基于真实世界分析哌拉西林钠/他唑巴坦钠在儿童的用药安全性

Midication Safety of Piperacillin/Tazobactam in Children Based on Real-World Data

目的:基于真实世界数据探讨儿童患者使用哌拉西林钠/他唑巴坦钠致药物不良反应(ADR)的发生率、临床表现及影响因素,为临床安全用药提供参考。方法:收集儿童使用哌拉西林钠/他唑巴坦钠的病例资料,以发生ADR的患者为病例组,描述性分析ADR发生率、临床表现及转归,以性别和感染部位1∶1在未发生ADR的患者中匹配对照组,采用单因素和多因素Logistic回归分析发生ADR危险因素。结果:纳入5212例患儿,247例患儿发生271例次ADR,ADR发生率为4.74%。年龄<3岁、有基础疾病、联用万古霉素、联用中药注射剂、用药种类数>3种的患儿和哌拉西林钠/他唑巴坦钠用药≤72 h的ADR发生率较高。ADR主要涉及9个器官(组织)损害,以皮肤及其附件损害、胃肠道损害和泌尿系统损害常见,分别占21.40%、18.08%和13.65%,主要表现为局部皮疹、恶心呕吐和血清肌酐水平升高。多因素Logistic回归显示,年龄<3岁(OR=2.118)、联用万古霉素(OR=3.642)和用药种类数>3种(OR=2.516)是发生ADR的独立危险因素(P<0.05)。结论:儿童使用哌拉西林钠/他唑巴坦钠致不良反应发生率为4.74%,年龄<3岁、联用万古霉素和用药种类数>3种的患儿应警惕ADR发生。

Objective:To probe into the incidence,clinical manifestations and influencing factors of adverse drug reactions(ADR)induced by piperacillin/tazobactam in children based on real-world data,so as to provide reference for clinical medication safety.Methods:Clinical data of children with piperacillin/tazobactam were collected.Patients with ADR were extracted as the case group,and the incidence,clinical manifestations and outcomes of ADR were analyzed descriptively.The control group were matched 1∶1 for gender and site of infection in patients who did not develop ADR.Risk factors of ADR were analyzed by univariate and multivariate Logistic regression.Results:A total of 5,212 patients were enrolled.There were 271 cases of ADR in 247 patients,with an incidence of 4.74%.The incidence of ADR was higher in patients with age<3 years,underlying diseases,combined use of vancomycin,combined use of traditional Chinese medicine injections,more than 3 kinds of drugs and the duration of piperacillin/tazobactam for⩽72 h.ADR mainly involved 9 organs(tissues),including skin and its appendages,gastrointestinal tract and urinary system,respectively accounting for 21.40%,18.08%and 13.65%.The main manifestations were local rash,nausea and vomiting,and increased serum creatinine level.Multivariate Logistic regression showed that age<3 years(OR=2.118),combined use of vancomycin(OR=3.642)and more than 3 kinds of drugs(OR=2.516)were independent risk factors for ADR(P<0.05).Conclusion:The incidence of ADR induced by piperacillin/tazobactam in children was 4.74%,children<3 years,with combined use of vancomycin and more than 3 kinds of drugs should be alert to ADR.