Renato de Filippis, John M Kane, Elena Arzenton, Ugo Moretti, Emanuel Raschi, Gianluca Trifirò, Corrado Barbui, Pasquale De Fazio, Chiara Gastaldon, Georgios Schoretsanitis
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引用次数: 0
摘要
导言：嗜酸性粒细胞增多和全身症状药物反应（DRESS）综合征越来越受到药物警戒的关注，但它与氯氮平以外的其他抗精神病药物的关系仍不清楚：我们基于世界卫生组织（WHO）的全球自发报告数据库 VigiBase® 进行了一项病例/非病例研究，并进行了比例失调分析。我们分析了与抗精神病药物有关的 DRESS 综合征的个案安全报告，并与以下几种药物进行了比较：(1) VigiBase® 中的所有其他药物；(2) 卡马西平（已知的阳性对照）；(3) 同类（典型/非典型）抗精神病药物。我们计算了报告几率比（ROR）和贝叶斯信息成分（IC），以及 95% 的置信区间（CI）。根据预先确定的标准，根据临床重要性对不相称报告进行了优先排序。此外，我们还比较了报告有严重/非严重反应的患者的特征：结果：共发现了 1534 份描述 19 种抗精神病药物 DRESS 综合征的报告。与所有其他药物相比，抗精神病药物的ROR为1.0（95% CI 0.9-1.1）。我们发现氯氮平（ROR 2.3，95% CI 2.1-2.5；IC 1.2，95% CI 1.1-1.3）、赛美嗪（ROR 2.3，95% CI 1.5-3.5；IC 1.2，95% CI 0.5-1.7）和氯丙嗪（ROR 1.5，95% CI 1.1-2.1；IC 0.6，95% CI 0.1-1.0）的报告比例过高。我们发现，35.7%的重症病例同时服用抗惊厥药物，25%的重症病例同时服用多种抗精神病药物，而非重症病例的这一比例仅为 8.6%（P = 0.03）。死亡病例为164例（10.7%）：结论：除了氯氮平的预期相关性外，氯丙嗪和环丙美嗪（具有相同的芳香杂环分子结构）的DRESS报告率也高于预期。更好地了解与抗精神病药相关的DRESS综合征应能提高临床医生的认识，从而更安全地开具抗精神病药处方。
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database.
Introduction: Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is gaining attention in pharmacovigilance, but its association with antipsychotics, other than clozapine, is still unclear.
Methods: We conducted a case/non-case study with disproportionality analysis based on the World Health Organization (WHO) global spontaneous reporting database, VigiBase®. We analyzed individual case safety reports of DRESS syndrome related to antipsychotics compared to (1) all other medications in VigiBase®, (2) carbamazepine (a known positive control), and (3) within classes (typical/atypical) of antipsychotics. We calculated reporting odds ratio (ROR) and Bayesian information component (IC), with 95% confidence intervals (CIs). Disproportionate reporting was prioritized based on clinical importance, according to predefined criteria. Additionally, we compared characteristics of patients reporting with serious/non-serious reactions.
Results: A total of 1534 reports describing DRESS syndrome for 19 antipsychotics were identified. The ROR for antipsychotics as a class as compared to all other medications was 1.0 (95% CI 0.9-1.1). We found disproportionate reporting for clozapine (ROR 2.3, 95% CI 2.1-2.5; IC 1.2, 95% CI 1.1-1.3), cyamemazine (ROR 2.3, 95% CI 1.5-3.5; IC 1.2, 95% CI 0.5-1.7), and chlorpromazine (ROR 1.5, 95% CI 1.1-2.1; IC 0.6, 95% CI 0.1-1.0). We found 35.7% of cases with co-reported anticonvulsants, and 25% with multiple concurrent antipsychotics in serious compared to 8.6% in non-serious cases (p = 0.03). Fatal cases were 164 (10.7%).
Conclusions: Apart from the expected association with clozapine, chlorpromazine and cyamemazine (sharing an aromatic heteropolycyclic molecular structure) emerged with a higher-than-expected reporting of DRESS. Better knowledge of the antipsychotic-related DRESS syndrome should increase clinicians' awareness leading to safer prescribing of antipsychotics.
期刊介绍：
Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes:
Overviews of contentious or emerging issues.
Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.
In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area.
Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics.
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