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Xinhua | Hōʻano hou ʻia: 2020-11-11 09:20

KIʻI WAIHO: Ua hōʻike ʻia ka logo ʻo Eli Lilly ma kekahi o nā keʻena o ka hui ma San Diego, Kaleponi, US, Kepakemapa 17, 2020. [Kiʻi/Nā Keʻena]
WASHINGTON — Ua hoʻopuka ka US Food and Drug Administration i kahi ʻae hoʻohana ulia pōpilikia (EUA) no ka lāʻau lapaʻau monoclonal antibody a ka mea hana lāʻau lapaʻau ʻAmelika ʻo Eli Lilly e mālama i ka COVID-19 ʻoluʻolu a kaulike i nā poʻe maʻi pākeke a me nā keiki.

Ua ʻae ʻia ka lāʻau lapaʻau, ʻo bamlanivimab, noNā poʻe maʻi COVID-19ʻo wai he 12 mau makahiki a ʻoi aʻe me ke kaumaha ma ka liʻiliʻi he 40 kilokani, a ʻo wai ka mea i pilikia nui no ka holomua ʻana i ka COVID-19 koʻikoʻi a (a i ʻole) ka hoʻokipa ʻia ʻana i ka haukapila, e like me kahi ʻōlelo a ka FDA ma ka Pōʻakahi.

Hoʻokomo pū kēia i ka poʻe he 65 mau makahiki a ʻoi paha, a i ʻole ka poʻe i loaʻa i kekahi mau maʻi olakino mau loa.

ʻO nā antibodies monoclonal he mau protein i hana ʻia e ka hale hana e hoʻohālike ana i ka hiki o ka ʻōnaehana pale e hakakā i nā antigens ʻino e like me nā virus. ʻO Bamlanivimab kahi antibody monoclonal i kuhikuhi kūikawā ʻia e kūʻē i ka protein spike o SARS-CoV-2, i hoʻolālā ʻia e ālai i ka hoʻopili ʻana o ka virus a me ke komo ʻana i loko o nā cell kanaka.

ʻOiai ke hoʻomau ʻia nei ka loiloi ʻana i ka palekana a me ka pono o kēia lāʻau hoʻokolokolo, ua hōʻike ʻia ʻo bamlanivimab i nā hoʻokolohua lapaʻau e hōʻemi i nā kipa hoʻokipa e pili ana i ka COVID-19 a i ʻole nā ​​​​​​kikowaena lumi pilikia (ER) i nā poʻe maʻi me ka pilikia nui no ka holomua o ka maʻi i loko o 28 mau lā ma hope o ka mālama ʻana i ka hoʻohālikelike ʻia me ka placebo, wahi a ka FDA.

Hoʻokumu ʻia ka ʻikepili e kākoʻo ana i ka EUA no bamlanivimab ma kahi loiloi waena mai kahi hoʻokolohua lapaʻau randomized, double-blind, placebo-controlled phase ʻelua i 465 mau pākeke i hoʻokomo ʻole ʻia i ka haukapila me nā hōʻailona COVID-19 ʻoluʻolu a kaulike.

No kēia mau maʻi, ua loaʻa i ka 101 kahi mahele o 700-milligram o bamlanivimab, ua loaʻa i ka 107 kahi mahele o 2,800-milligram, ua loaʻa i ka 101 kahi mahele o 7,000-milligram a ua loaʻa i ka 156 kahi placebo i loko o ʻekolu lā o ka loaʻa ʻana o ka hāpana lapaʻau no ka hoʻāʻo viral SARS-CoV-2 mua loa.

No nā poʻe maʻi i pilikia nui no ka holomua o ka maʻi, ua mālama ʻia nā haukapila a me nā kipa ʻana i ka lumi pilikia (ER) ma 3 pakeneka o nā poʻe maʻi i mālama ʻia me bamlanivimab ma ka awelika i hoʻohālikelike ʻia me 10 pakeneka i nā poʻe maʻi i mālama ʻia me ka placebo.

Ua like nā hopena ma ka ukana viral a ma ka hōʻemi ʻana i nā hoʻokipa ʻana i nā haukapila a me nā kipa ER, a ma ka palekana, i nā poʻe maʻi e loaʻa ana i kekahi o nā mahele bamlanivimab ʻekolu, e like me ka FDA.

ʻAe ka EUA i ka bamlanivimab e hoʻolaha ʻia a lawelawe ʻia ma ke ʻano he hoʻokahi mahele intravenous e nā mea lawelawe mālama ola.

"ʻO ka ʻae ʻia ʻana o ka FDA no ka bamlanivimab e hāʻawi i nā loea mālama ola kino ma ke alo o kēia maʻi ahulau me kahi mea hana ʻē aʻe i ka mālama ʻana i nā maʻi COVID-19," wahi a Patrizia Cavazzoni, ka luna hoʻomalu o ke Kikowaena no ka Loiloi a me ka Noiʻi Lāʻau Lapaʻau a ka FDA. "E hoʻomau mākou i ka loiloi ʻana i ka ʻikepili hou e pili ana i ka palekana a me ka pono o ka bamlanivimab ke loaʻa lākou."

Ma muli o ka loiloi ʻana i ka huina o nā hōʻike ʻepekema i loaʻa, ua hoʻoholo ka FDA he mea kūpono ke manaʻoʻiʻo he pono paha ka bamlanivimab i ka mālama ʻana i nā poʻe maʻi i hoʻokipa ʻole ʻia me ka COVID-19 ʻoluʻolu a kaulike paha. A, i ka wā e hoʻohana ʻia ai e mālama i ka COVID-19 no ka poʻe i ʻae ʻia, ʻoi aku ka nui o nā pono i ʻike ʻia a me nā pono kūpono ma mua o nā pilikia i ʻike ʻia a me nā pilikia kūpono no ka lāʻau lapaʻau, e like me ka FDA.

ʻO nā hopena ʻaoʻao e hiki mai ana o bamlanivimab e komo pū me ka anaphylaxis a me nā hopena e pili ana i ka infusion, ka nausea, ka maʻi diarrhea, ka dizziness, ka ʻeha poʻo, ka maneʻo a me ka luaʻi ʻana, e like me ka ʻoihana.

Ua hiki mai ka EUA i ka wā i ʻoi aku ai ʻo ʻAmelika Hui Pū ʻIa ma mua o 10 miliona mau hihia COVID-19 i ka Pōʻakahi, he 10 mau lā ma hope o ka hiki ʻana i 9 miliona. Ua ʻoi aku ka nui o nā maʻi hou i kēlā me kēia lā ma mua o 100,000, a ua ʻōlelo aku nā loea olakino lehulehu e komo ana ka ʻāina i ka wā ʻino loa o ka maʻi ahulau.