Amazwi awanakuchaza usizi nokungabi namandla esikuvayo xa umntu esimthandayo, mhlawumbi umama, utata, okanye umhlobo, efumana isifo se- Alzheimer , esibangela ukulahlekelwa yinkumbulo. Oogqirha kunye nososayensi kwihlabathi liphela basebenza nzima ukufumana unyango lwesi sifo. Ngenxa yemizamo enjalo, ihlabathi laqala ukuthetha ngeyeza i- Aducanumab , eliza phantsi kwegama le-Aduhelm. Kodwa nangona kwakukho amathemba amakhulu ngeli yeza, kwakukho nempikiswano enkulu. Ngoku ukuveliswa kweli yeza kuyekile. Ke namhlanje, masithethe malunga nokuba yintoni le Aduhelm, indlela esebenza ngayo, kunye nesizathu sokuba ingasafumaneki.
Kalula nje, yintoni le Aduhelm (Aducanumab)?
I-Aduhelm liyeza elinikwa izigulana ezikwinqanaba lokuqala lesifo sika-Alzheimer, oko kukuthi, abo baneengxaki ezincinci zokuqonda . Likudidi olukhethekileyo lwamayeza abizwa ngokuba yi -monoclonal antibodies .
Khawucinge nje, xa isifo sika-Alzheimer sivela, uhlobo lweproteni ebizwa ngokuba yi-amyloid luqokelelana phakathi kweeseli zemithambo-luvo engqondweni yethu, luzibeka njengenkunkuma. Oku sikubiza ngokuba yi -amyloid plaques . Ezi plaques zonakalisa iiseli zengqondo kwaye zibangele ukuba zife. Umsebenzi ophambili weyeza le-Aduhelm kukuchonga ii-amyloid plaques eziqokelelana engqondweni kwaye zincede umzimba ukuba uzisuse.
Eli yeza lavunywa yi-US FDA ngendlela engaqhelekanga, lingayinaki ingcebiso yebhodi yeengcebiso ye-arhente. Ngenxa yoko, ezinye iingcali zonyango zathandabuza imfuneko yophando oluthe kratya malunga nokhuseleko nokusebenza kweli yeza.
Nangona kunjalo, inkampani eyayivelisa eli yeza yayeka ukulivelisa ngokupheleleyo ngo-2024. Siza kubona isizathu kamva.
Eli yeza lisebenza njani emzimbeni?
Eli liyeza elinikwa kanye ngenyanga ngokufakwa kwe-IV infusion . Njengoko besitshilo ngaphambili, enye yeempawu eziphambili zesifo se-Alzheimer's kukuqokelelana kweproteni ebizwa ngokuba yi-amyloid-beta engqondweni, yenze iiplaque. Oku kubangela ukuba iiseli zengqondo zife, nto leyo ebangela ukulahleka kwenkumbulo kunye notshintsho kwindlela yokuziphatha.
Iyeza laseAduhelm lisebenza njengomcuphi okhethekileyo. Lingena engqondweni lize lichonge ngqo apho kukho khona ezo plaque ze-amyloid. Liyazibona lize linamathele kuzo. Emva koko lithumela umyalezo kwinkqubo yomzimba wethu yokuzikhusela , lisithi, "Nantsi into ekufuneka isuswe." Emva koko iiseli zenkqubo yokuzikhusela ziyangena zize zitshabalalise ezo plaque.
Izazinzulu zazicinga ukuba ngokususa i-plaque ngale ndlela, iiseli zengqondo ziya kuyeka ukufa kwaye ukuwohloka ngakumbi kwenkumbulo kunye nezakhono zokucinga kuya kulawulwa.
Ingaba eli yeza liyasebenza ngokwenene? Kutheni kukho ingxoxo engaka ngalo?
Lo ngumbuzo abantu abaninzi abanawo. Kwenziwe izifundo ezimbini eziphambili ukuphanda ukusebenza kakuhle kwesiyobisi i-Aduhelm.
1. Uphononongo lokuqala: Oku kubonise ukuba iyeza i-Aduhelm linciphise inani lee-amyloid plaques engqondweni. Likwanciphise kancinci izinga lokuncipha kwenkumbulo kunye nokukwazi ukwenza imisebenzi yemihla ngemihla kwabo bathatha idosi ephezulu yeyeza. Kodwa iyeza alikwazanga ukunqanda okanye ukubuyisela umva isifo.
2. Uphononongo lwesibini: Olu phononongo aluzange lubonise nzuzo kwizigulane. Ke ngoko, olu phononongo luye lwamiswa phakathi.
Iziphumo zolo phononongo lunye zodwa azizange zanele ukwanelisa ibhodi yeengcebiso ye-FDA. Kodwa i-FDA yagqiba ekubeni ivume eli yeza. Kodwa kwangaxeshanye, yanika iBiogen, inkampani eyenza eli yeza, iminyaka elithoba ukuba yenze olunye uphando ukuqinisekisa ukusebenza kweli yeza. Olu vunywa ngequbuliso lwabangela impikiswano enkulu, kwaye ezinye iinkqubo ezinkulu zezibhedlele zagqiba ekubeni zingaliniki izigulane zazo de kubekho ulwazi oluthe kratya malunga neli yeza.
Umahluko phakathi kwe-Aducanumab kunye ne-Lecanemab
Kukho elinye iyeza elibizwa ngokuba yiLecanemab (Leqembi) elifana neAducanumab (Aduhelm). Likwali-antibody ye-monoclonal. Zombini ezi zisebenza ngokujolisa kwiiproteni ze-amyloid engqondweni. Nangona kunjalo, kukho umahluko omncinci kwindlela ezisebenza ngayo. Oko kukuthi, la mayeza mabini asebenza kumanqanaba amabini ahlukeneyo kwinkqubo yokwakheka kwe-amyloid plaque. ILecanemab yamkelwe yi-FDA ngo-2023. Uphando lubonise ukuba inokucothisa ukuqhubela phambili kwesi sifo malunga ne-20%-30%.
Zithini iziphumo ebezingalindelekanga ze-Aducanumab?
Njengalo naliphi na iyeza, i-Aducanumab inokubangela iziphumo ebezingalindelekanga . Ezinye zezi zinokuba yingozi, ngoko ke kubalulekile ukuba uzazi.
| Imiphumela | Ingcaciso elula |
|---|---|
| Ukudumba kwengqondo okwethutyana | Esi sesona siphumo sixhaphakileyo esixelwayo. Sidla ngokuba singenazimpawu kwaye sifunyanwa ngokuskena. |
| Ukopha kancinci kwengqondo | Ezi zihlandlo zihlala zizinto ezingabonakaliyo ezibonakala ngokuphuma kwegazi ezinokubonwa kuphela ngeeskeni. |
| Intloko ebuhlungu | Isiphumo esiqhelekileyo esingalindelekanga. |
| Ukuwa | Kuye kwaxelwa ukuba umzimba uyawa njengoko ibhalansi yomzimba inokuchaphazeleka. |
| Urhudo | Iziphumo ebezingalindelekanga ezinxulumene nenkqubo yokugaya ukutya zinokwenzeka. |
| Ukudideka | Ukucaca kwendlela yokucinga kunokuchaphazeleka okwethutyana. |
Eyona nto ibalulekileyo kukuba ukuba umntu osebenzisa olu hlobo lwamayeza ufumana naziphi na iimpawu ezingaqhelekanga, kufuneka azise ugqirha wakhe ngoko nangoko.
Kutheni ke ngoko eli yeza layekiswa?
NgoJanuwari 2024, iBiogen yabhengeza ukuba iza kuyeka ukuvelisa nokuthengisa iAducanumab ngokupheleleyo. Abantu abaninzi babecinga ukuba oku kungenxa yenkxalabo yokhuseleko okanye ukungasebenzi kakuhle. Kodwa eso asisosizathu sokwenyani.
Le nkampani ichaze ukuba eli nyathelo lenziwe kuba igqibe ekubeni igxile kwizixhobo zayo (imali, amaqela ophando, njl.njl.) ekuphuhliseni nasekukhuthazeni amanye amayeza e-Alzheimer's, ingakumbi amayeza afana neLecanemab. Oko kukuthi, esi yayisisigqibo solawulo lweshishini kunye nezixhobo, kwaye asisosigqibo esenziwe ngenxa yenkxalabo malunga nokhuseleko okanye ukusebenza kakuhle kwamayeza.
Ngesi sigqibo, emva komhla woku-1 kweyeNkanga ngo-2024, kwanezigulana ezifumene eli yeza ngomyalelo kagqirha azisayi kukwazi ukulifumana.
Umyalezo Wokuya Ekhaya
- I-Aduhelm (i-Aducanumab) liyeza elaziswa ukunyanga isifo se-Alzheimer esikwinqanaba lokuqala, kodwa ngoku liyekile ukusetyenziswa .
- Inkqubo yayo esisiseko yayikukunceda umzimba ususe ii-amyloid plaques eziqokelelana engqondweni.
- Kubekho ingxoxo enzulu kuluntu lwezonyango malunga nokusebenza kakuhle kwale chiza. Nangona ezinye izifundo zibonise inzuzo encinci, ezinye azibonisanga.
- Oku akuzange kususwe kwimveliso ngenxa yengxaki yokhuseleko, kodwa kungenxa yokuba inkampani eyenza le mveliso igqibe ekubeni ijolise izixhobo zayo kwamanye amayeza.
- Ukuba wena okanye umntu omthandayo unemibuzo okanye iinkxalabo malunga nesifo i-Alzheimer's, eyona nto ingcono onokuyenza kukubonisana nogqirha wakho wosapho okanye ingcali. Kuphephe ukwenza izigqibo ngokusekelwe kulwazi olufumaneka kwi-Intanethi kuphela.
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