izindaba

Namuhla, isidakamizwa saseShayina esizithuthukisa ngokwaso se-placebo esilawulwa yi-placebo, i-Zenotevir, sisebhodini. NEJM> . Lolu cwaningo, olushicilelwe ngemuva kokuphela kobhubhane lwe-COVID-19 futhi lolu bhubhane selungene esigabeni esisha sobhubhane olujwayelekile, luveza inqubo yocwaningo lomtholampilo oluhlukumezayo olwethulwe phakathi nalolu bhubhane, futhi luhlinzeka ngolwazi oluhle lokugunyazwa okuphuthumayo kokuqubuka okulandelayo kwezifo ezithathelwanayo ezintsha.

Ukugula okubangelwa ukutheleleka ngegciwane lokuphefumula kubanzi, okubandakanya ukutheleleka nge-asymptomatic, ukutheleleka ngezimpawu (amacala aphakathi nendawo ngaphandle kokulaliswa esibhedlela), okunzima (okudinga ukulaliswa esibhedlela), nokufa. Kungaba kuhle uma lezi zilinganiso zokubhekwa komtholampilo zingafakwa esivivinyweni somtholampilo ukuze kuhlolwe inzuzo yomuthi ovimbela amagciwane, kodwa ohlotsheni oluba buthakathaka ngesikhathi sobhadane, kubalulekile ukukhetha ukugxilwa komtholampilo okuyinhloko futhi uhlole ngokufanelekile ukusebenza komuthi ovimbela amagciwane.

Izinjongo zocwaningo zemithi elwa namagciwane zingahlukaniswa cishe zibe ukunciphisa ukufa, ukukhuthaza ukuthuthukiswa kwezifo ezinzima, ukunciphisa izifo ezinzima, ukunciphisa ubude bezimpawu nokuvimbela ukutheleleka. Ezigabeni ezihlukene zobhubhane, iziphetho zomtholampilo ezikhethiwe zivame ukuhluka kakhulu. Njengamanje, awekho ama-antiviral e-Covid-19 aboniswe ukuthi alungile ekwehliseni ukufa kanye nokukhuthaza ukuxolelwa okukhulu.

Ngemithi elwa namagciwane yokutheleleka nge-COVID-19, i-Nematavir/Ritonavir yenza izivivinyo zomtholampilo ze-EPIC-HR (NCT04960202) [1], EPIC-SR (NCT05011513) kanye ne-EPIC-PEP (NCT05047601), ngokulandelana. Izinhloso ezintathu kwakuwukunciphisa izifo ezinzima, ukunciphisa ubude bezimpawu nokuvimbela ukutheleleka. I-Nematavir/ritonavir yaboniswa kuphela yi-EPIC-HR ukuze yehlise ukugula okunzima, futhi ayikho imiphumela emihle etholakele yezindawo ezimbili zokugcina.

Ngokushintshwa kobhubhane lwe-COVID-19 lube yi-omicron kanye nokwenyuka okuphawulekayo kwezinga lokugoma, izehlakalo zokudluliswa kwesisindo emaqenjini asengozini enkulu zehle kakhulu, futhi kunzima ukuthola imiphumela emihle ngokwamukela umklamo wesilingo ofana ne-EPIC-HR ngokudluliswa kwesisindo njengesiphetho. Isibonelo, i-NEJM ishicilele ucwaningo oluqhathanisayo lwe-VV116 ne-Nematavir/Ritonavir [2] olubonisa ukuthi olwangaphambili alubi kakhulu kunalolu lwakamuva mayelana nesikhathi sokululama okuqhubekayo emtholampilo kubantu abadala abane-Covid-19 emaphakathi kuya kwesesilinganisweni abasengozini yokuqhubekela phambili. Kodwa-ke, isilingo sokuqala somtholampilo se-VV116 sasebenzisa ukuguqulwa kwesisindo njengesiphetho socwaningo, futhi ngokuvela ngokushesha kwalolu bhubhane, kwakunzima ukubona inani elilindelekile lezehlakalo. Lezi zifundo ziphakamisa ukuthi indlela yokuhlola ukusebenza komtholampilo komuthi omusha nokuthi yikuphi ukuphela okuyinhloko okufanele kusetshenziswe njengendlela yokuhlola ukusebenza kahle kuye kwaba yizinkinga ezibalulekile zocwaningo lwezokwelapha esimweni sokuvela kwezifo ngokushesha, ikakhulukazi ukunciphisa ngokushesha izinga lokuguqulwa kwesisindo.

Uhlolo lwe-Nematavir/Ritonavir EPIC-SR, oluthathe izimpawu eziyi-14 ze-COVID-19 futhi lwasebenzisa isikhathi sokuxazululwa kwezimpawu njengesiphetho, luphinde lwaveza imiphumela engemihle. Singenza imibono emithathu: 1. Indlela yokusebenza ithembekile, okusho ukuthi i-nemavir ayisebenzi ekuthuthukiseni izimpawu zomtholampilo ze-COVID-19; 2. Imithi iyasebenza, kodwa amazinga okusebenza awathembekile; 3. Izinga lokusebenza alithembekile, futhi umuthi nawo awusebenzi kulesi sibonakaliso.

Njengoba imishanguzo ye-Covid-19 esungulwe ngokuzimela yaseChina isuka elabhorethri iye esigabeni sokuhlolwa komtholampilo, sibhekene nenkinga ebalulekile - ukuntuleka kwezinqubo zokuhlola ukusebenza kahle komtholampilo. Kwaziwa kahle ukuthi yonke ingxenye ebalulekile yomklamo wokuhlolwa komtholampilo ilungile, futhi kungenzeka ukufakazela ukusebenza ngempumelelo komuthi. Indlela yokucabanga ngale miphumela engemihle inquma ukuthi imithi emisha yaseShayina ingaphumelela yini.

Uma isikhathi sokunyamalala kwezimpawu ze-Covid-19 kungesona isiphetho esifanelekile sokuhlola imishanguzo elwa ne-SARS-CoV-2, kusho ukuthi izidakamizwa ezizimele zaseChina zingaqhubeka nokuhlola nokunciphisa isisindo ukuze kufakazele ukusebenza kahle kwazo, futhi lo mgwaqo wocwaningo nentuthuko uzophothulwa ngemuva kokuthi ubhubhane luqede ngokushesha ukutheleleka emhlabeni wonke kanye nokuvikeleka komhlambi kancane kancane kuyasungulwa. Iwindi lokufeza izinhloso zocwaningo lwezempilo ngesisindo esilula njengoba isiphetho esiyinhloko siyavalwa.

NgoJanuwari 18, 2023, isivivinyo somtholampilo sesigaba 2-3 sokwelashwa kokutheleleka nge-coronavirus yenoveli ephakathi nendawo emaphakathi yi-Cenotevir eyenziwa nguCao Bin et al. yanyatheliswa ku-New England Journal of Medicine (NEJM) [3]. Ucwaningo lwabo lukhombisa ubuhlakani bokuthi ungakunqoba kanjani ukushoda kwenqubo yokuhlola ukusebenza kwemithi elwa namagciwane e-COVID-19 ezivivinyweni zomtholampilo.

Lesi sivivinyo somtholampilo, esibhaliswe ku-clinicaltrials.gov ngo-Agasti 8, 2021 (NCT05506176), siyisivivinyo sokuqala esilawulwa yi-placebo esilawulwa yi-placebo somuthi womdabu wase-China wokulwa ne-COVID-19 wokuqala. Kulesi sigaba sesi-2-3 sokuhlola okungaboni kabili, okungahleliwe, okulawulwa yi-placebo, iziguli ezine-COVID-19 emaphakathi kuya kokumaphakathi phakathi nezinsuku ezi-3 ziqale zabelwa ngokungahleliwe u-1:1 ku-senotovir/ritonavir yomlomo (750 mg/100 mg) kabili ngosuku noma i-placebo izinsuku ezi-5. Isiphetho esiyinhloko sokusebenza kahle kwakuwubude besikhathi sokuxazululwa okuqhubekayo kwezimpawu eziwumgogodla eziyi-11, okungukuthi ukululama kwezimpawu kwathatha izinsuku ezi-2 ngaphandle kokuphindaphinda.

Kusukela kulesi sihloko, singathola isiphetho esisha “sezimpawu eziyi-11” zesifo esithambile. Abaphenyi abazange basebenzise izimpawu eziyi-14 ze-COVID-19 zokuhlolwa komtholampilo kwe-EPIC-SR, futhi abazange basebenzise ukudluliswa kwesisindo njengesiphetho esiyinhloko.

Ingqikithi yeziguli eziyi-1208 zabhaliswa, ezingama-603 kuzo zabelwa iqembu lokwelapha i-senotevir kwathi ezingama-605 eqenjini lokwelapha i-placebo. Imiphumela yocwaningo ikhombise ukuthi phakathi kweziguli ze-MIT-1 ezithole ukwelashwa kwezidakamizwa kungakapheli amahora angama-72 ziqalile, isikhathi sokuxazululwa kwezimpawu ze-COVID-19 eqenjini le-senotevir sasimfushane kakhulu kunaseqenjini le-placebo (amahora angu-180.1 [95% CI, 162.1-201.6] vs. 216.0 amahora [92n , 38; −35.8 amahora [95% CI, −60.1 kuya -12.4]; Ngosuku lwesi-5 lokubhaliswa, ukuncipha kwenani legciwane egazini kusukela kwesisekelo bekukukhulu eqenjini le-senotevir kuneqembu le-placebo (umehluko oqondile [±SE], −1.51±0.14 log10 amakhophi / ml; 95% CI, -1.79 kuya -1.24). Ngaphezu kwalokho, imiphumela yocwaningo kuzo zonke iziphetho zesibili kanye nokuhlaziywa kweqembu elincane kuphakamise ukuthi i-zenotevir ingafinyeza ubude bezimpawu ezigulini ze-COVID-19. Le miphumela ikhombisa ngokugcwele ukuthi i-Cenotevir inenzuzo enkulu kulesi sibonakaliso.

Okubaluleke kakhulu ngalolu cwaningo ukuthi lusebenzisa umbandela omusha wokuhlola ukusebenza kahle. Singabona kokunamathiselwe ephepheni ukuthi ababhali banikele isikhathi esiningi bekhombisa ukwethembeka kwalesi siphetho esisebenzayo, okuhlanganisa nokuvumelana kwezinyathelo eziphindaphindiwe zezimpawu eziwu-11 eziwumgogodla, kanye nokuhlotshaniswa kwayo nezimpawu eziyi-14. Izibalo zabantu abasengcupheni, ikakhulukazi labo abanezimo zezempilo ezicashile nalabo abakhuluphele ngokweqile, bazuza kakhulu ocwaningweni. Lokhu kuqinisekisa ukwethembeka kocwaningo ngama-engeli amaningi, futhi kukhombisa ukuthi i-Cenotevir isuke enanini locwaningo yaya enanini lomtholampilo. Ukukhishwa kwemiphumela yalolu cwaningo kusivumela ukuthi sibone impumelelo yabacwaningi baseShayina ukuze baxazulule ngobuciko izinkinga eziqashelwa umhlaba wonke. Ngokuthuthukiswa kwemithi emisha ezweni lethu, nakanjani sizobhekana nezinkinga zomklamo wokuhlolwa komtholampilo ofanayo okufanele zixazululwe ngokuzayo.