Maphunziro oyambirira omwe amasonyeza kuti zoopsa zinali zazikulu
Advair (fluticasone + salmeterol) ndi mankhwala opatsirana omwe amachititsa kuchiza matenda a mphumu komanso matenda osokoneza bongo (COPD) monga emphysema, bronchitis, ndi bronchiectasis.
Ngakhale kuti ikupitiriza kukhala imodzi mwa mankhwala opatsirana kwambiri a asthma padziko lapansi, Advair anapatsidwa chenjezo lakuda la bokosi mu 2003 kuchokera ku US Food and Drug Administration (FDA) akulangiza kuti salmeterol ikhoza kuonjezera chiwopsezo cha kupha masoka a mphumu .
Icho chinali chaka cha 2003. Kodi kafukufukuyu akutiuza chiyani lero, ndipo kodi pali chifukwa chosowa chidwi?
Kumvetsetsa Mndandanda wa Black Box machenjezo
Chochenjeza bokosi lakuda ndi mawu odziteteza omwe adatulutsidwa ndi FDA kuti adziwe anthu kuti mankhwala akhoza kuvulaza kwambiri komanso kuopseza moyo. "Bokosi lakuda" limatanthauzira molondola kwa bokosi lopangidwa mobwerezabwereza pazolemba zomwe zili ndi uphungu wa FDA.
Mankhwala a mabulosi amdima amaperekedwa poyankha maphunziro azachipatala atatulutsidwa kale. Ngati pali mavuto akuluakulu omwe amachokera ku kafukufuku wamsika, FDA idzalamula kuti pakhale ndondomeko yowonongeka. Zigawuni zidzafalitsidwa kuti zikachenjeze anthu za mavutowa.
FDA Makhalidwe Okhudza Advair
M'chaka cha 2003, kafukufuku wa zachipatala wotchedwa Salmeterol Multicenter Asthma Research Trial (SMART) adanena kuti mankhwalawa akugwirizanitsidwa ndi chiwerengero chaching'ono koma chodziwika kwambiri pa ngozi ya imfa ndi kuchipatala kwa anthu omwe ali ndi mphumu, makamaka a ku America.
Chifukwa cha zomwe adazipeza, chenjezo la bokosi lakuda linatulutsidwa pa mankhwala alionse omwe ali ndi salmeterol, kuphatikizapo Advair.
Phunziroli linapitiriza kufotokoza za ngozi yomweyi ya imfa ndi chipatala ndi formoterol, mankhwala omwe ali m'gulu la mankhwala omwe amadziwika kuti agonists omwe akhala akutalika nthawi yayitali (LABAs) .
Vuto ndi kufufuza kuti a LABA akhala akudziwika kuti amapereka chithandizo chokwanira pakagwiritsidwa ntchito payekha. Komanso, ngati amagwiritsidwa ntchito mwanjira imeneyi, a LABA angayambitse matenda a mphumu omwe amawerengedwa mu phunzirolo.
Ndi chifukwa chake chomwe chinapanga mankhwala ngati Advair poyamba adalengedwa. Mwa kuwonjezera corticosteroid yosakanizidwa , zotsatira zovulaza za LABAs zikhoza kuchepetsedwa kwambiri.
Ndipotu, pamene phunziroli linakambidwa, zinawululidwa kuti anthu omwe amagwiritsa ntchito LABA ndi corticosteroid yosavundikira anali ndi chiopsezo chachikulu cha imfa kapena chipatala kusiyana ndi omwe amagwiritsa ntchito corticosteroid okha. Ambiri ofufuza masiku ano amavomereza kuti kuyesedwa kwa SMART kunali kosakonzedwa bwino komanso kosagwirizana ndi zinthu zomwe zingathe kufotokozera molakwika za vutoli.
Zimene FDA Ikunena Masiku Ano
Mu 2016, oyamba mu maphunziro atsopano olamulidwa ndi a FDA anamasulidwa. Ataimbidwa mlandu wa AUSTRI, kafukufukuyu anafufuza za chitetezo cha salmeterol ndi fluticasone mwa anthu 12,000 omwe ali ndi mphumu, ena mwa iwo anali aang'ono 12. Ofufuzawo anaonetsetsa kuti 15 peresenti ya ophunzirawo ndi African American kuti azindikire ngati zovuta zina zikhale zokhudzana ndi mtundu.
Zimene afufuzi anapeza ndizoopsa za chifuwa cha mphumu kapena zotsatira zina zoipa sizinali zazikulu kwa anthu omwe amatenga salmeterol-fluticasone kuposa omwe anatenga fluticasone okha.
Chimene chinatsimikiziranso chinali chakuti Advair, popereka LABA ndi corticosteroid mu chinthu chimodzi, sanawononge zoopsa zomwe zafotokozedwa mu FDA zakuda.
Ngakhale izi, machenjezo a FDA akadali m'malo. Komabe, potsogoleredwa pakali pano pa ntchito yoyenera ya LABAs, a FDA adatsimikizira kuti:
- Ma LABA sayenera kugwiritsidwa ntchito popanda kugwiritsa ntchito mankhwala osokoneza bongo ochuluka monga corticosteroid yosakanizidwa.
- Ma LABA sayenera kugwiritsidwa ntchito kwa anthu omwe mphumu yawo imayang'aniridwa mokwanira pazitsipa zapansi kapena zapakatikati zimaphatikizapo corticosteroids.
- Ana omwe ali ndi mphumu ayenera kugwiritsira ntchito mankhwala awiri kapena awiri omwe ali ndi LABA ndipo amavomeretsa corticosteroid m'malo mwa mankhwala awiri.
> Zotsatira:
> Cates, C .; Wieland, L .; Oleszczuk, M .; ndi Kew, K. "Chitetezo cha Regular Formoterol kapena Salmeterol mwa Achikulire omwe ali ndi chifuwa: Zowona za Cochrane." Data Cochrane Sys Rev. 2014; 2: CD010314. DOI: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B .; Chartrand, C .; Ni Chroinin, M. et al. "Kuwonjezereka kwa Beta2-Agonist Yomwe Yakhala ikugwira ntchito yotulutsira Corticosteroids ya matenda opatsirana aumunthu opatsirana mwa ana." Data Cochrane Sys Rev. 2015; 11: CD007949. DOI: 10.1002 / 14651858.CD007949.pub2.
> Stempel, D .; Raphiou, I .; Kral, L. et al. "Zochitika Zambiri za Khunyu ndi Fluticasone kuphatikizapo Salmeterol motsutsana ndi Fluticasone Pokha." N Engl J Med. 2016; 374: 1822-33. DOI: 10.1056 / NEJMoa1511049.
> Utsogoleri wa US Food and Drug Administration. "FDA Drug Safety Communication: FDA imafuna mayesero otetezera malonda ku Beta-Agonists (LABAs) a Long-Acting." Silver Spring, Maryland; inatulutsidwa pa April 15, 2011.