Ngo-2010 i-FDA ivunyelwe ukunikezela ngomhlaza womhlaza we-prostate-refractory prostate. Ukubonelela ngonyango olusebenzayo ngokuphucula umzimba womzimba. Abanye abagxeki baye bathi ukuphumelela kokunikezela ngombuzo kuba ukuphumelela kwezilwanyana ezininzi unyango kuboniswa kwi-PSA yehla emva kokonyango. Nangona kunjalo, kunye neNkqubo yokubonelela ngonyango i-PSA amanqanaba ayisoloko ilahla.
Emva kokuba ijongene namadoda angamakhulu amaninzi Amadoda axhatshazwayo, ndiye ndabona imeko ekhethekileyo apho i-Provenge iphantsi kwePSA. Nangona kunjalo, ukwehla kwe-PSA ngokuqinisekileyo akuyiyo umgaqo jikelele njengoko ixesha elingaphambili le-PSA liyaqhubeka likhula emva kwe-Provenge.
Ukuba i-PSA ayigxothi, njani inokulondoloza ixesha lokusinda? Abaninzi bayalibala ukuba nangona unyango lwezonyango lugqityiwe kwixesha leveki ezintandathu, emva kokuba i-immune system isebenze imiphumo yayo iyaqhubeka. Ngako oko, nangona ukuba iMpendulo ikhupha ukukhula kwesifo nje kwisiganeko esincinci, ukunyusa okuqhubekayo ekukhuleni komhlaza kunempembelelo eqhubekayo ngaphezu kwexesha. Ngaphezulu kwexesha leminyaka, nokuba nempembelelo emnene ingongeza kwi-benefit benefit survival.
Uphando
Ukuba i-hypothesis yokuba iMpahla inokunyusa umonakalo onobubele, obunomhlala-mlilo onokuhlala uchanekile, ngoko ke amadoda afumana unyango kunye neNgcaciso kwinqanaba elingaphambili (onokuhlala ixesha elide) kufuneka afumane inzuzo enkulu yokusinda kunokuba amadoda athathwe kwixesha elizayo .
Ukuvavanya lo mbandela, uDendreon, umenzi we-Provenge idatha ehlaziyiweyo evela kwizifundo zangaphambili ezikhokelela kwi-FDA imvume. Nceda uqaphele, abaphandi abazange baqhathanise ukusinda kwamadoda aphathwe ngaphambili ngaphaya kokusinda kwamadoda athathwe kamva. Kucacile ukuba, amadoda aphathwayo kwinqanaba eliphambili ahlala ixesha elide.
Kunoko baqhathanisa ukusinda kwabesilisa abaphathwa ngamagciwane kunye nesifo sokuqala esesigxina kunye namadoda athathwe ngendlela efana ne-placebo . Benza uhlalutyo olufanayo (Amadoda axhatshazwayo ngokumelene namadoda aphethwe yi-placebo) kumadoda anezigaba ezahlukeneyo zesifo ezihluka ukususela ekuqaleni ukuya kwexesha elide. Enyanisweni, ukwahlula amadoda kumacandelo amane: isigaba sokuqala, isigaba esiphantsi, isigaba esiphakathi kunye nexesha elide. "Amanqanaba" ahlukeneyo achazwe ngokuphakanyiswa kwamanqanaba e-PSA ngelixa i-Provenge iqalile. Ngokomzekelo, isigaba sokuqala sasiphantsi kwe-PSA engaphantsi kwama-22; Isigaba esiphantsi sasiyi-PSA phakathi kwe-22-50; Isigaba esiphakamileyo siphakathi kwePSA phakathi kwama-50-134; kunye nendawo ephakamileyo yayinguPSA omkhulu kunama-134.
Itheyibhile ingezantsi ifingqa iziphumo zohlalutyo lwabo.
| Izigulane eziqulunqwe nguMgaqo-siseko wePSA | ≤22 | 22-50 | 50-134 | > 134 |
|---|---|---|---|---|
| NUMBER | 128 | 128 | 128 | 128 |
| UKUPHILWA KWONYANGA NGONYAKA: | ||||
| YENZA | 41.3 | 27.1 | 20.4 | 18.4 |
| PLACEBO | 28.3 | 20.1 | 15.0 | 15.6 |
| UKUSEBENZISWA KOLUNTU | 13.0 | 7.1 | 5.4 | 2.8 |
Njengoko kunokubonwa etafileni, onke amaqela aphathwe nge-Provenge, abonise inzuzo yokuphila xa kuthelekiswa namanqanaba afanayo athathwe nge-placebo. Nangona kunjalo, xa i-Provenge inikezelwa kwinqanaba eliphambili, inzuzo yokuphila yayikhulu. Amadoda anesigaba sokuqala (PSA <22) ahlala ixesha elide elilishumi elinama- 13 kunamadoda afana namanqanaba athile afana nawo.
Amadoda anesigxina esiphezulu kuphela ahlala ixesha elide ixesha elide kunezikhundla eziphambili ze-placebo.
Le ndlela yokuphila ngokuphuculweyo kunye nezifo ezisekuqaleni zibonakala zihambelana neengcamango zokuthi umphumo we-immune effect we-Provenge uphumelela kwimpembelelo enkulu yokusinda xa ivumelekile ukuqokelela ixesha elide. Enye ingcamango yokuchazela le nkcukacha kukuba ixabiso elincinci lomhlaza linama-clones ambalwa kwaye ngoko ke iphendulela ngakumbi kunyango. Ingaba kukho enye ingqiqo okanye enye, okanye zombini ibanjwe kunye, ubungqina bokuba ukuphathwa kweyeza kuqala kuqhubeka kugqityiweyo xa i-hypothesis ivavanywa.
Ngokuqinisekileyo, ngokusekelwe kule datha, umntu unokugqiba ngokugqibeleleyo ukuba isigqibo sinika inzuzo enkulu xa ilawulwa kwinqanaba lokuqala.