Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto, Rua Doutor Plácido da Costa, 4200-450 Porto, Portugal.
Eur J Clin Pharmacol. 2013 Mar;69(3):673-81. doi: 10.1007/s00228-012-1376-5. Epub 2012 Aug 23.
Anaphylaxis is a potentially fatal systemic adverse drug reaction (ADR). It is an unpredictable and mostly dose-independent event that occurs suddenly following exposure to the causative drug. Our objective was to characterize a case series of anaphylactic reactions reported to the Portuguese Pharmacovigilance authority during the past decade. Patients' demographic data and implicated drugs were analyzed as well as the severity of the ADR and time trends.
This study was a retrospective analysis of episodes of anaphylaxis, defined according to the Second Symposium on the Definition and Management of Anaphylaxis Criteria, reported to the Portuguese Pharmacovigilance System between 1 January 2000 and 1 November 2010
Amongst the 16,157 ADR reported to the Portuguese Pharmacovigilance System during the 10-year study period, we found 918 (6 %) cases of anaphylaxis that met the proposed criteria. The age of the patients varied from 7 days to 91 years, with 87 cases (9 %) of anaphylaxis involving patients under 18 years of age. There was an overall female predominance (67 %), but the majority of pediatric patients were male (56 %). There was a trend toward increased reporting as the decade progressed, and 31 % (284) of all anaphylaxis cases were reported during the last 2 years of the study period. Of the anaphylaxis episodes reported, 19 % led to hospitalization and 24 (3 %) had a fatal outcome. Antibiotics were responsible for most cases (17 %) followed by nonsteroidal anti-inflammatory drugs/acetaminophen (13 %), antineoplastic/cytotoxic drugs and immune-modulators. Vaccines and radiographic contrast media were also important contributors to an anaphylactic event.
In this series of drug-related anaphylaxis, we found that most of the reported episodes were associated with widely used drugs, such as antibiotics and analgesics. Anaphylaxis can occur at any age. The female gender was more highly represented, with the exception of pediatric patients.
过敏反应是一种潜在的致命的药物不良反应（ADR）。它是一种不可预测的、大多与剂量无关的事件，在接触致病药物后突然发生。我们的目的是描述过去十年中向葡萄牙药物警戒机构报告的过敏反应病例系列。分析了患者的人口统计学数据和涉及的药物，以及 ADR 的严重程度和时间趋势。
这是一项回顾性分析，根据第二次过敏反应定义和管理研讨会的标准，对 2000 年 1 月 1 日至 2010 年 11 月 1 日期间向葡萄牙药物警戒系统报告的过敏反应进行分析。
在 10 年研究期间向葡萄牙药物警戒系统报告的 16157 例 ADR 中，我们发现符合建议标准的过敏反应病例有 918 例（6%）。患者年龄从 7 天到 91 岁不等，其中 87 例（9%）过敏反应涉及 18 岁以下患者。总体上女性占优势（67%），但大多数儿科患者为男性（56%）。随着十年的进展，报告呈上升趋势，31%（284 例）的所有过敏反应病例发生在研究的最后两年。报告的过敏反应发作中有 19%导致住院，24 例（3%）有致命后果。抗生素是最常见的原因（17%），其次是非甾体抗炎药/对乙酰氨基酚（13%）、抗肿瘤/细胞毒性药物和免疫调节剂。疫苗和造影剂也是过敏反应的重要原因。
在本系列药物相关性过敏反应中，我们发现大多数报告的病例与广泛使用的药物有关，如抗生素和镇痛药。过敏反应可发生于任何年龄。女性比例较高，儿科患者除外。
