Tsoom Fwv Teb Chaws Asmeskas FDA pom zoo rau Isturisa (osilodrostat), yog thawj cov tshuaj uas ncaj qha daws cov tshuaj cortisol ntau dhau!

Tsoom Fwv Teb Chaws Asmeskas Khoom Noj thiab Tshuaj (Tsis ntev los no) tau pom zoo Isturisa® (osilodrostat, ntsiav tshuaj ntawm qhov ncauj) rau kev kho mob ntawm cov neeg laus uas muaj Cushing' s syndrome (CS), tshwj xeeb: kev phais mob phais tsis tuaj yeem ua, lossis kev phais tau raug ua. Cov neeg laus uas mob uas tseem muaj mob. Cushing' s syndrome (CS) yog ib tug mob uas tsis tshua muaj mob los ntawm kev ua xoos ntau heev los ntawm cov qog adrenal. Isturisa yog thawj zaug pom zoo tshuaj FDA uas daws ncaj qha ntau dhau ntawm cortisol los ntawm kev thaiv 11 hydro-hydroxylase thiab tiv thaiv cortisol biosynthesis.

Isturisa® yuav muab 1 mg, 5 mg, thiab 10 mg zaj duab xis-ntsiav tshuaj. Qhov ua tau zoo ntawm Isturisa® yog tias nws tuaj yeem tswj lossis ib txwm muaj cortisol ntau ntau hauv cov neeg laus CS cov neeg mob, thiab muaj kev tswj hwm kev nyab xeeb, ua cov khoom lag luam no muaj txiaj ntsig kev kho mob rau cov neeg mob CS.

Isturisa tau tsim los ntawm Novartis. Thaum Lub Xya Hli 2019, lub tuam txhab muag peb cov tshuaj endocrine rau Italian lub chaw lag luam Recordati rau $ 390 lab: Isturisa, ob txoj kev kho mob acromegaly tshuaj Signifor (pasireotide diaspartate) thiab cov tshuaj ua kom ntev ntev Signifor LAR (pasireotide) pamoate).

Hauv European Union, Isturisa tau pom zoo thaum Lub Ib Hlis 2020 rau kev kho mob ntawm endogenous Cushing syndrome (CS) hauv cov neeg laus. Cov tshuaj ua kua tshuaj hauv Isturisa® yog osilodrostat, cortisol synthesis inhibitor uas ua haujlwm los ntawm inhibiting 11-β hydroxylase, uas yog lub luag haujlwm rau theem kawg ntawm adrenal cortisol biosynthesis. Hauv Tebchaws Meskas thiab European Union, Isturisa tau tso cai rau cov menyuam ntsuag chaw nyob tsis zoo.

osilodrostat tshuaj qauv tshuaj (Source: medchemexpress.cn)

Cov ntaub ntawv los ntawm tag nrho cov kev pabcuam hauv tsev kho mob tau qhia tias Isturisa tuaj yeem kho cortisol ntau ntau hauv cov neeg mob feem ntau thiab txhim kho ntau cov chaw kuaj mob thiab muaj lub neej zoo ntawm tus kabmob, yog li muab cov kev pabcuam tseem ceeb hauv thaj chaw uas tsis muaj kev kho mob. Tshwj xeeb, hauv LINC-3 txoj kev tshawb nrhiav, thaum kawg ntawm 8 lub limtiam kev rho tawm lub sijhawm (Lub Limtiam 34), qhov feem pua ​​ntawm cov neeg mob nyob hauv Isturisa pawg uas tseem nyob hauv ib txwm muaj ntau ntawm corticosteroids tseem ceeb dua ntau dua hauv pawg placebo (86. {{4}}% vs 29. 4%). Cortisol qib tswj yog thawj lub hom phiaj ntawm CS cov neeg mob. Hauv kev tshawb nrhiav, qhov tshwm sim ntau tshaj plaws ntawm Isturisa yog adrenal tsis txaus, mob taub hau, ntuav, xeev siab, qaug zog thiab edema.

Mary Thanh Hai, MD, ua yeeb yam thawj coj hauv chav thib ob ntawm FDA Center rau Kev Tshuaj Ntsuam Xyuas thiab Tshawb Nrhiav, hais tias:" FDA txhawb kev txhim kho kev nyab xeeb thiab ua kom zoo rau cov kab mob tsis tshua muaj. Qhov kev kho mob tshiab no tuaj yeem pab cov neeg mob Cushing's syndrome, uas yog tus Kab Mob Tsis tshua muaj, ntau lawm cortisol ntau lawm ua rau cov neeg mob muaj feem yuav ua mob lwm yam mob. Los ntawm kev pab cov neeg mob kom tiav qib cortisol, cov tshuaj no yog qhov kev xaiv tseem ceeb rau kev kho mob rau cov neeg laus nrog Cushing' s kab mob."

Cov tsos mob ntawm CS-Cushing syndrome (Cov duab los ntawm: omicsonline.org)

Raws li Baidu Encyclopedia, Cushing' s syndrome (CS) tseem muaj npe hu ua hypercortisolism (hypercortisolism). Yav dhau los, qee tus neeg tseem hu nws ua Cushing' s syndrome. Cortisol) ua cov kev sim kho mob hauv lub cev, tseem hu ua endogenous Cushing syndrome. Lub hnub nyoog muaj qhov tshwm sim ntau yog 20 txog rau 40 xyoos, thiab qhov sib piv ntawm txiv neej mus rau poj niam muaj li ntawm 1: 3.

Raws li nws cov kev coj noj coj ua, nws tuaj yeem faib ua ob hom: ACTH tsis tos thiab tsis vam khom. Cov kev mob tseem ceeb yog lub ntsej muag tag nrho lub hli, pom cov ntshav, lub cev rog rog rog, mob rog, mob ntshav qab zib, ntshav daj, ntshav nce siab, ntshav qab zib thiab ntshav qab zib. Ntxiv rau, kev thov ncua ntev ntawm cov ntshav siab glucocorticoids lossis kev haus cawv ntau lub sijhawm ntev ntev kuj tseem tuaj yeem ua rau cov kev mob tshwm sim zoo ib yam li Cushing' s syndrome, paub zoo li exogenous, tshuaj muaj txiaj ntsig, lossis Cushing-like syndrome Cov.