重症感染患儿左氧氟沙星注射液超说明书使用的原因分析  

Analysis of Reasons for Off-label Use of Levofloxacin Injection in Children with Severe Infection

作　　者：陶兴茹 赵娟娟 裴保方 段彦彦[1] 刘晓玲 TAO Xing-ru;ZHAO Juan-juan;PEI Bao-fang;DUAN Yan-yan;LIU Xiao-ling(Children's Hospital Affiliated to Zhengzhou University,Zhengzhou 450000,China;Kaifeng Children's Hospital,Kaifeng He'nan 450000,China)

机构地区：[1]郑州大学附属儿童医院,郑州450000 [2]开封市儿童医院,河南开封475000

出　　处：《抗感染药学》2021年第10期1440-1444,共5页Anti-infection Pharmacy

基　　金：河南省医学科技攻关计划(联合共建项目)(编号:LHGJ20190974)。

摘　　要：目的:分析左氧氟沙星在儿童患者重症感染中超说明书(小于18岁儿童禁用)用药的原因。方法:采用回顾性分析方法,抽取郑州大学附属儿童医院2019年1月—12月收治的重症感染使用左氧氟沙星注射液治疗的儿童患者38例病历资料,分析其超说明书用药的原因以及有效性、安全性。结果:38例重症感染患儿中,其中肺炎支原体感染患儿16例,给予大环内酯类药物疗效不佳或耐药基因为阳性,其余22例为细菌感染初始治疗方案疗效不佳,总治疗有效率仅为81.58%;用药期间未出现与左氧氟沙星相关的不良反应症状。结论:左氧氟沙星注射液用于治疗儿童重症感染时疗效较好,短期使用相对安全,但属于超说明书用药,临床应权衡利弊,应做好患者的知情同意与药学监护。Objective: To analyze the reasons, efficacy and safety of off-label use of levofloxacin in children with severe infection(children under 18 years of age were not allowed). Methods: By retrospective analysis, medical records of 38 pediatric patients with severe infection treated with levofloxacin injection from January to December 2019 were selected to analyze the reasons, efficacy and safety of off-label medication. Results: In 38 children with severe infection, 16 children with Mycoplasma pneumoniae infection had poor efficacy of macrolides or positive drug resistance gene, and the other 22 children had poor efficacy of the initial treatment regimen for bacterial infection, and the total effective rate was only 81.58%. There were no adverse drug reactions symptoms related to levofloxacin during administration. Conclusions: Levofloxacin injection has good efficacy in the treatment of severe infection in children, and is relatively safe for short-term use, but it belongs to off-label drug use. The advantages and disadvantages should be weighed clinically, and informed consent and pharmaceutical care of patients should be well done.

关 键 词：儿童 左氧氟沙星 重症感染 超说明书用药 药学监护 

分 类 号：R969.3[医药卫生—药理学]