β-内酰胺类抗菌药物不良反应监测及风险预测模型的建立  

Adverse Drug Reaction Monitoring and Construction of Risk Prediction Model ofβ-Lactam Antibiotics

作　　者：蒋俊杰 王法财 沈炳香 聂松柳 段自皞 朱枝祥[2] Jiang Junjie;Wang Facai;Shen Bingxiang;Nie Songliu;Duan Zihao;Zhu Zhixiang(Lu’an Hospital Affiliated to Anhui Medical University,Anhui Lu’an 237005,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]安徽医科大学附属六安医院,安徽六安237005 [2]北京中医药大学,北京100029

出　　处：《儿科药学杂志》2023年第11期12-16,共5页Journal of Pediatric Pharmacy

摘　　要：目的:通过监测安徽医科大学附属六安医院患儿使用β-内酰胺类抗菌药物所致药物不良反应(ADR),分析ADR发生情况及影响因素,并建立其风险预测模型。方法:选取2018年5月至2022年2月安徽医科大学附属六安医院儿科使用β-内酰胺类抗菌药物的患儿作为ADR监测对象,统计分析ADR患儿临床资料。按使用β-内酰胺类抗菌药物是否发生ADR,分为ADR组和无ADR(nADR)组,并采用Logistic回归分析筛选其独立危险因素,建立列线图预测模型。结果:共监测使用β-内酰胺类抗菌药物的患儿453例,87例发生ADR(ADR组),366例未发生ADR(nADR组)。单因素和Logistic回归多因素分析显示,过敏史、给药频次不合理、高剂量、用药时间≥3 d、联合用药为β-内酰胺类抗菌药物所致ADR的独立危险因素(P<0.05)。据此建立预测β-内酰胺类抗菌药物所致ADR的列线图模型,一致性指数高达0.749(95%CI 0.691~0.807),校正曲线趋近于理想曲线(16%~81%),列线图预测β-内酰胺类抗菌药物引发患儿ADR风险净获益值较高,表明该模型临床预测效用良好。结论:β-内酰胺类抗菌药物所致ADR的危险因素包括过敏史、给药频次不合理、高剂量、用药时间≥3 d、联合用药,据此构建的列线图模型能有效预测β-内酰胺类抗菌药物致ADR的风险概率,具有一定临床价值。Objective:To analyze the occurrence and influencing factors of adverse drug reactions(ADR)induced by β-lactam antibiotics and establish the risk prediction model by monitoring ADR induced by β-lactam antibiotics in children from Lu’an Hospital Affiliated to Anhui Medical University.Methods:Children who received β-lactam antibiotics in Lu’an Hospital Affiliated to Anhui Medical University from May 2018 to Feb.2022 were extracted as subjects for ADR monitoring.Clinical data of children with ADR were collected and analyzed.Based on the occurrence of ADR,children were divided into the ADR group and non-ADR(nADR)group.Logistic regression analysis was used to identify independent risk factors and construct the nomogram prediction model.Results:A total of 453 children receiving β-lactam antibiotics were monitored,with 87 cases of ADR(ADR group),and 366 cases without ADR(nADR group).Univariate and multivariate Logistic regression analysis showed that history of allergy,inappropriate administration frequency,high dose,medication duration⩾3 d and drug combination were independent risk factors for ADR induced by β-lactam antibiotics(P<0.05).Based on these findings,nomogram model for predicting ADR induced byβ-lactam antibiotics was constructed,with C-index of 0.749(95%CI from 0.691 to 0.807).Correction curve was close to the ideal curve(from 16% to 81%),and the net risk benefit value of ADR induced by β-lactam antibiotics predicted by the column graph was high,indicating that the model was good in clinical prediction.Conclusion:Risk factors of ADR induced by β-lactam antibiotics include history of allergy,inappropriate administration frequency,high dose,medication duration⩾3 d and drug combination,and the constructed nomogram model can effectively predict the risk probability of ADR induced by β-lactam antibiotics,which is of some clinical value.

关 键 词：Β-内酰胺类抗菌药物 药物不良反应 危险因素 列线图 模型预测 

分 类 号：R969.3[医药卫生—药理学]