Sodium thiosulfate waxaa ansixisay FDA si loo yareeyo khatarta ototoxicity ee la xiriirta cisplatin ee bukaanada carruurta ee leh meel gaar ah, oo aan ahayn burooyinka adag ee metastatic.

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Nofeembar 2022: Carruurta da'doodu tahay hal bil iyo wixii ka weyn ee leh burooyinka adag ee aan metastatic ahayn, Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) si loo yareeyo khatarta ototoxicity ee la xidhiidha cisplatin.

Laba calaamadood oo furan oo kala duwan, daraasado la kontaroolay oo aan kala sooc lahayn, SIOPEL 6 (NCT00652132) iyo COG ACCL0431, ayaa lagu qabtay carruurta qaata cisplatin-ku-saleysan kiimiko ee kansarka (NCT00716976).

114 bukaan oo qaba halista hepatoblastoma ee caadiga ah ayaa lagu qoray SIOPEL 6 waxaana la mariyay 6 wareegyo oo ah daaweynta kemotherabi ku salaysan cisplatin ka dib. Iyadoo ku xiran miisaankooda dhabta ah, bukaanada ayaa la kala soocay (1: 1) si ay u helaan daaweyn ku salaysan cisplatin oo leh ama aan lahayn sodium thiosulfate qiyaaso kala duwan oo ah 10 g / m2, 15 g / m2, ama 20 g / m2. Badi bukaanada qaba maqal la'aanta darajada 1aad ee Brock, sida lagu go'aamiyay maqal-maqalka codka saafiga ah ka dib daawaynta ama da'da ugu yaraan 3.5 sano, hadba kii soo horeeyay, ayaa ahaa natiijada aasaasiga ah. Markii cisplatin lagu daray sodium thiosulfate, waxaa jiray hoos u dhac ku yimid maqal la'aanta (39% vs. 68%); Khatarta qaraabada ah ee aan la hagaajinin waxay ahayd 0.58 (95% CI: 0.40, 0.83).

Carruurta leh burooyin adag oo qaadanaya kiimoterabi oo ay ku jiraan iskudarka qiyaasaha cisplatin ee 200 mg/m2 ama ka badan iyo qiyaasaha cisplatin ee gaarka ah oo la maamulayo ugu badnaan lix saacadood ayaa lagu daray COG ACCL0431. Maamulka daaweynta kemotherabi ee ku salaysan cisplatin oo leh ama aan lahayn sodium thiosulfate ayaa si aan kala sooc lahayn loogu qoondeeyey (1: 1) bukaanka. Koox ka kooban 77 bukaan oo gudaha ku jira, burooyinka adag ee aan metastatic ahayn ayaa la qiimeeyay waxtarkooda. Shuruudaha Ururka Maqalka Hadalka-Luqadda-Maraykanka (ASHA) ee luminta maqalka ayaa lagu cabbiray gundhigga iyo afar toddobaad ka dib daawaynta kama dambaysta ah ee cisplatin. Tani waxay ahayd natiijada ugu weyn. Marka cisplatin lagu daro sodium thiosulfate, dhacdooyinka maqal la'aanta ayaa hoos u dhacay (44% vs. 58%); Khatarta qaraabada ah ee aan la hagaajinin waxay ahayd 0.75 (95% CI: 0.48, 1.18).

Matag, lallabbo, hoos u dhac ku yimaadda haemoglobin, hypernatremia, iyo hypokalemia ayaa ahaa saamaynta xun ee ugu badan ee labada daraasadood (25% farqi u dhexeeya gacmaha> 5% marka loo eego cisplatin oo keliya).

Qiyaasta sodium thiosulfate ee lagula taliyay waxay ku saleysan tahay aagga jirka ee jirka sida lagu cabbiro miisaanka dhabta ah. Ka dib faleebooyinka xididada ee cisplatin ee socda hal ilaa lix saacadood, sodium thiosulfate ayaa la bixiyaa 15 daqiiqo gudahood.

 

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