Анализ результатов раннего применения эверолимуса в комбинации с минимизированной дозой ингибиторов кальциневрина после трансплантации почки

Цель исследования: изучение эффективности и безопасности раннего применения эверолимуса в сочетании с минимизированной дозой ингибиторов кальциневрина (ИКН) после трансплантации почки и разработка на этой основе подходов к отбору и ведению реципиентов на поддерживающей иммуносупрессии на базе эверолимуса. Материалы и методы. В исследование включено 67 реципиентов почечного трансплантата, 40 из которых эверолимус назначался в первые сутки после трансплантации почки в комбинации с преднизолоном и ИКН, а 27 – через 2,9 ± 2,0 мес. после операции в результате конверсии с микофенолатов. Длительность наблюдения составила 51,2 ± 35,1 мес. Эффективность терапии эверолимусом оценивали по 4-летней выживаемости реципиентов и почечного трансплантата (ПТ), не цензурированной по смерти, и сравнивали эти показатели с таковыми в группе контроля (n = 89), в которой эверолимус не применялся. Оценивали также выживаемость методики лечения и бессобытийную выживаемость ПТ. При расчете выживаемости методики за конечную точку принимали события, требовавшие отмены препарата, а при анализе бессобытийной выживаемости – такие события, как отторжение, развитие/прогрессирование дисфункции ПТ или протеинурии. За 100% принимали число больных, поступивших под наблюдение после выписки из хирургического стационара. Результаты. 4-летняя выживаемость реципиентов и ПТ в группах эверолимуса и контроля не различалась (р < 0,79 и р < 0,4 соответственно). В группе эверолимуса 4-летняя выживаемость методики лечения составила 57,2%, а бессобытийная выживаемость ПТ – 47,9%. Наиболее частыми причинами отмены эверолимуса были отторжение (25,8% от общего числа всех причин), протеинурия (19%), прогрессирующая дисфункция ПТ (16,1%) и НЯ (16,1%). Бессобытийная выживаемость ПТ зависела от его начальной функции и достоверно снижалась до 32% в группе с исходным Pcr >0,13 ммоль/л против 59,3% в группе с нормальной начальной функцией ПТ, p < 0,04. Средние значения Pcr и протеинурии в динамике нарастали (p < 0,04 и p < 0,004 соответственно). Заключение. Эверолимус в сочетании с минимизированной дозой ИКН может применяться с ранних сроков после операции. Однако возможности такой терапии ограничиваются уже через 4 года почти у 43% больных из-за развития отторжения, прогрессирующей дисфункции трансплантата, протеинурии и нежелательных явлений.

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