Department of Internal Medicine, Henri-Mondor Hospital, Assistance Publique-Hôpitaux de Paris, Paris-Est Créteil University, 51 avenue du Maréchal de Lattre de Tassigny, 94000 Créteil, France
Centre for Clinical Epidemiology, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Centre of Research in Epidemiology and Statistics, Paris, France.
BMJ. 2020 May 14;369:m1844. doi: 10.1136/bmj.m1844.
To assess the effectiveness of hydroxychloroquine in patients admitted to hospital with coronavirus disease 2019 (covid-19) pneumonia who require oxygen.
Comparative observational study using data collected from routine care.
Four French tertiary care centres providing care to patients with covid-19 pneumonia between 12 March and 31 March 2020.
181 patients aged 18-80 years with documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia who required oxygen but not intensive care.
Hydroxychloroquine at a dose of 600 mg/day within 48 hours of admission to hospital (treatment group) versus standard care without hydroxychloroquine (control group).
The primary outcome was survival without transfer to the intensive care unit at day 21. Secondary outcomes were overall survival, survival without acute respiratory distress syndrome, weaning from oxygen, and discharge from hospital to home or rehabilitation (all at day 21). Analyses were adjusted for confounding factors by inverse probability of treatment weighting.
In the main analysis, 84 patients who received hydroxychloroquine within 48 hours of admission to hospital (treatment group) were compared with 89 patients who did not receive hydroxychloroquine (control group). Eight additional patients received hydroxychloroquine more than 48 hours after admission. In the weighted analyses, the survival rate without transfer to the intensive care unit at day 21 was 76% in the treatment group and 75% in the control group (weighted hazard ratio 0.9, 95% confidence interval 0.4 to 2.1). Overall survival at day 21 was 89% in the treatment group and 91% in the control group (1.2, 0.4 to 3.3). Survival without acute respiratory distress syndrome at day 21 was 69% in the treatment group compared with 74% in the control group (1.3, 0.7 to 2.6). At day 21, 82% of patients in the treatment group had been weaned from oxygen compared with 76% in the control group (weighted risk ratio 1.1, 95% confidence interval 0.9 to 1.3). Eight patients in the treatment group (10%) experienced electrocardiographic modifications that required discontinuation of treatment.
Hydroxychloroquine has received worldwide attention as a potential treatment for covid-19 because of positive results from small studies. However, the results of this study do not support its use in patients admitted to hospital with covid-19 who require oxygen.
评估羟氯喹在因 2019 年冠状病毒病（COVID-19）肺炎而需要吸氧的住院患者中的疗效。
使用常规护理中收集的数据进行的比较观察性研究。
2020 年 3 月 12 日至 31 日期间，法国四家三级保健中心为 COVID-19 肺炎患者提供护理。
181 名年龄在 18 至 80 岁之间的患者，有记录的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）肺炎，需要吸氧但不需要重症监护。
入院后 48 小时内给予羟氯喹 600mg/天（治疗组）或不给予羟氯喹的标准治疗（对照组）。
主要结局为第 21 天无转入重症监护室的生存情况。次要结局为总生存率、无急性呼吸窘迫综合征生存率、氧撤离和出院回家或康复（均为第 21 天）。通过逆概率治疗加权法对混杂因素进行调整分析。
在主要分析中，84 名在入院后 48 小时内接受羟氯喹治疗的患者（治疗组）与 89 名未接受羟氯喹治疗的患者（对照组）进行比较。另有 8 名患者在入院后超过 48 小时接受羟氯喹治疗。在加权分析中，治疗组第 21 天无转入重症监护室的生存率为 76%，对照组为 75%（加权风险比 0.9，95%置信区间 0.4 至 2.1）。治疗组第 21 天的总生存率为 89%，对照组为 91%（1.2，0.4 至 3.3）。治疗组第 21 天无急性呼吸窘迫综合征生存率为 69%，对照组为 74%（1.3，0.7 至 2.6）。第 21 天，治疗组 82%的患者已停止吸氧，而对照组为 76%（加权风险比 1.1，95%置信区间 0.9 至 1.3）。治疗组有 8 名（10%）患者出现需要停止治疗的心电图改变。
由于小型研究的阳性结果，羟氯喹作为 COVID-19 的潜在治疗方法受到了全球关注。然而，本研究结果不支持在需要吸氧的 COVID-19 住院患者中使用羟氯喹。
