Umthelela omubi ongase ube nawo we-Entyvio ukhathazeka odokotela.
I-Primum engeyona i-nocere . I-aphorism ehlanganisa umoya ohlala njalo wemithi: "Okokuqala, musa ukulimaza." Siphila ezweni lapho odokotela kulindeleke ukuba benze okuthile, benze noma yini ukuphatha isifo. Kodwa ngezinye izikhathi izimpikiswano zesenzo zidlula kakhulu inzuzo yokungasebenzi. Isibonelo, odokotela abahlinzeki ngokuhlinzwa kwabangenacala; odokotela abawunikeli umthamo we-high-dose kubantu abahlukunyezwa ngumdlavuza obulala umzimba; futhi odokotela bazama ukugwema ukuphatha iziguli ezinemithi ngemiphumela emibi engozini yokuphila.
I-Entyvio iyisidakamizwa esisha esihloselwe ukusiza abantu abanezifo zesifo sofuba (IBD), isifo esilimazayo esiqeda izinga lempilo kulabo abathintekayo. Umenzi walo (Takeda Pharmaceuticals), i-FDA kanye ne-gastroenterologists kuyo yonke indawo bakhathazeke, kodwa-ke, ukuthi abantu abazithatha i-Entyvio bangase bavulekele ukutheleleka nge-letifencephalophapathy multifocal (PML) eqhubekayo.
I-PML yisifo esingajwayelekile kubantu abasesimweni sokuzivikela esiphambanweni (cabanga ngabantu abane-AIDS). Kuze kube manje, i-Entyvio engakaze ibangele i-PML kunoma yikuphi abantu abayithatha, kodwa umzala wayo wamakhemikhali, omunye umphikisi we-integrin obizwa ngokuthi i-natalizumab, ubangela i-PML kumuntu ongu-1 ngomunye u-1000 othola ukwelashwa. Ngokubambile, imiphumela engalungile engaba yi-Entyvio ingase ibe ngaphezu komsebenzi wayo wokutholwa komzimba kubantu abane-IBD nezinhlelo zokuzivikela ezibuthakathaka.
Kuyini i-IBD?
Ubulunga bakho yindawo engcolile.
Igcwele amabhaktheriya asisiza ukuba sidle ukudla kwethu. Khumbula ukuthi amabhaktheriya ayizimbungulu, futhi, noma yikuphi ngaphandle kwamathambo, amabhaktheriya anjalo angabangela ukusabela kwamagciwane. (Ukucaphuna uhlamvu lukaBill Murray oluvela ku- Ghostbusters , "ukunikela kwabantu, izinja, namakati abahlala ndawonye, ukukhululeka okukhulu!") Ngenxa yalokho, amasosha omzimba emathunjini ethu ahlale eqaphile, futhi "ukuvuvukala ngokomzimba" yisimo sezinga.
Ngenhlanhla, ngokusebenzisa izindlela eziyinkimbinkimbi, umzimba wethu unciphise ngokugcwele ukuvuselelwa kwamathambo e-lymphoid ehambisana namanzi. Kuvunywa ukuthi konke lokhu okushiwo yi-hypothesis yokuvumelanisa, futhi sonke siyazi ukuthi ezinye izinkolelo zokuvumelana ziyaqala ukuphamba (i-pun ehloselwe ngokuphelele); Noma kunjalo, ukwazi lokho esikuziyo nge-IBD, konke lokhu kunengqondo.
Njengoba kubonakala egameni layo, izifo zesifo sofuba yisifo esiwuphawu oluvuthayo. Inokusabalaliswa kwe-bimodal ngezinsuku eziphakeme eziqala phakathi kuka-15 no-30 no-60 no-80 ngokukhula okwanda kuma-Ashkenazi amaJuda. Izimpawu zomtholampilo ze-IBD zimbi: ubuhlungu besisu, isifo sohudo, ukuphuma kwegazi, i-anemia, nokulahlekelwa kwesisindo. Kungabonakala nakwezinye izindawo ezingaphandle kwamathambo futhi kubangele i-arthritis, izinkinga zamehlo (uveitis ne-iritis), ukuqubuka (i-erythema nodosum) nokuningi.
I-IBD ivela ezinambithelweni ezimbili ezimbi: i-ulcerative colitis nesifo sikaCrohn . Nakuba kufana ngezindlela eziningi, kunezinye umehluko omkhulu phakathi kwalezi zinhlobo ezimbili ze-IBD. I-colitis yokulonda i-ulcerative igxile ekoloni futhi ihlupha izingxenye ezimbi noma ezithandekayo zesiguli; kanti isifo sikaCrohn singathinta noma yikuphi ingxenye yepheshana le-GI (kusuka emlonyeni kuya kwi-anus) futhi ihamba kahle ekudleni kwayo, elula ukweqa izindawo ze-GI ipheshana.
Ngokuvamile, isifo sikaCrohn sisusa indawo engasondelene ne-valve ileocecal. Isifo sikaCrohn senza nezilonda ezithinta umzimba eziphazamisa ukuqina kwamathumba okubangelwa ukuqina noma ngisho ne-fistula (imigudu engavunyelwe phakathi kwamathumbu).
Ngokuphathelene ne-IBD, odokotela bahlose ukulawula ukukhushulwa okukhulu noma ukuqhuma, ukugcina ukuxoxwa okuvela kulolu hlobo lwe-flare-ups nokuphatha i-fistula nokuvinjelwa (okubangelwa iziqu) futhi unikeze nezinye izinyathelo zokwelashwa okuphawulekayo. Abantu abaningi abane-IBD baqeda ukuhlinzwa esikhathini esithile empilweni yabo.
I-mainstay yezokwelapha eziningi ze-IBD ihlanganisa izidakamizwa ezingenakuzivikela ezifana ne-glucocorticoids, i-sulfasalazine, ne-5-aminosalicylic acid.
I-Azathioprine ne-cyclosporine yilezi ezinye izidakamizwa ezivimbela ukuvuvukala nezokuzivikela eziwusizo ekuphatheni i-IBD. Okwedlule, ama-biologic agents afana ne-natalizumab kanye ne-vedolizumab (i-Entyvio) esetshenziselwe ukuphatha i-IBD.
I-Entyvio ne-Progressive Multifocal Leukoencephalopathy (PML)
Ngokusho kwe-FDA:
I-Entyvio ingumphikisi ophikisayo we-integrin. I-Integrin receptors yizinhlelo zamaprotheni ezivezwe ebusweni bamaseli athile. I-Integrin receptors isebenza njengamabhuloho we-cell-cell interactions. I-Entyvio ivimbela ukuxhumana kwe-receptor ethize ye-integrin (evezwe ngokuhambisa amaseli avuthayo) ngeprotheyini ethize (evezwe ngamaseli odongeni lwangaphakathi lwegazi), ngaleyo ndlela ivimba ukufuduka kwalabo abahambisa amaseli avuthayo kulowo methini yegazi nasezindaweni ukuvuvukala emaphethelweni emathunjini.
Ngaphezu kwalokho, ngokwe-FDA:
Imiphumela yabonisa ukuthi amaphesenti amakhulu abahlanganyeli aphathwe nge-Entyvio uma kuqhathaniswa ne-placebo etholakele futhi agcinwe impendulo yomtholampilo, ukutholwa nokugcinwa kokugcinwa kwemitholampilo, kutholakale ukukhululwa komtholampilo ngaphandle kwe-corticosteroid, futhi njengoba kubonwe ngesikhathi sokuphela kwe-endoscopy, kuye kwabonakala kubukeka kahle kwekoloni
Ngamanye amazwi, i-Entyvio isebenza ngokunciphisa ukuvuvukala kumgqa we-GI futhi iphumelele ekuqinisekiseni uma kuphathwa ukuphazamisa nokugcina ukuxolelwa okukhululekile kwe-steroid. Okuphawulayo, ukuhlaziywa kwemeta ye-Entyvio namanye ama-biologic ebonisa ukuthi i-Entyvio yayisebenza ngokulinganayo ekugcineni ukuxolelwa kubantu abane-ulcerative colitis njengezinye izinhlobo zama-biologic agents. Inothi, i-entyvio ihloselwe abantu abangaphenduli noma ababekezelele eminye imithi esetshenziselwa ukuphatha i-IBD (njenge-steroids noma ama-biologic agents).
Kuze kube manje, ukusabela okubi okubhalwe phansi okubangelwa yi-Entyvio cishe kunomkhawulo okhanda ikhanda, ubuhlungu obuhlangene, isicashu, nomkhuhlane. Ukusabela okungathí sina kwakuhlanganisa ukungezwani komzimba kanye nesifo sofuba (isibindi sobindi). Kodwa odokotela, ama-feds, nomenzi wezidakamizwa bahlose umphumela omubi kakhulu ongakayikhulisa ikhanda lakhe elibi: i-multifocal leukoencephalopathy (PML) eqhubekayo.
I-PML iyisifo sezinzwa ezibangelwa ukutheleleka ngegciwane le-JC Iningi lethu linama-antibodies kule gciwane kanye nokutheleleka kubantu abanempilo ngokungajwayelekile. Kodwa kubantu abazivikela ngegciwane lesandulela ngculaza, umdlavuza, i-sarcoidosis nezinye izifo, i-PML ingabamba.
Kubantu abane-PML, igciwane le-JC lidiliza ama-oligodendrocyte noma amangqamuzana omzimba ikakhulukazi ema-hemispheres angama-cerebral kodwa futhi ubuchopho buba khona noma buyi-cerebellum. Ngamanye amazwi, leli gciwane lithinta indaba yethu emhlophe ye-myelin edingekayo ukuze kuqhutshwe izinzwa. Izimpawu zihlanganisa ukuwohloka komqondo, izinkinga zombono, ukukhubazeka (hemiparesis), ukukhathazeka ukukhuluma (aphasia) nokukhubazeka kwesisindo.
Phakathi nezinyanga ezintathu ukuya kwezi-6, i-PML ibulala cishe amaphesenti angu-50 alabo abathintekile. Ukubikezela kulabo abakha PML ngenxa ye-natalizumab therapy ye-multiple sclerosis kungcono kakhulu; amaphesenti angu-20 kuphela afa. Kodwa ngisho nakwabo abaphelela ukuhlala ne-PML, ukukhubazeka kukhulu. Ngokusho kukaHarrison's Principles of Medical Internal , njengokwezikhathi zayo zokushicilela ngo-2012, abantu abangu-104 abaphathwa nge-natalizumab ngenxa ye-multiple sclerosis baqhutshwa yi-PML, futhi umuntu oyedwa olashwe nge-Crohn's wahlakulela lesi sifo.
Ngaphansi
Uma wena noma othandekayo unenkinga ye-IBD, ikakhulukazi i-IBD engayiphenduli ama-steroids namanye ama-immunomodulators, i-Entyvio ibheka ukwelashwa okuthembisayo. Kodwa-ke, ngaphambi kokuqala ukwelashwa nge-Entyvio, kubalulekile ukuthi udalule noma yikuphi ukutheleleka kwamanje noma izifo "ezingahambi" futhi zingase ziphakamise amasosha omzimba abuthakathaka. Ngaphezu kwalokho, uma usanda kugonywa, akufanele uthathe i-Entyvio noma. (Okuphawula, akufanele uthathe i-Entyvio uma unenkinga yesibindi, ukusabela kwemizwa, nokunye okunye.) Uma uthuthukisa izinkinga zezinzwa (noma ngempela izinkinga ezibalulekile) ngenkathi ku-Entyvio, kubalulekile ukuthi uxhumana ngokushesha nokunakekela impilo yakho umhlinzeki.
Ngombhalo wokugcina, kubalulekile ukukhumbula ukuthi asikafiki i-PML kubantu abathatha i-Entyvio . Ngaphezu kwalokho, umenzi we-FDA no-Entyvio abheka ngokucophelela amacala we-PML eyesibili kuya kokuphatha kwe-Entyvio futhi njengamanje enza izifundo zokuthunyelwa kwe-post-marketing nokusiza ukubika okuthuthukisiwe nokuhambelana kwemiphumela emibi.
Imithombo:
> Friedman S, Blumberg RS. Isahluko 295. Isifo Sokukhukhumeza Isifo. Ku: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. I-Harrison's Principals of Internal Medicine, 18e . ENew York, NY: McGraw-Hill; 2012.
I-DA yaseGreenberg, i-Aminoff MJ, uSimon RP. Isahluko 5. Ukuhlukunyezwa Kwe-Dementia & Amnestic. Ku: DA Greenberg, Aminoff MJ, Simon RP. ama-eds. I-neurological Clinical, i-8e . ENew York, NY: McGraw-Hill; 2012.
"I-Vedolizumab (Entyvio) ye-Inflammatory Bowel Illness" evela kuThe Medical Letter on Drugs and Therapeutics eshicilelwe ngo-9/15/2014.
Wallace JL, Sharkey KA. Isahluko 47. Pharmacotherapy of Inflammatory Bowel Disease. Ku: Brunton LL, Chabner BA, Knollmann BC. ama-eds. Goodman & Gilman's The Baseline of Therapeutics, 12e . ENew York, NY: McGraw-Hill; 2011.