Titha tsopano kukonzanso matupi athu
A FDA avomereza chithandizo cha jini kwa nthawi yoyamba-kusuntha kwa mbiri yakale m'mabuku a mankhwala. Chithandizo chatsopano- Kymriah (tisagenlecleucel) -sintha ma T-cells kuti amenyane ndi khansa ya m'magazi.
Chivomerezo cha Kymriya chimakhala ngati chilolezo chovomerezeka ndi mitundu ina ya majeremusi yomwe ingamenyane ndi khansa ndi matenda ena akuluakulu pogwiritsa ntchito njira yatsopano ndi yosangalatsa: kubwezeretsa thupi kudzera njira zopangira.
Gene Therapy Yopangidwa ndi Magulu
Magulu othandizidwa ndi magulu amtunduwu amatanthauza kuyambitsa maselo atsopano m'magulu enaake ndikubwerezanso maselo osinthidwawo m'thupi. Kamodzi m'thupi, maselo atsopanowa akhoza kupanga mapuloteni omwe amathandiza kulimbana ndi khansa kapena matenda ena akuluakulu.
Kymriya imaphatikizapo kuyambitsidwa kwa T-maselo osinthika-mtundu-mtundu wa lymphocyte, kapena selo loyera la magazi-mu thupi. Maselo amtundu wa T omwe amatha kuzindikira ndikusokoneza maselo a khansa ya m'magazi.
Mankhwala a Gene amatha kukhala chemotherapy chifukwa mankhwala a jini alibe poizoni. Chemotherapy imakhudza thupi lonse ndipo imayambitsa mavuto onse m'thupi. Ndi maselo othandizidwa ndi jini, njira zowonjezeredwa zimalowetsedwamo ndipo zimalimbana ndi zotupa makamaka.
Kuphatikiza pa kukhala mawonekedwe a gene, mankhwala a Kymriah amakhalanso wothandizira thupi. Immunotherapy imapatsa mphamvu mphamvu ya chitetezo cha m'thupi pofuna kuchiza matenda.
Kymria Akufotokozedwa
Mwachidziwitso, Novartis's Kymriah ndi njira yowonongeka ya chimeric antigen receptor (CAR) ya T-cell yomwe imagwiritsidwa ntchito pofuna kuchiza kapena kubwezera (mwachitsanzo, kusagwira mankhwala) B-cell acute lymphoblastic leukemia.
Kymriah ndi mawonekedwe a immunotherapy omwe mthupi la T-wodwala amasonkhanitsidwa poyamba ndikutumizidwa ku malo opanga.
T-maselo amakololedwa pogwiritsa ntchito njira yotchedwa leukapharesis.
Kumalo osungirako zinthu, maselo awa T akusinthidwa kuti aphatikizepo jini yomwe imayimira CAR expression. Maselo osinthidwawa amalowetsedwanso mwa wodwalayo. Kamodzi m'thupi, ma CAR amayang'ana antigen wina wotchedwa CD19 amene ali pamwamba pa maselo a khansa ya m'magazi ndikupha maselo a khansa. Kamodzi m'magazi, maselo a T omwe akusinthika amakula ndikukula kuti athetse khansa mkati mwa masabata awiri kapena atatu.
Akatswiri a FDA adakondwera ndi Kymriah pa dzanja limodzi lachidziwitso cha ana awiri, omwe ana 63, achinyamata, ndi achikulire omwe anabwezeredwa kapena akutsutsa B-cell acute lymphoblastic leukemia analandira mankhwala amodzi. Mwa anthuwa, 83 peresenti adapita ku miyezi itatu. Komanso, 75 peresenti anakhalabe opanda matenda pambuyo pa miyezi isanu ndi umodzi. Chofunika kwambiri, Kymriah anapatsidwa kukambitsirana koyambirira ndi kusintha kwa njira zachipatala za FDA.
Kachilombo koyambitsa matenda a m'magazi ndi khansa ya mafupa ndi magazi. Zimayambitsa thupi kupanga ma lymphocyte osadziwika. Maselo osawonongeka a magaziwa amathamangira maselo abwino m'magazi. Timafunikira maselo athu kuti tipulumuke.
Pamene chiwerengero cha maselo enieni amagazi chimacheperatu, imfa imatha.
Ngakhale akuluakulu akhoza kukhala onse, makamaka matenda a ana. Pafupifupi 90 peresenti ya ana onse omwe amatha kupita kuchipatala atalandira chithandizo. Kymriya imavomerezedwa kuti igwiritsidwe ntchito kwa odwala omwe ali ndi zaka zoposa 25 ndipo ali ndi khansara yomwe yabwerera kapena khansa yomwe imatsutsa mankhwala.
Zokhudzana ndi Kymriah
Mmodzi wokhudzana ndi zotsatira zoipa za mtundu uliwonse wa monoclonal antibody therapy ndi cytokine release syndrome, yomwe imatchedwanso kuti cytokine. Cytokines ndi mapuloteni ang'onoang'ono omwe amadziwika ndi maselo ndipo zimakhudza maselo ena.
Kwa anthu ambiri, zizindikiro za cytokine release syndrome ndi zofatsa kapena zochepa ndipo zimatha kuchiritsidwa mosavuta. Zizindikiro izi zikuphatikizapo:
- kuthamanga kwa magazi
- kutopa
- tachycardia
- mutu
- malungo
- kunyoza
- zovuta
- kuthamanga
- kozizira khosi
- vuto lopuma
Komabe, odwala omwe ali ndi khansa ya magazi-monga onse-ali pachiopsezo chachikulu chokhala ndi chimphepo chachikulu cha cytokine ndi zizindikiro zoopsa. Pachifukwa ichi, chifuwachi chiyenera kuchitika pazipangizo zamakono ndi akatswiri ophunzitsidwa kuthetsa mavuto aakulu monga cytokine storm.
Pomalizira, Kymriah ikuyenera kuyendetsa madola 500,000. Komabe, mankhwala ndi Kymriah akadali otchipa kusiyana ndi kuika mafupa a mafupa, omwe amagwiritsidwa ntchito pochizira khansa ya m'magazi.
Mawu Ochokera
Kutsutsa kapena kubwereranso Zonse ndi matenda owopsa. Chivomerezo cha Kymria chimapereka chiyembekezo kwa achinyamata mazana angapo ku United States omwe alibe njira zothandizira zotsalira. Izo zatsimikiziridwa zogwira ntchito mu mayesero a zachipatala. Komabe, mayesero a kachipatala anali ochepa, ndipo amawonekeratu kuti Kymriah ikhoza kuwonetsa moyo wonse.
Mwachidule, chivomerezo cha FDA cha mtundu wa gene geneication nthawi yoyamba chimatulutsa zaka zatsopano za mankhwala: m'badwo umene tingathe kukhazikitsa maselo athu kuti timenyane ndi khansa ndi matenda ena owopsa.
> Zotsatira:
> Breslin S. Cytokine-release syndrome: kufotokoza mwachidule ndi kusamalira ana. Clinical Journal ya Oncology Nursing. 2007; 11: 37-42.
> Colwell J. Panel YAM'MBUYO YOTSATIRA TUMIZANI LINKI SINDIKIZANI Kupeza Khansa. July 27, 2017.
> FDA News Release. Chivomerezo cha FDA chimabweretsa mankhwala oyambirira a jini ku United States. August 30, 2017.
> High KA. Gene Therapy ku Clinical Medicine. Mu: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Mfundo za Harrison za Internal Medicine, 19e New York, NY: McGraw-Hill; 2014.
> Klepin HD, Powell BL. Maselo a White Cell. Mu: Halter JB, Ouslander JG, Studenski S, High KP, Asthana S, Supiano MA, Ritchie C. eds. Hazzard's Geriatric Medicine and Gerontology, 7e New York, NY: McGraw-Hill.