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Background: Ursodeoxycholic acid (UDCA), a bile acid, protects the liver through various mechanisms, including bile composition modulation and enhanced secretion. In ALL chemotherapy, 6MP is hepatotoxic, requiring dose reduction. UDCA is used to alleviate liver toxicity in ALL and other chronic cholestatic conditions. The study aims to evaluate the effectiveness of UDCA with chemotherapy in reducing 6MP treatment interruptions and its impact on treatment continuity in pediatric ALL.Methods: This randomized controlled trial study conducted at the Department of Pediatric Hematology and Oncology, BSMMU in pediatric ALL patients during chemotherapy from September 2018 to August 2019. Fifty children aged 1 to 18 years with ALL were enrolled, half receiving UDCA alongside chemotherapy and the rest forming the control group. Serum hepatic transaminases, total bilirubin, and CBC were monitored every 14 days. Statistical analysis was performed using SPSS, with significance set at p<0.05.Results: In this study of 50 pediatric ALL patients, there were no statistically significant age or gender differences between the "Case" (UDCA-treated) and "Control" groups. However, the UDCA group showed a significant decrease in abnormal liver function tests (32.0%) compared to controls (60.0%). Moreover, 6MP dose reduction was significantly lower in cases (4.0%) than controls (40.0%), indicating UDCA's potential hepatoprotective effects. Multivariate logistic regression revealed male gender and mean AST levels as significant factors associated with hepatotoxicity in pediatric ALL patients.Conclusions: Co-administration of UDCA with chemotherapy demonstrates a significant effect in treatment interruption by hepatotoxic drug specially 6 MP in pediatric ALL patients.
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Background: Chemotherapy-induced nausea and vomiting (CINV), represents a common and distressing side effect associated with antineoplastic treatment in pediatric patients. Aprepitant, a selective neurokinin-1 receptor antagonist, is recommended for preventing CINV in combination with a standard antiemetic regimen in children undergoing chemotherapy. This study aimed to evaluate the effectiveness of aprepitant as an add-on therapy to the standard antiemetic regimen for the prevention of CINV in children.Methods: This randomized control study was conducted in the BSMMU, Dhaka, Bangladesh from February 2020 to October 2020. Forty-six children with malignancy undergoing chemotherapy were divided into two arms: the Aprepitant arm (23 patients receiving granisetron, dexamethasone, and aprepitant) and the control arm (23 patients receiving Granisetron and Dexamethasone). Data were analyzed using SPSS version 22.0.Results: The complete response rates for the aprepitant versus control arm during the acute and overall phase were 82% vs. 40% (p=0.003) and 65% vs. 26% (p=0.008), respectively. However, a higher percentage of patients who achieved complete response in the delayed phase was also observed, though statistically not significant (65% vs 40%, p=0.077). In the acute phase, there was a significant reduction in mild to moderate vomiting in the Aprepitant arm as compared to the control arm (p=0.01). In the overall phase, 35% of patients in the Aprepitant arm had mild to moderate vomiting as compared to 74% in the control group (p=0.027). No major adverse effects were reported by patients or caregivers.Conclusions: Adding Aprepitant to the standard antiemetic regimen was effective and safe in preventing CINV, especially in the acute phase, in pediatric patients receiving the moderately and highly emetogenic chemotherapy (HEC).