Nidanib, nws yog tshuaj.Lub npe tshuaj 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland ntawm methyl] - 2 - oxygen -, methyl ester, (z) - Clinically, cov khoom no yog siv los kho idiopathic pulmonary fibrosis (IPF).
Nidanib tau kawm 1,529 cov neeg mob uas muaj idiopathic pulmonary fibrosis (IPF) hauv ntau qhov kev sim tshuaj.Cov ntaub ntawv kev nyab xeeb tau nthuav tawm yog raws li kev sib piv ntawm 1061 cov neeg mob tau muab nidanib 150 mg ob zaug ib hnub thiab cov placebo hauv ob 52-lub lim tiam theem 3, randomized, ob-dig muag, kev tshawb fawb placebo (INPULSIS-1 thiab INPULSIS-2).Cov xwm txheej tsis zoo uas tshwm sim feem ntau cuam tshuam nrog kev siv nidanib suav nrog raws plab, xeev siab thiab ntuav, mob plab, tsis qab los noj mov, poob phaus, thiab nce siab enzymes.Thov xa mus rau [Cov Lus Ceeb Toom] rau kev tswj xyuas qhov cuam tshuam tsis zoo.Qhov Systematic Organ Classification (SOC) ntawm MedDRA muab cov ntsiab lus ntawm cov kev cuam tshuam tsis zoo thiab kev faib tawm zaus.
Nidanib yog substrate rau P-gp (saib Pharmacokinetics).Hauv kev tshawb fawb tshwj xeeb ntawm kev sib cuam tshuam ntawm cov tshuaj, kev sib xyaw ua ke ntawm ketoconazole, muaj zog P-gp inhibitor, nce kev cuam tshuam rau nidanib mus rau 1.61 npaug ntawm thaj tsam hauv qab nkhaus (AUC) thiab 1.83 zaug los ntawm qhov siab tshaj plaws (Cmax).
Hauv kev tshawb fawb txog kev siv tshuaj nrog cov muaj zog P-gp inducer rifampicin, raug rau nidanib txo mus rau 50.3%, raws li ntsuas los ntawm cheeb tsam hauv qab nkhaus (AUC), thaum ua ke nrog rifampicin piv nrog Nidanib ib leeg.Los ntawm qhov siab tshaj plaws concentration (Cmax), nws txo mus rau 60.3%.
Thaum noj ua ke nrog cov khoom no, muaj zog P-gp inhibitors (piv txwv li, ketoconazole lossis erythromycin) tuaj yeem ua rau muaj kev cuam tshuam rau nidanib.Hauv cov xwm txheej no, tus neeg mob lub siab ntev rau nidanib yuav tsum tau saib xyuas zoo.Kev tswj xyuas qhov tsis zoo yuav xav tau kev txiav tawm, txo koob tshuaj, lossis txiav kev kho nrog cov khoom no (saib [Siv thiab ntau npaum li cas]).
P-gp muaj zog inducers (xws li, rifampicin, carbamazepine, phenytoin thiab St. John's wort) tuaj yeem txo qhov raug nidanib.Lwm txoj kev ua ke nrog tsis muaj lossis tsawg tsawg P-gp induction yuav tsum raug txiav txim siab.