一项评估接受瑞德西韦或羟氯喹治疗的COVID-19患者药物不良反应的前瞻性观察性研究：初步报告。
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.
作者信息
Falcão Fátima, Viegas Erica, Carmo Ines, Soares Joana, Falcao Margarida, Solano Mariana, Cavaco Patricia, Mendes Dina, Rijo João, Povoa Pedro, Pais Martins Antonio, Carmo Eduarda, Mansinho Kamal, Fonseca Candida, Campos Luis, Carvalho António, Mirco Ana, Farinha Helena, Aldir Isabel, Correia José
机构信息
Pharmacy, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal.
出版信息
Eur J Hosp Pharm. 2021 Sep;28(5):248-253. doi: 10.1136/ejhpharm-2020-002613. Epub 2021 Jan 15.
OBJECTIVES
Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM.
METHODS
An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts.
RESULTS
The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible.
CONCLUSIONS
Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.
目的
自严重急性呼吸综合征冠状病毒2（SARS-CoV-2）爆发以来，为尽量减少其对公众健康的影响，人们实施了不同的治疗策略，而这些策略在当时对2019冠状病毒病（COVID-19）的治疗效果尚不清楚。瑞德西韦（REM）于2020年6月在欧盟获得首个有条件上市许可。自那时起，欧洲药品管理局（EMA）和欧盟各地的地方卫生当局强烈建议开展药物警戒活动，以进一步评估这种新药的安全性。本研究的目的是评估葡萄牙里斯本西部中心医院收治的COVID-19患者中归因于REM或羟氯喹（HCQ）的药物不良反应（ADR）。我们呈现了报告HCQ或REM可能的不良反应的初步结果。
方法
于2020年3月16日至8月15日进行了一项观察性队列研究。参与者被分为两个队列：接受HCQ治疗方案的患者和接受REM治疗方案的患者。使用主动监测模型识别疑似ADR，并通过其在线通知工具报告给葡萄牙药物警戒系统。比较两个队列之间的ADR累积发生率。
结果
该研究纳入了149名患者，其中101名接受HCQ治疗，其余48名接受REM治疗。两个队列的基线特征相似。在研究期间共识别出102例ADR，HCQ队列中的发生率高于REM队列（47.5%对12.5%；p<0.001）。对81例ADR进行了因果关系评估，所有这些ADR均被认为是可能的。
结论
真实世界数据对于进一步确定REM的安全性至关重要。不再推荐使用HCQ治疗COVID-19。
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