Nat Commun:曾经“炙手可热”的氯喹到底会如何影响新冠患者死亡率?

2021-04-18 haibei MedSci原创

该研究表明,在新冠患者中,使用羟氯喹治疗与死亡率增加相关,而氯喹没有表现出益处。

已知新冠病毒的感染有可能造成患者的呼吸衰竭和死亡。截至2020年12月,全球已有超过150万新冠患者死亡,并且目前针对新冠的治疗方案有限。COVID-19大流行引起了对可能疗法的前所未有的搜索,2020年第一季度启动了近700项临床试验--其中五分之一的试验目标是羟氯喹(HCQ)或氯喹(CQ)。这主要是由于其具有良好的体外数据,免疫调节能力,以及口服配方和记录良好的安全配置文件。

2020年3月,美国食品和药物管理局(FDA)发布了HCQ的紧急使用授权,临床研究之外的处方和使用数量急剧上升。在许多国家,HCQ或CQ也被列入COVID-19的治疗指南中(包括中国、爱尔兰和美国等)。

最近,研究人员进行了一项探究,旨在从目前所有已发表和未发表的随机临床试验(RCT)证据中估计羟氯喹和氯喹对新冠患者生存的影响。研究人员旨在提出一个在正在进行的,已完成的,或停止的RCTs中,对羟氯喹或氯喹治疗任何新冠患者的快速荟萃分析(协议:https://osf.io/QESV4/)。

在这项研究中,研究人员系统地识别了未发表的RCTs(ClinicalTrials.gov,WHO国际临床试验注册平台,Cochrane COVID-registry,截至2020年6月11日),以及已发表的RCTs(PubMed,medRxiv和bioRxiv,截至2020年10月16日)。

纳入随机临床试验的流程图

全因死亡率被提取(出版物/预印本)或向研究者索取,并结合随机效应荟萃分析,分别计算针对羟氯喹和氯喹的具有95%置信区间(CIs)的优势比(ORs)。

预先指定的亚组分析包括患者设置、诊断确认、对照类型和发表状态。有63项试验可能符合条件。研究人员纳入了14项未发表的试验(1308名患者)和14项出版物/预印本的试验(9011名患者)。羟氯喹的结果以RECOVERY和WHO SOLIDARITY为主,这两项高度务实的试验采用了相对较高的剂量,分别纳入了4716名和1853名患者(占总样本量的67%)。羟氯喹对全因死亡率的综合OR为1.11(95%CI:1.02,1.20;I²=0%;26项试验;1012名患者),氯喹为1.77(95%CI:0.15,21.13,I²=0%;4项试验;307名患者)。此外,研究人员没有发现亚组效应

总之,该研究表明,在新冠患者中,使用羟氯喹治疗与死亡率增加相关,而氯喹没有表现出益处。研究结果对门诊患者、儿童、孕妇和有并发症患者的普适性不明确。

 

原始出处:

Cathrine Axfors et al. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nature Communications (2021). 

 

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    2021-11-28 liye789132251
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    2021-04-18 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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