EPO (erythropoietin) yog ib qho zoo - paub cov tshuaj thawj zaug hauv kev kho mob, nrog cov npe tsim xws li Epogen, Procrit, thiab Eprex yog cov npe paub tshaj plaws. Roche tom qab qhia txog qhov ntev - ua Mircera (methoxydiol recombinant human erythropoietin). Yooj yim muab tso, nws yog ib qho recombinant glycoprotein hormone uas tshwj xeeb ua kom cov pob txha pob txha ua rau cov qe ntshav liab ntau dua. Qhov no yog siv los kho cov ntshav tsis txaus los ntawm cov kab mob hauv lub raum ntev, kev kho tshuaj khomob, lossis zidovudine, thiab tseem tuaj yeem pab khaws cov ntshav ua ntej xaiv kev phais, txo qhov kev xav tau ntawm cov ntshav.
Core Advantages:
Lub hom phiaj meej; tshwj xeeb khi rau EPOR receptor, inhibiting erythroid progenitor cell apoptosis thiab txhawb erythrocyte maturation. Cov ntaub ntawv dav dav uas muaj nyob rau hauv pej xeem muab cov ntaub ntawv siv rau hematopoietic-cov qauv ntsig txog, ua rau cov txheej txheem sim ua kom rov ua dua yooj yim dua.
Ntxiv nrog rau kev ua haujlwm hematopoietic, nws tuaj yeem ua kom muaj ntau yam antioxidant thiab tiv thaiv -apoptotic txoj hauv kev, ua rau nws tsim nyog rau kev nthuav qhia kev tshawb fawb xws li kev raug mob hypoxia, tiv thaiv cov ntaub so ntswg ischemic, thiab kho cov paj hlwb. Ib qho reagent tuaj yeem txhawb nqa ntau- cov haujlwm tshawb fawb.
Cov hom muaj npe nrov muaj cov qauv tswj kev tswj hwm nruj, ua kom ruaj khov purity, qib endotoxin, thiab cov cim qhia txog bioactivity nrog tsawg kawg batch-rau-batch fluctuations. Qhov no kuj lav tau cov ntaub ntawv zoo dua qub nyob rau hauv ntev - cov kev sim sib luag.
Mature qhia tshuab ua kom cov protein folding zoo sib xws nrog lub ntuj conformation, ua rau muaj kev ruaj ntseg receptor affinity thiab kev ua si. Nws tsim nyog rau ntau txoj kev tswj hwm, suav nrog kab lis kev cai ntawm tes, intraperitoneal / intravenous kev tswj hwm hauv cov tsiaj, thiab muaj tus neeg siv - tus phooj ywg ua haujlwm zoo.
Lub hom phiaj drawbacks:
Lub thawv dub ceeb toom txog EPO tsis yog yuav tsum ua kom qis dua - nws tuaj yeem ua rau muaj kev pheej hmoo tuag, myocardial infarction, mob stroke, venous thrombosis, thiab qog nqaij hlav. Qhov tshwm sim feem ntau thiab teeb meem tshwm sim yog qhov tshwm sim ntawm cov ntshav siab, tshwm sim ze li 30% ntawm cov neeg mob. Qee cov neeg mob tau mob taub hau, tsis meej pem, lossis txawm tias mob hlab ntsha hlwb thaum tau txais EPO, ua rau tsis muaj kev nyab xeeb rau cov neeg mob ntshav siab.
Lwm qhov teeb meem uas ua rau hematologists thaum hmo ntuj yog ntshiab erythrocyte aplasia (PRCA)- qhov tshwm sim tam sim ntawd ntawm cov tshuaj tiv thaiv kab mob uas cuam tshuam EPO hauv tus neeg mob lub cev tiv thaiv kev tsim cov qe ntshav liab, ua rau muaj qhov txo qis hauv reticulocyte suav thiab ua rau cov ntshav tsis txaus. Thaum qhov no tshwm sim, cov tshuaj yuav tsum raug txiav mus tas li, thiab hloov mus rau lwm yam ESAs tsis tuaj yeem ua tau vim muaj peev xwm tiv thaiv kab mob khaub thuas -reactivity. Cov neeg mob qog noj ntshav yuav tsum ceev faj heev. Cov kev tshawb fawb qhia tau hais tias nyob rau hauv qee cov neeg mob uas muaj cov qog nqaij hlav thiab hematological malignancies, EPO tsis tsuas yog ua tsis tau kom muaj sia nyob ntev, tab sis kuj tseem tuaj yeem ua kom cov qog loj hlob sai.
Nqe- ntse, thawj cov tshuaj yeej tsis pheej yig, tshwj xeeb tshaj yog ntev - cov qauv ua yeeb yam. Cov nqi them rov qab thiab kev txwv tsis pub muaj qhov sib txawv raws cheeb tsam, thiab tawm - ntawm - cov nqi hnab tshos tuaj yeem yog lub nra hnyav rau cov tsev neeg zoo tib yam.
Kev cia khoom
Cov khoom ntim tsis tau qhib: Txias ntawm 2-8 degree, tiv thaiv los ntawm lub teeb. Tsis txhob khov los yog co. Muab pov tseg txhua lub fwj uas tau khov ib zaug, muaj cov pos huab nrog cov khoom siv flocculent, lossis muaj cov roj hmab dented. Epoetin multi- koob tshuaj vials tuaj yeem khaws cia hauv lub tub yees ntev li 21 hnub tom qab qhib; muab pov tseg tom qab ntawd. Ib zaug - koob tshuaj vials yuav tsum tsis txhob khaws cia txawm tias tsuas yog ib qho me me xwb. Tib yam siv rau Aranesp ua ntej- cov cwj mem puv: tso rau hauv lub thawv qub, tiv thaiv lub teeb. Luv luv txav lawv mus rau hauv thiab tawm ntawm chav tsev kub yog qhov tsim nyog, tab sis tsis txhob tshav ntuj ncaj qha thiab ua kom sov ntawm tes. Tag nrho cov txheej txheem kev thauj mus los yog nyob rau hauv cov saw hlau txias. Thaum tuaj txog, tam sim ntawd kov lub raj mis; tsis txhob siv tej yam uas khov.
Cov kev ceev faj:
Rau kev soj ntsuam kuaj tsuas siv xwb. Tib neeg daim ntawv thov raug txwv nruj heev. Daim ntawv tsis lees paub tiav yuav tsum muaj nyob rau ntawm nplooj ntawv khoom.
Rau kev tsim kho dua tshiab, siv nruab nrab tsis muaj menyuam PBS nrog cov khoom siv protein sib xws. Direct dilution nrog dej ntshiab nyob rau lub sij hawm ntev yuav ua rau cov protein adsorption mus rau lub raj phab ntsa thiab tsis ua hauj lwm.
Concentration gradient ua ntej- kev sim yuav tsum tau ua ua ntej kev sim. Tsis txhob ncaj qha luam cov ntaub ntawv ntau npaum li cas kom tsis txhob muaj cov qe ntshav liab ntau dhau thiab cuam tshuam kev sim ntxiv.
Ua cov txheej txheem aseptic thoob plaws tag nrho cov txheej txheem. Protein paug ua rau kev loj hlob ntawm cov kab mob microbial tsis tsuas yog rhuav tshem kev ua si tab sis kuj ua rau cov metabolic impurities ncaj qha kis kab mob ntawm tes.
Thaum noj tas li hauv kev sim tsiaj, nws raug nquahu kom saib xyuas cov ntshav suav tsis tu ncua thiab kho cov tshuaj noj kom sai kom tsis txhob muaj teeb meem los ntawm cov ntshav viscosity siab.
Paub qhov txawv ntawm EPO li niaj zaus thiab qhov ntev - ua yeeb yam hloov kho. Lawv qhov sib txawv pharmacokinetic yog qhov tseem ceeb; dosing regimens tsis tuaj yeem hloov pauv ncaj qha.
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