Zvidzidzo zvepakutanga zvinoratidza kuti njodzi dzakanga dzakawanda
Advair (fluticasone + salmeterol) inopindwa muropa nemishonga inoshandiswa kurapa zvirwere zvechirwere uye zvirwere zvisingagadziriswi zvinokonzerwa nemapirmonary (COPD) zvakadai se emphysema, chronic bronchitis, uye bronchiectasis.
Kunyange zvazvo ichiri kuwedzera kuva imwe yepamusoro-kutengesa mishonga yemapirma munyika, Advair yakapiwa nyema bhokisi kuchenesa muna 2003 kubva kuU.S. Food and Drug Administration (FDA) inopa zano kuti salmeterol inogona kuwedzera kungozi yekuuraya upenyu hwekushaya mweya .
Izvozvo zvakaitika muna 2003. Tsvakurudzo inotiudzei nhasi, uye kune chimwe chinhu chinodiwa here?
Kunzwisisa Black Box Manyevero
Bhokisi rakasvibira bhokisi nderekuti chirevo chekuchengetedza chakabudiswa neDFA kuudza vanhu kuti mishonga inogona kukuvadza zvakakomba uye kunyange kutyisa upenyu. I "bhokisi dema" rinoreva zvakananga kune bhokisi rakashandurwa rakashandurwa pamashoko ekuvhara mairi ane DHAA mazano.
Black box warnings inowanikwa mukupindura kuchipatara zvidzidzo zvakaitwa mushure mokunge mishonga yave yatosunungurwa. Kana pane zvimwe zvinonetsa zvakakonzerwa mushure mekutsvakurudza kwemashamba, FDA icharaira kugadziriswa patsva kwehuwandu hwemashoko. Zvekubudiswa kweMedia zvichapararira zvakare kuchenesa vanhu pamusoro pezvinetso.
FDA Kunetseka NezveAdvair
Muna 2003, chirwere chekliniki chinonzi Salmeterol Multicenter Asthma Research Trial (SMART) chakashuma kuti salmeterol iyi yakabatanidzana nekuwedzera kuwedzerwa mudambudziko rekufa uye kupararira kune vanhu vane astmma, zvikurukuru veAfrica America.
Somugumisiro wezvaakawana, nyevero yebhokisi dema yakabudiswa pamusoro pemishonga ipi neipi nemishonga ine salmeterol, kusanganisira Advair.
Chidzidzo ichi chakawedzera chiitiko chakafanana chekufa uye chipatara ne formoterol, mushonga weboka rimwechete remishonga inonzi inozivikanwa seve -long acting beta agonists (LABAs) .
Dambudziko nekuongororwa nderokuti LABAs vave vachizivikanwa kwenguva yakareba vachipa rubatsiro rusina kukodzera pavanoshandiswa vari voga. Uyezve, kana yakashandiswa nenzira iyi, LABAs inogona kukonzera kushushikana kwechirwere ichi chakataurwa mubhuku.
Ndicho chikonzero ichi chakakonzera mishonga yakafanana neAdvair yakatanga kusikwa. Nokuwedzera kori inokonzerwa nekristicosteroid, migumisiro yakaipa yeLABAs inogona kunge yakanyanya kuderedzwa.
Zvechokwadi, apo chidzidzo chacho chakazoongororwa, zvakaratidzwa kuti vanhu vakashandisa LABA vane corticosteroid yakanyungudzwa vakanga vasina ngozi kana kuti shoma yekufa kana yekurapa kupfuura avo vakashandisa corticosteroid voga. Vazhinji vatsvakurudzi nhasi vanobvuma kuti chirongwa che SMART chakanga chisina kugadziriswa uye chisina kusimbiswa izvo zvingave zvichitsanangurira zvisingaiti.
Izvo zvinonzi FDA Nhasi
Muna 2016, yekutanga munharaunda itsva yezvidzidzo yakagadzwa neCDA yakabudiswa. Inonzi chirongwa cheAUSTRI, chiongorori chakaongorora kuchengetedzwa kwe salmeterol uye fluticasone muvanhu 12 000 vane astmma, vamwe vavo vakanga vari vaduku se12. Vatsvakurudzi vakawedzera vakaona kuti 15 muzana yevatori vechikamu vaiva Africa American kuti vaone kana zviitiko zvipingamupinyi zvingave kuva neukama nedzinza.
Zvakawanikwa nevatsvakurudzi ndezviitiko zvekurwiswa kwepfu kana chimwe chinhu chakaipa chakanga chisina chikuru kuvanhu vanotora salmeterol-fluticasone kune avo vakatora fluticasone voga.
Izvo zvakasimbiswa ndezvekuti Advair, nekusunungura LABA uye corticosteroid mune chimwe chinhu chakasikwa, hapana chakaipa chinowanikwa muDBA black box warning.
Pasinei neizvi, nyevero ye FDA ichiripo. Zvisinei, mumutungamiri waro wezvino pamusoro pekushandiswa kwakakodzera kweLABAs, FDA yakatsigira kuti:
- LABA haafaniri kushandiswa pasina kushandiswa kwemishonga kwenguva refu yekurapa kwemishonga yakadai seyorticticeroid inhaled.
- I-LABA haifaniri kushandiswa kune vanhu vane mafi anokwana zvakakwana kutungamirirwa pamadekisi kana pasi-mizinga inoputira corticosteroids.
- Vana vane astmma vanofanira kungoshandisa zvikamu zviviri-mu-chimwe chigadzirwa chine LABA uye chakabatanidza corticosteroid panzvimbo yezvinhu zviviri zvakagadzirwa.
> Sources:
> Cates, C .; Wieland, L .; Oleszczuk, M .; uye Kew, K. "Kuchengetedzwa kweRegular Formoterol kana Salmeterol muVakuru Vane Chirwere cheApmma: Zvakajeka zveChorkrane." Data yeCorkrane Sys Rev. 2014; 2: CD010314. DOI: 10.1002 / 14651858.CD010314.pub2.
> Chauhan, B .; Chartrand, C .; Ni Chroinin, M. et al. "Kuwedzera kweBeta-Kubata Beta2-Agonist kuInhaled Corticosteroids yeHIV Hupenyu Husingaperi muvana." Data yeCorkrane Sys Rev. 2015; 11: CD007949. DOI: 10.1002 / 14651858.CD007949.pub2.
> Stempel, D .; Raphiou, I .; Kral, L. et al. "Zvinonyanya Kuitika Pumuviri Zviitiko neFluticasone uye Salmeterol neFluticasone Pamwechete." N Engl J Med. 2016; 374: 1822-33. DOI: 10.1056 / NEJMoa1511049.
> US Food and Drug Administration. "FDA Mishonga Yekuchengetedzwa Kwemishonga Kukurukurirana: FDA inoda miedzo yekuchengetedza misika mushure mekutengesa Beta-Agonists (LABAs)." Silver Spring, Maryland; yakabudiswa musi waApril 15, 2011.