Bayanan Lokaci na III a cikin sababbin Magungunan China a Nejm suna nuna inganci ga Paxlovid

A cikin farkon awanni 29 Disamba, nejm buga kan layi sabon asibiti III nazarin sabon salo na kasar Sin VV116. Sakamakon ya nuna cewa VV116 bai fi muni da paxlovid / ritonovir / ritonavir) dangane da lokacin da aka dawo da shi na asibiti maida hankali ne.

Tushen Tushen: Nejm

Lokacin dawo da lokaci 4, mummunan taron 67.4%

VV116 shine nucleosside anti-sabon caren-2 corwarvirus magunguna na (SARSH-2) tare da hadadden Gilesad tare da Gilead na Merprem & Doolvudine.

A shekarar 2021, wani lokaci na II na Clinical An kammala shari'ar VV116 a Uzbekistan. Sakamakon binciken ya nuna cewa rukuni na VV116 na iya mafi kyawun inganta bayyanar asibiti da muhimmanci sosai a haɗarin ci gaba da mahimmancin tsari da mutuwa idan aka kwatanta da kungiyar ke sarrafawa. Dangane da ingantaccen sakamakon wannan gwajin, VV116 an amince da shi a Uzbekistan don maganin cutar da ke da tsaurin kai da aka amince da su a kasashen waje a China [1].

Wannan lokaci na Clinical Tarihi [2] (NCT0539) Ingancin da aminci na VV116 aibus paxlovid don farkon maganin marasa lafiya da m zuwa matsakaici Covid-19. Manufar shine kimanta ingancin da amincin vv116 a kan paxlovid na farkon magani na marasa lafiya da m zuwa matsakaici Covid-19.

Tushen Ild: Bayani 2

Multicentre, mai lura da makanta, jarabawar sarrafawa, jarabawar manya-1922 zuwa 20 ga Mayu don tantance cancantar masu ci gaba da kuma m ga mahalarta miliyan bakwai a Shanghai, China. Daga karshe, mahalarta 771 sun karɓi VV116 (384, 600 mg kowane awa 12 da 300 mg nimatuvir + 100 mg a kowace awa 12

Sakamakon wannan binciken na asibitin ya nuna cewa fara magani tare da VV116 don matsi na Clinicol: 1.17; 95% ci, 1.02 zuwa 1.36; ƙananan iyaka.> 0.8; ƙananan iyaka.> 0.8; ƙananan iyaka.> 0.8).

Kulawa da lokacin dawo da hankali

Firamare da sakandare na sakandare (cikakken bincike na yawan jama'a)

Tushen Ild: Bayani 2

Dangane da aminci, mahalarta suna karbar VV116% fiye da wadanda suka karɓi paxlovid (77.3%) a cikin paxlovid na 3/4%) fiye da na VV116 (2.6%) fiye da paxlovid (5.7%).

Munanan abubuwa (masu aminci)

Tushen Ild: Bayani 2

Jayayya da tambayoyi

A ranar 23 ga Mayu, 2022, Jamiper ya bayyana cewa rajista na Clinical na lokaci na VV116 a kan Paxlovid na farko na Murmushi na Gabas ta Tsakiya.

Tushen Ild: Bayanai 1

A wani lokaci lokacin da aka rasa cikakkun bayanai game da shari'ar, da farko kuma nazarin makafi ya zama tagulla. Abu na biyu, akwai tambayoyi game da asibitin bincike.

Kamfanin Clinical Hukumar kula da Jamiper sune (I) kyakkyawan sakamako ga sabon gwajin kambi, (II) ko fiye da alamomin covid-19, da kuma (iii) marasa lafiya a hadarin hadarin da suka hadarin da suka yi. Koyaya, kawai farkon asibiti shine 'lokaci don ci gaba da dawo da asibiti'.

Kafin sanarwar, a ranar 14 ga Mayu, Jamiper ya bita da ƙarshen asibiti ta hanyar cire ɗayan ƙarshen asibiti, "gwargwado na tattaunawar rashin lafiya ko mutuwa" [3].

Tushen Ild: Bayanai 1

Hakanan ana magance waɗannan mahimman abubuwan babban taron mutane guda biyu a cikin binciken da aka buga.

Saboda barkewar Omicron, samar da allunan plembovid don paxlovid domin fara gudanar da wannan gwajin ta amfani da makafi biyu. Game da wani bangare na masoya na gwajin asibiti, Jamiper ya ce an gudanar da yarjejeniya da tsarin binciken da aka tsara har sai an kulle takamaiman mai binciken maganin.

Har zuwa lokacin bincike na karshe, babu wani daga cikin mahalarta taron ya samu mutuwa ko ci gaba mai rauni ga ingancin VV116 a hana ci gaba ko mai matukar muhimmanci-19 ko mutuwa. Bayanan sun nuna cewa kimanin lokacin da aka kiyasta daga bazuwar don ci gaba da rikice-rikice na COVID-19. Ba shi da wahala a bayyana dalilin da yasa ƙarshen ƙarshen ƙarshe na 'yawan juyawa zuwa mummunan rashin lafiya ko mutuwa', wanda aka fara saita kafin ƙarshen shari'ar, an cire shi.

A 18 Mayu 2022, ƙwayoyin cuta da ke fitowa da ƙwayoyin cuta & cututtukan da aka buga sakamakon shari'ar PV116 a cikin Bambancin Magana [4], a bude, mai binciken cohorron tare da inpatients 136.

Bayanai daga binciken ya nuna cewa marasa lafiyar Omicron wanda ya yi amfani da VV116 cikin kwanaki 5 na farko, kasa da kwanaki 11.13 a cikin rukunin sarrafawa. Gudanar da marasa lafiyar VV116 zuwa lokacin da wannan binciken na wannan binciken (kwanaki 2-10 na farko gwajin nucleic) ya rage lokacin zuwa tsinkaye na nucleic a duk marasa lafiya. A cikin sharuddan amincin magani, babu mummunan tasirin mummunan sakamako a cikin rukunin magani na VV116.

Tushen Ild: Bayani 4

Akwai wasu gwaji na asibiti guda uku a VV116, waɗanda biyu ke karatun lokaci na IIVID-19 (NCT052242042929). Sauran fitina don matsakaici mai tsanani COVID-19 wani yanki ne na duniya da yawa, wanda aka keɓe guda biyu na III Clinical Clinical (NCT052779235) don kimanta ingantaccen magani. Dangane da sanarwar ta juniper, an yi rajista da mai haƙuri da farko a cikin Maris 2022.

Maimai source: Clinicaltrials.gov

Nassoshi:

[1] Junshi Biotech: Sanarwa A Matsayin Babbar Mataki na III Rajistar Clinical na VV116 a kan Paxlovid na farkon

[2] HTTPS://www.nejm.org/Da/floa2208822Turtured_huv/CtPps=FETPETYURED.GOREDUSRETUREDO341609 Zhenang Gao, Johning Xu, Hao Yin, Zhiren Zhang, Rui Chen, Linangxin Wang. (2022) Bayanin Omicron Cikin bayanan Omicron da kuma ka'idar alurar riga kafi tsakanin 1881 na dasawa ta hanta: maimaitawa-cibiyar karfafa gwiwa. Motrobes Emerging & CEFECS 11: 1, shafukan 2636-2644.