patmedfarПациентоориентированная медицина и фармацияPatient-Oriented Medicine and Pharmacy2949-1924LLC Izdatelstvo OKI10.37489/2949-1924-0084FZWUVEpatmedfar-159Research ArticleКЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯCLINICAL PHARMACOLOGYТримебутин: обзор клинических данных с позиции эффективности и безопасностиTrimebutine: a review of clinical data in terms of efficacy and safetyhttps://orcid.org/0000-0002-0032-0341ХохловА. Л.KhokhlovA. L.

Александр Леонидович Хохлов, д. м. н., профессор, академик РАН, зав. кафедрой, ректор

кафедра фармакологии и клинической фармакологии

Ярославль

Alexandr L. Khokhlov, Dr. Sci (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Department, Rector

Department of Pharmacology and Clinical Pharmacology

Yaroslavl

al460935@yandex.ruhttps://orcid.org/0000-0001-8041-8770РыбачковаЮ. В.RybachkovaYu. V.

Юлия Владимировна Рыбачкова, к. м. н., ассистент

кафедра фармакологии и клинической фармакологи

Ярославль

Yulia V. Rybachkova, PhD, Cand. Sci. (Med), Assistant

Department of Pharmacology and Clinical Pharmacology

Yaroslavl

julia3111@mail.ruФГБОУ ВО «Ярославский государственный медицинский университет»РоссияYaroslavl State Medical UniversityRussian Federation20250308202532615Copyright © Хохлов А.Л., Рыбачкова Ю.В., 20252025Хохлов А.Л., Рыбачкова Ю.В.Khokhlov A.L., Rybachkova Y.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pomph.ru/jour/article/view/159

   Актуальность. Представлены результаты клинических исследований применения тримебутина малеата при функциональных расстройствах желудочно-кишечного тракта (ЖКТ).

   Цель работы — анализ применения тримебутина в клинической практике с позиции эффективности и безопасности согласно результатам проведённых клинических исследований, опубликованных в литературе.

   С конца 1960-х годов тримебутина малеат нашёл широкое применение в терапии функциональных расстройств ЖКТ, включая функциональную диспепсию (ФД), функциональные расстройства билиарного тракта и синдром раздражённого кишечника (СРК). Тримебутин обычно классифицируется как спазмолитик, однако его уникальные свойства делают его многофункциональным препаратом. Эффективность тримебутина в лечении СРК была подтверждена в нескольких метаанализах и обзорах. В одном из первых клинических исследований было показано, что препарат эффективно воздействует на стресс-индуцированные нарушения моторики и абдоминальную боль у пациентов с СРК. В метаанализе, включающем 26 рандомизированных контролируемых исследований (РКИ), была продемонстрирована высокая эффективность и безопасность тримебутина в сравнении с другими спазмолитиками и плацебо. Также его эффективность была подтверждена в терапии функциональной абдоминальной боли и диспепсии в метаанализе 22 РКИ, в котором участвовали 1778 пациентов с СРК. В 2011 году тримебутин был включён в Кокрейновский систематический обзор препаратов с различными механизмами действия для лечения СРК. Многочисленные исследования продемонстрировали влияние тримебутина на моторику верхних отделов ЖКТ и его эффективность как спазмолитика и прокинетика при лечении ФД. Безопасность применения тримебутина также была отмечена при послеоперационной паралитической непроходимости кишечника. Нежелательные реакции, такие как головокружение, тошнота, рвота, диарея и сухость во рту, были зарегистрированы в 4,1 % случаев (у 14 из 340 пациентов). Следует отметить также безопасность применения тримебутина в педиатрической практике. Согласно проведённым клиническим исследованиям, нежелательные реакции лёгкой и средней степени тяжести наблюдались у 7 % пациентов на фоне терапии тримебутином, получавших лечение тримебутином, при этом ни один нежелательный эффект не был зарегистрирован у более чем 1,8 % пациентов, и некоторые из них могли быть связаны с состоянием здоровья пациента, а не с лекарственным препаратом.

   Actuality. This article presents the results of clinical studies of trimebutine maleate in functional gastrointestinal disorders (GIT).   The objective of the work is to analyze the use of trimebutine in clinical practice from the standpoint of efficacy and safety according to the results of clinical studies published in the literature.   Since the late 1960s, trimebutine maleate has found wide application in the treatment of functional GIT disorders, including functional dyspepsia (FD), functional biliary tract disorders (FDBT), and irritable bowel syndrome (IBS). Trimebutine is usually classified as an antispasmodic, but its unique properties make it a multifunctional drug. The efficacy of trimebutine for treating IBS has bee n confirmed in several meta-analyses and reviews. One of the first clinical studies showed that the drug effectively affected stress-induced motility disorders and abdominal pain in patients with IBS. A meta-analysis including 26 randomized controlled trials (RCTs) demonstrated the high efficacy and safety of trimebutine compared with other antispasmodics and placebo. Its efficacy was also confirmed for treating functional abdominal pain and dyspepsia in a meta-analysis of 22 RCTs involving 1,778 patients with IBS. In 2011, trimebutine was included in the Cochrane systematic review of drugs with different mechanisms of action for treating IBS. Numerous studies have demonstrated the effect of trimebutine on upper gastrointestinal motility and its efficacy as an antispasmodic and prokinetic agent for treating FD. The safety of trimebutine was also noted in postoperative paralytic ileus. Adverse reactions such as dizziness, nausea, vomiting, diarrhea, and dry mouth were reported in 4.1 % of cases (14 of 340 patients). It should also be noted that trimebutine is safe to use in pediatric practice. According to clinical studies, mild to moderate adverse reactions were observed in 7 % of patients treated with trimebutine, while no adverse effects were reported in more than 1.8 % of patients, and some of them could be related to the patient's health condition rather than the drug.

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