Binciken farko da ya nuna cewa haɗari sun kasance mafi kuskure
Shawara (fluticasone + salmeterol) wani magani ne wanda aka shayar da shi don magance cututtukan fuka da kuma cututtuka na nakasa (COPD) irin su emphysema, ciwon daji, da bronchiectasis.
Yayinda yake ci gaba da kasancewa daya daga cikin magungunan asibiti mai cin gashi a duniya, an ba da sanarwar gargadi a cikin shekara ta 2003 daga Cibiyar Abinci da Druggun Amurka (FDA) ta bada shawara cewa salmeterol na iya haifar da haɗari na hare-haren ƙwayoyin asiri .
Wannan shi ne shekarar 2003. Mene ne bincike yake gaya mana a yau, kuma akwai wani bukatar damuwa?
Fahimtar Gargaɗi na Akwatin Black
Bayanin gargadi na baki shine bayanin sanarwa wanda FDA ya bayar don sanar da jama'a cewa magani zai iya haifar da mummunan cutar. "Akwatin baki" tana nufin ainihin sakon da aka sanya a cikin rubutun marufi wanda ya ƙunshi shawara na FDA.
An bayar da gargadi na fata don amsa tambayoyin da ake yi a asibiti bayan an sake sakin miyagun ƙwayoyi. Idan akwai damuwa da damuwa a cikin bincike na kasuwa, FDA za ta umarci sake sauke bayanan rubutun. Za a kuma watsa tarwatsa labarai don gargadi jama'a game da damuwa.
FDA Damuwa game da Advair
A shekara ta 2003, bincike na asibiti da ake kira Salmeterol Multicenter Asthma Research Trial (SMART) ya ruwaito cewa salmeterol na miyagun ƙwayoyi ya danganci karamin ƙarami a cikin haɗarin mutuwa da kuma asibiti a cikin wadanda ke fama da ciwon fuka, musamman Afrika ta Amirka.
A sakamakon binciken, an bayar da gargadi game da fata game da kowane magunguna da ke dauke salmeterol, ciki har da Advair.
Binciken ya ci gaba da bayar da rahoton yiwuwar mutuwa da kuma asibiti tare da formoterol, maganin da ke cikin magungunan likitancin da ake kira das agonists (LABAs) .
Matsalar tare da kima shine cewa LABAs sun san dadewa don samar da taimako mara dacewa idan aka yi amfani da shi kadai. Bugu da ƙari, idan aka yi amfani da wannan hanya, LABAs zai iya haifar da hare-haren da ƙananan haɗari suke yi a cikin binciken.
Saboda haka ne aka fara yin amfani da kwayoyi kamar yadda Advair suka fara. Ta hanyar ƙara corticosteroid wanda yake da ƙwayar cuta, za a iya haifar da mummunar tasirin LABA.
A gaskiya ma, lokacin da aka sake nazarin wannan binciken, an bayyana cewa mutane da suka yi amfani da LABA tare da corticosteroid wadanda suka kamu da su ba su da wata hadari ko mutuwa fiye da wadanda suka yi amfani da corticosteroid kadai. Yawancin masu bincike a yau sun fahimci cewa an kaddamar da jarrabawa ta SMART da kuma cire abubuwan da za su iya bayyana bayanin da ya faru.
Abin da FDA ta ce a yau
A shekara ta 2016, an saki na farko a wani sabon bincike na FDA. Da ake kira jarrabawar AUSTRI, nazarin ya kimanta lafiyar salmeterol da mutane 12,000 tare da ciwon fuka, wasu daga cikinsu sun kasance matasa kamar 12. Masu bincike sun tabbatar da cewa kashi 15 cikin dari na mahalarta sune Afrika na Amurka don ganewa ko duk wani abu mai ban tsoro zai iya kasance dangantaka da kabilanci.
Abinda masu bincike suka gano shine hadarin kamuwa da fuka-fuka ko wasu mummunar tasiri ba shine mafi girma ga mutane masu karɓar salmeterol-fluticasone ba fiye da wadanda suka dauki shi kadai.
Abin da wannan ya tabbatar shine Advair, ta hanyar fitar da LABA da corticosteroid a cikin samfurin guda, bai sanya wani haɗari da aka ba da shawara a cikin akwatin FDA ba.
Duk da haka, gargadi na FDA yana ci gaba. Duk da haka, a cikin jagorancin yanzu game da amfani da LABAs, FDA ta tabbatar da cewa:
- LABAs ba za a taba amfani dashi ba tare da amfani da maganin fuka na dogon lokaci kamar maganin corticosteroid.
- LABAs ba za a yi amfani da su ba a cikin mutanen da suke kwakwalwa da ƙwaƙwalwar ƙwayar ƙwayoyin ƙwayoyin ƙwayar ƙwayoyin ƙwayar ƙwayar ƙwayar ƙwayoyin cuta.
- Yara da ciwon sukari ya kamata su yi amfani da samfurori guda biyu cikin guda wanda ya ƙunshi LABA da kuma ciwon shayar da ƙwayar cuta fiye da samfurori guda biyu.
> Sources:
> Cates, C .; Wieland, L ;; Oleszczuk, M .; da kuma Kew, K. "Tsaro na Formulerol ko Salmeterol a cikin Adult da Asthma: Wani Bayani na Cochrane Reviews." Cochrane Data Sys Rev. 2014; 2: CD010314. DOI: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B. Chartrand, C. Ni Chroinin, M. et al. "Ƙara Ma'aikatan Beta2-Agonists zuwa Tsakanin Corticosteroids don Cikakken Asthma a Yara." Cochrane Data Sys Rev. 2015; 11: CD007949. DOI: 10.1002 / 14651858.CD007949.pub2.
> Stempel, D .; Raphiou, I ;; Kral, L. et al. "Ayyukan Tsira da ke faruwa tare da Fluticasone da Salmeterol da Fluticasone kadai." N Engl J Med. 2016; 374: 1822-33. DOI: 10.1056 / NEJMoa1511049.
> Cibiyar Abinci da Drug. "FDA Damag Safety Communication: FDA na buƙatar jarrabawar gwaje-gwaje a kasuwannin Beta-Agonists (LABAs)." Silver Spring, Maryland; bayar da Afrilu 15, 2011.