Amakuru

Xinhua | Yavuguruwe: 2020-11-11 09:20

IFOTO YA FILE: Ikirango cya Eli Lilly cyerekanwa kuri kimwe mu biro by’isosiyete i San Diego, muri Californiya, Amerika, ku ya 17 Nzeri 2020. [Ifoto / Ibigo]
WASHINGTON - Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika bwatanze uruhushya rwo gukoresha byihutirwa (EUA) ku muntu w’umunyamerika w’ibiyobyabwenge witwa Eli Lilly w’imiti ya antibody ya monoclonal yo kuvura COVID-19 yoroheje kandi yoroheje ku barwayi bakuze n’abana.

Ibiyobyabwenge, bamlanivimab, byemeweCOVID-19 abarwayibafite imyaka 12 nayirenga bapima byibura ibiro 40, kandi bafite ibyago byinshi byo gukomeza kwandura COVID-19 na (cyangwa) mu bitaro, nkuko byatangajwe na FDA kuri uyu wa mbere.

Ibi birimo abafite imyaka 65 cyangwa irenga, cyangwa abafite uburwayi budakira.

Antibodiyite za Monoclonal ni poroteyine zakozwe na laboratoire zigana ubushobozi bw'umubiri bwo kurwanya antigene zangiza nka virusi. Bamlanivimab ni antibody ya monoclonal igamije kurwanya proteine ​​ya spike ya SARS-CoV-2, igamije gukumira virusi no kwinjira mu ngirabuzimafatizo z'abantu.

Mu gihe umutekano n’ingirakamaro by’ubwo buvuzi bw’iperereza bikomeje gusuzumwa, bamlanivimab yerekanwe mu bigeragezo by’amavuriro kugira ngo agabanye ibitaro bijyanye na COVID-19 cyangwa ibitaro byihutirwa (ER) ku barwayi bafite ibyago byinshi byo kwandura indwara mu minsi 28 nyuma yo kuvurwa ugereranije Kuri placebo, nk'uko FDA yabivuze.

Amakuru ashyigikira EUA kuri bamlanivimab ashingiye ku isesengura ryagateganyo kuva mu cyiciro cya kabiri cyateganijwe, gihumye-impumyi, igenzurwa n’amavuriro ku bantu 465 batari mu bitaro bafite ibimenyetso byoroheje kandi bitagereranywa bya COVID-19.

Muri abo barwayi, 101 bahawe urugero rwa miligarama 700 ya bamlanivimab, 107 bahabwa ikinini cya miligarama 2.800, 101 bahabwa imiti ya miligarama 7000 naho 156 bahabwa ikibanza mu minsi itatu nyuma yo kubona icyitegererezo cy’amavuriro ya SARS-CoV- Ikizamini cya virusi 2.

Ku barwayi bafite ibyago byinshi byo kwandura indwara, ibitaro no gusura ibyumba byihutirwa (ER) byagaragaye ku bice 3 ku ijana by'abarwayi bavuwe na bamlanivimab ugereranije ugereranije na 10 ku ijana mu barwayi bavuwe na platbo.

FDA ivuga ko ingaruka ku mutwaro wa virusi no kugabanuka mu bitaro no gusura ER, ndetse no ku mutekano, wasangaga abarwayi bahabwa imwe muri dosiye eshatu bamlanivimab.

EUA yemerera bamlanivimab gukwirakwizwa no gutangwa nkumuti umwe winjiza abashinzwe ubuzima.

Umuyobozi w'agateganyo w'ikigo cya FDA gishinzwe gusuzuma no gukora ubushakashatsi kuri FDA, Patrizia Cavazzoni yagize ati: "FDA yihutirwa byihutirwa bamlanivimab iha inzobere mu buvuzi ku murongo w'iki cyorezo ikindi gikoresho gishobora kuvura abarwayi ba COVID-19". Ati: "Tuzakomeza gusuzuma amakuru mashya ku mutekano no ku mikorere ya bamlanivimab igihe azaboneka."

Hashingiwe ku gusuzuma ubwinshi bwibimenyetso bya siyansi bihari, FDA yemeje ko ari byiza kwizera ko bamlanivimab ishobora kugira akamaro mu kuvura abarwayi batari mu bitaro bafite COVID-19 yoroheje cyangwa yoroheje. Kandi, iyo ikoreshwa mu kuvura COVID-19 ku baturage babiherewe uburenganzira, inyungu zizwi kandi zishobora kuba nyinshi ziruta ingaruka zizwi kandi zishobora guteza ibiyobyabwenge nk'uko FDA ibivuga.

Ingaruka zishobora guterwa na bamlanivimab zirimo anaphylaxis hamwe na reaction ziterwa na infusion, isesemi, impiswi, umutwe, umutwe, kubabara umutwe, kuribwa no kuruka nkuko iki kigo kibitangaza.

Umuryango w'ubumwe bw’ibihugu by’Uburayi waje mu gihe Amerika yarenze miliyoni 10 za COVID-19 ku wa mbere, nyuma yiminsi 10 gusa ikubise miliyoni 9. Impuzandengo iheruka kwandura abantu bashya buri munsi yarenze 100.000, kandi impuguke mu buzima bw’ubuzima rusange ziburira ko iki gihugu cyinjiye mu cyiciro cy’icyorezo.