Novemba 2022: Ezinganeni ezinenyanga eyodwa nangaphezulu ezinamathumba aqinile asendaweni, angewona ama-metastatic, i-Food and Drug Administration igunyaze i-sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) ukuze yehlise ingcuphe ye-ototoxicity ehambisana ne-cisplatin.
Izifundo ezimbili ezivulekile ezivulekile, izifundo ezilawulwa ngokungahleliwe, i-SIOPEL 6 (NCT00652132) kanye ne-COG ACCL0431, zenziwa ezinganeni ezithola i-cisplatin-based chemotherapy yomdlavuza (NCT00716976).
Iziguli eziyi-114 ezinengozi evamile ye-hepatoblastoma zabhaliswa ku-SIOPEL 6 futhi zenza imijikelezo engu-6 ye-postoperative cisplatin-based chemotherapy. Ngokuya ngesisindo somzimba sazo sangempela, iziguli zazingahleliwe (1:1) ukuze zithole ukwelashwa okusekelwe ku-cisplatin noma ngaphandle kwe-sodium thiosulfate ngemithamo ehlukene ye-10 g/m2, 15 g/m2, noma 20 g/m2. Iningi leziguli ezinokulahlekelwa ukuzwa kwe-Brock Grade 1, njengoba kunqunywa ithoni ye-audiometry emsulwa ngemva kokwelashwa noma lapho ziseneminyaka okungenani engu-3.5 ubudala, kuye ngokuthi imuphi eza kuqala, kwaba umphumela oyinhloko. Lapho i-cisplatin ihlanganiswa ne-sodium thiosulfate, kwakukhona ukwehla kwezinga lokuzwa (39% vs. 68%); ingozi yesihlobo engalungisiwe yayingu-0.58 (95% CI: 0.40, 0.83).
Izingane ezinezimila eziqinile ebezithola ukwelashwa ngamakhemikhali okuhlanganisa imithamo ye-cisplatin eqoqiwe engu-200 mg/m2 noma ngaphezulu kanye nemithamo ngayinye ye-cisplatin okufanele inikezwe isikhathi esingaphezu kwamahora ayisithupha ifakwe ku-COG ACCL0431. Ukuphathwa kwe-chemotherapy esekelwe ku-cisplatin ene-sodium thiosulfate noma ngaphandle kwayo kwabelwa ngokungahleliwe (1: 1) ezigulini. Iqembu leziguli ezingama-77 ezinamathumba aqinile aqukethwe endaweni, angewona ama-metastatic ahlolwe ukusebenza kwawo. I-American Speech-Language-Hearing Association (ASHA) yokunquma yokulahlekelwa ukuzwa yalinganiswa ekuqaleni kanye namaviki amane kulandela ukwelashwa kokugcina kwe-cisplatin. Lokhu kwaba umphumela oyinhloko. Lapho i-cisplatin ihlanganiswa ne-sodium thiosulfate, izehlakalo zokulahlekelwa ukuzwa zehla (44% vs. 58%); ingozi yesihlobo engalungisiwe yayingu-0.75 (95% CI: 0.48, 1.18).
Ukuhlanza, isicanucanu, ukwehla kwe-hemoglobin, i-hypernatremia, ne-hypokalemia kwakuyimiphumela emibi kakhulu ezifundweni ezimbili (ama-25% anomehluko phakathi kwezingalo ezingaphezu kuka-5% uma kuqhathaniswa ne-cisplatin iyodwa).
Umthamo we-sodium thiosulfate owelulekwayo ususelwa endaweni engaphezulu yomzimba njengoba ikalwa ngesisindo sangempela. Kulandela ukujova ngemithambo ye-cisplatin ehlala ihora elilodwa kuya kwayisithupha, i-sodium thiosulfate inikezwa phakathi nemizuzu eyi-15.
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