Iimbalasane
Kwimeko yangoku yeendleko eziphezulu zonyango lomhlaza, uninzi lweziyobisi zomhlaza ezivunyiweyo ze-FDA kunye ne-EMA zingene kwimakethi ngokusekwe kumanqaku okuphela, ngaphandle kobungqina benzuzo ekusindeni ngokubanzi okanye kumgangatho wobomi, njengoko kuchaziwe zifundo zeklinikhi ezihlalutya ukuvunywa kwesiyobisi somhlaza phakathi 2008-2013: Uhlalutyo lweendleko zezibonelelo zoMhlaza.
Nangona ukusebenza kwentsha umhlaza Amachiza aphucuka kancinci, iindleko zinyuka ngendlela engazange ibonwe ngaphambili. Kukho umnxeba okhulayo wokuthatha amanyathelo ukuze amaqumrhu alawulayo anyuse umda wenzululwazi wokwamkelwa kwamachiza amatsha omhlaza akhoyo ngoku akwaziyo ukubonisa ubungqina obungahambelaniyo bokusebenza kunye nokungena emarikeni ngaphandle kobungqina bokwenyani bokuba iyeza liyakunceda isigulana ngokuphucula. ukusinda kunye nomgangatho wemilinganiselo yobomi. Kukho iindlela ezintsha zokulawula ezidalwe yi-FDA, ezinje ngokutyunjwa kwempumelelo, umkhondo okhawulezayo okanye iindlela ezikhawulezileyo, ukufumana amachiza asongela ubomi okanye izifo ezinqabileyo kwintengiso ngokukhawuleza okusekwe kwiziphelo zomntu omnye; kodwa kukho izifundo ezilandelayo ezigunyazisiweyo ukubonisa ubungqina bokusebenza. Ingxelo ye-ofisi karhulumente yoxanduva (i-GAO) ka-2009 yagxeka i-FDA yase-US ngokusilela ukunyanzelisa izibophelelo zophononongo lwentengiso ye-postmarketing kumachiza avunyiweyo kwi-surrogate endpoints (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61932 -2/isicatshulwa esipheleleyo). Ngaloo ndlela namhlanje, ngokusekelwe kuhlalutyo lwamachiza avunyiweyo kule minyaka ilishumi idlulileyo, kukho inkxalabo ekhulayo malunga nokubeka amayeza abiza kakhulu, amachiza anetyhefu kwi-toolkit kagqirha angaphuculi ukusinda ngokubanzi.
Ukutya okuTyiwa emva kokuChongwa koMhlaza!
Akukho mhlaza mibini ifanayo. Yiya ngaphaya kwezikhokelo zesondlo esiqhelekileyo kuwo wonke umntu kwaye wenze izigqibo ezizezakho malunga nokutya kunye nezongezo ngokuzithemba.
Ukusinda kwiZibonelelo zoMhlaza ezivunyiweyo
Zimbini ezi zifundo, esinye sijonga iziyobisi ezivunyiweyo phakathi kuka-2008-2012 yi-US FDA (UKim noPrasad, iJAMA Intern Med., 2015) naphakathi kuka-2009-2013 yi-EMA (iarhente yezonyango yaseYurophu) (UDavis C okqhubekayo, BMJ., 2017), bobabini beqaqambisa lo mbandela ungasentla. Uhlalutyo lwe-FDA luxele ukuba i-36 ye-54 (67%) yokuvunywa kwamachiza omhlaza ibisekwe kwiziphelo zesivumelwano sokunciphisa ubungakanani besisu okanye iintsuku zesigulana sihlala singenasifo (ukuqhubeka kokuphila simahla). Emva kweminyaka eyi-4.4 yokulandelelwa kwezi ziyobisi zomhlaza zivunyiweyo ze-FDA, zi-5 kuphela ezingama-36 (14%) ezivunyiweyo ezibonakalise ukuphucuka kokusinda jikelele, ngelixa i-31 (86%) yezi ziye zasilela okanye zasilela nayiphi na idatha kwimpembelelo yokusinda. Uhlalutyo lwe-EMA lweziyobisi zomhlaza ezivunyiweyo phakathi kuka-2009-2013, bekukho iziyobisi ezingama-48 ezivunyiweyo zokuya kwintengiso yeempawu ezingama-68 zomhlaza kwaye kuphela ezingama-35 (51%) kwezi zibonise ukuphucula ukusinda okanye umgangatho wobomi. Isibonelelo sokuphila kunye nentsingiselo yeklinikhi yala machiza kwagwetywa kusetyenziswa i-ESMO-MCBS (i-European Society for Medical Oncology Magnitude of Clinical Benefit Scale), eyindlela emiselweyo esetyenziselwa ukuvavanya ubungakanani bexabiso leklinikhi kunye nokunyaniseka kweziyobisi zomhlaza. Eyona nto ikhathaza nangakumbi kukuba ngaphandle kokusebenza okuthandabuzekayo kwezininzi zezi ziyobisi zomhlaza zivunyiweyo kwintengiso, iindleko zazo ziyaqhubeka nokuhlala ziphakamile ngokumasikizi.
Umzekelo othile woku sisiyobisi iRegorafenib esimiselwe ukunyanga amanqanaba asemva komhlaza wecolorectal, umhlaza wekolon okanye we-rectum ongowesithathu umhlaza oqhelekileyo e-United States (American Cancer Society). UReorafenib wanikwa ibakala le-1 ngesixhobo se-ESMO-MCBS esithetha ukuba iphantse yafumana izibonelelo zonyango okanye izibonelelo kumgangatho wobomi (UDavis C okqhubekayo, BMJ., 2017). Ukongeza, eli chiza lixabiso elininzi elingasebenziyo kunye neendleko ezixhomileyo kunye nesibonelelo sonyango esincinciU-Cho SK okqhubekayo, uMhlaza weColorectal Cancer., 2018). Kwaye okwangoku, yasungulwa kwimarike njengesixhobo 'sokuqhekeka' somhlaza emva kwexesha.
Ngokusisiseko, le bhlog yenzelwe ukwenza izigulana kunye nabathandekayo babo bazi izinto eziyinyani zomhlaba umhlaza amayeza kunye nokubakhuthaza ukuba benze uhlalutyo lweendleko-inzuzo, bathathele ingqalelo zonke iindlela zonyango abanokukhetha kuzo kwaye benze ukhetho olunengqiqo kunokuba balandele ngokumfamekileyo imarike yangoku ecetyiswayo kwiinketho ezintsha nezixabisa kakhulu.
Kukuphi ukutya okutyayo kwaye okuncedisayo kukuthatha sisigqibo osithathayo. Isigqibo sakho kufuneka sibandakanye ukuthathelwa ingqalelo kotshintsho lomhlaza kuhlobo lomhlaza, unyango oluqhubekayo kunye nezongezelelo, nakuphi na ukwaliwa, ulwazi ngobomi bakho, ubunzima, ukuphakama kunye nemikhwa.
Isicwangciso sesondlo somhlaza esivela kwi-addon asisekelwanga kukhangelo lwe-Intanethi. Isebenza ngokuzenzekelayo ukwenza izigqibo zakho kusekwe kwisayensi yemolekyuli ephunyezwe ngoososayensi kunye neenjineli zesoftware. Nokuba ukhathalele na ukuqonda iindlela ezisisiseko seemolekyuli okanye hayi - zokucwangciswa kwesondlo somhlaza ukuqonda kuyafuneka.
Qalisa NGOKU ngokucwangciswa kwesondlo ngokuphendula imibuzo ngegama lomhlaza, uguquko kwimfuza, unyango oluqhubekayo kunye nezincedisi, nakuphi na ukwaliwa, imikhwa, indlela yokuphila, iqela lobudala kunye nesini.
ISondlo esiSiqu soMhlaza!
Umhlaza uyatshintsha ngokuhamba kwexesha. Yenza ngokwezifiso kwaye uguqule isondlo sakho ngokusekwe kwisalathiso somhlaza, unyango, indlela yokuphila, ukhetho lokutya, i-allergies kunye nezinye izinto.
Izigulana ezinomhlaza zihlala zisebenza ngeendlela ezahlukeneyo iziphumo ebezingalindelekanga ezichaphazela umgangatho wobomi babo kwaye bajonge ezinye iindlela zonyango lomhlaza. Ukuthatha isondlo esifanelekileyo kunye nezongezelelo ezisekwe kuqwalaselo lwenzululwazi (ukunqanda ukuqikelela kunye nokukhetha okungahleliwe) sesona sixhobo sendalo somhlaza kunye neziphumo ebezingalindelekanga zonyango.