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

UMFANEKISO WEFAYILE: Uphawu lukaEli Lilly luboniswa kwenye yeeofisi zenkampani eSan Diego, eCalifornia, eUnited States, nge-17 kaSeptemba 2020. [Ifoto/Arhente]
E-WASHINGTON - Ulawulo lokutya kunye neziyobisi lwase-US lukhuphe isigunyaziso sosetyenziso olungxamisekileyo (i-EUA) kumenzi weziyobisi waseMelika u-Eli Lilly's monoclonal antibody unyango ukunyanga i-COVID-19 ephakathi ukuya kwi-19 yabantu abadala kunye nabantwana.

Ichiza, bamlanivimab, ligunyazisweIzigulana ze-COVID-19abaneminyaka eli-12 ubudala nangaphezulu abanobunzima beekhilogram ezingama-40, kwaye basemngciphekweni omkhulu wokuqhubela phambili kwi-COVID-19 kwaye (okanye) balaliswe esibhedlele, ngokwengxelo ye-FDA ngoMvulo.

Oku kubandakanya abo baneminyaka engama-65 ubudala okanye ngaphezulu, okanye abanezigulo ezithile ezingapheliyo.

Izilwa-buhlungu zeMonoclonal ziiproteni ezenziwe elabhoratri ezilinganisa isakhono somxokomezelo wokuzikhusela ekulweni ii-antigens eziyingozi ezifana neentsholongwane. I-Bamlanivimab yi-monoclonal antibody ejoliswe ngokuthe ngqo kwiprotein ye-spike ye-SARS-CoV-2, eyilelwe ukuthintela ukuncamathisela kwentsholongwane kunye nokungena kwiiseli zabantu.

Ngelixa ukhuseleko kunye nokusebenza kolu nyango lophando lusaqhubeka nokuvavanywa, i-bamlanivimab yaboniswa kulingo lwezonyango ukunciphisa ukulaliswa esibhedlele okunxulumene ne-COVID-19 okanye kwigumbi likaxakeka (ER) kwizigulana ezisemngciphekweni omkhulu wokuqhubela phambili kwesifo phakathi kweentsuku ezingama-28 emva konyango xa kuthelekiswa. kwi-placebo, yatsho i-FDA.

Idatha exhasa i-EUA ye-bamlanivimab isekwe kuhlalutyo lwexeshana olusuka kwisigaba sesibini esingahleliweyo, esingaboniyo kabini, kulingo lwekliniki olulawulwa yi-placebo kubantu abadala abangama-465 abangalaliswanga esibhedlele abaneempawu ezingephi ukuya kweziphakathi kwe-COVID-19.

Kwezi zigulana, i-101 ifumene idosi ye-700-milligram ye-bamlanivimab, i-107 yafumana idosi eyi-2,800-milligram, i-101 yafumana idosi eyi-7,000-milligram kwaye i-156 yafumana i-placebo phakathi kweentsuku ezintathu zokufumana isampuli yeklinikhi yokuqala elungileyo ye-SARS-CoV- 2 uvavanyo lwentsholongwane.

Kwizigulane ezisengozini enkulu yokuqhubela phambili kwesifo, izibhedlele kunye negumbi likaxakeka (ER) ukutyelela kwenzeka kwi-3 ipesenti yezigulane eziphathwe nge-bamlanivimab ngokomyinge xa ​​kuthelekiswa neepesenti ze-10 kwizigulane eziphathwe nge-placebo.

Iimpembelelo kumthamo wentsholongwane egazini kunye nokunciphisa izibhedlele kunye nokutyelela i-ER, kunye nokhuseleko, zifana nezigulane ezifumana naziphi na iidosi ezintathu ze-bamlanivimab, ngokutsho kwe-FDA.

I-EUA ivumela ukuba i-bamlanivimab isasazwe kwaye ilawulwe njengedosi enye emithanjeni ngababoneleli bezempilo.

"Ugunyaziso olungxamisekileyo lwe-FDA lwe-bamlanivimab lubonelela abaqeqeshi bezempilo kumgca ongaphambili kwesi sifo ngesinye isixhobo esinokubakho ekunyangeni abaguli be-COVID-19," utshilo uPatrizia Cavazzoni, umlawuli obambeleyo weZiko le-FDA loVavanyo lweZiyobisi kunye noPhando. "Siza kuqhubeka nokuvavanya idatha entsha malunga nokhuseleko kunye nokusebenza kwe-bamlanivimab njengoko zifumaneka."

Ngokusekwe kuphononongo lulonke lobungqina besayensi obukhoyo, i-FDA yagqiba ekubeni kunengqiqo ukukholelwa ukuba i-bamlanivimab inokusebenza ekunyangeni abaguli abangalaliswanga esibhedlele nge-COVID-19 ebuthathaka okanye ephakathi. Kwaye, xa isetyenziselwa ukunyanga i-COVID-19 kubemi abagunyazisiweyo, izibonelelo ezaziwayo nezinokubakho zodlula umngcipheko owaziwayo kunye nonokubakho kwechiza, ngokutsho kwe-FDA.

Iziphumo ezinokwenzeka ze-bamlanivimab ziquka i-anaphylaxis kunye neempendulo ezinxulumene ne-infusion, isicaphucaphu, isifo sohudo, isiyezi, intloko ebuhlungu, ukubetha kunye nokuhlanza, ngokwe-arhente.

I-EUA yeza njengoko iUnited States idlule kwi-10 yezigidi zeemeko ze-COVID-19 ngoMvulo, kwiintsuku nje ezili-10 emva kokubetha izigidi ezili-9. Umndilili wamva nje wosulelo olutsha lwemihla ngemihla ludlule kwi-100,000, kwaye iingcali zempilo yoluntu ziye zalumkisa ukuba ilizwe lingena kwelona nqanaba libi lobhubhane.