КЛИНИЧЕСКИЕ ИСПЫТАНИЯ ПРЕПАРАТА ВЕНТФОРТ

Posted by andrian 04.06.2020 120 Коментарий Клинические исследования,

«УТВЕРЖДАЮ»
Директор Медицинского центра
Санкт-Петербургского института биорегуляции
и геронтологии СЗО РАМН,
член корреспондент РАМН, профессор,
доктор медицинских наук
В. Х. Хавинсон

 

 

 

 

 

 

 

Отчет о результатах клинического изучения биологически активной добавки к пище Вентфорт

 

 

Биологически активная добавка к пище Вентфорт* содержит комплекс низкомолекулярных пептидов с молекулярной массой до 5 000 Да, выделенных из ткани сосудов (аорты) молодых животных — телят до 12-месячного возраста.
Вентфорт* выпускается в виде капсул с содержанием активных веществ 10 мг.

 

 

Экспериментальные исследования показали, что пептиды обладают тканеспецифическим действием на клетки тех тканей, из которых они выделены. Они улучшают трофику клеток тканей сосудистой стенки и оказывают регулирующее действие на обменные процессы в них, способствуют нормализации функциональных изменений в сосудистой стенке, регулируют содержание холестерина и липопротеидов в крови, снижая риск возникновения различных поражений сосудов. Это позволяет предполагать эффективность применения Вентфорт* для восстановления функции сосудов при различных заболеваниях, в том числе при атеросклерозе сосудов.

 

 

Атеросклероз и его последствия являются одной из ведущих причин инвалидизации смертности в развитых странах. Нарастающие с возрастом изменения сосудистой стенки и нарушение гемодинамики приводят к снижению периферического кровообращения, васкуляризации органов и тканей, развитию различных компонентов кислородной недостаточности и трофических расстройств (2,3,4,6).

 

 

Медикаментозное лечение атеросклероза направлено на нормализацию липидного обмена, процессов свертывания крови и метаболизма в сосудистой стенке (1,5).

 

Лекарственные средства, нормализующие уровень холестерина и В-липопротеидов:

 

  • препятствующие всасыванию холестерина в кишечнике – холестирамин, В-ситостерин, диоспонин, полиспонин;
  • нарушающие синтез холестерина а организме – клофибрат, мисклерон, регардин, цетамифен, никотиновая кислота, витамин РР;
  • усиливающие расщепление и выделение холестерина из организма – линетол, арахиден.

 

Средства, улучшающие микроциркуляцию, нормализующие проницаемость сосудов, уменьшающие отечность тканей сосудов и улучшающие метаболические процессы в стенке сосудов:

 

  • продектин, дицинон, доксиум, гливенол, эскузан и др.

 

Клинические испытания Вентфорт* проводили в Медицинском центре Санкт-Петербургского института биорегуляции и геронтологии у больных атеросклерозом различных артерий и сенильной пурпурой в период с ноября 2005г. по февраль 2006г.      

 

Клиническая характеристика больных

 

В клинических испытаниях приняли участие 49 больных атеросклерозом артерий и сенильной пурпурой (васкулопатия, обусловленная ухудшением трофики сосудов кожи с уменьшением их количества и сужением просвета, как в артериальном, так и в венозном отделах, дистрофия эндотелеоцитов и микротромбозы), 27 из которых составили основную группу (15 мужчин, 12 женщин) — им дополнительно к общепринятым средствам назначали Вентфорт* перорально за 10–15 минут до еды по 1–2 капсулы 2–3 раза в день в течение 10–15 дней в зависимости от степени выраженности патологического процесса. 22 больным (11 мужчин, 11 женщин), вошедшим в контрольную группу, назначали только общепринятые средства. Возраст пациентов обеих групп составлял от 52 до 84 лет (таблица 1).

 

 

У больных обеих групп отмечались различные клинические проявления  в зависимости от поражения сосудов разного калибра: гипертоническая болезнь, ишемическая болезнь сердца, цереброваскулярные расстройства с нарушением памяти, концентрации внимания, эффективной лабильностью. У всех больных отмечалась прогрессирующая динамика развития заболеваний.

 

 

Все больные ранее получали симптоматическую и патогенетическую терапию по поводу конкретных клинических проявлений сосудистой патологии.  

 

 

Таблица 1 «Распределения больных по нозологическим формам, полу и возрасту»

 

 

Диагноз

Возраст

Мужчины

Женщины

Всего

  

Контрольная

группа

Основная

группа

Контрольная

группа

Основная

группа

Контрольная

группа

Основная

группа

Атеро-склероз

артерий

52–71

9

11

6

9

15

20

Сениль-ная пурпура

72–84

2

4

4

3

7

7

Всего

 

11

15

10

12

22

27

                                                      

 

Методы исследования

 

В динамике оценивали жалобы больных, проводили общеклиническое исследование крови и мочи, биохимическое изучение крови на аппарате «РЕФЛОТРОН» (Германия). С целью исследования гомеостаза определяли коагулограмму крови и использовали пробу Гесса со жгутом.

 

Результаты исследования

 

Установлено, что применение Вентфорт* у больных атеросклерозом артерий способствовало улучшению общего самочувствия, особенно у больных с цереброваскулярными расстройствами.

 

Как видно из таблицы 2, применение Вентфорт* способствовало достоверному снижению уровня общего холестерина в крови. Также отмечалась тенденция к снижению содержания липопротеидов очень низкой плотности, являющихся наиболее атерогенными.

 

У больных сенильной пурпурой после применения Вентфорт* наблюдалось повышение прочности стенок капилляров, о чем свидетельствуют результаты пробы Гесса, частота появления пятен кровоизлияний уменьшилось. У большинства больных улучшилось состояние кожи и волос.

 

Таблица 2 «Влияние Вентфорт на показатели липидного обмена у больных атеросклерозом артерий»

 

 

Показатель

До лечения

После лечения 
с применением 
общепринятых средств

После лечения 
с применением 
Вентфорт

Общий холестерин,

(ммоль/ Л)

8,6 - 0,4

7,2 - 0,5

6,0 - 0,7

Липопротеиды очень

низкой плотности,

(моль/Л)

1,32 - 0,05

1,13 - 0,07

0,91 - 0,6

Триглицериды

(ммоль/Л)

4,7- 0,5

4,3 - 0,6

4,1 - 0,6

 

*Р <  0,05 – достоверно по сравнению с показателем до лечения.

 

 

 У больных с сенильной пурпурой после применения Вентфорт* наблюдались улучшение состояния кожи и повышение прочности стенок капилляров, о чем свидетельствовали результаты пробы Гесса. Частота появления пятен кровоизлияний уменьшилось.

 

 

Таким образом, результаты проведенного исследования свидетельствуют о терапевтической эффективности Вентфорт* и целесообразности его применения в комплексном лечении атеросклероза и сосудистой патологии.

 

 

При применении Вентфорт* не было выявлено побочного действия, осложнений, противопоказаний и лекарственной  зависимости.

 

 

Изучавшаяся готовая форма Вентфорт* удобна для применения в стационарных, амбулаторных условиях и на дому.

 

 

Вентфорт* может применяться с лечебно-профилактической целью в виде биологически активной добавки к пище, в качестве вспомогательного средства в комплексной терапии атеросклероза сосудов и улучшения микроциркуляции в различных тканях, в сочетании с любыми средствами симптоматической и патогенетической терапии.

 

 

Заключение

 

 

Биологически активная добавка к пище Вентфорт* оказывает регулирующее воздействие на содержание холестерина и липопротеидов крови и способствует улучшению состояния стенки сосудов.

 

 

Вентфорт* хорошо переносится при пероральном применении, не оказывает побочного действия, не имеет противопоказаний и может применяться в качестве вспомогательного средства в комплексном лечении и профилактики сосудистых заболеваний различного генеза.

 

 

Вентфорт* рекомендуется применять для улучшения функций сосудистой стенки при атеросклерозе, нарушении микроциркуляции в органах и тканях при различных заболеваниях, воздействии на организм различных экстремальных факторов. Также рекомендуется лицам пожилого возраста для поддержания функции сосудистой системы.

 

 

Рекомендуемые дозировки Вентфорт:

 

 

  • применять перорально за 10 - 15 минут до еды по 1–3 капсулы 2–3 раза в день в течение 10–30 дней.

 

 

Целесообразно проводить повторные курсы лечения каждые 3–6 месяцев.

 

 

Литература

 

  1.  Белоусов Ю.Б., Моисеев В.С., Лепахин В. К. Клиническая формакология и фармакотерапия: Руководство для врачей. — М.: Универсум, 1993. — 398 с.
  2. Болезни крови у пожилых: Пер. с англ. /Под ред. М.Дж.Денхэма, И. Чанарина. — М.: Медицина, 1989. — 352 с.
  3. Гормоны и сосудистые заболевания: Пер. с англ. /Под ред. Р.М.Гринхалга. — М.: Медицина, 1984. — 344 с.
  4. Коркушко О.В. Сердечно-сосудистая система и возраст. — М.: Медицина, 1983. — 176 с.
  5. Машковский М.Д. Лекарственные средства: Пособие по фармакотерапии для врачей: В 2 Ч. — Вильнюс: ЗАО «Гамта», 1993.
  6. Руководство по гериатрии / Под ред. Д.Ф. Чеботарева, Н.Б. Маньковского. — М.: Медицина, 1982. — 544 с.

 

 

Ответственный исполнитель:

Исполнитель:

Заместитель директора

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ООО «Медицинский центр Санкт-Петербургского института биорегуляции и геронтологии СЗО РАМН»

ООО «Медицинский центр Санкт-Петербургского института биорегуляции и геронтологии СЗО РАМН»

по клинической работе, кандидат медицинских наук, доцент А. А. Веретенко

кандидат медицинских наук О. Ю. Райгородский

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