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重症和危及生命的COVID-19患者康复期血治疗对临床改善的影响:随机临床试验
Ling Li1,2, Wei Zhang3,4, Yu Hu5
1Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.
JAMA
|June 4, 2020
概括
在随机试验中,康复性血治疗COVID-19并没有显著改善临床结果. 早期终止试验限制了检测差异的能力,但血组的病毒清除速度更快.
科学领域:
- 传染性疾病
- 免疫学
- 临床试验
背景情况:
- 康复性血 (CP) 是2019年冠状病毒疾病 (COVID-19) 的潜在治疗方法.
- 随机临床试验是确定CP对COVID-19的有效性和安全性的必要条件.
- 这项研究旨在评估严重或危及生命的COVID-19病例中的CP.
研究的目的:
- 评估重症或危及生命的COVID-19患者康复期血治疗的有效性和安全性.
- 为了确定康复期血是否能在28天内改善临床结果,与单独的标准治疗相比.
主要方法:
- 一个开放的,多中心的,随机的临床试验与103名参与者进行.
- 患者接受了康复期血加标准治疗或单独接受标准治疗.
- 主要结局是28天内临床改善的时间;次要结局包括死亡率和病毒清除.
主要成果:
- 在两组之间没有观察到28天内临床改善的统计学意义上的差异 (51. 9% vs 43. 1%).
- 然而,接受康复期血的患者在72小时内呈现显著更高的病毒聚合酶链反应 (PCR) 阴性率 (87.2%对37.5%).
- 这些不良事件是最小的,并且可以通过支持性治疗来控制.
结论:
- 康复性血治疗,当添加到标准治疗时,并没有显著改善严重或危及生命的COVID-19的临床改善时间.
- 试验的提前结束可能限制了其检测临床显著差异的能力.
- 较快的病毒清除表明潜在的益处,需要在充足的试验中进行进一步的研究.
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