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[RECOVERY研究预发表]:羟氯喹治疗新冠病毒感染住院患者
2020年07月22日 时讯速递, 进展交流 暂无评论

Effect of Hydroxychloroquine in Hospitalized Patients with COVID-19: Preliminary results from a multi-centre, randomized, controlled trial

ABSTRACT

Background 背景

Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (COVID-19) on the basis of in vitro activity, uncontrolled data, and small randomized studies.

根据体外活性,非对照研究数据以及小样本随机试验,羟氯喹和氯喹被用于治疗新冠病毒感染(COVID-19)。

Methods 方法

The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized, controlled, open-label, platform trial comparing a range of possible treatments with usual care in patients hospitalized with COVID-19. We report the preliminary results for the comparison of hydroxychloroquine vs. usual care alone. The primary outcome was 28-day mortality.

RECOVERY试验是一项随机、对照、开放标签、平台试验,比较数种治疗与常规治疗对于COVID-19住院患者的疗效。我们报告羟氯喹与常规治疗进行比较的初步结果。主要预后终点为28天病死率。

Results 结果

1561 patients randomly allocated to receive hydroxychloroquine were compared with 3155 patients concurrently allocated to usual care. Overall, 418 (26.8%) patients allocated hydroxychloroquine and 788 (25.0%) patients allocated usual care died within 28 days (rate ratio 1.09; 95% confidence interval [CI] 0.96 to 1.23; P=0.18). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to hydroxychloroquine were less likely to be discharged from hospital alive within 28 days (60.3% vs. 62.8%; rate ratio 0.92; 95% CI 0.85-0.99) and those not on invasive mechanical ventilation at baseline were more likely to reach the composite endpoint of invasive mechanical ventilation or death (29.8% vs. 26.5%; risk ratio 1.12; 95% CI 1.01-1.25). There was no excess of new major cardiac arrhythmia.

1561名患者被随机分至羟氯喹组,3155名患者被随机分至常规治疗组。总体上看,羟氯喹组中418名(26.8%)患者与常规治疗组中788名 (25.0%) 患者在28天内死亡(比值比1.09; 95% 可信区间 [CI] 0.96 to 1.23; P=0.18)。所有预先确定饿亚组均得到一致结果。羟氯喹组患者28天内存活出院比例更低 (60.3% vs. 62.8%; 比值比 0.92; 95% CI 0.85-0.99),且基线时未接受有创通气者更多达到符合终点(有创通气或死亡)(29.8% vs. 26.5%; 风险比 1.12; 95% CI 1.01-1.25)。羟氯喹治疗组新发严重心律失常风险并不增加。

Conclusions 结论

In patients hospitalized with COVID-19, hydroxychloroquine was not associated with reductions in 28-day mortality but was associated with an increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation or death.

对于COVID-19住院患者,羟氯喹治疗并不伴随28天病死率降低,但住院日延长,且病情恶化需要有创机械通气或死亡的风险增加。

Funding 资助

Medical Research Council and NIHR (Grant ref: MC_PC_19056).

Trial registrations 试验注册

The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).

[评论]

其实对这个研究结果没有太多感想。毕竟,体外研究的结果终究不能代替临床试验,这一点我们早就知道了。

但是,为什么面对COVID-19,我们偏偏就忘记了这个早已熟知的真理呢?

对于尚缺乏有效抗病毒药物的COVID-19(至少在武汉时),等待或者说对症支持治疗其实也是治疗。这一点,我们究竟在心里能否认同?为什么要把自己知道的和不知道的、有证据的和没有证据的,可能有效的和肯定无效的都用在临床上呢?

恐怕很多人这时候忘记了:First, Do No Harm!

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