From the Divisions of General Medicine, Infectious Diseases, and Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (J.G., J.Z., M.B., A.L., D.K.M., C.K., R.G.B., M.E.S., N.W.S.), the Departments of Biostatistics (Y.S.) and Epidemiology (J.P., R.G.B., N.W.S.), Mailman School of Public Health, and the Department of Biomedical Informatics (G.H.), Vagelos College of Physicians and Surgeons, Columbia University, and New York-Presbyterian Hospital-Columbia University Irving Medical Center (J.G., J.Z., M.B., A.L., D.K.M., C.K.,R.G.B., M.E.S., N.W.S.) - all in New York.
N Engl J Med. 2020 Jun 18;382(25):2411-2418. doi: 10.1056/NEJMoa2012410. Epub 2020 May 7.
Hydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use.
We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City. Data were obtained regarding consecutive patients hospitalized with Covid-19, excluding those who were intubated, died, or discharged within 24 hours after presentation to the emergency department (study baseline). The primary end point was a composite of intubation or death in a time-to-event analysis. We compared outcomes in patients who received hydroxychloroquine with those in patients who did not, using a multivariable Cox model with inverse probability weighting according to the propensity score.
Of 1446 consecutive patients, 70 patients were intubated, died, or discharged within 24 hours after presentation and were excluded from the analysis. Of the remaining 1376 patients, during a median follow-up of 22.5 days, 811 (58.9%) received hydroxychloroquine (600 mg twice on day 1, then 400 mg daily for a median of 5 days); 45.8% of the patients were treated within 24 hours after presentation to the emergency department, and 85.9% within 48 hours. Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloroquine (median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen, 223 vs. 360). Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32). Results were similar in multiple sensitivity analyses.
In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed. (Funded by the National Institutes of Health.).
羟氯喹在没有强有力的证据支持其使用的情况下，被广泛用于治疗新冠肺炎患者。
我们在纽约市的一家大型医疗中心研究了羟氯喹的使用与插管或死亡之间的关联。研究数据来源于连续收治的新冠肺炎住院患者，但不包括在急诊科就诊 24 小时内插管、死亡或出院的患者（研究基线）。主要终点是时间事件分析中的插管或死亡复合终点。我们通过多变量 Cox 模型，根据倾向评分进行逆概率加权，比较了接受羟氯喹治疗的患者与未接受羟氯喹治疗的患者的结局。
在 1446 例连续患者中，70 例在急诊科就诊 24 小时内插管、死亡或出院，被排除在分析之外。在其余 1376 例患者中，中位随访 22.5 天期间，811 例（58.9%）接受了羟氯喹治疗（第 1 天给予 600mg 羟氯喹，2 次，然后每日给予 400mg，中位治疗时间为 5 天）；45.8%的患者在急诊科就诊后 24 小时内接受治疗，85.9%在 48 小时内接受治疗。与未接受羟氯喹治疗的患者相比，接受羟氯喹治疗的患者基线时病情更严重（动脉血氧分压与吸入氧分数的比值中位数，223 比 360）。总体而言，346 例患者（25.1%）发生了主要终点事件（180 例患者需要插管，其中 66 例随后死亡，166 例无插管死亡）。在主要分析中，羟氯喹的使用与插管或死亡之间无显著关联（风险比为 1.04，95%置信区间为 0.82 至 1.32）。在多次敏感性分析中，结果相似。
在这项纳入已住院的新冠肺炎患者的观察性研究中，羟氯喹的使用与插管或死亡的复合终点降低或增加风险均无关联。需要进行羟氯喹治疗新冠肺炎患者的随机对照试验。（由美国国立卫生研究院资助）。
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