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Hlangana ne-Ubrelvy, umuthi omusha ogunyazwe yi-FDA olapha i-migraine

Izindaba

Cishe emindenini e-4 yase-U.S., Othile uhlushwa yi-migraine, ngokusho kwe- I-Migraine Research Foundation . Futhi abaningi balabo abathintekile abakatholi umuthi osebenzayo. Manje, kukhona okusha ukwelashwa kwe-migraine inketho emkhathizwe. I-FDA isanda kuvumela i-Ubrelvy (ubrogepant), umuthi osebenza ngokushesha ukusiza ukunciphisa ubude be-migraines.

Kuyini i-migraine?

I-Migraine akuyona nje ikhanda elibi kakhulu. Eqinisweni, i-migraine kubalwa njenge- isifo sesithupha esikhubaza kakhulu emhlabeni. Ngaphandle kobuhlungu obukhulu bekhanda, ukuphazamiseka okubukwayo, isicanucanu, ukuhlanza, isiyezi, ukuzwela ngokweqile komsindo, ukukhanya, ukuthinta nokuhogela, kanye nokushosholoza noma ukuba ndikindiki emaphethelweni noma ebusweni kuvame ukuhambisana nemigraines.

OKUhlobene : Ungakhuluma nini nodokotela wakho ngemithi kadokotela we-migraines

Zivame kangakanani imigraines?

I-12% yabantu-kufaka ne-10% yezingane-ihlangabezana ne-migraines. Zithinta u-18% wabesifazane baseMelika no-6% wamadoda. Ngokuphelele, lokho kungabantu abangaphezu kwezigidi ezine abane-migraine engapheli yansuku zonke futhi abahlangabezana nezinsuku ezingaphezu kwe-15 ze-migraine ngenyanga.

Amakhambi we-Migraine

Kunemithi eminingi kadokotela etholakalayo ukuvimbela i-migraine, futhi welaphe izimpawu uma umuntu eseqale. Ngaphezu kwalokho, odokotela kwesinye isikhathi bancoma ukuguqulwa kwendlela yokuphila (njengokunciphisa ukucindezeleka noma ukufiphaza izibani), banxuse iziguli ukuthi zithathe i-counter noma i-NSAID yamandla kadokotela (njenge ibuprofen ukuphatha izinhlungu, ukunquma imishanguzo yokuthithibalisa, imishanguzo yokulwa nokudangala, imishanguzo yokulwa nesifo sokuwa, ama-beta blockers, nokweluleka iziguli ukuthi zithole Imijovo yeBotox ukunciphisa imvamisa nezimpawu zemigraines yabo.

OKUhlobene : Ingabe kufanele uthathe i-Topamax yama-migraines akho?

Yini i-Ubrelvy (ubrogepant)?

I-Ubrelvy (ubrogepant) iyindlela yokwelashwa yakamuva ye-migraines (nge-aura noma ngaphandle kwayo). Kuyindlela yokwelapha yenoveli, okusho ukuthi, kungokokuqala ukuthi lesi sigaba semithi sivunyelwe ukwelapha i-migraines. Lokho kungaba izindaba eziguqula impilo yeziguli ezingakatholi ukukhululeka emithini esivele ikhona.

Imithi evunyelwe yi-FDA iqinisekiswe emtholampilo ukuthi inciphise ubude beziqephu ze-migraine, kanye nokunciphisa ubuhlungu nezimpawu ezihambisana nazo. Isebenza ngokuvimba imiphumela ye-calcitonin peptide ehlobene nohlobo lwe-peptide (CGRP) receptor. I-CGRP ikhonjisiwe njengengxenye eyodwa yangaphakathi edala futhi iqinise imigraines. Futhi yize kukhona ezinye izidakamizwa - imijovo egama lingu Aimovig , Ukuba namandla , futhi I-Ajovy —Okuvimbela ama-migraines ngokuvimba i-CGRP, i-Ubrelvy ime ngaphandle ngoba ngumuthi womlomo osebenza ukwelapha i-migraines lapho isivele isenzeka. Kuza nezindlela ezimbili zokukhetha (amaphilisi angama-50 no-100 mg) ukuhlinzeka ngokuguquguquka kwezidingo zeziguli nokwenza ngcono ukusebenza kwabantu abaningi.

I-Ubrelvy yadlulisa ukuhlolwa nokuhlolwa kwemitholampilo, okwaholela ekuvunyelweni kwayo kokugcina kubaphathi. Ngokusho kwe-FDA, ukusebenza komuthi kuboniswe kuzilingo ezimbili ezilawulwa ngokungahleliwe, eziyimpumputhe, ezilawulwa nge-placebo. Ngesikhathi sokufunda, iziguli zabantu abadala ezingama-1,439 ezinomlando we-migraine (nge-aura nangaphandle kwayo) zathola imithamo evunyelwe ye-Ubrelvy yokwelapha i-migraine eqhubekayo.

Kuzo zombili lezi zifundo, cishe iziguli ezingama-19% zabika ukuthi azizwa buhlungu emahoreni amabili ngemuva kokwelashwa (okuchazwa njengokuncipha kobuhlungu bekhanda obuvela ebuhlungwini obulinganiselayo noma obukhulu ngaphandle kobuhlungu) kanti ama-38.6% abike ukuthi azizwa ekhululeka ngokuphelele esibonelweni sabo esengeziwe esibuhlungu kakhulu se-migraine (isicanucanu , ukuzwela okulula, noma ukuzwela komsindo) emahoreni amabili ngemuva kokwelashwa. La maphesenti aphezulu kakhulu phakathi kweziguli ezithola i-Ubrelvy (nganoma yimuphi umthamo) uma kuqhathaniswa nalezo ezathola i-placebo.

Imiphumela emibi kakhulu ye-Ubrelvy yinhliziyo ebusayo kanye nokudangala (ukukhathala).

Njenge-gepant yokuqala yomlomo, i-Ubrelvy inikeza uhlobo olusha nolwehlukile lokukhetha ukwelashwa okunamandla kubantu abaphila nobuhlungu obuthakathaka nezinye izimpawu ze-migraine, uDavid Nicholson, iphini likamongameli omkhulu kanye nomphathi omkhulu we-R & D wenkampani elayisensi ye-Ubrelvy, u-Allergan, kusho isitatimende sephephandaba . Ukuphathwa kwayo ngomlomo ngamandla emithamo emibili kuvumela ukwelashwa okuguqukayo kanye nokukhululeka lapho kuhlaselwa i-migraine. Njengoba siqhubeka nokushayela izinto ezintsha ekwelashweni kwe-migraine, siyaziqhenya ngokunikeza iziguli enye indlela, futhi siyaqiniseka ukuthi kuzokwenza umehluko kulabo abaswele. E-Allergan, sikholelwa ukuthi iziguli ze-migraine zifanelwe ukufinyelela kuyo yonke imithi emisha yalesi sifo esiqeda amandla.