Jan 2023: Da miyagun ƙwayoyi nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) An amince da Hukumar Abinci da Magunguna don manya marasa lafiya da ke da babban haɗari, marasa amsawa marasa tsoka da ciwon mafitsara (NMIBC) wanda ke da carcinoma a wurin (CIS) tare da ko ba tare da ciwace-ciwacen papillary ba.
A cikin Nazarin CS-003 (NCT02773849), gwaji mai yawa, gwaji guda ɗaya wanda ya haɗa da marasa lafiya 157 tare da NMIBC mai haɗari da 98 wanda ke da CIS wanda za'a iya bincikar shi don amsawa, an kimanta tasiri. Sau ɗaya a kowane watanni uku har zuwa watanni 12, rashin jurewa mai guba, ko maimaita babban darajar NMIBC, marasa lafiya sun karɓi nadofaragene firadenovec-vncg 75 mL intravesical instillation (3 x 1011 viral particles/mL [vp/mL]). An ba marasa lafiya damar ci gaba da karɓar nadofaragene firadenovec-vncg kowane wata uku muddin ba a sake komawa ba.
Cikakken amsa (CR) a kowane lokaci da dorewar amsa sune manyan ma'aunin sakamako na inganci (DoR). Don cancanta a matsayin CR, ana buƙatar cystoscopy mara kyau tare da TURBT mai dacewa, biopsies, da cytology na fitsari. An dauki biopsies na mafitsara daban-daban guda biyar bazuwar daga marasa lafiya waɗanda har yanzu suna cikin CR bayan shekara guda. DoR na tsakiya shine watanni 9.7 (kewaye: 3, 52+), ƙimar CR shine 51% (95% CI: 41%, 61%), kuma 46% na marasa lafiya da ke amsawa sun kasance a cikin CR na akalla shekara guda.
Ƙara hyperglycemia, zubar da wuri, ƙara yawan triglycerides, gajiya, spasm mafitsara, gaggawar micturition, ƙara yawan creatinine, hematuria, rage phosphate, sanyi, dysuria, da pyrexia sune mafi yawan sakamako masu illa (lalacewar 10%), da kuma rashin daidaituwa na gwaji. > 15%).
Yin amfani da catheter na fitsari, ba da 75 ml na nadofaragene firadenovec-vncg a cikin mafitsara sau ɗaya kowane wata uku a matakin 3 x 1011 vp/mL. Ana ba da shawarar shan maganin anticholinergic a matsayin premedication kafin kowane instillation.
