Ikomiti yengcaphephe ye-FDA ixhasa ukudweliswa kwechiza lomlomo le-methadone Xinguan

Umthombo: yaozhi.com

Intshayelelo: ngokwedatha yeklinikhi yamva nje, i-molnupiravir inokwehlisa izinga lokulaliswa esibhedlele okanye ukufa ngama-30%.

Ngomhla wama-30 kaNovemba, icandelo le-FDA liye lavota ngo-13:10 ukwamkela isicelo se-EUA se-molnupiravir, ichiza elitsha elithathwa ngomlomo le-MSD.Ukuba kuvunyiwe, ukuba kukho umyalelo kagqirha, izigulana eziqinisekisiweyo okanye abantu abavezwe yintsholongwane banokusebenzisa ichiza ekhaya ngaphandle kokuya esibhedlele okanye ekliniki kunyango olufana namachiza e-monoclonal antibody.

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I-Molnupiravir lichiza elitsha elikhethekileyo eliphuhliswe yi-mosadon ngentsebenziswano nenkampani ye-Ridgeback biotherapy.Ngaphambili ifumene imvume yokusetyenziswa kongxamiseko e-UK, kodwa idatha yeklinikhi epapashwe yamva nje ibonisa ukuba izinga elisebenzayo liye lehla kakhulu.

Ngokwesibhengezo se-MSD kwiveki ephelileyo, iziphumo zovavanyo lokugqibela zibonise ukuba abantu abangama-68 kwiqela le-placebo balaliswe esibhedlele okanye basweleka, ngelixa kuphela ngama-48 kwabangama-709 abaguli abathatha i-monapiravir ebenokwehla ngakumbi, okuthe kwanciphisa umngcipheko wokulaliswa esibhedlele / wokusweleka ukusuka kwi-9.7% ukuya kutsho. I-6.8%, kwaye umlinganiselo wokunciphisa umngcipheko ufikelele kwi-30%.Kubalulekile ukukhankanya ukuba abantu abali-9 basweleke kwiqela le-placebo kwaye omnye kuphela kwiqela le-molnupiravir.

Nangona kunjalo, ikomiti yeengcaphephe ze-FDA yaseMelika ivotele i-13 ukuya kwi-10 ukuxhasa i-molnupiravir, ichiza le-antiviral le-methadone, isithi izibonelelo ziyodlula imingcipheko.I-FDA ayinyanzelekanga ukuba ilandele iingcebiso zekomiti, kodwa ihlala ikhetha ukuzilandela.

Ukongeza, iPfizer ikwafuna imvume ye-FDA kwiyeza layo elitsha lesithsaba.Isigaba sesi-III sophononongo lweklinikhi ye-paxlovid, isithsaba esitsha somlomo, sibonakalisa ukuba umngcipheko wokulaliswa esibhedlele okanye ukufa unokuncitshiswa malunga ne-89% kwizigulane ezinesithsaba esincinci ukuya kwimodareyitha entsha phakathi kweentsuku ezintathu zokuxilongwa, ezifaniswa nesiphumo sonyango. yokunciphisa i-antibody yesithsaba esitsha.

Umhleli onoxanduva: Liuli


Ixesha lokuposa: Dec-02-2021