摘要
目的建立主动监测规则,挖掘西妥昔单抗所致过敏反应的病例,分析其临床特征及相关影响因素。方法应用中国医院药物警戒系统(CHPS),主动监测2021年1月1日至2024年12月31日在厦门大学附属第一医院使用西妥昔单抗治疗的住院患者,挖掘发生过敏反应的阳性病例,纳入研究对象的临床资料及实验室结果,包括性别、年龄、BMI、用药信息、基础疾病、手术状态、21项实验室指标等,应用倾向性评分匹配(PSM),为每例过敏反应病例匹配3例对照病例。运用χ^(2)检验和Mann-Whitney U检验对其进行单因素分析,对有意义的结果纳入多因素Logistic回归分析,确定西妥昔单抗致过敏反应的独立影响因素。结果监测模型预警病例599例次,经药师筛选后确定阳性病例24例,监测模型的阳性发现率为4.01%,过敏反应的发生率为3.55%。多因素Logistic回归结果显示,糖尿病史、血清钠、总胆红素、尿酸是西妥昔单抗致过敏反应的独立风险因素(P<0.05)。结论应用CHPS系统主动监测西妥昔单抗致过敏反应的规则具有一定可行性,用药前关注患者是否患有糖尿病,以及钠水平、尿酸水平和总胆红素水平,有助于预测西妥昔单抗致过敏反应的风险,提升临床用药安全性。
Objective To establish active monitoring rules for identifying cases of allergic reactions induced by cetuximab,and to analyze their clinical characteristics and associated influencing factors.Methods Using the China hospital pharmacovigilance system(CHPS)actively monitored inpatients treated with cetuximab at The First Affiliated Hospital of Xiamen University from January 1,2021,to December 31,2024,to identify positive cases of allergic reactions.Clinical data and laboratory results of the study subjects were collected,including gender,age,BMI,medication information,underlying diseases,surgical status,and 21 laboratory parameters.Propensity score matching(PSM)was applied to match each case with an allergic reaction to three control cases.Univariate analysis was performed using the χ^(2)test and the Mann-Whitney U test.Statistically significant variables were subsequently included in a multivariate logistic regression analysis to identify independent influencing factors for cetuximab-induced allergic reactions.Results The monitoring model generated alerts for 599 case instances,after pharmacist screening,24 positive cases were confirmed,yielding a positive detection rate of 4.01%for the monitoring model and an overall allergic reaction incidence of 3.55%.Multivariate logistic regression results indicated that history of diabetes,serum sodium levels,total bilirubin,and uric acid were independent risk factors for cetuximab-induced allergic reactions(P<0.05).Conclusion The application of the CHPS for actively monitoring cetuximab-induced allergic reactions demonstrates feasibility.Prior to medication administration,attention to history of diabetes,as well as sodium,uric acid,and total bilirubin levels,may help predict the risk of cetuximab-induced allergic reactions and enhance clinical medication safety.
作者
吴艺燕
王渊
刘宏尉
潘宏
WU Yiyan;WANG Yuan;LIU Hongwei;PAN Hong(The First Affiliated Hospital of Xiamen University,Xiamen Fujian 361000,China)
出处
《药品评价》
2025年第11期1383-1387,共5页
Drug Evaluation
关键词
不良反应
药物警戒
主动监测
药物评价
Adverse reactions
Pharmacovigilance
Active monitoring
Drug evaluation
