Kukho ukuxhalaba malunga nombutho onokwenzeka phakathi kweyeza leXolair (omalizumab) kunye nomhlaza. Ngaphambi kokuba i-Xolair ivunyiwe ukuba isebenzise eUnited States, ingxelo yengxelo yegosa lokukhusela i-FDA iqulethe le ndinyana elandelayo:
"Ukuthelekiswa kweentlobo zenzululwazi kubonisa (kodwa awuyi kuseka) inqanaba elongeziweyo kwizifundo ezichaziweyo ze-Omalizumab ... Ukuthelekiswa kweenkcukacha zophando lwekliniki kwisiseko esiphezulu se-epidemiological esicetyiswayo siphakanyiswe ukuba izifundo ze-Omalizumab ziveze ngakumbi kunokuba zikulindeleke ngelixa iqela lolawulo lithatha izibizo. "
Kwiimvavanyo zesikliniki, i-cancer yafunyanwa kwenye yezovolontiya ezingama-200 ze-Xolair (izigulane ezingama-20 ze-4127) zifaniswa nomnye wabavolontiya abangama-500 abangazange bathathe i-Xolair (izigulane ezingama-5 ezingama-2236). Amanqwelana ayenendidi ezahlukahlukeneyo. Amanqamana ayenzeka ngaphezu kweyodwa kweli qela afaka:
- Umhlaza webele
- Umhlaza wesikhumba (i-melanoma kunye non-melanoma)
- Umhlaza weprostate
Kwakukho nezinye iisifo ezinomdlavuza ezenzeke ngexesha elinye.
Kubalulekile ukuqonda ukuba ukuba umntu unomhlaza ngaphambi kokuba athathe inxaxheba kwizifundo ze-Xolair, abazange bakhululwe ngaphandle kweso sifundo - eqinisweni, kucingelwa ukuba ubuncinane izigulane ezingama-5 zinempawu zomhlaza ngaphambi kokuthatha inxaxheba kwilingo leklinikhi. Ngenxa yoko, akunakwenzeka ukuba i-Xolair ibangela umdlavuza kwezi zi gulane.
Izigulane nazo zavelisa i-cancer ebudeni bexesha elifutshane kakhulu emva kokuqala unyango kunye ne-Xolair. Akunakwenzeka ukuba ii-cancer ziza kukhula ngexesha elincinci-elithetha, mhlawumbi sele lihlakulele umdlavuza ngaphambi kokuqala i-Xolair.
Emva koko, iphaneli ye-oncologists ithe ayiyiva ukuba unyango lwe-Xolair lubangela umdlavuza ngokusekelwe kwidatha efumanekayo yangoku.
Igalelo lokungena kwixesha elide kwiXolair okanye ukusetyenziswa kwalo kubantu abasengozini enkulu yomhlaza (njengababhemayo okanye abo banomdla wentsapho yomhlaza) awaziwa kodwa uyaqhubeka nokufunda.
Isifundo se-Epidemiologic ye-Xolair (omalizumab): Ukuphonononga ukuPhumelela kweeKlinikhi kunye noKhuseleko lwexesha elide kwizigulane nge-Asthma eQinisekisa kakhulu kuya kuhlola i-long-term effects ye-Xolair enxulumene neentlobo ezahlukeneyo zeekhensi.
Uhlolo lwe-2014 lwengxelo ye-5 yokhuseleko lwe-Xolair alufumani nantlukwano kwimilinganiselo yomhlaza phakathi kwezigulane ze-Xolair kunye nalabo abazange baphathwe nge-Xolair. Isilwayo siye sadibana neentambo ezincinane ezibizwa ngokuba yi- ischemic . Ukuhlasela kwentliziyo; iintlungu zentlungu ngokungazelelwe; Uxinzelelo lwegazi oluphezulu kwimibhobho yemiphunga ebizwa nge-pulmonary hypertension; kunye neengcambu zegazi emiphakeni nasemithanjeni. Nangona kunjalo, i-FDA ayikwazi ukuthetha nokuba okanye i-Xolair ayincedisi kule ngxaki okanye ingekelwe kwisifundo sabo sobu bungqina obukhoyo. Ngenxa yokuba i-FDA ayikwazi ukuchaza ngokucacileyo ukungabikho komngcipheko ohambelana nale ntliziyo kunye neengxaki zengqondo, i-FDA ibongezelele kwifayile yefayile kwiCandelo elingaHlangiyo leNgcaciso yileyibhile yeziyobisi. Ngokufanayo, i-FDA ayikwazi ukutsho ngokucacileyo ukuba akukho mngcipheko womhlaza kunye ne-Xolair, ngoko ke ulwazi oluxubusha ngale sihloko longezwe kwiCandelo leZilumkiso kunye nokuCetyiswa kwileyibhile yeziyobisi.
Ukuba uya kuqwalasela i-Xolair njengonyango yakho okanye isifuba somntwana wakho kufuneka uxoxe ngale miba kunye nogqirha wakho.
I-FDA ibonisa ukuba oogqirha bahlaziya ngokukhawuleza isidingo sokuqhubela phambili unyango lwe-Xolair esekelwe kwisifo sesigulane nesifo solawulo lwe-asthma.
> Imithombo:
> Lanier B. Imibuzo yeklinikhi engenakuphendulwa kunye neengcamango malunga nendima ye > anti-immunoglobulin > E kwi-atopic and nonatopic disease. I-Allergy Asthma Proc 27 >: S37 > -S42, 2006)
> Imvume yeMvume, ii-Letters, Reviews, kunye namaxwebhu adibeneyo. I-XOLAIR (OMALIZUMAB) I-Document Review
> Katie Eder. I-Pharmacy TimesFDA idibana neengozi zeNtliziyo kunye neengxaki zeBongo, umdlavuza kwi-Xolair Label.
> F SA.gov FDA UkuXhatshazwa kweeNkcukacha zoKhuseleko: I-FDA ivuma utshintsho lwelebula kwisifo se-asthma i-Xolair (omalizumab), kuquka ukuchaza> encinane > umngcipheko ophezulu wentliziyo kunye neengqondo ezimbi.