Department of Pharmacoepidemiology, Camaguey Children's Hospital, Camagüey Province, Cuba.
Arch Dis Child. 2010 Jun;95(6):474-7. doi: 10.1136/adc.2009.180786.
To determine the incidence of adverse drug reactions (ADRs) in children in Camagüey Province, Cuba.
A national pharmacovigilance programme has been established in Cuba and involves suspected ADRs being reported to provinces. All suspected ADRs reported to Camagüey Province during 2008 were analysed and classified in relation to causality and severity.
Over a 12-month period, there were 124 reports of 152 suspected ADRs in children. Most ADRs were mild (98, 79%), but two were fatal and five others were severe. Antibiotics were the group of medicines most likely to be associated with ADRs. The overall report rate of suspected ADRs was 634 per million children per year, which is considerably higher than previously reported rates.
ADRs in children are more frequent than previously reported. A successful pharmacovigilance programme can be established in lower middle income countries.
确定古巴卡马圭省儿童中药物不良反应（ADR）的发生率。
古巴建立了国家药物警戒计划，涉及向各省报告疑似 ADR。对 2008 年卡马圭省报告的所有疑似 ADR 进行了分析，并根据因果关系和严重程度进行了分类。
在 12 个月期间，有 124 份报告涉及 152 例儿童疑似 ADR。大多数 ADR 为轻度（98，79%），但有 2 例致命，5 例严重。抗生素是最有可能与 ADR 相关的药物类别。疑似 ADR 的总报告率为每百万儿童每年 634 例，明显高于之前报告的比率。
儿童中的 ADR 比之前报告的更频繁。中低收入国家可以成功建立药物警戒计划。
