Video: Lub thawv dub ceeb toom nyob qhov twg?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Hauv Tebchaws Meskas, a thawv ceeb toom (qee zaum " black box ceeb toom ", colloquially) yog hom ceeb toom uas tshwm nyob rau hauv pob ntxig rau qee yam tshuaj noj, yog li hu ua vim US Food and Drug Administration qhia tias nws yog formatted nrog ' lub thawv 'los yog ciam teb ib ncig ntawm cov ntawv nyeem.
Ua raws li qhov xav tau, yuav ua li cas cov tshuaj tau txais lub thawv dub ceeb toom?
FDA xav tau a black box ceeb toom rau ib qho ntawm cov xwm txheej hauv qab no: Cov tshuaj tuaj yeem ua rau muaj kev cuam tshuam loj heev (xws li ua rau tuag taus, ua rau muaj kev phom sij rau lub neej lossis ua rau muaj kev cuam tshuam tsis zoo) piv nrog cov txiaj ntsig zoo ntawm tshuaj.
Tsis tas li ntawd, puas yog txhua yam tshuaj muaj lub thawv dub ceeb toom? A black box ceeb toom los yog boxed ceeb toom yog US Food and Tshuaj Kev tswj hwm feem ntau loj ceeb toom rau tshuaj thiab cov khoom siv kho mob. A tshuaj los yog ntaus ntawv nrog a black box ceeb toom muaj cov kev mob tshwm sim uas yuav ua rau raug mob hnyav lossis tuag taus. Lawv kuj tuaj yeem ua rau cov neeg mob tsis txaus siab xav tau tshuaj los ntawm kev noj nws.
Yog li ntawd, lub ntsiab lus ntawm lub thawv dub ceeb toom yog dab tsi?
A black box ceeb toom tshwm nyob rau ntawm daim ntawv lo ntawm cov tshuaj noj kom ceeb toom rau cov neeg siv khoom thiab cov kws kho mob txog kev txhawj xeeb txog kev nyab xeeb, xws li kev phom sij loj lossis kev phom sij rau lub neej. A black box ceeb toom yog cov tshuaj loj tshaj plaws ceeb toom xav tau los ntawm US Food and Drug Administration (FDA).
Puas yog statins muaj lub thawv dub ceeb toom?
Txhua statins nqa ceeb toom hais txog kev pheej hmoo ntawm cov leeg mob hnyav, hu ua myopathy. Raws li ib zaj dab neeg los ntawm Law360.com, FDA muaj txiav txim siab tias ib qho tseem ceeb black box ceeb toom rau cov neeg mob ntawm rhabdomyolysis kev pheej hmoo tuaj yeem ua rau muaj kev pheej hmoo rau pej xeem kev noj qab haus huv vim tias cov txiaj ntsig kev noj qab haus huv ntawm statins.
Pom zoo:
Lub thawv dub ceeb toom txhais li cas?
Hauv Tebchaws Meskas, lub thawv ntawv ceeb toom (qee zaum 'lub thawv dub ceeb toom', sib tham) yog hom lus ceeb toom uas tshwm rau ntawm pob ntawv ntxig rau qee yam tshuaj, yog li hu ua vim US Food and Drug Administration qhia tias nws yog formatted nrog a 'box' los yog ciam teb ib ncig ntawm cov ntawv nyeem
Muaj pes tsawg cov tshuaj muaj cov lus ceeb toom ntawm lub thawv dub?
Nrog ntau dua 600 cov tshuaj nqa cov lus ceeb toom hauv lub thawv thiab ntau dua 40% ntawm cov neeg mob hauv qhov chaw kho mob thauj neeg mob tau txais tsawg kawg ib qho tshuaj nrog lub thawv dub ceeb toom, nws yog ib qho tseem ceeb rau cov kws kho mob kom paub txog cov tshuaj feem ntau uas muaj cov lus ceeb toom mob hnyav
Puas yog amiodarone muaj lub thawv dub ceeb toom?
Cov tshuaj no muaj lub thawv dub ceeb toom. Qhov no yog qhov ceeb toom loj tshaj plaws los ntawm Food and Drug Administration (FDA). Lub thawv dub ceeb toom ceeb toom cov kws kho mob thiab cov neeg mob txog kev siv tshuaj yeeb uas yuav ua rau muaj kev phom sij. Amiodarone yuav tsum tsuas yog siv yog tias koj muaj kev phom sij rau lub neej arrhythmia lossis lub plawv dhia tsis zoo
Daim ntawv ceeb toom them nyiaj puas tuaj yeem yog daim ntawv ceeb toom them tsawg dua?
Raws li peb tau hais los saum no, luv luv cov lus teb tsis yog. Raws li Txoj Cai Kev Tsim Kho 1996 (raws li tau teev tseg), ntu 111(1) tau tso cai rau tus neeg them nyiaj sib sau ua ke daim ntawv ceeb toom them nyiaj thiab daim ntawv ceeb toom txiav rau hauv ib daim ntawv ceeb toom (tsuas yog nws teev tag nrho cov ntsiab lus tsim nyog rau ob daim ntawv ceeb toom)
Cov tshuaj tua kab mob twg muaj cov lus ceeb toom lub thawv dub?
FDA xav tau daim ntawv ceeb toom thiab daim ntawv qhia tshuaj rau cov tshuaj fluoroquinolone, uas suav nrog Cipro, Levaquin, Avelox, Noroxin thiab Floxin. Pab pawg neeg siv khoom pej xeem tau thov FDA thaum Lub Yim Hli 2006 kom tso 'lub thawv dub' ceeb toom rau Cipro thiab lwm yam fluoroquinolones, thiab tseem ceeb toom rau cov kws kho mob