iindaba

Namhlanje, iyeza laseTshayina eliziphuhlisele ngokwalo le-placebo elilawulwa yi-placebo, i-Zenotevir, lisebhodini. NEJM> . Olu phononongo, lupapashwe emva kokuphela kobhubhani we-COVID-19 kwaye ubhubhani ungene kwinqanaba elitsha lobhubhani, utyhila inkqubo yophando lwezonyango yezonyango eyasungulwa ngexesha lobhubhane, kwaye ibonelela ngamava alungileyo ekuvunyweni okungxamisekileyo kokuqhambuka okutsha kwezifo ezosulelayo.

Uluhlu lwezifo ezibangelwa lusulelo lwentsholongwane yokuphefumla lubanzi, kubandakanywa usulelo olungabonakaliyo, ukusuleleka kweempawu (iimeko ezilula ukuya kweziphakathi ngaphandle kokulaliswa esibhedlele), ezinzima (ezifuna ukulaliswa esibhedlele), kunye nokufa. Kuya kuba kuhle ukuba le milinganiselo yoqwalaselo lwezonyango inokuqukwa kulingo lwezonyango lokuvavanya inzuzo yechiza le-antiviral, kodwa kuhlobo oluye lungabinabungozi kakhulu ngexesha lobhubhani, kubalulekile ukukhetha eyona ngqwalasela yeklinikhi kwaye uvavanye ngokufanelekileyo ukusebenza kwechiza le-antiviral.

Iinjongo zophando zamachiza e-antiviral zinokwahlulwa ngokurhabaxa ekunciphiseni ukufa, ukukhuthaza ukuphuculwa kwesifo esiqatha, ukunciphisa isifo esiqatha, ukunciphisa ubude beempawu kunye nokuthintela usulelo. Kwizigaba ezahlukeneyo zesibetho, iziphelo zeklinikhi ezikhethiweyo zihlala zihluka kakhulu. Okwangoku, akukho antiviral ye-Covid-19 ebonakaliswe ilungile ekunciphiseni ukusweleka kunye nokukhuthaza uxolelo oluqatha.

Kumachiza athomalalisa iintsholongwane kwi-COVID-19 usulelo, i-Nematavir/Ritonavir yenze i-EPIC-HR (NCT04960202) [1], EPIC-SR (NCT05011513) kunye ne-EPIC-PEP (NCT05047601) ulingo lwezonyango, ngokulandelelanayo. Iinjongo ezintathu yayikukunciphisa isifo esiqatha, ukunciphisa ubude beempawu kunye nokuthintela usulelo. I-Nematavir/ritonavir yaboniswa kuphela yi-EPIC-HR ukunciphisa ukugula okumandundu, kwaye akukho ziphumo zilungileyo zifunyenweyo kwezi ziphelo zimbini zokugqibela.

Ngotshintsho lwe-COVID-19 yobhubhane we-omicron kunye nokunyuka okubonakalayo kwinqanaba lokugonya, izehlo zokudluliselwa kobunzima kumaqela asemngciphekweni wehle kakhulu, kwaye kunzima ukufumana iziphumo ezilungileyo ngokwamkela uyilo lolingo olufana ne-EPIC-HR kunye nokudluliselwa kobunzima njengesiphelo. Umzekelo, i-NEJM ipapashe uphononongo oluthelekisayo lwe-VV116 ngokuchasene ne-Nematavir/Ritonavir [2] ebonisa ukuba eyangaphambili ayikho mbi kuneyamva ngokwexesha lokuchacha okuzinzileyo kweklinikhi kubantu abadala abane-Covid-19 ephakathi ukuya kwephakathi abasemngciphekweni wokuqhubekeka. Nangona kunjalo, ulingo lokuqala lweklinikhi lwe-VV116 lusebenzise ukuguqulwa kwesisindo njengesiphelo sokufunda, kunye nokuguquguquka ngokukhawuleza kwesi sifo, kwakunzima ukugcina inani elilindelekileyo leziganeko. Olu phononongo lubonisa ukuba indlela yokuvavanya ukusebenza kweklinikhi yeyeza elitsha kunye nokuba yeyiphi isiphelo esiphambili ekufuneka sisetyenziswe njengenqobo yokuvavanya ukusebenza kakuhle kuye kwaba yingxaki ebalulekileyo yophando lweklinikhi kwimeko yokuguquguquka kwezifo ngokukhawuleza, ngakumbi ukunciphisa ngokukhawuleza izinga lokuguqulwa kobunzima.

Ulingo lwe-Nematavir/Ritonavir EPIC-SR, oluthathe iimpawu ezili-14 ze-COVID-19 kwaye lasebenzisa ixesha lokusonjululwa kweempawu njengesiphelo, nalo lavelisa iziphumo ezibi. Singenza iingqikelelo ezintathu: 1. Iikhrayitheriya zokusebenza zithembekile, nto leyo ethetha ukuba i-nemavir ayisebenzi ekuphuculeni iimpawu zeklinikhi ze-COVID-19; 2. Amachiza ayasebenza, kodwa imigangatho yokusebenza ayithembekanga; 3. Umgangatho wokusebenza awuthembekanga, kwaye ichiza nalo alisebenzi kulo mqondiso.

Njengoko amachiza e-antiviral e-Covid-19 aseTshayina azimeleyo ephuma elabhoratri ukuya kwinqanaba lovavanyo lwezonyango, sijongene nengxaki ebalulekileyo-ukungabikho kwendlela yokuvavanya ukusebenza ngempumelelo kwezonyango. Kuyaziwa ukuba yonke inkalo engundoqo yoyilo lolingo lwezonyango ichanekile, kwaye kuyenzeka ukubonisa ukusebenza kwechiza. Indlela yokucinga ngezi ziphumo zibi imisela ukuba ingaba amachiza azimeleyo ase-China anokuphumelela na.

Ukuba ixesha lokunyamalala kweempawu ze-Covid-19 ayisosiphelo esifanelekileyo sokuvavanya amachiza e-anti-SARS-CoV-2, oko kuthetha ukuba amayeza azimeleyo aseTshayina angaqhubeka kuphela nokuvavanya kunye nokunciphisa ubunzima bokungqina ukusebenza kwawo, kwaye le ndlela yophando kunye nophuhliso iya kugqitywa emva kokuba ubhubhane ugqibezele ngokukhawuleza usulelo lwehlabathi kwaye ukunganyangeki komhlambi kusekwe ngokuthe ngcembe. Ifestile yokufezekisa iinjongo zophando lweklinikhi kunye nobunzima obulula njengoko isiphelo sokuqala sivala.

Ngomhla we-18 kaJanuwari, ngo-2023, isigaba se-2-3 solingo lwezonyango lonyango losulelo lwenoveli ye-coronavirus ephakathi ephakathi yi-Cenotevir eyenziwa nguCao Bin et al. yapapashwa kwiNew England Journal of Medicine (NEJM) [3]. Uphando lwabo lubonisa ubulumko bendlela yokoyisa ukunqongophala kweendlela zokuvavanya ukusebenza kwamachiza e-COVID-19 kulingo lwezonyango.

Olu vavanyo lwezonyango, lubhaliswe kwi-clinicaltrials.gov nge-8 ka-Agasti, 2021 (NCT05506176), sisigaba sokuqala esilawulwa yi-placebo solingo lwezonyango lwechiza lemveli laseTshayina elichasene ne-COVID-19. Kwesi sigaba sesi-2-3 solingo oluyimfama oluphindwe kabini, olungakhethiyo, olulawulwa yi-placebo, izigulana ezinobulali ukuya kwimodareyitha ye-COVID-19 phakathi kweentsuku ezi-3 zokuqala zaye zabelwa ngokungacwangciswanga 1:1 nokuba senotovir/ritonavir yomlomo (750 mg/100 mg) kabini yonke imihla okanye i-placebo kangangeentsuku ezi-5. Isiphelo esiphambili esisebenzayo yayilixesha lokusonjululwa okuzinzileyo kweempawu eziphambili ze-11, oko kukuthi ukubuyiswa kweempawu kuthathe iintsuku ze-2 ngaphandle kokuphindaphinda.

Kweli nqaku, sinokufumana isiphelo esitsha "seempawu ze-11 eziphambili" zesifo esincinci. Abaphandi abazange basebenzise iimpawu ezili-14 ze-COVID-19 zolingo lwezonyango lwe-EPIC-SR, kwaye abazange basebenzise ukuhanjiswa kobunzima njengesiphelo sokuqala.

Itotali yezigulane ze-1208 zabhaliswa, i-603 yazo yabelwa kwiqela lonyango lwe-senotevir kunye ne-605 kwiqela lonyango lwe-placebo. Iziphumo zophononongo zibonise ukuba phakathi kwezigulana ze-MIT-1 ezifumene unyango lwechiza kwiiyure ezingama-72 zokuqala, ixesha lokusonjululwa kweempawu ze-COVID-19 kwiqela le-senotevir lalifutshane kakhulu kunolo kwiqela le-placebo (iiyure eziyi-180.1 [95% CI, 162.1-201.6] vs. −35.8 iiyure [95% CI, −60.1 ukuya -12.4]; Ngomhla we-5 wobhaliso, ukunciphisa umthamo wentsholongwane egazini ukusuka kwisiseko kwakukhulu kwiqela le-senotevir kuneqela le-placebo (umehluko othetha [±SE], -1.51±0.14 log10 iikopi / ml; 95% CI, -1.79 ukuya -1.24). Ukongeza, iziphumo zophononongo kuzo zonke isiphelo sesibini kunye nohlalutyo lweqela elisezantsi lucebise ukuba i-zenotevir inokunciphisa ixesha leempawu kwizigulana ze-COVID-19. Ezi ziphumo zibonisa ngokupheleleyo ukuba i-Cenotevir inenzuzo ebalulekileyo kolu phawu.

Okubaluleke kakhulu ngolu phononongo kukuba lusebenzisa inqobo entsha yokuvavanya ukusebenza kakuhle. Sinokubona kwi-attachment kwiphepha ukuba ababhali bachithe ixesha elininzi lokubonisa ukuthembeka kwesi siphelo sokuphumelela, kubandakanywa ukuhambelana kwemilinganiselo ephindaphindiweyo yeempawu eziphambili ze-11, kunye nokudibanisa kwayo kunye neempawu ze-14. Abantu abasesichengeni, ngakumbi abo baneemeko zonyango eziphantsi kunye nabo batyebe ngokugqithiseleyo, bayazuza ngakumbi kuphononongo. Oku kuqinisekisa ukuthembeka kophononongo kwii-engile ezininzi, kwaye kukwabonisa ukuba i-Cenotevir iye yasuka kwixabiso lophando yaya kwixabiso lezonyango. Ukukhutshwa kweziphumo zolu phononongo kusivumela ukuba sibone impumelelo yabaphandi baseTshayina ukusombulula ngobuchule iingxaki ezivunyiweyo kumazwe ngamazwe. Ngophuhliso lwamachiza aqalayo kwilizwe lethu, ngokuqinisekileyo siya kujongana neengxaki ezifanayo zoyilo lolingo lwezonyango ezifuna ukucazululwa kwixesha elizayo.