加纳儿童的药物不良反应：对VigiBase中2000年至2012年报告的综述。
Adverse drug reactions in Ghanaian children: review of reports from 2000 to 2012 in VigiBase.
作者信息
Cliff-Eribo Kennedy Obebi, Choonara Imti, Dodoo Alex, Darko Delese M, Sammons Helen
机构信息
a 1 The University of Nottingham, Derbyshire Children's Hospital, Academic Division of Child Health , Derby, UK
b 2 University of Ghana, School of Medicine and Dentistry, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance , Accra, Ghana.
出版信息
Expert Opin Drug Saf. 2015;14(12):1827-33. doi: 10.1517/14740338.2015.1096927. Epub 2015 Oct 5.
OBJECTIVE
The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana.
METHODS
Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs.
RESULTS
A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases.
CONCLUSIONS
Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports.
目的
本文旨在描述加纳0至17岁儿童报告的药物不良反应（ADR）。
方法
提取加纳国家药物警戒中心截至2012年12月提交给世界卫生组织（WHO）全球药物不良反应数据库VigiBase的儿科报告。对每年的报告数量、报告者类型以及疑似药物不良反应和药物进行分析。
结果
在此期间共收到343份儿童报告。报告频率最高的药物类别是疫苗（115份，占31%）、抗疟药（106份，占28%）和抗生素（57份，占15%）。在前20种单一药物中，19种是抗感染药物。报告频率最高的药物不良反应是注射部位感染、发热和皮疹。报告有23例死亡，其中12例与抗疟药有关。
结论
疫苗、抗疟药和抗生素是据报告在加纳儿童中引起药物不良反应的主要药物。死亡率较高，许多死亡原因在个案安全报告中有解释。
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