Kodi Phase 1 Yophunzitsa Zomwe Amapanga Khansa Ndi iti?
Ngati mukuganiza za chiyeso chachigawo cha 1, kodi izi zikutanthauza chiyani? Kodi izi zimasiyana bwanji ndi magawo ena a mayesero a zachipatala? Ndi kupititsa patsogolo kwa kansangamsanga, gawo la mayesero oyamba a chipatala ndilofunikira kwambiri. Ngakhale panthawi ina mayeserowa atha kukhala ngati "chitsime chomaliza", panopo pali anthu ambiri omwe akukhalabe ndi khansa chifukwa cha mayeserowa.
Tiyeni tiyang'ane mayesero a kachipatala 1 omwe alipo pakapita kafukufuku wamakono ndikukambilana chifukwa chake mayesero oyamba a kachipatala sangakhale "owopsa" monga kale.
Kumbukirani kuti cholinga cha mayesero a kachipatala ndi kupeza mankhwala omwe amathandiza bwino kapena omwe alibe zotsatira zochepa kuposa mankhwala omwe tili nawo panopa. Mankhwala onse opatsirana khansa adayesedwa kale ngati gawo la mayesero a zachipatala. Ndipo panthaŵi imeneyo, anthu okhawo omwe adatha kupeza zofunikira za mankhwalawa ndi omwe anali mu gulu la phunziro lachidziwitso.
Tsatanetsatane ndi Cholinga cha Gawo 1 Zoyesedwa
Mayesero amachilendo a Phase 1 amachitidwa kuti aone ngati mankhwala osokoneza bongo kapena mankhwala ali otetezeka. Pambuyo pa mankhwala akuyesedwa mu labu kapena pa nyama, imalowa muyeso yoyamba ya mankhwala yomwe imachitika ndi anthu. Mayeserowa kawirikawiri amakhala ndi anthu ang'onoang'ono okha omwe angadziwe ngati mankhwala kapena mankhwala ali otetezeka komanso kuti adziwe momwe mungagwiritsire ntchito mankhwala ndi momwe mungaperekere (kaya ndi amlomo kapena intravenous).
Ngakhale cholinga chachikulu cha mayeserowa ndi kufufuza chitetezo, akhoza kudziwa ngati mankhwala akuwoneka kuti akugwira ntchito ya khansa.
Miyezi ina
Pali magawo atatu a mayesero okhudzana ndi matenda omwe ayenera kumalizidwa musanayambe mankhwala ndi FDA. Ngati mankhwala akuwoneka otetezeka kumapeto kwa mayesero oyamba a kachipatala, angayambe mayesero a chipatala 2, kafukufuku amene adachitidwa ngati mankhwalawa akugwira ntchito.
Ngati mankhwala kapena mankhwala akuyesedwa otetezeka mu chiyeso chachigawo 1 ndikugwira ntchito muyeso yachigawo chachiwiri, adzalowa muyeso ya katatu. Mayesero amachilombo a Phase 3 ndi aakulu kwambiri ndipo amachitika kuti mankhwalawa asakhale otetezeka komanso ogwira mtima koma amathandiza bwino kapena alibe zotsatira zochepa kusiyana ndi chithandizo chomwe chilipo panopo.
Gawo 1 Mayesero Amayendedwe M'zaka khumi zapitazo
Mayesero a Phase 1, ndi zomwe mungayembekezere ngati mwalembetsa chimodzi, zasintha kwambiri muzaka zochepa zokha. Mankhwala ambiri atsopano omwe akuyesedwa mu 2018 asankhidwa mwaluso kuti achite njira yeniyeni pa kukula kwa khansa. Mankhwala osokoneza bongo ndi omwe amachititsa kuti asakhale ndi zotsatira zoyipa kusiyana ndi mankhwala a mankhwala ammadzi (ngakhale amatha), koma pogwiritsa ntchito kapangidwe kameneka pali mwayi wokwanira kuti apange kusiyana kwa khansara yanu . Ndipotu, ngati mungathe kulepheretsa tsatanetsatane kuti khansa iyenera kudutsa (kotero kuti ikule ndi kufalikira), pali mwayi wokwanira kuti khansara yomwe yasonyezedwa kuti ikudalira pa sitepe imeneyo idzayankha.
Zikatero zikhoza kukhala kuti njira zokhazokha zothandizira khansa zikhoza kukhala mankhwala ochiritsira a mankhwala a chemotherapy. Mankhwala osokoneza bongo monga mankhwala omwe amagwiritsidwa ntchito nthawi zambiri amatha kukhala ndi khansa nthawi yambiri, ndipo mankhwala osamalitsa amadzimadzi, chifukwa chachepa peresenti ya anthu, angapangitse yankho lokhazikika (yankho la nthawi yaitali).
Ndi kupita patsogolo kwa mankhwala osamalitsa, zikutheka kuti mayesero oyamba a kachipatala adzapitiriza kupereka malonjezano kwa anthu m'malo moyesedwa kuti awone ngati mankhwalawa ali otetezeka.
Maganizo Poganizira Ntchito Yoyamba ya Gawo 1
Pali zifukwa zingapo zomwe wina angaganize kuti akuchita nawo chiyeso choyambitsa matenda. Chimodzi ndi chiyembekezo chopitiriza kufufuza komwe kungathandize ena ndi matenda anu m'tsogolomu. Chiyembekezo china ndi chakuti mankhwala atsopano kapena njira yomwe siinayesedwepo kwa anthu idzakupatsani mpata wopulumuka pamene mankhwala ena alephera. Njira yokhayo yomwe ikupita patsogolo pa chithandizo cha khansa, ndi kupulumuka kwapambuyo, kumapangidwa, ndikutenga nawo mbali muzitsulo zamatenda.
Icho chinati, mayesero achipatala si onse.
Mavuto ndi Mapindu
Ndikofunika kulingalira zoopsa ndi phindu lonse la mayesero a zachipatala ngati mukuganizira imodzi mwa maphunzirowa. Nthawi zambiri zimathandiza kulemba zonse zomwe zimapindulitsa pa pepala kotero kuti muwone bwinobwino zomwe mungasankhe. Palibe kusankha koyenera kapena kolakwika, kusankha nokha kumene kuli koyenera kapena kolakwika kwa inu.
Zosankha Zina Zothandizira Mankhwala Osokoneza Bongo
Kwa mbali yaikulu, njira yokha yomwe mungagwiritsire ntchito mankhwala oyesera (kufufuzira) ndikutenga nawo mbali muyeso la mankhwala. Sikuti nthawi zonse zimakhala choncho, ndipo anthu ena akhoza kukhala oyenerera kuti agwiritsidwe ntchito mwachifundo kapena kuwonjezera mwayi wopeza mankhwala osagonjetsedwa ndi FDA. Ngati simukuyenera kuyesedwa kuchipatala koma mankhwala osokoneza bongo akuwoneka kuti akulonjeza za khansara yanu, tengani kamphindi kuti muphunzire za kugwiritsa ntchito mankhwala osokoneza bongo .
Pansi
Mayesero amachilendo a Phase 1 ndiwo maphunziro oyambirira a zachipatala omwe mankhwala kapena ndondomeko amayesedwa kwa anthu. Ngakhale mwachizolowezi izi zakhala zikudetsa nkhaŵa ndipo zachititsa nthabwala zokhudzana ndi kukhala nkhumba, maphunzirowa oyambirira akhoza kuyang'aniridwa m'njira zosiyanasiyana. Kuchokera kumbali imodzi akhoza kukhala oopsa kwambiri. Ndipotu cholinga chachikulu cha mayeserowa ndi kudziwa ngati mankhwala ali otetezeka kwa anthu (komanso kupeza lingaliro la mlingo woyenera kugwiritsa ntchito).
Komabe, kuchokera kumbali ina, mayesero oyamba a chithandizo chamankhwala angakhale ndi zambiri. Masewera ambiri a masewera atatu amatsitsiramo mankhwala omwe ayang'ana kale. Chiyembekezo chikhoza kukhala chakuti mankhwala amatha kusintha kupulumuka ngati kwa miyezi ingapo chabe. Komabe, poyesedwa kachipatala ka 1, komabe mankhwala atsopano (ndipo mwinamwake ndi mankhwala atsopano) akuyang'anitsitsa omwe angathe kapena sangathandize, koma angathandize kwambiri kuposa china chili chonse. Zitsanzo za izi zakhala zikuchitika zaka zaposachedwapa. Popeza nkhawa idakalipo pokhudzana ndi mayesero a kachipatala, tengani kamphindi kuti mudziwe za nthano zokhudzana ndi mayesero a zachipatala ndi zomwe ziri zoona ndi zabodza.
> Zotsatira:
> Utsogoleri wa US Food and Drug Administration. Njira yothetsera mankhwala a FDA: Kuonetsetsa kuti mankhwala osokoneza bongo ndi otetezeka komanso ogwira mtima.