Agasti 2021: Umphikisi wokuqala we-oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (ORGOVYX, Myovant Sciences, Inc.), wagunyazwa yiFood and Drug Administration ngoDisemba 18, 2020, ezigulini ezikhulile ezinomdlavuza we-metastatic prostate.
I-HERO (NCT03085095), isilingo selebula esingahleliwe, esivulekile kwabesilisa esidinga okungenani unyaka owodwa wokwelashwa kokuncishwa kwe-androgen ukuze kuphindeke umdlavuza wendlala yesinye ngemva kokwelashwa nge-radiotherapy noma ukuhlinzwa noma umdlavuza wendlala yesinye osanda kutholakala ukuthi uyathena, wasetshenziselwa ukuhlola ukusebenza kahle. I-Relugolix 360 mg umthamo wokulayisha ngomlomo ngosuku lokuqala, olandelwa imithamo yomlomo yansuku zonke engu-120 mg, noma i-leuprolide acetate 22.5 mg umjovo ongaphansi kwesikhumba njalo ezinyangeni ezi-3 amaviki angu-48 wanikezwa iziguli (N=934).
Isinyathelo sokuphela kokusebenza okuyisisekelo kwakuyizinga lokuthathwa kwezokwelapha, elalichazwa njengokufeza nokugcina ukucindezelwa kwe-serum testosterone kumazinga we-castrate (50 ng / dL) ngosuku lwe-29 lokwelashwa nokuyigcina emasontweni angama-48 alandelayo. Engalweni ye-relugolix, isilinganiso sokuthathwa kwezokwelapha sasingu-96.7% (95% CI: 94.9%, 97.9%).
Ukushisa okushisayo, ubuhlungu bemisipha, ukukhathala, uhudo, nokuqunjelwa kwakuyimiphumela emibi kakhulu (amaphesenti ayishumi) ezigulini ezithatha i-relugolix ku-HERO. Ukwanda kwe-glucose, i-triglycerides, i-alanine aminotransferase, ne-aspartate aminotransferase kwakuyizinto ezazenzeka kakhulu elabhoratri (15%). Amazinga e-hemoglobin nawo atholakele ukuthi aphansi.
Umthamo wokulayisha we-360 mg ngosuku lokuqala ukhonjisiwe, kulandelwa umthamo wansuku zonke womlomo we-120 mg cishe ngesikhathi esifanayo usuku ngalunye, noma ngaphandle kokudla.
Inkomba: https://www.fda.gov/
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