Nuhou Uea

Ho'āʻo hou e hoʻomaikaʻi i ka ʻike o ka maʻi Alzheimer

i kakauia ma hoʻoponopono

Ua ʻae ka US Food and Drug Administration i kēia lā i ke kūʻai aku ʻana no ka hoʻāʻo diagnostic in vitro mua no ka ʻike mua ʻana i nā pā amyloid e pili ana i ka maʻi o Alzheimer. Hoʻohana ʻia ka hoʻāʻo ʻo Lumipulse G β-Amyloid Ratio (1-42/1-40) i nā poʻe maʻi makua, 55 mau makahiki a ʻoi aʻe, e hōʻike ana me ka hōʻino naʻau e loiloi ʻia nei no ka maʻi Alzheimer a me nā kumu ʻē aʻe o ka emi ʻana o ka naʻau.           

"ʻO ka loaʻa ʻana o kahi hōʻike diagnostic in vitro e hiki ai ke hoʻopau i ka pono no ka hoʻopau ʻana i ka manawa a me ka pipiʻi PET scans he nūhou maikaʻi loa ia no nā poʻe a me nā ʻohana e pili ana i ka hiki ke loaʻa kahi maʻi maʻi o Alzheimer," wahi a Jeff Shuren, MD, JD, luna hoʻomalu. o ka FDA's Center for Devices and Radiological Health. "Me ka ho'āʻo Lumipulse, aia kahi koho hou e hiki ke hoʻopau maʻamau i ka lā hoʻokahi a hiki ke hāʻawi i nā kauka i ka ʻike like e pili ana i ke kūlana amyloid lolo, me ka ʻole o ka hopena radiation, e kōkua i ka hoʻoholo ʻana inā no ka maʻi Alzheimer ka mea maʻi. ”

Wahi a ka National Institutes of Health, ʻoi aku ma mua o ʻeono miliona ʻAmelika, ʻoi aku ka nui o nā makahiki 65 a ʻoi paha, i loaʻa i ka dementia ma muli o ka maʻi o Alzheimer, kahi maʻi lolo i ʻike ʻia e hoʻopau mālie i ka hoʻomanaʻo a me ka noʻonoʻo noʻonoʻo, a, i ka hopena, ka hiki ke hoʻokō i ka nā hana maʻalahi. I ka nui o ka poʻe me ka maʻi Alzheimer, ʻike mua ʻia nā hōʻailona lapaʻau ma hope o ke ola. 

Ke holomua nei ka maʻi o Alzheimer, ʻo ia hoʻi, e piʻi aʻe ka maʻi i ka wā lōʻihi. He mea nui ka ʻike mua a me ka pololei e kōkua i nā maʻi a me nā mea mālama i ka hoʻolālā a me nā koho lapaʻau mua. Loaʻa kahi pono kūpono ʻole no kahi hoʻokolohua hilinaʻi a palekana e hiki ke hoʻomaopopo pololei i nā poʻe maʻi me nā pā amyloid e kūlike me ka maʻi o Alzheimer. ʻOiai hiki ke loaʻa ka amyloid plaques i nā maʻi ʻē aʻe, hiki ke ʻike i ke ʻano o ka plaque, me nā loiloi ʻē aʻe, kōkua i ke kauka e hoʻoholo i ke kumu kūpono o nā hōʻailona a me nā ʻike o ka mea maʻi. Ma mua o ka ʻae ʻia ʻana o kēia lā, ua hoʻohana nā kauka i ka positron emission tomography (PET) scans, kahi koho nui a paʻakikī, e ʻike / ʻike i nā pā amyloid i loko o ka lolo o ka mea maʻi, he mau makahiki ma mua o ka hoʻomaka ʻana o ka hōʻailona hōʻailona, ​​​​e kōkua i ka ʻike ʻana i ka maʻi o Alzheimer.

Ua manaʻo ʻia ka hoʻāʻo Lumipulse e ana i ka ratio o β-amyloid 1-42 a me β-amyloid 1-40 (nā protein kūikawā hiki ke hōʻiliʻili a hana i nā plaques) i loaʻa i loko o ka wai cerebral spinal fluid (CSF), hiki ke kōkua i nā kauka e hoʻoholo inā Loaʻa paha i ka mea maʻi nā pāpaʻi amyloid, kahi hōʻailona hōʻailona o ka maʻi o Alzheimer. Pono e unuhi ʻia nā hualoaʻa me nā ʻike lapaʻau maʻi ʻē aʻe.

ʻO ka hopena hoʻāʻo ʻo Lumipulse G β-amyloid Ratio (1-42/1-40) kūpono me ka loaʻa ʻana o nā pā amyloid, e like me ka mea e ʻike ʻia ma kahi scan PET. ʻO ka hopena maikaʻi ʻole ke kūlike me ka hopena amyloid PET scan maikaʻi ʻole. ʻO ka hopena o ka hoʻāʻo maikaʻi ʻole e hōʻemi i ka hiki ke loaʻa ka hemahema o ka naʻau o ka mea maʻi ma muli o ka maʻi Alzheimer, e hiki ai i nā kauka ke ʻimi i nā kumu ʻē aʻe o ka emi ʻana o ka naʻau a me ka dementia. ʻAʻole i manaʻo ʻia ka hoʻāʻo ʻana ma ke ʻano he kānana a i ʻole ke kū hoʻokahi diagnostic assay. Aia kekahi hiki ke ʻike ʻia kahi hopena hoʻokolohua maikaʻi i nā poʻe maʻi me nā ʻano maʻi neurologic ʻē aʻe, a me nā poʻe olakino cognitively kahiko, e hōʻike ana i ke koʻikoʻi o ka hoʻohana ʻana i kēia hoʻāʻo me ka hui pū ʻana me nā loiloi lapaʻau ʻē aʻe. 

Ua loiloi ka FDA i ka palekana a me ka maikaʻi o kēia hoʻāʻo ʻana ma kahi noiʻi lapaʻau o 292 CSF samples mai ka Alzheimer's Disease Neuroimaging Initiative sample bank. Ua hoʻāʻo ʻia nā laʻana e ka Lumipulse G β-amyloid Ratio (1-42/1-40) a hoʻohālikelike ʻia me nā hopena scan amyloid PET. I loko o kēia haʻawina hoʻomaʻamaʻa, 97% o nā poʻe me Lumipulse G β-amyloid Ratio (1-42/1-40) nā hopena maikaʻi i loaʻa i nā pā amyloid e ka PET scan a ʻo 84% o nā kānaka me nā hopena maikaʻi ʻole i loaʻa ka amyloid PET scan maikaʻi ʻole. .

ʻO nā pilikia e pili ana i ka hoʻāʻo ʻana o Lumipulse G β-amyloid Ratio (1-42/1-40) ʻo ia ka hopena o nā hopena hōʻike maikaʻi ʻole a hoʻopunipuni. ʻO nā hopena maikaʻi hoʻopunipuni, i hui pū ʻia me nā ʻike lapaʻau ʻē aʻe, hiki ke alakaʻi i kahi hōʻailona kūpono ʻole, a me ka mālama pono ʻole ʻana no ka maʻi Alzheimer. Hiki i kēia ke alakaʻi i ka pilikia noʻonoʻo, hoʻopaneʻe i ka loaʻa ʻana o kahi hōʻailona kūpono a me nā lilo a me ka pilikia o nā hopena ʻaoʻao mai ka mālama pono ʻole. Hiki i nā hopena ho'āʻo hoʻopunipuni hoʻopunipuni ke loaʻa i nā hoʻāʻo diagnostic pono ʻole a hiki ke lohi i ka mālama pono. ʻO ka mea nui, ʻo ka Lumipulse G β-amyloid Ratio (1-42/1-40) ʻaʻole ia he hoʻokolohua kū hoʻokahi a pono e hoʻohana ʻia nā loiloi lapaʻau ʻē aʻe a i ʻole nā ​​hoʻokolohua hou no ka hoʻoholo ʻana i nā koho lapaʻau. 

Ua nānā ka FDA i ka mea hana ma o ka De Novo premarket review alahele, he ala hoʻoponopono no nā mea haʻahaʻa a haʻahaʻa-pilikia o kahi ʻano hou. Hoʻokumu kēia hana i kahi hoʻonohonoho hoʻoponopono hou, ʻo ia hoʻi, hiki i nā mea hana ma hope o ke ʻano like me ka hoʻohana like i manaʻo ʻia e hele ma o ka FDA 510 (k) kaʻina premarket, kahi e loaʻa ai i nā mea hana ka mana kūʻai aku ma ka hōʻike ʻana i ke kūlike nui me kahi mea predicate.

Ua hāʻawi ʻia ka Lumipulse G β-amyloid Ratio (1-42/1-40) i ka inoa ʻo Breakthrough Device, kahi kaʻina i hoʻolālā ʻia e hoʻolalelale i ka hoʻomohala ʻana a me ka nānā ʻana i nā mea hana e hiki ai ke hāʻawi i ka lāʻau lapaʻau maikaʻi a i ʻole ka hōʻoia ʻana i nā maʻi hoʻoweliweli a i ʻole e hoʻihoʻi ʻole ʻia. a i ʻole nā ​​kūlana.

Ua ʻae ka FDA i ke kūʻai aku ʻana o ka Lumipulse G ß-Amyloid Ratio (1-42/1-40) iā Fujirebio Diagnostics, Inc.

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