Nkhani

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

CHITHUNZI CHA FILE: Chizindikiro cha Eli Lilly chikuwonetsedwa pa ofesi imodzi ya kampaniyo ku San Diego, California, US, pa Seputembala 17, 2020. [Chithunzi/Mabungwe]
WASHINGTON — US Food and Drug Administration yapereka chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) kwa wopanga mankhwala aku America Eli Lilly's monoclonal antibody therapy kuti achiritse COVID-19 yocheperako mpaka yocheperako mwa odwala akuluakulu ndi ana.

Mankhwalawa, bamlanivimab, ndi ovomerezeka kuti agwiritsidwe ntchitoOdwala a COVID-19omwe ali ndi zaka 12 kapena kuposerapo ndipo amalemera makilogalamu osachepera 40, ndipo ali pachiwopsezo chachikulu chopita patsogolo ku COVID-19 yayikulu komanso (kapena) kugonekedwa m'chipatala, malinga ndi lipoti la FDA Lolemba.

Izi zikuphatikizapo anthu azaka 65 kapena kuposerapo, kapena omwe ali ndi matenda enaake osatha.

Ma antibodies a monoclonal ndi mapuloteni opangidwa m'ma laboratories omwe amatsanzira mphamvu ya chitetezo cha mthupi yolimbana ndi ma antigen oopsa monga mavairasi. Bamlanivimab ndi antibody ya monoclonal yomwe imayendetsedwa makamaka motsutsana ndi mapuloteni othamanga a SARS-CoV-2, omwe adapangidwa kuti aletse kulowa kwa kachilomboka m'maselo a anthu.

Ngakhale chitetezo ndi kugwira ntchito kwa chithandizo chofufuzachi chikupitilirabe kuyesedwa, bamlanivimab yawonetsedwa m'mayesero azachipatala kuti ichepetse kupita kuchipatala chifukwa cha COVID-19 kapena kupita kuchipatala chadzidzidzi (ER) kwa odwala omwe ali pachiwopsezo chachikulu cha matenda mkati mwa masiku 28 kuchokera pamene chithandizocho chachitika poyerekeza ndi placebo, adatero FDA.

Deta yothandizira EUA ya bamlanivimab yachokera pa kusanthula kwakanthawi kuchokera ku mayeso azachipatala a gawo lachiwiri, osawoneka bwino, olamulidwa ndi placebo mwa akuluakulu 465 omwe sanagonekedwe m'chipatala omwe ali ndi zizindikiro zochepa mpaka zochepa za COVID-19.

Mwa odwala awa, 101 adalandira mlingo wa 700-milligram wa bamlanivimab, 107 adalandira mlingo wa 2,800-milligram, 101 adalandira mlingo wa 7,000-milligram ndipo 156 adalandira placebo mkati mwa masiku atatu kuchokera pamene adapeza chitsanzo chachipatala cha mayeso oyamba a kachilombo ka SARS-CoV-2.

Kwa odwala omwe ali pachiwopsezo chachikulu cha matenda, 3 peresenti ya odwala omwe adalandira chithandizo cha bamlanivimab adapita kuchipatala ndikupita kuchipatala chadzidzidzi (ER) poyerekeza ndi 10 peresenti ya odwala omwe adalandira chithandizo cha placebo.

Zotsatirapo zake pa kuchuluka kwa mavairasi komanso kuchepetsa kugonekedwa m'chipatala ndi kupita kuchipatala kwa ER, komanso chitetezo, zinali zofanana mwa odwala omwe amalandira mlingo uliwonse mwa itatu ya bamlanivimab, malinga ndi FDA.

EUA imalola kuti bamlanivimab igawidwe ndi kuperekedwa ngati mlingo umodzi kudzera m'mitsempha ndi opereka chithandizo chamankhwala.

"Chilolezo chadzidzidzi cha FDA cha bamlanivimab chimapatsa akatswiri azaumoyo omwe ali patsogolo pa mliriwu chida china chomwe chingagwiritsidwe ntchito pochiza odwala a COVID-19," adatero Patrizia Cavazzoni, mkulu wa FDA's Center for Drug Evaluation and Research. "Tipitiliza kuwunika deta yatsopano yokhudza chitetezo ndi kugwira ntchito kwa bamlanivimab ikapezeka."

Kutengera ndi kuwunika kwa umboni wonse wa sayansi womwe ulipo, FDA idatsimikiza kuti ndikoyenera kukhulupirira kuti bamlanivimab ikhoza kukhala yothandiza pochiza odwala omwe sanagoneke m'chipatala omwe ali ndi COVID-19 yocheperako kapena yochepa. Ndipo, ikagwiritsidwa ntchito pochiza COVID-19 kwa anthu ovomerezeka, ubwino wodziwika komanso womwe ungachitike umaposa zoopsa zodziwika komanso zomwe zingachitike pa mankhwalawa, malinga ndi FDA.

Zotsatira zoyipa zomwe zingachitike chifukwa cha bamlanivimab ndi monga anaphylaxis ndi zotsatira zokhudzana ndi kulowetsedwa m'thupi, nseru, kutsegula m'mimba, chizungulire, mutu, kuyabwa ndi kusanza, malinga ndi bungweli.

EUA yabwera pamene United States yadutsa milandu 10 miliyoni ya COVID-19 Lolemba, patangopita masiku 10 kuchokera pamene yafika pa 9 miliyoni. Chiwerengero chaposachedwa cha matenda atsopano tsiku lililonse chapitirira 100,000, ndipo akatswiri azaumoyo achenjeza kuti dzikolo likulowa mu gawo loyipa kwambiri la mliriwu.