Daraasado hore oo soo jeedinaya khatarta ayaa inta badan cilladaysan
Advert (fluticasone + salmeterol) waa daawo la isticmaalo oo lagu daaweeyo xiiqda iyo cudurada joogtada ah ee xannuunada sanbabada (COPD) sida amphysema, boronkiitada daba dheeraatay, iyo bronchiectasis.
Inkastoo ay sii waddo mid ka mid ah daawooyinka ugu badan ee neefta adduunka, Advair waxa la siiyay digniin sanduuq madow sannadkii 2003 oo ka yimid Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) oo ku taliyay in salmeterol ay kordhin karto khatarta nafta halis u ah weerarka neefta .
Taasi waxay ahayd sannadkii 2003. Maxay cilmi-baaristu maanta noo sheegaysaa, oo ma jiraan baahi loo qabo welwel?
Fahmitaanka Calaamadaha Black Box
Digniinta sanduuqa madow waa faafin taxaddar ah oo ay soo saartay FDA si ay dadweynaha ugu sheegto in daawo ay sababi karto halis iyo xitaa halis nolosha ah. "Sanduuqa madow" wuxuu u jeedaa macnaha ereyga geesinimada leh ee ku jira macluumaadka baakidhka kaas oo ka kooban lataliyaha FDA.
Digniinta sanduuqa madow waxaa lagu soo saaray jawaab-celinta kiliinikada la sameeyay ka dib markii daroogada horeba la sii daayey. Haddii walwal kasta oo halis ah lagu soo kordhiyo cilmi-baarista kadib, FDA waxay amar ku bixineysaa dib-u-habeynta degdegga ah ee macluumaadka baakidhka. Warbaahinnada warbaahinta ayaa sidoo kale lagu faafin doonaa si dadweynaha loogu digo dareenka.
Faahfaahinta FDA ee ku saabsan Advent
Sanadkii 2003, daraasad cilmi baaris ah oo la yiraahdo Salmeterol Multicenter Trial Trial Trial (SMART) ayaa soo warisay in salmeterol daroogada uu ku xiran yahay kor u kaca halista dhimashada iyo isbitaaleynta dadka qaba asmada, gaar ahaan Afrikaanka Maraykanka.
Natiijada ka soo baxday natiijada, digniinta sanduuqa madow ayaa la soo saaray oo ku saabsan wax kasta iyo dhammaan daawooyinka ay ku jiraan salmeterol, oo ay ku jiraan Advair.
Daraasadan ayaa sii werisay khatarta dhimashada iyo isbitaaleynta iyadoo la adeegsanaayo qaab-daweyneed, daawo ay ka mid yihiin isla heerka daroogada loo yaqaanno agagaaraha dilaaga ah ee beta (LABAs) .
Dhibaatada ka jirta qiimeynta ayaa ah in LABAs waqti dheer loo yaqaan inay bixiyaan gargaar aan ku filneyn marka loo isticmaalo kaligaa. Intaa waxaa dheer, haddii loo isticmaalo habkan, LABAs waxay kicin kartaa weerarrada xiiqda ee lagu soo sheegay daraasadda.
Sababtaas awgeed ayaa daroogooyinka loo wada sameeyay sida Advair ayaa markii hore la abuuray. Marka lagu daro corticosteroid-ka la neefsado , saameynta xun ee LABAs ayaa si weyn loo yareyn karaa.
Xaqiiqdii, markii daraasada dib loo eegay, waxaa la ogaaday in shaqsiyaadka isticmaala LABA ee qaba corticosteroid-ka la qabadsiiyay aysan lahayn khatar ama dhimasho khatar ama dhimasho ka badan kuwa isticmaala corticosteroid oo kali ah. Cilmi-baadhayaasha badankoodu waxay qirayaan in tijaabinta SMART ay tahay mid si liidata loo qorsheeyey lagana reebay oo laga yaabo inay sharaxaad ka bixiso dabiiciga.
Waa maxay FDA-da maanta
Sannadka 2016-ka, ugu horreyntii wareega cusub ee waxbarashadda ee FDA ayaa la sii daayay. Daraasada AUSTRI waxay baadhis ku samaysay nabadgelyada salmeterol iyo fluticasone 12,000 oo qof oo qaba neefta, qaar ka mid ah da'doodu ahayd 12 jir. Baadhayaashu waxay sii xaqiijiyeen in boqolkiiba 15 ka mid ah ka-qaybgalayaashu ay ahaayeen Afrikaan Maraykan ah si ay u ogaadaan in wax kasta oo dhacdooyin ah lala xiriiriyo qowmiyadda.
Maxay baadhayaashu ogaadeen inay ahayd halista astaamaha neefta ama saameyn kale oo aan fiicneyn ayaa loogu talagalay dadka qaata salmeterol-fluticasone marka loo eego kuwii ka soo jeeda qoyskooda.
Maxaa loo xaqiijiyay in uu ahaa Advair, adoo dhiibaya LABA iyo corticosteroid hal sheyga, ma aysan keenin halisaha lagu soo jeediyey digniinta sanduuqa madow ee FDA.
Inkastoo taas, digniinta FDA ayaa weli jirta. Si kastaba ha noqotee, haggeda hadda ee isticmaalka haboon ee LABAs, FDA waxay xaqiijisay in:
- LABAs waa inaan marnaba la isticmaalin iyada oo aan la isticmaalin dawo xakameyn ah oo muddo dheer ah sida daaweynta corticosteroid.
- LABAs waa in aan loo isticmaalin dadka ay neefta si fiican ugu xakameyso corticosteroids oo hooseeya ama dhexdhexaad ah.
- Carruurta qaba neefta waa inay isticmaalaan oo kaliya hal shay oo laba-mid ah oo ay ku jiraan labadaba LABA iyo corticosteroid oo loo yaqaan 'corticosteroid' halkii laba shey oo sheybaarka ah.
> Ilo:
> Cates, C .; Wieland, L .; Oleszczuk, M .; iyo Kew, K. "Nabadgelyada Daawada Fooma Bixisa ama Salmeterol ee Dadka Qaangaarka ah ee Neefta: Aragti Kordhinta Kochrane." Macluumaadka Cochrane Sys Rev. 2014; 2: CD010314. DOI: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B .; Chartrand, C .; Ni Chroinin, M. et al. "Ku darista Beta2-Agonistayaasha Long-Acting Corticosteroids ee Neefsashada Xanuunka ah ee Carruurta." Macluumaadka Cochrane Sys Rev. 2015; 11: CD007949. DOI: 10.1002 / 14651858.CD007949.pub2.
> Stempel, D .; Raphiou, I .; Kral, L. et al. "Munaasabadaha Calaamadaha Neefsashada oo leh Fluticasone iyo Salmeterol oo ka soo horjeeda Fluticasone." N Engl J Med. 2016; 374: 1822-33. DOI: 10.1056 / NEJMoa1511049.
> Maamulka Cuntada iyo Dawooyinka Mareykanka. "FDA Ammaanka Daroogada Daroogada: FDA waxay u baahan tahay tijaabooyinka nabadgelyada dambe ee suuqa ee loogu talagalay Xanuunka Beta-Agonists (LABAs)." Silver Spring, Maryland; soo saaray Abriil 15, 2011.