Практические аспекты применения пробиотиков: исследование Дельфи

Горелов А.В., Ливзан М.А., Зырянов С.К., Бельмер С.В., Зольникова О.Ю., Захаренко С.М., Усенко Д.В., Довгань Е.В. Практические аспекты применения пробиотиков: исследование Дельфи. Терапевтический архив. 2024;96(12):1190–1197. DOI: 10.26442/00403660.2024.12.203102

© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.

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Gorelov AV, Livzan MA, Zyryanov SK, Belmer SV, Zolnikova OYu, Zakharenko SM, Usenko DV, Dovgan EV. Practical aspects of probiotics application: A Delphi study. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(12):1190–1197. DOI: 10.26442/00403660.2024.12.203102

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Аннотация

Цель. Оценить степень осведомленности представителей врачебного сообщества о возможностях и подходах к применению пробиотиков для профилактики и лечения заболеваний желудочно-кишечного тракта в рутинной клинической практике.
Материалы и методы. С использованием метода Дельфи проведен анонимный опрос 35 ведущих экспертов в области гастроэнтерологии, терапии, педиатрии и клинической фармакологии.
Результаты. Опрошенные эксперты считают пробиотики эффективными и безопасными для лечения острой диареи и функциональных расстройств желудочно-кишечного тракта. Участники опроса также признали пробиотики эффективными в отношении профилактики антибиотик-ассоциированной диареи, а также согласились с утверждением о доказанной эффективности Lactobacillus acidophilus LA-5 и Bifidobacterium animalis subsp. lactis BB-12. По мнению экспертов, обосновано раннее назначение пробиотиков с продолжением приема в течение 1–2 нед после завершения антибактериальной терапии.
Заключение. В ходе совета экспертов получен консенсус по вопросам эффективности и безопасности пробиотиков, важности оценки доказательной базы конкретного препарата, а также внимательной и взвешенной оценки качества биологически активной добавки с пробиотиками.

Ключевые слова: пробиотики, микробиом, микрофлора, желудочно-кишечный тракт, Lactobacillus, Bifidobacterium

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Aim. To evaluate the awareness of healthcare professionals on possibilities and approaches to probiotics use in prevention and treatment of gastrointestinal disease in routine practice.
Materials and methods. An anonymous survey of 35 leading experts in the field of gastroenterology, therapy, pediatrics and clinical pharmacology was conducted using the Delphi method.
Results. Experts consider probiotics effective and safe for acute diarrhea and functional gastrointestinal disorders treatment. Participants stated there are enough evidence that probiotics could be effective for prevention of antibiotic-associated diarrhea, including agreement with the statement that Lactobacillus acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 effectiveness has been studied and is known for AAD indication. Early use of probiotics with extension for 1–2 weeks after the end of antibacterial treatment is considered rational.
Conclusion. During the Advisory board the consensus has been reached for matters of efficacy and safety of probiotics, along with importance of evidence evaluation of each medicine, as well as the need for careful and thorough assessment of quality for probiotic supplements.

Keywords: probiotics, microbiome, microflora, gastrointestinal tract, Lactobacillus, Bifidobacterium

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Список литературы

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15. Snydman DR. The safety of probiotics. Clin Inf Dis. 2008;46(Suppl. 2):S104-11. DOI:10.1086/523331
16. Doron S, Snydman DR. Risk and safety of probiotics. Clin Inf Dis. 2015;60(Suppl. 2):S129-34. DOI:10.1093/cid/civ085
17. Heiser CR, Ernst JA, Barrett JT, et al. Probiotics, soluble fiber, and L-glutamine (GLN) reduce nelfinavir (NFV) or lopinavir/ritonavir (LPV/r)-related diarrhea. J Int Assoc Physicians AIDS Care (Chic). 2004;3(4):121-9. DOI:10.1177/154510970400300403
18. Alexis S, Hummelen R, Hekmat S, et al. Probiotic yogurt consumption is associated with an increase of CD4 count among people living with HIV/AIDS. J Clin Gastroenterol. 2010;44(9):e201-5. DOI:10.1097/MCG.0b013e3181d8fba8
19. Bin-Nun A, Bromiker R, Wilschanski M, et al. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005;147(2):192-6. DOI:10.1016/j.jpeds.2005.03.054
20. Salminen S. Demonstration of safety of probiotics – A review. Int J Food Microbiol. 1998;44(1-2):93-106. DOI:10.1016/S0168-1605(98)00128-7
21. Mattia A, Merker R. Regulation of probiotic substances as ingredients in foods: Premarket approval or “Generally Recognized as Safe” notification. Clin Infect Dis.
2008;46(s2):S115-8. DOI:10.1086/523329
22. Горелов А.В., Андреева И.В., Захаренко С.М., Синопальников А.И. Применение пробиотиков, содержащих комбинацию штаммов Lactobacillus acidophilus LA-5 и Bifidobacterium animalis subsp. lactis BB-12: метаанализ эффективности для профилактики антибиотик-ассоциированной диареи и в схемах эрадикационной терапии Helicobacter pylori. Терапия. 2023;10:74-82 [Gorelov AV, Andreeva IV, Zakharenko SM, Sinopalnikov AI. The use of probiotics containing a combination of Lactobacillus acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 strains: Meta-analysis of efficacy in the prevention of antibiotic-associated diarrhea and in Helicobacter pylori eradication therapy. Therapy. 2023;10:74-82 (in Russian)]. DOI:10.18565/therapy.2023.10.74-82
23. Guo Q, Goldenberg JZ, Humphrey C, et al. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane IBD Group, ed. Cochrane Database Syst Rev. 2019;4(4):CD004827. DOI:10.1002/14651858.CD004827.pub5
24. Goodman C, Keating G, Georgousopoulou E, et al. Probiotics for the prevention of antibiotic-associated diarrhoea: A systematic review and meta-analysis. BMJ Open. 2021;11(8):e043054. DOI:10.1136/bmjopen-2020-043054
25. Zhang L, Zeng X, Guo D, et al. Early use of probiotics might prevent antibiotic-associated diarrhea in elderly (>65 years): A systematic review and meta-analysis. BMC Geriatrics. 2022;22(1):562. DOI:10.1186/s12877-022-03257-3
26. Dascălu RI, Bolocan A, Păduaru DN, et al. Multidrug resistance in Helicobacter pylori infection. Front Microbiol. 2023;14:1128497. DOI:10.3389/fmicb.2023.1128497
27. Yang Z, Zhou Y, Han Z, et al. The effects of probiotics supplementation on Helicobacter pylori standard treatment: An umbrella review of systematic reviews with meta-analyses. Sci Rep. 2024;14(1):10069. DOI:10.1038/s41598-024-59399-4
28. Zavišić G, Popović M, Stojkov S, et al. Antibiotic resistance and probiotics: Knowledge gaps, market overview and preliminary screening. Antibiotics (Basel). 2023;12(8):1281. DOI:10.3390/antibiotics12081281
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1. Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States: 2012 Update. Gastroenterology. 2012;143(5):1179-87.e3. DOI:10.1053/j.gastro.2012.08.002
2. Buono JL, Carson RT, Flores NM. Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea. Health Qual Life Outcomes. 2017;15(1):35. DOI:10.1186/s12955-017-0611-2
3. Rau S, Gregg A, Yaceczko S, Limketkai B. Prebiotics and probiotics for gastrointestinal disorders. Nutrients. 2024;16(6):778. DOI:10.3390/nu16060778
4. World Gastroenterology Organisation Global Guidelines. Probiotics and prebiotics. World Gastroenterology Organisation. 2023. Available at: https://www.worldgastroenterology.org/UserFiles/file/guidelines/probiotics-and-prebiotics-english-20.... Accessed: 09.09.2024.
5. Wilkins T, Sequoia J. Probiotics for gastrointestinal conditions: A summary of the evidence. Am Fam Physician. 2017;96(3):170-8. PMID:28762696
6. Parker EA, Roy T, D’Adamo CR, Wieland LS. Probiotics and gastrointestinal conditions: An Overview of evidence from the Cochrane collaboration. Nutrition. 2018;45:125-34.e11. DOI:10.1016/j.nut.2017.06.024
7. Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021;11(4):116. DOI:10.5662/wjm.v11.i4.116
8. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311(7001):376-80. DOI:10.1136/bmj.311.7001.376
9. Collinson S, Deans A, Padua-Zamora A, et al. Probiotics for treating acute infectious diarrhoea. Cochrane Infectious Diseases Group, ed. Cochrane Database Syst Rev. 2020;12(12):CD003048. DOI:10.1002/14651858.CD003048.pub4
10. Huang R, Xing HY, Liu HJ, et al. Efficacy of probiotics in the treatment of acute diarrhea in children: A systematic review and meta-analysis of clinical trials. Transl Pediatr. 2021;10(12):3248-60. DOI:10.21037/tp-21-511
11. Agah S, Akbari A, Heshmati J, et al. Systematic review with meta-analysis: Effects of probiotic supplementation on symptoms in functional dyspepsia. J Function Foods. 2020;68:103902. DOI:10.1016/j.jff.2020.103902
12. Zhang J, Wu HM, Wang X, et al. Efficacy of prebiotics and probiotics for functional dyspepsia: A systematic review and meta-analysis. Medicine. 2020;99(7):e19107. DOI:10.1097/MD.0000000000019107
13. Solovyeva OI, Nekrasova AS, Topalova IG, et al. Long-term probiotic administration for irritable bowel syndrome: A legal need. Terapevticheskii Arkhiv (Ter. Arkh.). 2023;95(8):679-85 (in Russian). DOI:10.26442/00403660.2023.08.202378
14. Khalaidzheva KN, Nikitina NV, Astrashkova OV, et al. Features of the effect of a probiotic, containing Lactobacillus and Bifidobacterium on the intestinal microbiota and clinical symptoms of irritable bowel syndrome. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(4):356-63 (in Russian). DOI:10.26442/00403660.2024.04.202690
15. Snydman DR. The safety of probiotics. Clin Inf Dis. 2008;46(Suppl. 2):S104-11. DOI:10.1086/523331
16. Doron S, Snydman DR. Risk and safety of probiotics. Clin Inf Dis. 2015;60(Suppl. 2):S129-34. DOI:10.1093/cid/civ085
17. Heiser CR, Ernst JA, Barrett JT, et al. Probiotics, soluble fiber, and L-glutamine (GLN) reduce nelfinavir (NFV) or lopinavir/ritonavir (LPV/r)-related diarrhea. J Int Assoc Physicians AIDS Care (Chic). 2004;3(4):121-9. DOI:10.1177/154510970400300403
18. Alexis S, Hummelen R, Hekmat S, et al. Probiotic yogurt consumption is associated with an increase of CD4 count among people living with HIV/AIDS. J Clin Gastroenterol. 2010;44(9):e201-5. DOI:10.1097/MCG.0b013e3181d8fba8
19. Bin-Nun A, Bromiker R, Wilschanski M, et al. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005;147(2):192-6. DOI:10.1016/j.jpeds.2005.03.054
20. Salminen S. Demonstration of safety of probiotics – A review. Int J Food Microbiol. 1998;44(1-2):93-106. DOI:10.1016/S0168-1605(98)00128-7
21. Mattia A, Merker R. Regulation of probiotic substances as ingredients in foods: Premarket approval or “Generally Recognized as Safe” notification. Clin Infect Dis.
2008;46(s2):S115-8. DOI:10.1086/523329
22. Gorelov AV, Andreeva IV, Zakharenko SM, Sinopalnikov AI. The use of probiotics containing a combination of Lactobacillus acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 strains: Meta-analysis of efficacy in the prevention of antibiotic-associated diarrhea and in Helicobacter pylori eradication therapy. Therapy. 2023;10:74-82 (in Russian). DOI:10.18565/therapy.2023.10.74-82
23. Guo Q, Goldenberg JZ, Humphrey C, et al. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane IBD Group, ed. Cochrane Database Syst Rev. 2019;4(4):CD004827. DOI:10.1002/14651858.CD004827.pub5
24. Goodman C, Keating G, Georgousopoulou E, et al. Probiotics for the prevention of antibiotic-associated diarrhoea: A systematic review and meta-analysis. BMJ Open. 2021;11(8):e043054. DOI:10.1136/bmjopen-2020-043054
25. Zhang L, Zeng X, Guo D, et al. Early use of probiotics might prevent antibiotic-associated diarrhea in elderly (>65 years): A systematic review and meta-analysis. BMC Geriatrics. 2022;22(1):562. DOI:10.1186/s12877-022-03257-3
26. Dascălu RI, Bolocan A, Păduaru DN, et al. Multidrug resistance in Helicobacter pylori infection. Front Microbiol. 2023;14:1128497. DOI:10.3389/fmicb.2023.1128497
27. Yang Z, Zhou Y, Han Z, et al. The effects of probiotics supplementation on Helicobacter pylori standard treatment: An umbrella review of systematic reviews with meta-analyses. Sci Rep. 2024;14(1):10069. DOI:10.1038/s41598-024-59399-4
28. Zavišić G, Popović M, Stojkov S, et al. Antibiotic resistance and probiotics: Knowledge gaps, market overview and preliminary screening. Antibiotics (Basel). 2023;12(8):1281. DOI:10.3390/antibiotics12081281
29. Andreev VA, Stetsiouk OU, Andreeva IV. Probiotics: Controversial issues. CMAC. 2022;24(4):345-60 (in Russian). DOI:10.36488/cmac.2022.4.345-360

Авторы

А.В. Горелов*^1–3, М.А. Ливзан⁴, С.К. Зырянов^5,6, С.В. Бельмер⁷, О.Ю. Зольникова², С.М. Захаренко⁸, Д.В. Усенко¹, Е.В. Довгань⁹

¹ФБУН «Центральный научно-исследовательский институт эпидемиологии» Роспотребнадзора, Москва, Россия;
²ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
³ФГБОУ ВО «Российский университет медицины» Минздрава России, Москва, Россия;
⁴ФГБОУ ВО «Омский государственный медицинский университет» Минздрава России, Омск, Россия;
⁵ФГАОУ ВО «Российский университет дружбы народов им. Патриса Лумумбы», Москва, Россия;
⁶ГБУЗ «Городская клиническая больница №24» Департамента здравоохранения г. Москвы, Москва, Россия;
⁷ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
⁸ФГБУ «Детский научно-клинический центр инфекционных болезней» ФМБА России, Санкт-Петербург, Россия;
⁹ОГБУЗ «Смоленская областная клиническая больница», Смоленск, Россия
*agorelov_05@mail.ru

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Aleksandr V. Gorelov*^1–3, Maria А. Livzan⁴, Sergey K. Zyryanov^5,6, Sergey V. Belmer⁷, Oxana Yu. Zolnikova², Sergey M. Zakharenko⁸, Denis V. Usenko¹, Evgenii V. Dovgan⁹

¹Central Research Institute of Epidemiology, Moscow, Russia;
²Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
³Russian University of Medicine, Moscow, Russia;
⁴Omsk State Medical University, Omsk, Russia;
⁵Patrice Lumumba Peoples’ Friendship University of Russia, Moscow, Russia;
⁶City Clinical Hospital No. 24, Moscow, Russia;
⁷Pirogov Russian National Research Medical University, Moscow, Russia;
⁸Pediatric Research and Clinical Center for Infectious Diseases, Saint Petersburg, Russia;
⁹Smolensk Regional Clinical Hospital, Smolensk, Russia
*agorelov_05@mail.ru

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