Isha ku dhawaaqida ganacsiga: Maamulka Cuntada iyo Dawooyinka ee Gobolka, Tengshengbo farmashiyaha, Jaamacadda Tsinghua
Hagaha: Hanti maskaxeedkii ugu horreeyay ee iskiis wax u bartay ee Shiinaha COVID-19 ka saaraya daawaynta isku-darka ka hortagga jirka.
Fiidnimadii Diseembar 8, 2021, mareegaha rasmiga ah ee Maamulka Dawooyinka ee Gobolka wuxuu ku dhawaaqay in codsiga COVID-19 ka hortagga antibody-ka ee ay weheliso BRII-196 iyo BRII-198 uu ka diiwaan gashan yahay Maamulka Gobolka ee maamulka daroogada.Waa hantidii maskaxeed ee ugu horreysay ee Shiinuhu iskeed wax u barato COVID-19 ka takhalusta daawaynta isku-darka lidka ku ah jidhka.
Marka loo eego qodobada khuseeya sharciga maamulka dawada, Maamulka Cunnada iyo Dawooyinka ee Dawladdu waa in ay dib u eegis iyo oggolaansho degdeg ah ku sameeyaan habraacyada oggolaanshaha gaarka ah ee dawooyinka, waxaanay ansixiyaan isku darka labada dawo ee kor ku xusan oo loogu talagalay daawaynta iftiinka iyo dadka waaweyn ee caadiga ah. iyo da'yarta (12 ilaa 17 jir, oo miisaankoodu ka badan yahay 40kg) qaba caabuqa Coronavirus-ka cusub (COVID-19) kuwaas oo ah arrimo khatartoodu sarreyso (ay ku jirto isbitaal dhigga ama dhimashada).Waxaa ka mid ah, dhalinyarada (12-17 sano jir, miisaanka ≥ 40kg) oo leh calaamado waxay ku xiran yihiin ogolaansho shuruudaysan.
BRII-196/BRII-198 isku darka therapy waxaa hogaaminayay Professor Zhang Linqi, agaasimaha xarunta cilmi baarista dhamaystiran ee AIDS iyo caafimaadka caalamiga ah iyo cudurada faafa ee Tsinghua University School of Medicine iyo Tsinghua University.Dawooyinka Tengsheng waxaa la dalacsiiyay iyadoo lala kaashanayo Jaamacadda Tsinghua iyo Isbitaalka dadka saddexaad ee Shenzhen.Daawadu waxay caddaysay dawooyinka ka-hortagga COVID-19 ee waxtarka leh iyada oo loo marayo daraasad si adag loo kala soocay, laba-indho la'aan, oo la xakameynayo placebo.Dhanka kale, oggolaanshaha ayaa calaamad u ah iskii ugu horreeyay ee R&D ee Shiinaha wuxuuna caddeeyay waxtarka ka hortagga COVID-19 dawooyinka gaarka ah iyada oo loo marayo daraasad si adag loo kala soocay, laba-indho la'aan, daraasad la xakameynayo placebo.
Professor Zhang Linqi wuxuu yiri: "Oggolaanshaha daawaynta isku dhafka ah ee dawaynta Zumab / romistimub waxay keentay daawadii ugu horreysay ee daawaynta taaj cusub ee Shiinaha.Daawayntan isku dhafan waxay muujisay badbaado iyo ilaalin aad u wanaagsan tijaabada caalamiga ah ee xarumaha badan.Waa dawada kaliya ee ka hortagta unugyada aduunka ee fulisay qiimaynta saamaynta daawaynta ee dadka qaba noocyada kala duwan oo helay xogta ugu fiican.Daawaynta isku-darka ka-hortagga jidhka ayaa ii fiican aniga Shiinuhu waxay siiyeen daweyn heer caalami ah oo COVID-19 ah.Waxay si buuxda u muujisay uruurinta qoto dheer iyo kaydka farsamada ee Jaamacadda Tsinghua ee la dagaalanka cudurada faafa, iyo awooda iyo awooda loogu yeero inay timaado, la dagaalanto, la dagaalanto iyo la dagaalanto.Waxay gacan ka geysatay ka-hortagga iyo xakamaynta cudurka faafa ee Shiinaha iyo xitaa adduunka.Aad baanu u sharfay inaanu ku salayno cusbitaalka dadka saddexaad ee Shenzhen iyo daawada Tengsheng Bo.Wadashaqeyn tayo sare leh, cilmi-baaris caafimaad iyo isbeddel ayaa ka dhigtay guushan taariikhiga ah.Tallaabada xigta, waxaan sii wadi doonaa inaan barano doorka ka-hortagga ah ee daaweynta isku-darka unugyada difaaca jirka ee monoclonal ee khatarta sare leh iyo kooxaha difaaca jirka.”
Oggolaanshahan wuxuu ku salaysan yahay wajiga 3 tijaabada kiliinikada ee activ-2 oo ay taageerayaan machadyada caafimaadka qaranka (NIH), oo ay ku jiraan ku meel gaadhka wanaagsan iyo natiijooyinka kama dambaysta ah ee 847 bukaanada diiwaangashan.Natiijooyinka kama dambaysta ah waxay muujiyeen in daawaynta isku-dhafka ambavizumab / romistuzumab ay yarayn karto halista cusbitaalka iyo dhimashada bukaan-socodka cusub ee khatarta sare leh 80% (natiijooyinka ku-meel-gaadhka ah waxay ahaayeen 78%) marka la barbar dhigo placebo, taas oo ahayd tirakoob ahaan.Ilaa barta dhamaadka kiliinikada ee 28 maalmood, ma jiraan wax dhimasho ah oo ku jira kooxda daaweynta iyo 9 dhimashada kooxda placebo, iyo badbaadada bukaan-socodka ayaa ka fiicnaaday kooxda placebo.Isla mar ahaantaana, haddii daawaynta lagu bilaabay marxaladda hore (gudahood 5 maalmood gudahooda ka dib bilawga calaamadaha) ama marxaladda dambe (6 ilaa 10 maalmood gudahooda ka dib bilawga calaamadaha) Maadooyinka, isbitaal dhigga iyo dhimashada ayaa si weyn u dhacay. la dhimay, taas oo siisay daaqad daawaynta dheer bukaanka qaba taaj cusub.
In ka yar 20 bilood, Jaamacadda Tsinghua, iyada oo la kaashanaysa Shenzhen ee Cisbitaalka Dadka Saddexaad iyo Tengshengbo farmashiyaha, si degdeg ah u dallacsiiyay daawaynta isku dhafka ah ee TVzumab / romisvir laga bilaabo kala-soocidda antibody-ka bilawga ah iyo baadhista dhamaystirka wajiga caalamiga ah ee 3 tijaabo caafimaad, ugu dambeyntiina waxay heshay liiska Shiinaha oggolaansho.Guushani waa dadaalka wadajirka ah ee Shiinaha iyo saynisyahano heer caalami ah iyo cilmi-baarayaasha kiliinikada Natiijooyinka waxaa ka mid ah taageerada Machadka Cilmi-baarista Caalamiga ah ee ACTIV-2, Machadka Qaranka ee xasaasiyadda iyo cudurrada faafa (NIAID) ee Machadyada Caafimaadka Qaranka (NIH) ), iyo ACTIV-2 kooxda tijaabada bukaan-socodka (ACTG), taasoo horseedda cilmi-baaris caafimaad.
Liu Lei, oo ah agaasimaha xarunta cilmi baarista ee cudurada faafa ee Shenzhen iyo Xoghayaha Guddiga Xisbiga ee Isbitaalka dadka saddexaad ee Shenzhen, ayaa yiri: "Laga soo bilaabo bilawga cudurka, waxaan dejinay yoolka ka hortagga faafitaanka tignoolajiyada.Kooxdayagu waxay si guul leh uga soo saareen labo ka mid ah unugyada difaaca jirka ee aadka u firfircoon ee serum ee bukaannada dhaqancelinta taajka cusub, iyagoo aasaas adag u ah horumarka xiga ee dawadan ka hortagga COVID-19.Aad ayaan ugu faraxsanahay inaan la shaqeyno Professor Zhang Linqi iyo shirkadda dawooyinka Tengsheng ee Jaamacadda Tsinghua si ay u sameeyaan taaj cusub oo ka hortagga Shiinaha.Daawooyinka fayrasku waxay gacan ka geystaan xikmad iyo khibrad.Waxaan rajeyneynaa in dadaalka wadajirka ah ee tirada badan ee shaqaalaha cilmi-baarista iyo shaqaalaha caafimaadka, aan ka adkaan karno COVID-19 sida ugu dhaqsaha badan.
Luo Yongqing, Madaxweynaha iyo maareeyaha guud ee Shiinaha, ayaa yiri: "Waan ku faraxsanahay inaan gaarno guushan muhiimka ah, waxaanan si adag uga shaqeyneynaa sidii aan kor ugu qaadi lahayn helitaanka daawaynta isku dhafka ah ee bukaanka cusub ee Shiinaha.Guushan waxa ay caddaynaysaa in aan si adag uga go'annay dardargelinta hal-abuurka caalamiga ah ee dhinaca cudurrada faafa iyo buuxinta baahiyaha caafimaad ee aan la daboolin oo leh natiijooyin hufan, cilmi ah, adag oo wanaagsan.Anigoo ah shirkad caalami ah oo ka shaqeysa Shiinaha iyo Mareykanka Biotech Corp, waxaan ku hanweynahay guusha Tengsheng Bo ee dawada, wax dadaal ah kuma bixineyno inaan ka caawino Shiinaha sidii uu ula qabsan lahaa baahiyaha kakan ee COVID-19 si cilmiyeysan, oo aan u daboolo baahiyaha caafimaad ee horyaalladeena cusub .
About hagaajinzumab / romistuzumab
( hore brii-196 / brii-198)
Unugyada monoclonal antibody-ka monoclonal antibody iyo qolalka monoclonal antibody waa nooc cusub oo aan tartan ahayn fayraska daran ee neef-mareenka 2 (SARS-CoV-2) oo laga helay Isbitaalka dadka saddexaad ee Shenzhen iyo Jaamacadda Tsinghua ee muddada baxnaaninta ee Coronavirus-ka cusub. oof-wareen (COVID-19).Monoclonal ka-hortagga unugyada difaaca jirka, gaar ahaan tignoolajiyada bioengineering, ayaa loo isticmaalaa si loo dhimo khatarta ka hortagga dhexdhexaadinta ku-tiirsanaanta dhexdhexaadinta iyo sii dheereynta nolosha nuska ah ee balaasmaha si loo helo saameyno daweyn oo waara.
Oktoobar 2021, tengshengbo farmashiyaha ayaa dhamaystirtay codsiga oggolaanshaha isticmaalka degdega ah (EUA) ee daawaynta isku darka ah ee daawaynta isku darka ah ee Maamulka Cunnada iyo Dawooyinka ee US (FDA).
Intaa waxaa dheer, Tengshengbo waxay si firfircoon u dhiirrigelinaysaa codsiga diiwaangelinta ee daawaynta isku dhafka ah ee dharkazumab / romisizumab ee suuqyada kale ee qaan-gaarka ah iyo kuwa soo ifbaxaya ee adduunka, marka hore hubinta helitaanka suuqa ee wadamada sameeyay tijaabooyin caafimaad iyo waddamo badan oo farqi weyn u leh helitaanka daaweyn hufan. .Tengshengbo waxa kale oo ay cilmi-baadhis dheeraad ah ku samayn doontaa Shiinaha si ay u qiimeyso macnahazumab/ Kahortagga iyo saamaynta difaaca jirka ee daawaynta la isku daray ee romisvir mAb ee dadka difaaca jirka ah.
Dhanka "delta" ee Shiinaha COVID-19, Tengsheng Bo, oo ay sababtay nooca mutant, ayaa ku deeqay ku dhawaad 3000 oo qof oo ku dhow laba milyan oo qof oo ka kala yimid Gobolka Guangdong, Gobolka Yunnan, Gobolka Jiangsu, Gobolka Hunan, Gobolka Henan, Fujian Gobolka, ismaamulka Ningxia, Gobolka Gansu, Ismaamulka Mongolia gudaha, Gobolka Heilongjiang, Gobolka Qinghai, Gobolka Shiinaha iyo gobolka bishii Juun 2021. dalka.Tiro badan oo xirfadlayaal caafimaad ah ayaa khibrad iyo kalsooni ka helay isticmaalka daawayntan isku-dhafka ah waxayna gacan weyn ka geysteen la dagaallanka cudurka faafa.
Ku saabsan activ-2 tijaabada wajiga 3
Oggolaanshaha suuq-geynta ee daawaynta isku-darka daawaynta daawazumab / romistuzumab ee Maamulka Dawooyinka ee Shiinaha (nmpa) waxay ku saleysan tahay tijaabada activ-2 (nct04518410) oo ay taageerto Machadka Qaranka ee Caafimaadka (NIH) Ku-meel-gaadhka iyo natiijooyinka kama dambaysta ah ee wejiga 3. Natiijooyinka kama dambaysta ah waxay muujiyeen in Marka la barbar dhigo placebo, daawayntan isku dhafan waxay hoos u dhigtay barta dhamaadka isku dhafan ee isbitaalka iyo dhimashada bukaan-socodka covid-19 ee khatarta sare leh ee horumarka kiliinikada 80%, taas oo ahayd tirakoob ahaan muhiim ah.Ilaa 28-kii maalmood ee ugu dambeeyay ee bukaan-socodka, ma jiraan wax dhimasho ah oo ku jira kooxda daawaynta iyo 9 dhimashada kooxda placebo.Ma jirin khataro cusub oo nabdoon oo la arkay
Natiijooyinka ku meel gaadhka ah ee la daabacay Oktoobar 4, 2021 waxay tuseen in daawaynta isku darka ahzumab / romisizumab ay hoos u dhigtay barta dhamaadka ah ee isbitaalka iyo dhimashada bukaan-socodka covid-19 ee khatarta sare leh ee horumarinta bukaan-socodka 78% marka la barbar dhigo placebo, taas oo ahayd xisaab ahaan muhiim ah (aan la hagaajin, Tijaabada hal dhinac ah ee qiimaha <0.00001) 2% (4/196) ee maaddooyinka helay daawaynta isku dhafka ah ee Dawzumab / romisizumab 5 maalmood gudahood ka dib markii ay calaamaduhu u gudbeen isbitaal ama dhimasho, marka la barbar dhigo 11% (21 / 197) ee placebo koox.Sidoo kale, 2% (5/222) ee maaddooyinka helay teraabiyada isku dhafka ah ee Tarzumab / romisizumab 6 ilaa 10 maalmood ka dib bilawga astaamuhu.Falanqaynta ayaa sidoo kale muujisay in aysan jirin wax dhimasho ah oo ku yimid kooxda daawaynta 28 maalmood gudahood, halka ay jiraan 8 dhimasho ah oo ku jira kooxda placebo.Kooxda daawaynta isku-darka ah ee Tarazumab/romistumab, dhacdooyinka xun (AE) ee fasalka 3 ama ka sareeya way ka yaraayeen kuwa ku jira kooxda placebo, kuwaas oo ahaa 3.8% (16/418) iyo 13.4% (56/419), siday u kala horreeyaan, maya Dhacdooyinka xun xun ee daroogada la xiriira (SAE) ama falcelinta faleebo ayaa la arkay.
Daraasada ayaa lagu sameeyay dhowr xarumood oo tijaabo caafimaad oo adduunka ah, oo ay ku jiraan Mareykanka, Brazil, Koonfur Afrika, Mexico, Argentina iyo Filibiin.Daraasadda waxaa ka mid ahaa bukaannada ku diiwaangashan xilliga soo ifbaxa degdega ah ee caalamiga ah ee kala duwanaanshaha sars-cov-2 laga bilaabo Janaayo ilaa Luulyo 2021. Iyada oo qayb ka ah daraasaddan, xogta waxtarka caafimaad ee daaweynta isku dhafka ambavizumab / romisizumab waxay sidoo kale ku saleysnaan doontaa nooca noocyada fayraska. Qiimaynta.Xogta tijaabada fayraska chimeric ee hadda jirta waxay muujinaysaa in daawaynta isku-darka ah ee Tharzumab / romistumab ay ilaaliso dhexdhexaadinta dhaqdhaqaaqa ka dhanka ah noocyada sars-cov-2 ee walaaca weyn leh, oo ay ku jiraan b.1.1.7 (“alpha”), b.1.351 (“ beta”), P.1 (“gamma”), b.1.429 (“epsilon”), b.1.617.2 (“Delta”) , ay.4.2 ("delta +", Deltaplus), c.37 ("ramda", lambda) iyo b.1.621 ("Miao", mu).Tijaabada kala duwanaanshaha b.1.1.529 (Omicron) ayaa hadda socda.
Waqtiga boostada: Dec-10-2021