Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.
BMJ Open. 2017 Aug 21;7(8):e016273. doi: 10.1136/bmjopen-2017-016273.
Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups.
MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen.
Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings.
CRD42017055428.
头孢曲松在儿童脓毒症的治疗中被广泛应用。然而，人们对头孢曲松的安全性，特别是在婴幼儿中的安全性表示担忧。本综述的目的是系统地评估所有年龄段儿童使用头孢曲松的安全性。
将系统地检索 MEDLINE、PubMed、Cochrane 对照试验中心注册库、EMBASE、CINAHL、国际药学文摘和药物不良反应（ADR）监测系统，以寻找评估儿童使用头孢曲松安全性的随机对照试验（RCT）、队列研究、病例对照研究、横断面研究、病例系列和病例报告。将使用 Cochrane 偏倚风险工具、纽卡斯尔-渥太华量表和美国国立卫生研究院制定的质量评估工具进行质量评估。将对 RCT 和前瞻性研究中 ADR 发生率进行荟萃分析。将根据年龄和剂量方案进行亚组分析。
由于不收集原始数据，因此不需要正式的伦理批准。本系统评价将通过同行评审的出版物和会议会议进行传播。
PROSPERO 注册号：CRD42017055428。
