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.
Arch Dis Child. 2020 Oct;105(10):981-985. doi: 10.1136/archdischild-2019-317950. Epub 2020 Mar 6.
To determine the safety of ceftriaxone in paediatric patients and systematically evaluate the categories and incidences of adverse drug reactions (ADRs) of ceftriaxone in paediatric patients.
We performed a systematic search in Medline, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and bibliographies of relevant articles up to December 2018 for all types of studies that assessed the safety of ceftriaxone in paediatric patients aged ≤18 years.
112 studies met the inclusion criteria involving 5717 paediatric patients who received ceftriaxone and reported 1136 ADRs. The most frequent ADRs reported in prospective studies were gastrointestinal (GI) disorders (37.4 %, 292/780), followed by hepatobiliary disorders (24.6%, 192/780). Serious ADRs leading to withdrawal or discontinuation of ceftriaxone were reported in 86 paediatric patients. Immune haemolytic anaemia (34.9%, 30/86) and biliary pseudolithiasis (26.7%, 23/86) were the two major causes. Haemolytic anaemia following intravenous ceftriaxone led to death in 11 children whose primary disease was sickle cell disease. Almost all biliary pseudolithiasis are reversible. However, the incidence was high affecting one in five paediatric patients (20.7%).
GI ADRs are the most common toxicity of ceftriaxone in paediatric patients. Immune haemolytic anaemia and biliary pseudolithiasis are the most serious ADRs and the major reasons for discontinuation of ceftriaxone. Immune haemolytic anaemia is more likely in children with sickle cell disease and may cause death. Ceftriaxone should be used with caution in children with sickle cell disease.
CRD42017055428.
确定头孢曲松在儿科患者中的安全性，并系统评估头孢曲松在儿科患者中的不良反应（ADR）类别和发生率。
我们对 Medline、PubMed、Cochrane 对照试验中心注册库、EMBASE、CINAHL、国际药学文摘和相关文章的参考文献进行了系统检索，以获取所有类型的研究，这些研究评估了≤18 岁儿科患者使用头孢曲松的安全性。
112 项研究符合纳入标准，涉及 5717 名接受头孢曲松治疗并报告 1136 例 ADR 的儿科患者。前瞻性研究中报告的最常见 ADR 是胃肠道（GI）疾病（37.4%，292/780），其次是肝胆疾病（24.6%，192/780）。86 名儿科患者报告了导致头孢曲松停药或中断的严重 ADR。免疫溶血性贫血（34.9%，30/86）和胆石假结石形成（26.7%，23/86）是两个主要原因。静脉注射头孢曲松后引起的溶血性贫血导致 11 名镰状细胞病患儿死亡。几乎所有的胆石假结石都是可逆的。然而，其发生率很高，影响五分之一的儿科患者（20.7%）。
GI ADR 是头孢曲松在儿科患者中最常见的毒性。免疫溶血性贫血和胆石假结石形成是最严重的 ADR，也是头孢曲松停药的主要原因。免疫溶血性贫血在镰状细胞病患儿中更常见，可能导致死亡。头孢曲松在镰状细胞病患儿中应谨慎使用。
CRD42017055428。
