Pharmacy Department, St James's Hospital, Dublin, Ireland.
Department of Genitourinary Medicine and Infectious Disease (GUIDe), Hospital 5 St James's Hospital, Dublin, Ireland.
Br J Clin Pharmacol. 2021 Mar;87(3):1150-1154. doi: 10.1111/bcp.14482. Epub 2020 Aug 2.
To assess clinical outcomes and adverse drug events in patients hospitalised with COVID-19 treated with off-label hydroxychloroquine (HCQ) and azithromycin (Az).
We performed a retrospective analysis of hospitalised patients who had a positive polymerase chain reaction test for SARS-CoV-2 and received HCQ plus Az or no targeted therapy. The primary end point was clinical improvement on day 7 defined as either hospital discharge or an improvement of 2 points on a 6-category ordinal scale. Secondary outcomes included mortality at day 28, intensive care admission, requirement for mechanical ventilation and incidence of adverse events.
Data from a total of 134 patients were evaluated; 82 patients received HCQ/Az and 52 patients received no targeted therapy. Clinical improvement was seen in 26.8% of patients who received HCQ/Az but this was not significant. The rates of intensive care transfer and mechanical ventilation were higher in the treatment group, but these differences were not significant. Mortality at day 28 was significantly higher in the treatment group (P = .03). Hypoglycaemia elevated liver function tests and QT prolongation were monitored in both groups. The risk of QT prolongation was significantly higher in the treatment group. Treatment was stopped early in 6 (7.3%) patients due to adverse events.
Although patients who received HCQ/Az were more severely ill the administration of these repurposed drugs did not result in clinical improvement and was associated with a significant increase in toxicity. This descriptive study highlights the importance of monitoring all repurposed agents for adverse events.
评估因 COVID-19 住院并接受未上市的羟氯喹（HCQ）和阿奇霉素（Az）治疗的患者的临床结果和药物不良反应事件。
我们对接受过 SARS-CoV-2 聚合酶链反应检测呈阳性并接受 HCQ+Az 或无靶向治疗的住院患者进行了回顾性分析。主要终点是第 7 天的临床改善，定义为出院或 6 级分类量表上的 2 分改善。次要结局包括第 28 天的死亡率、入住重症监护病房、需要机械通气以及不良事件的发生率。
共评估了 134 例患者的数据；82 例患者接受了 HCQ/Az 治疗，52 例患者未接受靶向治疗。接受 HCQ/Az 治疗的患者中有 26.8%出现临床改善，但无显著差异。治疗组的重症监护病房转移和机械通气率较高，但这些差异无统计学意义。治疗组第 28 天的死亡率显著较高（P=0.03）。两组均监测低血糖、肝功能检查异常和 QT 延长。治疗组 QT 延长的风险显著较高。由于不良反应，有 6 例（7.3%）患者提前停止治疗。
尽管接受 HCQ/Az 治疗的患者病情更严重，但这些药物的使用并未带来临床改善，反而导致毒性显著增加。这项描述性研究强调了监测所有重新定位药物不良事件的重要性。
