Ngoku sinokurhoxisa imizimba yethu
I-FDA iye yamkela unyango lweyeza lomzimba okokuqala ngqa-ukuhamba kwimbali kwiingxelo zamayeza. Ulwaphulo olutsha- I-Kymriah (tisagenlecleucel) -yatshintshile i-T-cell ukulwa ne-leukemia.
Ukuvunyelwa kweKymri kuyasebenza njenge-harbinger yokuvunyelwa kwezinye iifayili zonyango eziza kulwa nomhlaza kunye nezinye izifo ezibi kakhulu usebenzisa inombolo kunye nendlela enomdla: ukulungiswa komzimba ngeendlela zokufakelwa.
I-Articular Based Genetic Treatment
Ulwaphulo lwe-gene olusekelwe kwi-Cell lubhekisela kumsebenzi wokuzisa izinto ezintsha zofuzo kwisitokethi esithile kwaye emva koko kufakela la maseli aguquguqukileyo emzimbeni. Kanye emzimbeni, la maseli amatsha angavelisa amaprotheni anceda ukulwa nomhlaza okanye ezinye izifo ezinzulu.
I-Kymriah ibandakanya ukuqaliswa kwe-T-cells eguqulwa ngokwemizimba-uhlobo lwe-lymphocyte, okanye i-white cell cell-into emzimbeni. Ezi seli-T eziguqulwayo ziyabona kwaye zihlasela iiseli ze-leukemia.
Ulwaphulo lwe-Gene lukhethwa ukuchithwa kwe-chemotherapy ngenxa yokuba izifo zonyango ziyingozi. I-Chemotherapy ithinta wonke umzimba kwaye ibangela iziphumo ezimbi zomzimba. Ngomnxeba we-gene based-based, iiseli ezenziwe ngokutsha zifakwe ngaphakathi kwaye zilwa nezicathulo ngokuthe ngqo.
Ukongezelela ekubeni yindlela yokwelapha i-gene, uKymriah nayo i-agent e-immunotherapeutic agent. I-Immunotherapy iphakamisa amandla omzimba wamasosha ukuphatha izifo.
Kymriah ichazwa
Ngokomsebenzi wobugcisa, i-Novartis's Kymriah iyisistim ye-anti-imgen anti -gengen (CAR) ye-anti-receptor (CAR).
I-Kymri yindlela ekhethiweyo ye-immunotherapy apho i-T-cells yesiguli iqokelelwa kuqala ize ithunyelwe kwiziko lokuvelisa.
I-T-seli ivunwa ngokusebenzisa inkqubo ebizwa ngokuba yi-leukapharesis.
Kwiziko lokuvelisa, ezi T-seli ziguqulwa ukuba zibandakanye imfuza ebonisa iikhowudi ze-CAR. Ezi iiseli eziguqulwayo zifakelwa kwakhona kwisigulane. Kanye emzimbeni, i-CAR ijolise kwi-antigen ethile ebizwa ngokuba yi-CD19 ekhoyo kwiintsholongwane ze-leukemia ize ibulale la maseli omhlaza. Ngenye egazini, ezi zi-T-cell zatshintsha kwaye zandisa ukunqanda umdlavuza kwiiveki ezimbini okanye ezintathu.
Iingcali kwi-FDA zisekelwe imvume yazo yeKymriah kwisandla esisodwa sesilingo sesigaba se-II apho abantwana abangama-63, abatsha, kunye nabaselula abathatywayo okanye abachasayo okanye i-B-cell acute lymphoblastic leukemia bafumana inqanaba elilodwa lonyango. Kulaba bathathi-nxaxheba, ama-83 ekhulwini ayenokuxolelwa emva kweenyanga ezintathu. Ngaphezu koko, iipesenti ezingama-75 zahlala zingenasifo emva kweenyanga ezintandathu. Okubaluleke kakhulu, uKymriya wanikezelwa ukuHlola okuPhambili kunye nokuPhuhliswa kweeNyango ze-ADA.
I-acute lymphoblastic leukemia ngumhlaza wesifo somnyo kunye negazi. Yenza ukuba umzimba wenze i-lymphocytes engavamile. La maseli egazi angacwangciswanga ngokukhawuleza ahluthe amathambo egazi asempilweni kwintsi. Sidinga iiseli zethu zegazi ukuze zisinde.
Xa inani leeseli eziqhelekileyo zegazi liyancipha, ukufa kungaqinisekisa.
Nangona abantu abadala bekhulile bangakhula BONKE, kubaluleke kakhulu isifo sabantwana. Phantse i-90 ekhulwini yabantwana kunye NONKE baya kuxolelwa emva kokonyango. I-Kymria ivunyiwe ukuba isebenzise kwizigulane ezingaphantsi kweminyaka engama-25 ubudala kwaye zibe nomhlaza obuye wabuyela okanye umhlaza ongasimanyanga unyango.
Ukukhathazeka NgoKymriah
Enye malunga nomphumo ongathandekiyo woluphi uhlobo lwe-antioclonal anti-corrosion syndrome, i-cytokine release syndrome, i-reaction infusion ebizwa ngokuba yi-cytokine. I-Cytokines iiprotheni ezincinci ezifihliwe iiseli kwaye ziphumo kwezinye iiseli.
Kwinkoliso yabantu, iimpawu ze-cytokine release syndrome zinyameko okanye zithintela kwaye ziyakucatshwa lula. Ezi zimpawu ziquka:
- uxinzelelo lwegazi oluphantsi
- ukukhathala
- tachycardia
- intloko
- umkhuhlane
- isicaphulelo
- bhinqa
- ukukhawuleza
- emqaleni
- ukuphefumula ukuphefumula
Nangona kunjalo, izigulane ezinomdlavuza wegazi-njengazo ZONKE-zisesichengeni esiphezulu sokukhula kwesiqhwithi se-cytokine kunye neempawu ezisongela ubomi. Ngenxa yoko, ukunyanzelisa kufuneka kuqhutywe kumaziko aphezulu aphezulu kunye neengcali eziqeqeshwe ukulawula iingxaki ezinzulu ezifana nesiphepho se-cytokine.
Ekugqibeleni, uKymriah kulindeleke ukuba ixabise i-$ 500,000. Nangona kunjalo, unyango kunye neKymriah lusemncinci ngaphezu kokutsalwa kwethambo lomongo, oluqhelekileyo lisetyenziselwa unyango lwe-leukemia.
ILizwi
Ukukhankanya okanye ukubuyisela kwakhona ISIBHILE isifo esibulalayo. Ukuvunyelwa kukaKymria kunika ithemba kubantu abancinci abancinci baseUnited States abangenakho unyango olukhethiweyo. Kuye kwabonakalisa ukuphumelela kwizilingo zeklinikhi. Nangona kunjalo, izilingo zekliniki zazincitshiswa ngexesha, kwaye lihlala libonakala ukuba iKymriah inokubangela ukukhutshwa kwexesha lonke.
Ngamazwi atshabalalayo, imvume ye-FDA yendlela yokwelapha i-gene okokuqala ngethuba elidala kwiyeza elitsha: unyaka apho singakwazi ukurhoxisa iiseli zethu ukulwa nomhlaza kunye nezinye izifo ezibulalayo.
> Imithombo:
> I-Breslin S. Cytokine-release syndrome: impembelelo kunye nefuthe lokunesi. I-Clinical Journal ye-Oncology Nursing. 2007; 11: 37-42.
> I-Colwell J. Panel OKs I-CAR T Ukhuseleko lwe-Leukemia. Ukufumana iNgcahla. Julayi 27, 2017.
> FDA News Release. Ukuvunyelwa kwe-FDA kuzisa unyango lokuqala lwe-gene kwi-United States. Agasti 30, 2017.
> High KA. Ulwabiwo lweGene kwiMithi yamayeza. Ku: Kasper D, Fauci A, Hauser S, uLongo D, Jameson J, Loscalzo J. eds. Imigaqo yeHarrison ye-Medicine yangaphakathi, i-19e eNew York, i-NY: i-McGraw-Hill; 2014.
> Klepin HD, uPowell BL. Iingxaki zeeSeli ezimhlophe. Ku: I-Halter JB, i-Ouslander JG, i-Studenski S, i-KP ephezulu, i-Asthana S, i-Supiano MA, i- Ritchie C. eds. I-Gazethi ye-Geriatric Medicine neGerontology, i-7e eNew York, i-NY: iMcGraw-Hill.