Emergency Live | FDA approves Recarbio to treat hospital-acquired and ventilator-associated bacterial pneumonia

FDA pom zoo kom Recarbio kho cov mob pw hauv tsev kho mob thiab muaj lub tshuab tso pa tawm

By Newsroom On Jun 16, 2020

Tsoom Fwv Teb Chaws Asmeskas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Recarbrio (kev sib xyaw ua ke ntawm imipenem, cilastatin thiab relebactam) rau kev kho mob ntawm tsev kho mob-tau txais cov kab mob ntsws thiab ua rau muaj tus kab mob ntsws ua kom mob ntsws (HABP / VABP) hauv cov neeg mob hnub nyoog 18 xyoo thiab laus dua Cov.

Recarbrio tau raug pom zoo yav dhau los los ntawm FDA rau kev nyuaj ua mob txeeb zig thiab mob nyuaj rau mob plab. Tam sim no, FDA tau tshaj tawm tias nws tuaj yeem yog tshuaj tua kab mob rau mob ntsws.

Recarbrio, nws puas tuaj yeem yog cov tshuaj tua kab mob rau kev mob ntsws hauv tsev kho mob?

Kev nyab xeeb thiab kev ua tau zoo ntawm Recarbrio rau cov kev qhia ntxiv no tau raug ntsuas hauv kev soj ntsuam kev sib tw hauv 535 tus neeg laus pw hauv tsev kho mob nrog HABP / VABP vim cov kab mob Gram-tsis zoo: 266 cov neeg mob tau kho nrog Recarbrio thiab 269 tus neeg mob piperacillin-tazobactam.

Zuag qhia tag nrho, los ntawm hnub 28 ntawm txoj kev tshawb no, 16% ntawm cov neeg mob kho nrog Recarbrio thiab 21% ntawm lwm tus tau tuag.

Tshuaj tua kab mob rau kab mob ntsws: feem ntau cov kev phiv tshuaj

Feem ntau cov kev mob tshwm sim uas tau pom tshwm sim hauv cov neeg mob kho nrog Recarbrio suav nrog kev nce aspartate / alanine aminotransferase, ua kom ntshav khov, zawv plab, hypokalemia thiab hyponatraemia.

Recarbrio tau txais Kev Tsim Nyog Kev Muaj Kab Mob (QIDP) tsim los ntawm FDA Kev Ruaj Ntseg thiab Kev Tsim Kho Txoj Kev Tsim Ua Tshiab Ua Rau Kev Tiv Thaiv Tam Sim No (GAIN), uas lub koomhaum Asmeskas tau tso cai rau cov tshuaj tua kab mob thiab tshuaj tua kabmob los npaj kho tus mob hnyav lossis tuag taus. Ua ib feem ntawm QIDP tsim ntawv, Recarbrio tau xaiv Tus Thawj Saib Xyuas Ua Ntej thiab tau pom zoo nrog Fast Track.