基于HIS真实世界注射用更昔洛韦儿科临床应用安全性评价  

Safety analysis of clinical application of ganciclovir for injection in children based on real world research

作　　者：薛智民[1] 高明娥[1] 秦倩倩[1] 张云霞[1] 赵杰[1] 赵瑞玲[1] XUE Zhimin;GAO Minge;QIN Qianqian;ZHANG Yunxia;ZHAO Jie;ZHAO Ruiling(Department of Pharmacy,Children's Hospital of Shanxi,Taiyuan 030013,China)

机构地区：[1]山西省儿童医院药剂科,山西太原030013

出　　处：《药物评价研究》2022年第5期952-956,共5页Drug Evaluation Research

基　　金：山西省儿童医院院内项目(201949)。

摘　　要：目的 基于HIS真实世界评价儿童应用注射用更昔洛韦的安全性。方法 回顾性选取2020年1月-2020年12月山西省儿童医院使用注射用更昔洛韦的患儿进行真实世界研究,对患儿的人口学信息、临床诊断、药物用法用量、溶媒、联合用药及不良反应(ADR)发生率进行总结分析。结果 2020年1月-2020年12月山西省儿童医院使用注射用更昔洛韦的患儿共942例,ADR发生率为8.92%(84/942),均为一般不良反应,主要表现为中性粒细胞减少和皮疹;10%葡萄糖注射液溶媒组(14.55%)及1岁及以下儿童(14.56%)ADR发生率比较高,且有统计学差异(P<0.05)。结论 注射用更昔洛韦在儿童的临床应用存在超适应证用药情况;ADR多发生在用药1周内,程度较轻,与原患疾病、合并用药可能相关,临床用药时应注意监测血常规、肝肾功能等,保障儿童用药安全。Objective To evaluate safety of ganciclovir for injection among children, and so as to provide reference for clinical rational use. Methods A real-world study was conducted on children using ganciclovir for injection between January 2020 to December 2020 in Children’s Hospital of Shanxi. The demographic information, clinical diagnosis, drug usage and dosage, solvent,combined medication and the incidence of adverse reactions(ADR) were summarized and analyzed. Results The overall incidence of ADR was 8.92%(84/942);The incidence was higher in 10% glucose injection group(14.55%) and Children aged 1 and under(14.56%), and there was significant difference(P< 0.05). Conclusion The clinical application of ganciclovir for injection in children has exceeding indications, ADR mostly occur within one week after using medicin, and the degree is relatively light, which may be related to the Primary disease and combined medication. During clinical medication, attention should be paid to monitoring blood routine, liver and kidney function, so as to ensure the safety of medication for children.

关 键 词：更昔洛韦 儿童 安全用药 真实世界研究 

分 类 号：R985[医药卫生—药品]