pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2008-0-2-73-80pulmo-1793Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESБезопасность и эффективность различных лекарственных форм амоксициллина / клавулановой кислоты при инфекциях нижних дыхательных путей у взрослых: открытое проспективное рандомизированное исследованиеSafety and efficacy of different drug forms of amoxicillin / clavulanic acid in treatment of lower respiratory tract infections in adults: an open prospective randomized trialГучевИ. А.GuchevI. A.

г. Смоленск

КозловР. С.KozlovR. S.

г. Смоленск

терапевтическое отделение ФГУ "421 военный госпиталь Московского военного округа" МО РФRussian FederationНаучно-исследовательский институт антимикробной химиотерапии ГОУ ВПО "Смоленская государственная медицинская академия" РосздраваRussian Federation200828042008027380Copyright © Гучев И.А., Козлов Р.С., 20082008Гучев И.А., Козлов Р.С.Guchev I.A., Kozlov R.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.pulmonology.ru/pulm/article/view/1793

Амоксициллин / клавулановая кислота (АМК) – один из препаратов выбора в лечении инфекций нижних дыхательных путей (ИНДП) у взрослых. Одной из существенных проблем использования АМК в клинической практике является сравнительно высокая частота нежелательных реакций (НР) со стороны желудочно-кишечного тракта (ЖКТ). Применение новой лекарственной формы (ЛФ) АМК диспергируемых таблеток Солютаб за счет более быстрой и предсказуемой абсорбции клавулановой кислоты из кишечника потенциально может способствовать снижению частоты нежелательных реакций (НР) и улучшению клинических исходов лечения в связи с более высокой приверженностью проводимой терапии. Цель исследования – сравнить частоту НР и клиническую эффективность новой ЛФ АМК и обычного таблетированного АМК у взрослых пациентов с нетяжелыми ИНДП, назначаемых внутрь в дозе 500 / 125 мг 3 раза в день в течение 5–12 дней. Открытое проспективное рандомизированное исследование, выполненное на базе 4 лечебных учреждений. Взрослые пациенты с клинически и рентгенологически подтвержденной нетяжелой внебольничной пневмонией (ВП) или обострением ХОБЛ I типа или II типа с наличием гнойной мокроты получали диспергируемые таблетки АМК (1-я группа) или АМК в форме таблеток, покрытых оболочкой (2-я группа) в соотношении 1: 1. Клиническая эффективность оценивалась на основании динамики клинических симптомов, данных физического обследования, дополнительных лабораторных и инструментальных методов; безопасность – на основании жалоб, данных физического и лабораторного обследования, полученных во время 2-го (3–4-й дни), 3-го (5–12-й дни) и 4-го (30-40-й дни с момента приема первой дозы исследуемого препарата) визитов. В исследовании участвовали 200 пациентов, средний возраст которых составил 32,7 ± 18,7 и 33,3 ± 18,6 года в 1-й и 2-й группах соответственно. Пациенты в группах были сопоставимы по анамнестическим данным, тяжести и характеру течения заболевания. Клиническая эффективность среди пациентов, подлежащих клинической оценке, составила во время 3-го визита 96,9 %, 4-го визита – 95,9 % и 96,9 % в 1-й и 2-й группах соответственно. Средняя длительность антибактериальной терапии в 1-й группе составила 7,1 ± 1,5 суток, во 2-й группе – 7,2 ± 1,4 суток. НР регистрировались у 15 и 31 % пациентов в 1-й и 2-й группах соответственно (p = 0,01). В структуре НР в обеих группах преобладали патологические изменения со стороны ЖКТ. В группе пациентов, получавших диспергируемые таблетки АМК, выявлена меньшая частота развития такой НР, как диарея: 6 % vs. 17 % в группе контроля (p = 0,027). Новая лекарственная форма АМК диспергируемые таблетки у взрослых пациентов с нетяжелыми ИНДП характеризовалась несколько лучшим профилем безопасности по сравнению с обычным АМК, что проявлялось уменьшением частоты встречаемости НР, особенно диареи. Оба препарата продемонстрировали высокую эквивалентную клиническую эффективность.

Amoxicillin/clavulanic acid (ACA) is one of the drugs of choice for treatment of lower respiratory tract infections (LRTI) in adults. One of the serious disadvantages of ACA is relatively high rate of gastrointestinal adverse events (AE). A new form of ACA, which is dispersable tablets Solutab, could potentially reduce the rate of AE because of more rapid and predictable absorption of clavulanic acid from intestine and improve clinical outcomes due to higher adherence to treatment. This trial was aimed to compare AE rate and clinical efficacy of the new dispersable ACA form Solutab with those of traditional ACA tabs in adult patients with non-severe LRTI. The treatment regimen comprised 500/125 mg t.i.d. during 5 to12 days. This was an open, prospective randomized trial performed at 4 clinical centres. Adults with clinically and radiologically detected non-severe community-acquired pneumonia or I or II types COPD exacerbations with purulent sputum received dispersable ACA tablets (the 1st group) or traditional coated tabs of ACA (the 2nd group) in a random proportion of 1 : 1. Clinical efficacy was evaluated with clinical signs, physical symptoms, additional laboratory and instrumental testing. The safety was assessed based on the patient's complaints and results of physical and laboratory examination in visits 2 (Day 3 or 4), 3 (Day 5 to 12), and 4 (Day 30 to 40 after taking the first dose of the drug). The trial involved 200 patients, the mean age, 32.7 ± 18.7 and 33.3 ± 18.6 yrs in the 1st and the 2nd groups, respectively. The groups were similar for history, severity, and clinical course of the disease. Clinical efficacy was 96.9 % in both groups in visit 3, 95.9 % and 96.9 % in the 1st and the 2nd group, respectively, in visit 4. The mean duration of antibacterial therapy was 7.1 ± 1.5 days in the 1st group and 7.2 ± 1.4 days in the 2nd group. AE were reported in 15 % and 31 % of the patients, respectively (p = 0.01). Gastrointestinal AE predominated in both the groups but the rate of diarrhea was lower in patients receiving dispersable ACA: 6 % vs. 17 % in the 2nd group (p = 0.027). Therefore, the new dispersable drug form of ACA has better safety profile in adult patients with non-severe LRTI compared to traditional ACA that was demonstrated by reduction in the AE, mainly diarrhea, rate. Both drug forms showed equally high clinical efficacy.

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