Allergy and Clinical Immunology Service, University Hospital Center of Porto , Porto, Portugal.
Porto Pharmacovigilance Centre, Faculty of Medicine of University of Porto , Porto, Portugal.
Expert Opin Drug Saf. 2020 Jul;19(7):915-922. doi: 10.1080/14740338.2020.1771305. Epub 2020 Jun 22.
Adverse drug reactions (ADR) cause significant morbidity, mortality and health costs and have an important prevalence in all ages. Few studies focus on ADR in adolescents. The goal of this study was to characterize a case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) of the National Authority of Medicines and Health Products (INFARMED, I.P.) during an eleven-year period (from 2006 to 2016) concerning this specific population.
Retrospective analysis of reports concerning patients from 10 to 18 years received by the PPS between 2006 and 2016. The authors evaluated patients' demographics (age and sex). The characteristics and seriousness of the reactions, the type of reaction reported, and the drugs involved were assessed.
The authors found 782 reports (59% females). Most reports came from physicians (61%). Overall 80% of the reports described serious ADR. A greater proportion of serious events was found among males. Most reactions referred to general disorders and administration site conditions (38%), followed by skin and subcutaneous tissue reactions (33%). In 3 and 4 were gastrointestinal disorders (24%) and the nervous system disorders (23%), the former more frequent among females. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (19%).
Major findings considering drugs involved and the reported reactions varied according to age and sex.
药物不良反应（ADR）可导致重大发病率、死亡率和卫生保健费用，在各年龄段均有较高的发生率。很少有研究关注青少年的 ADR。本研究旨在描述 2006 年至 2016 年期间葡萄牙药品监管机构（INFARMED，I.P.）药品监测系统（PPS）报告的这一特定人群的 ADR 病例系列。
对 2006 年至 2016 年期间 PPS 收到的年龄在 10 至 18 岁之间的患者报告进行回顾性分析。作者评估了患者的人口统计学特征（年龄和性别）。评估了反应的特征和严重程度、报告的反应类型以及涉及的药物。
作者发现了 782 份报告（59%为女性）。大多数报告来自医生（61%）。总体而言，80%的报告描述了严重的 ADR。男性中严重事件的比例更高。大多数反应涉及一般疾病和给药部位情况（38%），其次是皮肤和皮下组织反应（33%）。胃肠道疾病（24%）和神经系统疾病（23%）分别排在第 3 和第 4 位，前者在女性中更为常见。疫苗是最具代表性的药物（42%），其次是全身用抗菌药物（19%）。
根据年龄和性别，所涉及的药物和报告的反应的主要发现有所不同。
