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Ua ʻae ʻia ka lāʻau naʻau hou o Bayer ʻo Vericiguat ma Kina

Ma Mei 19, 2022, Ua ʻae ka National Medical Products Administration (NMPA) o Kina i ka noi kūʻai aku no Bayer's Vericiguat (2.5 mg, 5 mg, a me 10 mg) ma lalo o ka inoa inoa Verquvo™.

Hoʻohana ʻia kēia lāʻau lapaʻau i nā poʻe maʻi maʻi me ka hōʻino ʻole o ka naʻau maʻi a me ka haʻihaʻi ejection i hoʻemi ʻia (ejection fraction <45%) i hoʻopaʻa ʻia ma hope o kahi hanana decompensation hou me ka intravenous therapy, e hōʻemi i ka pilikia o ka hale maʻi no ka hōʻole ʻana o ka naʻau a i ʻole ka maʻi diuretic intravenous.

Ua hoʻokumu ʻia ka ʻae ʻana o Vericiguat ma nā hopena maikaʻi mai ka noiʻi ʻo VICTORIA, ka mea i hōʻike ʻia e hiki iā Vericiguat ke hōʻemi hou i ka hopena o ka make ʻana o ka maʻi cardiovascular a me ka hoʻokipa ʻana no ka hōʻemi ʻana o ka naʻau e 4.2% (event absolute risk reduction/100 patient-years) no nā maʻi me ka puʻuwai. ʻaʻole i loaʻa i kahi hanana decompensation hōʻino puʻuwai hou a paʻa i ka lāʻau lapaʻau intravenous me ka haʻihaʻi ejection i hōʻemi ʻia (haʻina ejection <45%).

I Ianuali 2021, Ua'āponoʻiaʻo Vericiguat maʻAmelika Hui PūʻIa no ka mālamaʻana i ka hōʻailona maʻiʻole o ka naʻau i nā poʻe maʻi me ka'āpana ejection ma lalo o 45% ma hope o kaʻikeʻana i kahi hanana hōʻino o ka naʻau.

I ʻAukake 2021, ua ʻae ʻia ka palapala noi lāʻau hou no Vericiguat e ka CDE a ua hoʻokomo ʻia i loko o ka loiloi mua a me ke kaʻina hana ʻae ʻia ma ke kumu o "nā lāʻau lapaʻau koʻikoʻi, nā lāʻau hou a me nā lāʻau lapaʻau hou no ka pale ʻana a me ka mālama ʻana i nā maʻi infectious nui a me nā maʻi maʻamau" .

I ʻApelila 2022, ka 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, i hoʻopuka pū ʻia e ka American College of Cardiology (ACC), ka American Heart Association (AHA), a me ka Heart Failure Society of America (HFSA), i hōʻano hou ʻia. ka lāʻau pharmacologic o ka puʻuwai puʻuwai me ka emi ʻana o ka ejection fraction (HFrEF) a hoʻokomo ʻia ʻo Vericiguat i loko o nā lāʻau lapaʻau i hoʻohana ʻia no ka mālama ʻana i nā maʻi me ka HFrEF kiʻekiʻe a me nā exacerbations puʻuwai ma muli o ka lāʻau maʻamau.

ʻO Vericiguat kahi mea hoʻoulu sGC (soluble guanylate cyclase) me ka mīkini hou i hoʻomohala ʻia e Bayer a me Merck Sharp & Dohme (MSD).Hiki iā ia ke komo pololei i ka maʻi mīkini hōʻailona cell a hoʻoponopono i ke ala NO-sGC-cGMP.

Ua hōʻike ʻia nā haʻawina preclinical a me nā noiʻi lapaʻau ʻo NO-soluble guanylate cyclase (sGC) -cyclic guanosine monophosphate (cGMP) ala hōʻailona he pahuhopu kūpono no ka piʻi ʻana o ka puʻuwai mau loa a me ka hoʻomaʻamaʻa puʻuwai.Ma lalo o nā kūlana physiological, ʻo kēia ala hōʻailona he ala hoʻoponopono koʻikoʻi no ka mīkini myocardial, ka hana naʻau, a me ka hana endothelial vascular.

Ma lalo o nā kūlana pathophysiological o ka pau ʻole o ka naʻau, hoʻonui ʻia ka mumū a me ka maʻi vascular e hōʻemi i ka NO bioavailability a me ka synthesis cGMP lalo.ʻO ka hemahema cGMP ke alakaʻi nei i ka dysregulation o ka vascular tension, vascular and cardiac sclerosis, fibrosis a me hypertrophy, a me ka coronary a me ka renal microcirculatory dysfunction, no laila ke alakaʻi hou aku nei i ka hōʻeha myocardial holomua, hoʻonui i ka mumū a me ka emi ʻana o ka hana naʻau a me ka renal.


Ka manawa hoʻouna: Mei-19-2022