Izifundo zakuqala ezikhomba ukuthi izingozi zazingalungile
I-Advair (i-fluticasone + salmeterol) imithi ephazamisekile esetshenziselwa ukwelapha izifo ze- asthma nezifo ezingavamile zokuphefumula (COPD) njenge-emphysema, i-bronchitis engapheli, ne-bronchiectasis.
Ngenkathi iqhubeka ingenye yemithi yokwelapha i-asthma emhlabeni, u-Advair wanikezwa isixwayiso sebhokisi elimnyama ngonyaka ka-2003 evela e-US Food and Drug Administration (FDA) elulekisa ukuthi i-salmeterol ingase ikhulise ingozi yokuhlaselwa yisifo se-asthma esongela ukuphila .
Lokho kwakuyi-2003. Ucwaningo lusitshelani namuhla, kanti kukhona isidingo sokukhathazeka?
Ukuqonda izixwayiso ze-Black Box
Isixwayiso sebhokisi elimnyama yisitatimende sokuqapha esikhishwe yi-FDA ukukwazisa umphakathi ukuthi imithi ingabangela ingozi enkulu noma engozini yokuphila. "Ibhokisi elimnyama" libhekisela ngokweqile ebhokisini eliguqulelwe ngesibindi emininingwaneni yephakheji equkethe iseluleko se-FDA.
Izixwayiso zebhokisi elimnyama zikhishwa ngokuphendula izifundo zokwelashwa ezenziwe ngemuva kokuba isidakamizwa sesivele sikhululwe. Uma ngabe kukhona ukukhathazeka okukhulu okuphakanyisiwe ekucwaningweni kwamakethe, i-FDA izoyala ukubuyekezwa okusheshayo kolwazi lokupakisha. Ukukhishwa kwemidiya kuzosakazeka futhi ukuxwayisa umphakathi mayelana nokukhathazeka.
I-FDA Ikhathazeka Nge-Advair
Ngo-2003, isifundo somtholampilo esibizwa ngokuthi i-Salmeterol Multicenter Asthma Research Trial (SMART) sabika ukuthi i-salmeterol yezidakamizwa zaxhunyaniswa nokwanda okuphawulekayo engozini yokufa nokugula esibhedlela kubantu abane-asthma, ikakhulukazi base-Afrika baseMelika.
Ngenxa yalokho okufunyenwe, isilumkiso sebhokisi elimnyama sikhishwe mayelana nanoma yimiphi imithi equkethe i-salmeterol, kuhlanganise ne-Advair.
Ucwaningo oluqhubekayo lwabika ingozi efanayo yokufa kanye nokuhlala esibhedlela nge formoterol, imithi yeklasi elifanayo lemithi eyaziwa ngokuthi ama-agonists asebenza isikhathi eside (i-LABAs) .
Inkinga ngokuhlola ukuthi i-LABA yesaziwa isikhathi eside ukuthi inikeze ukukhululeka okungenele uma isetshenziswe yedwa. Ngaphezu kwalokho, uma kusetshenziswe ngale ndlela, ama-LABA angabangela ukuhlaselwa kwesifo sofuba okubikwe ekutadisheni.
Kungenxa yalesi sizathu ukuthi ukudala izidakamizwa ezifana ne-Advair kuqala kuqala. Ngokwengeza i- corticosteroid engatholakali , imiphumela emibi ye-LABA ingahle ibe nencishisiwe.
Eqinisweni, lapho ucwaningo lubuye lwabuyekezwa kamuva, kwavezwa ukuthi abantu abasebenzisa i-LABA nge-corticosteroid engatholakali babenengozi yokufa noma yokuhlala esibhedlela ngaphandle kwalabo abasebenzisa i-corticosteroid kuphela. Abaningi abacwaningi namuhla bayavuma ukuthi ukuhlolwa kwe-SMART kwakungakhethi kahle futhi kungabandakanyi izici ezingase zichaze ngenye indlela i-anomaly.
Okushiwo yi-FDA Namuhla
Ngonyaka we-2016, owokuqala ohlangothini olusha lwezifundo olugunyazwe yi-FDA akhululwa. Ebizwa ngokuthi i-AUSTRI, lolu cwaningo lwahlola ukuphepha kwe-salmeterol no-fluticasone kubantu abangu-12 000 abane-asthma, abanye babo ababengabafana nabangu-12. Abaphenyi baqhubeka beqinisekisa ukuthi amaphesenti angu-15 alabo ababambe iqhaza babengama-African American ukuze banqume ukuthi yiziphi izenzakalo ezimbi ezingase zibe zihlobene nobuhlanga.
Lokho abaphenyi abathola ukuthi ingozi yokuhlaselwa yisifo se-asthma noma enye impikiswano embi kwakungeyona enkulu kulabo abathatha i-salmeterol-fluticasone kunelabo abathatha i-fluticasone yedwa.
Okukuqinisekisile ukuthi yi-Advair, ngokuletha i-LABA kanye ne-corticosteroid emkhiqizo owodwa, akubanga nezezicabangela eziphakanyisiwe kwi-FDA black box.
Naphezu kwalokhu, isixwayiso se-FDA sisesekhona. Kodwa-ke, esiqondisweni sayo samanje ngokusetshenziswa okufanele kwe-LABAs, i-FDA iqinisekisile ukuthi:
- Ama-LABA akufanele asetshenziswe ngaphandle kokusebenzisa imithi yokulawula i-asthma yesikhathi eside efana ne-corticosteroid engatholakali.
- Ama-LABA akufanele asetshenziswe kubantu abane-asthma abalawulwa ngokwanele kwi-corticosteroids engaphansi noma ephakathi.
- Izingane ezine-asthma kufanele zisebenzise kuphela umkhiqizo womunye nomunye oqukethe i-LABA kanye ne-corticosteroid enganyelwanga esikhundleni semikhiqizo emibili.
> Imithombo:
> Amakhodi, C .; Wieland, L .; Oleszczuk, M .; no-Kew, K. "Ukuphepha kwe-Formoterol njalo noma i-Salmeterol kubantu abadala abane-Asthma: Ukubukeza kokubuyekezwa kwe-Cochrane." Idatha ye-Cochrane Sys Rev. 2014; 2: CD010314. I-DOI: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B .; I-Chartrand, i-C .; Ni Chroinin, M. et al. "Ukwengezwa kwama-Beta2-Agonists ase-Long-Acing2 kuya kuma-corticosteroids angeniswe ngaphakathi kwe-Asthma e-Chronicle yezingane." Idatha ye-Cochrane Sys Rev. 2015; 11: CD007949. I-DOI: 10.1002 / 14651858.CD007949.pub2.
> Stempel, D .; I-Raphiou, I .; Kral, L. et al. "Izenzakalo ezimbi kakhulu ze-Asthma Events ne-Fluticasone plus i-Salmeterol ehambisana ne-Fluticasone eyedwa." N Engl J Med. 2016; 374: 1822-33. I-DOI: 10.1056 / NEJMoa1511049.
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. "Ukuxhumana Kokuphepha Kwezidakamizwa ze-FDA: I-FDA idinga ukuhlolwa kokuphepha kwamakethe kuma-Beta-Agonists ase-Long-Acting (LABAs)." I-Silver Spring, e-Maryland; ikhishwe ngo-Ephreli 15, 2011.