Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19
Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19
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DOI：
10.1056/nejmoa2012410
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发表时间：
2020-06-18
影响因子：
158.5
通讯作者：
Schluger, Neil W.
中科院分区：
文献类型：
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作者：
Geleris, Joshua;Sun, Yifei;Schluger, Neil W.
背景羟氯喹已被广泛用于新型冠状病毒肺炎患者，但没有强有力的证据支持其使用。方法我们在纽约市的一家大型医疗中心检查了羟氯喹的使用与插管或死亡之间的关系。获得了关于因Covid-19住院的连续患者的数据，不包括在急诊科就诊后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-事件分析中插管或死亡的复合终点。我们使用多变量考克斯模型，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。结果在1446例连续患者中，70例患者在就诊后24小时内插管、死亡或出院，并从分析中排除。在其余1376例患者中，在中位随访22.5天期间，811例（58.9%）接受羟氯喹（第1天600 mg两次，然后每天400 mg，中位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。基线时，接受羟氯喹治疗的患者比未接受羟氯喹治疗的患者病情更严重（动脉氧分压与吸入氧分数的中位比值，223 vs. 360）。总体而言，346例患者（25.1%）发生了主要终点事件（180例患者插管，其中66例随后死亡，166例未插管死亡）。在主要分析中，羟氯喹使用与插管或死亡之间没有显著相关性（风险比，1.04，95%置信区间，0.82 - 1.32）。多项敏感性分析的结果相似。结论在这项涉及已住院的COVID-19患者的观察性研究中，羟氯喹给药与插管或死亡复合终点的风险大幅降低或增加无关。需要对新型冠状病毒肺炎患者进行羟氯喹的随机对照试验。（由美国国立卫生研究院资助。在纽约市一家医院收治的1376名新冠肺炎患者中，59%接受了羟氯喹治疗。选择接受治疗的患者病情更为严重。校正患者基线特征后，羟氯喹使用与插管或死亡之间无显著相关性（风险比，1.04; 95%CI，0.82 - 1.32）。
Background Hydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use. Methods 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. Results 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. Conclusions 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.)Among 1376 patients with Covid-19 admitted to a New York City hospital, 59% were treated with hydroxychloroquine. Patients selected for treatment were more severely ill. After adjustment for patients' baseline characteristics, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04; 95% CI, 0.82 to 1.32).