Evaluation of the efficacy and safety of the hybrid scheme for eradication therapy of Helicobacter pylori infection


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Abstract

The aim is to conduct a comprehensive comparative study of the efficacy and safety of the hybrid scheme of eradication therapy (ET) in patients with peptic ulcer of the stomach or duodenum associated with Helicobacter pylori. Materials and methods. In a prospective, randomized comparative study, 180 patients were divided into three equal groups of 60 people, depending on the prescribed 10-day ET regimen. Group 1 - the standard triple scheme (omeprazole, amoxicillin and clarithromycin); group 2 - four-component therapy with preparations of bismuth (omeprazole, tetracycline, metronidazole, bismuth tricalium dicitrate); group 3 - hybrid scheme (first 5 days: omeprazole and amoxicillin, the next 5 days: omeprazole, amoxicillin, clarithromycin, metronidazole). The effectiveness of ET was determined with the help of a breath test a month after the end of therapy. Adverse events were recorded by patients in specially developed diaries. Pharmacoeconomic analysis was carried out using the "cost-effectiveness" method with calculation of the CER coefficient. Results and discussion. The effectiveness of standard triple therapy was 73.3% (ITT), 75.9% (PP); four-component therapy with bismuth preparations - 78.3% (ITT), 82.4% (PP); hybrid scheme - 85% (ITT), 91% (PP). Hybrid therapy proved to be significantly more effective than standard triple therapy with a odds ratio (OR) of 3.25; 95% confidence interval (CI) 1.08-9.73 (p=0.043, χ2=4.75, p-level=0.029298). The incidence of adverse events with the use of triple, four-component and hybrid ET regimens was 15; 18.3 and 28.3% respectively. The OR of at least one adverse event in patients receiving a hybrid ET regimen compared with triple therapy was 2.24 (95% CI 0.91-5.53, p=0.0823, χ2=3.14, p-level=0.076394), and compared with the four-component therapy - 1.76 (95% CI 0.74-4.17, p=0.2804, χ2=1.68, p-level=0.194924). According to the results of the pharmacoeconomic analysis, the most profitable from an economic point of view was a hybrid ET scheme with a CER of 20.1. The conclusion. Hybrid therapy showed the greatest effectiveness in comparison with the triple and four-component ET regimens, however, the incidence of side effects in patients receiving the hybrid ET scheme was higher, although it remained within the acceptable level for use in clinical practice. Pharmacoeconomic analysis also showed the advisability of designating a hybrid ET scheme. The obtained data allow to draw a conclusion about the necessity of further study of the efficiency and safety of the hybrid ET scheme.

About the authors

G L Yurenev

A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia

д.м.н., проф. каф. пропедевтики внутренних болезней и гастроэнтерологии Moscow, Russia

E V Partzvania-Vinogradova

A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia

аспирант каф. пропедевтики внутренних болезней и гастроэнтерологии Moscow, Russia

D N Andreev

A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia

Email: dna-mit8@mail.ru
к.м.н., ассистент каф. пропедевтики внутренних болезней и гастроэнтерологии, н.с. лаб. функциональных методов исследования в гастроэнтерологии Moscow, Russia

D T Dicheva

A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia

к.м.н., доц. каф. пропедевтики внутренних болезней и гастроэнтерологии Moscow, Russia

I V Maiev

A.I. Evdokimov Moscow State Medicine and Dentistry, University of the Ministry of Health of Russia

д.м.н., проф., акад. РАН, зав. каф. пропедевтики внутренних болезней и гастроэнтерологии Moscow, Russia

References

  1. Маев И.В., Самсонов А.А., Андреев Д.Н. Болезни желудка. Москва: ГЭОТАР-Медиа; 2015 [.
  2. Ивашкин В.Т., Шептулин А.А., Маев И.В., Баранская Е.К., Трухманов А.С., Лапина Т.Л., Бурков С.Г., Калинин А.В., Ткачев А.В. Клинические рекомендации Российской гастроэнтерологической ассоциации по диагностике и лечению язвенной болезни. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2016; 26(6):40-54.
  3. Chan F.K, Lau J.Y. Peptic Ulcer Disease. In: Feldman M, Friedman L.S, Brandt L.J, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Elsevier; 2015.
  4. Андреев Д.Н., Оганесян Т.С., Кучерявый Ю.А., Андреев Н.Г. Язвенная болезнь желудка и двенадцатиперстной кишки: диагностика и лечение. Справочник поликлинического врача. 2014;(10):42-44.
  5. Lanas A, Chan F.K. Peptic ulcer disease. Lancet. 2017;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7
  6. Маев И.В., Самсонов А.А., Андреев Д.Н. Инфекция Helicobacter pylori. Москва: ГЭОТАР-Медиа; 2016. C. 256.
  7. 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.
  8. Kusters J.G, van Vliet A.H, Kuipers E.J. Pathogenesis of Helicobacter pylori infection. Clin. Microbiol Rev. 2006;19(3):449-490. doi: 10.1128/ CMR.00054-05
  9. Malfertheiner P, Megraud F, O’Morain C.A, Gisbert J.P, Kuipers E.J, Axon A.T, Bazzoli F, Gasbarrini A, Atherton J, Graham D.Y, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar E.M. Management of Helicobacter pylori infection - the Maastricht V/Florence Consensus Report. Gut. 2017;66(1):6-30. doi: 10. 1136/gutjnl-2016-312288
  10. Venerito M, Krieger T, Ecker T, Leandro G, Malfertheiner P. Meta - analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion. 2013;88(1):33-45. doi: 10.1159/000350719
  11. Feng L, Wen M.Y, Zhu Y.J, Men R.T, Yang L. Sequential Therapy or Standard Triple Therapy for Helicobacter pylori Infection: An Updated Systematic Review. Am J Ther. 2016;23(3):880-893. doi: 10.1097/MJT. 0000000000000191
  12. Puig I, Baylina M, Sánchez-Delgado J, López-Gongora S, Suarez D, García-Iglesias P, Muñoz N, Gisbert J.P, Dacoll C, Cohen H, Calvet X. Systematic review and meta - analysis: triple therapy combining a proton - pump inhibitor, amoxicillin and metronidazole for Helicobacter pylori first - line treatment. J Antimicrob Chemother. 2016;71(10):2740-2753. doi: 10.1093/jac/dkw220
  13. Андреев Д.Н., Маев И.В., Кучерявый Ю.А., Дичева Д.Т., Парцваниа-Виноградова Е.В. Эффективность и безопасность антихеликобактерной терапии у пациентов с сопутствующим хроническим гепатитом С. Терапевтический архив. 2016;88(4):75-81. doi: 10.17116/terarkh201688475-81
  14. Самсонов А.А., Гречушников В.Б., Андреев Д.Н., Юренев Г.Л., Коровина Т.И., Лежнева Ю.А., Маев И.В. Оценка фармакоэкономических показателей лечения пациентов с заболеваниями, ассоциированными с Helicobacter pylori. Терапевтический архив. 2014;(8):57-61.
  15. Luther J, Higgins P.D, Schoenfeld P.S, Moayyedi P, Vakil N, Chey W.D. Empiric quadruple vs. triple therapy for primary treatment of Helicobacter pylori infection: Systematic review and meta - analysis of efficacy and tolerability. Am J Gastroenterol. 2010;105(1):65-73. doi: 10.1038/ajg.2009.508
  16. Маев И.В., Андреев Д.Н. Молекулярно - генетические предикторы резистентности к антихеликобактерной терапии. Терапевтический архив. 2017;89(8):5-12. doi: 10.17116/terarkh20178985-12
  17. 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
  18. Maev I.V, Andreev D.N, Kucheryavyi Yu.A, Dicheva D.T. Host factors influencing the eradication rate of Helicobacter pylori. World Applied Sci J. 2014;30:134-140. doi: 10.5829/idosi.wasj.2014.30.mett.61
  19. Hsu P.I, Wu D.C, Wu J.Y, Graham D.Y. Modified sequential Helicobacter pylori therapy: Proton pump inhibitor and amoxicillin for 14 days with clarithromycin and metronidazole added as a quadruple (hybrid) therapy for the final 7 days. Helicobacter. 2011;16:139-145. doi: 10.1111/ j.1523-5378.2011.00828.x
  20. Юренев Г.Л., Андреев Д.Н., Парцваниа-Виноградова Е.В., Дичева Д.Т. Гибридная схема эрадикационной терапии инфекции Helicobacter pylori: систематизация литературных данных. Фарматека. 2017;335(2):71-74.
  21. Gisbert J.P, Calvet X, O’Connor J.P, Mégraud F, O’Morain C.A. The sequential therapy regimen for Helicobacter pylori eradication. Expert Opin Pharmacother. 2010;11:905-918. doi: 10.1517/14656561 003657152
  22. Song Z.Q, Liu J, Zhou L.Y. Hybrid Therapy Regimen for Helicobacter Pylori Eradication. Chin Med J (Engl). 2016;129(8):992-999. doi: 10.4103/0366-6999.179803
  23. 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):94-99.
  24. 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. doi: 10.17116/terarkh201789284-90
  25. Lee J.Y, Park K.S. Optimal First-Line Treatment for Helicobacter pylori Infection: Recent Strategies. Gastroenterol Res Pract. 2016;2016: 9086581. doi: 10.1155/2016/9086581
  26. Cuadrado-Lavín A, Salcines-Caviedes J.R, Diaz-Perez A, Carrascosa M.F, Ochagavía M, Fernandez-Forcelledo J.L, Cobo M, Fernández-Gil P, Ayestarán B, Sánchez B, Campo C, Llorca J, Lorenzo S, Illaro A. First - line eradication rates comparing two shortened non - bismuth quadruple regimens against Helicobacter pylori:An open - label, randomized, multicentre clinical trial. J Antimicrob Chemother. 2015;70:2376-2381. doi: 10.1093/jac/dkv089
  27. Hsu P.I, Lin P.C, Graham D.Y. Hybrid therapy for Helicobacter pylori infection: A systemic review and meta - analysis. World J Gastroenterol. 2015;21(45):12954-12962. doi: 10.3748/wjg.v21.i45.12954
  28. Song Z.Q, Zhou L.Y. Hybrid, sequential and concomitant therapies for Helicobacter pylori eradication: A systematic review and meta - analysis. World J Gastroenterol. 2016;22(19):4766-4775. doi: 10.3748/wjg. v22.i19.4766
  29. Andreev D. Helicobacter pylori Eradication Therapy: Current Regimens. Adv Res Gastroentero Hepatol. 2017;7(2):555710. doi: 10.19080/ARGH. 2017.07.555710
  30. Li B.Z, Threapleton D.E, Wang J.Y, Xu J.M, Yuan J.Q, Zhang C, Li P, Ye Q.L, Guo B, Mao C, Ye D.Q. Comparative effectiveness and tolerance of treatments for Helicobacter pylori: systematic review and network meta - analysis. BMJ. 2015;351:h4052. doi: 10.1136/bmj.h4052
  31. Бурбелло А.Т., Бабак C.В., Андреев Б.В., Колбин А.С., Горячкина К.А. Неблагоприятные побочные реакции лекарственных средств (пособие для врачей). Санкт-Петербург; 2008.
  32. Андреев Д.Н., Маев И.В., Дичева Д.Т., Кучерявый Ю.А. Комплексная оценка безопасности двух режимов эрадикационной терапии инфекции Helicobacter pylori у пациентов с хроническим гепатитом C. Фарматека. 2016;(2):19-22.
  33. Андреев Д.Н., Маев И.В., Самсонов А.А., Лобанова Е.Г., Парцваниа-Виноградова Е.В. Безопасность эрадикационной терапии инфекции Helicobacter pylori: систематизация литературных данных. Фарматека. 2017;13:71-79.
  34. Lv Z, Wang B, Zhou X, Wang F, Xie Y, Zheng H, Lv N. Efficacy and safety of probiotics as adjuvant agents for Helicobacter pylori infection: A meta - analysis. Exp Ther Med. 2015;9(3):707-716. oi: 10.3892/etm.2015.2174
  35. 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;140(4):103-110.

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