炎琥宁注射剂致儿童严重过敏反应的影响因素分析  

Influencing factors of severe anaphylactic reactions of Yanhuning injections in children

作　　者：张静宇[1] 张媛媛 王晶[1] 马博 李文娟[1] ZHANG Jingyu;ZHANG Yuanyuan;WANG Jing;MA Bo;LI Wenjuan(Department of Pharmacy,Hengshui Second People’s Hospital,Hengshui Hebei 053000,China;Department of Pharmacy,Hengshui People’s Hospital,Hengshui Hebei 053000,China)

机构地区：[1]衡水市第二人民医院药学部,河北衡水053000 [2]衡水市人民医院药学部,河北衡水053000

出　　处：《中国药物警戒》2022年第9期1019-1022,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨炎琥宁注射剂致儿童发生严重过敏反应的影响因素,为临床合理用药提供参考。方法采用回顾性研究,收集2017年10月1日至2020年10月31日2家医院使用炎琥宁注射剂的7320例儿童患者的病历资料,根据严重过敏反应(SA)诊断标准筛选出SA者和非SA者,将SA者纳入SA组(n=57),采用倾向评分匹配从非SA者中按1∶4比例匹配对照组(n=228)。比较2组患儿的一般情况、原患疾病、炎琥宁用药情况,采用单因素和多因素Logistic回归分析炎琥宁注射剂致SA的影响因素。结果炎琥宁注射剂致儿童相关SA发生率为0.78%(57/7320)。单因素方差分析显示,患儿肌酐清除率、联合用药数目、给药剂量、输液浓度和预处理与SA发生有关,差异有统计学意义(P<0.05)。进一步Logistic回归分析显示,肌酐清除率<30 mL·min^(-1)(OR=2.336,95%CI:1.227~4.362,P=0.009)、联合用药数目≥3种(OR=2.147,95%CI:1.189~3.878,P=0.015)、超剂量用药(OR=3.708,95%CI:1.942~7.014,P=0.000)是炎琥宁注射剂引起SA的独立危险因素,而预处理(OR=0.473,95%CI:0.248~0.887,P=0.043)是保护因素。结论肾功能不全、超剂量和高浓度用药、联合用药可增加炎琥宁注射剂致儿童相关SA发生风险,输液前后冲管可减少SA发生。Objective To investigate the influencing factors of severe anaphylactic reactions(SAR)of Yanhuning injections in children,and to provide reference for clinical rational drug use.Methods A retrospective study was performed.The medical records of 7320 children who had received Yanhuning injections in two hospitals from October 1,2017 to October 31,2020 were collected.SAR patients and non-SAR patients were selected by the diagnostic criteria of SAR.The SAR patients were included into the SAR group(n=57).Propensity score matching was used to match the control group from non-SAR patients at a ratio of 1:4(n=228).The general data,primary diseases,drug combinations,and usage of Yanhuning injections were compared between the two groups.Univariate analysis and multivariate logistic analysis were used to analyze the factors that affected SARs of Yanhuning injections.Results The incidence of SAR in children who had used Yanhuning injections in our hospital was 0.78%(57/7320).Univariate analysis showed that there was statistically significant difference between the two groups in the incidence of renal insufficiency,number of combined drugs,rate of overdose,infusion concentrations and ways of pretreatment.More logistic regression analysis showed that a creatinine clearance rate less than 30 mL/min(OR=2.336,95%CI:1.227 to 4.362,P=0.009),more than 3 types of combined drugs(OR=2.147,95%CI:1.189 to 3.878,P=0.015),and overdose(OR=3.708,95%CI:1.942 to 7.014,P=0.000)were independent risk factors for SARs induced by Yanhuning injections in children,while pretreatment(OR=0.473,95%CI:0.248 to 0.887,P=0.043)was a protective factor.Conclusion Renal dysfunction,overdose of drugs,and drug combinations can increase the risk of SAR in children using Yanhuning injections,while tube flushing before and after infusion can reduce the incidence of SAR.

关 键 词：炎琥宁注射液 儿童 严重过敏反应 危险因素 

分 类 号：R994.1[医药卫生—毒理学]