Dalili mai yiwuwa na yiwuwa Entyvio ya damu da likitoci.
Mahimmin ba shi da kyau . Wata ta'addanci da ke tattare da magungunan magani: "Na farko, kada ku cutar." Muna zaune a duniya inda ake sa ran likitoci suyi wani abu, yi wani abu don magance cutar. Amma wasu lokuta mawuyacin aikin ya fi ƙarfin rashin aiki. Alal misali, likitoci ba su yin tiyata a kan 'yan takara ba daidai ba; likitoci ba su bayar da kashi uku na chemo ba ga mutanen da suka kamu da ciwon daji na ciwon sukari; kuma likitoci sunyi ƙoƙarin guje wa marasa lafiya da maganin magunguna tare da rayukan mummunar rayuka.
Entyvio sabon maganin da ake nufi ne don taimaka wa mutane tare da cututtukan zuciya na huhu (IBD), rashin lafiya mai lalacewa wanda zai sa rayuwar rayuwa ta kasance cikin wadanda suka shafi. Mahaliccinsa (Takeda Pharmaceuticals), FDA da kuma masu gastroenterologists a ko'ina suna damuwa, duk da haka, mutanen da ke dauke da Entyvio na iya bude kansu zuwa kamuwa da cuta tare da ci gaba mai yawa na leukoencephalopathy (PML).
PML shine kamuwa da cuta mai tsanani na tsarin kulawa na tsakiya wanda yawancin wadanda ke fama da mummunar rikici (tunanin mutanen da ke fama da cutar AIDS) ne kawai ke fuskanta. Ya zuwa yanzu, Entyvio bai riga ya haifar da PML ba a kowane mutane da ke dauke da shi, amma dan uwansa na sinadarin, wani mai karɓar sakonta na intgrin wanda ake kira natalizumab, yana haifar da PML a game da mutum 1 a kan jiyya 1000. A takaice dai, abubuwan da zai yiwu na Entyvio na iya ƙetare mai amfani da asibiti a cikin mutane tare da IBD kuma ya raunana tsarin rigakafi.
Mene ne IBD?
Gutunku wuri ne mai datti.
Yana cike da kwayoyin da ke taimaka mana mu gano abincinmu. Ka tuna cewa kwayoyin cutar ne kwari, kuma, a ko'ina a waje da gut, irin wannan kwayoyin zai haifar da maganin mega-immune. (Yayinda yake magana game da halin Muryar Murray daga Ghostbusters , "sadaukar da mutane, karnuka, da cats suna zaune tare, muryar mutum"!) Saboda haka, kwayoyin da ke jikinmu ba su da kariya, kuma "mummunan ilimin lissafi" shine matsayi.
Abin farin ciki, ta hanyar dabarun tsari, jikinmu yana shafe yawan ciwon kwayar lymphoid. Tabbas duk wannan ƙaddamarwa kawai ƙaddara ne kawai, kuma mun sani, wasu ra'ayoyin rikice-rikice sun zama tsattsauran ra'ayi (wanda aka nufa); Duk da haka, sanin abin da muka sani game da IBD, duk wannan yana da ma'ana.
Kamar yadda yake fitowa daga sunansa, cututtukan ƙwayar cututtukan ƙwayar cuta shine yanayin wanda yake da ƙonewa. Yana da rarraba bimodal tare da shekarun da suka fara daga farkon 15 zuwa 30 da 60 da 80 tare da karuwa a cikin Yahudawa a Ashkenazi. Maganin asibiti na IBD sune mummunan: ciwon ciki, cututtuka, zub da jini, anemia, da asarar nauyi. Hakanan yana iya bayyana a wurare masu tasowa a waje da gut da kuma haifar da cututtukan zuciya, matsalolin ido (uveitis da iritis), rash (erythema nodosum) da sauransu.
IBD ya zo cikin abubuwa masu ban sha'awa guda biyu: cututtukan ulcerative colitis da cutar Crohn . Duk da cewa irin wannan a hanyoyi da dama, akwai wasu bambance-bambance tsakanin waɗannan nau'o'in IBD guda biyu. Ulcerative colitis an tsare shi ne a cikin mallaka kuma ya haddasa ɓangare ko ɓangare na ciki; yayinda cutar Crohn zai iya rinjayar wani ɓangare na gin na GI (daga bakin zuwa mahaukaci) kuma yana da kwarewa a cikin ilimin halittarsa, yana mai da hankali don ƙetare yankunan GI.
Yawancin lokaci, cutar Crohn ta ƙaddamar da dukiyar da ke kusa da ɗakin basira. Kwayar Crohn kuma yana haifar da raunin jini wanda ya shafi dukan kauri daga cikin karfin da zai haifar da kwarewa ko ma fistulas (ƙananan hanyoyi tsakanin sassan hanji).
Dangane da IBD, likitoci suna so su sarrafa matsalolin ƙyama ko ƙuƙwalwa, suna kula da gyara daga irin wannan fuka-fukan da kuma bi da fistulas da obstructions (haifar da rauni) da kuma samar da wasu matakai na jiyya. Yawancin mutanen da ke tare da IBD sun ƙare da yin tiyata a wani lokaci a rayuwarsu.
Mafi mahimmancin magani na IBD ya hada da kwayoyin immunosuppressant kamar glucocorticoids, sulfasalazine, da kuma 5-aminosalicylic acid.
Azathioprine da cyclosporine wasu kwayoyi ne masu kare kumburi da kwayoyin immunosuppressant da suke da amfani wajen magance IBD. Mafi yawan kwanan nan, masu amfani da ilimin halitta kamar su natalizumab da vedolizumab (Entyvio) sun kasance sunyi amfani da IBD.
Entyvio da Progressive Multifocal Leukoencephalopathy (PML)
A cewar FDA:
Entyvio mai amfani ne mai karɓar mai karɓa. Masu haɗin gwargwadon haɗin sunadaran sunadarai sun bayyana a kan wasu kwayoyin halitta. Masu haɗin mai haɗa aiki suna aiki a matsayin alamomi don hulɗar cell-cell. Entyvio yana ƙulla hulɗar wani ƙwayar ƙwayar ƙwayar ƙwayar cuta ta musamman (aka bayyana a kan sel a cikin bango na ciki na jini), kuma ta haka ne ke hana ƙaura daga waɗanda ke rarraba kwayoyin ƙwayoyin ƙwayoyin jini a fadin waɗannan jini da kuma cikin yankunan na ƙonewa a cikin ƙwayar gastrointestinal.
Bugu da ƙari, bisa ga FDA:
Sakamako ya nuna cewa mafi yawan yawan masu halartar da aka bi da Entyvio idan aka kwatanta da wani wuribo da kuma kiyaye maganin asibiti, cimmawa da kuma kiyaye maganin asibiti, samu remission na asibiti marasa lafiya, kuma kamar yadda aka gani a lokacin endoscopy
A wasu kalmomi, Entyvio yana aiki ne ta hanyar ƙin ƙonewa a cikin GI na fili kuma ya tabbatar da tasiri a yayin da yake magance ƙusoshin wuta da kuma kiyaye remission-free remission. Bayanan kulawa, zane-zane na Entyvio da sauran jami'o'in nazarin halittu sun nuna cewa Entyvio yana da tasiri sosai wajen kiyaye remission ga mutane tare da ciwon ƙwayar cuta kamar sauran nau'o'in halittu. Bayanin kula, an yi amfani da shi don mutanen da ba su amsawa ko magungunan wasu magunguna da aka yi amfani da ita don magance IBD (kamar masu steroid ko masana kimiyya).
Ya zuwa yanzu, an rubuta magungunan halayen da Entyvio ya haifar da yafi iyakance ga ciwon kai, haɗin gwiwa, tashin zuciya, da zazzaɓi. Ƙananan halayen haɗar haɗari sun haɗa da rashin lafiyar jiki da rashin haɓaka (haukacin hanta). Amma likitoci, magunguna, da magungunan miyagun ƙwayoyi sun kasance a kan ido don wani mummunar tasiri mai tsanani wanda bai riga ya dawo da mummunan shugabansa: ci gaba mai mahimmanci leukoencephalopathy (PML).
PML wata cuta ne da ke haifar da kamuwa da cuta tare da kwayar cutar ta JC Yawancin mu suna da kwayoyin cuta ga wannan cutar da kuma kamuwa da cuta a cikin mutanen lafiya yana da wuya. Amma a cikin mutanen da cutar HIV, ciwon daji, sarcoidosis, da kuma sauran cututtuka, PML na iya ɗaukar.
A cikin mutane tare da PML, kwayar cutar ta JC ta haifar da oligodendrocytes ko kuma kwayoyin jikinsu da farko a cikin kwayoyin cerebral amma kuma kwakwalwa ta tsakiya ko cerebellum. A wasu kalmomi, wannan cutar ta raba kwayoyin mu na fata da ake bukata don maganin nasu. Kwayoyin cututtuka sun hada da lalata, matsalolin hangen nesa, inganci (hemiparesis), maganganun magana (aphasia) da rashin lafiya.
A cikin watanni 3 zuwa 6, PML ya kashe kimanin kashi 50 cikin wadanda suka kamu da cutar. Fassara ga wadanda suka ci gaba da PML saboda tsarin natalizumab don maganin sclerosis da yawa shine mafi kyau; kawai kashi 20 cikin 100 ne ke mutuwa. Amma har ma wa anda suka ƙare tare da PML, rashin lafiya yana da zurfi. Bisa ga ka'idodin Harrison na Magungunan Hoto , a matsayin fitowarsa na shekara ta 2012, mutane 104 suka bi da natalizumab saboda ƙwayoyin sclerosis da suka kamu da PML, kuma mutum daya ne kawai ya kula da cutar Crohn.
Layin Ƙasa
Idan kai ko wanda kake ƙauna yana shan wahala daga IBD, musamman IBD wanda ba shi da amsa ga steroids da sauran immunomodulators, Entyvio yana kama da alamar magani. Duk da haka, kafin fara jiyya tare da Entyvio, yana da mahimmanci ka bayyana duk wani cututtuka na yanzu ko cututtuka da "kada ku tafi" kuma yana iya bayar da shawarar tsarin rashin ƙarfi. Bugu da ƙari, idan an kwanan nan kin rigakafin ku, kada ku karbi Entyvio ko dai. (A lura, kada ku dauki Entyvio idan kuna da matsalolin hanta, rashin halayen haɗari, da sauransu.) Idan kuna ci gaba da matsalolin da ke cikin ƙananan ƙwayoyin cuta (ko kuma duk wani matsala mai mahimmanci) yayin da yake Entyvio, yana da mahimmanci ka fara tuntuɓar lafiyar ku mai bada.
A bayanin karshe, yana da mahimmanci mu tuna cewa har yanzu muna lura da PML a cikin mutane da ke shan Entyvio . Bugu da ƙari kuma, FDA da Entyvio suna yin nazarin lamarin PML na biyu zuwa gwamnatin Entyvio kuma suna gudanar da karatun bayanan sayar da kayan aiki kuma suna samar da rahotanni masu sauri da kuma gaggawa akan abubuwan da ke faruwa.
Sources:
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Greenberg DA, Aminoff MJ, Simon RP. Babi na 5. Raɗaɗɗa da nakasa. A cikin: Greenberg DA, Aminoff MJ, Simon RP. eds. Clinical Neurology, 8th . New York, NY: McGraw-Hill; 2012.
"Vedolizumab (Entyvio) don Flammatory Bowel cuta" daga The Medical Letter on Drugs and Therapeutics da aka buga a ranar 9/15/2014.
Wallace JL, Sharkey KA. Babi na 47. Pharmacotherapy na Flammatory Bowel cuta. A cikin: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12th . New York, NY: McGraw-Hill; 2011.