Polscy naukowcy przeprowadzą pierwsze na świecie badania kliniczne nad AZS u dzieci od 2. roku życia
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Polscy naukowcy przeprowadzą pierwsze na świecie badania kliniczne nad AZS u dzieci od 2. roku życia

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Agencja Badań Medycznych przekazała specjalistom z Uniwersytetu Medycznego w Łodzi grant w wysokości 16 mln zł. Dzięki temu naukowcy przeprowadzą pierwsze na świecie badania kliniczne u pacjentów od 2. roku życia z umiarkowaną i ciężka postacią atopowego zapalenia skóry.

Dotychczas prowadzone badania nie pomogły w wynalezieniu zadowalających metod terapeutycznych, biorąc pod uwagę w szczególności leczenie dzieci z AZS. Jedynym lekiem zarejestrowanym na tę chorobę jest dupilumab, który jest preparatem biologicznym. Został on dopuszczony do użytku w Europie przez Europejską Agencję Leków (EMA) dla pacjentów od 6. roku życia, z umiarkowaną i ciężką postacią AZS.

Preparat ten oprócz tego, że do tej pory nie był refundowany, to jeszcze nie mógł być stosowany przez młodsze dzieci. Te natomiast były leczone lekami immunosupresyjnymi, m.in. metotreksatem i cyklosporyną, które również nie są objęte refundacją.

– Stąd też nasz projekt ma na celu przeprowadzenie pierwszego na świecie, randomizowanego, podwójnie zaślepionego i kontrolowanego placebo badania klinicznego u pacjentów z umiarkowaną i ciężką postacią AZS, od 2. roku życia – podkreśla prof. Joanna Narbutt z Uniwersytetu Medycznego w Łodzi, koordynator projektu.

Badania nad cyklosporyną i metotreksatem

Projekt, który został dofinansowany przez Agencję Badań Medycznych pozwoli wykazać poziom skuteczności i bezpieczeństwa stosowania cyklosporyny i metotreksatu u dzieci, szczególnie tych najmłodszych. Projekt przewiduje liczne badania oraz konsultacje, które pozwolą na objęcie tej grupy pacjentów opieką holistyczną. Jest to o tyle istotne, ponieważ pozwoli na poznanie ich problemów dotyczących zdrowia fizycznego, ale też psychicznego.

– Przeprowadzone szeroko badania i konsultacje przyczynią się do lepszego zrozumienia istoty choroby i umożliwią klinicystom prowadzenie bezpiecznej i skutecznej terapii w oparciu o uzyskanie obiektywnych wyników badania – zaznaczyła prof. Joanna Narbutt.

Jak podkreślili specjaliści, projekt jest unikatowy, a otrzymane wyniki będą miały bardzo istotne konsekwencje kliniczne.

W Polsce na atopowe zapalenie skóry choruje ok. 8 proc. dzieci. Jest to ciężka choroba zapalna, która najczęściej dotyka dzieci, a jej pierwsze objawy pojawiają się zazwyczaj do 5. roku życia. Choroba charakteryzuje się zmianami zapalnymi na skórze, które niekiedy mogą obejmować 80-90 proc. powierzchni. Ponadto, z uwagi na przesuszoną skórę pacjenci odczuwają silny i uporczywy świąd.

Źródło: PAP

Przeczytaj także: Naukowcy odkryli związek, który wspomaga gojenie kości i chrząstek

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