Tus kab mob hauv qhov ncauj tshiab tau pom zoo los ntawm FDA rau kev kho mob ntawm cov kab mob tsis sib raug zoo

Iterum muab tshaj tawm thaum Lub Kaum Hlis 25 tias Asmeskas Cov Tshuaj Tiv Thaiv Tsev Neeg (FDOPE) , Kluca pneumoniae, lossis proteus mirabilis), rau leej twg tsis muaj lossis yuav luag tsis muaj lwm txoj kev tiv thaiv kab mob antimicrobial kho.

Cov kab mob tsis sib raug zoo, tseem hu ua qhov kev tawm tsam yooj yim, yog qhov ua rau tso zis thiab tus neeg mob tsis muaj mob ntshav qab zib, thiab tsis muaj zog. Cov kev kwv yees ntawm kev kwv yees li 1% ntawm cov kab mob tau tshwm sim los ntawm pathogens uas tiv taus txhua yam ntawm cov tshuaj tua kab mob.

SulopenemEtzadroxil yog ib qho kev tswj hwm dav dav (tseem hu ua carbapenem)) tshuaj tua kab mob, sib tov nrog probenecid los ua cov ntsiav tshuaj bilayer. Etzadroxil yog qhov muag hluav taws xob qhov ncauj tiv thaiv daim ntawv ntawm sulopropenem. Sulopropenem yog ib lub thiopenem nrog cov kab mob antibacterial cov kev ua tau tawm tsam feem ntau thiab cov kab mob tsis zoo, thiab probenecid nce qhov ncauj ntawm qhov ncauj.

Raws li cov ntawv tshaj tawm, Orlynvah yog thawj qhov ncauj portem tshuaj tiv thaiv los ntawm FDA thiab thib ob uuti kho yeeb tshuaj tau pom zoo los ntawm FDA hauv ob xyoo dhau los.

Nyob rau lub Plaub Hlis Ntuj ntawm lub xyoo no, Asmeskas FDA pom zoo qhov ncauj kuj tshuaj tua kab mob sib tw (utis) PIVYA, tsim los ntawm British Biotechnology tuam txhab siv tshuaj txhiv tawm tsam me me, yog ib qho kev sib tw tshuaj tiv thaiv kab mob me me - PIVYA yog thawj txoj kev kho mob ua noj kom tau txais FDA pom zoo hauv ob xyoo dhau los.

Kev pom zoo FDA ntawm Orlynvah yog nyob ntawm cov chaw kuaj mob loj los ntawm ob theem kev sim siab 3 (xa mus rau kom paub tseeb 1 thiab qhov tseeb).

Nyob rau hauv qhov tseeb 1 (NCT03354598))))))), cov neeg muaj kev tshawb nrhiav, thiab cov neeg tshawb fawb tau siv cov yeeb tshuaj piv txwv, thiab cov kws tshawb fawb ob npaug rau ntawm qhov ncauj / probenecid nrog rau ntawm ncauj Cov neeg mob tau txais kev kho mob randedized nyob rau hauv 1: 1 piv, nrog cov neeg mob tau txais cov ntsiav tshuaj ob zaug rau 5 hnub, thiab cov neeg mob tau txais Ciprofloxacin noj cov ntsiav tshuaj ib hnub ob zaug rau 3 hnub. Thawj qhov kawg yog tag nrho cov lus teb, thaum lwm qhov xaus lus suav nrog kev kho mob hauv hnub 12, tag nrho cov kev kho mob thiab chaw kho mob nyob rau hnub 28, thiab cov xwm txheej kawg.

Cov txiaj ntsig tau pom tias cov kev kho mob ntawm Sulepinam Etzadroxil / probenecid yog 62.6%, uas tau zoo dua rau Ciproflofloxacin's 36%. Ib qho ntxiv, cov neeg cov neeg tshawb xyuas tau pom tias cov kws tshawb nrhiav pom tias qhov tsis ua rau cov yeeb tshuaj yog 66.8% thiab 78.6%, feem. Raws li tsab ntawv ceeb toom, qhov zaus ntawm kev zawv plab tshwm sim los ntawm etzadroxil / probenecid yog 12.4%, thaum Ciprofloxacin yog 2.5%.

Qhov tseeb (NCT05584657) Kev kawm yog Randomized, multicenter, ob qho tsis pom kev sib cav sib ceg. Cov neeg tuaj koom kev tshawb fawb tau muab rau Sucepinam etzadroxil 500 mg (n {}}}}) ob zaug ib hnub rau tag nrho 5 hnub Cov.

Cov txiaj ntsig kev tshawb fawb qhia tau tias kev kho mob ntawm Sulepinam etzadroxil / probenecid yog cov lus zoo dua amoxicillin / clavulanic acid. Cov pab pawg tag nrho kev ua tiav ntawm Suluailinan etzadroxil / probenecid pawg thiab amoxicillin / clavulanate pab pawg yog 61.7% thiab 55%, feem. Cov kev soj ntsuam kev ua tiav thiab cov microbiological ua tiav tus nqi ntawm amoxicillin thiab 75.2% thiab 66.7%, feem.

Orlynvah pom kev ua kom zoo ntawm ob leeg kom paub tseeb 1 thiab kev sim ua kom pom kev sim. Kev kho mob ntau zaus hauv cov neeg mob Orlynvah Kev Kho Mob Dausea, xeev siab, mob txiv kab mob txaj, thiab ntuav.

Tsis tas li ntawd, raws li FDA cov cai, Sulepinam etzadroxil / probenecid tsis haum rau cov mob tso zis lossis kev nce qib hauv plab. Cov tshuaj noj ib zaug ob zaug ib hnub, ib lub sijhawm txhua lub sijhawm, rau 5 hnub sib law liag.