Tshuaj tua kab mob Zevtera (Ceftobiprole medocaril) pom zoo los ntawm FDA rau kev kho mob ntawm CABP, ABSSSI thiab SAB 

Cov tshuaj tua kab mob cephalosporin tiam tsib uas muaj ntau yam kev phiv , Zevtera ( Ceftobiprole medocaril sodium Inj.) tau txais kev pom zoo los ntawm FDA 1 rau kev kho peb yam kab mob viz.

  1. Cov kab mob Staphylococcus aureus (bacteremia) (SAB), suav nrog cov neeg uas muaj kab mob endocarditis sab xis;  
  1. mob kab mob ntawm daim tawv nqaij thiab kab mob ntawm daim tawv nqaij (ABSSSI); thiab  
  1. community-acquired bacterial pneumonia (CABP).  

Qhov no ua raws li qhov txaus siab rau theem 3 kev sim tshuaj ntsuam xyuas.  

Ceftobiprole medocaril tau txais kev pom zoo hauv ntau lub tebchaws European, nrog rau Canada rau kev kho mob ntsws uas tau los ntawm tsev kho mob (tsis suav nrog mob ntsws uas tau los ntawm lub tshuab ua pa) thiab mob ntsws uas tau los ntawm zej zog rau cov neeg laus 2.

Hauv UK, Ceftobiprole medocaril tam sim no nyob rau theem III kev sim tshuaj 3 txawm li cas los xij, nws raug lees txais rau kev siv txwv hauv NHS Scotland 4.

Hauv EU, nws tshwm sim hauv Union Register of refused medicinal products for human use 5.

Ceftobiprole medocaril, yog ib hom tshuaj cephalosporin tiam tsib uas siv tau zoo rau cov kab mob Gram-positive xws li methicillin-resistant Staphylococcus aureus thiab penicillin-resistant Streptococcus pneumoniae, thiab cov kab mob Gram-negative xws li Pseudomonas aeruginosa. Nws tau pom tias muaj txiaj ntsig zoo rau kev kho mob ntsws hauv zej zog thiab mob ntsws hauv tsev kho mob, tshwj tsis yog mob ntsws uas cuam tshuam nrog lub tshuab ua pa 6,7.

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References:  

  1. FDA Xov xwm tawm. FDA Pom Zoo Tshiab Tshuaj tua kab mob rau peb qhov sib txawv siv. Tshaj tawm 03 Plaub Hlis 2024. Muaj nyob ntawm https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses/ 
  1. Jame W., Basgut B., thiab Abdi A., 2024. Ceftobiprole mono-therapy piv rau kev sib xyaw ua ke lossis tsis sib xyaw ua ke ntawm tus qauv tshuaj tua kab mob rau kev kho mob ntawm cov kab mob nyuaj: Kev tshuaj xyuas thiab kev tshuaj xyuas meta. Kev kuaj mob Microbiology thiab Kab Mob Sib Kis. Muaj nyob online 16 March 2024, 116263. DOI: https://doi.org/10.1016/j.diagmicrobio.2024.116263  
  1. NIHR. Health Technology Briefing Kaum Ib Hlis 2022. Ceftobiprole medocaril rau kev kho mob ntsws hauv tsev kho mob lossis mob ntsws hauv zej zog uas yuav tsum tau mus pw hauv tsev kho mob hauv cov menyuam yaus. Muaj nyob ntawm https://www.io.nihr.ac.uk/wp-content/uploads/2023/04/28893-Ceftobiprole-medocaril-for-pneumonia-V1.0-NOV2022-NONCONF.pdf  
  1. Scottish Medicine Consortium. Ceftobiprole medocaril (Zevtera). Muaj nyob ntawm https://www.scottishmedicines.org.uk/medicines-advice/ceftobiprole-medocaril-zevtera-resubmission-94314/  
  1. European Commission. Union Register ntawm tsis kam tshuaj cov khoom rau tib neeg siv. Hloov tshiab kawg ntawm 21 Lub Ob Hlis 2024. Muaj nyob ntawm https://ec.europa.eu/health/documents/community-register/html/ho10801.htm 
  1. Lupia T. thiab al 2022. Ceftobiprole Perspective: Tam sim no thiab muaj peev xwm yav tom ntej Indications. Tshuaj tua kab mob Volume 10 Issue 2. DOI: https://doi.org/10.3390/antibiotics10020170  
  1. Méndez1 R., Latorre A., and González-Jiménez P., 2022. Ceftobiprole medocaril. Rev Esp Quimioter. 2022; 35 (Ntawv qhia zaub mov 1): 25–27. Luam tawm online 2022 Plaub Hlis 22. DOI: https://doi.org/10.37201/req/s01.05.2022  

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