Yoshino iron carrier cephalosporin Fetcroja (cefider raws cai) tau pom zoo nyob hauv European Union sai, tau teev npe hauv Tebchaws Meskas!

Lub tuam txhab Japanese tshuaj tshiab Shionogi tsis ntev los no tau tshaj tawm tias Pawg Neeg Saib Xyuas Kev Noj Tshuaj Hauv Tebchaws (EMA) rau Tib Neeg Cov Khoom Siv Tshuaj (CHMP) tsis ntev los no tau tshaj tawm cov lus pom zoo, pom zoo rau kev pom zoo rau cov tshuaj tua kab mob tshiab Fetcroja (cefiderocol, cefdil) rau kev kho mob rau cov neeg laus nrog txwv cov kab mob tsawg (18 xyoo thiab laus dua), kho cov kab mob los ntawm cov kab mob aerobic gram-tsis zoo. Tam sim no, CHMP 0010010 # 39; lub tswv yim yuav raug saib xyuas los ntawm European Commission (EC), uas yuav tsum ua qhov kev txiav txim siab zaum kawg li ntawm 2-3 lub hlis tom ntej.

Hauv Tebchaws Meskas, cefiderocol (hom npe: Fetroja) tau pom zoo los ntawm FDA rau lub Kaum Ib Hlis 14, 2019 rau kev kho mob rau cov neeg mob laus uas muaj hnub nyoog 18 xyoos thiab dhau los nrog txwv lossis tsis kho xaiv. Cov kev kho mob yog tshwm sim los ntawm cov kab mob hauv qab Gram-negative microorganisms Complex urinary mob (cUTI, suav nrog pyelonephritis): E. coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae complex. Ua ntej qhov no, cefiderocol tau txais daim ntawv pov thawj ntawm Cov Khoom Muaj Kab Mob Zoo Lawm (QIDP) Kev Tsim Nyog, Kev Kuaj Ncauj Qha, thiab Kev Ntsuas Ua Ntej Kev Ntsuas Xyuas los ntawm FDA.

Tam sim no, cefiderocol (hom npe: Fetroja) tau muag hauv Asmeskas. Cefiderocol yog thawj qhov kev pom zoo nrog cov tshuaj tua kab mob nrog cov hlau nqa khoom muaj nuj nqi, tuaj yeem kov yeej ntau qhov kev tawm tsam ntawm Gram-cov kab mob tsis zoo rau cov tshuaj tua kab mob, los ntawm inhibiting tsim peptidoglycan (ib qho tseem ceeb ntawm cov kab mob hauv phab ntsa). Ntxiv rau, cefiderocol tsuas yog muaj cov tshuaj tua kab mob nkaus xwb nrog cov kev ua haujlwm hauv vitro tiv thaiv txhua tus kab mob gram-negative nrog lub siab tshaj plaws tau txiav txim siab los ntawm World Health Organization (WHO).

Cefiderocol tau txais kev pom zoo los ntawm Asmeskas FDA thiab pom zoo los ntawm EU CHMP, thiab raws li cov ntaub ntawv los ntawm cov kev tshawb fawb tseem ceeb APEKS-cUTI. Qhov no yog qhov chaw ntau lub teb chaws, ntau lub chaw, ob lub qhov muag tsis pom kev soj ntsuam kev soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm Fetroja thiab imipenem / cilastatin (IPM / CS) hauv kev kho mob ntawm cov neeg mob cUTI. Qhov pib xaus ntawm txoj kev tshawb no yog kho sim (TOC) Cov lus teb soj ntsuam thiab cov kab mob kev tua cov neeg mob cov lus teb kawg ntawm lub sijhawm mus ntsib.

Cov txiaj ntsig tau pom tias: 72. {{1}}% ntawm cov neeg mob hauv pawg kho mob cefiderocol kev ua tiav tau txais cov lus teb soj ntsuam thiab cov kab mob tua kab mob, thiab qhov sib piv ntawm cov neeg mob hauv IPM / CS kho pawg yog {{ {2}}. {{1}}%. Qhov hloov tau sib txawv ntawm ob pawg yog 18. 58% (95% CI: {{{{14 {}} 2}}}}. {{ 8}}%, 2 8.. 2%)). Thaum mus ntsib TOC, cov lus teb hauv chaw txhaj tshuaj ntawm Fetroja kho pab pawg thiab IPM / CS kho pawg neeg tau zoo sib xws. Hais txog kev mob tshwm sim loj, Fetroja kho pab pawg yog {{{1 1}}. {{1 2}}%, thiab IPM / CS pawg yog {{ {{1} 2}}}.} 1%. Feem ntau cov kev mob tshwm sim hauv ≥ 2% Fetroja-kho cov neeg mob yog zawv plab, infusion qhov chaw cov tshuaj tiv thaiv, cem quav, ua pob liab vog, candidiasis, hnoos, ua kom siab daim siab, mob taub hau, hypokalemia, xeev siab, thiab ntuav.

cefiderocol qauv txheej txheem qauv (Source: eBiochemicals)

Cov tshuaj nquag muaj ntawm Fetroja / Fetcroja yog cefiderocol, uas yog hom tshiab ntawm cov cab kuj muaj hlau cephalosporin, uas muaj cov txheej txheem tshwj xeeb ntawm kev nkag mus rau cov cell membrane ntawm cov kab mob gram-tsis zoo (suav nrog cov tshuaj tua kab mob ntau yam) thiab muaj peev xwm kov yeej carbapenicillium Lub peev xwm tshwj xeeb ntawm peb lub tswv yim tseem ceeb ntawm kev tiv thaiv ene (hloov cov kab hauv dej, kev ua haujlwm ntawm β-lactamase, thiab ntau dhau ntawm cov kab xa tawm efflux). Cefider raws txoj cai khi rau ferric hlau thiab nquag thauj mus rau hauv cov kab mob hauv cov kab mob mus rau sab nraud ntawm daim nyias nyias ntawm tes ntawm cov kab mob los ntawm cov hlau thauj cov protein. Qhov Trojan nees lub tswv yim no tso cai rau cefider raws mus txog kom muaj kev sib txuam ntau dua hauv cov kab mob cell periplasm, khi rau penicillin-khi cov protein nyob hauv qhov chaw periplasmic thiab inhibits kab mob cell cell ntsa ua ke.

Hauv cov kev tshawb fawb hauv vitro tau qhia tias cefiderocol muaj cov haujlwm muaj zog tiv thaiv txhua yam kab mob Gram-tsis zoo nrog lub siab tshaj plaws tau txheeb xyuas los ntawm World Health Organization (WHO), suav nrog cov carbapenem-tiv thaiv Gram-tsis zoo tsis-fermentative Acinetobacter baumannii, aeruginosa Pseudomonas, refractory carbapenem- tiv taus Enterobacteriaceae. Cefiderocol yog tsim rau siv rau hauv cov kab mob thaum cov neeg tuag coob thiab muaj cov mob tsis tseem ceeb.

Tshuaj tua kab mob tiv thaiv (AMR) yog lub luag haujlwm noj qab haus huv uas yuav tsum tau daws sai sai. Hauv Tebchaws Meskas thiab Tebchaws Europe nkaus xwb, 56, 000 tus neeg tuag los ntawm kev siv tshuaj tua kab mob nyob rau txhua xyoo. Yog tias tsis muaj kev ntsuas, 10 lab tus tib neeg yuav tuag txhua xyoo los ntawm cov tshuaj tua kab mob, thiab los ntawm 2050, lub ntiaj teb cov nyiaj lag luam yuav yog $ 100 trillion.

Raws li qhov tsis sib xws ntawm kev nkag mus ntawm phab ntsa cell ntawm Gram-cov kab mob tsis zoo thiab muaj peev xwm los kov yeej ntau yam txheej txheem ntawm cov kab mob rau cov tshuaj tua kab mob, cefiderocol yuav pab ua qhov tsis tseem ceeb rau kev kho mob tom qab nws tau tsim.