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Эффективность рабепразола для лечения гастроэзофагеальной рефлюксной болезни в рамках 7-дневного неинтервенционного исследования
Эффективность рабепразола для лечения гастроэзофагеальной рефлюксной болезни в рамках 7-дневного неинтервенционного исследования
Цуканов В.В., Онучина Е.В., Васютин А.В., Дамбаева Б.Б., Тонких Ю.Л., Павлова Н.В. Эффективность рабепразола для лечения гастроэзофагеальной рефлюксной болезни в рамках 7-дневного неинтервенционного исследования. Терапевтический архив. 2024;96(8):804–811.
DOI: 10.26442/00403660.2024.08.202895
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
DOI: 10.26442/00403660.2024.08.202895
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
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Аннотация
Цель. Оценить эффективность 7-дневного лечения рабепразолом (Разо®) в дозе 20 мг 1 раз в сутки у пациентов с неэрозивной рефлюксной болезнью (НЭРБ) и эзофагитом на основании мониторирования результатов pH-импедансометрии желудка и пищевода и оценки клинической симптоматики.
Материалы и методы. Обследованы 30 больных с типичными проявлениями гастроэзофагеальной рефлюксной болезни (ГЭРБ). В исследование включались пациенты, которым проведены pH-импедансометрия, эндоскопическое обследование и назначено лечение рабепразолом в дозе 20 мг 1 раз в день. Клинический мониторинг осуществлялся во время трех визитов: до начала лечения, через 3 и 7 дней лечения. Контрольная pH-импедансометрия выполнялась через 7 дней терапии. Третий визит являлся конечной точкой исследования.
Результаты. Через 7 дней лечения ответ для изжоги составил 86,7% в общей группе пациентов с ГЭРБ, 94,4% – у лиц с НЭРБ и 75,0% – у больных с эзофагитом в стадии А и В. После 7-дневной терапии рабепразолом мы зарегистрировали у больных ГЭРБ достоверное снижение общего количества рефлюксов (с 88 до 54; p<0,001), количества кислых рефлюксов (с 53 до 22; p<0,001), индекса DeMeester (с 23,81 до 7,62; p<0,001), AET (с 7,54 до 2,01; p<0,001) в пищеводе и увеличение медианы суточной рН (с 1,8 до 5,4; p<0,001) и времени с pH>4 в желудке (c 2,57 ч и 10,7% до 12,3 ч и 51,3%; p<0,001). Семидневная терапия рабепразолом сопровождалась выраженным улучшением у больных ГЭРБ по всем параметрам качества жизни. Сто процентов пациентов с ГЭРБ оценивали свою удовлетворенность терапией как «хорошую» и «очень хорошую».
Заключение. В результате 7-дневной терапии пациентов с НЭРБ и эзофагитом препаратом Разо® в дозе 20 мг/сут получен прекрасный клинический ответ, подтвержденный выраженной оптимизацией показателей pH-импедансометрии.
Ключевые слова: гастроэзофагеальная рефлюксная болезнь, рабепразол, pH-импедансометрия, лечение, качество жизни
Materials and methods. Thirty patients with typical GERD manifestations were examined. The study included patients who underwent pH-impedancemetry, endoscopic examination, and were prescribed treatment with rabeprazole at a dose of 20 mg once a day. Clinical monitoring was performed during three visits: before treatment, after 3 days, and after 7 days of treatment. Control pH-impedancemetry was performed after 7 days of therapy. The third visit was the endpoint of the study.
Results. After 7 days of treatment, the response rate for heartburn was 86.7% in the overall group of patients with GERD, 94.4% in those with NERD, and 75.0% in patients with esophagitis stage A and B. After 7 days of therapy with rabeprazole, we registered a significant decrease in the total number of refluxes (from 88 to 54; p<0.001), the number of acid refluxes (from 53 to 22; p<0.001), the DeMeester index (from 23.81 to 7.62; p<0.001), and AET (from 7.54 to 2.01; p<0.001) in the esophagus and an increase in the median daily pH (from 1.8 to 5.4; p<0.001) and the time with pH>4 in the stomach (from 2.57 hours and 10.7% up to 12.3 hours and 51.3%; p<0.001). 7-day therapy with rabeprazole was accompanied by a significant improvement in GERD patients in all parameters of quality of life. 100% of patients with GERD rated their satisfaction with therapy as “good” and “very good”.
Conclusion. As a result of 7-day therapy of patients with NERD and esophagitis with Razo® at a dose of 20 mg per day, an excellent clinical response was obtained, confirmed by a marked optimization of pH-impedancemetry parameters.
Keywords: gastroesophageal reflux disease, rabeprazole, pH-impedancemetry, treatment, quality of life
Материалы и методы. Обследованы 30 больных с типичными проявлениями гастроэзофагеальной рефлюксной болезни (ГЭРБ). В исследование включались пациенты, которым проведены pH-импедансометрия, эндоскопическое обследование и назначено лечение рабепразолом в дозе 20 мг 1 раз в день. Клинический мониторинг осуществлялся во время трех визитов: до начала лечения, через 3 и 7 дней лечения. Контрольная pH-импедансометрия выполнялась через 7 дней терапии. Третий визит являлся конечной точкой исследования.
Результаты. Через 7 дней лечения ответ для изжоги составил 86,7% в общей группе пациентов с ГЭРБ, 94,4% – у лиц с НЭРБ и 75,0% – у больных с эзофагитом в стадии А и В. После 7-дневной терапии рабепразолом мы зарегистрировали у больных ГЭРБ достоверное снижение общего количества рефлюксов (с 88 до 54; p<0,001), количества кислых рефлюксов (с 53 до 22; p<0,001), индекса DeMeester (с 23,81 до 7,62; p<0,001), AET (с 7,54 до 2,01; p<0,001) в пищеводе и увеличение медианы суточной рН (с 1,8 до 5,4; p<0,001) и времени с pH>4 в желудке (c 2,57 ч и 10,7% до 12,3 ч и 51,3%; p<0,001). Семидневная терапия рабепразолом сопровождалась выраженным улучшением у больных ГЭРБ по всем параметрам качества жизни. Сто процентов пациентов с ГЭРБ оценивали свою удовлетворенность терапией как «хорошую» и «очень хорошую».
Заключение. В результате 7-дневной терапии пациентов с НЭРБ и эзофагитом препаратом Разо® в дозе 20 мг/сут получен прекрасный клинический ответ, подтвержденный выраженной оптимизацией показателей pH-импедансометрии.
Ключевые слова: гастроэзофагеальная рефлюксная болезнь, рабепразол, pH-импедансометрия, лечение, качество жизни
________________________________________________
Materials and methods. Thirty patients with typical GERD manifestations were examined. The study included patients who underwent pH-impedancemetry, endoscopic examination, and were prescribed treatment with rabeprazole at a dose of 20 mg once a day. Clinical monitoring was performed during three visits: before treatment, after 3 days, and after 7 days of treatment. Control pH-impedancemetry was performed after 7 days of therapy. The third visit was the endpoint of the study.
Results. After 7 days of treatment, the response rate for heartburn was 86.7% in the overall group of patients with GERD, 94.4% in those with NERD, and 75.0% in patients with esophagitis stage A and B. After 7 days of therapy with rabeprazole, we registered a significant decrease in the total number of refluxes (from 88 to 54; p<0.001), the number of acid refluxes (from 53 to 22; p<0.001), the DeMeester index (from 23.81 to 7.62; p<0.001), and AET (from 7.54 to 2.01; p<0.001) in the esophagus and an increase in the median daily pH (from 1.8 to 5.4; p<0.001) and the time with pH>4 in the stomach (from 2.57 hours and 10.7% up to 12.3 hours and 51.3%; p<0.001). 7-day therapy with rabeprazole was accompanied by a significant improvement in GERD patients in all parameters of quality of life. 100% of patients with GERD rated their satisfaction with therapy as “good” and “very good”.
Conclusion. As a result of 7-day therapy of patients with NERD and esophagitis with Razo® at a dose of 20 mg per day, an excellent clinical response was obtained, confirmed by a marked optimization of pH-impedancemetry parameters.
Keywords: gastroesophageal reflux disease, rabeprazole, pH-impedancemetry, treatment, quality of life
Полный текст
Список литературы
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2. Tsukanov VV, Kasparov EV, Onuchina EV, et al. The frequency and clinical aspects of extraesophageal syndromes in elderly patients with gastroesophageal reflux disease. Terapevticheskii Arkhiv (Ter. Arkh.). 2016;88(2):28-32 (in Russian). DOI:10.17116/terarkh201688228-32
3. Tsukanov VV, Onuchina EV, Vasiutin AV, et al. Clinical aspects of gastroesophageal reflux disease in elderly patients: Results of a 5-year prospective study. Terapevticheskii Arkhiv (Ter. Arkh.). 2014;86(2):23-6. Available at: https://ter-arkhiv.ru/0040-3660/article/view/31425. Accessed: 20.08.2024 (in Russian).
4. Gyawali CP, Yadlapati R, Fass R, et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024;73(2):361-71. DOI:10.1136/gutjnl-2023-330616
5. Argüero J, Sifrim D. Pathophysiology of gastro-oesophageal reflux disease: implications for diagnosis and management. Nat Rev Gastroenterol Hepatol. 2024;21(4):282-93. DOI:10.1038/s41575-023-00883-z
6. Davis TA, Gyawali CP. Refractory Gastroesophageal Reflux Disease: Diagnosis and Management. J Neurogastroenterol Motil. 2024;30(1):17-28. DOI:10.5056/jnm23145
7. Lakananurak N, Pitisuttithum P, Susantitaphong P, et al. The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies. Nutrients. 2024;16(3):464. DOI:10.3390/nu16030464
8. Ota K, Takeuchi T, Higuchi K, et al. Frontiers in Endoscopic Treatment for Gastroesophageal Reflux Disease. Digestion. 2024;105(1):5-10. DOI:10.1159/000533200
9. Tsukanov VV, Vasyutin AV, Tonkikh JL. Modern aspects of managing patients with non-erosive reflux disease. Medical Council. 2023;(18):28-33 (in Russian).
DOI:10.21518/ms2023-218
10. Bakulina NV, Tikhonov SV, Topalova YG, et al. Esophagoprotective therapy in patients with erosive esophagitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(8):985-91 (in Russian). DOI:10.26442/00403660.2022.08.201828
11. Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20. DOI:10.1111/j.1572-0241.2006.00630.x
12. Modlin IM, Hunt RH, Malfertheiner P, et al. Diagnosis and management of non-erosive reflux disease – the Vevey NERD Consensus Group. Digestion. 2009;80(2):74-88. DOI:10.1159/000219365
13. Modlin IM, Hunt RH, Malfertheiner P, et al. Non-erosive reflux disease – defining the entity and delineating the management. Digestion. 2008;78(Suppl. 1):1-5. DOI:10.1159/000151248
14. Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal Disorders. Gastroenterology. 2016;150(6):1380-92. DOI:10.1053/j.gastro.2016.02.011
15. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45(2):172-80. DOI:10.1136/gut.45.2.172
16. Jamieson JR, Stein HJ, DeMeester TR, et al. Ambulatory 24-h esophageal pH monitoring: normal values, optimal thresholds, specificity, sensitivity, and reproducibility. Am J Gastroenterol. 1992;87(9):1102-11. Available at: https://www.gastroscan.ru/literature/pdf/demeester1992-6.pdf. Accessed: 18.01.2024.
17. Frazzoni M, de Bortoli N, Frazzoni L, et al. Impedance-pH Monitoring for Diagnosis of Reflux Disease: New Perspectives. Dig Dis Sci. 2017;62(8):1881-9.
DOI:10.1007/s10620-017-4625-8
18. Miner PJr, Orr W, Filippone J, et al. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002;97(6):1332-9. DOI:10.1111/j.1572-0241.2002.05769.x
19. Kahrilas PJ, Miner P, Johanson J, et al. Efficacy of rabeprazole in the treatment of symptomatic gastroesophageal reflux disease. Dig Dis Sci. 2005;50(11):2009-18. DOI:10.1007/s10620-005-3000-3
20. Miwa H, Sasaki M, Furuta T, et al. Efficacy of rabeprazole on heartburn symptom resolution in patients with non-erosive and erosive gastro-oesophageal reflux disease: a multicenter study from Japan. Aliment Pharmacol Ther. 2007;26(1):69-77. DOI:10.1111/j.1365-2036.2007.03350.x
21. Cutler A, Robinson M, Murthy A, Delemos B. Rabeprazole 20 mg for erosive esophagitis-associated symptoms in a large, community-based study: additional results. Dig Dis Sci. 2010;55(2):338-45. DOI:10.1007/s10620-009-0864-7
22. Caos A, Moskovitz M, Dayal Y, et al. Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Rebeprazole Study Group. Am J Gastroenterol. 2000;95(11):3081-88. DOI:10.1111/j.1572-0241.2000.03179.x
23. Caos A, Breiter J, Perdomo C, Barth J. Long-term prevention of erosive or ulcerative gastro-oesophageal reflux disease relapse with rabeprazole 10 or 20 mg vs. placebo: results of a 5-year study in the United States. Aliment Pharmacol Ther. 2005;22(3):193-202. DOI:10.1111/j.1365-2036.2005.02555.x
24. Tsukanov VV, Cherepnin MA, Vasyutin AV, et al. Efficacy of rabeprazole (Razo®) in the treatment of various clinical variants of GERD: results from the GERBERA study. Medical Council. 2022;(7):28-35 (in Russian). DOI:10.21518/2079-701X-2022-16-7-28-35
25. Saitoh T, Fukushima Y, Otsuka H, et al. Effects of rabeprazole, lansoprazole and omeprazole on intragastric pH in CYP2C19 extensive metabolizers. Aliment Pharmacol Ther. 2002;16(10):1811-7. DOI:10.1046/j.1365-2036.2002.01348.x
26. Ashida K, Kinoshita Y, Hongo M; Japan Rabeprazole Study Group for NERD. Acid-suppressive effect of rabeprazole 5 mg and 10 mg once daily by 24-hour esophageal pH monitoring in patients with non-erosive reflux disease in Japan: a multicenter, randomized, parallel-group, double-blind pharmacodynamic study. Dig Dis Sci. 2011;56(8):2333-42. DOI:10.1007/s10620-011-1583-4
27. Shimatani T, Inoue M, Kuroiwa T, et al. Acid-suppressive efficacy of a reduced dosage of rabeprazole: comparison of 10 mg twice daily rabeprazole with 20 mg twice daily rabeprazole, 30 mg twice daily lansoprazole, and 20 mg twice daily omeprazole by 24-hr intragastric pH-metry. Dig Dis Sci. 2005;50(7):1202-6. DOI:10.1007/s10620-005-2760-0
28. Zhang HJ, Zhang XH, Liu J, et al. Effects of genetic polymorphisms on the pharmacokinetics and pharmacodynamics of proton pump inhibitors. Pharmacol Res. 2020;152:104606. DOI:10.1016/j.phrs.2019.104606
29. Ichikawa H, Sugimoto M, Sugimoto K, et al. Rapid metabolizer genotype of CYP2C19 is a risk factor of being refractory to proton pump inhibitor therapy for reflux esophagitis. J Gastroenterol Hepatol. 2016;31(4):716-26. DOI:10.1111/jgh.13233
30. Miner PJr, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol. 2003;98(12):2616-20. DOI:10.1111/j.1572-0241.2003.08783.x
31. Morelli G, Chen H, Rossiter G, et al. An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers. Aliment Pharmacol Ther. 2011;33(7):845-54. DOI:10.1111/j.1365-2036.2011.04580.x
32. Li ZS, Zhan XB, Xu GM, et al. Effect of esomeprazole and rabeprazole on intragastric pH in healthy Chinese: an open, randomized crossover trial. J Gastroenterol Hepatol. 2007;22(6):815-20. DOI:10.1111/j.1440-1746.2006.04709.x
33. Robinson M, Maton PN, Rodriguez S, et al. Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1997;11(5):973-80. DOI:10.1046/j.1365-2036.1997.00244.x
34. Norris V, Baisley K, Dunn K, et al. Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers. Aliment Pharmacol Ther. 2007;25(4):501-10. DOI:10.1111/j.1365-2036.2006.03221.x
2. Цуканов В.В., Каспаров Э.В., Онучина Е.В., и др. Частота и клинические аспекты внепищеводных синдромов у пациентов с гастроэзофагеальной рефлюксной болезнью пожилого возраста. Терапевтический архив. 2016;88(2):28-32 [Tsukanov VV, Kasparov EV, Onuchina EV, et al. The frequency and clinical aspects of extraesophageal syndromes in elderly patients with gastroesophageal reflux disease. Terapevticheskii Arkhiv (Ter. Arkh.). 2016;88(2):28-32 (in Russian)]. DOI:10.17116/terarkh201688228-32
3. Цуканов В.В., Онучина Е.В., Васютин А.В., и др. Клинические аспекты гастроэзофагальной рефлюксной болезни у лиц пожилого возраста: результаты 5-летнего проспективного исследования. Терапевтический архив. 2014;86(2):23-6. Режим доступа: https://ter-arkhiv.ru/0040-3660/article/view/31425. Ссылка активна на 20.08.2024 [Tsukanov VV, Onuchina EV, Vasiutin AV, et al. Clinical aspects of gastroesophageal reflux disease in elderly patients: Results of a 5-year prospective study. Terapevticheskii Arkhiv (Ter. Arkh.). 2014;86(2):23-6. Available at: https://ter-arkhiv.ru/0040-3660/article/view/31425. Accessed: 20.08.2024 (in Russian)].
4. Gyawali CP, Yadlapati R, Fass R, et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024;73(2):361-71. DOI:10.1136/gutjnl-2023-330616
5. Argüero J, Sifrim D. Pathophysiology of gastro-oesophageal reflux disease: implications for diagnosis and management. Nat Rev Gastroenterol Hepatol. 2024;21(4):282-93. DOI:10.1038/s41575-023-00883-z
6. Davis TA, Gyawali CP. Refractory Gastroesophageal Reflux Disease: Diagnosis and Management. J Neurogastroenterol Motil. 2024;30(1):17-28. DOI:10.5056/jnm23145
7. Lakananurak N, Pitisuttithum P, Susantitaphong P, et al. The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies. Nutrients. 2024;16(3):464. DOI:10.3390/nu16030464
8. Ota K, Takeuchi T, Higuchi K, et al. Frontiers in Endoscopic Treatment for Gastroesophageal Reflux Disease. Digestion. 2024;105(1):5-10. DOI:10.1159/000533200
9. Цуканов В.В., Васютин А.В., Тонких Ю.Л. Современные аспекты ведения пациентов с неэрозивной рефлюксной болезнью. Медицинский Совет. 2023;(18):28-33 [Tsukanov VV, Vasyutin AV, Tonkikh JL. Modern aspects of managing patients with non-erosive reflux disease. Medical Council. 2023;(18):28-33 (in Russian)]. DOI:10.21518/ms2023-218
10. Бакулина Н.В., Тихонов С.В., Топалова Ю.Г., и др. Эзофагопротективная терапия у пациентов с эрозивным эзофагитом. Терапевтический архив. 2022;94(8):985-91 [Bakulina NV, Tikhonov SV, Topalova YG, et al. Esophagoprotective therapy in patients with erosive esophagitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(8):985-91 (in Russian)]. DOI:10.26442/00403660.2022.08.201828
11. Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20. DOI:10.1111/j.1572-0241.2006.00630.x
12. Modlin IM, Hunt RH, Malfertheiner P, et al. Diagnosis and management of non-erosive reflux disease – the Vevey NERD Consensus Group. Digestion. 2009;80(2):74-88. DOI:10.1159/000219365
13. Modlin IM, Hunt RH, Malfertheiner P, et al. Non-erosive reflux disease – defining the entity and delineating the management. Digestion. 2008;78(Suppl. 1):1-5. DOI:10.1159/000151248
14. Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal Disorders. Gastroenterology. 2016;150(6):1380-92. DOI:10.1053/j.gastro.2016.02.011
15. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45(2):172-80. DOI:10.1136/gut.45.2.172
16. Jamieson JR, Stein HJ, DeMeester TR, et al. Ambulatory 24-h esophageal pH monitoring: normal values, optimal thresholds, specificity, sensitivity, and reproducibility. Am J Gastroenterol. 1992;87(9):1102-11. Available at: https://www.gastroscan.ru/literature/pdf/demeester1992-6.pdf. Accessed: 18.01.2024.
17. Frazzoni M, de Bortoli N, Frazzoni L, et al. Impedance-pH Monitoring for Diagnosis of Reflux Disease: New Perspectives. Dig Dis Sci. 2017;62(8):1881-9.
DOI:10.1007/s10620-017-4625-8
18. Miner PJr, Orr W, Filippone J, et al. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002;97(6):1332-9. DOI:10.1111/j.1572-0241.2002.05769.x
19. Kahrilas PJ, Miner P, Johanson J, et al. Efficacy of rabeprazole in the treatment of symptomatic gastroesophageal reflux disease. Dig Dis Sci. 2005;50(11):2009-18. DOI:10.1007/s10620-005-3000-3
20. Miwa H, Sasaki M, Furuta T, et al. Efficacy of rabeprazole on heartburn symptom resolution in patients with non-erosive and erosive gastro-oesophageal reflux disease: a multicenter study from Japan. Aliment Pharmacol Ther. 2007;26(1):69-77. DOI:10.1111/j.1365-2036.2007.03350.x
21. Cutler A, Robinson M, Murthy A, Delemos B. Rabeprazole 20 mg for erosive esophagitis-associated symptoms in a large, community-based study: additional results. Dig Dis Sci. 2010;55(2):338-45. DOI:10.1007/s10620-009-0864-7
22. Caos A, Moskovitz M, Dayal Y, et al. Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Rebeprazole Study Group. Am J Gastroenterol. 2000;95(11):3081-88. DOI:10.1111/j.1572-0241.2000.03179.x
23. Caos A, Breiter J, Perdomo C, Barth J. Long-term prevention of erosive or ulcerative gastro-oesophageal reflux disease relapse with rabeprazole 10 or 20 mg vs. placebo: results of a 5-year study in the United States. Aliment Pharmacol Ther. 2005;22(3):193-202. DOI:10.1111/j.1365-2036.2005.02555.x
24. Цуканов В.В., Черепнин М.А., Васютин А.В., и др. Эффективность рабепразола (Разо®) для лечения различных клинических вариантов ГЭРБ: результаты исследования GERBERA. Медицинский Совет. 2022;(7):28-35 [Tsukanov VV, Cherepnin MA, Vasyutin AV, et al. Efficacy of rabeprazole (Razo®) in the treatment of various clinical variants of GERD: results from the GERBERA study. Medical Council. 2022;(7):28-35 (in Russian)]. DOI:10.21518/2079-701X-2022-16-7-28-35
25. Saitoh T, Fukushima Y, Otsuka H, et al. Effects of rabeprazole, lansoprazole and omeprazole on intragastric pH in CYP2C19 extensive metabolizers. Aliment Pharmacol Ther. 2002;16(10):1811-7. DOI:10.1046/j.1365-2036.2002.01348.x
26. Ashida K, Kinoshita Y, Hongo M; Japan Rabeprazole Study Group for NERD. Acid-suppressive effect of rabeprazole 5 mg and 10 mg once daily by 24-hour esophageal pH monitoring in patients with non-erosive reflux disease in Japan: a multicenter, randomized, parallel-group, double-blind pharmacodynamic study. Dig Dis Sci. 2011;56(8):2333-42. DOI:10.1007/s10620-011-1583-4
27. Shimatani T, Inoue M, Kuroiwa T, et al. Acid-suppressive efficacy of a reduced dosage of rabeprazole: comparison of 10 mg twice daily rabeprazole with 20 mg twice daily rabeprazole, 30 mg twice daily lansoprazole, and 20 mg twice daily omeprazole by 24-hr intragastric pH-metry. Dig Dis Sci. 2005;50(7):1202-6. DOI:10.1007/s10620-005-2760-0
28. Zhang HJ, Zhang XH, Liu J, et al. Effects of genetic polymorphisms on the pharmacokinetics and pharmacodynamics of proton pump inhibitors. Pharmacol Res. 2020;152:104606. DOI:10.1016/j.phrs.2019.104606
29. Ichikawa H, Sugimoto M, Sugimoto K, et al. Rapid metabolizer genotype of CYP2C19 is a risk factor of being refractory to proton pump inhibitor therapy for reflux esophagitis. J Gastroenterol Hepatol. 2016;31(4):716-26. DOI:10.1111/jgh.13233
30. Miner PJr, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol. 2003;98(12):2616-20. DOI:10.1111/j.1572-0241.2003.08783.x
31. Morelli G, Chen H, Rossiter G, et al. An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers. Aliment Pharmacol Ther. 2011;33(7):845-54. DOI:10.1111/j.1365-2036.2011.04580.x
32. Li ZS, Zhan XB, Xu GM, et al. Effect of esomeprazole and rabeprazole on intragastric pH in healthy Chinese: an open, randomized crossover trial. J Gastroenterol Hepatol. 2007;22(6):815-20. DOI:10.1111/j.1440-1746.2006.04709.x
33. Robinson M, Maton PN, Rodriguez S, et al. Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1997;11(5):973-80. DOI:10.1046/j.1365-2036.1997.00244.x
34. Norris V, Baisley K, Dunn K, et al. Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers. Aliment Pharmacol Ther. 2007;25(4):501-10. DOI:10.1111/j.1365-2036.2006.03221.x
________________________________________________
2. Tsukanov VV, Kasparov EV, Onuchina EV, et al. The frequency and clinical aspects of extraesophageal syndromes in elderly patients with gastroesophageal reflux disease. Terapevticheskii Arkhiv (Ter. Arkh.). 2016;88(2):28-32 (in Russian). DOI:10.17116/terarkh201688228-32
3. Tsukanov VV, Onuchina EV, Vasiutin AV, et al. Clinical aspects of gastroesophageal reflux disease in elderly patients: Results of a 5-year prospective study. Terapevticheskii Arkhiv (Ter. Arkh.). 2014;86(2):23-6. Available at: https://ter-arkhiv.ru/0040-3660/article/view/31425. Accessed: 20.08.2024 (in Russian).
4. Gyawali CP, Yadlapati R, Fass R, et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024;73(2):361-71. DOI:10.1136/gutjnl-2023-330616
5. Argüero J, Sifrim D. Pathophysiology of gastro-oesophageal reflux disease: implications for diagnosis and management. Nat Rev Gastroenterol Hepatol. 2024;21(4):282-93. DOI:10.1038/s41575-023-00883-z
6. Davis TA, Gyawali CP. Refractory Gastroesophageal Reflux Disease: Diagnosis and Management. J Neurogastroenterol Motil. 2024;30(1):17-28. DOI:10.5056/jnm23145
7. Lakananurak N, Pitisuttithum P, Susantitaphong P, et al. The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies. Nutrients. 2024;16(3):464. DOI:10.3390/nu16030464
8. Ota K, Takeuchi T, Higuchi K, et al. Frontiers in Endoscopic Treatment for Gastroesophageal Reflux Disease. Digestion. 2024;105(1):5-10. DOI:10.1159/000533200
9. Tsukanov VV, Vasyutin AV, Tonkikh JL. Modern aspects of managing patients with non-erosive reflux disease. Medical Council. 2023;(18):28-33 (in Russian).
DOI:10.21518/ms2023-218
10. Bakulina NV, Tikhonov SV, Topalova YG, et al. Esophagoprotective therapy in patients with erosive esophagitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(8):985-91 (in Russian). DOI:10.26442/00403660.2022.08.201828
11. Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20. DOI:10.1111/j.1572-0241.2006.00630.x
12. Modlin IM, Hunt RH, Malfertheiner P, et al. Diagnosis and management of non-erosive reflux disease – the Vevey NERD Consensus Group. Digestion. 2009;80(2):74-88. DOI:10.1159/000219365
13. Modlin IM, Hunt RH, Malfertheiner P, et al. Non-erosive reflux disease – defining the entity and delineating the management. Digestion. 2008;78(Suppl. 1):1-5. DOI:10.1159/000151248
14. Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal Disorders. Gastroenterology. 2016;150(6):1380-92. DOI:10.1053/j.gastro.2016.02.011
15. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45(2):172-80. DOI:10.1136/gut.45.2.172
16. Jamieson JR, Stein HJ, DeMeester TR, et al. Ambulatory 24-h esophageal pH monitoring: normal values, optimal thresholds, specificity, sensitivity, and reproducibility. Am J Gastroenterol. 1992;87(9):1102-11. Available at: https://www.gastroscan.ru/literature/pdf/demeester1992-6.pdf. Accessed: 18.01.2024.
17. Frazzoni M, de Bortoli N, Frazzoni L, et al. Impedance-pH Monitoring for Diagnosis of Reflux Disease: New Perspectives. Dig Dis Sci. 2017;62(8):1881-9.
DOI:10.1007/s10620-017-4625-8
18. Miner PJr, Orr W, Filippone J, et al. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002;97(6):1332-9. DOI:10.1111/j.1572-0241.2002.05769.x
19. Kahrilas PJ, Miner P, Johanson J, et al. Efficacy of rabeprazole in the treatment of symptomatic gastroesophageal reflux disease. Dig Dis Sci. 2005;50(11):2009-18. DOI:10.1007/s10620-005-3000-3
20. Miwa H, Sasaki M, Furuta T, et al. Efficacy of rabeprazole on heartburn symptom resolution in patients with non-erosive and erosive gastro-oesophageal reflux disease: a multicenter study from Japan. Aliment Pharmacol Ther. 2007;26(1):69-77. DOI:10.1111/j.1365-2036.2007.03350.x
21. Cutler A, Robinson M, Murthy A, Delemos B. Rabeprazole 20 mg for erosive esophagitis-associated symptoms in a large, community-based study: additional results. Dig Dis Sci. 2010;55(2):338-45. DOI:10.1007/s10620-009-0864-7
22. Caos A, Moskovitz M, Dayal Y, et al. Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Rebeprazole Study Group. Am J Gastroenterol. 2000;95(11):3081-88. DOI:10.1111/j.1572-0241.2000.03179.x
23. Caos A, Breiter J, Perdomo C, Barth J. Long-term prevention of erosive or ulcerative gastro-oesophageal reflux disease relapse with rabeprazole 10 or 20 mg vs. placebo: results of a 5-year study in the United States. Aliment Pharmacol Ther. 2005;22(3):193-202. DOI:10.1111/j.1365-2036.2005.02555.x
24. Tsukanov VV, Cherepnin MA, Vasyutin AV, et al. Efficacy of rabeprazole (Razo®) in the treatment of various clinical variants of GERD: results from the GERBERA study. Medical Council. 2022;(7):28-35 (in Russian). DOI:10.21518/2079-701X-2022-16-7-28-35
25. Saitoh T, Fukushima Y, Otsuka H, et al. Effects of rabeprazole, lansoprazole and omeprazole on intragastric pH in CYP2C19 extensive metabolizers. Aliment Pharmacol Ther. 2002;16(10):1811-7. DOI:10.1046/j.1365-2036.2002.01348.x
26. Ashida K, Kinoshita Y, Hongo M; Japan Rabeprazole Study Group for NERD. Acid-suppressive effect of rabeprazole 5 mg and 10 mg once daily by 24-hour esophageal pH monitoring in patients with non-erosive reflux disease in Japan: a multicenter, randomized, parallel-group, double-blind pharmacodynamic study. Dig Dis Sci. 2011;56(8):2333-42. DOI:10.1007/s10620-011-1583-4
27. Shimatani T, Inoue M, Kuroiwa T, et al. Acid-suppressive efficacy of a reduced dosage of rabeprazole: comparison of 10 mg twice daily rabeprazole with 20 mg twice daily rabeprazole, 30 mg twice daily lansoprazole, and 20 mg twice daily omeprazole by 24-hr intragastric pH-metry. Dig Dis Sci. 2005;50(7):1202-6. DOI:10.1007/s10620-005-2760-0
28. Zhang HJ, Zhang XH, Liu J, et al. Effects of genetic polymorphisms on the pharmacokinetics and pharmacodynamics of proton pump inhibitors. Pharmacol Res. 2020;152:104606. DOI:10.1016/j.phrs.2019.104606
29. Ichikawa H, Sugimoto M, Sugimoto K, et al. Rapid metabolizer genotype of CYP2C19 is a risk factor of being refractory to proton pump inhibitor therapy for reflux esophagitis. J Gastroenterol Hepatol. 2016;31(4):716-26. DOI:10.1111/jgh.13233
30. Miner PJr, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol. 2003;98(12):2616-20. DOI:10.1111/j.1572-0241.2003.08783.x
31. Morelli G, Chen H, Rossiter G, et al. An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers. Aliment Pharmacol Ther. 2011;33(7):845-54. DOI:10.1111/j.1365-2036.2011.04580.x
32. Li ZS, Zhan XB, Xu GM, et al. Effect of esomeprazole and rabeprazole on intragastric pH in healthy Chinese: an open, randomized crossover trial. J Gastroenterol Hepatol. 2007;22(6):815-20. DOI:10.1111/j.1440-1746.2006.04709.x
33. Robinson M, Maton PN, Rodriguez S, et al. Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1997;11(5):973-80. DOI:10.1046/j.1365-2036.1997.00244.x
34. Norris V, Baisley K, Dunn K, et al. Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers. Aliment Pharmacol Ther. 2007;25(4):501-10. DOI:10.1111/j.1365-2036.2006.03221.x
Авторы
В.В. Цуканов*1, Е.В. Онучина2, А.В. Васютин1, Б.Б. Дамбаева2, Ю.Л. Тонких1, Н.В. Павлова3
1ФГБНУ «Федеральный исследовательский центр “Красноярский научный центр”» СО РАН, Красноярск, Россия;
2Иркутская государственная медицинская академия последипломного образования – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Иркутск, Россия;
3ООО «Др. Редди’c Лабораторис», Москва, Россия
*gastro@impn.ru
1Federal Research Center “Krasnoyarsk Science Center”, Krasnoyarsk, Russia;
2Irkutsk State Medical Academy of Postgraduate Education – Branch of the Russian Medical Academy of Continuous Professional Education, Irkutsk, Russia;
3Dr. Reddy’s Laboratories Ltd, Moscow, Russia
*gastro@impn.ru
1ФГБНУ «Федеральный исследовательский центр “Красноярский научный центр”» СО РАН, Красноярск, Россия;
2Иркутская государственная медицинская академия последипломного образования – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Иркутск, Россия;
3ООО «Др. Редди’c Лабораторис», Москва, Россия
*gastro@impn.ru
________________________________________________
1Federal Research Center “Krasnoyarsk Science Center”, Krasnoyarsk, Russia;
2Irkutsk State Medical Academy of Postgraduate Education – Branch of the Russian Medical Academy of Continuous Professional Education, Irkutsk, Russia;
3Dr. Reddy’s Laboratories Ltd, Moscow, Russia
*gastro@impn.ru
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