Department of Paediatrics and Adolescent Medicine, Faculty of Medicine, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), 91054, Erlangen, Germany.
Chair of Medical Informatics, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), 91058, Erlangen, Germany.
Paediatr Drugs. 2022 Jan;24(1):45-56. doi: 10.1007/s40272-021-00481-z. Epub 2021 Dec 8.
Metamizole use is controversially discussed due to its potentially serious adverse drug reactions (ADRs). In Germany, however, it remains a popular analgesic and antipyretic drug.
The aim of this study was to discuss the safety profile of metamizole in children by analysing the inpatient prescription patterns and presenting the metamizole-related ADRs at a paediatric hospital between 2015 and 2020.
Metamizole utilisation data were retrospectively analysed from electronic medical records. ADRs were prospectively recorded via the hospital's stimulated reporting system and analysed accordingly. Patients aged < 18 years admitted to one of the general wards of the department of paediatrics and adolescent medicine of a German university hospital between June 2015 and May 2020 who received at least one drug therapy within their inpatient stay were included in the analysis. Causality of ADRs was rated according to the World Health Organisation causality assessment.
In 31.7% (3759/11,857) of the inpatient stays of 7809 patients, metamizole was administered. Metamizole exposure was highest in adolescents (37.9%) and lowest in newborns (9.9%). Overall, metamizole was administered parenterally in about 90%. Three cases of agranulocytosis, one allergic shock and one rash with possible or higher causality to metamizole treatment were reported. Three of these occurred prior to hospitalisation. All patients recovered without remaining harm.
Metamizole is commonly used in paediatric inpatients in Germany. Serious ADRs occur but rarely. Continuous monitoring of drug therapy through, for example, stimulated reporting systems ensures that serious ADRs are detected, and appropriate interventions can be introduced.
由于潜在的严重药物不良反应（ADR），扑热息痛的使用存在争议。然而，在德国，它仍然是一种流行的镇痛药和退烧药。
本研究旨在通过分析 2015 年至 2020 年期间一家儿科医院的住院处方模式并报告扑热息痛相关 ADR，讨论儿童使用扑热息痛的安全性概况。
回顾性地从电子病历中分析扑热息痛的使用数据。通过医院的刺激报告系统前瞻性地记录 ADR，并进行相应分析。纳入分析的患者为 2015 年 6 月至 2020 年 5 月期间在德国一家大学医院儿科和青少年医学系普通病房住院且住院期间至少接受一种药物治疗的年龄<18 岁的患者。根据世界卫生组织因果关系评估标准对 ADR 的因果关系进行评估。
在 7809 例患者的 31.7%（3759/11857）住院期间使用了扑热息痛。青少年（37.9%）的扑热息痛暴露率最高，新生儿（9.9%）最低。总体而言，约 90%的患者接受了注射用扑热息痛。报告了三例粒细胞缺乏症、一例过敏性休克和一例可能或更高因果关系的皮疹。其中三例发生在住院前。所有患者均康复，无遗留伤害。
扑热息痛在德国儿科住院患者中广泛使用。严重 ADR 虽罕见但确实发生。通过刺激报告系统等方式对药物治疗进行持续监测，可确保发现严重 ADR，并采取适当的干预措施。
