Ngo-2010 i-FDA ivunyelwe ukuhlinzeka ngomdlavuza we-hormone-refractory prostate. Ukuhlinzeka ngukuthi ukwelashwa okusebenza ngokuthuthukisa isimiso somzimba sokuzivikela. Abanye abagxeki baye bathi ukuphumelela kokuhlinzekela okungaqinisekisiwe ngoba ukusebenza kwemithi eminingi yomdlavuza kubonakala ekunciphiseni kwePSA ngemuva kokwelashwa. Noma kunjalo, ngokuhlinzekela ama-PSA ama-Prapy amazinga ngokuvamile awayeki.
Njengoba eqondise ngabanye abantu abangamakhulu amaningana Abahlinzekiwe, ngiye ngabona amacala avelele lapho i-Provenge ihlehlisa khona i-PSA. Kodwa-ke, ukwehla kwe-PSA ngokuqinisekile akuyona imithetho ejwayelekile njengoba isikhathi esiningi i-PSA iqhubeka ikhuphuka emva kwe-Provenge.
Uma i-PSA ingabeki, inganikeza isikhathi eside sokusinda? Abaningi bakhohlwe ukuthi nakuba ukuhlinzekwa ukwelashwa kugcwaliswa isikhathi esingaphezu kwamasonto ayisithupha, uma isimiso somzimba sokuzivikela sisasebenza kuqhubeka. Ngakho-ke, ngisho noma ukuhlinzekwa kuphelisa ukukhula kwesifo nje kuphela, umphumela oqhubekayo wokukhula komdlavuza unomthelela omkhulu ekuhambeni kwesikhathi. Esikhathini esithile seminyaka, ngisho nomthelela omubi ongangenelela ungangezela kuze kube nenzuzo enkulu yokuphila.
Ucwaningo
Uma i-hypothesis yokuthi Isibonelelo sinciphisa umphumela onomusa, ohlala njalo unomphela, khona-ke amadoda athola ukwelashwa nge-Provenge esiteji esingaphambili (onokuphila okusinda isikhathi eside) kufanele athole inzuzo enkulu yokuphila kunamadoda aphathwe kamuva .
Ukuze uhlole lesi sisekelo, uDendreon, umkhiqizi we-Provenge uhlaziye idatha kusuka ezifundweni zangempela eziholela ekugunyazweni kwe-FDA. Sicela uqaphele, abacwaningi abazange baqhathanise ukusinda kwamadoda aphathwe ngaphambili ngokusinda kwamadoda aphathwe kamuva. Ngokusobala, amadoda aphathwe esiteji sangaphambili aphile isikhathi eside.
Kunalokho baqhathanisa ukusinda kwabantu abahlinzekiwe ngezifo abanesifo sangaphambili esinezifo ezifanayo eziphathekayo . Benza ukuhlaziywa okufanayo (Amadoda ahlinzekwe-aphikisana nama-treatbo-tracted men) emadodeni anezigaba ezihlukahlukene zezifo ezihluka kusukela ekuqaleni kuya ekupheleni kwesikhathi. Eqinisweni, lahlukanisa laba bantu ngezigaba ezine: Isigaba sokuqala, isigaba esiphansi, esiteji esiphakeme kanye nesigaba sekwephuzile. "Izigaba" ezahlukene zachazwa ukuthi amazinga e-PSA aphezulu kangakanani ngesikhathi i-Provenge iqalile. Isibonelo, ekuqaleni-sigaba kwakuyi-PSA engaphansi kuka-22; Isigaba esiphakathi kwaba iPSA phakathi kuka-22-50; Isigaba esiphakeme sePSA phakathi kuka 50-134; futhi izinga eliphezulu laliyi-PSA enkulu kunezingu-134.
Ithebula elingezansi lifingqa imiphumela yokuhlaziywa kwabo.
| Iziguli Ezihlanganiswe Ngqangi PSA | ≤22 | 22-50 | 50-134 | > 134 |
|---|---|---|---|---|
| NUMBER | 128 | 128 | 128 | 128 |
| UKUPHILA KWAMINYANGA: | ||||
| VULA | 41.3 | 27.1 | 20.4 | 18.4 |
| PLACEBO | 28.3 | 20.1 | 15.0 | 15.6 |
| UKUPHILA OKUPHAKATHI | 13.0 | 7.1 | 5.4 | 2.8 |
Njengoba kungabonakala kusukela etafuleni, wonke amaqembu aphethwe nge-Provenge, abonise inzuzo yokuphila uma kuqhathaniswa nesigaba esifanayo amadoda aphathwe nge-placebo. Kodwa-ke, lapho i-Provenge inikezwa esiteji sokuqala, izinzuzo zokusinda zazikhulu. Amadoda anesiteji sokuqala (PSA <22) ahlala isikhathi eside izinyanga ezingu-13 kunamadoda afanayo esiteji esaphathwa nge-placebo.
Amadoda anezigaba ezithuthukile ahlala izinyanga ezimbalwa isikhathi eside kunamadoda aphathelene ne-placebo-aphatha.
Le ndlela yokuphila okuthuthukisiwe nesifo sesisandulela sibonakala ifana ne-hypothesis ukuthi umphumela wokuvimbela omzimba wokuhlinzeka nge-immune umphumela wempembelelo enkulu yokusinda uma ivunyelwe ukuqoqa isikhathi eside. Enye inhloso yokuchaza le datha ukuthi inani elincane lomdlavuza linama-clones ambalwa futhi ngenxa yalokho liyakwazi ukulalela ukwelashwa. Kungakhathaliseki ukuthi yinto eyodwa noma enye, noma kokubili kuthathwe ndawonye, ubufakazi bokuthi ukuphathwa kokwelashwa kwangaphambili kuthuthukisa imiphumela kuqhubeka nokuqinisekiswa noma nini lapho i-hypothesis ihlolwa.
Ngokuqinisekile, ngokusekelwe kulolu datha, umuntu angaphetha ngokulingana ukuthi ukuhlinzekela kudala izinzuzo ezinkulu lapho kulawulwa esiteji sokuqala.