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Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2020-05-07 , DOI: 10.1056/nejmoa2012410
Joshua Geleris 1 , Yifei Sun 1 , Jonathan Platt 1 , Jason Zucker 1 , Matthew Baldwin 1 , George Hripcsak 1 , Angelena Labella 1 , Daniel K Manson 1 , Christine Kubin 1 , R Graham Barr 1 , Magdalena E Sobieszczyk 1 , Neil W Schluger 1
Affiliation  

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.).

中文翻译:

羟氯喹治疗 Covid-19 住院患者的观察性研究。

背景 羟氯喹已被广泛用于 Covid-19 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联。数据获得了连续住院的 Covid-19 患者的数据,不包括那些在急诊科就诊后 24 小时内插管、死亡或出院的患者(研究基线)。主要终点是事件时间分析中插管或死亡的复合终点。我们使用多变量 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果。结果 在 1446 名连续患者中,70 名患者在就诊后 24 小时内插管、死亡或出院,并被排除在分析之外。其余 1376 名患者中,在中位随访 22.5 天期间,811 名患者(58.9%)接受了羟氯喹治疗(第 1 天两次 600 毫克,然后每天 400 毫克,中位 5 天);45.8% 的患者在送往急诊室后 24 小时内得到治疗,85.9% 的患者在 48 小时内得到治疗。接受羟氯喹治疗的患者在基线时比未接受羟氯喹的患者病情更严重(动脉氧分压与吸入氧分数的中位比,223 vs. 360)。总体而言,346 名患者 (25.1%) 出现主要终点事件(180 名患者接受插管,其中 66 名患者随后死亡,166 名患者未插管死亡)。在主要分析中,羟氯喹的使用与插管或死亡之间没有显着关联(风险比为 1.04,95% 置信区间为 0.82 至 1.32)。多项敏感性分析的结果相似。结论 在这项涉及已入院的 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风险的大幅降低或增加无关。需要对 Covid-19 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)。
更新日期:2020-05-07
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