Background

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.

Objective

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.

Methods

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.

Results

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.

Discussion

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.

中文翻译：

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安乃近在儿童中的使用：2015 年至 2020 年间德国大学医院的药物使用和药物不良反应分析

背景

由于其潜在的严重药物不良反应（ADRs），安乃近的使用引起了争议。然而，在德国，它仍然是一种流行的镇痛和解热药。

客观的

本研究的目的是通过分析 2015 年至 2020 年间一家儿科医院的住院患者处方模式并介绍安乃近相关的不良反应，讨论安乃近在儿童中的安全性。

方法

从电子病历中回顾性分析安乃近使用数据。通过医院的刺激报告系统前瞻性地记录 ADR 并进行相应的分析。分析纳入了 2015 年 6 月至 2020 年 5 月期间入住德国大学医院儿科和青少年医学科普通病房之一且在住院期间接受至少一种药物治疗的年龄 < 18 岁的患者。ADR 的因果关系根据世界卫生组织的因果关系评估进行评级。

结果

在 7809 名住院患者中，有 31.7% (3759/11,857) 使用了安乃近。安乃近暴露在青少年中最高（37.9%），在新生儿中最低（9.9%）。总体而言，大约 90% 的安乃近是通过肠胃外给药的。报告了 3 例粒细胞缺乏症、1 例过敏性休克和 1 例皮疹，这些病例可能与安乃近治疗有关。其中三起发生在住院之前。所有患者都康复了，没有留下任何伤害。

讨论

在德国，安乃近常用于儿科住院患者。严重的 ADR 会发生，但很少发生。例如，通过刺激报告系统对药物治疗进行持续监测可确保检测到严重的 ADR，并可以引入适当的干预措施。