Lancet Respir Med:秋水仙碱对COVID-19患者预后的影响

2021-11-11 小文子 MedSci原创

秋水仙碱并不能降低COVID-19住院成人患者28天死亡率。

秋水仙碱具有抗炎作用,已被提议作为COVID-19的治疗药物。Lancet Respir Med的一项研究评估了秋水仙碱对COVID-19住院患者的疗效和安全性。

在英国177家医院、印度尼西亚两家医院和尼泊尔两家医院进行随机对照研究,对COVID-19住院患者的几种可能治疗方法与常规治疗进行比较。纳入临床疑似或确诊的新冠肺炎患者且无参与试验面临重大风险的病史。采用基于网络的简单随机化方法,将符合标准的患者随机分组(1:1)接受单独常规治疗(常规治疗组)或常规治疗加秋水仙碱(秋水仙碱组)。随机分组后,患者服用1mg秋水仙碱,12小时后服用500µg,然后口服或鼻胃管服用500µg,每日两次,共10天或直到出院。对于服用中效CYP3A4抑制剂(如地尔硫卓)的患者,估计肾小球滤过率低于30ml/min/1.73m²的患者以及估计体重低于70kg的患者,剂量频率减半。主要终点为28天死亡率,次要终点包括出院时间、28天内出院患者比例,以及在无创机械通气的患者中,有创机械通气或死亡的复合终点。

2020年11月27日至2021年3月4日期间,纳入康复试验的19423例入组RECOVERY研究的患者,11340例(58%)符合接受秋水仙碱治疗的条件。5610例(49%)患者随机分配到秋水仙碱组,5730名(51%)患者分配到常规治疗组。秋水仙碱组1173例(21%)患者和常规治疗组1190例(21%)患者在28天内死亡(RR=1.01; 95%CI, 0.93~1.10; p=0.77)。在所有亚组患者中均观察到一致的结果。两组患者中位出院存活时间(10天; IQR, 5 ~ >28])相同,28天内出院存活患者比例无差异(秋水仙碱组3901例[70%], 常规治疗组4032例[70%]; RR=0.98; 95%CI, 0.94~1.03; p=0.44)。在基线时未接受有创机械通气的患者中,有创机械通气或死亡复合终点的比例无差异(秋水仙碱组1344例[25%], 常规治疗组1343例[25%]; RR=1.02, 95%CI, 0.96~1.09; p=0.47)。

结果表明,秋水仙碱并不能降低COVID-19住院成人患者28天死亡率、住院时间或有创机械通气或死亡的风险。

原文出处:

Horby P W , Campbell M , Spata E , et al. Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. 2021, https://doi.org/10.1016/S2213-2600(21)00435-5.

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