Iziphi Izifundo Zomtholampilo ZesiGaba se-Phase 1 ezenziwe nge-Cancer?
Uma ucabangela ukuhlolwa kwesigaba se-1, lokho kusho ukuthini ngempela? Lokhu kuhluke kanjani kwezinye izigaba zokwelashwa kwemitholampilo? Ngentuthuko yakamuva yonyango lomdlavuza, indima yesilingo sesigaba sokuqala se-clinic ibaluleke kakhulu. Ngesikhathi esisodwa lezi zilingo kungenzeka ukuthi zacatshangwa ngokuthi "yimigodi yokugcina", manje kukhona abantu abaningi abasinda umdlavuza ngenxa yokutholakala kwalezi zilingo.
Ake sihlole izivivinyo zesigaba sesi-1 endaweni yokucwaninga kwanamuhla futhi sixoxe ukuthi kungani isigaba sokuqala se-clinic singase sibe "njengengozi" njengasekuqaleni.
Khumbula ukuthi inhloso yokuhlolwa kwemitholampilo ukuthola ukwelashwa okusebenza kangcono noma kube nemiphumela emibi kakhulu kunemithi esikhona manje. Yonke imithi esetshenziselwa ukwelapha umdlavuza yabuye yahlolelwa njengengxenye yesilingo somtholampilo. Futhi phakathi naleso sikhathi, abantu abodwa abakwazi ukuvuna izinzuzo zalezi zelashwa yilabo ababengaphansi kweqembu lokutadisha kwecala lokutholwa.
Incazelo kanye nenhloso yesigaba sesi-1 sezilingo zomtholampilo
Izivivinyo zomtholampilo ze-Phase 1 zenziwa ukuze ubone ukuthi imithi yokuhlola noma ukwelashwa iphephile. Ngemuva kokuba ukwelashwa kuvivinywa ebhodini noma ezilwaneni, kungena kwesigaba sokuqala sesilingo se-clinic esenziwa nabantu. Lezi zilingo ngokuvamile zibandakanya inani elincane labantu ukuthi banqume ukuthi ngabe imithi noma ukwelashwa kuphephile nokuthi kunqunywe umthamo omuhle womuthi nokuthi kufanele unikezwe (kungaba ngomlomo noma nge-intravenously).
Nakuba inhloso eyinhloko yalezi zivivinyo ukuhlola ukuphepha, bangase banqume ukuthi ngabe ukwelashwa kubonakala kusebenza kanjani umdlavuza.
Ezinye izigaba
Kunezigaba ezintathu zokuvivinywa komtholampilo okumelwe kugcwaliswe ngaphambi kokuba izidakamizwa zivunyelwe i-FDA. Uma ukwelashwa kubonakala kuphephile ekupheleni kwesilingo semithi yesigaba somtholampilo, singase singene izivivinyo zokwelapha zesigaba 2, isifundo esenziwe ukuze sibone ukuthi ukwelashwa kuphumelela yini.
Uma izidakamizwa noma ukwelashwa kuthathwa njengokuphephile esilingweni sesigaba sokuqala futhi kuphumelele esilingo sesigaba sesibili, sizobe sesifaka isilingo sesigaba sesi-3 sesilingo. Izivivinyo zesigaba sesi-3 zikhulu kakhulu futhi zenziwa ukuze ubone ukuthi ukwelashwa akuphephile kuphela kodwa kusebenza kangcono noma kunemiphumela emibi kakhulu kunezokwelapha ezikhona manje.
Izivivinyo zemibuzo yesigaba sesi-1 ziye zashintsha kule minyaka eyishumi edlule
Izivivinyo ze-Phase 1, nokuthi yini ongayilindela uma ubhalisiwe kwelinye, ushintshe ngokuphawulekayo eminyakeni embalwa edlule. Izidakamizwa eziningi ezihlolwe ngo-2018 zenziwe ngokucophelela ukuba zenze ngendlela eqondile ekukhuleni komdlavuza. Akukhona nje ukuthi izidakamizwa ezifana nalezi zivame ukuba nemiphumela emibi kakhulu kunezidakamizwa zendabuko (nakuba zingakwazi), kodwa ngokusekelwe ekudaleni kukhona ithuba elihle lokuthi bazokwenza umehluko ngomdlavuza wakho . Phela, uma ungakwazi ukuvimbela isinyathelo esithile ukuthi umdlavuza kufanele uhambe ngawo ukuze uhlukanise (futhi ngaleyo ndlela ukhule futhi usakaze), kunethuba elihle lokuthi umdlavuza oboniswe ukuthi uncike kuleso sinyathelo uzophendula.
Ezimweni ezinjalo kungenzeka ukuthi kuphela okukhethwa kukho ukwelashwa komdlavuza kungaba izidakamizwa ezivamile zamakhemikhali. Izidakamizwa ezifana nezidakamizwa ezihlosiwe zivame ukuba nomdlavuza isikhathi eside, futhi izidakamizwa zokuzivikela, ngamaphesenti amancane abantu okungenani, zingabangela impendulo ehlala njalo (impendulo yesikhathi eside).
Ngokuthuthuka kwemithi eqondile, kungenzeka ukuthi izivivinyo zesigaba sokuqala ze-clinic zizoqhubeka zinikeza isithembiso esengeziwe kubantu ngabanye kunokuba nje kuvivinywa okwenziwe ukuze kutholakale ukuthi izidakamizwa ziphephile.
Imicabango Uma Ucabanga Ngesivivinyo Sesivivinyo Sesibili Sigaba
Kunezizathu ezimbalwa umuntu angase acabange ukuthi uhlanganyele ekuvivinyweni kwesigaba se-1. Enye yithemba lokucwaninga okuqhubekayo okungasiza abanye ngesifo sakho esikhathini esizayo. Enye ithemba lokuthi umuthi omusha noma inqubo engakaze ivivinywe kubantu izonikeza ithuba lokusinda lapho ezinye izifo zihlulekile. Indlela kuphela eqhubekayo ekwelapheni komdlavuza, kanye nokusinda okulandelayo, kwenziwa, ngokuhlanganyela kwesiguli ekuvivinyweni kwemitholampilo.
Lokho kuthiwa, ukuvivinywa komtholampilo akuwona wonke umuntu.
Izingozi nezinzuzo
Kubalulekile ukucabangela zonke izingozi nezinzuzo zezivivinyo zemitholampilo uma ucabangela enye yalezi zifundo. Kuvame ukusiza ukubhala phansi kokubili ubuhle nobubi bokutadisha ephepheni ukuze ubonakale ulinganisa izinketho zakho. Akukho okulungile noma okungalungile okukhethayo, kuphela ukukhetha okulungile noma okungalungile kuwe.
Ezinye izinketho zokuthola izidakamizwa zokuhlola
Ngokuyinhloko, indlela kuphela ongayisebenzisa ngayo isilingo sokuhlola (ukuphenyisisa) ukuthi uhlanganyele ekuvivinyweni komtholampilo. Lokho akusilo njalo, futhi abanye abantu bangase bafanelekele ukusetshenziswa kozwela noma ukunwetshwa kokufinyelela kwezidakamizwa okwamanje okungakavunywanga yi-FDA. Uma ungafanelanga ukuvivinywa komtholampilo kodwa isidakamizwa sokuphenya sibonakala sethembisa umdlavuza wakho othize, thatha isikhashana ufunde mayelana nokusetshenziswa kwezidakamizwa zesihawu .
Ngaphansi
Izivivinyo zomtholampilo zeSigaba 1 ziyizifundo zokuqala zezokwelapha lapho isidakamizwa noma inqubo ihlolwe kubantu. Ngenkathi ngesintu lokhu kuye kwaba ukukhathazeka okukhathazayo futhi kuye kwabangela amahlaya mayelana nokuba yingulube, lezi zifundo zokuqala zingabhekwa ngezindlela ezahlukene. Ukusuka kolunye uhlangothi bangase babe nengozi kakhulu. Phela, inhloso eyinhloko yalezi zivivinyo ukucacisa ukuthi ngabe izidakamizwa ziphephile yini kubantu (nokuthi futhi uthole umqondo mayelana nomthamo ongcono wokusebenzisa).
Noma kunjalo, kusukela ngenye indlela, ukuhlolwa kwesigaba sokuqala kwesigaba 1 kungase kube nokuningi okuzokunikeza. Amaningi amaningi esigaba sesi-3 evivinyelwa ukwelashwa aqhathanise nezidakamizwa ezivele zibukwe. Ithemba kungenzeka ukuthi isidakamizwa sizokwenza ngcono ukusinda uma nje izinyanga ezimbalwa kuphela. Ngesilingo sesigaba sokuqala sesigaba somtholampilo, noma kunjalo, isidakamizwa esisha (futhi mhlawumbe isigaba esisha semithi) sibukwa okungenzeka noma singasize, kepha singasiza ngaphezu kwanoma yini enye okwamanje etholakalayo. Izibonelo zalokhu ziye zanda kakhulu eminyakeni yamuva. Njengoba ukukhathazeka kusele ngokubandakanyeka ekuvivinyweni komtholampilo, thatha isikhashana ukufunda ngezinganekwane mayelana nokuhlolwa kwemitholampilo nokuthi yiqiniso neqiniso.
> Imithombo:
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. Inqubo Yokubukeza Izidakamizwa ze-FDA: Ukuqinisekisa ukuthi izidakamizwa ziphephile futhi ziyasebenza.