Nuwamba 2022: A cikin yara masu shekaru wata daya da haihuwa tare da ƙananan ƙananan ƙwayoyin cuta, marasa ciwon ƙwayar cuta, Cibiyar Abinci da Drug ta amince da sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) don rage haɗarin ototoxicity da ke hade da cisplatin.
Label mai buɗewa guda biyu masu yawa, nazarin sarrafa bazuwar, SIOPEL 6 (NCT00652132) da COG ACCL0431, an gudanar da su a cikin yaran da ke karɓar cutar sankara ta cisplatin don ciwon daji (NCT00716976).
Marasa lafiya 114 tare da daidaitaccen haɗarin hepatoblastoma sun yi rajista a cikin SIOPEL 6 kuma sun yi tazarar 6 na tushen cutar sankara na cisplatin bayan tiyata. Dangane da ainihin nauyin jikin su, marasa lafiya sun kasance bazuwar (1: 1) don karɓar jiyya na tushen cisplatin tare da ko ba tare da sodium thiosulfate a nau'i daban-daban na 10 g / m2, 15 g / m2, ko 20 g / m2. Yawancin marasa lafiya da ke da raunin ji na Brock Grade 1, kamar yadda aka ƙaddara ta hanyar sautin sauti mai tsafta bayan jiyya ko kuma suna da shekaru aƙalla shekaru 3.5, duk wanda ya zo na farko, shine sakamako na farko. Lokacin da aka haɗa cisplatin tare da sodium thiosulfate, an sami raguwar raunin ji (39% vs. 68%); haɗarin dangi wanda ba a daidaita shi ba shine 0.58 (95% CI: 0.40, 0.83).
Yaran da ke da ciwace-ciwacen ciwace-ciwacen ƙwayoyi waɗanda ke karɓar chemotherapy waɗanda suka haɗa da adadin cisplatin tara na 200 mg/m2 ko fiye da daidaikun allurai na cisplatin da za a gudanar na tsawon awanni shida an haɗa su cikin COG ACCL0431. Gudanar da maganin chemotherapy dangane da cisplatin tare da ko ba tare da sodium thiosulfate an ba da izini ba (1: 1) ga marasa lafiya. Rukunin marasa lafiya 77 da ke cikin gida, ciwace-ciwacen ciwace-ciwace marasa ƙarfi an tantance ingancin su. An auna ma'auni na Ƙungiyar Jiyya-Harshen-Harshen Amurka (ASHA) don asarar ji a tushe da makonni huɗu bayan jiyya na ƙarshe na cisplatin. Wannan shi ne babban sakamako. Lokacin da aka haɗa cisplatin tare da sodium thiosulfate, an rage yawan asarar ji (44% vs. 58%); haɗarin dangi wanda ba a daidaita shi ba shine 0.75 (95% CI: 0.48, 1.18).
Amai, tashin zuciya, raguwar haemoglobin, hypernatremia, da hypokalemia sune mafi yawan sakamako masu illa a cikin binciken biyu (25% tare da bambanci tsakanin makamai na> 5% idan aka kwatanta da cisplatin kadai).
Matsakaicin adadin sodium thiosulfate wanda aka ba da shawarar ya dogara ne akan yanayin yanayin jiki kamar yadda aka auna ta ainihin nauyi. Bayan infusions na cisplatin na cikin jijiya wanda ya wuce awa ɗaya zuwa shida, ana ba da sodium thiosulfate a cikin mintuna 15.
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