Nuwamba 2023: Ga marasa lafiya na yara masu shekaru shekara ɗaya zuwa sama tare da lokaci na yau da kullun (CP) Ph + cutar sankarar jini ta myelogenous (CML), ko dai sabon kamuwa da cuta (ND) ko juriya ko rashin haƙuri (R / I) zuwa maganin da ya gabata, Hukumar Abinci da Magunguna ta amince da bosutinib. Bosulif, Pfizer). Bugu da ƙari, wani sabon nau'in sashi na capsule tare da adadin 50 MG da 100 MG FDA ta amince da shi.
Gwajin BCHILD (NCT04258943) ta tantance ingancin bosutinib a cikin marasa lafiya na yara tare da ND CP Ph + CML da R/I CP Ph+ CML. Gwajin ya kasance ta tsakiya da yawa, ba a kayyade ba, kuma buɗaɗɗen lakabin, tare da maƙasudin ƙayyadaddun adadin da aka ba da shawarar, kimanta aminci da haƙuri, tantance inganci, da tantancewa. bosutinib pharmacokinetics a cikin wannan yawan marasa lafiya. Gwajin ya haɗa da marasa lafiya 21 tare da ND CP Ph + CML da aka bi da su a 300 mg / m2 sau ɗaya kowace rana da marasa lafiya 28 tare da R / I CP Ph + CML tare da bosutinib a 300 mg / m2 zuwa 400 mg / m2 baki sau ɗaya kowace rana.
Babban amsawar cytogenetic (MCyR), cikakkiyar amsawar cytogenetic (CCyR), da kuma manyan martanin kwayoyin halitta (MMR) sune ma'aunin sakamako na farko na inganci. Babban (MCyR) da cikakken (CCyR) cytogenetic martani ga marasa lafiya na yara tare da ND CP Ph + CML sune 76.2% (95% CI: 52.8, 91.8) da 71.4% (95% CI: 47.8, 88.7), bi da bi. 28.6% (95% CI: 11.3, 52.3) shine MMR, kuma watanni 14.2 shine lokacin biyan kuɗi na tsakiya (kewaye: 1.1, 26.3 watanni).
Babban (MCyR) da cikakken (CCyR) cytogenetic martani ga marasa lafiya na yara tare da R / I CP Ph + CML sun kasance 82.1% (95% CI: 63.1, 93.9) da 78.6% (95% CI: 59, 91.7), bi da bi. 50% (95% CI: 30.6, 69.4) shine MMR. Biyu daga cikin marasa lafiya 14 da suka kai MMR sun rasa MMR bayan sun karɓi jiyya na watanni 13.6 da 24.7, bi da bi. Bibiyar watanni 23.2 ita ce tsaka-tsaki (kewaya: 1, watanni 61.5).
Daga cikin marasa lafiya na yara, zawo, ciwon ciki, amai, tashin zuciya, rash, lethargy, hepatic dysfunction, ciwon kai, pyrexia, rage cin abinci, da maƙarƙashiya sune abubuwan da aka fi ruwaito akai-akai (≥20%). A cikin marasa lafiya na yara, ƙara yawan creatinine, ƙarar alanine aminotransferase ko aspartate aminotransferase, rage yawan adadin farin jini, da rage yawan adadin platelet sune mafi yawan abubuwan da suka fi dacewa a cikin dakin gwaje-gwaje waɗanda suka tsananta daga asali (≥45%).
Ga marasa lafiya na yara tare da ND CP Ph + CML, shawarar da aka ba da shawarar na bosutinib shine 300 mg / m2 baki sau ɗaya kowace rana tare da abinci; ga marasa lafiya na yara tare da R/I CP Ph + CML, shawarar da aka ba da shawarar shine 400 mg/m2 a baki sau ɗaya kowace rana tare da abinci. Ana iya haɗa abubuwan da ke cikin capsules tare da yoghurt ko applesauce ga mutanen da ba za su iya haɗiye su ba.
