nogrЭкспериментальная и клиническая гастроэнтерологияExperimental and Clinical Gastroenterology1682-8658«Global Media Technologies»10.31146/1682-8658-ecg-190-6-57-62nogr-1676Research ArticleКЛИНИЧЕСКАЯ ГАСТРОЭНТЕРОЛОГИЯCLINICAL GASTROENTEROLOGYЭффективность и безопасность Lactobacillus paracasei CNCM I-1572 и фруктоолигосахаридов в лечении больных СРК с запоромEfficacy and safety of Lactobacillus paracasei CNCM I-1572 and fructo- oligosaccharides in the treatment of patients with irritable bowel syndrome with constipationХлыновИ. Б.KhlinovI. B.

Хлынов Игорь Борисович, д. м. н., доцент кафедры факультетской терапии и гериатрии

г. Екатеринбург, ул. Репина, 3, 620219

Igor B. Khlinov, MD, assistant professor of intermediate therapy and geriatrics department

Russian Federation, 620028, Ekaterinburg, 3 Repina St.

hlinov.doc@yandex.ruХлыноваР. И.KhlynovaR. I.

Хлынова Регина Игоревна, Ассистент кафедры факультетской терапии и гериатрии

г. Екатеринбург, ул. Репина, 3, 620219

Regina I. Khlynova, Assistant of intermediate therapy and geriatrics department

Russian Federation, 620028, Ekaterinburg, 3 Repina St.

ВороноваЕ. И.VoronovaE. I.

Воронова Елена Ивановна, Врач-гастроэнтеролог

г. Екатеринбург, ул. Шейнкмана, 113, 620144

Elena I. Voronova, Gastroenterologist

620144, Ekaterinburg, 113 Sheinkmana st.

ГаранинаЕ. В.GaraninaE. V.

Гаранина Елена Владиславовна, к. м. н., врач-гастроэнтеролог

г. Екатеринбург, ул. Шейнкмана, 113, 620144

Elena V. Garanina, PhD, gastroenterologist

620144, Ekaterinburg, 113 Sheinkmana st.

ГуриковаИ. А.GurikovaI. A.

Гурикова Ирина Анатольевна, к. м. н., врач-гастроэнтеролог

г. Екатеринбург, ул. Шейнкмана, 113, 620144

Irina A. Gurikova, PhD, gastroenterologist

620144, Ekaterinburg, 113 Sheinkmana st.

КобзарьТ. И.KobzarT. I.

Кобзарь Татьяна Ивановна, Врач-гастроэнтеролог

г. Екатеринбург, ул. Военная, 22, 620109

Tatiana I. Kobzar, gastroenterologist

Yekaterinburg, st. Military, 22, 620109

ЛосеваМ. Э.LosevaM. E.

Лосева Марина Эдуардовна, Врач-гастроэнтеролог

г. Екатеринбург, ул. Заводская, 29, 620109

Marina E. Loseva, Gastroenterologist

Russian Federation, 620109, Ekaterinburg, 29 Zavodskaya st.

ОдинецС. В.OdinetsS. V.

Одинец Светлана Владимировна, Врач-гастроэнтеролог

г. Екатеринбург, ул. Заводская, 32/2, 620131

Svetlana V. Odinets, Gastroenterologist

Russian Federation, 620131, Ekaterinburg, 32/2 Zavodskaya st.

РябининаО. А.RyabininaO. A.

Рябинина Ольга Альбертовна, Врач-гастроэнтеролог

г. Екатеринбург, ул. Волгоградская, 189, 620102

Olga A. Ryabinina, Gastroenterologist

Russian Federation, 620102, Ekaterinburg, 189 Volgogradskaya st.

СагутдиноваЛ. Т.SagutdinovaL. T.

Сагутдинова Лилия Тагировна, врач-гастроэнтеролог

г. Екатеринбург, ул. Кузнечная, 83, 620075

Liliya T. Sagutdinova, gastroenterologist

Russian Federation, 620075, Ekaterinburg, 83 Kuznechnaya st.

ФрезеЕ. Б.FrezeE. B.

Фрезе Елена Борисовна, к. м. н., врач-гастроэнтеролог

г. Екатеринбург, ул. Кузнечная, 83, 620075

Elena B. Freze, PhD, gastroenterologist

Russian Federation, 620075, Ekaterinburg, 83 Kuznechnaya st.

ФГБОУ ВО «Уральский государственный медицинский университет» Минздрава РоссииРоссияUral State Medical UniversityRussian FederationЕвропейский медицинский центр «УГМК-Здоровье»РоссияEuropean Medical Center “UMMC-Health” Russian FederationRussian FederationМедицинский центр «Консилиум»Россияmedical center “Consilium”Russian FederationМедицинское объединение «Новая больница»РоссияMedical Association “New Hospital”Russian FederationМедицинский центр «Парацельс»РоссияMedical Center “Paracelsus”Russian Federation«Городская клиническая больница № 40»РоссияCity Clinical Hospital № 40Russian FederationМногопрофильная клиника «Здоровье-365»РоссияMultidisciplinary clinic “Health-365”Russian Federation202131082021165762Copyright © Хлынов И.Б., Хлынова Р.И., Воронова Е.И., Гаранина Е.В., Гурикова И.А., Кобзарь Т.И., Лосева М.Э., Одинец С.В., Рябинина О.А., Сагутдинова Л.Т., Фрезе Е.Б., 20212021Хлынов И.Б., Хлынова Р.И., Воронова Е.И., Гаранина Е.В., Гурикова И.А., Кобзарь Т.И., Лосева М.Э., Одинец С.В., Рябинина О.А., Сагутдинова Л.Т., Фрезе Е.Б.Khlinov I.B., Khlynova R.I., Voronova E.I., Garanina E.V., Gurikova I.A., Kobzar T.I., Loseva M.E., Odinets S.V., Ryabinina O.A., Sagutdinova L.T., Freze E.B.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.nogr.org/jour/article/view/1676

Цель исследования — оценить эффективность и безопасность сочетанного применения спазмолитика и синбиотика (Lactobacillus paracasei CNCM I-1572 в комбинации с фруктоолигосахаридами) у больных синдромом раздраженного кишечника с запором.

Материалы и методы — проспективное рандомизированное контролируемое исследование 80 больных синдромом раздраженного кишечника с запором. Больные в основной группе (40 человек) принимали мебеверина гидрохлорид 200 мг 2 раза в день и синбиотик (5х109 КОЕ Lactobacillus paracasei CNCM I-1572 и 5,2 г фруктоолигосахаридов). Пациенты контрольной группы (40 человек) получали мебеверина гидрохлорид 200 мг 2 раза в день. Курс терапии 28 дней. До и после лечения пациенты заполняли опросник GSPS.

Результаты — лечение больных синдромом раздраженного кишечника с запором, принимавших только спазмолитик, позволило достигнуть клинической ремиссии у 52,6% пациентов. В группе пациентов, получавших спазмолитик и синбиотик клиническая ремиссия установлена у 92,3%. Прирост больных, достигших клинической эффективности, в основной группе по сравнению с контрольной составил 39,7% (p<0,01). Относительный риск клинической ремиссии при включении синбиотика в схему лечения СРК с запором — 1,75 (95% ДИ 1,28–2,4; p<0,01). При анализе нежелательных явлений сравниваемых схем лечения статистически значимых различий не выявлено (р=0,75).

Заключение — результаты исследования демонстрируют достоверное повышение эффективности терапии больных СРК с запором при сочетанном использовании спазмолитика и синбиотика.

The aim is to study the effect and safety of using the antispasmodic and synbiotic (Lactobacillus paracasei CNCM I-1572 in combination with fructooligosaccharides) in patients with irritable bowel syndrome with constipation.

Materials and methods — prospective randomized controlled trial of 80 patients with irritable bowel syndrome with constipation. Patients in the main group (40 people) took mebeverine hydrochloride 200 mg 2 times a day and synbiotic (5x109 CFU Lactobacillus paracasei CNCM I-1572 and 5.2 g fructooligosaccharides) during 28 days. Patients in the control group (40 people) received mebeverine hydrochloride 200 mg 2 times a day during 28 days. Before and after treatment, patients underwent the GSPS questionnaire.

Results — in control group clinical remission was achieved in 52.6% of patients. In the main group clinical remission was established in 92.3%, the increase was 39.7% (p <0.01). The relative risk of clinical remission when synbiotic included in the treatment for patients with irritable bowel syndrome with constipation is 1.75 (95% CI 1.28–2.4; p <0.01). When analyzing adverse events of the compared treatment regimens, no statistically significant differences were found (p = 0.75).

Conclusion — the results of study demonstrate a significant increase in the effectiveness of therapy in patients with irritable bowel syndrome with constipation with the combined use of antispasmodic and synbiotic.

синдром раздраженного кишечника с запоромLactobacillus paracasei CNCM I-1572фруктоолигосахаридымебеверина гидрохлоридirritable bowel syndrome with constipationLactobacillus paracasei CNCM I-1572fructooligosaccharidesmebeverine hydrochlorideReferencesMearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18: S0016–5085(16)00222–5. doi: 10.1053/j.gastro.2016.02.031Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18: S0016–5085(16)00222–5. doi: 10.1053/j.gastro.2016.02.031Ivashkin V.T., Shelygin Yu.A., Baranskaya Y. K., et al. Diagnosis and treatment of the irritable bowel syndrome: clinical guidelines of the Russian gastroenterological association and Russian association of coloproctology. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2017;27(5):76–93. (In Russ.) doi: 10.22416/1382–4376–2017–27–5–76–93Ivashkin V.T., Shelygin Yu.A., Baranskaya Y. K., et al. Diagnosis and treatment of the irritable bowel syndrome: clinical guidelines of the Russian gastroenterological association and Russian association of coloproctology. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2017;27(5):76–93. (In Russ.) doi: 10.22416/1382–4376–2017–27–5–76–93Barbara G, Feinle-Bisset C, Ghoshal UC, et al. The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18: S0016–5085(16)00219–5. doi: 10.1053/j.gastro.2016.02.028Barbara G, Feinle-Bisset C, Ghoshal UC, et al. The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18: S0016–5085(16)00219–5. doi: 10.1053/j.gastro.2016.02.028Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979–88. doi: 10.1053/j.gastro.2009.02.074Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979–88. doi: 10.1053/j.gastro.2009.02.074Rajilić- Stojanović M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792–801. doi: 10.1053/j.gastro.2011.07.043Rajilić- Stojanović M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792–801. doi: 10.1053/j.gastro.2011.07.043Jalanka- Tuovinen J, Salojärvi J, Salonen A, et al. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut. 2014 Nov;63(11):1737–45. doi: 10.1136/gutjnl-2013–305994Jalanka- Tuovinen J, Salojärvi J, Salonen A, et al. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut. 2014 Nov;63(11):1737–45. doi: 10.1136/gutjnl-2013–305994Francisco Guarner, Mary Ellen Sanders, Rami Eliakim; World Gastroenterology Organization, et al. World Gastroenterology Organisation Global Guidelines: probiotics and prebiotics. 2017. (in Russ.)Francisco Guarner, Mary Ellen Sanders, Rami Eliakim; World Gastroenterology Organization, et al. World Gastroenterology Organisation Global Guidelines: probiotics and prebiotics. 2017. (in Russ.)Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx- Orenstein AE, Brandt LJ, Quigley EM. Th e efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325–32. doi: 10.1136/gut.2008.167270Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx- Orenstein AE, Brandt LJ, Quigley EM. Th e efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325–32. doi: 10.1136/gut.2008.167270Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soff er EE, Spiegel BM, Moayyedi P. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014 Oct;109(10):1547–61; quiz 1546, 1562. doi: 10.1038/ajg.2014.202Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soff er EE, Spiegel BM, Moayyedi P. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014 Oct;109(10):1547–61; quiz 1546, 1562. doi: 10.1038/ajg.2014.202Cremon C, Guglielmetti S, Gargari G, et al. Eff ect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 2018 May;6(4):604–613. doi: 10.1177/2050640617736478Cremon C, Guglielmetti S, Gargari G, et al. Eff ect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 2018 May;6(4):604–613. doi: 10.1177/2050640617736478Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75–83. doi: 10.1023/a:1008841022998Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75–83. doi: 10.1023/a:1008841022998Wiklund IK, Fullerton S, Hawkey CJ, et al. An irritable bowel syndrome- specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947–54. doi: 10.1080/00365520310004209Wiklund IK, Fullerton S, Hawkey CJ, et al. An irritable bowel syndrome- specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947–54. doi: 10.1080/00365520310004209Ruepert L, Quartero AO, de Wit NJ, van der Heijden GJ, Rubin G, Muris JW. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD003460. doi: 10.1002/14651858.CD003460.pub3Ruepert L, Quartero AO, de Wit NJ, van der Heijden GJ, Rubin G, Muris JW. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD003460. doi: 10.1002/14651858.CD003460.pub3Compare D, Rocco A, Coccoli P, et al. Lactobacillus casei DG and its postbiotic reduce the inflammatory mucosal response: an ex-vivo organ culture model of postinfectious irritable bowel syndrome. BMC Gastroenterology. 2017 Apr 14;17(1):53. doi: 10.1186/s12876–017–0605-xCompare D, Rocco A, Coccoli P, et al. Lactobacillus casei DG and its postbiotic reduce the inflammatory mucosal response: an ex-vivo organ culture model of postinfectious irritable bowel syndrome. BMC Gastroenterology. 2017 Apr 14;17(1):53. doi: 10.1186/s12876–017–0605-xFerrario C, Taverniti V, Milani C, et al. Modulation of fecal Clostridiales bacteria and butyrate by probiotic intervention with Lactobacillus paracasei DG varies among healthy adults. J Nutr. 2014 Nov;144(11):1787–96. doi: 10.3945/jn.114.197723.Ferrario C, Taverniti V, Milani C, et al. Modulation of fecal Clostridiales bacteria and butyrate by probiotic intervention with Lactobacillus paracasei DG varies among healthy adults. J Nutr. 2014 Nov;144(11):1787–96. doi: 10.3945/jn.114.197723.Tursi A, Brandimarte G, Elisei W, et al. Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease – a double-blind, randomised, placebo- controlled study. Aliment Pharmacol Th er. 2013 Oct;38(7):741–51. doi: 10.1111/apt.12463Tursi A, Brandimarte G, Elisei W, et al. Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease – a double-blind, randomised, placebo- controlled study. Aliment Pharmacol Th er. 2013 Oct;38(7):741–51. doi: 10.1111/apt.12463Azpiroz F., Molne L., Mendez S., et al. Effect of Chicoryderived Inulin on Abdominal Sensations and Bowel Motor Function. J. Clin. Gastroenterol. 2017;51:619–625. doi: 10.1097/MCG.0000000000000723Azpiroz F., Molne L., Mendez S., et al. Effect of Chicoryderived Inulin on Abdominal Sensations and Bowel Motor Function. J. Clin. Gastroenterol. 2017;51:619–625. doi: 10.1097/MCG.0000000000000723Benjamin JL, Hedin CR, Koutsoumpas A, Ng SC, McCarthy NE, Hart AL, Kamm MA, Sanderson JD, Knight SC, Forbes A, Stagg AJ, Whelan K, Lindsay JO. Randomised, double- blind, placebo- controlled trial of fructo- oligosaccharides in active Crohn’s disease. Gut. 2011 Jul;60(7):923–9. doi: 10.1136/gut.2010.232025Benjamin JL, Hedin CR, Koutsoumpas A, Ng SC, McCarthy NE, Hart AL, Kamm MA, Sanderson JD, Knight SC, Forbes A, Stagg AJ, Whelan K, Lindsay JO. Randomised, double- blind, placebo- controlled trial of fructo- oligosaccharides in active Crohn’s disease. Gut. 2011 Jul;60(7):923–9. doi: 10.1136/gut.2010.232025J de Vries, Le Bourgot C, Calame W, Respondek F. Effects of β-Fructans Fiber on Bowel Function: A Systematic Review and Meta- Analysis. Nutrients. 2019 Jan 4;11(1):91. doi: 10.3390/nu11010091J de Vries, Le Bourgot C, Calame W, Respondek F. Effects of β-Fructans Fiber on Bowel Function: A Systematic Review and Meta- Analysis. Nutrients. 2019 Jan 4;11(1):91. doi: 10.3390/nu11010091

The authors declare that there are no conflicts of interest present.