Impembelelo enokuthi yenzeke ye-Entyvio ixhalabisa oogqirha.
Primum non nocere . I-aphorism efaka umoya ohlalayo weyeza: "Okokuqala, musa ukulimaza." Siphila kwihlabathi apho kulindeleke ukuba oogqirha benze okuthile, benze nantoni na ukuphatha izifo. Kodwa ngamanye amaxesha iziphumo zentshukumo zigqithise ngakumbi inzuzo yokungasebenzi. Ngokomzekelo, oogqirha abayenzi utyando kubaviwa abangabhenyuli; oogqirha abanikeli isitifiketi esiphezulu kubantu abaxhatshazwa ngumdlavuza obulalayo; kwaye oogqirha bazama ukuphepha ukugulisa izigulane ngeyeza kunye nemiphumo ebungozi yobomi.
I-Entyvio isilwanyana esitsha esiluncedo ekuncedeni abantu abanezifo zesibindi sokuvuvukala (IBD), isifo esiyingozi esonakalisa umgangatho wobomi kulabo bachaphazelekayo. Umenzi walo (Takeda Pharmaceuticals), i-FDA kunye ne-gastroenterologists kuyo yonke into ixhalabile, nangona kunjalo, ukuba abantu abathatha i-Entyvio bavulele ukusuleleka kwiintsholongwane ze-letifencephalopathy (PML).
I-PML yintsholongwane engabonakaliyo yinkqubo yesantya esisiseko edlalwa ngamava anesistim e-immune (icinga abantu abane-AIDS). Kuze kube ngoku, i-Entyvio ayizange ibangele i-PML kunoma yiyiphi na abantu abayithathayo, kodwa umzala wayo wamakhemikhali, omnye umntu ophikisanayo no-natalizumab, ubangela i-PML malunga nomntu ongu-1 ukuya ku-1000 efumana unyango. Ngokubalulekayo, iziphumo ezinobungozi ze-Entyvio zingaphaya kweenkonzo zonyango kubantu abane-IBD kunye neenkqubo ezikhuselweyo zokuzivikela.
Yintoni IBD?
Ubhudo bakho yindawo engcolileyo.
Izaliswe ngeibhaktheriya ezinokusinceda sidle ukutya kwethu. Khumbula ukuba iibhaktheriya ziyi-bugs, kwaye, naphi na ngaphandle kwimizi, loo bhaktheriya iya kubangela ukuphendula kwamagciwane. (Ukucaphula umlingiswa kaBill Murray ovela kwi- Ghostbusters , "imibingelelo yabantu, izinja kunye neekati ezihlala kunye, ukuxhatshazwa kwamanzi!") Ngenxa yoko, amangqamuzana omzimba omzimba emathunjini ethu ahlala ekhuselekileyo, kwaye "ukuvuvukala ngokomzimba" yimo simo.
Ngethamsanqa, ngokusebenzisa iindlela eziyinkimbinkimbi, umzimba wethu unciphisa ngokupheleleyo ukusetyenziswa kweethambo ezinxulumene nomzimba we-lymphoid. Kuyavunywa ukuba konke oku kulandelwayo kukuphela kweengcamango zokuvumelana, kwaye sonke siyazi, ezinye iingcamango zokubambisana ziphendulela (i-pun itholakala ngokupheleleyo); nangona, ukwazi oko sikuyazi malunga ne-IBD, konke oku kunengqiqo.
Njengoko kubonakala kwigama layo, isifo sesisu sesifo siyimeko apho uphawu lwayo luvuthayo. Ikwabiwa kwe-bimodal ngexesha elide lokuqala phakathi kwe-15 no-30 kunye no-60 no-80 ngokunyuka kwama-Ashkenazi amaYuda. Izimpawu zekliniki ze-IBD zibi: iintlungu zesisu, isifo sohudo, ukuphuma kwintsholongwane, ukuphazamiseka kwegazi, kunye nokulahleka kwesisindo. Ingabonakalisa nakwiindawo ze-anatomic ngaphandle kwethambo kwaye zibangele i-arthritis, iingxaki zamehlo (uveitis kunye ne-iritis), ukugquma (i-erythema nodosum) kunye nokunye.
I-IBD ifikeleleke kwizinto ezimbi ezimbi: i-ulcerative colitis kunye nesifo sikaCrohn . Nangona zifana ngeendlela ezininzi, kukho ukungafani okubalulekileyo phakathi kwezi ntlobo ezimbini ze-IBD. I-colcer ulcerative igxininiswe kwikoloni kwaye ixabisa iindawo ezingxenyeni okanye ezithandekayo zesibilini; ngelixa isifo sikaCrohn sinokuchaphazela nayiphi na inxalenye yeGI iphecana (ukusuka emlonyeni ukuya kwi-anus) kwaye ichanekile kwi-pathology yayo, ifuna ukunqumla kwiindawo zeGI.
Ngokuqhelekileyo, isifo sikaCrohn sihlamba i-real estate esecaleni kwesava ye-ileocecal. Isifo sikaCrohn senza ukuba izilonda ezithintekayo zithintele ubukhulu bomzimba obunobangela obunzima okanye i-fistula (imizila engavumelekanga phakathi kwamathambo).
Ngokubhekiselele kwi-IBD, oogqirha bajolise ekulawuleni ukukhubeka kwamanzi okanye ukuphazamiseka, ukugcina ukuxolelwa kwizinto ezinjalo kunye nokuphatha i-fistula kunye nokukhutshwa (kubangelwa yimigangatho) kunye nokubonelela ngamanyathelo enyango. Uninzi lwabantu abane-IBD luphela ekutyunjweni ngexesha elithile ebomini babo.
Iyona nto ingundoqo yonyango lwempilo ye-IBD iquka izidakamizwa ezingenayo i-glucocorticoids, i-sulfasalazine kunye ne-5-aminosalicylic acid.
I-Azathioprin kunye ne-cyclosporine yilezi ezinye izidakamizwa ezichasayo kunye nezifo ezingenazifo ezinomzimba eziwusizo ekuphatheni i-IBD. Ngoku kuninzi, ama-biologic agents afana ne-natalizumab kunye ne-vedolizumab (i-Entyvio) isetyenziselwe ukuphatha i-IBD.
I-Entyvio kunye ne-Progressive Multifocal Leukoencephalopathy (PML)
Ngokutsho kwe-FDA:
I-Entyvio i-integrin receptor antagonist. I-Integrin receptors iiprotheni ezichazwe kumanqanaba athile. I-Integrin receptors isebenze njengeebhanti ze-cell-cell interactions. I-Entyvio ibimbela ukusebenzisana kwe-receptor ethile ye-integrin (ibonakaliswe ngokujikeleza iiseli ezivuthayo) kunye neprotheni ethile (echazwe kwiiseli kwindonga yangaphakathi yemithambo yegazi), kwaye iyakhusela ukufuduka kwalawo maseli avuthayo kuloo mijelo yegazi kunye nakwiindawo ukuvuvukala kwiphepha lesisu.
Ngaphezu koko, ngokwe-FDA:
Iziphumo zabonisa ukuba ipesenti enkulu yabathathi-nxaxheba baphathwa nge-Entyvio xa kuthelekiswa ne-placebo ifumaneka kwaye igcinwe impendulo yeklinikhi, iphumelele kwaye igcinwe ukuxolelwa kweekliniki, iphumelele ukukhululwa kweeklinikhi ze-corticosteroid, kwaye njengoko yabonwa ngexesha lokuphela kwee-endoscopy, yayibonakala ijonge
Ngamanye amagama, i-Entyvio isebenza ngokunciphisa ukuvuvukala kwiphecana le-GI kwaye iphumelele xa iphathwa ngokutsha kunye nokugcina ukuxolelwa kwe-steroid. Ingqalelo, ukuhlaziywa kwemeta ye-Entyvio kunye nezinye i-agent ze-biologic kubonisa ukuba i-Entyvio yayisebenza ngokulinganayo ekugcineni ukuxolelwa kubantu abane-ulcerative colitis njengezinye iindidi ze-biologic agents. Ingqalelo, i-entyvio ijoliswe kubantu abangayithobeliyo okanye abangayithobeliyo iminye imithi esetyenziselwa ukuphatha i-IBD (njenge-steroids okanye i-biologic agents).
Kuze kube ngoku, iziganeko ezingekho phantsi kweengxelo ezibangelwa yi-Entyvio zazincinci kwi-headache, intlungu edibeneyo, isisongela, kunye nomkhuhlane. Ukuphendula okunzulu ngakumbi kubandakanya ukungabikho komzimba kunye ne-hepatotoxicity (isifo sobungozi besibindi). Kodwa oogqirha, iiflanzi, kunye nomenzi weziyobisi bajonge umphumo ongathintekiyo ongasayi kubuyisa intloko yayo eyingozi: i-letiencephalopathy ye-multifocal leukoencephalopathy (PML).
I-PML yintlupheko yesifo esivela kukusuleleka kwintsholongwane ye-JC Uninzi lwethu unama-antibodies kule ntsholongwane kunye nosuleleko kubantu abaphilileyo. Kodwa kubantu abaxhomekeke kwi-HIV, umhlaza, i-sarcoidosis kunye nezinye izifo, i-PML inokubamba.
Kubantu abane-PML, intsholongwane ye-JC igxotha i-oligodendrocyte okanye iiseli ze-nerve ngokuyinhloko kwi-hemispheres ye-cerebral kodwa i-brain is stem okanye i-cerebellum. Ngamanye amazwi, le ntsholongwane ithatha imbali yethu emhlophe ye-myelin efunekayo ukuze kuqhutywe i-nerve conduction. Iimpawu ziquka ukugula komzimba, iingxaki zombono, ukukhubazeka (hemiparesis), ingxaki yokuthetha (aphasia) kunye nokuphazamiseka kwengqondo.
Kwiinyanga ezi-3 ukuya kwezi-6, i-PML ibulala ama-50 ekhulwini abo bachasulelwe. Ukugxekwa kwabo bahlakulela i-PML ngenxa ye-natalizumab unyango lwe-sclerosis ezininzi kulunge ngakumbi; iipesenti ezingama-20 kuphela ziyafa. Kodwa nakwabo baphela baphila ne-PML, ukhubazekile. Ngokutsho kweMigaqo ye-Harrison ye-Internal Medicine , njengomhla wayo wokushicilela ngo-2012, abantu abangama-104 baphathwa nge-natalizumab ngenxa ye-multiple sclerosis eyenziwa yi-PML, kwaye umntu oyedwa kuphela ophathwa ngayo ngenxa ye-Crohn.
Okukwintsusa
Ukuba wena okanye othandekayo unenkathazo ye-IBD, ngokukodwa i-IBD engayithobeli i-steroids kunye nezinye i-immunomodulators, i-Entyvio ibonakala njengonyango oluthembisayo. Nangona kunjalo, ngaphambi kokuba uqale unyango kunye ne-Entyvio, kubalulekile ukuba utyhilele naziphi na izifo ezikhoyo okanye izifo "ezingahambi" kwaye zingabonisa ukuba i-immune system iyancipha. Ngaphezu koko, ukuba usanda kugonywa, awufanele uthabathe i-Entyvio. (Ingqalelo, akufanele uthathe i-Entyvio ukuba unengxaki yesibindi, ukuphendula okuthintekayo, njalonjalo.) Ukuba uhlakulela iingxaki zeengxaki (okanye ngokwenene naziphi iingxaki ezibalulekileyo) ngelixa ku-Entyvio, kubalulekile ukuba uqhagamshelane ngokukhawuleza kwezempilo yakho umniki.
Kwinqaku yokugqibela, kubalulekile ukukhumbuza ukuba asisayi kubona i-PML kubantu abathatha i-Entyvio . Ukongezelela koko, umenzi we-FDA kunye ne-Entyvio bajonge ngokubhekiselele kwiimeko ze-PML eyesiqhelo kulawulo lwe-Entyvio kwaye okwangoku ziqhuba izifundo zophando emva kokuthengisa kunye nokuququzelela ukuhanjiswa kwexesha eliphambili kunye nokukhawuleza kweziphumo ezimbi.
Imithombo:
> Friedman S, Blumberg RS. Isahluko 295. Izifo ezithintekayo zezifo. Ku: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Imigaqo yeHarrison ye-Medicine yangaphakathi, i-18e . New York, NY: McGraw-Hill; 2012.
I-DA yaseGreenberg, i-Aminoff MJ, uSimon RP. Isahluko 5. I-Dementia & Amnestic Disorders. Ku: I-DA yaseGreenberg, i-Aminoff MJ, uSimon RP. eds. I-Neurology Clinic, 8e . New York, NY: McGraw-Hill; 2012.
"I-Vedolizumab (Entyvio) yeZifo eziBulisayo" ezivela kwi-Medical Letter kwiDrugs and Therapeutics epapashwe ngo-9/15/2014.
UWallace JL, u-Sharkey KA. Isahluko 47. I-Pharmotherapy of Inflammatory Bowel Disease. Ku: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's The Basmacological Basis of Therapeutics, 12e . New York, NY: McGraw-Hill; 2011.