培门冬酶致儿童不良反应临床病例分析

Analysis of clinical cases of adverse reactions in children caused by pegaspargase

目的 探讨培门冬酶治疗儿童恶性血液系统疾病致药物不良反应的发生情况与临床特点,为临床安全用药提供参考。方法 对我院2016年1月至2023年6月儿科血液病房报告的24例培门冬酶相关的不良反应病例进行回顾性分析,对患者的基本资料、药物不良反应(ADR)严重程度、用药剂量、给药途径、ADR临床表现、发生时间及转归情况等进行统计分析。结果 24例ADR报告中男性15例(62.50%),女性9例(37.50%)。年龄2~15岁,平均年龄(7.79±4.68)岁,10岁以下儿童16例(66.67%)。原患疾病以急性淋巴细胞白血病为主(87.50%)。24例患者给药方式均为肌肉注射给药,给药剂量为1 200~3 750 U。24例患者共发生了30例次ADR,其中10例患者为严重ADR,ADR累及器官以胃肠系统损害(8例次,27.59%)最多,其次为全身性(6例次,20.69%)和皮肤及皮下组织(5例次,17.24%)。ADR发生时间最短为用药后5 min,最长为用药后56 d。结论 临床应关注培门冬酶ADR的发生特点,用药后需要在较长时间内对患者进行安全性监测,严密监测患者临床症状及相关检验指标,尤其是低龄儿童,降低ADR对患者造成的损害。

Objective Exploring the occurrence and clinical characteristics of adverse drug reactions caused by the treatment of malignant hematological diseases in children with pegaspargase,in order to provide reference for safe drug use in clinical practice.Methods Summarize and organize 24 cases of adverse reactions related to pegaspargase reported in the pediatric hematology ward of our hospital from January 2016 to June 2023 for analysis and re evaluation.The basic information,severity of adverse drug reaction(ADR),dosage,route of administration,clinical manifestations,occurrence time and outcome of ADR were analyzed statistically.Results Among the 24 ADR reports,there were 15 males(62.50%) and 9 females(37.50%).The age ranged from 2 to 15 years,with an average age of(7.79±4.68) years.There were 16 children under 10 years old(66.67%).The primary disease is acute lymphocytic leukemia(87.50%).The administration mode of 24 patients was intramuscular injection,and the dosage was 1200-3 750 U.A total of 30 ADRs occurred in 24 patients,10 of which were serious ADRs.The most common organ involved in ADR was gastrointestinal system damage(8 cases,27.59%),followed by systemic(6 cases,20.69%) and skin and Subcutaneous tissue(5cases,17.24%).The shortest occurrence time of ADR is 5 minutes after medication,and the longest is 56 days after medication.Conclusion Clinical attention should be paid to the occurrence characteristics of asparaginase ADR.After medication,patients need to be monitored for safety over a long period of time,closely monitoring their clinical symptoms and related test indicators,especially in young children,to reduce the damage caused by ADR to patients.