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Clinical efficacy of hydroxychloroquine in patients with covid-19 pneumonia who require oxygen: observational comparative study using routine care data.
The BMJ ( IF 93.6 ) Pub Date : 2020-05-14 , DOI: 10.1136/bmj.m1844
Matthieu Mahévas 1 , Viet-Thi Tran 2 , Mathilde Roumier 3 , Amélie Chabrol 4 , Romain Paule 3 , Constance Guillaud 5 , Elena Fois 5 , Raphael Lepeule 6 , Tali-Anne Szwebel 7 , François-Xavier Lescure 8 , Frédéric Schlemmer 9 , Marie Matignon 10 , Mehdi Khellaf 5 , Etienne Crickx 5 , Benjamin Terrier 7 , Caroline Morbieu 7 , Paul Legendre 7 , Julien Dang 2 , Yoland Schoindre 3 , Jean-Michel Pawlotsky 11 , Marc Michel 5 , Elodie Perrodeau 2 , Nicolas Carlier 12 , Nicolas Roche 12 , Victoire de Lastours 13 , Clément Ourghanlian 14 , Solen Kerneis 15 , Philippe Ménager 16 , Luc Mouthon 7 , Etienne Audureau 17 , Philippe Ravaud 2 , Bertrand Godeau 5 , Sébastien Gallien 18 , Nathalie Costedoat-Chalumeau 2, 7
Affiliation  

OBJECTIVE To assess the effectiveness of hydroxychloroquine in patients admitted to hospital with coronavirus disease 2019 (covid-19) pneumonia who require oxygen. DESIGN Comparative observational study using data collected from routine care. SETTING Four French tertiary care centres providing care to patients with covid-19 pneumonia between 12 March and 31 March 2020. PARTICIPANTS 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. INTERVENTIONS Hydroxychloroquine at a dose of 600 mg/day within 48 hours of admission to hospital (treatment group) versus standard care without hydroxychloroquine (control group). MAIN OUTCOME MEASURES 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. RESULTS 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. CONCLUSIONS 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.

中文翻译:

羟氯喹对需要吸氧的 covid-19 肺炎患者的临床疗效:使用常规护理数据的观察性比较研究。

目的 评估羟氯喹对因 2019 年冠状病毒病 (covid-19) 肺炎住院且需要吸氧的患者的有效性。设计使用从常规护理中收集的数据进行比较观察研究。地点 2020 年 3 月 12 日至 3 月 31 日期间,法国四家三级护理中心为 covid-19 肺炎患者提供护理。 参与者 181 名年龄在 18-80 岁之间、患有严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 肺炎且需要吸氧的患者但不是重症监护。干预措施 入院 48 小时内每天服用 600 毫克羟氯喹(治疗组)与不使用羟氯喹的标准治疗(对照组)。主要结局指标 主要结局是第 21 天时未转入重症监护室的生存率。次要结局是总生存率、无急性呼吸窘迫综合征的生存率、戒断吸氧、出院回家或康复(均在第 21 天) 。通过治疗加权的逆概率来调整混杂因素的分析。结果 在主要分析中,84 名入院 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)进行了比较。另外 8 名患者在入院 48 小时以上后接受了羟氯喹治疗。在加权分析中,治疗组第 21 天未转入重症监护室的生存率为 76%,对照组为 75%(加权风险比为 0.9,95% 置信区间为 0.4 至 2.1)。第 21 天时,治疗组的总生存率为 89%,对照组为 91%(1.2、0.4 至 3.3)。第 21 天时,治疗组无急性呼吸窘迫综合征的生存率为 69%,而对照组为 74%(1.3、0.7 至 2.6)。第 21 天时,治疗组 82% 的患者已脱离氧气,而对照组这一比例为 76%(加权风险比 1.1,95% 置信区间 0.9 至 1.3)。治疗组中有 8 名患者 (10%) 出现心电图改变,需要停止治疗。结论 由于小型研究的积极结果,羟氯喹作为 covid-19 的潜在治疗方法受到了全世界的关注。然而,这项研究的结果并不支持其用于因 covid-19 入院且需要吸氧的患者。
更新日期:2020-05-14
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