August 2021: Yekutanga oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (ORGOVYX, Myovant Sayenzi, Inc.), yakabvumidzwa neFood and Drug Administration musi waZvita 18, 2020, yevarwere vakuru vane metastatic prostate cancer.
HERO (NCT03085095), muedzo wakasununguka, wakazaruka wevarume unoda gore risati rasvika uyerogen deprivation therapy yekudzokazve kwekenza yeprostate mushure meradiotherapy kana kuvhiyiwa kana kuti ichangobva kuonekwa inonzi castration-sensitive advanced prostate cancer, yakashandiswa kuongorora kushanda. Relugolix 360 mg oral loading dosage pazuva rokutanga, inoteverwa nemazuva ose emuromo doses ye120 mg, kana leuprolide acetate 22.5 mg jekiseni subcutaneously mwedzi yose ye3 kwemavhiki makumi mana nemasere yakapiwa kuvarwere (N = 48).
Iyo yakakosha kushanda kwekupedzisira chiyero yaive yekurapa castration mwero, iyo yakatsanangurwa sekuzadzikisa uye kuchengetedza serum testosterone kudzvinyirira kune castrate mazinga (50 ng / dL) nezuva 29 rekurapa uye kuichengeta iyo kweanotevera mavhiki e48. Mune relugolix ruoko, iyo yekurapa castration mwero yaive 96.7 muzana (95 muzana CI: 94.9 muzana, 97.9 muzana).
Kupisa kupisa, musculoskeletal kurwadziwa, kuneta, manyoka, uye kupatira ndiko kwakanyanya kujairika mhedzisiro (gumi muzana) kune varwere vanotora relugolix muHERO. Kuwedzera kweglucose, triglycerides, alanine aminotransferase, uye aspartate aminotransferase ndiwo akanyanya kuwanda murabhoritari (15%). Hemoglobin mazinga akawanikwa zvakare ave akaderera.
Iyo yekurodha dosi ye360 mg pazuva rekutanga inoratidzwa, inoteverwa neyemazuva ese yemumuromo yedosi ye120 mg panguva inenge yakafanana zuva rega rega, uine kana usina kudya.
Referensi: https://www.fda.gov/
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