Эффективность и безопасность применения ребамипида в схеме тройной эрадикационной терапии инфекции Helicobacter pylori: проспективное рандомизированное сравнительное исследование
Эффективность и безопасность применения ребамипида в схеме тройной эрадикационной терапии инфекции Helicobacter pylori: проспективное рандомизированное сравнительное исследование
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Аннотация
Цель исследования. Оценить эффективность и безопасность применения ребамипида в составе схемы тройной эрадикационной терапии (ЭТ) инфекции Helicobacter pylori.
Материалы и методы. В проспективное рандомизированное сравнительное исследование включено 94 пациента с неосложненной H. pylori-ассоциированной язвенной болезнью (ЯБ) желудка / двенадцатиперстной кишки. В процессе рандомизации пациенты разделены на три группы в зависимости от назначаемой терапии. Первая группа (n=36) получала классическую тройную схему ЭТ первой линии (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки) в течение 10 дней. Пациентам второй группы (n=33) назначалась классическая тройная схема ЭТ с включением в ее состав ребамипида (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки, ребамипид 100 мг 3 раза в сутки) в течение 10 дней. Пациентам третьей группы (n=25) назначалась классическая тройная схема ЭТ с включением ребамипида (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки, ребамипид 100 мг 3 раза в сутки) в течение 10 дней, с пролонгацией приема ребамипида на протяжении последующих 20 дней. Эффективность ЭТ определялась дыхательным тестом через 6 нед после окончания лечения. Побочные явления регистрировались пациентами в специально разработанных дневниках. Всем пациентам с ЯБ желудка на 6-й неделе проводилось гистологическое исследование биоптатов антрального отдела и тела желудка с оценкой воспалительной активности процесса по балльной системе в соответствии с обновленной Сиднейской системой.
Результаты и обсуждение. Эффективность эрадикации H. pylori в первой группе составила 77,7% (ITT), 82,3% (PP), во второй – 81,8% (ITT), 84,4% (PP), а в третьей – 84% (ITT), 87,5% (PP). Применение ребамипида в составе тройной схемы ЭТ ассоциировалось с повышением эффективности эрадикации H. pylori как при одновременном использовании со схемой [отношение шансов (ОШ) 1,16; 95% доверительный интервал (ДИ) 0,32–4,24], так и при последующем пролонгированном приеме (ОШ 1,5; 95% ДИ 0,34–6,7). Отмечена несколько более выраженная динамика эпителизации эрозивно-язвенных изменений слизистой оболочки желудка и двенадцатиперстной кишки к 21-м и 28-м суткам в третьей группе пациентов. Частота побочных явлений между группами оказалась сопоставимой: 22,2% в первой группе, 24,2% во второй группе и 20% в третьей группе. При патоморфологической оценке биоптатов пациентов с ЯБ желудка на 6-й неделе после проведенного лечения выявлены достоверные различия между первой и третьей группами по показателю воспалительной активности в антральном отделе желудка (2±0,63 против 1,4±0,52; p=0,0399).
Заключение. Включение ребамипида в состав классической тройной схемы ЭТ инфекции H. pylori повышает эффективность лечения и не влияет на профиль безопасности. В постэрадикационный период целесообразно продолжение использования ребамипида для потенцирования репарации слизистой оболочки желудка и регрессии воспалительных процессов.
Ключевые слова: Helicobacter pylori, язвенная болезнь, эрадикация, цитопротекция, ребамипид.
Materials and methods. A prospective, randomized comparative study included 94 patients with uncomplicated H. pylori-associated stomach / duodenal ulcer. In the process of randomization, patients are divided into three groups depending on the intended therapy. The first group (n=36) received a classical triple scheme of the first-line ET (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day) for 10 days. Patients of the second group (n=33) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day day) for 10 days. Patients of the third group (n=25) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day) in for 10 days, with the prolongation of the administration of rebamipide for the next 20 days. The effectiveness of ET was determined by the respiratory test after 6 weeks after the end of treatment. Adverse events were recorded by patients in specially developed diaries. All patients with gastric ulcer at the 6th week underwent a histological examination of the biopsy specimens of the antrum and the body of the stomach, assessing the inflammatory activity of the process on a point system in accordance with the updated Sydney system.
Results and discussion. Efficiency of H. pylori eradication in the first group was 77.7% (ITT), 82.3% (PP), in the second group – 81.8% (ITT), 84.4% (PP), and in the third group – 84% (ITT), 87.5% (PP). The use of rebamipide in the triple ET regimen was associated with an increase in H. pylori eradication efficiency, both with simultaneous use with the scheme [odds ratio (OR) 1.16; 95% confidence interval (CI) 0.32–4.24], and with subsequent prolonged admission (OR 1.5, 95% CI 0.34–6.7). A somewhat more pronounced dynamics of the epithelization of erosive and ulcerative changes in the mucous membrane of the stomach and duodenum to the 21st and 28th days in the third group of patients was noted. The incidence of adverse events between the groups was comparable: 22.2% in the first group, 24.2% in the second group and 20% in the third group. In the pathomorphological evaluation of biopsy specimens of patients with gastric ulcer at the 6th week after the treatment, significant differences were revealed between the first and third groups in terms of the inflammatory activity in the antrum stomach (2±0.63 vs. 1.4±0.52; p=0,0399).
The conclusion. The inclusion of rebamipide in the classical triple scheme of H. pylori ET increases the effectiveness of treatment and does not affect the safety profile. In the post-eradication period, it is advisable to continue the use of rebamipide to potentiate the repair of the gastric mucosa and regress the inflammatory processes.
Keywords: Helicobacter pylori, peptic ulcer, eradication, cytoprotection, rebamipide.
Материалы и методы. В проспективное рандомизированное сравнительное исследование включено 94 пациента с неосложненной H. pylori-ассоциированной язвенной болезнью (ЯБ) желудка / двенадцатиперстной кишки. В процессе рандомизации пациенты разделены на три группы в зависимости от назначаемой терапии. Первая группа (n=36) получала классическую тройную схему ЭТ первой линии (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки) в течение 10 дней. Пациентам второй группы (n=33) назначалась классическая тройная схема ЭТ с включением в ее состав ребамипида (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки, ребамипид 100 мг 3 раза в сутки) в течение 10 дней. Пациентам третьей группы (n=25) назначалась классическая тройная схема ЭТ с включением ребамипида (омепразол 20 мг 2 раза в сутки, амоксициллин 1000 мг 2 раза в сутки, кларитромицин 500 мг 2 раза в сутки, ребамипид 100 мг 3 раза в сутки) в течение 10 дней, с пролонгацией приема ребамипида на протяжении последующих 20 дней. Эффективность ЭТ определялась дыхательным тестом через 6 нед после окончания лечения. Побочные явления регистрировались пациентами в специально разработанных дневниках. Всем пациентам с ЯБ желудка на 6-й неделе проводилось гистологическое исследование биоптатов антрального отдела и тела желудка с оценкой воспалительной активности процесса по балльной системе в соответствии с обновленной Сиднейской системой.
Результаты и обсуждение. Эффективность эрадикации H. pylori в первой группе составила 77,7% (ITT), 82,3% (PP), во второй – 81,8% (ITT), 84,4% (PP), а в третьей – 84% (ITT), 87,5% (PP). Применение ребамипида в составе тройной схемы ЭТ ассоциировалось с повышением эффективности эрадикации H. pylori как при одновременном использовании со схемой [отношение шансов (ОШ) 1,16; 95% доверительный интервал (ДИ) 0,32–4,24], так и при последующем пролонгированном приеме (ОШ 1,5; 95% ДИ 0,34–6,7). Отмечена несколько более выраженная динамика эпителизации эрозивно-язвенных изменений слизистой оболочки желудка и двенадцатиперстной кишки к 21-м и 28-м суткам в третьей группе пациентов. Частота побочных явлений между группами оказалась сопоставимой: 22,2% в первой группе, 24,2% во второй группе и 20% в третьей группе. При патоморфологической оценке биоптатов пациентов с ЯБ желудка на 6-й неделе после проведенного лечения выявлены достоверные различия между первой и третьей группами по показателю воспалительной активности в антральном отделе желудка (2±0,63 против 1,4±0,52; p=0,0399).
Заключение. Включение ребамипида в состав классической тройной схемы ЭТ инфекции H. pylori повышает эффективность лечения и не влияет на профиль безопасности. В постэрадикационный период целесообразно продолжение использования ребамипида для потенцирования репарации слизистой оболочки желудка и регрессии воспалительных процессов.
Ключевые слова: Helicobacter pylori, язвенная болезнь, эрадикация, цитопротекция, ребамипид.
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Materials and methods. A prospective, randomized comparative study included 94 patients with uncomplicated H. pylori-associated stomach / duodenal ulcer. In the process of randomization, patients are divided into three groups depending on the intended therapy. The first group (n=36) received a classical triple scheme of the first-line ET (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day) for 10 days. Patients of the second group (n=33) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day day) for 10 days. Patients of the third group (n=25) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day) in for 10 days, with the prolongation of the administration of rebamipide for the next 20 days. The effectiveness of ET was determined by the respiratory test after 6 weeks after the end of treatment. Adverse events were recorded by patients in specially developed diaries. All patients with gastric ulcer at the 6th week underwent a histological examination of the biopsy specimens of the antrum and the body of the stomach, assessing the inflammatory activity of the process on a point system in accordance with the updated Sydney system.
Results and discussion. Efficiency of H. pylori eradication in the first group was 77.7% (ITT), 82.3% (PP), in the second group – 81.8% (ITT), 84.4% (PP), and in the third group – 84% (ITT), 87.5% (PP). The use of rebamipide in the triple ET regimen was associated with an increase in H. pylori eradication efficiency, both with simultaneous use with the scheme [odds ratio (OR) 1.16; 95% confidence interval (CI) 0.32–4.24], and with subsequent prolonged admission (OR 1.5, 95% CI 0.34–6.7). A somewhat more pronounced dynamics of the epithelization of erosive and ulcerative changes in the mucous membrane of the stomach and duodenum to the 21st and 28th days in the third group of patients was noted. The incidence of adverse events between the groups was comparable: 22.2% in the first group, 24.2% in the second group and 20% in the third group. In the pathomorphological evaluation of biopsy specimens of patients with gastric ulcer at the 6th week after the treatment, significant differences were revealed between the first and third groups in terms of the inflammatory activity in the antrum stomach (2±0.63 vs. 1.4±0.52; p=0,0399).
The conclusion. The inclusion of rebamipide in the classical triple scheme of H. pylori ET increases the effectiveness of treatment and does not affect the safety profile. In the post-eradication period, it is advisable to continue the use of rebamipide to potentiate the repair of the gastric mucosa and regress the inflammatory processes.
Keywords: Helicobacter pylori, peptic ulcer, eradication, cytoprotection, rebamipide.
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32. Fujioka T, Arakawa T, Shimoyama T, Yoshikawa T, Itoh M, Asaka M, Ishii H, Kuwayama H, Sato R, Kawai S, Takemoto T, Kobayashi K. Effects of rebamipide, a gastro-protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double-blind placebo-controlled multicentre trial. Aliment Pharmacol Ther. 2003;18 Suppl 1:146-152. doi: 10. 1046/j.1365-2036.18.s1.20.x
33. Kamada T, Sato M, Tokutomi T, Watanabe T, Murao T, Matsumoto H, Manabe N, Ito M, Tanaka S, Inoue K, Shiotani A, Akiyama T, Hata J, Haruma K. Rebamipide improves chronic inflammation in the lesser curvature of the corpus after Helicobacter pylori eradication: a multicenter study. Biomed Res Int. 2015;2015:865146. doi: 10.1155/ 2015/865146
2. Morgan DR, Crowe S.E. Helicobacter pylori infection. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015. doi: 616.3.3_dc23
3. Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022
4. [Maev IV, Samsonov AA, Andreev DN, Grechushnikov VB, Korovina TI. Clinical significance of Helicobacter pylori infection. Klinicheskaya Meditsina. 2013;91(8):4-12 (In Russ.)].
5. Lanas A, Chan FK. Peptic ulcer disease. Lancet. 2017;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7
6. Bauer B, Meyer TF. The Human Gastric Pathogen Helicobacter pylori and Its Association with Gastric Cancer and Ulcer Disease. Ulcers. 2011;2011:Article ID 340157. doi: 10.1155/2011/340157
7. Hansel SL. Peptic Ulcer Disease. In.: Mayo Clinic Gastroenterology and Hepatology Board Review. NY; 2015. doi: 616.330076_dc23
8. Chan FK, Lau JY. Peptic Ulcer Disease. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015.
9. Malfertheiner P, Megraud F, O’Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017;66(1):6-30. doi: 10. 1136/gutjnl-2016-312288
10. Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016;151(1):51-69. doi: 10.1053/j.gastro. 2016.04.006
11. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017;112(2):212-239. doi: 10.1038/ajg.2016.563
12. [Maev IV, Kucheryavyi YuA, Andreev DN, Barkalova EV. Eradication therapy for Helicobacter pylori infection: review of world trends. Terapevticheskiy Arkhiv. 2014;86(3):94-99 (In Russ.)].
13. [Andreev DN, Dicheva DT, Maev IV. Possibilities for optimization of eradication therapy for Helicobacter pylori infection in modern clinical practice. Terapevticheskiy Arkhiv. 2017;89(2): 84-90 (In Russ.)]. doi: 10.17116/terarkh201789284-90
14. Lee JY, Park KS. Optimal First-Line Treatment for Helicobacter pylori Infection: Recent Strategies. Gastroenterol Res Pract. 2016;2016:9086581. doi: 10.1155/2016/9086581
15. [Kazyulin AN. Rebamipide for the treatment of peptic ulcer associated with Helicobacter pylori infection. Lechebnoe Delo. 2016;(2):51-57 (In Russ.)].
16. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert Rev Gastroenterol Hepatol. 2010 Jun;4(3):261-270. doi: 10.1586/egh.10.25
17. [Andreev DN, Dicheva DT, Partsvania-Vinogradova EV. Rebamipide in a Combination Therapy of Helicobacter pylori-Associated Gastroduodenal Ulcer: Systematized Published Data. Effektivnaya Farmakoterapiya = Effective Pharmacotherapy. 2017;16:34-36 (In Russ.)].
18. Iinuma S, Naito Y, Yoshikawa T, Takahashi S, Takemura T, Yoshida N, Kondo M. In vitro studies indicating antioxidative properties of rebamipide. Dig Dis Sci. 1998 Sep;43(9 Suppl):35S-39S. PMID: 9753224
19. Yoshida N, Yoshikawa T, Iinuma S, Arai M, Takenaka S, Sakamoto K, Miyajima T, Nakamura Y, Yagi N, Naito Y, Mukai F, Kondo M. Rebamipide protects against activation of neutrophils by Helicobacter pylori. Dig Dis Sci. 1996;41(6):1139-1144. doi: 10.1007/BF02088229
20. Hayashi S, Sugiyama T, Amano K, Isogai H, Isogai E, Aihara M, Kikuchi M, Asaka M, Yokota K, Oguma K, Fujii N, Hirai Y. Effect of rebamipide, a novel antiulcer agent, on Helicobacter pylori adhesion to gastric epithelial cells. Antimicrob Agents Chemother. 1998 Aug; 42(8):1895-1899. PMID: 9687380
21. Suzuki M, Miura S, Mori M, Kai A, Suzuki H, Fukumura D, Suematsu M, Tsuchiya M. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994 Oct;35(10):1375-1378.
doi: 10.1136/gut.35.10.1375
22. Nishizawa T, Nishizawa Y, Yahagi N, Kanai T, Takahashi M, Suzuki H. Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2014;29 Suppl 4:20-24. doi: 10.1111/jgh.12769
23. Uotani T, Miftahussurur M, Yamaoka Y. Effect of bacterial and host factors on Helicobacter pylori eradication therapy. Expert Opin Ther Targets. 2015;19(12):1637-1650. doi: 10.1517/14728222.2015.1073261
24. [Maev IV, Andreev DN. Molecular genetic predictors of resistance to anti-Helicobacter pylori therapy. Terapevticheskiy Arkhiv. 2017;89(8):5-12 (In Russ.)]. doi: 10.17116/terarkh20178985-12
25. Li M, Li T, Guo S, Liang H, Jiang D. The effect of MDR1 C3435T polymorphism on the eradication rate of H. pylori infection in PPI-based triple therapy: A meta-analysis. Medicine (Baltimore). 2017;96(13):e6489. doi: 10.1097/MD.0000000000006489
26. De Boer WA, Thys JC, Borody TJ, Graham DY, O’Morain C, Tytgat GN. Proposal for use of a standard side effect scoring system in studies exploring Helicobacter pylori treatment regimens. Eur J Gastroenterol Hepatol. 1996;8(7):641-643. PMID: 8853251
27. Sipponen P, Price AB. The Sydney system for classification of gastritis 20 years ago. J Gastroenterol Hepatol. 2011;26 Suppl 1:31-34. doi: 10. 1111/j.14401746.2010.06536.x
28. Andreev D. Helicobacter pylori Eradication Therapy: Current
Regimens. Adv Res Gastroentero Hepatol. 2017;7(2):555710.
doi: 10.19080/ARGH.2017.07.555710
29. [Maev IV, Andreev DN, Samsonov AA, Veliev AM. Modern schemes of eradication therapy of infection Helicobacter pylori: strategy of differentiated application, efficiency and safety. Eksperimental’naya i Klinicheskaya Gastroenterologiya. 2017;4(140):103-110 (In Russ.)].
30. Terano A, Arakawa T, Sugiyama T, et al. Rebamipide, a gastro-protective and anti-inflammatory drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori in a Japanese population: a randomized, double-blind, placebo-controlled trial. J Gastroenterol. 2007;42(8):690-693. doi: 10.1007/s00535-007-2076-2
31. Song KH, Lee YC, Fan DM, et al. Healing effects of rebamipide and omeprazole in Helicobacter pylori-positive gastric ulcer patients after eradication therapy: a randomized double-blind, multinational, multi-institutional comparative study. Digestion. 2011;84(3):221-229.
doi: 10.1159/000329353
32. Fujioka T, Arakawa T, Shimoyama T, Yoshikawa T, Itoh M, Asaka M, Ishii H, Kuwayama H, Sato R, Kawai S, Takemoto T, Kobayashi K. Effects of rebamipide, a gastro-protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double-blind placebo-controlled multicentre trial. Aliment Pharmacol Ther. 2003;18 Suppl 1:146-152. doi: 10. 1046/j.1365-2036.18.s1.20.x
33. Kamada T, Sato M, Tokutomi T, Watanabe T, Murao T, Matsumoto H, Manabe N, Ito M, Tanaka S, Inoue K, Shiotani A, Akiyama T, Hata J, Haruma K. Rebamipide improves chronic inflammation in the lesser curvature of the corpus after Helicobacter pylori eradication: a multicenter study. Biomed Res Int. 2015;2015:865146. doi: 10.1155/ 2015/865146
2. Morgan DR, Crowe S.E. Helicobacter pylori infection. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015. doi: 616.3.3_dc23
3. Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022
4. Маев И.В., Самсонов А.А., Андреев Д.Н., Гречушников В.Б., Коровина Т.И. Клиническое значение инфекции Helicobacter pylori. Клиническая медицина. 2013;91(8):4-12 [Maev IV, Samsonov AA, Andreev DN, Grechushnikov VB, Korovina TI. Clinical significance of Helicobacter pylori infection. Klinicheskaya Meditsina. 2013;91(8):4-12 (In Russ.)].
5. Lanas A, Chan FK. Peptic ulcer disease. Lancet. 2017;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7
6. Bauer B, Meyer TF. The Human Gastric Pathogen Helicobacter pylori and Its Association with Gastric Cancer and Ulcer Disease. Ulcers. 2011;2011:Article ID 340157. doi: 10.1155/2011/340157
7. Hansel SL. Peptic Ulcer Disease. In.: Mayo Clinic Gastroenterology and Hepatology Board Review. NY; 2015. doi: 616.330076_dc23
8. Chan FK, Lau JY. Peptic Ulcer Disease. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015.
9. Malfertheiner P, Megraud F, O’Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017;66(1):6-30. doi: 10. 1136/gutjnl-2016-312288
10. Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016;151(1):51-69. doi: 10.1053/j.gastro. 2016.04.006
11. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017;112(2):212-239. doi: 10.1038/ajg.2016.563
12. Маев И.В., Кучерявый Ю.А., Андреев Д.Н., Баркалова Е.В. Эрадикационная терапия инфекции Helicobacter pylori: обзор мировых тенденций. Терапевтический архив. 2014;86(3):94-9 [Maev IV, Kucheryavyi YuA, Andreev DN, Barkalova EV. Eradication therapy for Helicobacter pylori infection: review of world trends. Terapevticheskiy Arkhiv. 2014;86(3):94-99 (In Russ.)].
13. Андреев Д.Н., Дичева Д.Т., Маев И.В. Возможности оптимизации эрадикационной терапии инфекции Helicobacter pylori в современной клинической практике. Терапевтический архив. 2017;89(2):84-90 [Andreev DN, Dicheva DT, Maev IV. Possibilities for optimization of eradication therapy for Helicobacter pylori infection in modern clinical practice. Terapevticheskiy Arkhiv. 2017;89(2): 84-90 (In Russ.)]. doi: 10.17116/terarkh201789284-90
14. Lee JY, Park KS. Optimal First-Line Treatment for Helicobacter pylori Infection: Recent Strategies. Gastroenterol Res Pract. 2016;2016:9086581. doi: 10.1155/2016/9086581
15. Казюлин А.Н. Использование ребамипида в качестве гастропротективного и противовоспалительного препарата при лечении язвенной болезни, ассоциированной с инфекцией Helicobacter pylori. Лечебное дело. 2016;(2):51-57 [Kazyulin AN. Rebamipide for the treatment of peptic ulcer associated with Helicobacter pylori infection. Lechebnoe Delo. 2016;(2):51-57 (In Russ.)].
16. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert Rev Gastroenterol Hepatol. 2010 Jun;4(3):261-270. doi: 10.1586/egh.10.25
17. Андреев Д.Н., Дичева Д.Т., Парцваниа-Виноградова Е.В. Использование ребамипида в рамках комплексной терапии Helicobacter pylori–ассоциированной язвенной болезни желудка и двенадцатиперстной кишки: систематизация данных литературы. Эффективная фармакотерапия. 2017;16:34-36 [Andreev DN, Dicheva DT, Partsvania-Vinogradova EV. Rebamipide in a Combination Therapy of Helicobacter pylori-Associated Gastroduodenal Ulcer: Systematized Published Data. Effektivnaya Farmakoterapiya = Effective Pharmacotherapy. 2017;16:34-36 (In Russ.)].
18. Iinuma S, Naito Y, Yoshikawa T, Takahashi S, Takemura T, Yoshida N, Kondo M. In vitro studies indicating antioxidative properties of rebamipide. Dig Dis Sci. 1998 Sep;43(9 Suppl):35S-39S. PMID: 9753224
19. Yoshida N, Yoshikawa T, Iinuma S, Arai M, Takenaka S, Sakamoto K, Miyajima T, Nakamura Y, Yagi N, Naito Y, Mukai F, Kondo M. Rebamipide protects against activation of neutrophils by Helicobacter pylori. Dig Dis Sci. 1996;41(6):1139-1144. doi: 10.1007/BF02088229
20. Hayashi S, Sugiyama T, Amano K, Isogai H, Isogai E, Aihara M, Kikuchi M, Asaka M, Yokota K, Oguma K, Fujii N, Hirai Y. Effect of rebamipide, a novel antiulcer agent, on Helicobacter pylori adhesion to gastric epithelial cells. Antimicrob Agents Chemother. 1998 Aug; 42(8):1895-1899. PMID: 9687380
21. Suzuki M, Miura S, Mori M, Kai A, Suzuki H, Fukumura D, Suematsu M, Tsuchiya M. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994 Oct;35(10):1375-1378.
doi: 10.1136/gut.35.10.1375
22. Nishizawa T, Nishizawa Y, Yahagi N, Kanai T, Takahashi M, Suzuki H. Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2014;29 Suppl 4:20-24. doi: 10.1111/jgh.12769
23. Uotani T, Miftahussurur M, Yamaoka Y. Effect of bacterial and host factors on Helicobacter pylori eradication therapy. Expert Opin Ther Targets. 2015;19(12):1637-1650. doi: 10.1517/14728222.2015.1073261
24. Маев И.В., Андреев Д.Н. Молекулярно-генетические предикторы резистентности к антихеликобактерной терапии.Терапевтический архив. 2017;89(8):5-12 [Maev IV, Andreev DN. Molecular genetic predictors of resistance to anti-Helicobacter pylori therapy. Terapevticheskiy Arkhiv. 2017;89(8):5-12 (In Russ.)]. doi: 10.17116/terarkh20178985-12
25. Li M, Li T, Guo S, Liang H, Jiang D. The effect of MDR1 C3435T polymorphism on the eradication rate of H. pylori infection in PPI-based triple therapy: A meta-analysis. Medicine (Baltimore). 2017;96(13):e6489. doi: 10.1097/MD.0000000000006489
26. De Boer WA, Thys JC, Borody TJ, Graham DY, O’Morain C, Tytgat GN. Proposal for use of a standard side effect scoring system in studies exploring Helicobacter pylori treatment regimens. Eur J Gastroenterol Hepatol. 1996;8(7):641-643. PMID: 8853251
27. Sipponen P, Price AB. The Sydney system for classification of gastritis 20 years ago. J Gastroenterol Hepatol. 2011;26 Suppl 1:31-34. doi: 10. 1111/j.14401746.2010.06536.x
28. Andreev D. Helicobacter pylori Eradication Therapy: Current
Regimens. Adv Res Gastroentero Hepatol. 2017;7(2):555710.
doi: 10.19080/ARGH.2017.07.555710
29. Маев И.В., Андреев Д.Н., Самсонов А.А., Велиев А.М. Современные схемы эрадикационной терапии инфекции Helicobacter pylori: стратегия дифференцированного применения, эффективность и безопасность. Экспериментальная и клиническая гастроэнтерология. 2017;4(140):103-110 [Maev IV, Andreev DN, Samsonov AA, Veliev AM. Modern schemes of eradication therapy of infection Helicobacter pylori: strategy of differentiated application, efficiency and safety. Eksperimental’naya i Klinicheskaya Gastroenterologiya. 2017;4(140):103-110 (In Russ.)].
30. Terano A, Arakawa T, Sugiyama T, et al. Rebamipide, a gastro-protective and anti-inflammatory drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori in a Japanese population: a randomized, double-blind, placebo-controlled trial. J Gastroenterol. 2007;42(8):690-693. doi: 10.1007/s00535-007-2076-2
31. Song KH, Lee YC, Fan DM, et al. Healing effects of rebamipide and omeprazole in Helicobacter pylori-positive gastric ulcer patients after eradication therapy: a randomized double-blind, multinational, multi-institutional comparative study. Digestion. 2011;84(3):221-229.
doi: 10.1159/000329353
32. Fujioka T, Arakawa T, Shimoyama T, Yoshikawa T, Itoh M, Asaka M, Ishii H, Kuwayama H, Sato R, Kawai S, Takemoto T, Kobayashi K. Effects of rebamipide, a gastro-protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double-blind placebo-controlled multicentre trial. Aliment Pharmacol Ther. 2003;18 Suppl 1:146-152. doi: 10. 1046/j.1365-2036.18.s1.20.x
33. Kamada T, Sato M, Tokutomi T, Watanabe T, Murao T, Matsumoto H, Manabe N, Ito M, Tanaka S, Inoue K, Shiotani A, Akiyama T, Hata J, Haruma K. Rebamipide improves chronic inflammation in the lesser curvature of the corpus after Helicobacter pylori eradication: a multicenter study. Biomed Res Int. 2015;2015:865146. doi: 10.1155/ 2015/865146
________________________________________________
2. Morgan DR, Crowe S.E. Helicobacter pylori infection. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015. doi: 616.3.3_dc23
3. Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022
4. [Maev IV, Samsonov AA, Andreev DN, Grechushnikov VB, Korovina TI. Clinical significance of Helicobacter pylori infection. Klinicheskaya Meditsina. 2013;91(8):4-12 (In Russ.)].
5. Lanas A, Chan FK. Peptic ulcer disease. Lancet. 2017;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7
6. Bauer B, Meyer TF. The Human Gastric Pathogen Helicobacter pylori and Its Association with Gastric Cancer and Ulcer Disease. Ulcers. 2011;2011:Article ID 340157. doi: 10.1155/2011/340157
7. Hansel SL. Peptic Ulcer Disease. In.: Mayo Clinic Gastroenterology and Hepatology Board Review. NY; 2015. doi: 616.330076_dc23
8. Chan FK, Lau JY. Peptic Ulcer Disease. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015.
9. Malfertheiner P, Megraud F, O’Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017;66(1):6-30. doi: 10. 1136/gutjnl-2016-312288
10. Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016;151(1):51-69. doi: 10.1053/j.gastro. 2016.04.006
11. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017;112(2):212-239. doi: 10.1038/ajg.2016.563
12. [Maev IV, Kucheryavyi YuA, Andreev DN, Barkalova EV. Eradication therapy for Helicobacter pylori infection: review of world trends. Terapevticheskiy Arkhiv. 2014;86(3):94-99 (In Russ.)].
13. [Andreev DN, Dicheva DT, Maev IV. Possibilities for optimization of eradication therapy for Helicobacter pylori infection in modern clinical practice. Terapevticheskiy Arkhiv. 2017;89(2): 84-90 (In Russ.)]. doi: 10.17116/terarkh201789284-90
14. Lee JY, Park KS. Optimal First-Line Treatment for Helicobacter pylori Infection: Recent Strategies. Gastroenterol Res Pract. 2016;2016:9086581. doi: 10.1155/2016/9086581
15. [Kazyulin AN. Rebamipide for the treatment of peptic ulcer associated with Helicobacter pylori infection. Lechebnoe Delo. 2016;(2):51-57 (In Russ.)].
16. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert Rev Gastroenterol Hepatol. 2010 Jun;4(3):261-270. doi: 10.1586/egh.10.25
17. [Andreev DN, Dicheva DT, Partsvania-Vinogradova EV. Rebamipide in a Combination Therapy of Helicobacter pylori-Associated Gastroduodenal Ulcer: Systematized Published Data. Effektivnaya Farmakoterapiya = Effective Pharmacotherapy. 2017;16:34-36 (In Russ.)].
18. Iinuma S, Naito Y, Yoshikawa T, Takahashi S, Takemura T, Yoshida N, Kondo M. In vitro studies indicating antioxidative properties of rebamipide. Dig Dis Sci. 1998 Sep;43(9 Suppl):35S-39S. PMID: 9753224
19. Yoshida N, Yoshikawa T, Iinuma S, Arai M, Takenaka S, Sakamoto K, Miyajima T, Nakamura Y, Yagi N, Naito Y, Mukai F, Kondo M. Rebamipide protects against activation of neutrophils by Helicobacter pylori. Dig Dis Sci. 1996;41(6):1139-1144. doi: 10.1007/BF02088229
20. Hayashi S, Sugiyama T, Amano K, Isogai H, Isogai E, Aihara M, Kikuchi M, Asaka M, Yokota K, Oguma K, Fujii N, Hirai Y. Effect of rebamipide, a novel antiulcer agent, on Helicobacter pylori adhesion to gastric epithelial cells. Antimicrob Agents Chemother. 1998 Aug; 42(8):1895-1899. PMID: 9687380
21. Suzuki M, Miura S, Mori M, Kai A, Suzuki H, Fukumura D, Suematsu M, Tsuchiya M. Rebamipide, a novel antiulcer agent, attenuates Helicobacter pylori induced gastric mucosal cell injury associated with neutrophil derived oxidants. Gut. 1994 Oct;35(10):1375-1378.
doi: 10.1136/gut.35.10.1375
22. Nishizawa T, Nishizawa Y, Yahagi N, Kanai T, Takahashi M, Suzuki H. Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2014;29 Suppl 4:20-24. doi: 10.1111/jgh.12769
23. Uotani T, Miftahussurur M, Yamaoka Y. Effect of bacterial and host factors on Helicobacter pylori eradication therapy. Expert Opin Ther Targets. 2015;19(12):1637-1650. doi: 10.1517/14728222.2015.1073261
24. [Maev IV, Andreev DN. Molecular genetic predictors of resistance to anti-Helicobacter pylori therapy. Terapevticheskiy Arkhiv. 2017;89(8):5-12 (In Russ.)]. doi: 10.17116/terarkh20178985-12
25. Li M, Li T, Guo S, Liang H, Jiang D. The effect of MDR1 C3435T polymorphism on the eradication rate of H. pylori infection in PPI-based triple therapy: A meta-analysis. Medicine (Baltimore). 2017;96(13):e6489. doi: 10.1097/MD.0000000000006489
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Авторы
Д.Н. Андреев, И.В. Маев, Д.Т. Дичева, А.А. Самсонов, Е.В. Парцваниа-Виноградова
ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия
A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia, Moscow, Russia
ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия
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A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia, Moscow, Russia
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