万古霉素儿童临床应用安全性评价

Safety Evaluation of Clinical Application of Vancomycin in Children

目的为儿童临床安全使用万古霉素提供参考。方法采用计算机检索中国期刊全文数据库、维普期刊全文数据库、万方数据库、中国生物医学文献服务系统,以及PubMed,Springer,Wiley等数据库,儿童使用万古霉素导致药品不良反应(ADR)的相关文献,检索时限为建库起至2021年5月28日,分析ADR发生特点及严重ADR发生的危险因素。结果共纳入文献109篇,涉及患儿157例,关联性评价结果为,肯定10例、很可能132例、可能15例。ADR发生183例次,累及系统/器官以皮肤及皮下组织,肾脏及泌尿系统为主,多发生在用药后10 d(含)内(115例次,73.25%);联合用药63例次,主要联用药类别为氨基苷类(27例次,42.86%)和其他β-内酰胺类抗菌药物(16例次,25.40%),品种以庆大霉素(16例次,25.40%)、哌拉西林他唑巴坦(11例次,17.46%)等肾功能损害药物为主;药物过敏史[OR=6.893,95%CI(1.395,34.059),P=0.018]和联合用药[OR=2.447,95%CI(1.072,5.586),P=0.034]是其发生严重ADR的独立危险因素。共发生万古霉素新的ADR 29例次,其中新的一般ADR 15例次,新的严重ADR 14例次。结论儿童使用万古霉素前应询问其药物过敏史,慎重联用肾功能损害药物,应监测血药浓度和肾功能,以防止相应ADR发生。

Objective To provide a reference for clinical safety use of vancomycin in children.Methods The literature related to vancomycin-induced adverse drug reaction(ADR)in children in databases such as CNKI,VIP,WanFang,CBM,PubMed,Springer and Wiley were electronically searched from the inception to May 28th,2021.The characteristics of ADR occurrence and the risk factors of severe ADR were analyzed.Results A total of 109 studies were included,involving 157 children.The correlation evaluation results were positive in 10 cases,likely in 132 cases and possible in 15 cases.ADR occurred 183 times,the main systems/organs involved in ADR were skin and subcutaneous tissue,kidney and urinary system,which mostly occurred within 10 d(including)after treatment(115 cases,73.25%).ADR occurred 63 times in combined medication,and the main types of combination drugs were aminoglycosides(27 cases,42.86%)and othersβ-lactam antibiotics(16 cases,25.40%),the varieties of combination drugs were gentamicin(16 cases,25.40%),piperacillin-tazobactam(11 cases,17.46%).Drug allergy history[OR=6.893,95%CI(1.395,34.059),P=0.018]and combined medication[OR=2.447,95%CI(1.072,5.586),P=0.034]were independent risk factors for severe ADR.There were 29 cases of vancomycin-induced new ADR,including 15 cases of new general ADR and 14 cases of new severe ADR.Conclusion Children should be asked about their drug allergy history before using vancomycin,and vancomycin should be carefully combined with drugs that induce renal function impairment,and the blood drug concentration and renal function should be monitored to prevent the occurrence of corresponding ADR.