Tšusumetso e mpe ea Entyvio e ameha ka lingaka.
Primum ha e na mocha . Tlhahlobo e kenyang moea oa ho phekola o sa feleng: "Ntlha ea pele, u se ke ua ntša kotsi." Re phela lefats'eng moo lingaka li lebeletsoeng hore li etse ntho e 'ngoe, li etse ntho leha e le efe ho phekola mafu. Empa ka linako tse ling liphello tsa ketso li feta molemo oa ho se sebetse. Ka mohlala, lingaka ha li etse opereishene ho batho ba sa etsoeng ka molao; lingaka ha li fane ka chemo e phahameng ho batho ba senyehileng ke kankere ea metastatic e bolaeang; 'me lingaka li leka ho qoba ho phekola bakuli ba nang le meriana le liphello tse kotsi bophelong.
Entyvio ke lithethefatsi tse ncha tse reretsoeng ho thusa batho ba nang le mafu a ho ruruha (IBD), boloetse bo senyang bo senyang boleng ba bophelo ho ba amehileng. Moetsi oa eona (Takeda Pharmaceuticals), FDA le gastroenterologists hohle ba tšoenyehile, leha ho le joalo, hore batho ba nkang Entyvio ba ka 'na ba itumella hore ba tšoaetsoe ke tšoaetso e tsoelang pele ea leihloencephalopathy (PML) e tsoelang pele.
PML ke tšoaetso e sa tloaelehang ea tsamaiso ea methapo e meholo hangata e fumanoang feela ke ba nang le mekhoa e mengata ea ho itšireletsa mafung (nahana ka batho ba nang le AIDS). Ho fihlela joale, Entyvio ha e e-s'o bake PML ho batho leha e le bafe ba e nkang, empa motsoala oa eona oa lik'hemik'hale, motsoako o mong oa li-antinist ea bitsoang natalizumab, o baka PML ho motho a le mong ho ba 1000 ho fumana phekolo. Ka kakaretso, liphello tse bohloko tse ka hlahisoang ke Entyvio li ka 'na tsa feta matla a eona a bophelo bo botle ho batho ba nang le IBD le mekhoa ea ho itšireletsa mafung.
BD ke eng?
Matlalo a hau ke sebaka se litšila.
E tletse libaktheria tse re thusang ho cheka lijo tsa rona. Hopola hore libaktheria ke likokoana-hloko, 'me, kae kapa kae ka ntle ho maru, libaktheria tse joalo li ka baka tšoaetso ea' mele ea 'mele. (Ho qotsa sebopeho sa Bill Murray ho Ghostbusters , "mahlabelo a batho, lintja le likatse tse phelang hammoho, boima bo feteletseng!") Ka hona, lisele tsa 'mele tsa' mele oa rona li sireletsehile, 'me "ho ruruha ha' mele" ke maemo a quo.
Ka lehlohonolo, ka mekhoa e rarahaneng, 'mele oa rona o fokotsa ka botlalo-ts'ebetsong ea moriana oa lymphoid. Ha ho pelaelo hore sena sohle se hlahella ke tumellano ea tumellano, 'me bohle rea tseba hore litabeng tsa tumellano li lumellana (pun e reriloe ka ho feletseng); leha ho le joalo, ho tseba seo re se tsebang ka IBD, sena sohle sea utloahala.
Joalokaha ho hlakile ka lebitso la lona, mafu a ho ruruha ke lefu la boea ke boemo boo pontšo ea bona e leng ho ruruha. E na le kabo ea bimodal ka nako e telele e qalehang pakeng tsa 15 le 30 le 60 le 80 ka ho ata hoaholo ho Bajuda ba Ashkenazi. Matšoao a meriana a IBD a bobebe: bohloko ba mpa, letšollo, mali, mali le ho lahleheloa ke boima. E ka boela ea bonahala libakeng tsa anatomic ka ntle ho sekoti le ho baka lefu la ramatiki, mathata a mahlo (uveitis le iritis), ho phatloha (erythema nodosum) le ho feta.
IBD e na le menyetla e 'meli e tšabehang: lefu la ulcerative le lefu la Crohn . Le hoja ho le joalo ka litsela tse ngata, ho na le phapang e khōlō pakeng tsa mefuta ena e 'meli ea IBD. Lefu la ho ruruha ha lefu le kenngoa ka har'a colon mme le otla likarolo tsa likhohlopo kapa tse khotsofatsang; athe lefu la Crohn le ka ama karolo leha e le efe ea pampitšana ea GI (ho tloha molomong ho ea ho anus) 'me e na le patchy ea mafu a eona, e batlang ho tlōla libaka tsa pampitšana ea GI.
Hangata, lefu la Crohn le senya mohaho o haufi le valve ea ileocecal. Lefu la Crohn le boetse le baka lisele tse fetisisang tse amanang le botenya bohle ba moriana o bakoang ke litekanyetso kapa esita le fistula (litsela tse sa amoheleheng pakeng tsa likarolo tsa mala).
Mabapi le IBD, lingaka li ikemiselitse ho laola bohale bo feteletseng, ho boloka phoso ea liphoso tse joalo le ho tšoara fistula le ho thibela (ho bakoang ke li-strictures) le ho fana ka mehato e meng ea phekolo ea matšoao. Batho ba bangata ba nang le IBD qetellong ba buuoa ka nako e itseng bophelong ba bona.
Ntho e ka sehloohong ea phekolo ea bongaka ea IBD e akarelletsa lithethefatsi tse sa tšoaneng tse kang glucocorticoids, sulfasalazine, le 5-aminosalicylic acid.
Azathioprine le cyclosporine ke lithethefatsi tse ling tse khahlanong le ho ruruha le li-immunosuppressant tse thusang ho phekola IBD. Haufinyane tjena, mahlahana a biologic a kang natalizumab le a vedolizumab (Entyvio) a 'nile a sebelisetsoa ho tšoara IBD.
Entyvio le Progressive Multifocal Leukoencephalopathy (PML)
Ho ea ka FDA:
Entyvio ke mohanyetsi oa batho ba amohelang molaetsa. Li-receptor tsa Integrin ke liprotheine tse hlalositsoeng holim'a lisele tse itseng. Li-receptor tsa Integrin li sebetsa joaloka marokho bakeng sa ho sebelisana ha sele-cell. Entyvio e thibela tšebelisano ea mokelikeli o khethehileng oa integrin (o hlalositsoeng ka ho potoloha lisele tsa ho ruruha) ka protheine e khethehileng (e hlalositsoeng ka lisele tse ka hare ho lerako la methapo ea mali), kahoo e thibela ho falla ha lisele tsa ho ruruha ho pholletsa le methapo ea mali le libakeng ea ho ruruha ka pampiri ea meno.
Ho feta moo, ho ea ka FDA:
Liphello li bontšitse hore karolo e kholo ea barupeluoa ba tšoaroa ka Entyvio ha e bapisoa le sebaka sa placebo se fihletsoeng le se bolokiloeng karabo ea litleliniki, ho finyelloa le ho ts'oaroa kerekeng, ho finyelloa ha kliniki e sa lefelloeng ea corticosteroid, 'me joalokaha ho bone nakong ea endoscopy, ho bile le ponahalo e ntlafetseng ea kolone
Ka mantsoe a mang, Entyvio e sebetsa ka ho fokotsa ho ruruha pampitšaneng ea GI 'me e ipakile e sebetsa ha e sebetsana le liphoso le ho boloka pholiso ea mahala ea steroid. Ka hloko, ho hlahloba litlhapi tsa Entyvio le mahlahana a mang a li-biologic ho bontšitse hore Entyvio e ne e sebetsa ka mokhoa o tšoanang ho boloka ho fokotsoa ho batho ba nang le lefu la ho ruruha ha diso joaloka mefuta e meng ea mahlaseli a biologic. Tlhokomelo, entyvio e reretsoe batho ba sa amoheleng meriana e meng ea ho phekola IBD (joaloka li-steroids kapa li-biologic agents).
Ho tla fihlela joale, litlaleho tse mpe tse ngotsoeng ke Entyvio li ne li fokolloa haholo ke hlooho, bohloko bo kopantsoeng, ho nyeheloa ke pelo, le feberu. Liphetoho tse tebileng haholo li kenyelletsoa ho tsoa hohle le ho hepatotoxicity (sebete sa sebete). Empa lingaka, libethe le moetsi oa lithethefatsi li lebeletse phello e tebileng haholo e sa ntseng e hlahisa hlooho ea eona e bobe: e tsoelang pele ea multitifocal leukoencephalopathy (PML).
PML ke lefu la pelo le bakoang ke tšoaetso le kokoana-hloko ea JC Boholo ba rona re na le li-antibodies ho kokoana-hloko ena le tšoaetso ho batho ba phetseng hantle ba sa tloaelehang haholo. Empa ho batho bao mekhoa ea bona ea ho itšireletsa mafung e etsoang ke HIV, kankere, sarcoidosis le maloetse a mang, PML e ka tšoara.
Ho batho ba nang le PML, kokoana-hloko ea JC e senya li-oligodendrocyte kapa methapo ea methapo haholo-holo likokotlong tsa bongoana empa hape li bakoa ke boko kapa cerebellum. Ka mantsoe a mang, kokoana-hloko ena e nka taba ea rona e tšoeu ea myelin e hlokahalang bakeng sa ho khanna methapo. Matšoao a kenyelletsa 'dementia', mathata a pono, ho holofala (hemiparesis), bothata ba ho bua (aphasia) le ho holofala ha maikutlo.
Ka likhoeli tse 3 ho isa ho tse 6, PML e bolaea karolo ea 50 lekholong ea ba tšoaelitsoeng. Ho phatloha ha batho ba hlahisang PML ka lebaka la phekolo ea natalizumab bakeng sa multiple sclerosis ho batla ho le molemo; ke karolo ea 20 lekholong feela e shoang. Empa esita le bakeng sa ba qetellang ba phela le PML, bokooa bo tebile. Ho ea ka Melao ea Harrison ea Internal Medicine , ho ea ka khatiso ea eona ea 2012, batho ba 104 ba tšoaroa ke natalizumab bakeng sa multiple sclerosis ba hlahisitsoe ke PML, mme motho a le mong feela ea tšoeroeng ke Crohn o ile a ntlafatsa lefu lena.
Ntho e ka tlaase
Haeba uena kapa motho eo u mo ratang a e-na le bothata ba IBD, haholo-holo IBD e sa amoheleng li-steroids le li-immunomodulator tse ling, Entyvio e shebahala joaloka phekolo e tšepisang. Leha ho le joalo, pele o qala kalafo ka Entyvio, ho hlokahala hore u senole tšoaetso leha e le efe ea hona joale kapa mafu a "sa tsamaee" 'me a ka fana ka maikutlo a hore tsamaiso ea' mele ea ho itšireletsa mafung e fokotsehile. Ho feta moo, haeba u sa tsoa entoa, ha ua lokela ho nka Entyvio kapa. (Tlhokomeliso, ha ua lokela ho nka Entyvio haeba u e-na le mathata a sebete, liphello tsa khatello ea maikutlo, joalo-joalo.) Haeba u hlahisa mathata a kelello (kapa mathata a bohlokoa) ha u ntse u le Entyvio, ho hlokahala hore u ikopanye hang-hang tlhokomelo ea hau ea bophelo. mofani.
Tlalehong ea ho qetela, ke habohlokoa ho hopola hore ha re e-s'o hlokomele PML ho batho ba nkang Entyvio . Ho feta moo, moetsi oa FDA le Entyvio ba shebile haufi-ufi linyeoe tsa PML tse nyenyane ho tsamaiso ea Entyvio 'me hona joale ba khanna lithuto tsa morao-rao le ho tsamaisa litlaleho tse tsoetseng pele le tse potlakileng tsa liphello tse bohloko.
Lisebelisoa:
> Friedman S, Blumberg RS. Khaolo ea 295. Maloetse a Bohale a Tšoaetso. Ka: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Melao-motheo ea Harrison ea Internal Medicine, 18e . New York, NY: Hill ea McGraw; 2012.
DA Greenberg, Aminoff MJ, Simon RP. Khaolo ea 5. Dementia & Mathata a Amnestic. Ka: Greenberg DA, Aminoff MJ, Simon RP. eds. Clinical Neurology, 8e . New York, NY: Hill ea McGraw; 2012.
"Vedolizumab (Entyvio) bakeng sa Maloetse a Bokooa" a The Medical Letter on Drugs and Therapeutics e hatisitsoeng ka 9/15/2014.
Wallace JL, Sharkey KA. Khaolo ea 47. Pharmacotherapy ea Matšoafo a Mafu a Tšoaetso. Ka: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's The Basic Pharmacological Therapeutics, ea 12e . New York, NY: Hill ea McGraw; 2011.