盐酸阿糖胞苷致肿瘤患儿肝肾损伤和电解质紊乱相关因素分析

Analysis of the Related Risk Factors in Liver and Kidney Injury and Electrolyt Disorder Induced by Cytarabine Hydrochloride for Injection Used in Children with Tumor

目的:分析某院注射用盐酸阿糖胞苷对肿瘤患儿肝、肾功能和电解质的影响及其相关因素,为临床合理用药提供参考。方法:应用中国医院药物警戒系统(CHPS)等软件,回顾性分析武汉儿童医院2017~2018年使用注射用盐酸阿糖胞苷的134例患儿用药情况及其导致肝、肾功能损害和引起电解质紊乱等不良反应发生特点。结果:134例患儿中14例发生肝损伤,发生率为10.45%,其中轻度肝损伤11例,中度肝损伤2例,重度肝损伤1例;发生肾损伤2例,发生率为1.49%,其中1级和2级各1例;发生电解质紊乱10例,发生率为7.46%,其中2例较重,分别为低钾血症和低钙血症。相关因素分析显示:与肝功能正常组比较,肝损伤组患者低龄(0~2岁)、盐酸阿糖胞苷用药剂量,以及联用甲氨蝶呤、长春地辛、环磷酰胺或培门冬酶等因素的差异有统计学意义(P<0.05);与肾功能正常组比较,肾损伤组患者的中龄(3~9岁)、大龄(≥10岁)和联用培门冬酶等因素差异有统计学意义(P<0.05);与电解质正常组比较,电解质紊乱组患者低龄(0~2岁)和中龄(3~9岁)等因素差异有统计学意义(P<0.05)。结论:注射用盐酸阿糖胞苷对患儿肝肾功能和电解质确有影响,其中低龄(0~2岁)、阿糖胞苷用药剂量,以及联用甲氨蝶呤、长春地辛、环磷酰胺或培门冬酶等药物可能增加患儿肝损伤风险;中龄(3~9岁)、大龄(≥10岁)和联用培门冬酶可能增加患儿肾损伤风险;低龄(0~2岁)和中龄(3~9岁)可能增加患儿电解质紊乱风险。

Objective: To analyze the clinical use of cytarabine and its impacts on liver function, renal function and electrolyte of hospitalized children with tumor in order to provide reference for clinical rational use. Methods: It was a single-center retrospective analysis involving 134 patients treated with cytarabine in the hematology department of a children’s hospital from January 2017 to December 2018. China Hospital Pharmacovigilance System(CHPS) and SPSS software were used to assess the incidence, severity and risk factors of liver injury;kidney injury and electrolyte disorder, respectively. Results: Among the 134 patients admitted, there were 14 patients(10.45%) with liver injure, and among them, 11 patients were with mild liver injury, 2 patients with moderate liver injury and one patient with severe liver injury. There were 2 patients(1.49%) with kidney injury, one case of grade 1 and another case of grade 2. There were 9 patients(7.46%) with electrolyte disorder, and among them, 2 cases were serious(hypokalemia and hypocalcemia). The related factors analysis showed that young age(0-2 years), dose of cytarabine used, combined use with methotrexate, cyclophosphamide, vindesine and pegaspargas were the significant factors affecting the liver injury when compared to the normal liver function group;middle age(3-9 years), older age(≥10 years) and combined use with pegaspargase were the significant factors affecting kidney function when compared to the normal kidney function group;young age(0-2 years)and middle age(3-9 years) were the notable factors affecting electrolyte.Conclusion: Cytarabine hydrochloride for injection shows certain effects on the liver function, kidney function and electrolytes of children patients, and young age(0-2 years), dose of cytarabine used, combined use with methotrexate, cyclophosphamide, vindesine and pegaspargas may increase the risk of liver injury, the middle age(3-9 years), older age(≥10 years) and combined use with pegaspargase may increase the risk of renal injury, and young age(0-2 years) and middle age(3-9 years) may increase the risk of electrolyte disorder in children.