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Исследование показало, что лечение аденомы простаты с iTind действует более четырех лет
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Olympus Corporation

Jul 13, 2023, 17:35 ET

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ГАМБУРГ, Германия, 13 июля 2023 г /PRNewswire/ -- Olympus Corporation, международная компания в области медицинских технологий, объявила о публикации данных исследования, свидетельствующих о том, что минимально инвазивная терапия iTind™ позволяет надолго, более чем на четыре года, облегчить состояние людей, страдающих от симптомов увеличенной простаты, известной также как ДГПЖ.

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The iTind™ procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device remains in place for five to seven days, and upon removal, patients experience rapid and effective relief of their benign prostatic hyperplasia (BPH) symptoms.
The iTind™ procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device remains in place for five to seven days, and upon removal, patients experience rapid and effective relief of their benign prostatic hyperplasia (BPH) symptoms.

Данные долгосрочного исследования показывают, что процедура iTind приводит к значительному и стойкому снижению СНМП (симптомов нижних мочевых путей), связанных с ДГПЖ, и улучшению показателей IPSS (шкала для оценки степени тяжести ДГПЖ) и QoL (качества жизни) в течение более 50 месяцев и до 79 месяцев (6,6 лет) после лечения.1

В связи с пандемией COVID-19 пациенты не могли быть обследованы лично для проведения функционального тестирования на сроке наблюдения > 48 месяцев. Поэтому протокол был адаптирован таким образом, чтобы данные о длительном облегчении симптомов, (IPSS), улучшении QoL и необходимости повторного лечения можно было собрать по телефону.

Краткое изложение результатов долгосрочного исследования

  • Пятьдесят пациентов продолжили проспективное, одномоментное, многоцентровое исследование по истечении 36 месяцев после лечения. В исследовании проанализированы результаты для 41 из 50 пациентов по истечении 48 месяцев. Девять из 50 пациентов были недоступны для последующего наблюдения: пять пациентов были потеряны для последующего наблюдения; два пациента умерли без связи с применением устройства iTind; двум пациентам (36-48 месяцев наблюдения) потребовалось повторное хирургическое вмешательство (одна трансуретральная резекция простаты, одна тулиевая лазерная энуклеация гиперплазии). 
  • Лечение с помощью устройства iTind показало значительное улучшение симптомов, снижение IPSS на 45,3% и IPSS-QoL на 45,1% от исходного уровня до 79 месяцев после процедуры (оба P<0,0001).
  • После 36 месяцев наблюдения не было зарегистрировано поздних послеоперационных осложнений, и ни одному пациенту не потребовалось дополнительное медикаментозное лечение.
  • Частота повторных хирургических вмешательств через 36 месяцев составила 4%, а общая кумулятивная частота повторных вмешательств от исходного уровня до 79 месяцев - 11,1%.

Это исследование финансировалось компанией Medi-Tate - дочерней организацией, полностью принадлежащей компании Olympus Corporation.

Полный текст пресс-релиза представлен на сайт: www.olympus-europa.com

Информация о компании Olympus

На протяжении более 100 лет компания Olympus стремится внести свой вклад в развитие общества, создавая продукты, разработанные с целью достижения оптимальных результатов для своих клиентов по всему миру. Более подробная информация представлена сайте www.olympus-europa.com.

1

Ампароре Д., Де Силлис С., Шульман С., Каднер Г., Фиори С., Порпилья Ф. временное имплантируемое нитиноловое устройство для лечения симптомов нижних мочевых путей, связанных с доброкачественной гиперплазией предстательной железы: результаты за 48 месяцев [опубликовано в Интернете до печати, 23 июня 2023 года]. Minerva Urol Nephrol. 2023;10.23736/S2724-6051.23.05322-3. doi:10.23736/S2724-6051.23.05322-3

Фото - https://mma.prnewswire.com/media/2152729/Olympus_Corporation_itind_threesteps.jpg 
Логотип - https://mma.prnewswire.com/media/1774929/4160711/Olympus_Logo.jpg

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