Isigaba 1 kuya eSigabeni 4 Izivivinyo Zomtholampilo - Zihluke kanjani?
Yiziphi Izigaba Ezihlukene Zemibuzo Yomtholampilo?
Kunezigaba ezintathu ezihlukene zokuhlolwa kwemitholampilo ngezinhloso ezehlukene, kuqala ngokusetshenziswa kokuqala kwezidakamizwa noma ukwelashwa kubantu, nokuqeda ngokuvunywa ukusetshenziswa komphakathi jikelele yi-FDA. Kukhona nesigaba esingeziwe sokuhlolwa kweemitholampilo kubheka izinqubo nemithi ngemuva kokuvunywa yi-FDA.
Kukhona nezinhlobo ezahlukene zokuhlolwa kwemitholampilo . Isibonelo, ezinye izilingo zihlola ukusetshenziswa kwezidakamizwa zamakhemikhali, ezinye izifundo zibheke izindlela zokuthuthukisa izinga lokuphila kubantu abahambayo nakuba ukwelashwa komdlavuza, kanti ezinye izifundo zibheke izindlela zokuvimbela umdlavuza kuqala.
Izivivinyo Zemitholampilo Zesigaba 1 - Ingabe I-Treatment Safe?
Izivivinyo zomtholampilo ze-Phase 1 yizivivinyo zokuqala ezenziwa kubantu ukuthola imithi yokuhlola noma ukwelashwa. Ngokuvamile zibandakanya inani elincane labantu - ngokuvamile 10 ukuya ku-30 - futhi lenzelwe ukubona ukuthi ukwelashwa kuphephile. Kubalulekile ukuqaphela ukuthi ngaphambi kokuqala kwesigaba I trial, umuthi omusha uvame ukuhlolwe kabanzi ebhodini. Isibonelo, ngaphambi kokuqala isilingo sesiguli se-Phase I, imithi ye-chemotherapy ingase ihlolwe kumangqamuzana omdlavuza omuntu asetshenziswe ebhodini, nasezilwaneni zelabhutrikhi.
Isibonelo sesicingo sesigaba esisodwa singabe sihlola umuthi owaye wahlolwa kuphela kumagundane kubantu ukuze abone ukuthi uphephile.
Izivivinyo Zesivivinyo Sesivivinyo 2 - Ingabe I-Treatment isebenza? Ingabe Iphumelela?
Ngemuva kokuthi umuthi noma ukwelashwa kutholakale sengathi kuphephile, ihlolwe esivivinyweni sesigaba sesibili ukuze sibone ukuthi siyasebenza yini. Njengoba inombolo enkulu yabantu - ngokuvamile 30 kuya ku-120 - ibhalisiwe kulezi zifundo, ulwazi oluthe xaxa lutholakala ngokuphepha.
Izivivinyo zemibuzo yesigaba sesi-3 - Ingabe i-Treatment isebenza kangcono kune-Standard Standard Treatment noma ingabe ingabi nemiphumela emibi kune-Standard Standard Treatment?
Uma imishanguzo noma ukwelashwa kubonakala sengathi kuphephile futhi kuphumelele, kufundiswa esilweni sesithathu sokuhlola ukuthi ngabe kusebenza kangcono kunokuthi, noma kunemiphumela emibi kakhulu kunalokho, ukwelapha okuvamile. Izivivinyo zesigaba sesi-3 zivame ukuqhutshwa emakhulwini kuya ezinkulungwaneni zabantu futhi ngokuvamile "izifundo eziphindwe kabili"; okusho ukuthi noma isiguli noma umphenyi akakwazi ukuthi iyiphi isisetshenziswa esetshenziswayo. Uma ukwelashwa kokuhlolwa kutholakala ukuthi kunomuntu ophakeme noma ophansi kunokwelashwa okuvamile, lezi zifundo ngokuvamile ziyeke ukuqala ukuvumela abantu ukuba bathole ukwelashwa okungcono kunokwenzeka.
Isibonelo kungase kube ukuhlola ukuhlinzwa okuncane okungavamile komdlavuza wamaphaphu ukuze ubone ukuthi ngabe izinga lokusinda liphakeme kunezokuhlinzwa kwendabuko, noma uma ukuhlinzeka okusha kunemiphumela embalwa emibi kanye nezinkinga kunokuhlinzwa okujwayelekile (okujwayelekile).
Izivivinyo zemibuzo yesigaba sesi-4
Kukhona futhi izivivinyo zesigaba sesi-4. Emva kokuba izidakamizwa zivunyelwe ukusetshenziswa okujwayelekile, isilingo sesigaba sesi-4 singenziwa ukuze sibuke ukuphepha kwesidakamizwa noma inqubo ngokuhamba kwesikhathi, noma ukubheka ezinye ukusetshenziswa zomuthi.
Ukubaluleka Kwezilingo Zemitholampilo
Kunezinkolelo eziningi mayelana nokuhlolwa kwemitholampilo, ukwahlulela ezidwetsheni ezivamile ezikhombisa izingulube zezinyane noma amagundane esitokisini. Lezi zifundo zezokwelapha, empeleni, yindlela kuphela yokuthola imithi emisha yokwelapha umdlavuza noma ezinye izifo.
Yeka ukuthi kubaluleke kangakanani lezi zilingo ezingenakubantu nje kuphela, kodwa ngenxa yokukwazi kwabo ngabanye, zingagcizelela ngokubonisa ukuthi kwenzekani ngomdlavuza wamaphaphu eminyakeni yamuva. Phakathi nesikhathi phakathi kuka-2011 no-2015, izidakamizwa ezintsha ezengeziwe zavunyelwa ekwelapheni umdlavuza wamaphaphu kunalokho okwamukelwe eminyakeni engama - 40 ngaphambi kuka-2011.
Cabanga ukuthi umuntu ngamunye owahlanganyela kulezi zivivinyo ngaphambi kokuba avunywe, wayenethuba lokuthola izidakamizwa noma inqubo eyatholakala ukuthi ingcono kunezidakamizwa noma inqubo ejwayelekile ngaleso sikhathi, izinombolo zembula ukuthi abantu abaningi, ngokuhlanganyela ezinkulweni zomtholampilo, wayenethuba lokusebenzisa ukwelashwa okusindisa impilo ngaphambi kokuthi litholakale emphakathini jikelele.
Ukufunda Okuqhubekayo Ngezivivinyo Zemitholampilo:
> Imithombo:
> Society of American of Clinical Oncology. I-Cancer.Net. Izigaba Zemizamo Yomtholampilo. Kubuyekezwe i-12/2015. http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials