355
24. Zakaria S, El-Sisi A. Rebamipide retards CCl4-induced hepatic fibrosis in rats: Possible role for PGE2. J Immunotoxicol. 2016;13(4):453-62. DOI:10.3109/1547691X.2015.1128022
25. Lee SM, Kim KH. Rebamipide ameliorates hepatic dysfunction induced by ischemia/reperfusion in rats. Eur J Pharmacol. 1995;294(1):41-6. DOI:10.1016/0014-2999(95)00507-2
26. Elmansy RA, Seleem HS, Mahmoud AR, et al. Rebamipide potentially mitigates methotrexate-induced nephrotoxicity via inhibition of oxidative stress and inflammation: A molecular and histochemical study. Anat Rec (Hoboken). 2021;304(3):647-61. DOI:10.1002/ar.24482
27. Arakaki R, Eguchi H, Yamada A, et al. Anti-inflammatory effects of rebamipide eyedrop administration on ocular lesions in a murine model of primary Sjögren’s syndrome. PloS One. 2014;9(5):e98390. DOI:10.1371/journal.pone.0098390
28. Kukes VG. Farmakoekonomicheskii analis. V kn.: Klinicheskaia farmakologiia: uchebnik. Pod red. DA Sycheva. 5-e izd., ispr. i dop. Moscow: GEOTAR-Media, 2017; р. 56 (in Russian).
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Авторы
Н.В. Бакулина1, С.В. Тихонов*1, С.В. Оковитый2, Е.А. Лутаенко1, А.О. Большаков1, В.А. Приходько2, А.С. Некрасова1
1 ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия;
2 ФГБОУ ВО «Санкт-Петербургский государственный химико-фармацевтический университет» Минздрава России, Санкт-Петербург
*sergeyvt2702@gmail.com
1 Mechnikov North-Western State Medical University, Saint Petersburg, Russia;
2 Saint Petersburg State Chemical Pharmaceutical University, Saint Petersburg, Russia
*sergeyvt2702@gmail.com
1 ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия;
2 ФГБОУ ВО «Санкт-Петербургский государственный химико-фармацевтический университет» Минздрава России, Санкт-Петербург
*sergeyvt2702@gmail.com
________________________________________________
1 Mechnikov North-Western State Medical University, Saint Petersburg, Russia;
2 Saint Petersburg State Chemical Pharmaceutical University, Saint Petersburg, Russia
*sergeyvt2702@gmail.com
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