Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Tuscan Regional Centre of Pharmacovigilance, Florence, Italy.
Intern Emerg Med. 2021 Apr;16(3):697-710. doi: 10.1007/s11739-020-02586-8. Epub 2020 Dec 23.
Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug-drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients' demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.
由于 COVID-19 需要早期和紧急的有效治疗，在全球紧急情况下，可能对其安全性的关注度较低。此外，COVID-19 患者中药物-药物相互作用（DDI）相关不良反应（ADR）的特点尚未得到深入研究。本病例系列研究的目的是描述 COVID-19 住院患者的临床和药理学特征，重点是 ADR，特别是与 DDI 相关的 ADR。我们评估了 2020 年 1 月 1 日至 5 月 31 日期间佛罗伦萨 Careggi 大学医院 COVID-19 护理单元内收集的所有 COVID-19 药物相关 ADR 报告。收集了有关 COVID-19 药物、患者人口统计学和临床特征、伴随药物、ADR 描述和结果的信息。对每个病例进行因果关系评估，并确定是否存在 DDI。在研究期间，23 名白人患者（56.5%为男性，平均年龄 76.1 岁）经历了一种或多种 ADR。他们中的大多数人服用了多种药物，17.4%的人患有合并症。ADR 涉及心血管、精神和胃肠道疾病。报告最多的首选术语是 QT 延长（平均 QT 间期 496.1 ms）。60.8%的病例中 ADR 得到改善或完全解决。对于所有患者，逐一评估显示存在一种或多种 DDI，特别是与药代动力学相互作用相关的 DDI。尽管患者人数较少，但我们的证据强调了 DDI 在 SARS-CoV-2 住院患者中的临床负担，以及意外和不常见的精神 ADR 的风险。
