Effectiveness of mebeverine in patients with post-cholecystectomy gastrointestinal spasm: results of prospective observational program “odyssey”

  • Authors: Maev IV1, Kucheravy Y.A1, Tsukanov VV2, Eremnia EY.3, Andreev DN1, Abdulhakov SR4,5, Akhmedov VA6, Batskov SS7, Vasyutin AV2, V’yuchnova ES1, Ivanchenko DN8, Luzina EV9, Krapivnaya OV10, Onuchina EV11, Osipenko MF12, Simanenkov VI13, Tonkih Y.L2, Khomeriki NM14, Shklyaev AE15, Akimov AV16, Sokolov KA16
  • Affiliations:
    1. A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia
    2. Federal Research Centre “Krasnoyarsk Science Centre” of the Siberian Branch of Russian Academy of Science”(FRC KSC SB RAS), Scientific Research Institute of medical problems of the North (SRI MPN)
    3. N.P. Ogarev National Research Mordovia State University
    4. Kazan State Medical Univesity, Ministry of Health of Russia
    5. Kazan Federal University
    6. Omsk State Medical Univesity, Ministry of Health of Russia
    7. A.M. Nikiforov All-Russian Center for Emergency and Radiation Medicine, Russian Ministry for Emergency Situations
    8. Rostov State Medical University, Ministry of Health of Russia
    9. Chita State Medical Academy, Ministry of Health of Russia
    10. Road Clinical Hospital at Khabarovsk-1 station of OAO RzhD
    11. Irkutsk State Medical Academy for Postgraduate Education - affiliated branch of Russian Medical Academy of Continuous Professional Training, Ministry of Health of Russia
    12. Novosibirsk State Medical University, Ministry of Health of Russia
    13. I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia
    14. Hospital of Pushchino Scientific Center
    15. Izhevsk State Medical Academy, Ministry of Health of Russia
    16. Abbott Laboratories
  • Issue: Vol 90, No 8 (2018)
  • Pages: 40-47
  • Section: Editorial
  • URL: https://journals.rcsi.science/0040-3660/article/view/32782
  • DOI: https://doi.org/10.26442/terarkh201890840-47
  • ID: 32782

Cite item

Full Text

Abstract

Aim: to assess the effectiveness of mebeverine 200 mg BID in patients with post-cholecystectomy gastrointestinal spasm not requiring surgical treatment. Materials and methods. 218 patients were included in 16 clinical centers in 14 cities in Russia. All patients had post-cholecystectomy gastrointestinal spasms, not requiring surgical treatment and received mebeverine (Duspatalin®) 200 mg BID. The observational assessment period lasted from the moment of their inclusion into the study up to 6 weeks post inlusion. The therapy results were evaluated using visual analog scales (GPA and 11-point numeric rating scale) by patient self-assessment of the dynamics of spasm/discomfort and other post-cholecystectomic gastrointestinal symptoms after 2 and 6 weeks of treatment. Gastrointestinal Quality of Life Index (GIQLI) was used to assess patient quality of life. Results and discussion. All 218 patients completed the 2-week mebeverine treatment course, 101 of them finished the 6-week course (“prolonged population”). Significant positive changes in the relief of abdominal pain and dyspepsia were noted as well as normalization of stool frequency and consistency. A more marked change in values was observed during prolonged (up to 6 weeks) therapy. Both 2-week and 6-week mebeverine courses led to a normalization of patient quality of life. After 6 week therapy, an effect of mebeverine on the quality of life 91% of patients was observed comparable to cholecystectomy itself, speficially related to the quality of life subscore ‘symptoms’. Conclusion. The results of our study demonstrate that mebeverine (Duspatalin®) therapy leads to an effective elimination of clinical symptoms associated with post-cholecystectomy GI-spasm disorders, like abdominal pain, symptoms of dyspepsia and stooldisorders. A more marked change in values was observed during prolonged (up to 6 weeks) therapy.

About the authors

I V Maev

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

акад. РАН, д.м.н., проф., зав. каф. пропедевтики внутренних болезней и гастроэнтерологии лечебного факультета МГМСУ им. А.И. Евдокимова

Yu A Kucheravy

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

Email: proped@mail.ru
к.м.н., доц. каф. пропедевтики внутренних болезней и гастроэнтерологии лечебного факультета МГМСУ им. А.И. Евдокимова

V V Tsukanov

Federal Research Centre “Krasnoyarsk Science Centre” of the Siberian Branch of Russian Academy of Science”(FRC KSC SB RAS), Scientific Research Institute of medical problems of the North (SRI MPN)

д.м.н., проф., зав. клин. отд-нием патологии пищеварительной системы у взрослых и детей НИИ медицинских проблем Севера, ФИЦ КНЦ СО РАН

E Yu Eremnia

N.P. Ogarev National Research Mordovia State University

д.м.н., проф., зав. каф. пропедевтики внутренних болезней Мордовского государственного университета им. Н.П. Огарева, дир. Гастроэнтерологического центра МГУ им. Н.П. Огарева, спей-эксперт Минздрава Республики Мордовия по гастроэнтерологии

D N Andreev

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

к.м.н., ассистент каф. пропедевтики внутренних болезней и гастроэнтерологии МГМСУ им. А.И. Евдокимова

S R Abdulhakov

Kazan State Medical Univesity, Ministry of Health of Russia; Kazan Federal University

к.м.н., с.н.с. OpenLab «Генные и клеточные технологии» ИФМиБ, Казанский (Приволжский) федеральный университет; доц. Казанского ГМУ

V A Akhmedov

Omsk State Medical Univesity, Ministry of Health of Russia

д.м.н., проф., зав. каф. мед. реабилитации ДПО ЦПК и ППС Омской ГМА

S S Batskov

A.M. Nikiforov All-Russian Center for Emergency and Radiation Medicine, Russian Ministry for Emergency Situations

д.м.н., проф., начальник клинического отд. гастроэнтерологии и гепатологии ВЦЭРМ им. А.М. Никифорова

A V Vasyutin

Federal Research Centre “Krasnoyarsk Science Centre” of the Siberian Branch of Russian Academy of Science”(FRC KSC SB RAS), Scientific Research Institute of medical problems of the North (SRI MPN)

к.м.н., с.н.с. клинического отд-ния патологии пищеварительной системы у взрослых и детей НИИ медицинских проблем Севера, ФИЦ КНЦ СО РАН

E S V’yuchnova

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

к.м.н., зав. гастроэнтерологическим отд-нием ЦКБ №1 ОАО «РЖД», доц. каф. пропедевтики внутренних болезней и гастроэнтерологии леч. факультета МГМСУ им. А.И. Евдокимова

D N Ivanchenko

Rostov State Medical University, Ministry of Health of Russia

к.м.н., ассистент каф. терапии ФПК и ППС Ростовского ГМУ

E V Luzina

Chita State Medical Academy, Ministry of Health of Russia

к.м.н., доц. каф. терапии ФПК ППС Читинской ГМА

O V Krapivnaya

Road Clinical Hospital at Khabarovsk-1 station of OAO RzhD

д.м.н., зав. гастроэнтерологическим отд-нием Дорожной клинической больницы на станции Хабаровск-1 ОАО «РЖД»

E V Onuchina

Irkutsk State Medical Academy for Postgraduate Education - affiliated branch of Russian Medical Academy of Continuous Professional Training, Ministry of Health of Russia

д.м.н., проф. каф. терапии и кардиологии терапевтического факультета Иркутской ГМАПО

M F Osipenko

Novosibirsk State Medical University, Ministry of Health of Russia

д.м.н., проф., зав. каф. пропедевтики внутренних болезней лечебного факультета Новосибирского ГМУ

V I Simanenkov

I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia

д.м.н., проф., зав. каф. терапии и клинической фармакологии Северо-Западного ГМУ им. И.И. Мечникова

Yu L Tonkih

Federal Research Centre “Krasnoyarsk Science Centre” of the Siberian Branch of Russian Academy of Science”(FRC KSC SB RAS), Scientific Research Institute of medical problems of the North (SRI MPN)

к.м.н., в.н.с. клинического отд-ния патологии пищеварительной системы у взрослых и детей НИИ медицинских проблем Севера, ФИЦ КНЦ СО РАН

N M Khomeriki

Hospital of Pushchino Scientific Center

к.м.н., врач-гастроэнтеролог Больницы Пущинского научного центра РАН

A E Shklyaev

Izhevsk State Medical Academy, Ministry of Health of Russia

д.м.н., проф. каф. факультетской терапии, проректор по научной работе Ижевской ГМА

A V Akimov

Abbott Laboratories

менеджер по медицинским вопросам ООО «Эбботт»

K A Sokolov

Abbott Laboratories

менеджер по медицинским вопросам ООО «Эбботт»

References

  1. Ивашкин В.Т., Маев И.В., Баранская Е.К. и др. Рекомендации Российской гастроэнтерологической ассоциации по диагностике и лечению желчнокаменной болезни. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2016;26(3):64-80.
  2. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016;65(1):146-181.
  3. Hauser S.C, ed. Mayo Clinic gastroenterology and hepatology board review. 5th ed. Oxford University Press; 2015. 425 p.
  4. Wang D.Q, Afdhal N.H. Gallstone 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.
  5. Ros E, Zambon D. Postcholecystectomy symptoms. A prospective study of gall stone patients before and two years after surgery. Gut. 1987;28(11):1500-1504.
  6. Finan K.R, Leeth R.R, Whitley B.M, Klapow J.C, Hawn M.T. Improvement in gastrointestinal symptoms and quality of life after cholecystectomy. Am J Surg. 2006;192(2):196-202.
  7. Weinert C.R, Arnett D, Jacobs D. Jr, Kane R.L. Relationship between persistence of abdominal symptoms and successful outcome after cholecystectomy. Arch Intern Med. 2000;160(7):989-995.
  8. Еремина Е.Ю. Желчнокаменная болезнь: до и после холецистэктомии. Методические указания для врачей. Саранск; 2014.
  9. Арутюнов Г.П., Мартынов А.И., Спасский А.А. Руководство по внутренней медицине. Москва; 2015.
  10. Kennedy T.M, Jones R.H. Epidemiology of cholecystectomy and irritable bowel syndrome in a UK population. Br J Surg. 2000;87:1658-1663.
  11. Kirk G, Kennedy R, Mc Kie L, et al. Preoperative symptoms of irritable bowel syndrome predict poor outcome after laparoscopic cholecyst - ecomy. Surg Endosc. 2011;25:3379-3384.
  12. Yamada T, ed. Textbook of gastroenterology. 2nd ed. Philadelphia: Lippincott; 1995.
  13. Zhou P.H, Liu F.L, Yao L.Q, Qin X.Y. Endoscopic diagnosis and treatment of postcholecystectomy syndrome. Hepatobil Pancreat Dis Int. 2003;2:117-120.
  14. Jaunoo S.S, Mohandas S, Almond L.M. Postcholecystectomy syndrome (PCS). Int J Surg. 2010;8(1):15-17.
  15. Минушкин О.Н. Синдром после холецистэктомии в практике терапевта и гастроэнтеролога. Лечащий врач. 2015;(2):40-6.
  16. Jensen S.W. Postcholecystectomy Syndrome Clinical Presentation. In.: MedScape. 2016. Available from: https://emedicine.medscape.com/article/192761-clinical
  17. Filip M, Saftoiu A, Popescu C, Gheonea D.I, Iordache S, Sandulescu L, Ciurea T. Postcholecystectomy Syndrome - an Algoritmic Approach. J Gastrointestin Liv Dis. 2009;18(1):67-71.
  18. Трухан Д.И., Викторова И.А., Лялюкова Е.А. Болезни желчного пузыря и желчевыводящих путей. Санкт-Петербург: СпецЛит; 2011. 127 с.
  19. Ильченко А.А. Болезни желчного пузыря и желчных путей: Руководство для врачей. 2-е изд., переработ. и доп. Москва: Медицинское информационное агентство; 2011. 880 с.
  20. Ильченко А.А., Быстровская Е.В. Опыт применения Дюспаталина при функциональных нарушениях сфинктера Одди у больных, перенесших холецистэктомию. Экспериментальная и клиническая гастроэнтерология. 2002;(4):21-22.
  21. Мовчун В.А., Ардатская М.Д., Исакова О.В., Липницкий Е.М Эффективность дюспаталина в лечении и профилактике постхолецистэктомического синдрома. Вестник Российской Академии медицинских наук. 2011;(1):7-11.
  22. Drossman D.A. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-1390.
  23. Shi H.Y.1, Lee K.T, Lee H.H, Uen Y.H,et al. The minimal clinically important difference in the Gastrointestinal Quality - of-Life Index after cholecystectomy. Surg Endosc. 2009;23(12):2708-2712.
  24. Lamberts M.P, Lugtenberg M, Rovers M.M, Roukema A.J, Drenth J.P, Westert G.P, van Laarhoven C.J. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-718.
  25. Гриднева С.В. Дисфункция сфинктера Одди после холецистэктомии: механизмы развития и тактика лечения. Сучасна гастроентерологія. 2015;3(83):122-127.
  26. Fisher M et al. Diarrhoea after laparoscopic cholecystectomy: incidence and main determinants. ANZ J Surg. 2008;78:482-486.
  27. Кучерявый Ю.А., Селезнева Э.Я., Котовский А.Е. и др. Состояние после холецистэктомии: хирург, терапевт, пациент. Отчет экспертного совета по вопросам постхолецистэктомических расстройств. Фарматека. 2013;20:64-68.
  28. Kulkarni A. Sphincter of Oddi dysfunction. Pract Gastroenterol. 2010;March:28-41.
  29. Kalaitzakis E, Ambrose T, et al. Management of patients with biliary sphincter of Oddi disorder without sphincter of Oddi manometry. BMC Gastroenterol. 2010 Oct 22;10:124. doi: 10.1186/1471-230X-10-124
  30. Khuroo M.S, et al. Efficacy of nifedipine therapy in patients with sphincter of Oddi dysfunction: a prospective, double - blind, randomized, placebo - controlled, cross - over trial. Br J Clin Pharmac. 1992;33:477-485.
  31. Федеральное руководство по использованию лекарственных средств (формулярная система). Выпуск ХVIII. Москва: Видокс; 2017.
  32. Рыжичкина А.Н., Осипенко М.Ф., Холин С.И. Хроническая абдоминальная боль и синдром раздраженного кишечника. Лечащий врач. 2011;(2):30-34.
  33. Cash B.D, Lacy B.E, Schoenfeld P.S. Safety of Eluxadoline in Patients with Irritable Bowel Syndrome with Diarrhea. Am J Gastroenterol. 2017;112:365-374. doi: 10.1038/ajg.2016.542
  34. Инструкция по медицинскому примению препарата Тримедат®. Таблетки 100 мг, 200 мг, от 20.03.2017.
  35. Хубутия М.Ш., Попова Т.С., Салтанов А.И., редакторы. Парентеральное и энтеральное питание: Национальное руководство. Москва: ГЭОТАР-Медиа; 2014. 800 с. ISBN 978-5-9704-2853-5
  36. FDA Safety Alerts for Human Medicinal Products. Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder. Posted 03/15/2017.
  37. Lindner A, Seizer H, Claassen V, et al. Pharmacological properties of mebeverine, a smooth - muscle relaxant. Arch Int Pharmacodyn. 1963;145(3):378-395.
  38. Evans P, Bak Y, Kellow J. Mebeverine altered small bowel motility in irritable bowel syndrome. Aliment Pharmacol Ther. 1996;5:787-793.
  39. Den Hertog A, Van den Akker J. Modification of a1-receptor channels by mebeverine in smooth muscle cells of guinea pig taenia caeci. Eur J Pharm. 1987;138:367-374.
  40. Stockis A, et al. Identification of mebeverine acid as the main circulating metabolite of mebeverine in man. J Pharm Biomed Anal. 2002;29:335-340.
  41. Abdel-Hamid S.M, Abdel-Hady S.E, El-Shamy, et al. Formulation of an antispasmodic drug as a topical local anestetic. Int J Pharm. 2006;326:107-118.

Copyright (c) 2018 Consilium Medicum

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
 
 


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies