Xinhua | Whakahōungia: 2020-11-11 09:20
Whakaahua Kōnae: Kei te whakaatuhia te tohu a Eli Lilly i runga i tētahi o ngā tari o te kamupene i San Diego, California, US, Mahuru 17, 2020. [Whakaahua/Ngā Tari]
WASHINGTON — Kua tukuna e te Tari Kai me te Rongoā o Amerika he whakaaetanga whakamahinga ohorere (EUA) mō te rongoā paturopi monoclonal a te kaihanga rongoā o Amerika a Eli Lilly hei rongoā i te COVID-19 ngawari ki te ngawari i roto i ngā tūroro pakeke me ngā tamariki.
Kua whakamanahia te rongoā, bamlanivimab, mōNgā tūroro COVID-19e 12 tau te pakeke, neke atu rānei, he 40 kirokaramu te taumaha, ā, he nui te mōrearea ki te horapa ki te mate COVID-19 kino, ki te whakauru rānei ki te hōhipera, e ai ki tētahi kōrero a te FDA i te Rāhina.
Kei roto i tēnei ko te hunga 65 tau te pakeke, neke atu rānei, he mate pūmau tō rātou rānei.
Ko ngā paturopi monoclonal he pūmua i hangaia i roto i te taiwhanga e whai ana i te kaha o te pūnaha ārai mate ki te whawhai ki ngā antigens kino pēnei i ngā huaketo. Ko Bamlanivimab he paturopi monoclonal e aro motuhake ana ki te pūmua pīataata o te SARS-CoV-2, i hangaia hei aukati i te piri me te urunga o te huaketo ki roto i ngā pūtau tangata.
Ahakoa kei te arotakehia tonutia te haumaru me te whai huatanga o tēnei rongoā rangahau, i whakaaturia i roto i ngā whakamātautau haumanu te whakaiti i te haerenga hōhipera COVID-19, te haerenga rānei ki te rūma whawhati tata (ER) i roto i ngā tūroro e tino mōrearea ana ki te whanaketanga o te mate i roto i ngā rā 28 i muri i te maimoatanga, ina whakaritea ki te placebo, e ai ki te FDA.
Ko ngā raraunga e tautoko ana i te EUA mō te bamlanivimab i ahu mai i tētahi tātaritanga wā poto mai i tētahi whakamātautau haumanu matapōkere, matapo-rua, whakahaere-placebo i te wāhanga tuarua i roto i te 465 ngā pakeke kāore i te hōhipera me ngā tohu COVID-19 ngawari ki te whakaōrite.
O ēnei tūroro, 101 i whiwhi i te horopeta 700-mirikaramu o te bamlanivimab, 107 i whiwhi i te horopeta 2,800-mirikaramu, 101 i whiwhi i te horopeta 7,000-mirikaramu, ā, 156 i whiwhi i te placebo i roto i ngā rā e toru i muri i te whiwhinga o te tauira haumanu mō te whakamātautau huaketo SARS-CoV-2 tuatahi i kitea he pai.
Mō ngā tūroro he nui te mōrearea ki te horapa haere o te mate, e 3 ōrau o ngā tūroro i rongoatia ki te bamlanivimab i tae ki te hōhipera me ngā haerenga ki te rūma whawhati tata (ER) i te toharite, ki te whakaritea ki te 10 ōrau o ngā tūroro i rongoatia ki te placebo.
E ai ki te FDA, he rite tonu ngā pānga ki te kawenga huaketo me te whakaiti i ngā whakaurunga hōhipera me ngā haerenga ki te ER, me te haumaru hoki, i roto i ngā tūroro e whiwhi ana i tētahi o ngā horopeta bamlanivimab e toru.
E whakaaetia ana e te EUA te tohatoha me te hoatu i te bamlanivimab hei horopeta kotahi ma te uaua e ngā kaiwhakarato hauora.
"Ko te whakamanatanga ohorere a te FDA mō te bamlanivimab ka hoatu ki ngā tohunga hauora kei te rārangi mua o tēnei mate urutā tētahi atu taputapu pea hei rongoā i ngā tūroro COVID-19," te kī a Patrizia Cavazzoni, te kaiwhakahaere whakakapi o te Pokapū Arotake me te Rangahau Rongoā a te FDA. "Ka haere tonu tā mātou aromatawai i ngā raraunga hou mō te haumaru me te whai huatanga o te bamlanivimab ina wātea mai."
I runga i te arotake i te katoa o ngā taunakitanga pūtaiao e wātea ana, i whakatau te FDA he mea tika kia whakaponohia he whai hua pea te bamlanivimab ki te rongoā i ngā tūroro kāore i te hōhipera me te COVID-19 ngawari, ngawari rānei. Ā, ina whakamahia hei rongoā i te COVID-19 mō te taupori whai mana, ko ngā painga e mōhiotia ana me ngā painga pea ka nui ake i ngā mōrearea e mōhiotia ana me ngā mōrearea pea mō te rongoā, e ai ki te FDA.
E ai ki te tari, ko ngā pānga taha pea o te bamlanivimab ko te anaphylaxis me ngā tauhohenga e pā ana ki te werohanga, te whakapairuaki, te korere, te whanoke, te ānini, te mākūkū me te ruaki.
I puta te EUA i te mea kua neke atu i te 10 miriona ngā keehi COVID-19 o te United States i te Rāhina, 10 noa iho ngā rā i muri i te ekenga ki te 9 miriona. Kua neke atu i te 100,000 te toharite o ngā mate hou o ia rā, ā, kua whakatūpato ngā tohunga hauora tūmatanui kei te uru te whenua ki te wāhanga kino rawa atu o te mate urutā.
Wā tuku: Hakihea-19-2021