Izifundo zakuqala ezibonisa ukuba izingozi zazingalunganga
I-Advair (i-fluticasone + i-salmeterol) yipilisi ekhuselweyo esetyenziselwa ukwelapha isifo se-asthma kunye nezifo ezingapheliyo zokuphefumula (COPD) ezifana ne-emphysema, i-bronchitis engapheliyo kunye ne-bronchiectasis.
Nangona iqhubeka iyingxaki yokuthengisa i-asthma kwi-world, i-Advair yanikezelwa isilumkiso sebhokisi emnyama ngo-2003 evela kwi-US Food and Drug Administration (FDA) icebisa ukuba i-salmeterol inokunyusa umngcipheko wokuhlaselwa kwesifo se-asthma .
Kwakuyi-2003. Uphando litsho ukuthini namhlanje, kwaye ngaba kukho nawuphi na umfuno wokukhathazeka?
Ukuqonda isilumkiso seBhokisi leNnyama
Isixwayiso sebhokisi ebomnyama isitatimende sokulondoloza esikhutshwe yi-FDA ukwazisa uluntu ukuba unyango lunokulimaza nakwingozi engozini. "Ibhokisi elimnyama" libhekisela ngqo kwibhokisi ekhutshwe ngesibindi kwi-packaging information equlethe isiluleko se-FDA.
Izixwayiso zebhokisi ebomnyama zikhutshwa ngokuphendula kwizifundo zeklinikhi eziqhutywe emva kokuba isilwanyana sele sikhululwe. Ukuba kukho nayiphi na inkxalabo ephakamileyo ekuphakanyweni kwe-market, i-FDA iya kulandisa ukuhlaziywa kwangoku kwenkcazelo yokupakisha. Ukukhutshwa kweendaba kuza kwasasazeka ukuxela uluntu malunga neengxaki.
I-FDA Ixhalaba malunga neAdvair
Ngo-2003, isifundo seklinikhi esibizwa ngokuba yi-Salmeterol Multicenter Uvavanyo lwe-Asthma Research (SMART) libike ukuba i-salmeterol yesilwanyana yayixhomekeke kwindleko encinci kodwa ebonakalayo emngciphekweni wokufa nokulala esibhedlele kubantu abane-asthma, ngakumbi i-Afrika yaseMelika.
Njengomphumo weziphumo, isilumkiso sebhokisi emnyama sikhutshwe malunga naluphi na onke amayeza ane-salmeterol, kuquka i-Advair.
Uphando oluthe lwaqhubeka luchaza ingozi efanayo yokufa kunye nokulaliswa esibhedlele kunye neforoterol, iyeza eliseklasini efanayo neziyobisi ezibizwa ngokuba yi -agaists (BABA) .
Ingxaki ngolu vavanyo kukuba i-LABA sele ikwaziwa ukubonelela ngokukhululeka xa isetyenziswe yodwa. Ngaphezu koko, ukuba isetyenziswe ngale ndlela, i-LABAs ingabangela ukuhlaselwa kwesifo se-asthma esichazwe kwisifundo.
Kungenxa yesi sizathu esenza ukuba izidakamizwa zanjenge-Advair zenziwe kuqala. Ngokudibanisa i- corticosteroid enganyangekiyo , imiphumo emibi ye-LABA ingaxhomekeka kakhulu.
Enyanisweni, xa isifundo sagqithwa kamva, kubonakaliswe ukuba abantu abasebenzisa i-LABA kunye ne-corticosteroid enganyangekiyo babenomngcipheko wokufa okanye ukulaliswa esibhedlele kunabo abasebenzisa i-corticosteroid yedwa. Uninzi lwaphando namhlanje luyavuma ukuba ilingo le-SMART lenzelwe iimeko ezingenakulungiswa kwaye zingabandakanyi izinto ezingachaza ngenye indlela i-anomaly.
Oko i-FDA ithi Namhlanje
Ngo-2016, owokuqala kwiphondo elitsha lophando olugunyazwe yi-FDA lwakhululwa. Ebizwa ngokuba yi-AUSTRI, uvavanyo luhlolisise ukhuseleko lwe-salmeterol kunye ne-fluticasone kubantu abayi-12,000 abane-asthma, abanye babo babeneminyaka engama-12. Abaphandi baqinisekisa ngakumbi ukuba i-15 ekhulwini yabathathi-nxaxheba babengama-Afrika aseMelika ukuba bancede ukuba bancome ukuba ngaba nayiphi na imiphumo emibi zihlobene nohlanga.
Oko abaphandi bafumene ingozi yokuhlaselwa sisifo se-asthma okanye enye imiphumo emibi kwakungekho mkhulu kubantu abathatha i-salmeterol-fluticasone kunabo bawathatha i-fluticasone yodwa.
Oko oku kuqinisekisile kukuba ngu-Advair, ngokuhambisa i-LABA kunye ne-corticosteroid kwimveliso enye, ayikho enye ingozi ephakanyisiwe kwi-bhokisi ye-FDA ebusilumkiso.
Nangona kunjalo, isilumkiso se-FDA sisesekhona. Nangona kunjalo, kwisikhokelo sayo samanje malunga nokusetyenziswa okufanelekileyo kwe-LABAs, i-FDA iqinisekisile ukuba:
- I-LABA ayifanele isetyenziswe ngaphandle kokusetyenziswa kwemithi yokulawula i-asthma i-long-term efana ne-corticosteroid enganyangekiyo.
- I-LABA ayifanele isetyenziswe kubantu abane-asthma elawulwa ngokwaneleyo kwi-corticosteroids ephantsi okanye ephakathi.
- Abantwana abane-asthma kufuneka basebenzise kuphela imveliso emibili ngemveliso equkethe i-LABA kunye ne-corticosteroid enganyelwanga kuyo kunezinto ezimbini.
> Imithombo:
> Iinkonzo, iC .; Wieland, L .; Oleszczuk, M .; kunye neKew, K. "Ukhuseleko lweFomoterotol okanye iSalmeterol rhoqo kubantu abadala abane-Asthma: Ingqwalasela yeChranean Reviews." Idatha yeCchrane Data Sys Rev. 2014; 2: CD010314. INGXELO: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B; Chartrand, C; Ni Chroinin, M. et al. "Ukongezwa kwe-Beta2-Agonists e-Long-Acting-Agonists kwi-Corticosteroids yokuHlenga i-asthma engapheliyo kubantwana." Idatha yeCchrane Data Sys Rev. 2015; 11: CD007949. INGXELO: 10.1002 / 14651858.CD007949.pub2.
> IStempel, D .; Raphiou, I .; Kral, L. et al. Iziganeko ezinkulu ze-Asthma ze-Fluticasone kunye neSalmeterol kunye ne-Fluticasone. " N Engl J Med. 2016; 374: 1822-33. INGXELO: 10.1056 / NEJMoa1511049.
> Ulawulo lweZiko lokuTya kunye neDrug. I-FDA Inxibelelwano yoKhuseleko lweMithi: I-FDA idinga iimvavanyo zokhuseleko lwangemva kwemali kwi-Beta-Agonists (LABAs). Silver Spring, eMaryn; kukhutshwa ngo-Apreli 15, 2011.