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FDA zatwierdziła nowy produkt w leczeniu oparzeń. To alternatywa dla chirurgii

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Amerykańska Agencja ds. Żywności i Leków (FDA) zatwierdziła produkt medyczny StrataGraft, powstały z dwóch rodzajów ludzkich komórek skóry, przeznaczony do leczenia ciężkich oparzeń termicznych. Rozwiązanie pozwoli ograniczyć interwencje chirurgiczne u pacjentów, którzy doznali głębokich oparzeń.

Firma Mallinckrodt Pharmaceuticals z Irlandii stworzyła alternatywę dla chirurgicznego leczenia oparzeń. Produkt StrataGraft wytwarzany jest z dwóch rodzajów komórek ludzkiej skórykeratynocytów i fibroblastów, które tworzą tzw. rusztowanie w miejscu oparzenia dla wzrostu nowych komórek.

Leczenie StrataGraft wyeliminowało potrzebę autoprzeszczepu u 71 na 101 pacjentów

StrataGraft jest w formie cienkiego, przezroczystego materiału, o powierzchni około 100 centymetrów kwadratowych. Przeznaczony jest wyłącznie do użytku miejscowego. Produkt można przycinać do rozmiaru rany.

FDA oparła swoją decyzję na podstawie badań klinicznych, które objęły łącznie 101 pacjentów z głębokimi oparzeniami termicznymi. Uczestnicy poddani zostali dwóm metodom leczenia – autoprzeszczepowi oraz produktem StrataGraft. Badacze wykazali, iż leczenie StrataGraft wyeliminowało potrzebę przeszczepu u 71 pacjentów. Po trzech miesiącach leczenia 92 proc. ran pooparzeniowych zamknęło się. Produkt nie został  odrzucony przez układ odpornościowy żadnego z pacjentów, nie zgłoszono również przypadków infekcji.

Najczęstszym działaniem niepożądanym było swędzenie (u 11 uczestników badań), powstanie pęcherzy, blizn przerostowych i zaburzenia procesu gojenia się rany. FDA oceniła, że profil bezpieczeństwa StrataGraft jest bardzo podobny do profilu bezpieczeństwa autoprzeszczepu.

Źródło: Mallinckrodt Pharmaceuticals

StrataGraft może zmniejszyć potrzebę interwencji chirurgicznych

Dr n. med. Peter Marks, dyrektor Centrum Oceny i Badań Biologicznych w FDA, zwraca uwagę, iż oparzenia mogą być niezwykle trudnym do leczenia urazem. W przypadku wielu głębokich oparzeń leczenie często polega na interwencji chirurgicznej, usunięciu uszkodzonych tkanek i zastąpienie ich przeszczepem z innego miejsca ciała pacjenta. Autoprzeszczep pozostawia jednak ranę w innym miejscu. Dyrektor naukowy Mallinckrodt, Steven Romano, podkreśla, że zatwierdzenie StrataGraft to kamień milowy dla dziedziny medycyny zajmującej się leczeniem oparzeń.

– W ciągu ostatnich dwóch, trzech dekad było niewiele postępów w leczeniu tego typu oparzeń, dla których StrataGraft jest wskazany. Chirurdzy mają teraz do dyspozycji nową metodę leczenia, która pomoże zmniejszyć potrzebę stosowania autoprzeszczepów – dodał ekspert.

Źródło: FDA, medcitynews.com, Mallinckrodt Pharmaceuticals

Więcej tematów związanych z leczeniem oparzeń będzie poruszanych na konferencji Oparzenia 2021, która odbędzie się w dniach 18-20 listopada w Zakopanem.

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