Zotsatira zovuta za Entyvio zimakhudza madokotala.
Primum palibe nocere . Chidziwitso chomwe chimasokoneza mzimu wathanzi: "Choyamba, musamavulaze." Tikukhala m'dziko limene madokotala amayenera kuchita, achite chirichonse chochiza matenda. Koma nthawi zina zotsatira za zochita zimaposa phindu la kusagwirizana. Mwachitsanzo, madokotala samachita opaleshoni kwa ofuna ofuna ntchito; madokotala samapereka chemo yapamwamba kwa anthu omwe amawonongeka ndi khansa yakufa; ndipo madokotala amayesetsa kupeĊµa kuchiza odwala omwe ali ndi mankhwala omwe amawopsyeza moyo wawo wonse.
Entyvio ndi mankhwala atsopano othandizira anthu omwe ali ndi matenda opatsirana (IBD), matenda olepheretsa omwe amawononga moyo wa iwo omwe akudwala. Wopanga makina (Takeda Pharmaceuticals), a FDA ndi a gastroenterologists kulikonse kudandaula, komabe, anthu omwe amatenga Entyvio akhoza kutseguka kuti athane ndi matenda opatsirana ndi leukoencephalopathy (PML).
PML ndi kachilombo kosavuta kachitidwe kakang'ono ka mitsempha kamene kawirikawiri kamangodziwika ndi omwe ali ndi machitidwe amphamvu oteteza mthupi (aganizire anthu omwe ali ndi AIDS). Pakadali pano, Entyvio siinayambitse PML kwa anthu onse kutenga, koma msuwani wake wa mankhwalawa, wothandizira wina wotchedwa natalizumab, amachititsa PML kukhala pafupifupi 1 munthu mmodzi pa 1000 kulandira chithandizo. Mwachidule, zotsatira zowonongeka za Entyvio zingapitirire ntchito zomwe amagwiritsidwa ntchito ndi anthu omwe ali ndi IBD ndi kufooketsa chitetezo cha mthupi.
Kodi IBD ndi chiyani?
Matumbo anu ndi malo odetsedwa.
Yadzaza ndi mabakiteriya omwe amatithandiza kudyetsa chakudya chathu. Kumbukirani kuti mabakiteriya ndi mimbulu, ndipo, kulikonse kunja kwa matumbo, mabakiteriya oterowa amachititsa kuti thupi liziyenda mthupi. (Kutchula khalidwe la Bill Murray kuchokera ku Ghostbusters , "zopereka za anthu, agalu, ndi amphaka akukhala pamodzi, chiwonongeko chochuluka!") Chifukwa chake, maselo a mthupi m'matumbo athu amakhala otetezedwa nthawi zonse, ndipo "kutupa thupi" ndilo chikhalidwe.
Mwamwayi, kudzera mu njira zovuta, thupi lathu limapangitsa kuti thupi lonse lizikhala ndi mavitamini. Zowona zonsezi ndizovomerezeka zokha, ndipo tonse tikudziwa kuti ziganizo zina zimagwirizana (pun) kwenikweni; Komabe, kudziwa zomwe tikudziwa zokhudza IBD, zonsezi ndi zomveka.
Monga momwe zikuonekera kuchokera ku dzina lake, matenda opweteka matumbo ndi chikhalidwe chomwe chimadziwika ndi kutupa. Kugawidwa kwa bimodal kwa zaka zambiri kuyambira pakati pa 15 ndi 30 ndi 60 ndi 80 ndi kuchulukitsitsa kwa Ayuda a Ashkenazi. Zizindikiro za matenda a IBD ndizovuta: kupweteka m'mimba, kutsekula m'mimba, kutuluka m'magazi, kuchepa magazi m'thupi, ndi kulemera. Ikhoza kuwonetsanso m'malo amtundu kunja kwa matumbo ndipo imayambitsa matenda a nyamakazi, mavuto a maso (uveitis ndi iritis), kuthamanga (erythema nodosum) ndi zina zambiri.
IBD imabweretsa zowawa ziwiri: zilonda zam'mimba ndi matenda a Crohn . Ngakhale zofanana m'njira zambiri, pali kusiyana kwakukulu pakati pa mitundu iwiri ya IBD. Ulcerative colitis imangokhala pamtunda ndipo imagwilitsa magawo amtundu wamba; pamene matenda a Crohn angakhudze mbali iliyonse ya kapangidwe ka GI (kuchokera pakamwa kupita ku anus) ndipo imakhala yovuta kwambiri, poyendayenda m'magawo a GI.
Kawirikawiri, matenda a Crohn akuwononga malo omwe ali pafupi ndi velovu ya ileocecal. Matenda a Crohn amachititsanso zilonda zamkati zomwe zimakhudza makulidwe onse a matumbo omwe amachititsa mitsempha kapena fistula (njira zosavomerezeka pakati pamatumbo).
Ponena za IBD, madokotala amayesetsa kuthetsa kuopsa koopsa, kukhululukira zolakwa zoterozo ndi kuchiza matenda a fistula ndi zolepheretsa (zomwe zimayambitsa mavuto) ndikupereka njira zina zochiritsira. Anthu ambiri omwe ali ndi IBD amatha opaleshoni nthawi ina.
Chofunika kwambiri cha mankhwala ambiri a IBD chimaphatikizapo mankhwala osokoneza bongo monga glucocorticoids, sulfasalazine, ndi asidi 5 aminosalicylic.
Azathioprine ndi cyclosporine ndi mankhwala ena odana ndi kutupa komanso omwe amathandiza kuti athetse vutoli. Posachedwapa, mawotchi a biologic monga monga natalizumab ndi vedolizumab (Entyvio) akhala akugwiritsidwa ntchito pochiza IBD.
Entyvio ndi Progressive Multifocal Leukoencephalopathy (PML)
Malingana ndi FDA:
Entyvio ndi mdani wothandizira. Integrin receptors ndi mapuloteni omwe amawonetsedwa pamwamba pa maselo ena. Integrin receptors amagwira ntchito ngati milatho ya kugwirizanitsa maselo. Entyvio imalepheretsa kuyanjana kwa maselo ena othandizira ena (omwe amawonekera pozungulira maselo otupa) ndi mapuloteni enieni (omwe amafotokozedwa m'maselo omwe ali mkatikati mwa khoma la mitsempha), motero amalepheretsa kusuntha kwa maselo otupa m'mitsempha ya m'magazi ndi kumadera za kutupa m'matumbo.
Komanso, malinga ndi a FDA:
Zotsatira zinasonyeza kuti kuchulukitsa kwa anthu omwe amachitira nawo mankhwalawa ndi Entyvio poyerekeza ndi malo a placebo omwe amapeza ndikusungirako machitidwe a chipatala, kupindula ndi kusungidwa kwa chipatala, kuchipatala kopanda kuchipatala, ndipo monga momwe anawonera pamapeto pake, mawonekedwe a colon
Mwa kuyankhula kwina, Entyvio imagwira ntchito pochepetsa kutupa mu thirakiti la GI ndipo zatsimikiziridwa zogwira mtima pochita zolaula ndikusunga chikhululukiro cha steroid. Taonani, meta-analysis of Entyvio ndi ena biologic mawonekedwe anasonyeza kuti Entyvio anali ogwira ntchito mofanana pakusungira chikhululukiro mwa anthu okhala ndi zilonda za zilonda monga zamoyo zina zamagetsi. Zindikirani, entyvio imapangidwira anthu omwe samvera mankhwala kapena mankhwala osagwiritsidwa ntchito pochiza IBD (monga steroids kapena biologic agents).
Pakadali pano, zochitika zosiyana siyana zomwe zinayambitsidwa ndi Entyvio zinkangokhala pamutu, kupweteka pamodzi, kunyowa, ndi malungo. Zochitika zazikulu zowonjezereka zinaphatikizapo zozizira ndi hepatotoxicity (chiwindi cha chiwindi). Koma madokotala, feds, ndi wopanga mankhwala akuyang'ana zotsatira zovuta kwambiri zomwe sizinayambitse mutu wake woipa: mapulogalamu a multifocal leukoencephalopathy (PML) omwe amapita patsogolo.
PML ndi matenda a ubongo omwe amayamba chifukwa cha matenda a JC. Ambiri a ife timakhala ndi ma antibodies kwa kachilombo ka HIV ndipo matenda omwe ali ndi thanzi labwino ndi osowa kwambiri. Koma mwa anthu amene chitetezo chawo cha mthupi chimayambitsidwa ndi HIV, khansara, sarcoidosis, ndi matenda ena, PML ikhoza kugwira.
Kwa anthu omwe ali ndi PML, kachilombo ka JC imayimitsa oligodendrocyte kapena maselo a mitsempha makamaka mu ubongo wa hemispheres komanso ubongo kapena cerebellum. Mwa kuyankhula kwina, kachilomboka kamatulutsa nkhani yathu yoyera ya myelin yofunikira kuti tipangidwe ndi mitsempha. Zizindikiro zikuphatikizapo matenda a maganizo, mavuto a masomphenya, kufooka (hemiparesis), kuvutika kulankhula (aphasia) ndi kuwonongeka kwa maganizo.
Pakadutsa miyezi itatu kapena 6, PML imapha 50 peresenti ya anthu omwe ali ndi kachirombo ka HIV. Kugonjera kwa iwo omwe amapanga PML chifukwa cha natalizumab therapy kwa multiple sclerosis ndi bwino; 20 peresenti yokha amamwalira. Koma ngakhale kwa iwo omwe amatha kukhala ndi PML, kulemala kumakhala kwakukulu. Malinga ndi mfundo za Harrison za Internal Medicine , zomwe zalembedwa m'chaka cha 2012, anthu 104 anachitidwa ndi natalizumab chifukwa cha multiple sclerosis yomwe inakhazikitsidwa ndi PML, ndipo munthu mmodzi yekha amene adachiritsidwa ndi Crohn ndi matendawa.
Pansi
Ngati inu kapena wokondedwa wanu muli ndi IBD, makamaka IBD yomwe imatsutsa steroids ndi ena omwe amateteza thupi lawo, Entyvio ikuwoneka ngati chithandizo cholonjeza. Komabe, musanayambe kulandira chithandizo ndi Entyvio, nkofunika kuti muwulule matenda omwe alipo omwe alipo omwe "asachoke" ndipo angasonyeze kuti chitetezo cha m'thupi chimachepa. Komanso, ngati mwangotenga katemera, musayambe kutenga Entyvio. (Zindikirani, simuyenera kutenga Entyvio ngati muli ndi vuto la chiwindi, kusintha kwa matenda, ndi zina zotero.) Ngati mukumana ndi mavuto a ubongo (kapena kwenikweni mavuto aakulu) pamene muli pa Entyvio, nkofunika kuti mwamsanga muzitha kulandira chithandizo chamankhwala anu perekani.
Pamapeto pake, ndizofunika kukumbukira kuti sitiyenera kusunga PML mwa anthu omwe amatenga Entyvio . Kuwonjezera pamenepo, wopanga FDA ndi Entyvio akuyang'anitsitsa madandaulo a PML omwe akuyang'aniridwa ndi Entyvio ndipo akuchititsa maphunziro apamwamba ndikukapangitsa kuti awonetsere zotsatira za mavuto.
Zotsatira:
> Friedman S, Blumberg RS. Chaputala 295. Matenda Opatsirana Opatsirana. Mu: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Mfundo za Harrison za Internal Medicine, 18e . New York, NY: Hill ya McGraw; 2012.
Greenberg DA, Aminoff MJ, Simon RP. Mutu 5. Dementia & Amnestic Disorders. Mu: Greenberg DA, Aminoff MJ, Simon RP. eds. Clinical Neurology, 8e . New York, NY: Hill ya McGraw; 2012.
"Vedolizumab (Entyvio) ya Matenda Opatsirana Opatsirana" kuchokera ku Medical Letter on Drugs and Therapeutics yofalitsidwa pa 9/15/2014.
Wallace JL, Sharkey KA. Mutu 47. Pharmacotherapy of Inflammatory Dwel. Mu: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's The Basic Pharmacological Therapeutics, 12e . New York, NY: Hill ya McGraw; 2011.