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Maanta, daawo Shiineys ah oo iskood u samaystay oo ay maamusho placebo, Zenotevir, ayaa ku jira guddiga. NEJM> . Daraasaddan, oo la daabacay ka dib dhammaadka masiibada COVID-19 oo cudurku wuxuu galay marxaladda cusub ee cudurrada faafa ee caadiga ah, waxay daaha ka qaadaysaa habka cilmi-baarista caafimaad ee xanuunka badan ee daawada la bilaabay intii lagu jiray cudurka faafa, waxayna siisaa khibrad wanaagsan oo loogu talagalay oggolaanshaha degdegga ah ee dillaaca soo socda ee cudurrada faafa ee cusub.

Noocyada kala duwan ee jirrada uu keeno caabuqa fayraska neef-mareenka waa mid ballaaran, oo ay ku jiraan infekshan asymptomatic ah, caabuqa calaamadaha (xaalad khafiif ah ilaa dhexdhexaad ah oo aan isbitaal la dhigin), daran (oo u baahan isbitaal), iyo dhimasho. Way fiicnaan lahayd haddii cabbirradan indho-indhaynta bukaan-socodka lagu dari karo tijaabo caafimaad si loo qiimeeyo faa'iidada daawada fayraska, laakiin culayska ka sii yaraanaya fayraska muddada masiibada, waa muhiim in la doorto diiradda bukaan-socodka aasaasiga ah oo si qumman loo qiimeeyo waxtarka daawada fayraska.

Ujeeddooyinka cilmi-baarista ee dawooyinka fayraska ka hortagga ah ayaa qiyaas ahaan loo qaybin karaa dhimista dhimashada, kor u qaadista horumarinta cudurrada daran, yaraynta cudurrada daran, soo gaabin muddada calaamadaha iyo ka hortagga caabuqa. Marxalado kala duwan ee cudurka faafa, meelaha dhamaadka kiliinikada ee la doortay badanaa aad bay u kala duwan yihiin. Waqtigan xaadirka ah, ma jiro Covid-19 ka-hortagga fayraska oo lagu muujiyey inuu togan yahay dhimista dhimashada iyo kor u qaadista cafiska daran.

Dawooyinka ka hortagga fayraska ee caabuqa COVID-19, Nematavir/Ritonavir waxa ay sameeyeen EPIC-HR (NCT04960202) [1], EPIC-SR (NCT05011513) iyo EPIC-PEP (NCT05047601), siday u kala horreeyaan. Saddexda yool waxay ahaayeen in la yareeyo cudurrada daran, la gaabiyo muddada calaamadaha iyo ka hortagga caabuqa. Nematavir/ritonavir waxa kaliya oo ay muujisay EPIC-HR si loo yareeyo jirrada daran, mana jirto natiijooyin wax ku ool ah oo laga helay labada dhibcood ee dambe.

Isbeddelka cadaadiska COVID-19 ee cudurka faafa ee omicron iyo korodhka weyn ee heerka tallaalka, dhacdooyinka wareejinta miisaanka ee kooxaha khatarta sare leh ayaa si weyn hoos ugu dhacay, wayna adagtahay in la helo natiijooyin wax ku ool ah iyadoo la qaadanayo naqshadda tijaabada ee la mid ah EPIC-HR oo leh wareejinta miisaanka meesha ugu dambeysa. Tusaale ahaan, NEJM waxa ay daabacday daraasad is barbar dhig ah oo ah VV116 oo ka soo horjeeda Nematavir/Ritonavir [2] oo muujinaysa in kii hore aanu ka xumaanin kan dambe marka loo eego wakhtiga soo kabashada caafimaad ee joogtada ah ee dadka qaangaarka ah ee dhexdhexaadka ah ama dhexdhexaadka ah ee Covid-19 kuwaas oo halis ugu jira horumarka. Si kastaba ha ahaatee, tijaabadii ugu horeysay ee bukaan-socodka ee VV116 waxay isticmaashay dib-u-celinta miisaanka sida dhammaadka daraasadda, iyo kobcinta degdegga ah ee faafitaanka, way adagtahay in la ilaaliyo tirada dhacdooyinka la filayo. Daraasadahani waxay soo jeedinayaan in sida loo qiimeeyo waxtarka bukaan-socodka ee daroogada cusub iyo waxa ugu dambeeya ee asaasiga ah waa in loo isticmaalo sida shuruudaha qiimeynta waxtarka leh waxay noqdeen dhibaatooyin cilmi-baaris caafimaad oo muhiim ah oo ku saabsan horumarinta cudurrada degdega ah, gaar ahaan hoos u dhigista degdega ah ee heerka beddelka miisaanka.

Tijaabada Nematavir/Ritonavir EPIC-SR, oo qaadatay 14 COVID-19 calamadaha oo u adeegsatay wakhtiga xalinta calaamadaha meel dhamaadka, sidoo kale waxay keentay natiijooyin taban. Waxaan samayn karnaa saddex mala-awaal: 1. Shuruudaha waxtarka leh waa kuwo la isku halleyn karo, taas oo macnaheedu yahay in nematavir aanu waxtar u lahayn hagaajinta calaamadaha caafimaad ee COVID-19; 2. Daawooyinku waa kuwo waxtar leh, laakiin heerarka waxtarka waa kuwo aan la isku halleyn karin; 3. Heerka waxtarka ma aha mid la isku halayn karo, iyo daroogadu sidoo kale waa mid aan waxtar lahayn tilmaantan.

Maaddaama ay dawooyinka ka hortagga fayraska ee Covid-19 ee Shiinaha ee madaxbannaan ay ka guuraan shaybaadhka una gudbayaan marxaladda tijaabada caafimaad, waxa na soo food saartay dhibaato muhiim ah - la'aanta shuruudaha qiimaynta waxtarka caafimaad. Waxaa la og yahay in dhinac kasta oo muhiim ah ee naqshadaynta tijaabada caafimaad ay sax tahay, waxaana suurtagal ah in la caddeeyo waxtarka daroogada. Sida looga fikiro natiijooyinkan xun ayaa go'aaminaya in dawooyinka hal-abuurka leh ee madax-bannaan ee Shiinaha ay guulaysan karaan.

Haddii waqtiga la waayo calaamadaha Covid-19 aysan ahayn meel ku habboon qiimeynta daawooyinka ka hortagga SARS-CoV-2, waxay la macno tahay in dawooyinka hal-abuurka leh ee madaxa-bannaan ee Shiinaha ay sii wadi karaan oo keliya inay qiimeeyaan oo ay yareeyaan culeyska si ay u caddeeyaan waxtarkooda, iyo waddadan cilmi-baarista iyo horumarinta ayaa la dhammaystiri doonaa ka dib markii masiibada si degdeg ah u dhammaystirto caabuqa caalamiga ah iyo difaaca xoolaha ayaa si tartiib tartiib ah loo aasaasay. Daaqadda lagu gaarayo yoolalka cilmi-baarista bukaan-socodka oo leh miisaan fudud maaddaama barta ugu dambeysa ee ugu dambeysa ay xirmeyso.

Janaayo 18, 2023, wajiga 2-3 tijaabada caafimaad ee daawaynta caabuqa coronavirus-ka dhexdhexaadka ah ee dhexdhexaadka ah ee uu sameeyay Cenotevir oo uu fuliyay Cao Bin et al. waxaa lagu daabacay joornaalka New England Journal of Medicine (NEJM) [3]. Cilmi baaristoodu waxay tusinaysaa xikmad ku saabsan sida looga gudbi karo shuruudaha la'aanta ee lagu qiimeeyo waxtarka dawooyinka ka hortagga fayraska ee COVID-19 ee tijaabooyinka caafimaadka.

Kiliinikadan, oo ka diiwaan gashan clinicaltrials.gov Agoosto 8, 2021 (NCT05506176), waa placebo-lagu xakameeyo wajigii 3 kiliinikada hal-abuurka wadaniga ah ee Shiinaha ee ka hortagga COVID-19. Marxaladdan 2-3 laba-indho-indho la'aan, randomized, tijaabo-koontarool placebo, bukaannada qaba COVID-19 fudud ama dhexdhexaad ah 3 maalmood gudahooda ayaa si aan kala sooc lahayn loogu qoondeeyay 1: 1 midkood afka senotovir/ritonavir (750 mg/100 mg) laba jeer maalintii ama placebo muddo 5 maalmood ah. Meesha ugu dambeysa ee waxtarka leh waxay ahayd muddada xallinta joogtada ah ee 11ka calaamadood ee asaasiga ah, ie soo kabashada calaamadaha waxay socotay 2 maalmood iyada oo aan dib loo soo celin.

Laga soo bilaabo maqaalkan, waxaan ka heli karnaa barta dhamaadka cusub ee "11 calaamadaha asaasiga ah" ee cudurada fudud. Baarayaashu ma aysan isticmaalin 14-ka calaamadood ee COVID-19 ee tijaabada caafimaad ee EPIC-SR, mana u isticmaalin wareejinta miisaanka meesha ugu dambeysa.

Wadarta 1208 bukaan ayaa la diiwaan geliyay, 603 ka mid ah waxaa loo qoondeeyay kooxda daawaynta senotevir iyo 605 kooxda daawaynta placebo. Natiijooyinka cilmi-baaristu waxay muujisay in bukaannada MIT-1 ee helay daaweynta daroogada gudaha 72 saacadood ee bilawga, muddada xallinta calaamadaha COVID-19 ee kooxda senotevir waxay aad uga gaaban tahay tan kooxda placebo (180.1 saacadood [95% CI, 162.1-201.6] vs. 216.0 hours [925% 3, 4] -35.8 saacadood [95% CI, -60.1 ilaa -12.4]; P = 0.006). Maalinta 5 ee diiwaangelinta, hoos u dhigista culeyska fayraska ee salka ayaa ka weyneyd kooxda senotevir marka loo eego kooxda placebo (macnaha farqiga [± SE], -1.51 ± 0.14 log10 nuqul / ml; 95% CI, -1.79 ilaa -1.24). Intaa waxaa dheer, natiijooyinka daraasadda ee dhammaan dhibcaha dhammaadka sare iyo falanqaynta dadweynaha ee koox-hoosaadka ayaa soo jeediyay in zenotevir ay soo gaabin karto muddada calaamadaha bukaannada COVID-19. Natiijooyinkani waxay si buuxda u muujinayaan in Cenotevir ay faa'iido weyn u leedahay tilmaantan.

Waxa aadka u qiimaha badan ee daraasaddan ku saabsan waa in ay qaadatay shuruudo cusub oo lagu qiimeeyo waxtarka. Waxaan ka arki karnaa lifaaqa warqadda in qorayaashu ay u hureen waqti aad u badan si ay u muujiyaan isku halaynta bartan waxtarka leh, oo ay ku jiraan joogteynta tallaabooyinka soo noqnoqda ee 11 calaamadaha asaasiga ah, iyo xiriirka ay la leeyihiin 14 calaamadaha. Dadka nugul, gaar ahaan kuwa leh xaalado caafimaad oo hoose iyo kuwa cayilan, ayaa aad uga faa'iidaysta daraasadda. Tani waxay xaqiijinaysaa isku halaynta daraasadda dhinacyo badan, sidoo kale waxay muujinaysaa in Cenotevir ay ka soo wareegtay qiimihii cilmi-baarista ilaa qiimaha bukaan-socodka. Siideynta natiijooyinka daraasaddan waxay noo ogolaaneysaa inaan aragno guusha cilmi-baarayaasha Shiinaha si ay u xalliyaan dhibaatooyinka caalamiga ah ee la aqoonsan yahay. Horumarinta dawooyinka hal-abuurka leh ee waddankeena, waxaan si lama filaan ah u wajihi doonaa dhibaatooyin naqshadayn tijaabo caafimaad oo la mid ah oo u baahan in la jabiyo mustaqbalka.