Xinhua | Updated: 2020-11-11 09:20
MUFANANIDZO WEMUFANANIDZO: Eli Lilly logo inoratidzwa pane imwe yemahofisi ekambani iyi muSan Diego, California, US, Gunyana 17, 2020. [Mufananidzo/Masangano]
WASHINGTON - US Chikafu neDrug Administration yakapa mvumo yekushandisa emergency (EUA) yeAmerican drugmaker Eli Lilly's monoclonal antibody therapy kurapa zvinyoro-kusvika-zvine mwero COVID-19 muvarwere vakuru nevana.
Mushonga, bamlanivimab, unotenderwaVarwere veCOVID-19vane makore gumi nemaviri ekuberekwa zvichikwira vanorema makirogiramu makumi mana, uye vari panjodzi huru yekufambira mberi kune yakanyanya COVID-19 uye (kana) kuchipatara, sekureva kweFDA nemusi weMuvhuro.
Izvi zvinosanganisira avo vane makore makumi matanhatu nemashanu kana kupfuura, kana vane zvimwe zvirwere zvisingaperi.
Monoclonal antibodies mapuroteni akagadzirwa murabhoritari anotevedzera kugona kwe immune system kurwisa maantigen anokuvadza senge mavhairasi. Bamlanivimab ndeye monoclonal antibody yakanangana neiyo spike protein yeSARS-CoV-2, yakagadzirirwa kuvhara hutachiona 'kunamatira uye kupinda mumaseru evanhu.
Ipo kuchengetedzeka uye kushanda kweiyi kurapa kwekuferefeta kuchiri kuongororwa, bamlanivimab yakaratidzwa mukuyedza kudzikisa chipatara chine chekuita neCCIDID-19 kana kamuri yekukurumidzira (ER) kushanya kwevarwere vari panjodzi huru yekukura kwechirwere mukati memazuva makumi maviri nemasere mushure mekurapwa kana vachienzaniswa. kuenda ku placebo, akadaro FDA.
Iyo data inotsigira EUA ye bamlanivimab yakavakirwa pakuongorora kwechinguvana kubva pachikamu chechipiri chisingarondedzereki, kaviri-mapofu, placebo-inodzorwa kiriniki kuyedzwa mu465 vanhu vakuru vasina muchipatara vane hunyoro kusvika pakati nepakati COVID-19 zviratidzo.
Pavarwere ava, zana vakagamuchira 700-milligram dose ye bamlanivimab, 107 vakagamuchira 2,800-milligram dose, 101 vakagamuchira 7,000-milligram dose uye 156 vakagamuchira placebo mukati memazuva matatu ekuwana kiriniki sampuli yekutanga yakanaka SARS-CoV- 2 viral test.
Kune varwere vari pangozi yakakura yekufambira mberi kwechirwere, zvipatara uye nzvimbo yekukurumidzira (ER) kushanya kwakaitika mu3 muzana yevarwere vanobatwa ne bamlanivimab paavhareji vachienzaniswa ne10 muzana muvarwere vanobatwa ne placebo.
Migumisiro pahutachiwana hwehutachiwana uye pakuderedzwa kwezvipatara uye ER kushanya, uye pakuchengeteka, zvakafanana nevarwere vaigamuchira chero yeatatu bamlanivimab doses, maererano neFDA.
IEUA inobvumira kuti bamlanivimab igoverwe uye ishandiswe sedoro rimwe chete richipinzwa mutsinga nevarapi vehutano.
"Mvumo yekukurumidzira yeFDA ye bamlanivimab inopa vashandi vehutano kumberi kwedenda iri nechimwe chishandiso chinogona kurapa varwere veCCIDID-19," akadaro Patrizia Cavazzoni, acting director weFDA's Center for Drug Evaluation and Research. "Tichaenderera mberi nekuongorora data nyowani nezvekuchengetedza uye kushanda kwe bamlanivimab pavanenge vawanikwa."
Zvichienderana nekuongorora kwehumbowo hwesainzi huripo, iyo FDA yakaona kuti zvine musoro kutenda kuti bamlanivimab inogona kushanda mukurapa varwere vasina kuchipatara vane nyoro kana pakati nepakati COVID-19. Uye, kana ichishandiswa kurapa COVID-19 kune vanhu vane mvumo, izvo zvinozivikanwa uye zvinogona mabhenefiti zvinopfuura zvinozivikanwa uye zvinogona kuitika njodzi pamushonga, sekureva kweFDA.
Zvinogoneka mhedzisiro ye bamlanivimab inosanganisira anaphylaxis uye infusion-inoenderana nekuita, kusvotwa, manyoka, dzungu, musoro, kutemwa uye kurutsa, maererano nesangano.
EUA yakauya apo United States yakapfuura mamirioni gumi eCCIDID-10 kesi Muvhuro, mazuva gumi chete mushure mekurova mamirioni mapfumbamwe. Huwandu huchangobva kuitika hwehutachiona hutsva hwemazuva ese hwakapfuura zviuru zana, uye nyanzvi dzehutano hweveruzhinji dzakayambira kuti nyika iri kupinda muchikamu chakaipisisa chedenda.
Nguva yekutumira: Zvita-19-2021