Синдром раздраженного кишечника в Российской Федерации – результаты многоцентрового наблюдательного исследования ROMERUS
Синдром раздраженного кишечника в Российской Федерации – результаты многоцентрового наблюдательного исследования ROMERUS
Маев И.В., Охлобыстина О.З., Халиф И.Л., Андреев Д.Н. Синдром раздраженного кишечника в Российской Федерации – результаты многоцентрового наблюдательного исследования ROMERUS. Терапевтический архив. 2023;95(1):38–51. DOI: 10.26442/00403660.2023.01.202043
Maev IV, Okhlobystina OZ, Khalif IL, Andreev DN. Irritable bowel syndrome in the Russian Federation: results of the ROMERUS multicenter observational study. Terapevticheskii Arkhiv (Ter. Arkh.). 2023;95(1):38–51.
DOI: 10.26442/00403660.2023.01.202043
Синдром раздраженного кишечника в Российской Федерации – результаты многоцентрового наблюдательного исследования ROMERUS
Маев И.В., Охлобыстина О.З., Халиф И.Л., Андреев Д.Н. Синдром раздраженного кишечника в Российской Федерации – результаты многоцентрового наблюдательного исследования ROMERUS. Терапевтический архив. 2023;95(1):38–51. DOI: 10.26442/00403660.2023.01.202043
Maev IV, Okhlobystina OZ, Khalif IL, Andreev DN. Irritable bowel syndrome in the Russian Federation: results of the ROMERUS multicenter observational study. Terapevticheskii Arkhiv (Ter. Arkh.). 2023;95(1):38–51.
DOI: 10.26442/00403660.2023.01.202043
Обоснование. Cиндром раздраженного кишечника (СРК) – одно из наиболее часто встречающихся функциональных расстройств желудочно-кишечного тракта. Согласно российским рекомендациям для установки диагноза СРК необходимо выполнить стандартное обследование, включающее лабораторные и инструментальные методы оценки, в том числе колоноскопию. Цель. Описать российскую популяцию пациентов с СРК. Материалы и методы. Многоцентровое наблюдательное проспективное исследование ROMERUS проводили в 35 клинических центрах в Российской Федерации. В исследование включали пациентов мужского и женского пола в возрасте от 18 до 50 лет с диагнозом СРК, установленным на основании Римских критериев IV, при отсутствии указаний на органическое заболевание желудочно-кишечного тракта. Длительность наблюдения составляла 6 мес, во время которых пациент трижды посещал исследовательский центр. В ходе исследования выполняли сбор данных о демографических и клинических характеристиках пациентов, ранее установленных диагнозах и получаемой лекарственной терапии. Вторичными параметрами стали оценка доли пациентов с диагнозом СРК, подтвержденным стандартным обследованием, среди всех пациентов, удовлетворяющих Римским критериям IV, оценка динамики симптомов СРК, качества жизни (КЖ) и приверженности терапии. Описание характеристик популяции выполняли с помощью методов описательной статистики. Результаты стандартного обследования представляли как процент пациентов с СРК, подтвержденным стандартным обследованием, среди всех пациентов, удовлетворяющих Римским критериям IV, с построением двустороннего 95% доверительного интервала. Результаты. В исследование включили 1004 пациентов с диагнозом СРК, установленным в соответствии с Римскими критериями IV, в финальный анализ вошли данные 790 (78,7%) пациентов. Средний возраст пациентов составлял 34,0±7,5 года, преобладали пациенты женского пола (70,4%), европеоидной расы (99,4%), состоящие в браке (55,1%), городские жители (97,5%) с высшим образованием (64,5%), имеющие постоянное место работы (74,9%). Для пациентов, включенных в исследование, характерны низкая физическая активность и отсутствие рационального питания. Частота курения составляла 26,3%. У 28,1% пациентов наблюдались симптомы СРК с преобладанием запора, у 28,9% – СРК с преобладанием диареи, у 11,9% – CРК смешанного типа и у 31,1% – неклассифицируемого типа СРК. Основные симптомы СРК – боль (99,7%), вздутие живота (71,1%) и чувство распирания (36,8%). Из сопутствующих заболеваний с наибольшей частотой регистрировали дисфункцию желчевыводящих путей (18,9%) и гастрит (17,2%). До включения в исследование лекарственную терапию получали 28% пациентов. Во время исследования самым часто назначаемым препаратом стал мебеверин (54,1%). За 6 мес наблюдения наблюдалось статистически значимое снижение частоты жалоб на боль, вздутие и распирание живота, а в подгруппах пациентов с СРК с преобладанием запора и СРК с преобладанием диареи – двукратное снижение частоты запора и диареи соответственно. Общая оценка КЖ, измеренная с помощью опросника СРК-КЖ, за время исследования увеличилась с 83,0 до 95,2 балла (p<0,05). При общей оценке своего состояния 69,6% пациентов отметили отсутствие симптомов и 25,3% – выраженное улучшение, по шкале общей оценки состояния пациента врачом у 35% пациентов отсутствовали симптомы и у 51,8% наблюдалось выраженное улучшение. Заключение. В ходе исследования получены характеристики пациентов с СРК в РФ. Диагноз СРК, установленный в соответствии с Римскими диагностическими критериями IV, подтвержден результатами стандартного обследования у 96,3% пациентов. Использование Римских критериев IV для диагностики СРК позволяет установить диагноз с вероятностью 94,7%. На протяжении 6 мес наблюдения отмечалось клиническое улучшение состояния пациентов, характеризующееся уменьшением тяжести симптомов и улучшением КЖ.
Ключевые слова: синдром раздраженного кишечника, Римские критерии IV, мебеверин
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Background. Irritable bowel syndrome (IBS) is one of the most common functional disorders of the gastrointestinal tract. According to Russian guidelines, a standard examination using laboratory and instrumental evaluation methods, including colonoscopy, should be performed to establish the diagnosis of IBS. Aim. To characterize the Russian population of IBS patients. Materials and methods. A multicenter observational prospective study ROMERUS was conducted at 35 clinical centers in the Russian Federation. The study included male and female patients aged 18 to 50 with a diagnosis of IBS based on the Rome IV criteria, with no signs of structural gastrointestinal disease. The follow-up duration was 6 months and included three patients' visits to the study site. During the study, data were collected on patients' demographic and clinical characteristics, medical history, and drug therapy. The secondary parameters included the assessment of the proportion of patients with a diagnosis of IBS confirmed by a standard examination among all patients meeting the Rome IV criteria, the evaluation of the change over time of the IBS symptoms, quality of life (QoL), and adherence to therapy. Characterization of the population was performed using descriptive statistics methods. The standard examination results were presented as the percentage of patients with IBS confirmed by the standard examination among all patients meeting the Rome IV criteria, with a two-sided 95% confidence interval. Results. The study included 1004 patients with a diagnosis of IBS according to the Rome IV criteria, with 790 (78.7%) patients included in the final analysis. The mean age of patients was 34.0±7.5 years; they were predominantly female (70.4%), Caucasian (99.4%), married (55.1%), urban residents (97.5%) with higher education (64.5%) and a permanent position (74.9%). Patients enrolled in the study have low physical activity and lack a healthy diet. The smoking rate was 26.3%. IBS symptoms with predominant constipation (IBS-C) were observed in 28.1% of patients; 28.9% had IBS with predominant diarrhea (IBS-D), 11.9% had mixed-type IBS, and 31.1% had non-classified IBS. The main IBS symptoms were pain (99.7%), abdominal distension (71.1%), and fullness (36.8%). Biliary tract dysfunction (18.9%) and gastritis (17.2%) were the most frequently reported comorbidities. Prior to enrollment, 28% of patients received drug therapy. The most commonly prescribed drug during the study was mebeverine (54.1%). At 6 months of follow-up, there was a significant reduction of abdominal pain, bloating, and distention, and a twofold reduction in the incidence of constipation and diarrhea in the subgroups of patients with IBS-C and IBS-D, respectively. The overall QoL score measured by the IBS-QoL questionnaire increased from 83.0 to 95.2 points (p<0.05) during the study. In the overall assessment of their condition, 69.6% of patients noted no symptoms and 25.3% reported marked improvement, 35% were asymptomatic according to the physician's overall assessment of the patient's condition, and 51.8% showed significant improvement. Conclusion. IBS patients in the Russian Federation were characterized. The diagnosis of IBS, established following the Rome IV criteria, is confirmed by the results of a standard examination in 96.3% of patients. The Rome IV criteria for the IBS diagnosis make it possible to establish a diagnosis with a probability of 94.7%. For 6 months of follow-up, there was a clinical improvement with a decrease in the severity of symptoms and a QoL improvement.
Keywords: irritable bowel syndrome, Rome IV criteria, mebeverine
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1. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014;6:71-80. DOI:10.2147/CLEP.S40245
2. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712-21.e4. DOI:10.1016/j.cgh.2012.02.029
3. Paré P, Gray J, Lam S, et al. Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study. Clin Ther. 2006;28(10):1726-11. DOI:10.1016/j.clinthera.2006.10.010
4. Smith GD, Steinke DT, Kinnear M, et al. A comparison of irritable bowel syndrome patients managed in primary and secondary care: the Episode IBS study. Br J Gen Pract. 2004;54:503-7.
5. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States, part II: lower gastrointestinal diseases. Gastroenterology. 2009;136(3):741-54. DOI:10.1053/j.gastro.2009.01.015
6. Grodzinsky E, Hallert C, Faresjö T, et al. Could gastrointestinal disorders differ in two close but divergent social environments? Int J Health Geogr. 2012;11:5.
DOI:10.1186/1476-072X-11-5
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1 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия;
2 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
3 ФГБУ «Государственный научный центр колопроктологии им. А.Н. Рыжих» Минздрава России, Москва, Россия
*dna-mit8@mail.ru
________________________________________________
Igor V. Maev1, Olga Z. Okhlobystina2, Igor L. Khalif 3, Dmitry N. Andreev*1
1 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia;
2 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
3 Ryzikh State Scientific Center for Coloproctology, Moscow, Russia
*dna-mit8@mail.ru