November 2022: Muvana vane mwedzi mumwe chete zvichikwira vane mamota akasimba enzvimbo, asiri-metastatic akasimba, Food and Drug Administration yakabvumidza sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) kuderedza njodzi yeototoxicity inoenderana necisplatin.
Two multicenter open-label, randomised controlled studies, SIOPEL 6 (NCT00652132) and COG ACCL0431, were conducted in children receiving cisplatin-based chemotherapy for cancer (NCT00716976).
Varwere ve114 vane ngozi yakawanda yehepatoblastoma vakanyoreswa muSIOPEL 6 uye vakawana 6 miitiro ye postoperative cisplatin-based chemotherapy. Zvichienderana nehuremu hwavo chaihwo hwemuviri, varwere vaive vasina kurongeka (1: 1) kuti vagamuchire cisplatin-yakavakirwa kurapwa kana isina sodium thiosulfate pamhando dzakasiyana dze10 g / m2, 15 g / m2, kana 20 g / m2. Ruzhinji rwevarwere vane Brock Giredhi 1 kurasikirwa kwekunzwa, sekutsanangurwa kwakachena toni audiometry inotevera kurapwa kana pazera reanokwana makore 3.5, chero yakauya pekutanga, yaive yekutanga mhedzisiro. Apo cisplatin yakabatanidzwa ne sodium thiosulfate, pakanga pane kuderera kwekunzwa kurasikirwa (39% vs. 68%); iyo isina kugadziridzwa njodzi yehukama yaive 0.58 (95% CI: 0.40, 0.83).
Vana vane mapundu akasimba avo vaigamuchira chemotherapy iyo yaisanganisira cumulative cisplatin doses ye200 mg/m2 kana kupfuura uye yega cisplatin doses inofanira kupihwa kweanopfuura maawa matanhatu akaiswa muCOG ACCL0431. Kutungamirirwa kwekemotherapy inobva pa cisplatin ine kana kuti isina sodium thiosulfate yakagoverwa (1: 1) kuvarwere. Boka revarwere makumi manomwe nevanomwe vaive nemukati, vasina-metastatic solid tumors vakaongororwa kushanda kwavo. IAmerican Speech-Language-Hearing Association (ASHA) maitiro ekurasikirwa kwekunzwa akayerwa pakutanga uye mavhiki mana achitevera kurapwa kwekupedzisira kwe cisplatin. Uyu ndiwo waiva mugumisiro mukuru. Apo cisplatin yakabatanidzwa ne sodium thiosulfate, chiitiko chekunzwa kurasikirwa kwakaderera (77% vs. 44%); iyo isina kugadziridzwa njodzi yehukama yaive 58 (0.75% CI: 95, 0.48).
Kurutsa, kusvotwa, kuderedzwa kwehemoglobin, hypernatremia, uye hypokalemia ndiyo yaiwanzoipa mhedzisiro muzvidzidzo zviviri (25% ine musiyano pakati pemaoko> 5% ichienzaniswa necisplatin chete).
Muyero wesodium thiosulfate unorairwa unobva panzvimbo yemuviri sekuyerwa nehuremu chaihwo. Kutevera intravenous infusions yecisplatin inotora awa imwe kusvika kumatanhatu, sodium thiosulfate inopihwa mukati memaminitsi gumi nemashanu.
View full prescribing information for Pedmark.
