ОБЗОР ПО РЕЗУЛЬТАТАМ ИССЛЕДОВАНИЯ CAPTAIN II — ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ПРИМЕНЕНИЯ ЦЕРЕБРОЛИЗИНА ДЛЯ НЕЙРОВОССТАНОВЛЕНИЯ ПОСЛЕ ЧЕРЕПНО-МОЗГОВОЙ ТРАВМЫ СРЕДНЕЙ И ТЯЖЕЛОЙ СТЕПЕНИ

ЦЕЛЬЮ данного исследования была оценка эффективности и безопасности Церебролизина при лечении пациентов после средней и тяжелой черепно-мозговой травмы (ЧМТ) в качестве дополнения к стандартным протоколам оказания медицинской помощи в острой (нейропротекторной) стадии и на этапах раннего и долгосрочного восстановления в рамках стратегии нейровосстановления.
МАТЕРИАЛЫ И МЕТОДЫ. Было проведено одноцентровое, проспективное, рандомизированное, двойное слепое, плацебо-контролируемое клиническое исследование IIIB/IV фазы. Для участия в нем отбирались пациенты, состояние которых по шкале комы Глазго (ШКГ) оценивалась 7–12 баллов. В дополнение к стандартному протоколу лечения они получали исследуемый лекарственный препарат Церебролизин или физиологический раствор 50 мл/сутки в течение 10 дней, а затем еще 2 дополнительных курса лечения этими же средствами в дозе 10 мл/сутки в течение 10 дней). Критерии эффективности оценивали на 10, 30, 90-й день после ЧМТ в соответствии с принципом a priori упорядоченных гипотез с помощью многомерного направленного теста, отражающего глобальный статус пациентов после ЧМТ. В исследование были включены 142 пациента, из них у 139 проводилась формальная оценка состояния (средний возраст = 47,4, средний балл по ШКГ при поступлении = 10,4 и средний прогностический показатель исходного риска = 2,6). Первичная конечная точка, многомерный комплекс из 13 шкал исходов, продемонстрировали эффект «от малого до среднего» в пользу Церебролизина, который был статистически достоверным на 90-й день. (MУ= 0,59, 95 % ДИ 0,52–0,66, Р = 0,0119). Показатели безопасности и переносимости были сопоставимы между группами лечения.
ВЫВОДЫ: исследование подтверждает предыдущие положительные эффекты мультимодального биологического агента Церебролизина в плане его влияния на общий исход ЧМТ средней и тяжелой степени, результаты исследования нужно оценивать и обобщать в сочетании с имеющимися данными литературы. Из данного широкомасштабного обсервационного исследования можно извлечь пользу для широко применяемого фармакологического препарата — обозначить рамки его использования и установить сравнительную эффективность в реальных клинических условиях 

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