Качество жизни, связанное со здоровьем детей: обзор литературы
Abstract
Исторически, дети редко участвовали в исследованиях препаратов, что может быть связано со сложностью использования детей как объектов медицинских исследований. В отсутствие контролируемых клинических исследований с участием детей врачи и родители не могли быть уверены во многих эффектах лечения этой категории больных. Поэтому регулирующие органы США и Европы недавно приняли ряд нормативных документов, способствующих исследованию эффектов препаратов у детей в качестве компонента клинической разработки лекарств.
Фармацевтические компании откликнулись на это увеличением количества исследований с участием детей. Эти исследования были направлены в основном на изучение эффективности и безопасности, и лишь в относительно небольшом их количестве оценивалось влияние лечения на качество жизни, связанного со здоровьем детей – Health-Related Quality of Life / HRQoL (далее по тексту КЖ). Как и у взрослых, эффекты заболеваний и лечения детей выходят за физиологические рамки.
About the Author
Д. Белоусов
http://www.healtheconomics.ru/
ООО "Центр фармакоэкономических исследований", г. Москва
Russian Federation
ООО "Центр фармакоэкономических исследований", г. Москва
Russian Federation
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