Aagaard Lise, Hansen Ebba Holme
Faculty of Health Sciences, Institute of Public Health, University of Southern Denmark, J.B. Winsløws Vej 19, 5000, Odense C, Denmark,
Int J Clin Pharm. 2014 Dec;36(6):1222-9. doi: 10.1007/s11096-014-0020-0. Epub 2014 Oct 7.
Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children.
To characterize paediatric ADRs reported for asthma medications licensed for paediatric use.
Spontaneous ADR reports located in the European ADR database, EudraVigilance.
ADRs reported for asthma medications licensed for paediatric use from 2007 to 2011 were analysed. The included substances were beclometasone, budesonide, fenoterol, fluticasone, formoterol, mometasone, montelukast, salbutamol and terbutaline and the combinations of budesonide/formoterol, fenoterol/ipratropium and fluticasone/salmeterol.
Reported ADRs were categorized with respect to distribution on age, sex, type and seriousness of reported ADRs, medications and type of reporter. The unit of analysis was one ADR.
We located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85% of reported ADRs were serious including six fatal cases. In total, 57% of ADRs were reported for boys. One quarter of all ADRs occurred in children up to 1 year of age. Physicians reported the majority of ADRs. Across medicines, the majority of reported ADRs were of the type "psychiatric disorders" (13% of total ADRs), followed by "respiratory, thoracic and mediastinal disorders" (10% of total ADRs) and "skin and subcutaneous disorders" (9% of total ADRs). The largest number of ADRs was reported for budesonide (21% of total ADRs), followed by salbutamol (20% of total ADRs) and fluticasone (19% of total ADRs). For salbutamol, the largest numbers of serious ADRs were "tachycardia", "accidental exposure/incorrect dose administered" and "respiratory failure".
Only a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious including fatal cases.
关于儿童使用哮喘药物的安全问题信息有限。自发的药物不良反应（ADR）报告可提供有关儿童严重且罕见的ADR的信息。
描述已获儿科使用许可的哮喘药物报告的儿科ADR特征。
欧洲ADR数据库EudraVigilance中的自发ADR报告。
分析2007年至2011年期间已获儿科使用许可的哮喘药物报告的ADR。纳入的药物有倍氯米松、布地奈德、非诺特罗、氟替卡松、福莫特罗、莫米松、孟鲁司特、沙丁胺醇和特布他林，以及布地奈德/福莫特罗、非诺特罗/异丙托溴铵和氟替卡松/沙美特罗的组合。
报告的ADR按年龄、性别、报告的ADR类型和严重程度、药物及报告者类型进行分类。分析单位为一例ADR。
我们在EudraVigilance数据库中找到了326份自发报告，对应774例纳入的哮喘药物的ADR。报告的ADR中约85%为严重ADR，包括6例死亡病例。总体而言，57%的ADR是男孩报告的。所有ADR中有四分之一发生在1岁以下儿童中。大多数ADR由医生报告。在所有药物中，报告的ADR大多数为“精神障碍”类型（占ADR总数的13%），其次是“呼吸、胸及纵隔疾病”（占ADR总数的10%）和“皮肤及皮下组织疾病”（占ADR总数的9%）。报告ADR数量最多的是布地奈德（占ADR总数的21%），其次是沙丁胺醇（占ADR总数的20%）和氟替卡松（占ADR总数的19%）。对于沙丁胺醇，严重ADR数量最多的是“心动过速”“意外暴露/用药剂量错误”和“呼吸衰竭”。
在EudraVigilance ADR数据库中仅识别出少数儿童使用哮喘药物的ADR，但其中绝大多数为严重ADR，包括死亡病例。
