An sake yin amfani da allunan Psoriasis don EBS
Nazarin da ke amfani da magani mai lasisi a halin yanzu don psoriasis wanda ake sa ran zai rage alamun kumburin EBS mai tsanani a cikin manya da yara.
Dr Christine Chiaverini tana aiki a Cibiyar Asibiti Universitaire de Nice, Faransa akan wannan aikin don fara sake fasalin allunan da ake amfani da su a halin yanzu don maganin psoriasis. Mutane XNUMX, masu shekaru shida ko sama da haka, waɗanda mummunan EBS ke haifar da aƙalla sabbin blisters huɗu a rana, za a ba da allunan apremilast. Nazarin zai ɗauki makonni ashirin ga kowane mutum: bayan gwajin farko za su ɗauki allunan na tsawon makonni takwas, dakatar da makonni huɗu sannan su sake ɗaukar allunan don ƙarin makonni takwas. Za a auna sakamako kamar kumburi, zafi, ƙaiƙayi da ingancin rayuwa yayin lokutan tare da ba tare da jiyya ba kuma idan aka kwatanta da su. Sakamako mai kyau zai goyi bayan mataki na gaba na gwaji na asibiti da aka sarrafa placebo.
Game da kudaden mu
| Jagoran Bincike | Dr Christine Chiaverini |
| Institution | Archet 2 Hospital, Cibiyar Asibiti Jami'ar De Nice, Faransa |
| Nau'in EB | EBS |
| Hanyar haƙuri | Mutane XNUMX, masu shekaru shida da haihuwa suna da EBS |
| Adadin kuɗi | €157,670 |
| Tsawon aikin | 2 shekaru |
| Fara kwanan wata | 18 Yuni 2024 |
| DEBRA ID na ciki | GR000008 |
Bayanan aikin
Wannan gwaji kan yadda apremilast ke aiki ga manya da yara masu tsananin EBS ya fara a ƙarshen 2024. Uku daga cikin cibiyoyin huɗu da ke cikin buɗewa kuma suna shirye don maraba da marasa lafiya.
The cikakkun bayanai na yadda za a gudanar da shari'ar an buga shi a cikin 2025 tare da labarin harshe bayyananne nan.
Dr Chiaverini ya gabatar da sabuntawa kan aikin a karshen mako na 2024:
Dr Christine Chiaverini kwararriyar fata ce a asibitin Archet 2, Nice. Ta an buga sakamako na farko kan jinyar EBS tare da apremilast a cikin 2019 wanda aka ruwaito a cikin wani labarin harshe bayyananne.
Masu bincike: Dr Emmanuelle Bourat; Farfesa Christine Bodemer, Dr Christine Labreze-Hautier, Farfesa Juliette Mazereeuw.
"Manufar wannan binciken shine don kimanta inganci da juriya na apremilast, maganin rigakafi da aka riga aka yi amfani da shi don psoriasis da cutar Becet, don kula da marasa lafiya tare da EBS mai tsanani fiye da shekaru 6."
- Christine Chiaverini
Sunan baiwa: GEBULO. Tsakanin Makonni 20 na Makowa, Buɗe Nazari Yana Ƙimar Inganci da Tsaro na Apremilast (Otezla®) a cikin marasa lafiya> shekaru 6 tare da EB simplex gabaɗaya.
Epidermolysis bullosa simplex yana da alamun fata da raunin mucosa. Siffa mai tsanani (EBS-sev) yana da alaƙa da manyan cututtuka da canjin yanayin rayuwa, duka biyu.
a yara da manya. A halin yanzu babu takamaiman magani ga EBS. Kwanan nan, mun nuna cewa marasa lafiya tare da EBS-sev suna da alamun asibiti na cututtukan fata mai kumburi
da kuma cewa wani takamaiman hanyar kumburi, maganin rigakafi na Th17, yana da alama yana shiga cikin farawar fata. Dangane da waɗannan bayanan, mun bi da apremilast (maganin psoriasis tare da tasirin TH17) 4 manya tare da EBS-sev. An sami raguwa mai ban mamaki kuma mai dorewa a cikin adadin blisters, tare da yarda da haƙuri ga marasa lafiya 3.
Don haka muna ba da shawarar yin ɗimbin cibiyar na mako 20, buɗe binciken da ke kimanta inganci da amincin apremilast a cikin marasa lafiya ≥ 6 shekaru tare da EBS-sev.
Mun shirya haɗa marasa lafiya 20 tare da KRT5/14 EBS-sev mafi rinjaye kuma aƙalla sabbin blisters 4 a rana.
Babban makasudin shine a siffanta:
- inganci na apremilast a cikin lokutan 3 na ƙalubalen ƙalubalen-kalubalantar ƙira kamar binciken a cikin waɗannan marasa lafiya.
Makasudin na biyu shine a siffanta:
- amincin maganin apremilast akan lokacin binciken.
- juyin halittar inganci da matakan sakamakon lafiya a cikin kowane lokacin karatu.
Nazarin ya ƙunshi lokuta 4:
- lokaci na 1: Lokacin dubawa.
- lokaci 2: Lokacin jiyya na farko (Mako 0 zuwa 8).
- lokaci na 3: Babu lokacin jiyya (Mako na 8 zuwa 12).
- lokaci 4: Lokacin jiyya na biyu (Mako 12 zuwa 20).
Nazarin EBULO don kimanta ingancin apremilast a cikin kula da yara da manya tare da EBS mai tsanani ya fara a ƙarshen 2024.
Uku daga cikin cibiyoyin hudu (Saint Louis Paris, Toulouse, Nice) an buɗe kuma suna iya haɗawa da marasa lafiya. Ya kamata a buɗe cibiyar ta ƙarshe a cikin 'yan makonni masu zuwa. An duba marasa lafiya biyu a Nice amma ba sa son shiga cikin binciken. Ana sa ran marasa lafiya uku na manya (1 a Toulouse da 2 a St Louis) nan ba da jimawa ba.
A halin yanzu ana rage abubuwan haɗawa ta hanyar
- yanayi tare da yanayin sanyi don haka ƙananan blisters wanda ke da kyau ga marasa lafiya amma baya ba da damar isa ga ma'auni na haɗawa,
- kuma sama da duka rashin samuwa don siyan yara APREMILAST, duk da amincewarta da EMA. Ita ma dakin gwaje-gwaje na AMGEN ta ki sayar mana da magungunanta domin yin nazari. Don haka dole ne mu jira yarjejeniyar biyan kuɗi da hukumomin Faransa.
Muna fatan hada da karin marasa lafiya a cikin makonni masu zuwa. (Daga rahoton ci gaba na 2025.)